Leping

Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 EUROPEAN HEALTH AND DIGITAL EXECUTIVE AGENCY (HADEA) Director GRANT AGREEMENT Project 101129187 — EST-2-MyHealth PREAMBLE This Agreement (‘the Agreement’) is between the following parties: on the one part, the European Health and Digital Executive Agency (HADEA) (‘EU executive agency’ or ‘granting authority’), under the powers delegated by the European Commission (‘European Commission’), and on the other part, 1. ‘the coordinator’: SOTSIAALMINISTEERIUM (MSAE), PIC 998429731, established in Suur-Ameerika 1, TALLINN 10122, Estonia, Unless otherwise specified, references to ‘beneficiary’ or ‘beneficiaries’ include the coordinator and affiliated entities (if any). If only one beneficiary signs the grant agreement (‘mono-beneficiary grant’), all provisions referring to the ‘coordinator’ or the ‘beneficiaries’ will be considered — mutatis mutandis — as referring to the beneficiary. The parties referred to above have agreed to enter into the Agreement. By signing the Agreement and the accession forms, the beneficiaries accept the grant and agree to implement the action under their own responsibility and in accordance with the Agreement, with all the obligations and terms and conditions it sets out. The Agreement is composed of: Preamble Terms and Conditions (including Data Sheet) 1 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Annex 1 Description of the action1 Annex 2 Estimated budget for the action Annex 2a Additional information on unit costs and contributions (if applicable) Annex 3 Accession forms (if applicable)2 Annex 3a Declaration on joint and several liability of affiliated entities (if applicable)3 Annex 4 Model for the financial statements Annex 5 Specific rules (if applicable) 1 Template published on Portal Reference Documents. 2 Template published on Portal Reference Documents. 3 Template published on Portal Reference Documents. 2 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 TERMS AND CONDITIONS TABLE OF CONTENTS GRANT AGREEMENT.................................................................................................................................................... 1 PREAMBLE........................................................................................................................................................................1 TERMS AND CONDITIONS...........................................................................................................................................3 DATASHEET...................................................................................................................................................................... 8 CHAPTER 1 GENERAL..............................................................................................................................................12 ARTICLE 1 — SUBJECT OF THE AGREEMENT ..................................................................................... 12 ARTICLE 2 — DEFINITIONS........................................................................................................................12 CHAPTER 2 ACTION................................................................................................................................................. 13 ARTICLE 3 — ACTION................................................................................................................................. 13 ARTICLE 4 — DURATION AND STARTING DATE...................................................................................13 CHAPTER 3 GRANT...................................................................................................................................................13 ARTICLE 5 — GRANT...................................................................................................................................13 5.1 Form of grant......................................................................................................................................13 5.2 Maximum grant amount..................................................................................................................... 14 5.3 Funding rate........................................................................................................................................14 5.4 Estimated budget, budget categories and forms of funding.............................................................. 14 5.5 Budget flexibility................................................................................................................................14 ARTICLE 6 — ELIGIBLE AND INELIGIBLE COSTS AND CONTRIBUTIONS......................................15 6.1 General eligibility conditions............................................................................................................. 15 6.2 Specific eligibility conditions for each budget category................................................................... 16 6.3 Ineligible costs and contributions...................................................................................................... 20 6.4 Consequences of non-compliance...................................................................................................... 21 CHAPTER 4 GRANT IMPLEMENTATION............................................................................................................ 21 SECTION 1 CONSORTIUM: BENEFICIARIES, AFFILIATED ENTITIES AND OTHER PARTICIPANTS........................................................................................................................................ 21 ARTICLE 7 — BENEFICIARIES................................................................................................................... 21 ARTICLE 8 — AFFILIATED ENTITIES....................................................................................................... 23 ARTICLE 9 — OTHER PARTICIPANTS INVOLVED IN THE ACTION................................................... 24 9.1 Associated partners.............................................................................................................................24 9.2 Third parties giving in-kind contributions to the action.................................................................... 24 9.3 Subcontractors.....................................................................................................................................24 3 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 9.4 Recipients of financial support to third parties..................................................................................25 ARTICLE 10 — PARTICIPANTS WITH SPECIAL STATUS....................................................................... 25 10.1 Non-EU participants......................................................................................................................... 25 10.2 Participants which are international organisations...........................................................................25 10.3 Pillar-assessed participants............................................................................................................... 26 SECTION 2 RULES FOR CARRYING OUT THE ACTION...........................................................................28 ARTICLE 11 — PROPER IMPLEMENTATION OF THE ACTION............................................................ 28 11.1 Obligation to properly implement the action................................................................................... 28 11.2 Consequences of non-compliance.................................................................................................... 28 ARTICLE 12 — CONFLICT OF INTERESTS.............................................................................................. 28 12.1 Conflict of interests.......................................................................................................................... 28 12.2 Consequences of non-compliance.................................................................................................... 29 ARTICLE 13 — CONFIDENTIALITY AND SECURITY............................................................................ 29 13.1 Sensitive information........................................................................................................................29 13.2 Classified information...................................................................................................................... 29 13.3 Consequences of non-compliance.................................................................................................... 30 ARTICLE 14 — ETHICS AND VALUES...................................................................................................... 30 14.1 Ethics.................................................................................................................................................30 14.2 Values................................................................................................................................................ 30 14.3 Consequences of non-compliance.................................................................................................... 30 ARTICLE 15 — DATA PROTECTION.......................................................................................................... 30 15.1 Data processing by the granting authority....................................................................................... 30 15.2 Data processing by the beneficiaries............................................................................................... 31 15.3 Consequences of non-compliance.................................................................................................... 31 ARTICLE 16 — INTELLECTUAL PROPERTY RIGHTS (IPR) — BACKGROUND AND RESULTS — ACCESS RIGHTS AND RIGHTS OF USE................................................................................ 31 16.1 Background and access rights to background..................................................................................32 16.2 Ownership of results.........................................................................................................................32 16.3 Rights of use of the granting authority on materials, documents and information received for policy, information, communication, dissemination and publicity purposes...................................32 16.4 Specific rules on IPR, results and background................................................................................ 33 16.5 Consequences of non-compliance.................................................................................................... 33 ARTICLE 17 — COMMUNICATION, DISSEMINATION AND VISIBILITY............................................ 33 17.1 Communication — Dissemination — Promoting the action........................................................... 33 17.2 Visibility — European flag and funding statement......................................................................... 33 17.3 Quality of information — Disclaimer..............................................................................................34 4 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 17.4 Specific communication, dissemination and visibility rules............................................................34 17.5 Consequences of non-compliance.................................................................................................... 35 ARTICLE 18 — SPECIFIC RULES FOR CARRYING OUT THE ACTION............................................... 35 18.1 Specific rules for carrying out the action........................................................................................ 35 18.2 Consequences of non-compliance.................................................................................................... 35 SECTION 3 GRANT ADMINISTRATION......................................................................................................... 35 ARTICLE 19 — GENERAL INFORMATION OBLIGATIONS.................................................................... 35 19.1 Information requests......................................................................................................................... 35 19.2 Participant Register data updates..................................................................................................... 35 19.3 Information about events and circumstances which impact the action............................................35 19.4 Consequences of non-compliance.................................................................................................... 36 ARTICLE 20 — RECORD-KEEPING............................................................................................................ 36 20.1 Keeping records and supporting documents.................................................................................... 36 20.2 Consequences of non-compliance.................................................................................................... 37 ARTICLE 21 — REPORTING........................................................................................................................ 37 21.1 Continuous reporting........................................................................................................................ 37 21.2 Periodic reporting: Technical reports and financial statements....................................................... 37 21.3 Currency for financial statements and conversion into euros..........................................................38 21.4 Reporting language...........................................................................................................................39 21.5 Consequences of non-compliance.................................................................................................... 39 ARTICLE 22 — PAYMENTS AND RECOVERIES — CALCULATION OF AMOUNTS DUE................. 39 22.1 Payments and payment arrangements.............................................................................................. 39 22.2 Recoveries.........................................................................................................................................39 22.3 Amounts due.....................................................................................................................................40 22.4 Enforced recovery.............................................................................................................................44 22.5 Consequences of non-compliance.................................................................................................... 45 ARTICLE 23 — GUARANTEES....................................................................................................................46 23.1 Prefinancing guarantee..................................................................................................................... 46 23.2 Consequences of non-compliance.................................................................................................... 46 ARTICLE 24 — CERTIFICATES................................................................................................................... 46 24.1 Operational verification report (OVR).............................................................................................46 24.2 Certificate on the financial statements (CFS).................................................................................. 46 24.3 Certificate on the compliance of usual cost accounting practices (CoMUC).................................. 47 24.4 Systems and process audit (SPA).....................................................................................................47 24.5 Consequences of non-compliance.................................................................................................... 47 5 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 ARTICLE 25 — CHECKS, REVIEWS, AUDITS AND INVESTIGATIONS — EXTENSION OF FINDINGS..................................................................................................................................... 47 25.1 Granting authority checks, reviews and audits................................................................................ 47 25.2 European Commission checks, reviews and audits in grants of other granting authorities..............49 25.3 Access to records for assessing simplified forms of funding.......................................................... 49 25.4 OLAF, EPPO and ECA audits and investigations........................................................................... 49 25.5 Consequences of checks, reviews, audits and investigations — Extension of results of reviews, audits or investigations.................................................................................................................... 50 25.6 Consequences of non-compliance.................................................................................................... 51 ARTICLE 26 — IMPACT EVALUATIONS................................................................................................... 51 26.1 Impact evaluation............................................................................................................................. 51 26.2 Consequences of non-compliance.................................................................................................... 51 CHAPTER 5 CONSEQUENCES OF NON-COMPLIANCE.................................................................................. 51 SECTION 1 REJECTIONS AND GRANT REDUCTION.................................................................................52 ARTICLE 27 — REJECTION OF COSTS AND CONTRIBUTIONS...........................................................52 27.1 Conditions......................................................................................................................................... 52 27.2 Procedure.......................................................................................................................................... 52 27.3 Effects............................................................................................................................................... 52 ARTICLE 28 — GRANT REDUCTION........................................................................................................ 52 28.1 Conditions......................................................................................................................................... 52 28.2 Procedure.......................................................................................................................................... 53 28.3 Effects............................................................................................................................................... 53 SECTION 2 SUSPENSION AND TERMINATION............................................................................................53 ARTICLE 29 — PAYMENT DEADLINE SUSPENSION............................................................................. 53 29.1 Conditions......................................................................................................................................... 53 29.2 Procedure.......................................................................................................................................... 53 ARTICLE 30 — PAYMENT SUSPENSION...................................................................................................54 30.1 Conditions......................................................................................................................................... 54 30.2 Procedure.......................................................................................................................................... 54 ARTICLE 31 — GRANT AGREEMENT SUSPENSION..............................................................................55 31.1 Consortium-requested GA suspension............................................................................................. 55 31.2 EU-initiated GA suspension.............................................................................................................55 ARTICLE 32 — GRANT AGREEMENT OR BENEFICIARY TERMINATION......................................... 56 32.1 Consortium-requested GA termination............................................................................................ 56 32.2 Consortium-requested beneficiary termination................................................................................ 57 32.3 EU-initiated GA or beneficiary termination.................................................................................... 59 6 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 SECTION 3 OTHER CONSEQUENCES: DAMAGES AND ADMINISTRATIVE SANCTIONS............... 62 ARTICLE 33 — DAMAGES...........................................................................................................................62 33.1 Liability of the granting authority....................................................................................................62 33.2 Liability of the beneficiaries............................................................................................................ 62 ARTICLE 34 — ADMINISTRATIVE SANCTIONS AND OTHER MEASURES....................................... 62 SECTION 4 FORCE MAJEURE.......................................................................................................................... 63 ARTICLE 35 — FORCE MAJEURE.............................................................................................................. 63 CHAPTER 6 FINAL PROVISIONS...........................................................................................................................63 ARTICLE 36 — COMMUNICATION BETWEEN THE PARTIES...............................................................63 36.1 Forms and means of communication — Electronic management................................................... 63 36.2 Date of communication.................................................................................................................... 63 36.3 Addresses for communication.......................................................................................................... 64 ARTICLE 37 — INTERPRETATION OF THE AGREEMENT.....................................................................64 ARTICLE 38 — CALCULATION OF PERIODS AND DEADLINES..........................................................64 ARTICLE 39 — AMENDMENTS.................................................................................................................. 64 39.1 Conditions......................................................................................................................................... 64 39.2 Procedure.......................................................................................................................................... 65 ARTICLE 40 — ACCESSION AND ADDITION OF NEW BENEFICIARIES........................................... 65 40.1 Accession of the beneficiaries mentioned in the Preamble............................................................. 65 40.2 Addition of new beneficiaries.......................................................................................................... 65 ARTICLE 41 — TRANSFER OF THE AGREEMENT................................................................................. 66 ARTICLE 42 — ASSIGNMENTS OF CLAIMS FOR PAYMENT AGAINST THE GRANTING AUTHORITY.................................................................................................................................66 ARTICLE 43 — APPLICABLE LAW AND SETTLEMENT OF DISPUTES.............................................. 66 43.1 Applicable law..................................................................................................................................66 43.2 Dispute settlement............................................................................................................................ 66 ARTICLE 44 — ENTRY INTO FORCE.........................................................................................................67 7 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 DATA SHEET 1. General data Project summary: Project summary The objective of this project will be to: - ensure stable operations of the deployed MyHealth@EU services, more especially the Patient Summary service by bringing it to a new platform, which will enable a more reliable service and create better opportunities for any updates in the future; - improve the national allergy related data exchange standards to ensure allergy data for Patient Summary, which is currently incomplete. Keywords: – MyHealth@EU, primary use of health data, Patient Summary Project number: 101129187 Project name: Estonia towards MyHealth@EU Project acronym: EST-2-MyHealth Call: EU4H-2022-DGA-MS-IBA2 Topic: EU4H-2022-DGA-MS-IBA-3 Type of action: EU4H Project Grants Granting authority: European Health and Digital Executive Agency Grant managed through EU Funding & Tenders Portal: Yes (eGrants) Project starting date: first day of the month following the entry into force date Project end date: starting date + months of duration Project duration: 36 months Consortium agreement: No 2. Participants List of participants: Total Max grant N° Role Short name Legal name Ctry PIC eligible costs amount (BEN and AE) 1 COO MSAE SOTSIAALMINISTEERIUM EE 998429731 27 001.45 21 601.14 1.1 AE TEHIK TERVISE JA HEAOLU INFOSÜSTEEMIDE KESKUS EE 895885405 1 062 777.50 850 222.00 Total 1 089 778.95 871 823.14 Coordinator: – SOTSIAALMINISTEERIUM (MSAE) 3. Grant Maximum grant amount, total estimated eligible costs and contributions and funding rate: 8 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Total eligible costs Funding rate Maximum grant amount Maximum grant amount (BEN and AE) (%) (Annex 2) (award decision) 1 089 778.95 80 871 823.14 871 823.14 Grant form: Budget-based Grant mode: Action grant Budget categories/activity types: - A. Personnel costs - A.1 Employees, A.2 Natural persons under direct contract, A.3 Seconded persons - A.4 SME owners and natural person beneficiaries - B. Subcontracting costs - C. Purchase costs - C.1 Travel and subsistence - C.2 Equipment - C.3 Other goods, works and services - D. Other cost categories - D.1 Financial support to third parties - E. Indirect costs Cost eligibility options: - Standard supplementary payments - Limitation for subcontracting - Travel and subsistence: - Travel: Unit or Actual costs - Accommodation: Unit or Actual costs - Subsistence: Unit or Actual costs - Equipment: depreciation only - Costs for providing financial support to third parties (actual cost; max amount for each recipient: EUR 0.00) - Indirect cost flat-rate: 7% of the eligible direct costs (categories A-D, except volunteers costs and exempted specific cost categories, if any) - VAT: Yes - Other ineligible costs Budget flexibility: Yes (no flexibility cap) 4. Reporting, payments and recoveries 4.1 Continuous reporting (art 21) Deliverables: see Funding & Tenders Portal Continuous Reporting tool 4.2 Periodic reporting and payments 9 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Reporting and payment schedule (art 21, 22): Reporting Payments Deadline Reporting periods Type Deadline Type (time to pay) RP No Month from Month to 30 days from entry into force/10 days before starting date/ Initial prefinancing financial guarantee (if required) – whichever is the latest 1 1 18 Periodic report 60 days after end Interim payment 90 days from of reporting period receiving periodic report 2 19 36 Periodic report 60 days after end Final payment 90 days from of reporting period receiving periodic report Prefinancing payments and guarantees: Prefinancing payment Prefinancing guarantee Guarantee Type Amount Division per participant amount Prefinancing 1 (initial) 261 546.94 n/a 1 - MSAE n/a 1.1 - TEHIK n/a Reporting and payment modalities (art 21, 22): Mutual Insurance Mechanism (MIM): No Restrictions on distribution of initial prefinancing: The prefinancing may be distributed only if the minimum number of beneficiaries set out in the call condititions (if any) have acceded to the Agreement and only to beneficiaries that have acceded. Interim payment ceiling (if any): 90% of the maximum grant amount No-profit rule: Yes Late payment interest: ECB + 3.5% Bank account for payments: EE891010220034796011 Conversion into euros: Double conversion Reporting language: Language of the Agreement 4.3 Certificates (art 24): Certificates on the financial statements (CFS): Conditions: Schedule: interim/final payment, if threshold is reached Standard threshold (beneficiary-level): 10 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 - financial statement: requested EU contribution to costs ≥ EUR 325 000.00 4.4 Recoveries (art 22) First-line liability for recoveries: Beneficiary termination: Beneficiary concerned Final payment: Coordinator After final payment: Beneficiary concerned Joint and several liability for enforced recoveries (in case of non-payment): Limited joint and several liability of other beneficiaries — up to the maximum grant amount of the beneficiary Joint and several liability of affiliated entities — n/a 5. Consequences of non-compliance, applicable law & dispute settlement forum Applicable law (art 43): Standard applicable law regime: EU law + law of Belgium Dispute settlement forum (art 43): Standard dispute settlement forum: EU beneficiaries: EU General Court + EU Court of Justice (on appeal) Non-EU beneficiaries: Courts of Brussels, Belgium (unless an international agreement provides for the enforceability of EU court judgements) 6. Other Specific rules (Annex 5): Yes Standard time-limits after project end: Confidentiality (for X years after final payment): 5 Record-keeping (for X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Reviews (up to X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Audits (up to X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Extension of findings from other grants to this grant (no later than X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) Impact evaluation (up to X years after final payment): 5 (or 3 for grants of not more than EUR 60 000) 11 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 CHAPTER 1 GENERAL ARTICLE 1 — SUBJECT OF THE AGREEMENT This Agreement sets out the rights and obligations and terms and conditions applicable to the grant awarded for the implementation of the action set out in Chapter 2. ARTICLE 2 — DEFINITIONS For the purpose of this Agreement, the following definitions apply: Actions — The project which is being funded in the context of this Agreement. Grant — The grant awarded in the context of this Agreement. EU grants — Grants awarded by EU institutions, bodies, offices or agencies (including EU executive agencies, EU regulatory agencies, EDA, joint undertakings, etc.). Participants — Entities participating in the action as beneficiaries, affiliated entities, associated partners, third parties giving in-kind contributions, subcontractors or recipients of financial support to third parties. Beneficiaries (BEN) — The signatories of this Agreement (either directly or through an accession form). Affiliated entities (AE) — Entities affiliated to a beneficiary within the meaning of Article 187 of EU Financial Regulation 2018/10464 which participate in the action with similar rights and obligations as the beneficiaries (obligation to implement action tasks and right to charge costs and claim contributions). Associated partners (AP) — Entities which participate in the action, but without the right to charge costs or claim contributions. Purchases — Contracts for goods, works or services needed to carry out the action (e.g. equipment, consumables and supplies) but which are not part of the action tasks (see Annex 1). Subcontracting — Contracts for goods, works or services that are part of the action tasks (see Annex 1). In-kind contributions — In-kind contributions within the meaning of Article 2(36) of EU Financial 4 For the definition, see Article 187 Regulation (EU, Euratom) 2018/1046 of the European Parliament and of the Council of 18 July 2018 on the financial rules applicable to the general budget of the Union, amending Regulations (EU) No 1296/2013, (EU) No 1301/2013, (EU) No 1303/2013, (EU) No 1304/2013, (EU) No 1309/2013, (EU) No 1316/2013, (EU) No 223/2014, (EU) No 283/2014, and Decision No 541/2014/EU and repealing Regulation (EU, Euratom) No 966/2012 (‘EU Financial Regulation’) (OJ L 193, 30.7.2018, p. 1): “affiliated entities [are]: (a) entities that form a sole beneficiary [(i.e. where an entity is formed of several entities that satisfy the criteria for being awarded a grant, including where the entity is specifically established for the purpose of implementing an action to be financed by a grant)]; (b) entities that satisfy the eligibility criteria and that do not fall within one of the situations referred to in Article 136(1) and 141(1) and that have a link with the beneficiary, in particular a legal or capital link, which is neither limited to the action nor established for the sole purpose of its implementation”. 12 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Regulation 2018/1046, i.e. non-financial resources made available free of charge by third parties. Fraud — Fraud within the meaning of Article 3 of EU Directive 2017/13715 and Article 1 of the Convention on the protection of the European Communities’ financial interests, drawn up by the Council Act of 26 July 19956, as well as any other wrongful or criminal deception intended to result in financial or personal gain. Irregularities — Any type of breach (regulatory or contractual) which could impact the EU financial interests, including irregularities within the meaning of Article 1(2) of EU Regulation 2988/957. Grave professional misconduct — Any type of unacceptable or improper behaviour in exercising one’s profession, especially by employees, including grave professional misconduct within the meaning of Article 136(1)(c) of EU Financial Regulation 2018/1046. Applicable EU, international and national law — Any legal acts or other (binding or non-binding) rules and guidance in the area concerned. Portal — EU Funding & Tenders Portal; electronic portal and exchange system managed by the European Commission and used by itself and other EU institutions, bodies, offices or agencies for the management of their funding programmes (grants, procurements, prizes, etc.). CHAPTER 2 ACTION ARTICLE 3 — ACTION The grant is awarded for the action 101129187 — EST-2-MyHealth (‘action’), as described in Annex 1. ARTICLE 4 — DURATION AND STARTING DATE The duration and the starting date of the action are set out in the Data Sheet (see Point 1). CHAPTER 3 GRANT ARTICLE 5 — GRANT 5.1 Form of grant 5 Directive (EU) 2017/1371 of the European Parliament and of the Council of 5 July 2017 on the fight against fraud to the Union’s financial interests by means of criminal law (OJ L 198, 28.7.2017, p. 29). 6 OJ C 316, 27.11.1995, p. 48. 7 Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). 13 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 The grant is an action grant8 which takes the form of a budget-based mixed actual cost grant (i.e. a grant based on actual costs incurred, but which may also include other forms of funding, such as unit costs or contributions, flat-rate costs or contributions, lump sum costs or contributions or financing not linked to costs). 5.2 Maximum grant amount The maximum grant amount is set out in the Data Sheet (see Point 3) and in the estimated budget (Annex 2). 5.3 Funding rate The funding rate for costs is 80% of the action’s eligible costs. Contributions are not subject to any funding rate. 5.4 Estimated budget, budget categories and forms of funding The estimated budget for the action is set out in Annex 2. It contains the estimated eligible costs and contributions for the action, broken down by participant and budget category. Annex 2 also shows the types of costs and contributions (forms of funding)9 to be used for each budget category. If unit costs or contributions are used, the details on the calculation will be explained in Annex 2a. 5.5 Budget flexibility The budget breakdown may be adjusted — without an amendment (see Article 39) — by transfers (between participants and budget categories), as long as this does not imply any substantive or important change to the description of the action in Annex 1. However: - changes to the budget category for volunteers (if used) always require an amendment - changes to budget categories with lump sums costs or contributions (if used; including financing not linked to costs) always require an amendment - changes to budget categories with higher funding rates or budget ceilings (if used) always require an amendment - addition of amounts for subcontracts not provided for in Annex 1 either require an amendment or simplified approval in accordance with Article 6.2 8 For the definition, see Article 180(2)(a) EU Financial Regulation 2018/1046: ‘action grant’ means an EU grant to finance “an action intended to help achieve a Union policy objective”. 9 See Article 125 EU Financial Regulation 2018/1046. 14 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 - other changes require an amendment or simplified approval, if specifically provided for in Article 6.2 - flexibility caps: not applicable. ARTICLE 6 — ELIGIBLE AND INELIGIBLE COSTS AND CONTRIBUTIONS In order to be eligible, costs and contributions must meet the eligibility conditions set out in this Article. 6.1 General eligibility conditions The general eligibility conditions are the following: (a) for actual costs: (i) they must be actually incurred by the beneficiary (ii) they must be incurred in the period set out in Article 4 (with the exception of costs relating to the submission of the final periodic report, which may be incurred afterwards; see Article 21) (iii) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 (iv) they must be incurred in connection with the action as described in Annex 1 and necessary for its implementation (v) they must be identifiable and verifiable, in particular recorded in the beneficiary’s accounts in accordance with the accounting standards applicable in the country where the beneficiary is established and with the beneficiary’s usual cost accounting practices (vi) they must comply with the applicable national law on taxes, labour and social security and (vii) they must be reasonable, justified and must comply with the principle of sound financial management, in particular regarding economy and efficiency (b) for unit costs or contributions (if any): (i) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 (ii) the units must: - be actually used or produced by the beneficiary in the period set out in Article 4 (with the exception of units relating to the submission of the final periodic report, which may be used or produced afterwards; see Article 21) - be necessary for the implementation of the action and (iii) the number of units must be identifiable and verifiable, in particular supported by records and documentation (see Article 20) 15 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 (c) for flat-rate costs or contributions (if any): (i) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 (ii) the costs or contributions to which the flat-rate is applied must: - be eligible - relate to the period set out in Article 4 (with the exception of costs or contributions relating to the submission of the final periodic report, which may be incurred afterwards; see Article 21) (d) for lump sum costs or contributions (if any): (i) they must be declared under one of the budget categories set out in Article 6.2 and Annex 2 (ii) the work must be properly implemented by the beneficiary in accordance with Annex 1 (iii) the deliverables/outputs must be achieved in the period set out in Article 4 (with the exception of deliverables/outputs relating to the submission of the final periodic report, which may be achieved afterwards; see Article 21) (e) for unit, flat-rate or lump sum costs or contributions according to usual cost accounting practices (if any): (i) they must fulfil the general eligibility conditions for the type of cost concerned (ii) the cost accounting practices must be applied in a consistent manner, based on objective criteria, regardless of the source of funding (f) for financing not linked to costs (if any): the results must be achieved or the conditions must be fulfilled as described in Annex 1. In addition, for direct cost categories (e.g. personnel, travel & subsistence, subcontracting and other direct costs) only costs that are directly linked to the action implementation and can therefore be attributed to it directly are eligible. They must not include any indirect costs (i.e. costs that are only indirectly linked to the action, e.g. via cost drivers). 6.2 Specific eligibility conditions for each budget category For each budget category, the specific eligibility conditions are as follows: Direct costs A. Personnel costs A.1 Costs for employees (or equivalent) are eligible as personnel costs if they fulfil the general eligibility conditions and are related to personnel working for the beneficiary under an employment contract (or equivalent appointing act) and assigned to the action. They must be limited to salaries, social security contributions, taxes and other costs linked to the 16 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 remuneration, if they arise from national law or the employment contract (or equivalent appointing act) and be calculated on the basis of the costs actually incurred, in accordance with the following method: {daily rate for the person multiplied by number of day-equivalents worked on the action (rounded up or down to the nearest half-day)}. The daily rate must be calculated as: {annual personnel costs for the person divided by 215}. The number of day-equivalents declared for a person must be identifiable and verifiable (see Article 20). The total number of day-equivalents declared in EU grants, for a person for a year, cannot be higher than 215. The personnel costs may also include supplementary payments for personnel assigned to the action (including payments on the basis of supplementary contracts regardless of their nature), if: - it is part of the beneficiary’s usual remuneration practices and is paid in a consistent manner whenever the same kind of work or expertise is required - the criteria used to calculate the supplementary payments are objective and generally applied by the beneficiary, regardless of the source of funding used. A.2 and A.3 Costs for natural persons working under a direct contract other than an employment contract and costs for seconded persons by a third party against payment are also eligible as personnel costs, if they are assigned to the action, fulfil the general eligibility conditions and: (a) work under conditions similar to those of an employee (in particular regarding the way the work is organised, the tasks that are performed and the premises where they are performed) and (b) the result of the work belongs to the beneficiary (unless agreed otherwise). They must be calculated on the basis of a rate which corresponds to the costs actually incurred for the direct contract or secondment and must not be significantly different from those for personnel performing similar tasks under an employment contract with the beneficiary. A.4 The work of SME owners for the action (i.e. owners of beneficiaries that are small and medium- sized enterprises10 not receiving a salary) or natural person beneficiaries (i.e. beneficiaries that are 10 For the definition, see Commission Recommendation 2003/361/EC: micro, small or medium-sized enterprise (SME) are enterprises - engaged in an economic activity, irrespective of their legal form (including, in particular, self- employed persons and family businesses engaged in craft or other activities, and partnerships or associations regularly engaged in an economic activity) and 17 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 natural persons not receiving a salary) may be declared as personnel costs, if they fulfil the general eligibility conditions and are calculated as unit costs in accordance with the method set out in Annex 2a. B. Subcontracting costs Subcontracting costs for the action (including related duties, taxes and charges, such as non- deductible or non-refundable value added tax (VAT)) are eligible, if they are calculated on the basis of the costs actually incurred, fulfil the general eligibility conditions and are awarded using the beneficiary’s usual purchasing practices — provided these ensure subcontracts with best value for money (or if appropriate the lowest price) and that there is no conflict of interests (see Article 12). Beneficiaries that are ‘contracting authorities/entities’ within the meaning of the EU Directives on public procurement must also comply with the applicable national law on public procurement. Subcontracting may cover only a limited part of the action. The tasks to be subcontracted and the estimated cost for each subcontract must be set out in Annex 1 and the total estimated costs of subcontracting per beneficiary must be set out in Annex 2 (or may be approved ex post in the periodic report, if the use of subcontracting does not entail changes to the Agreement which would call into question the decision awarding the grant or breach the principle of equal treatment of applicants; ‘simplified approval procedure’). C. Purchase costs Purchase costs for the action (including related duties, taxes and charges, such as non-deductible or non-refundable value added tax (VAT)) are eligible if they fulfil the general eligibility conditions and are bought using the beneficiary’s usual purchasing practices — provided these ensure purchases with best value for money (or if appropriate the lowest price) and that there is no conflict of interests (see Article 12). Beneficiaries that are ‘contracting authorities/entities’ within the meaning of the EU Directives on public procurement must also comply with the applicable national law on public procurement. C.1 Travel and subsistence Purchases for travel, accommodation and subsistence must be calculated as follows: - travel: as unit costs in accordance with the method set out in Annex 2a if covered by Decision C(2021)3511 or otherwise as costs actually incurred and in line with the beneficiary’s usual practices on travel - accommodation: as unit costs in accordance with the method set out in Annex 2a if covered by - employing fewer than 250 persons (expressed in ‘annual working units’ as defined in Article 5 of the Recommendation) and which have an annual turnover not exceeding EUR 50 million, and/or an annual balance sheet total not exceeding EUR 43 million. 11 Commission Decision of 12 January 2021 authorising the use of unit costs for travel, accommodation and subsistence costs under an action or work programme under the 2021-2027 multi-annual financial framework (C(2021)35). 18 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Decision C(2021)3512 or otherwise as costs actually incurred and in line with the beneficiary’s usual practices on travel - subsistence: as unit costs in accordance with the method set out in Annex 2a if covered by Decision C(2021)3513 or otherwise as costs actually incurred and in line with the beneficiary’s usual practices on travel. C.2 Equipment Purchases of equipment, infrastructure or other assets used for the action must be declared as depreciation costs, calculated on the basis of the costs actually incurred and written off in accordance with international accounting standards and the beneficiary’s usual accounting practices. Only the portion of the costs that corresponds to the rate of actual use for the action during the action duration can be taken into account. Costs for renting or leasing equipment, infrastructure or other assets are also eligible, if they do not exceed the depreciation costs of similar equipment, infrastructure or assets and do not include any financing fees. C.3 Other goods, works and services Purchases of other goods, works and services must be calculated on the basis of the costs actually incurred. Such goods, works and services include, for instance, consumables and supplies, promotion, dissemination, protection of results, translations, publications, certificates and financial guarantees, if required under the Agreement. D. Other cost categories D.1 Financial support to third parties Costs for providing financial support to third parties (in the form of grants, prizes or similar forms of support; if any) are eligible, if and as declared eligible in the call conditions, if they fulfil the general eligibility conditions, are calculated on the basis of the costs actually incurred and the support is implemented in accordance with the conditions set out in Annex 1. These conditions must ensure objective and transparent selection procedures and include at least the following: (a) for grants (or similar): (i) the maximum amount of financial support for each third party (‘recipient’); this amount may not exceed the amount set out in the Data Sheet (see Point 3) or otherwise agreed with the granting authority 12 Commission Decision of 12 January 2021 authorising the use of unit costs for travel, accommodation and subsistence costs under an action or work programme under the 2021-2027 multi-annual financial framework (C(2021)35). 13 Commission Decision of 12 January 2021 authorising the use of unit costs for travel, accommodation and subsistence costs under an action or work programme under the 2021-2027 multi-annual financial framework (C(2021)35). 19 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 (ii) the criteria for calculating the exact amount of the financial support (iii) the different types of activity that qualify for financial support, on the basis of a closed list (iv) the persons or categories of persons that will be supported and (v) the criteria and procedures for giving financial support (b) for prizes (or similar): (i) the eligibility and award criteria (ii) the amount of the prize and (iii) the payment arrangements. Indirect costs E. Indirect costs Indirect costs will be reimbursed at the flat-rate of 7% of the eligible direct costs (categories A-D, except volunteers costs and exempted specific cost categories, if any). Contributions Not applicable 6.3 Ineligible costs and contributions The following costs or contributions are ineligible: (a) costs or contributions that do not comply with the conditions set out above (Article 6.1 and 6.2), in particular: (i) costs related to return on capital and dividends paid by a beneficiary (ii) debt and debt service charges (iii) provisions for future losses or debts (iv) interest owed (v) currency exchange losses (vi) bank costs charged by the beneficiary’s bank for transfers from the granting authority (vii) excessive or reckless expenditure (viii) deductible or refundable VAT (including VAT paid by public bodies acting as public authority) (ix) costs incurred or contributions for activities implemented during grant agreement suspension (see Article 31) 20 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 (x) in-kind contributions by third parties (b) costs or contributions declared under other EU grants (or grants awarded by an EU Member State, non-EU country or other body implementing the EU budget), except for the following cases: (i) Synergy actions: not applicable (ii) if the action grant is combined with an operating grant14 running during the same period and the beneficiary can demonstrate that the operating grant does not cover any (direct or indirect) costs of the action grant (c) costs or contributions for staff of a national (or regional/local) administration, for activities that are part of the administration’s normal activities (i.e. not undertaken only because of the grant) (d) costs or contributions (especially travel and subsistence) for staff or representatives of EU institutions, bodies or agencies (e) other : (i) country restrictions for eligible costs: not applicable (ii) costs or contributions declared specifically ineligible in the call conditions. 6.4 Consequences of non-compliance If a beneficiary declares costs or contributions that are ineligible, they will be rejected (see Article 27). This may also lead to other measures described in Chapter 5. CHAPTER 4 GRANT IMPLEMENTATION SECTION 1 CONSORTIUM: BENEFICIARIES, AFFILIATED ENTITIES AND OTHER PARTICIPANTS ARTICLE 7 — BENEFICIARIES The beneficiaries, as signatories of the Agreement, are fully responsible towards the granting authority for implementing it and for complying with all its obligations. They must implement the Agreement to their best abilities, in good faith and in accordance with all the obligations and terms and conditions it sets out. They must have the appropriate resources to implement the action and implement the action under their own responsibility and in accordance with Article 11. If they rely on affiliated entities or other 14 For the definition, see Article 180(2)(b) of EU Financial Regulation 2018/1046: ‘operating grant’ means an EU grant to finance “the functioning of a body which has an objective forming part of and supporting an EU policy”. 21 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 participants (see Articles 8 and 9), they retain sole responsibility towards the granting authority and the other beneficiaries. They are jointly responsible for the technical implementation of the action. If one of the beneficiaries fails to implement their part of the action, the other beneficiaries must ensure that this part is implemented by someone else (without being entitled to an increase of the maximum grant amount and subject to an amendment; see Article 39). The financial responsibility of each beneficiary in case of recoveries is governed by Article 22. The beneficiaries (and their action) must remain eligible under the EU programme funding the grant for the entire duration of the action. Costs and contributions will be eligible only as long as the beneficiary and the action are eligible. The internal roles and responsibilities of the beneficiaries are divided as follows: (a) Each beneficiary must: (i) keep information stored in the Portal Participant Register up to date (see Article 19) (ii) inform the granting authority (and the other beneficiaries) immediately of any events or circumstances likely to affect significantly or delay the implementation of the action (see Article 19) (iii) submit to the coordinator in good time: - the prefinancing guarantees (if required; see Article 23) - the financial statements and certificates on the financial statements (CFS) (if required; see Articles 21 and 24.2 and Data Sheet, Point 4.3) - the contribution to the deliverables and technical reports (see Article 21) - any other documents or information required by the granting authority under the Agreement (iv) submit via the Portal data and information related to the participation of their affiliated entities. (b) The coordinator must: (i) monitor that the action is implemented properly (see Article 11) (ii) act as the intermediary for all communications between the consortium and the granting authority, unless the Agreement or granting authority specifies otherwise, and in particular: - submit the prefinancing guarantees to the granting authority (if any) - request and review any documents or information required and verify their quality and completeness before passing them on to the granting authority - submit the deliverables and reports to the granting authority 22 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 - inform the granting authority about the payments made to the other beneficiaries (report on the distribution of payments; if required, see Articles 22 and 32) (iii) distribute the payments received from the granting authority to the other beneficiaries without unjustified delay (see Article 22). The coordinator may not delegate or subcontract the above-mentioned tasks to any other beneficiary or third party (including affiliated entities). However, coordinators which are public bodies may delegate the tasks set out in Point (b)(ii) last indent and (iii) above to entities with ‘authorisation to administer’ which they have created or which are controlled by or affiliated to them. In this case, the coordinator retains sole responsibility for the payments and for compliance with the obligations under the Agreement. Moreover, coordinators which are ‘sole beneficiaries’15 (or similar, such as European research infrastructure consortia (ERICs)) may delegate the tasks set out in Point (b)(i) to (iii) above to one of their members. The coordinator retains sole responsibility for compliance with the obligations under the Agreement. The beneficiaries must have internal arrangements regarding their operation and co-ordination, to ensure that the action is implemented properly. If required by the granting authority (see Data Sheet, Point 1), these arrangements must be set out in a written consortium agreement between the beneficiaries, covering for instance: - the internal organisation of the consortium - the management of access to the Portal - different distribution keys for the payments and financial responsibilities in case of recoveries (if any) - additional rules on rights and obligations related to background and results (see Article 16) - settlement of internal disputes - liability, indemnification and confidentiality arrangements between the beneficiaries. The internal arrangements must not contain any provision contrary to this Agreement. ARTICLE 8 — AFFILIATED ENTITIES The following entities which are linked to a beneficiary will participate in the action as ‘affiliated entities’: - TERVISE JA HEAOLU INFOSÜSTEEMIDE KESKUS (TEHIK), PIC 895885405, linked to SOTSIAALMINISTEERIUM (MSAE) 15 For the definition, see Article 187(2) EU Financial Regulation 2018/1046: “Where several entities satisfy the criteria for being awarded a grant and together form one entity, that entity may be treated as the sole beneficiary, including where it is specifically established for the purpose of implementing the action financed by the grant.” 23 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Affiliated entities can charge costs and contributions to the action under the same conditions as the beneficiaries and must implement the action tasks attributed to them in Annex 1 in accordance with Article 11. Their costs and contributions will be included in Annex 2 and will be taken into account for the calculation of the grant. The beneficiaries must ensure that all their obligations under this Agreement also apply to their affiliated entities. The beneficiaries must ensure that the bodies mentioned in Article 25 (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.) can exercise their rights also towards the affiliated entities. Breaches by affiliated entities will be handled in the same manner as breaches by beneficiaries. Recovery of undue amounts will be handled through the beneficiaries. If the granting authority requires joint and several liability of affiliated entities (see Data Sheet, Point 4.4), they must sign the declaration set out in Annex 3a and may be held liable in case of enforced recoveries against their beneficiaries (see Article 22.2 and 22.4). ARTICLE 9 — OTHER PARTICIPANTS INVOLVED IN THE ACTION 9.1 Associated partners Not applicable 9.2 Third parties giving in-kind contributions to the action Other third parties may give in-kind contributions to the action (i.e. personnel, equipment, other goods, works and services, etc. which are free-of-charge), if necessary for the implementation. Third parties giving in-kind contributions do not implement any action tasks. They may not charge costs or contributions to the action and the costs for the in-kind contributions are not eligible. The third parties and their in-kind contributions should be set out in Annex 1. 9.3 Subcontractors Subcontractors may participate in the action, if necessary for the implementation. Subcontractors must implement their action tasks in accordance with Article 11. The costs for the subcontracted tasks (invoiced price from the subcontractor) are eligible and may be charged by the beneficiaries, under the conditions set out in Article 6. The costs will be included in Annex 2 as part of the beneficiaries’ costs. The beneficiaries must ensure that their contractual obligations under Articles 11 (proper implementation), 12 (conflict of interest), 13 (confidentiality and security), 14 (ethics), 17.2 (visibility), 18 (specific rules for carrying out action), 19 (information) and 20 (record-keeping) also apply to the subcontractors. The beneficiaries must ensure that the bodies mentioned in Article 25 (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.) can exercise their rights also towards the subcontractors. 24 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 9.4 Recipients of financial support to third parties If the action includes providing financial support to third parties (e.g. grants, prizes or similar forms of support), the beneficiaries must ensure that their contractual obligations under Articles 12 (conflict of interest), 13 (confidentiality and security), 14 (ethics), 17.2 (visibility), 18 (specific rules for carrying out action), 19 (information) and 20 (record-keeping)also apply to the third parties receiving the support (recipients). The beneficiaries must also ensure that the bodies mentioned in Article 25 (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.) can exercise their rights also towards the recipients. ARTICLE 10 — PARTICIPANTS WITH SPECIAL STATUS 10.1 Non-EU participants Participants which are established in a non-EU country (if any) undertake to comply with their obligations under the Agreement and: - to respect general principles (including fundamental rights, values and ethical principles, environmental and labour standards, rules on classified information, intellectual property rights, visibility of funding and protection of personal data) - for the submission of certificates under Article 24: to use qualified external auditors which are independent and comply with comparable standards as those set out in EU Directive 2006/43/EC16 - for the controls under Article 25: to allow for checks, reviews, audits and investigations (including on-the-spot checks, visits and inspections) by the bodies mentioned in that Article (e.g. granting authority, OLAF, Court of Auditors (ECA), etc.). Special rules on dispute settlement apply (see Data Sheet, Point 5). 10.2 Participants which are international organisations Participants which are international organisations (IOs; if any) undertake to comply with their obligations under the Agreement and: - to respect general principles (including fundamental rights, values and ethical principles, environmental and labour standards, rules on classified information, intellectual property rights, visibility of funding and protection of personal data) - for the submission of certificates under Article 24: to use either independent public officers or external auditors which comply with comparable standards as those set out in EU Directive 2006/43/EC - for the controls under Article 25: to allow for the checks, reviews, audits and investigations by the bodies mentioned in that Article, taking into account the specific agreements concluded by them and the EU (if any). 16 Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts or similar national regulations (OJ L 157, 9.6.2006, p. 87). 25 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 For such participants, nothing in the Agreement will be interpreted as a waiver of their privileges or immunities, as accorded by their constituent documents or international law. Special rules on applicable law and dispute settlement apply (see Article 43 and Data Sheet, Point 5). 10.3 Pillar-assessed participants Pillar-assessed participants (if any) may rely on their own systems, rules and procedures, in so far as they have been positively assessed and do not call into question the decision awarding the grant or breach the principle of equal treatment of applicants or beneficiaries. ‘Pillar-assessment’ means a review by the European Commission on the systems, rules and procedures which participants use for managing EU grants (in particular internal control system, accounting system, external audits, financing of third parties, rules on recovery and exclusion, information on recipients and protection of personal data; see Article 154 EU Financial Regulation 2018/1046). Participants with a positive pillar assessment may rely on their own systems, rules and procedures, in particular for: - record-keeping (Article 20): may be done in accordance with internal standards, rules and procedures - currency conversion for financial statements (Article 21): may be done in accordance with usual accounting practices - guarantees (Article 23): for public law bodies, prefinancing guarantees are not needed - certificates (Article 24): - certificates on the financial statements (CFS): may be provided by their regular internal or external auditors and in accordance with their internal financial regulations and procedures - certificates on usual accounting practices (CoMUC): are not needed if those practices are covered by an ex-ante assessment and use the following specific rules, for: - recoveries (Article 22): in case of financial support to third parties, there will be no recovery if the participant has done everything possible to retrieve the undue amounts from the third party receiving the support (including legal proceedings) and non-recovery is not due to an error or negligence on its part - checks, reviews, audits and investigations by the EU (Article 25): will be conducted taking into account the rules and procedures specifically agreed between them and the framework agreement (if any) - impact evaluation (Article 26): will be conducted in accordance with the participant’s internal rules and procedures and the framework agreement (if any) - grant agreement suspension (Article 31): certain costs incurred during grant suspension are eligible (notably, minimum costs necessary for a possible resumption of the action and costs 26 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 relating to contracts which were entered into before the pre-information letter was received and which could not reasonably be suspended, reallocated or terminated on legal grounds) - grant agreement termination (Article 32): the final grant amount and final payment will be calculated taking into account also costs relating to contracts due for execution only after termination takes effect, if the contract was entered into before the pre-information letter was received and could not reasonably be terminated on legal grounds - liability for damages (Article 33.2): the granting authority must be compensated for damage it sustains as a result of the implementation of the action or because the action was not implemented in full compliance with the Agreement only if the damage is due to an infringement of the participant’s internal rules and procedures or due to a violation of third parties’ rights by the participant or one of its employees or individual for whom the employees are responsible. Participants whose pillar assessment covers procurement and granting procedures may also do purchases, subcontracting and financial support to third parties (Article 6.2) in accordance with their internal rules and procedures for purchases, subcontracting and financial support. Participants whose pillar assessment covers data protection rules may rely on their internal standards, rules and procedures for data protection (Article 15). The participants may however not rely on provisions which would breach the principle of equal treatment of applicants or beneficiaries or call into question the decision awarding the grant, such as in particular: - eligibility (Article 6) - consortium roles and set-up (Articles 7-9) - security and ethics (Articles 13, 14) - IPR (including background and results, access rights and rights of use), communication, dissemination and visibility (Articles 16 and 17) - information obligation (Article 19) - payment, reporting and amendments (Articles 21, 22 and 39) - rejections, reductions, suspensions and terminations (Articles 27, 28, 29-32) If the pillar assessment was subject to remedial measures, reliance on the internal systems, rules and procedures is subject to compliance with those remedial measures. Participants whose assessment has not yet been updated to cover (the new rules on) data protection may rely on their internal systems, rules and procedures, provided that they ensure that personal data is: - processed lawfully, fairly and in a transparent manner in relation to the data subject - collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes 27 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 - adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed - accurate and, where necessary, kept up to date - kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the data is processed and - processed in a manner that ensures appropriate security of the personal data. Participants must inform the coordinator without delay of any changes to the systems, rules and procedures that were part of the pillar assessment. The coordinator must immediately inform the granting authority. Pillar-assessed participants that have also concluded a framework agreement with the EU, may moreover — under the same conditions as those above (i.e. not call into question the decision awarding the grant or breach the principle of equal treatment of applicants or beneficiaries) — rely on the provisions set out in that framework agreement. SECTION 2 RULES FOR CARRYING OUT THE ACTION ARTICLE 11 — PROPER IMPLEMENTATION OF THE ACTION 11.1 Obligation to properly implement the action The beneficiaries must implement the action as described in Annex 1 and in compliance with the provisions of the Agreement, the call conditions and all legal obligations under applicable EU, international and national law. 11.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 12 — CONFLICT OF INTERESTS 12.1 Conflict of interests The beneficiaries must take all measures to prevent any situation where the impartial and objective implementation of the Agreement could be compromised for reasons involving family, emotional life, political or national affinity, economic interest or any other direct or indirect interest (‘conflict of interests’). They must formally notify the granting authority without delay of any situation constituting or likely to lead to a conflict of interests and immediately take all the necessary steps to rectify this situation. The granting authority may verify that the measures taken are appropriate and may require additional measures to be taken by a specified deadline. 28 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 12.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28) and the grant or the beneficiary may be terminated (see Article 32). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 13 — CONFIDENTIALITY AND SECURITY 13.1 Sensitive information The parties must keep confidential any data, documents or other material (in any form) that is identified as sensitive in writing (‘sensitive information’) — during the implementation of the action and for at least until the time-limit set out in the Data Sheet (see Point 6). If a beneficiary requests, the granting authority may agree to keep such information confidential for a longer period. Unless otherwise agreed between the parties, they may use sensitive information only to implement the Agreement. The beneficiaries may disclose sensitive information to their personnel or other participants involved in the action only if they: (a) need to know it in order to implement the Agreement and (b) are bound by an obligation of confidentiality. The granting authority may disclose sensitive information to its staff and to other EU institutions and bodies. It may moreover disclose sensitive information to third parties, if: (a) this is necessary to implement the Agreement or safeguard the EU financial interests and (b) the recipients of the information are bound by an obligation of confidentiality. The confidentiality obligations no longer apply if: (a) the disclosing party agrees to release the other party (b) the information becomes publicly available, without breaching any confidentiality obligation (c) the disclosure of the sensitive information is required by EU, international or national law. Specific confidentiality rules (if any) are set out in Annex 5. 13.2 Classified information 29 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 The parties must handle classified information in accordance with the applicable EU, international or national law on classified information (in particular, Decision 2015/44417 and its implementing rules). Deliverables which contain classified information must be submitted according to special procedures agreed with the granting authority. Action tasks involving classified information may be subcontracted only after explicit approval (in writing) from the granting authority. Classified information may not be disclosed to any third party (including participants involved in the action implementation) without prior explicit written approval from the granting authority. Specific security rules (if any) are set out in Annex 5. 13.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 14 — ETHICS AND VALUES 14.1 Ethics The action must be carried out in line with the highest ethical standards and the applicable EU, international and national law on ethical principles. Specific ethics rules (if any) are set out in Annex 5. 14.2 Values The beneficiaries must commit to and ensure the respect of basic EU values (such as respect for human dignity, freedom, democracy, equality, the rule of law and human rights, including the rights of minorities). Specific rules on values (if any) are set out in Annex 5. 14.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 15 — DATA PROTECTION 15.1 Data processing by the granting authority 17 Commission Decision 2015/444/EC, Euratom of 13 March 2015 on the security rules for protecting EU classified information (OJ L 72, 17.3.2015, p. 53). 30 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Any personal data under the Agreement will be processed under the responsibility of the data controller of the granting authority in accordance with and for the purposes set out in the Portal Privacy Statement. For grants where the granting authority is the European Commission, an EU regulatory or executive agency, joint undertaking or other EU body, the processing will be subject to Regulation 2018/172518. 15.2 Data processing by the beneficiaries The beneficiaries must process personal data under the Agreement in compliance with the applicable EU, international and national law on data protection (in particular, Regulation 2016/67919). They must ensure that personal data is: - processed lawfully, fairly and in a transparent manner in relation to the data subjects - collected for specified, explicit and legitimate purposes and not further processed in a manner that is incompatible with those purposes - adequate, relevant and limited to what is necessary in relation to the purposes for which they are processed - accurate and, where necessary, kept up to date - kept in a form which permits identification of data subjects for no longer than is necessary for the purposes for which the data is processed and - processed in a manner that ensures appropriate security of the data. The beneficiaries may grant their personnel access to personal data only if it is strictly necessary for implementing, managing and monitoring the Agreement. The beneficiaries must ensure that the personnel is under a confidentiality obligation. The beneficiaries must inform the persons whose data are transferred to the granting authority and provide them with the Portal Privacy Statement. 15.3 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 16 — INTELLECTUAL PROPERTY RIGHTS (IPR) — BACKGROUND AND RESULTS —ACCESS RIGHTS AND RIGHTS OF USE 18 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39). 19 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (‘GDPR’) (OJ L 119, 4.5.2016, p. 1). 31 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 16.1 Background and access rights to background The beneficiaries must give each other and the other participants access to the background identified as needed for implementing the action, subject to any specific rules in Annex 5. ‘Background’ means any data, know-how or information — whatever its form or nature (tangible or intangible), including any rights such as intellectual property rights — that is: (a) held by the beneficiaries before they acceded to the Agreement and (b) needed to implement the action or exploit the results. If background is subject to rights of a third party, the beneficiary concerned must ensure that it is able to comply with its obligations under the Agreement. 16.2 Ownership of results The granting authority does not obtain ownership of the results produced under the action. ‘Results’ means any tangible or intangible effect of the action, such as data, know-how or information, whatever its form or nature, whether or not it can be protected, as well as any rights attached to it, including intellectual property rights. 16.3 Rights of use of the granting authority on materials, documents and information received for policy, information, communication, dissemination and publicity purposes The granting authority has the right to use non-sensitive information relating to the action and materials and documents received from the beneficiaries (notably summaries for publication, deliverables, as well as any other material, such as pictures or audio-visual material, in paper or electronic form) for policy, information, communication, dissemination and publicity purposes — during the action or afterwards. The right to use the beneficiaries’ materials, documents and information is granted in the form of a royalty-free, non-exclusive and irrevocable licence, which includes the following rights: (a) use for its own purposes (in particular, making them available to persons working for the granting authority or any other EU service (including institutions, bodies, offices, agencies, etc.) or EU Member State institution or body; copying or reproducing them in whole or in part, in unlimited numbers; and communication through press information services) (b) distribution to the public (in particular, publication as hard copies and in electronic or digital format, publication on the internet, as a downloadable or non-downloadable file, broadcasting by any channel, public display or presentation, communicating through press information services, or inclusion in widely accessible databases or indexes) (c) editing or redrafting (including shortening, summarising, inserting other elements (e.g. meta-data, legends, other graphic, visual, audio or text elements), extracting parts (e.g. audio or video files), dividing into parts, use in a compilation) (d) translation (e) storage in paper, electronic or other form 32 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 (f) archiving, in line with applicable document-management rules (g) the right to authorise third parties to act on its behalf or sub-license to third parties the modes of use set out in Points (b), (c), (d) and (f), if needed for the information, communication and publicity activity of the granting authority (h) processing, analysing, aggregating the materials, documents and information received and producing derivative works. The rights of use are granted for the whole duration of the industrial or intellectual property rights concerned. If materials or documents are subject to moral rights or third party rights (including intellectual property rights or rights of natural persons on their image and voice), the beneficiaries must ensure that they comply with their obligations under this Agreement (in particular, by obtaining the necessary licences and authorisations from the rights holders concerned). Where applicable, the granting authority will insert the following information: “© – [year] – [name of the copyright owner]. All rights reserved. Licensed to the [name of granting authority] under conditions.” 16.4 Specific rules on IPR, results and background Specific rules regarding intellectual property rights, results and background (if any) are set out in Annex 5. 16.5 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such a breach may also lead to other measures described in Chapter 5. ARTICLE 17 — COMMUNICATION, DISSEMINATION AND VISIBILITY 17.1 Communication — Dissemination — Promoting the action Unless otherwise agreed with the granting authority, the beneficiaries must promote the action and its results by providing targeted information to multiple audiences (including the media and the public), in accordance with Annex 1 and in a strategic, coherent and effective manner. Before engaging in a communication or dissemination activity expected to have a major media impact, the beneficiaries must inform the granting authority. 17.2 Visibility — European flag and funding statement Unless otherwise agreed with the granting authority, communication activities of the beneficiaries related to the action (including media relations, conferences, seminars, information material, such as brochures, leaflets, posters, presentations, etc., in electronic form, via traditional or social media, etc.), dissemination activities and any infrastructure, equipment, vehicles, supplies or major result funded 33 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 by the grant must acknowledge EU support and display the European flag (emblem) and funding statement (translated into local languages, where appropriate): The emblem must remain distinct and separate and cannot be modified by adding other visual marks, brands or text. Apart from the emblem, no other visual identity or logo may be used to highlight the EU support. When displayed in association with other logos (e.g. of beneficiaries or sponsors), the emblem must be displayed at least as prominently and visibly as the other logos. For the purposes of their obligations under this Article, the beneficiaries may use the emblem without first obtaining approval from the granting authority. This does not, however, give them the right to exclusive use. Moreover, they may not appropriate the emblem or any similar trademark or logo, either by registration or by any other means. 17.3 Quality of information — Disclaimer Any communication or dissemination activity related to the action must use factually accurate information. Moreover, it must indicate the following disclaimer (translated into local languages where appropriate): “Funded by the European Union. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or [name of the granting authority]. Neither the European Union nor the granting authority can be held responsible for them.” 17.4 Specific communication, dissemination and visibility rules Specific communication, dissemination and visibility rules (if any) are set out in Annex 5. 34 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 17.5 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 18 — SPECIFIC RULES FOR CARRYING OUT THE ACTION 18.1 Specific rules for carrying out the action Specific rules for implementing the action (if any) are set out in Annex 5. 18.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such a breach may also lead to other measures described in Chapter 5. SECTION 3 GRANT ADMINISTRATION ARTICLE 19 — GENERAL INFORMATION OBLIGATIONS 19.1 Information requests The beneficiaries must provide — during the action or afterwards and in accordance with Article 7 — any information requested in order to verify eligibility of the costs or contributions declared, proper implementation of the action and compliance with the other obligations under the Agreement. The information provided must be accurate, precise and complete and in the format requested, including electronic format. 19.2 Participant Register data updates The beneficiaries must keep — at all times, during the action or afterwards — their information stored in the Portal Participant Register up to date, in particular, their name, address, legal representatives, legal form and organisation type. 19.3 Information about events and circumstances which impact the action The beneficiaries must immediately inform the granting authority (and the other beneficiaries) of any of the following: (a) events which are likely to affect or delay the implementation of the action or affect the EU’s financial interests, in particular: (i) changes in their legal, financial, technical, organisational or ownership situation (including changes linked to one of the exclusion grounds listed in the declaration of honour signed before grant signature) 35 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 (ii) linked action information: not applicable (b) circumstances affecting: (i) the decision to award the grant or (ii) compliance with requirements under the Agreement. 19.4 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 20 — RECORD-KEEPING 20.1 Keeping records and supporting documents The beneficiaries must — at least until the time-limit set out in the Data Sheet (see Point 6) — keep records and other supporting documents to prove the proper implementation of the action in line with the accepted standards in the respective field (if any). In addition, the beneficiaries must — for the same period — keep the following to justify the amounts declared: (a) for actual costs: adequate records and supporting documents to prove the costs declared (such as contracts, subcontracts, invoices and accounting records); in addition, the beneficiaries’ usual accounting and internal control procedures must enable direct reconciliation between the amounts declared, the amounts recorded in their accounts and the amounts stated in the supporting documents (b) for flat-rate costs and contributions (if any): adequate records and supporting documents to prove the eligibility of the costs or contributions to which the flat-rate is applied (c) for the following simplified costs and contributions: the beneficiaries do not need to keep specific records on the actual costs incurred, but must keep: (i) for unit costs and contributions (if any): adequate records and supporting documents to prove the number of units declared (ii) for lump sum costs and contributions (if any): adequate records and supporting documents to prove proper implementation of the work as described in Annex 1 (iii) for financing not linked to costs (if any): adequate records and supporting documents to prove the achievement of the results or the fulfilment of the conditions as described in Annex 1 (d) for unit, flat-rate and lump sum costs and contributions according to usual cost accounting practices (if any): the beneficiaries must keep any adequate records and supporting documents to prove that their cost accounting practices have been applied in a consistent manner, based on 36 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 objective criteria, regardless of the source of funding, and that they comply with the eligibility conditions set out in Articles 6.1 and 6.2. Moreover, the following is needed for specific budget categories: (e) for personnel costs: time worked for the beneficiary under the action must be supported by declarations signed monthly by the person and their supervisor, unless another reliable time-record system is in place; the granting authority may accept alternative evidence supporting the time worked for the action declared, if it considers that it offers an adequate level of assurance (f) additional record-keeping rules: not applicable The records and supporting documents must be made available upon request (see Article 19) or in the context of checks, reviews, audits or investigations (see Article 25). If there are on-going checks, reviews, audits, investigations, litigation or other pursuits of claims under the Agreement (including the extension of findings; see Article 25), the beneficiaries must keep these records and other supporting documentation until the end of these procedures. The beneficiaries must keep the original documents. Digital and digitalised documents are considered originals if they are authorised by the applicable national law. The granting authority may accept non-original documents if they offer a comparable level of assurance. 20.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, costs or contributions insufficiently substantiated will be ineligible (see Article 6) and will be rejected (see Article 27), and the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 21 — REPORTING 21.1 Continuous reporting The beneficiaries must continuously report on the progress of the action (e.g. deliverables, milestones, outputs/outcomes, critical risks, indicators, etc; if any), in the Portal Continuous Reporting tool and in accordance with the timing and conditions it sets out (as agreed with the granting authority). Standardised deliverables (e.g. progress reports not linked to payments, reports on cumulative expenditure, special reports, etc; if any) must be submitted using the templates published on the Portal. 21.2 Periodic reporting: Technical reports and financial statements In addition, the beneficiaries must provide reports to request payments, in accordance with the schedule and modalities set out in the Data Sheet (see Point 4.2): - for additional prefinancings (if any): an additional prefinancing report - for interim payments (if any) and the final payment: a periodic report. 37 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 The prefinancing and periodic reports include a technical and financial part. The technical part includes an overview of the action implementation. It must be prepared using the template available in the Portal Periodic Reporting tool. The financial part of the additional prefinancing report includes a statement on the use of the previous prefinancing payment. The financial part of the periodic report includes: - the financial statements (individual and consolidated; for all beneficiaries/affiliated entities) - the explanation on the use of resources (or detailed cost reporting table, if required) - the certificates on the financial statements (CFS) (if required; see Article 24.2 and Data Sheet, Point 4.3). The financial statements must detail the eligible costs and contributions for each budget category and, for the final payment, also the revenues for the action (see Articles 6 and 22). All eligible costs and contributions incurred should be declared, even if they exceed the amounts indicated in the estimated budget (see Annex 2). Amounts that are not declared in the individual financial statements will not be taken into account by the granting authority. By signing the financial statements (directly in the Portal Periodic Reporting tool), the beneficiaries confirm that: - the information provided is complete, reliable and true - the costs and contributions declared are eligible (see Article 6) - the costs and contributions can be substantiated by adequate records and supporting documents (see Article 20) that will be produced upon request (see Article 19) or in the context of checks, reviews, audits and investigations (see Article 25) - for the final periodic report: all the revenues have been declared (if required; see Article 22). Beneficiaries will have to submit also the financial statements of their affiliated entities (if any). In case of recoveries (see Article 22), beneficiaries will be held responsible also for the financial statements of their affiliated entities. 21.3 Currency for financial statements and conversion into euros The financial statements must be drafted in euro. Beneficiaries with general accounts established in a currency other than the euro must convert the costs recorded in their accounts into euro, at the average of the daily exchange rates published in the C series of the Official Journal of the European Union (ECB website), calculated over the corresponding reporting period. If no daily euro exchange rate is published in the Official Journal for the currency in question, they must be converted at the average of the monthly accounting exchange rates published on the European Commission website (InforEuro), calculated over the corresponding reporting period. 38 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Beneficiaries with general accounts in euro must convert costs incurred in another currency into euro according to their usual accounting practices. 21.4 Reporting language The reporting must be in the language of the Agreement, unless otherwise agreed with the granting authority (see Data Sheet, Point 4.2). 21.5 Consequences of non-compliance If a report submitted does not comply with this Article, the granting authority may suspend the payment deadline (see Article 29) and apply other measures described in Chapter 5. If the coordinator breaches its reporting obligations, the granting authority may terminate the grant or the coordinator’s participation (see Article 32) or apply other measures described in Chapter 5. ARTICLE 22 — PAYMENTS AND RECOVERIES — CALCULATION OF AMOUNTS DUE 22.1 Payments and payment arrangements Payments will be made in accordance with the schedule and modalities set out in the Data Sheet (see Point 4.2). They will be made in euro to the bank account indicated by the coordinator (see Data Sheet, Point 4.2) and must be distributed without unjustified delay (restrictions may apply to distribution of the initial prefinancing payment; see Data Sheet, Point 4.2). Payments to this bank account will discharge the granting authority from its payment obligation. The cost of payment transfers will be borne as follows: - the granting authority bears the cost of transfers charged by its bank - the beneficiary bears the cost of transfers charged by its bank - the party causing a repetition of a transfer bears all costs of the repeated transfer. Payments by the granting authority will be considered to have been carried out on the date when they are debited to its account. 22.2 Recoveries Recoveries will be made, if — at beneficiary termination, final payment or afterwards — it turns out that the granting authority has paid too much and needs to recover the amounts undue. The general liability regime for recoveries (first-line liability) is as follows: At final payment, the coordinator will be fully liable for recoveries, even if it has not been the final recipient of the undue amounts. At beneficiary termination or after final payment, recoveries will be made directly against the beneficiaries concerned. Beneficiaries will be fully liable for repaying the debts of their affiliated entities. 39 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 In case of enforced recoveries (see Article 22.4): - the beneficiaries will be jointly and severally liable for repaying debts of another beneficiary under the Agreement (including late-payment interest), if required by the granting authority (see Data Sheet, Point 4.4) - affiliated entities will be held liable for repaying debts of their beneficiaries under the Agreement (including late-payment interest), if required by the granting authority (see Data Sheet, Point 4.4). 22.3 Amounts due 22.3.1 Prefinancing payments The aim of the prefinancing is to provide the beneficiaries with a float. It remains the property of the EU until the final payment. For initial prefinancings (if any), the amount due, schedule and modalities are set out in the Data Sheet (see Point 4.2). For additional prefinancings (if any), the amount due, schedule and modalities are also set out in the Data Sheet (see Point 4.2). However, if the statement on the use of the previous prefinancing payment shows that less than 70% was used, the amount set out in the Data Sheet will be reduced by the difference between the 70% threshold and the amount used. Prefinancing payments (or parts of them) may be offset (without the beneficiaries’ consent) against amounts owed by a beneficiary to the granting authority — up to the amount due to that beneficiary. For grants where the granting authority is the European Commission or an EU executive agency, offsetting may also be done against amounts owed to other Commission services or executive agencies. Payments will not be made if the payment deadline or payments are suspended (see Articles 29 and 30). 22.3.2 Amount due at beneficiary termination — Recovery In case of beneficiary termination, the granting authority will determine the provisional amount due for the beneficiary concerned. Payments (if any) will be made with the next interim or final payment. The amount due will be calculated in the following step: Step 1 — Calculation of the total accepted EU contribution Step 1 — Calculation of the total accepted EU contribution The granting authority will first calculate the ‘accepted EU contribution’ for the beneficiary for all reporting periods, by calculating the ‘maximum EU contribution to costs’ (applying the funding rate to the accepted costs of the beneficiary), taking into account requests for a lower contribution to costs and CFS threshold cappings (if any; see Article 24.5) and adding the contributions (accepted unit, flat-rate or lump sum contributions and financing not linked to costs, if any). 40 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 After that, the granting authority will take into account grant reductions (if any). The resulting amount is the ‘total accepted EU contribution’ for the beneficiary. The balance is then calculated by deducting the payments received (if any; see report on the distribution of payments in Article 32), from the total accepted EU contribution: {total accepted EU contribution for the beneficiary minus {prefinancing and interim payments received (if any)}}. If the balance is positive, the amount will be included in the next interim or final payment to the consortium. If the balance is negative, it will be recovered in accordance with the following procedure: The granting authority will send a pre-information letter to the beneficiary concerned: - formally notifying the intention to recover, the amount due, the amount to be recovered and the reasons why and - requesting observations within 30 days of receiving notification. If no observations are submitted (or the granting authority decides to pursue recovery despite the observations it has received), it will confirm the amount to be recovered and ask this amount to be paid to the coordinator (confirmation letter). The amounts will later on also be taken into account for the next interim or final payment. 22.3.3 Interim payments Interim payments reimburse the eligible costs and contributions claimed for the implementation of the action during the reporting periods (if any). Interim payments (if any) will be made in accordance with the schedule and modalities set out the Data Sheet (see Point 4.2). Payment is subject to the approval of the periodic report. Its approval does not imply recognition of compliance, authenticity, completeness or correctness of its content. The interim payment will be calculated by the granting authority in the following steps: Step 1 — Calculation of the total accepted EU contribution Step 2 — Limit to the interim payment ceiling Step 1 — Calculation of the total accepted EU contribution The granting authority will calculate the ‘accepted EU contribution’ for the action for the reporting period, by first calculating the ‘maximum EU contribution to costs’ (applying the funding rate to the accepted costs of each beneficiary), taking into account requests for a lower contribution to costs, and CFS threshold cappings (if any; see Article 24.5) and adding the contributions (accepted unit, flat-rate or lump sum contributions and financing not linked to costs, if any). 41 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 After that, the granting authority will take into account grant reductions from beneficiary termination (if any). The resulting amount is the ‘total accepted EU contribution’. Step 2 — Limit to the interim payment ceiling The resulting amount is then capped to ensure that the total amount of prefinancing and interim payments (if any) does not exceed the interim payment ceiling set out in the Data Sheet (see Point 4.2). Interim payments (or parts of them) may be offset (without the beneficiaries’ consent) against amounts owed by a beneficiary to the granting authority — up to the amount due to that beneficiary. For grants where the granting authority is the European Commission or an EU executive agency, offsetting may also be done against amounts owed to other Commission services or executive agencies. Payments will not be made if the payment deadline or payments are suspended (see Articles 29 and 30). 22.3.4 Final payment — Final grant amount — Revenues and Profit — Recovery The final payment (payment of the balance) reimburses the remaining part of the eligible costs and contributions claimed for the implementation of the action (if any). The final payment will be made in accordance with the schedule and modalities set out in the Data Sheet (see Point 4.2). Payment is subject to the approval of the final periodic report. Its approval does not imply recognition of compliance, authenticity, completeness or correctness of its content. The final grant amount for the action will be calculated in the following steps: Step 1 — Calculation of the total accepted EU contribution Step 2 — Limit to the maximum grant amount Step 3 — Reduction due to the no-profit rule Step 1 — Calculation of the total accepted EU contribution The granting authority will first calculate the ‘accepted EU contribution’ for the action for all reporting periods, by calculating the ‘maximum EU contribution to costs’ (applying the funding rate to the total accepted costs of each beneficiary), taking into account requests for a lower contribution to costs, CFS threshold cappings (if any; see Article 24.5) and adding the contributions (accepted unit, flat-rate or lump sum contributions and financing not linked to costs, if any). After that, the granting authority will take into account grant reductions (if any). The resulting amount is the ‘total accepted EU contribution’. Step 2 — Limit to the maximum grant amount If the resulting amount is higher than the maximum grant amount set out in Article 5.2, it will be limited to the latter. 42 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Step 3 — Reduction due to the no-profit rule If the no-profit rule is provided for in the Data Sheet (see Point 4.2), the grant must not produce a profit (i.e. surplus of the amount obtained following Step 2 plus the action’s revenues, over the eligible costs and contributions approved by the granting authority). ‘Revenue’ is all income generated by the action, during its duration (see Article 4), for beneficiaries that are profit legal entities. If there is a profit, it will be deducted in proportion to the final rate of reimbursement of the eligible costs approved by the granting authority (as compared to the amount calculated following Steps 1 and 2 minus the contributions). The balance (final payment) is then calculated by deducting the total amount of prefinancing and interim payments already made (if any), from the final grant amount: {final grant amount minus {prefinancing and interim payments made (if any)}}. If the balance is positive, it will be paid to the coordinator. The final payment (or part of it) may be offset (without the beneficiaries’ consent) against amounts owed by a beneficiary to the granting authority — up to the amount due to that beneficiary. For grants where the granting authority is the European Commission or an EU executive agency, offsetting may also be done against amounts owed to other Commission services or executive agencies. Payments will not be made if the payment deadline or payments are suspended (see Articles 29 and 30). If the balance is negative, it will be recovered in accordance with the following procedure: The granting authority will send a pre-information letter to the coordinator: - formally notifying the intention to recover, the final grant amount, the amount to be recovered and the reasons why - requesting observations within 30 days of receiving notification. If no observations are submitted (or the granting authority decides to pursue recovery despite the observations it has received), it will confirm the amount to be recovered (confirmation letter), together with a debit note with the terms and date for payment. If payment is not made by the date specified in the debit note, the granting authority will enforce recovery in accordance with Article 22.4. 22.3.5 Audit implementation after final payment — Revised final grant amount — Recovery If — after the final payment (in particular, after checks, reviews, audits or investigations; see 43 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Article 25) — the granting authority rejects costs or contributions (see Article 27) or reduces the grant (see Article 28), it will calculate the revised final grant amount for the beneficiary concerned. The beneficiary revised final grant amount will be calculated in the following step: Step 1 — Calculation of the revised total accepted EU contribution Step 1 — Calculation of the revised total accepted EU contribution The granting authority will first calculate the ‘revised accepted EU contribution’ for the beneficiary, by calculating the ‘revised accepted costs’ and ‘revised accepted contributions’. After that, it will take into account grant reductions (if any). The resulting ‘revised total accepted EU contribution’ is the beneficiary revised final grant amount. If the revised final grant amount is lower than the beneficiary’s final grant amount (i.e. its share in the final grant amount for the action), it will be recovered in accordance with the following procedure: The beneficiary final grant amount (i.e. share in the final grant amount for the action) is calculated as follows: {{total accepted EU contribution for the beneficiary divided by total accepted EU contribution for the action} multiplied by final grant amount for the action}. The granting authority will send a pre-information letter to the beneficiary concerned: - formally notifying the intention to recover, the amount to be recovered and the reasons why and - requesting observations within 30 days of receiving notification. If no observations are submitted (or the granting authority decides to pursue recovery despite the observations it has received), it will confirm the amount to be recovered (confirmation letter), together with a debit note with the terms and the date for payment. Recoveries against affiliated entities (if any) will be handled through their beneficiaries. If payment is not made by the date specified in the debit note, the granting authority will enforce recovery in accordance with Article 22.4. 22.4 Enforced recovery If payment is not made by the date specified in the debit note, the amount due will be recovered: (a) by offsetting the amount — without the coordinator or beneficiary’s consent — against any amounts owed to the coordinator or beneficiary by the granting authority. In exceptional circumstances, to safeguard the EU financial interests, the amount may be offset before the payment date specified in the debit note. 44 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 For grants where the granting authority is the European Commission or an EU executive agency, debts may also be offset against amounts owed by other Commission services or executive agencies. (b) by drawing on the financial guarantee(s) (if any) (c) by holding other beneficiaries jointly and severally liable (if any; see Data Sheet, Point 4.4) (d) by holding affiliated entities jointly and severally liable (if any, see Data Sheet, Point 4.4) (e) by taking legal action (see Article 43) or, provided that the granting authority is the European Commission or an EU executive agency, by adopting an enforceable decision under Article 299 of the Treaty on the Functioning of the EU (TFEU) and Article 100(2) of EU Financial Regulation 2018/1046. The amount to be recovered will be increased by late-payment interest at the rate set out in Article 22.5, from the day following the payment date in the debit note, up to and including the date the full payment is received. Partial payments will be first credited against expenses, charges and late-payment interest and then against the principal. Bank charges incurred in the recovery process will be borne by the beneficiary, unless Directive 2015/236620 applies. For grants where the granting authority is an EU executive agency, enforced recovery by offsetting or enforceable decision will be done by the services of the European Commission (see also Article 43). 22.5 Consequences of non-compliance 22.5.1 If the granting authority does not pay within the payment deadlines (see above), the beneficiaries are entitled to late-payment interest at the rate applied by the European Central Bank (ECB) for its main refinancing operations in euros (‘reference rate’), plus the rate specified in the Data Sheet (Point 4.2). The reference rate is the rate in force on the first day of the month in which the payment deadline expires, as published in the C series of the Official Journal of the European Union. If the late-payment interest is lower than or equal to EUR 200, it will be paid to the coordinator only on request submitted within two months of receiving the late payment. Late-payment interest is not due if all beneficiaries are EU Member States (including regional and local government authorities or other public bodies acting on behalf of a Member State for the purpose of this Agreement). If payments or the payment deadline are suspended (see Articles 29 and 30), payment will not be considered as late. 20 Directive (EU) 2015/2366 of the European Parliament and of the Council of 25 November 2015 on payment services in the internal market, amending Directives 2002/65/EC, 2009/110/EC and 2013/36/EU and Regulation (EU) No 1093/2010, and repealing Directive 2007/64/EC (OJ L 337, 23.12.2015, p. 35). 45 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Late-payment interest covers the period running from the day following the due date for payment (see above), up to and including the date of payment. Late-payment interest is not considered for the purposes of calculating the final grant amount. 22.5.2 If the coordinator breaches any of its obligations under this Article, the grant may be reduced (see Article 28) and the grant or the coordinator may be terminated (see Article 32). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 23 — GUARANTEES 23.1 Prefinancing guarantee If required by the granting authority (see Data Sheet, Point 4.2), the beneficiaries must provide (one or more) prefinancing guarantee(s) in accordance with the timing and the amounts set out in the Data Sheet. The coordinator must submit them to the granting authority in due time before the prefinancing they are linked to. The guarantees must be drawn up using the template published on the Portal and fulfil the following conditions: (a) be provided by a bank or approved financial institution established in the EU or — if requested by the coordinator and accepted by the granting authority — by a third party or a bank or financial institution established outside the EU offering equivalent security (b) the guarantor stands as first-call guarantor and does not require the granting authority to first have recourse against the principal debtor (i.e. the beneficiary concerned) and (c) remain explicitly in force until the final payment and, if the final payment takes the form of a recovery, until five months after the debit note is notified to a beneficiary. They will be released within the following month. 23.2 Consequences of non-compliance If the beneficiaries breach their obligation to provide the prefinancing guarantee, the prefinancing will not be paid. Such breaches may also lead to other measures described in Chapter 5. ARTICLE 24 — CERTIFICATES 24.1 Operational verification report (OVR) Not applicable 24.2 Certificate on the financial statements (CFS) If required by the granting authority (see Data Sheet, Point 4.3), the beneficiaries must provide 46 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 certificates on their financial statements (CFS), in accordance with the schedule, threshold and conditions set out in the Data Sheet. The coordinator must submit them as part of the periodic report (see Article 21). The certificates must be drawn up using the template published on the Portal, cover the costs declared on the basis of actual costs and costs according to usual cost accounting practices (if any), and fulfil the following conditions: (a) be provided by a qualified approved external auditor which is independent and complies with Directive 2006/43/EC21 (or for public bodies: by a competent independent public officer) (b) the verification must be carried out according to the highest professional standards to ensure that the financial statements comply with the provisions under the Agreement and that the costs declared are eligible. The certificates will not affect the granting authority's right to carry out its own checks, reviews or audits, nor preclude the European Court of Auditors (ECA), the European Public Prosecutor’s Office (EPPO) or the European Anti-Fraud Office (OLAF) from using their prerogatives for audits and investigations under the Agreement (see Article 25). If the costs (or a part of them) were already audited by the granting authority, these costs do not need to be covered by the certificate and will not be counted for calculating the threshold (if any). 24.3 Certificate on the compliance of usual cost accounting practices (CoMUC) Not applicable 24.4 Systems and process audit (SPA) Not applicable 24.5 Consequences of non-compliance If a beneficiary does not submit a certificate on the financial statements (CFS) or the certificate is rejected, the accepted EU contribution to costs will be capped to reflect the CFS threshold. If a beneficiary breaches any of its other obligations under this Article, the granting authority may apply the measures described in Chapter 5. ARTICLE 25 — CHECKS, REVIEWS, AUDITS AND INVESTIGATIONS — EXTENSION OF FINDINGS 25.1 Granting authority checks, reviews and audits 25.1.1 Internal checks The granting authority may — during the action or afterwards — check the proper implementation of 21 Directive 2006/43/EC of the European Parliament and of the Council of 17 May 2006 on statutory audits of annual accounts and consolidated accounts or similar national regulations (OJ L 157, 9.6.2006, p. 87). 47 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 the action and compliance with the obligations under the Agreement, including assessing costs and contributions, deliverables and reports. 25.1.2 Project reviews The granting authority may carry out reviews on the proper implementation of the action and compliance with the obligations under the Agreement (general project reviews or specific issues reviews). Such project reviews may be started during the implementation of the action and until the time-limit set out in the Data Sheet (see Point 6). They will be formally notified to the coordinator or beneficiary concerned and will be considered to start on the date of the notification. If needed, the granting authority may be assisted by independent, outside experts. If it uses outside experts, the coordinator or beneficiary concerned will be informed and have the right to object on grounds of commercial confidentiality or conflict of interest. The coordinator or beneficiary concerned must cooperate diligently and provide — within the deadline requested — any information and data in addition to deliverables and reports already submitted (including information on the use of resources). The granting authority may request beneficiaries to provide such information to it directly. Sensitive information and documents will be treated in accordance with Article 13. The coordinator or beneficiary concerned may be requested to participate in meetings, including with the outside experts. For on-the-spot visits, the beneficiary concerned must allow access to sites and premises (including to the outside experts) and must ensure that information requested is readily available. Information provided must be accurate, precise and complete and in the format requested, including electronic format. On the basis of the review findings, a project review report will be drawn up. The granting authority will formally notify the project review report to the coordinator or beneficiary concerned, which has 30 days from receiving notification to make observations. Project reviews (including project review reports) will be in the language of the Agreement. 25.1.3 Audits The granting authority may carry out audits on the proper implementation of the action and compliance with the obligations under the Agreement. Such audits may be started during the implementation of the action and until the time-limit set out in the Data Sheet (see Point 6). They will be formally notified to the beneficiary concerned and will be considered to start on the date of the notification. The granting authority may use its own audit service, delegate audits to a centralised service or use external audit firms. If it uses an external firm, the beneficiary concerned will be informed and have the right to object on grounds of commercial confidentiality or conflict of interest. The beneficiary concerned must cooperate diligently and provide — within the deadline requested — 48 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 any information (including complete accounts, individual salary statements or other personal data) to verify compliance with the Agreement. Sensitive information and documents will be treated in accordance with Article 13. For on-the-spot visits, the beneficiary concerned must allow access to sites and premises (including for the external audit firm) and must ensure that information requested is readily available. Information provided must be accurate, precise and complete and in the format requested, including electronic format. On the basis of the audit findings, a draft audit report will be drawn up. The auditors will formally notify the draft audit report to the beneficiary concerned, which has 30 days from receiving notification to make observations (contradictory audit procedure). The final audit report will take into account observations by the beneficiary concerned and will be formally notified to them. Audits (including audit reports) will be in the language of the Agreement. 25.2 European Commission checks, reviews and audits in grants of other granting authorities Where the granting authority is not the European Commission, the latter has the same rights of checks, reviews and audits as the granting authority. 25.3 Access to records for assessing simplified forms of funding The beneficiaries must give the European Commission access to their statutory records for the periodic assessment of simplified forms of funding which are used in EU programmes. 25.4 OLAF, EPPO and ECA audits and investigations The following bodies may also carry out checks, reviews, audits and investigations — during the action or afterwards: - the European Anti-Fraud Office (OLAF) under Regulations No 883/201322 and No 2185/9623 - the European Public Prosecutor’s Office (EPPO) under Regulation 2017/1939 - the European Court of Auditors (ECA) under Article 287 of the Treaty on the Functioning of the EU (TFEU) and Article 257 of EU Financial Regulation 2018/1046. If requested by these bodies, the beneficiary concerned must provide full, accurate and complete information in the format requested (including complete accounts, individual salary statements or 22 Regulation (EU, Euratom) No 883/2013 of the European Parliament and of the Council of 11 September 2013 concerning investigations conducted by the European Anti-Fraud Office (OLAF) and repealing Regulation (EC) No 1073/1999 of the European Parliament and of the Council and Council Regulation (Euratom) No 1074/1999 (OJ L 248, 18/09/2013, p. 1). 23 Council Regulation (Euratom, EC) No 2185/96 of 11 November 1996 concerning on-the-spot checks and inspections carried out by the Commission in order to protect the European Communities' financial interests against fraud and other irregularities (OJ L 292, 15/11/1996, p. 2). 49 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 other personal data, including in electronic format) and allow access to sites and premises for on-the-spot visits or inspections — as provided for under these Regulations. To this end, the beneficiary concerned must keep all relevant information relating to the action, at least until the time-limit set out in the Data Sheet (Point 6) and, in any case, until any ongoing checks, reviews, audits, investigations, litigation or other pursuits of claims have been concluded. 25.5 Consequences of checks, reviews, audits and investigations — Extension of results of reviews, audits or investigations 25.5.1 Consequences of checks, reviews, audits and investigations in this grant Findings in checks, reviews, audits or investigations carried out in the context of this grant may lead to rejections (see Article 27), grant reduction (see Article 28) or other measures described in Chapter 5. Rejections or grant reductions after the final payment will lead to a revised final grant amount (see Article 22). Findings in checks, reviews, audits or investigations during the action implementation may lead to a request for amendment (see Article 39), to change the description of the action set out in Annex 1. Checks, reviews, audits or investigations that find systemic or recurrent errors, irregularities, fraud or breach of obligations in any EU grant may also lead to consequences in other EU grants awarded under similar conditions (‘extension to other grants’). Moreover, findings arising from an OLAF or EPPO investigation may lead to criminal prosecution under national law. 25.5.2 Extension from other grants Results of checks, reviews, audits or investigations in other grants may be extended to this grant, if: (a) the beneficiary concerned is found, in other EU grants awarded under similar conditions, to have committed systemic or recurrent errors, irregularities, fraud or breach of obligations that have a material impact on this grant and (b) those findings are formally notified to the beneficiary concerned — together with the list of grants affected by the findings — within the time-limit for audits set out in the Data Sheet (see Point 6). The granting authority will formally notify the beneficiary concerned of the intention to extend the findings and the list of grants affected. If the extension concerns rejections of costs or contributions: the notification will include: (a) an invitation to submit observations on the list of grants affected by the findings (b) the request to submit revised financial statements for all grants affected (c) the correction rate for extrapolation, established on the basis of the systemic or recurrent errors, to calculate the amounts to be rejected, if the beneficiary concerned: 50 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 (i) considers that the submission of revised financial statements is not possible or practicable or (ii) does not submit revised financial statements. If the extension concerns grant reductions: the notification will include: (a) an invitation to submit observations on the list of grants affected by the findings and (b) the correction rate for extrapolation, established on the basis of the systemic or recurrent errors and the principle of proportionality. The beneficiary concerned has 60 days from receiving notification to submit observations, revised financial statements or to propose a duly substantiated alternative correction method/rate. On the basis of this, the granting authority will analyse the impact and decide on the implementation (i.e. start rejection or grant reduction procedures, either on the basis of the revised financial statements or the announced/alternative method/rate or a mix of those; see Articles 27 and 28). 25.6 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, costs or contributions insufficiently substantiated will be ineligible (see Article 6) and will be rejected (see Article 27), and the grant may be reduced (see Article 28). Such breaches may also lead to other measures described in Chapter 5. ARTICLE 26 — IMPACT EVALUATIONS 26.1 Impact evaluation The granting authority may carry out impact evaluations of the action, measured against the objectives and indicators of the EU programme funding the grant. Such evaluations may be started during implementation of the action and until the time-limit set out in the Data Sheet (see Point 6). They will be formally notified to the coordinator or beneficiaries and will be considered to start on the date of the notification. If needed, the granting authority may be assisted by independent outside experts. The coordinator or beneficiaries must provide any information relevant to evaluate the impact of the action, including information in electronic format. 26.2 Consequences of non-compliance If a beneficiary breaches any of its obligations under this Article, the granting authority may apply the measures described in Chapter 5. CHAPTER 5 CONSEQUENCES OF NON-COMPLIANCE 51 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 SECTION 1 REJECTIONS AND GRANT REDUCTION ARTICLE 27 — REJECTION OF COSTS AND CONTRIBUTIONS 27.1 Conditions The granting authority will — at beneficiary termination, interim payment, final payment or afterwards — reject any costs or contributions which are ineligible (see Article 6), in particular following checks, reviews, audits or investigations (see Article 25). The rejection may also be based on the extension of findings from other grants to this grant (see Article 25). Ineligible costs or contributions will be rejected. 27.2 Procedure If the rejection does not lead to a recovery, the granting authority will formally notify the coordinator or beneficiary concerned of the rejection, the amounts and the reasons why. The coordinator or beneficiary concerned may — within 30 days of receiving notification — submit observations if it disagrees with the rejection (payment review procedure). If the rejection leads to a recovery, the granting authority will follow the contradictory procedure with pre-information letter set out in Article 22. 27.3 Effects If the granting authority rejects costs or contributions, it will deduct them from the costs or contributions declared and then calculate the amount due (and, if needed, make a recovery; see Article 22). ARTICLE 28 — GRANT REDUCTION 28.1 Conditions The granting authority may — at beneficiary termination, final payment or afterwards — reduce the grant for a beneficiary, if: (a) the beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.), or (b) the beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU grants 52 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (see Article 25). The amount of the reduction will be calculated for each beneficiary concerned and proportionate to the seriousness and the duration of the errors, irregularities or fraud or breach of obligations, by applying an individual reduction rate to their accepted EU contribution. 28.2 Procedure If the grant reduction does not lead to a recovery, the granting authority will formally notify the coordinator or beneficiary concerned of the reduction, the amount to be reduced and the reasons why. The coordinator or beneficiary concerned may — within 30 days of receiving notification — submit observations if it disagrees with the reduction (payment review procedure). If the grant reduction leads to a recovery, the granting authority will follow the contradictory procedure with pre-information letter set out in Article 22. 28.3 Effects If the granting authority reduces the grant, it will deduct the reduction and then calculate the amount due (and, if needed, make a recovery; see Article 22). SECTION 2 SUSPENSION AND TERMINATION ARTICLE 29 — PAYMENT DEADLINE SUSPENSION 29.1 Conditions The granting authority may — at any moment — suspend the payment deadline if a payment cannot be processed because: (a) the required report (see Article 21) has not been submitted or is not complete or additional information is needed (b) there are doubts about the amount to be paid (e.g. ongoing audit extension procedure, queries about eligibility, need for a grant reduction, etc.) and additional checks, reviews, audits or investigations are necessary, or (c) there are other issues affecting the EU financial interests. 29.2 Procedure The granting authority will formally notify the coordinator of the suspension and the reasons why. The suspension will take effect the day the notification is sent. If the conditions for suspending the payment deadline are no longer met, the suspension will be lifted — and the remaining time to pay (see Data Sheet, Point 4.2) will resume. If the suspension exceeds two months, the coordinator may request the granting authority to confirm if the suspension will continue. 53 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 If the payment deadline has been suspended due to the non-compliance of the report and the revised report is not submitted (or was submitted but is also rejected), the granting authority may also terminate the grant or the participation of the coordinator (see Article 32). ARTICLE 30 — PAYMENT SUSPENSION 30.1 Conditions The granting authority may — at any moment — suspend payments, in whole or in part for one or more beneficiaries, if: (a) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed or is suspected of having committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.), or (b) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant. If payments are suspended for one or more beneficiaries, the granting authority will make partial payment(s) for the part(s) not suspended. If suspension concerns the final payment, the payment (or recovery) of the remaining amount after suspension is lifted will be considered to be the payment that closes the action. 30.2 Procedure Before suspending payments, the granting authority will send a pre-information letter to the beneficiary concerned: - formally notifying the intention to suspend payments and the reasons why and - requesting observations within 30 days of receiving notification. If the granting authority does not receive observations or decides to pursue the procedure despite the observations it has received, it will confirm the suspension (confirmation letter). Otherwise, it will formally notify that the procedure is discontinued. At the end of the suspension procedure, the granting authority will also inform the coordinator. The suspension will take effect the day after the confirmation notification is sent. If the conditions for resuming payments are met, the suspension will be lifted. The granting authority will formally notify the beneficiary concerned (and the coordinator) and set the suspension end date. 54 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 During the suspension, no prefinancing will be paid to the beneficiaries concerned. For interim payments, the periodic reports for all reporting periods except the last one (see Article 21) must not contain any financial statements from the beneficiary concerned (or its affiliated entities). The coordinator must include them in the next periodic report after the suspension is lifted or — if suspension is not lifted before the end of the action — in the last periodic report. ARTICLE 31 — GRANT AGREEMENT SUSPENSION 31.1 Consortium-requested GA suspension 31.1.1 Conditions and procedure The beneficiaries may request the suspension of the grant or any part of it, if exceptional circumstances — in particular force majeure (see Article 35) — make implementation impossible or excessively difficult. The coordinator must submit a request for amendment (see Article 39), with: - the reasons why - the date the suspension takes effect; this date may be before the date of the submission of the amendment request and - the expected date of resumption. The suspension will take effect on the day specified in the amendment. Once circumstances allow for implementation to resume, the coordinator must immediately request another amendment of the Agreement to set the suspension end date, the resumption date (one day after suspension end date), extend the duration and make other changes necessary to adapt the action to the new situation (see Article 39) — unless the grant has been terminated (see Article 32). The suspension will be lifted with effect from the suspension end date set out in the amendment. This date may be before the date of the submission of the amendment request. During the suspension, no prefinancing will be paid. Costs incurred or contributions for activities implemented during grant suspension are not eligible (see Article 6.3). 31.2 EU-initiated GA suspension 31.2.1 Conditions The granting authority may suspend the grant or any part of it, if: (a) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed or is suspected of having committed: (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, 55 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.), or (b) a beneficiary (or a person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (c) other: (i) linked action issues: not applicable (ii) additional GA suspension grounds: not applicable. 31.2.2 Procedure Before suspending the grant, the granting authority will send a pre-information letter to the coordinator: - formally notifying the intention to suspend the grant and the reasons why and - requesting observations within 30 days of receiving notification. If the granting authority does not receive observations or decides to pursue the procedure despite the observations it has received, it will confirm the suspension (confirmation letter). Otherwise, it will formally notify that the procedure is discontinued. The suspension will take effect the day after the confirmation notification is sent (or on a later date specified in the notification). Once the conditions for resuming implementation of the action are met, the granting authority will formally notify the coordinator a lifting of suspension letter, in which it will set the suspension end date and invite the coordinator to request an amendment of the Agreement to set the resumption date (one day after suspension end date), extend the duration and make other changes necessary to adapt the action to the new situation (see Article 39) — unless the grant has been terminated (see Article 32). The suspension will be lifted with effect from the suspension end date set out in the lifting of suspension letter. This date may be before the date on which the letter is sent. During the suspension, no prefinancing will be paid. Costs incurred or contributions for activities implemented during suspension are not eligible (see Article 6.3). The beneficiaries may not claim damages due to suspension by the granting authority (see Article 33). Grant suspension does not affect the granting authority’s right to terminate the grant or a beneficiary (see Article 32) or reduce the grant (see Article 28). ARTICLE 32 — GRANT AGREEMENT OR BENEFICIARY TERMINATION 32.1 Consortium-requested GA termination 32.1.1 Conditions and procedure 56 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 The beneficiaries may request the termination of the grant. The coordinator must submit a request for amendment (see Article 39), with: - the reasons why - the date the consortium ends work on the action (‘end of work date’) and - the date the termination takes effect (‘termination date’); this date must be after the date of the submission of the amendment request. The termination will take effect on the termination date specified in the amendment. If no reasons are given or if the granting authority considers the reasons do not justify termination, it may consider the grant terminated improperly. 32.1.2 Effects The coordinator must — within 60 days from when termination takes effect — submit a periodic report (for the open reporting period until termination). The granting authority will calculate the final grant amount and final payment on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before the end of work date (see Article 22). Costs relating to contracts due for execution only after the end of work are not eligible. If the granting authority does not receive the report within the deadline, only costs and contributions which are included in an approved periodic report will be taken into account (no costs/contributions if no periodic report was ever approved). Improper termination may lead to a grant reduction (see Article 28). After termination, the beneficiaries’ obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. 32.2 Consortium-requested beneficiary termination 32.2.1 Conditions and procedure The coordinator may request the termination of the participation of one or more beneficiaries, on request of the beneficiary concerned or on behalf of the other beneficiaries. The coordinator must submit a request for amendment (see Article 39), with: - the reasons why - the opinion of the beneficiary concerned (or proof that this opinion has been requested in writing) - the date the beneficiary ends work on the action (‘end of work date’) 57 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 - the date the termination takes effect (‘termination date’); this date must be after the date of the submission of the amendment request. If the termination concerns the coordinator and is done without its agreement, the amendment request must be submitted by another beneficiary (acting on behalf of the consortium). The termination will take effect on the termination date specified in the amendment. If no information is given or if the granting authority considers that the reasons do not justify termination, it may consider the beneficiary to have been terminated improperly. 32.2.2 Effects The coordinator must — within 60 days from when termination takes effect — submit: (i) a report on the distribution of payments to the beneficiary concerned (ii) a termination report from the beneficiary concerned, for the open reporting period until termination, containing an overview of the progress of the work, the financial statement, the explanation on the use of resources, and, if applicable, the certificate on the financial statement (CFS; see Articles 21 and 24.2 and Data Sheet, Point 4.3) (iii) a second request for amendment (see Article 39) with other amendments needed (e.g. reallocation of the tasks and the estimated budget of the terminated beneficiary; addition of a new beneficiary to replace the terminated beneficiary; change of coordinator, etc.). The granting authority will calculate the amount due to the beneficiary on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before the end of work date (see Article 22). Costs relating to contracts due for execution only after the end of work are not eligible. The information in the termination report must also be included in the periodic report for the next reporting period (see Article 21). If the granting authority does not receive the termination report within the deadline, only costs and contributions which are included in an approved periodic report will be taken into account (no costs/ contributions if no periodic report was ever approved). If the granting authority does not receive the report on the distribution of payments within the deadline, it will consider that: - the coordinator did not distribute any payment to the beneficiary concerned and that - the beneficiary concerned must not repay any amount to the coordinator. If the second request for amendment is accepted by the granting authority, the Agreement is amended to introduce the necessary changes (see Article 39). If the second request for amendment is rejected by the granting authority (because it calls into question the decision awarding the grant or breaches the principle of equal treatment of applicants), the grant may be terminated (see Article 32). 58 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Improper termination may lead to a reduction of the grant (see Article 31) or grant termination (see Article 32). After termination, the concerned beneficiary’s obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. 32.3 EU-initiated GA or beneficiary termination 32.3.1 Conditions The granting authority may terminate the grant or the participation of one or more beneficiaries, if: (a) one or more beneficiaries do not accede to the Agreement (see Article 40) (b) a change to the action or the legal, financial, technical, organisational or ownership situation of a beneficiary is likely to substantially affect the implementation of the action or calls into question the decision to award the grant (including changes linked to one of the exclusion grounds listed in the declaration of honour) (c) following termination of one or more beneficiaries, the necessary changes to the Agreement (and their impact on the action) would call into question the decision awarding the grant or breach the principle of equal treatment of applicants (d) implementation of the action has become impossible or the changes necessary for its continuation would call into question the decision awarding the grant or breach the principle of equal treatment of applicants (e) a beneficiary (or person with unlimited liability for its debts) is subject to bankruptcy proceedings or similar (including insolvency, winding-up, administration by a liquidator or court, arrangement with creditors, suspension of business activities, etc.) (f) a beneficiary (or person with unlimited liability for its debts) is in breach of social security or tax obligations (g) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has been found guilty of grave professional misconduct (h) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed fraud, corruption, or is involved in a criminal organisation, money laundering, terrorism-related crimes (including terrorism financing), child labour or human trafficking (i) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) was created under a different jurisdiction with the intent to circumvent fiscal, social or other legal obligations in the country of origin (or created another entity with this purpose) (j) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed: 59 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 (i) substantial errors, irregularities or fraud or (ii) serious breach of obligations under this Agreement or during its award (including improper implementation of the action, non-compliance with the call conditions, submission of false information, failure to provide required information, breach of ethics or security rules (if applicable), etc.) (k) a beneficiary (or person having powers of representation, decision-making or control, or person essential for the award/implementation of the grant) has committed — in other EU grants awarded to it under similar conditions — systemic or recurrent errors, irregularities, fraud or serious breach of obligations that have a material impact on this grant (extension of findings from other grants to this grant; see Article 25) (l) despite a specific request by the granting authority, a beneficiary does not request — through the coordinator — an amendment to the Agreement to end the participation of one of its affiliated entities or associated partners that is in one of the situations under points (d), (f), (e), (g), (h), (i) or (j) and to reallocate its tasks, or (m) other: (i) linked action issues: not applicable (ii) additional GA termination grounds: not applicable. 32.3.2 Procedure Before terminating the grant or participation of one or more beneficiaries, the granting authority will send a pre-information letter to the coordinator or beneficiary concerned: - formally notifying the intention to terminate and the reasons why and - requesting observations within 30 days of receiving notification. If the granting authority does not receive observations or decides to pursue the procedure despite the observations it has received, it will confirm the termination and the date it will take effect (confirmation letter). Otherwise, it will formally notify that the procedure is discontinued. For beneficiary terminations, the granting authority will — at the end of the procedure — also inform the coordinator. The termination will take effect the day after the confirmation notification is sent (or on a later date specified in the notification; ‘termination date’). 32.3.3 Effects (a) for GA termination: The coordinator must — within 60 days from when termination takes effect — submit a periodic report (for the last open reporting period until termination). The granting authority will calculate the final grant amount and final payment on the basis of the report submitted and taking into account the costs incurred and contributions for activities 60 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 implemented before termination takes effect (see Article 22). Costs relating to contracts due for execution only after termination are not eligible. If the grant is terminated for breach of the obligation to submit reports, the coordinator may not submit any report after termination. If the granting authority does not receive the report within the deadline, only costs and contributions which are included in an approved periodic report will be taken into account (no costs/contributions if no periodic report was ever approved). Termination does not affect the granting authority’s right to reduce the grant (see Article 28) or to impose administrative sanctions (see Article 34). The beneficiaries may not claim damages due to termination by the granting authority (see Article 33). After termination, the beneficiaries’ obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. (b) for beneficiary termination: The coordinator must — within 60 days from when termination takes effect — submit: (i) a report on the distribution of payments to the beneficiary concerned (ii) a termination report from the beneficiary concerned, for the open reporting period until termination, containing an overview of the progress of the work, the financial statement, the explanation on the use of resources, and, if applicable, the certificate on the financial statement (CFS; see Articles 21 and 24.2 and Data Sheet, Point 4.3) (iii) a request for amendment (see Article 39) with any amendments needed (e.g. reallocation of the tasks and the estimated budget of the terminated beneficiary; addition of a new beneficiary to replace the terminated beneficiary; change of coordinator, etc.). The granting authority will calculate the amount due to the beneficiary on the basis of the report submitted and taking into account the costs incurred and contributions for activities implemented before termination takes effect (see Article 22). Costs relating to contracts due for execution only after termination are not eligible. The information in the termination report must also be included in the periodic report for the next reporting period (see Article 21). If the granting authority does not receive the termination report within the deadline, only costs and contributions included in an approved periodic report will be taken into account (no costs/ contributions if no periodic report was ever approved). If the granting authority does not receive the report on the distribution of payments within the deadline, it will consider that: 61 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 - the coordinator did not distribute any payment to the beneficiary concerned and that - the beneficiary concerned must not repay any amount to the coordinator. If the request for amendment is accepted by the granting authority, the Agreement is amended to introduce the necessary changes (see Article 39). If the request for amendment is rejected by the granting authority (because it calls into question the decision awarding the grant or breaches the principle of equal treatment of applicants), the grant may be terminated (see Article 32). After termination, the concerned beneficiary’s obligations (in particular Articles 13 (confidentiality and security), 16 (IPR), 17 (communication, dissemination and visibility), 21 (reporting), 25 (checks, reviews, audits and investigations), 26 (impact evaluation), 27 (rejections), 28 (grant reduction) and 42 (assignment of claims)) continue to apply. SECTION 3 OTHER CONSEQUENCES: DAMAGES AND ADMINISTRATIVE SANCTIONS ARTICLE 33 — DAMAGES 33.1 Liability of the granting authority The granting authority cannot be held liable for any damage caused to the beneficiaries or to third parties as a consequence of the implementation of the Agreement, including for gross negligence. The granting authority cannot be held liable for any damage caused by any of the beneficiaries or other participants involved in the action, as a consequence of the implementation of the Agreement. 33.2 Liability of the beneficiaries The beneficiaries must compensate the granting authority for any damage it sustains as a result of the implementation of the action or because the action was not implemented in full compliance with the Agreement, provided that it was caused by gross negligence or wilful act. The liability does not extend to indirect or consequential losses or similar damage (such as loss of profit, loss of revenue or loss of contracts), provided such damage was not caused by wilful act or by a breach of confidentiality. ARTICLE 34 — ADMINISTRATIVE SANCTIONS AND OTHER MEASURES Nothing in this Agreement may be construed as preventing the adoption of administrative sanctions (i.e. exclusion from EU award procedures and/or financial penalties) or other public law measures, in addition or as an alternative to the contractual measures provided under this Agreement (see, for instance, Articles 135 to 145 EU Financial Regulation 2018/1046 and Articles 4 and 7 of Regulation 2988/9524). 24 Council Regulation (EC, Euratom) No 2988/95 of 18 December 1995 on the protection of the European Communities financial interests (OJ L 312, 23.12.1995, p. 1). 62 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 SECTION 4 FORCE MAJEURE ARTICLE 35 — FORCE MAJEURE A party prevented by force majeure from fulfilling its obligations under the Agreement cannot be considered in breach of them. ‘Force majeure’ means any situation or event that: - prevents either party from fulfilling their obligations under the Agreement, - was unforeseeable, exceptional situation and beyond the parties’ control, - was not due to error or negligence on their part (or on the part of other participants involved in the action), and - proves to be inevitable in spite of exercising all due diligence. Any situation constituting force majeure must be formally notified to the other party without delay, stating the nature, likely duration and foreseeable effects. The parties must immediately take all the necessary steps to limit any damage due to force majeure and do their best to resume implementation of the action as soon as possible. CHAPTER 6 FINAL PROVISIONS ARTICLE 36 — COMMUNICATION BETWEEN THE PARTIES 36.1 Forms and means of communication — Electronic management EU grants are managed fully electronically through the EU Funding & Tenders Portal (‘Portal’). All communications must be made electronically through the Portal, in accordance with the Portal Terms and Conditions and using the forms and templates provided there (except if explicitly instructed otherwise by the granting authority). Communications must be made in writing and clearly identify the grant agreement (project number and acronym). Communications must be made by persons authorised according to the Portal Terms and Conditions. For naming the authorised persons, each beneficiary must have designated — before the signature of this Agreement — a ‘legal entity appointed representative (LEAR)’. The role and tasks of the LEAR are stipulated in their appointment letter (see Portal Terms and Conditions). If the electronic exchange system is temporarily unavailable, instructions will be given on the Portal. 36.2 Date of communication The sending date for communications made through the Portal will be the date and time of sending, as indicated by the time logs. 63 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 The receiving date for communications made through the Portal will be the date and time the communication is accessed, as indicated by the time logs. Formal notifications that have not been accessed within 10 days after sending, will be considered to have been accessed (see Portal Terms and Conditions). If a communication is exceptionally made on paper (by e-mail or postal service), general principles apply (i.e. date of sending/receipt). Formal notifications by registered post with proof of delivery will be considered to have been received either on the delivery date registered by the postal service or the deadline for collection at the post office. If the electronic exchange system is temporarily unavailable, the sending party cannot be considered in breach of its obligation to send a communication within a specified deadline. 36.3 Addresses for communication The Portal can be accessed via the Europa website. The address for paper communications to the granting authority (if exceptionally allowed) is the official mailing address indicated on its website. For beneficiaries, it is the legal address specified in the Portal Participant Register. ARTICLE 37 — INTERPRETATION OF THE AGREEMENT The provisions in the Data Sheet take precedence over the rest of the Terms and Conditions of the Agreement. Annex 5 takes precedence over the Terms and Conditions; the Terms and Conditions take precedence over the Annexes other than Annex 5. Annex 2 takes precedence over Annex 1. ARTICLE 38 — CALCULATION OF PERIODS AND DEADLINES In accordance with Regulation No 1182/7125, periods expressed in days, months or years are calculated from the moment the triggering event occurs. The day during which that event occurs is not considered as falling within the period. ‘Days’ means calendar days, not working days. ARTICLE 39 — AMENDMENTS 39.1 Conditions The Agreement may be amended, unless the amendment entails changes to the Agreement which would call into question the decision awarding the grant or breach the principle of equal treatment of applicants. 25 Regulation (EEC, Euratom) No 1182/71 of the Council of 3 June 1971 determining the rules applicable to periods, dates and time-limits (OJ L 124, 8/6/1971, p. 1). 64 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 Amendments may be requested by any of the parties. 39.2 Procedure The party requesting an amendment must submit a request for amendment signed directly in the Portal Amendment tool. The coordinator submits and receives requests for amendment on behalf of the beneficiaries (see Annex 3). If a change of coordinator is requested without its agreement, the submission must be done by another beneficiary (acting on behalf of the other beneficiaries). The request for amendment must include: - the reasons why - the appropriate supporting documents and - for a change of coordinator without its agreement: the opinion of the coordinator (or proof that this opinion has been requested in writing). The granting authority may request additional information. If the party receiving the request agrees, it must sign the amendment in the tool within 45 days of receiving notification (or any additional information the granting authority has requested). If it does not agree, it must formally notify its disagreement within the same deadline. The deadline may be extended, if necessary for the assessment of the request. If no notification is received within the deadline, the request is considered to have been rejected. An amendment enters into force on the day of the signature of the receiving party. An amendment takes effect on the date of entry into force or other date specified in the amendment. ARTICLE 40 — ACCESSION AND ADDITION OF NEW BENEFICIARIES 40.1 Accession of the beneficiaries mentioned in the Preamble The beneficiaries which are not coordinator must accede to the grant by signing the accession form (see Annex 3) directly in the Portal Grant Preparation tool, within 30 days after the entry into force of the Agreement (see Article 44). They will assume the rights and obligations under the Agreement with effect from the date of its entry into force (see Article 44). If a beneficiary does not accede to the grant within the above deadline, the coordinator must — within 30 days — request an amendment (see Article 39) to terminate the beneficiary and make any changes necessary to ensure proper implementation of the action. This does not affect the granting authority’s right to terminate the grant (see Article 32). 40.2 Addition of new beneficiaries In justified cases, the beneficiaries may request the addition of a new beneficiary. 65 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 For this purpose, the coordinator must submit a request for amendment in accordance with Article 39. It must include an accession form (see Annex 3) signed by the new beneficiary directly in the Portal Amendment tool. New beneficiaries will assume the rights and obligations under the Agreement with effect from the date of their accession specified in the accession form (see Annex 3). Additions are also possible in mono-beneficiary grants. ARTICLE 41 — TRANSFER OF THE AGREEMENT In justified cases, the beneficiary of a mono-beneficiary grant may request the transfer of the grant to a new beneficiary, provided that this would not call into question the decision awarding the grant or breach the principle of equal treatment of applicants. The beneficiary must submit a request for amendment (see Article 39), with - the reasons why - the accession form (see Annex 3) signed by the new beneficiary directly in the Portal Amendment tool and - additional supporting documents (if required by the granting authority). The new beneficiary will assume the rights and obligations under the Agreement with effect from the date of accession specified in the accession form (see Annex 3). ARTICLE 42 — ASSIGNMENTS OF CLAIMS FOR PAYMENT AGAINST THE GRANTING AUTHORITY The beneficiaries may not assign any of their claims for payment against the granting authority to any third party, except if expressly approved in writing by the granting authority on the basis of a reasoned, written request by the coordinator (on behalf of the beneficiary concerned). If the granting authority has not accepted the assignment or if the terms of it are not observed, the assignment will have no effect on it. In no circumstances will an assignment release the beneficiaries from their obligations towards the granting authority. ARTICLE 43 — APPLICABLE LAW AND SETTLEMENT OF DISPUTES 43.1 Applicable law The Agreement is governed by the applicable EU law, supplemented if necessary by the law of Belgium. Special rules may apply for beneficiaries which are international organisations (if any; see Data Sheet, Point 5). 43.2 Dispute settlement 66 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 If a dispute concerns the interpretation, application or validity of the Agreement, the parties must bring action before the EU General Court — or, on appeal, the EU Court of Justice — under Article 272 of the Treaty on the Functioning of the EU (TFEU). For non-EU beneficiaries (if any), such disputes must be brought before the courts of Brussels, Belgium — unless an international agreement provides for the enforceability of EU court judgements. For beneficiaries with arbitration as special dispute settlement forum (if any; see Data Sheet, Point 5), the dispute will — in the absence of an amicable settlement — be settled in accordance with the Rules for Arbitration published on the Portal. If a dispute concerns administrative sanctions, offsetting or an enforceable decision under Article 299 TFEU (see Articles 22 and 34), the beneficiaries must bring action before the General Court — or, on appeal, the Court of Justice — under Article 263 TFEU. For grants where the granting authority is an EU executive agency (see Preamble), actions against offsetting and enforceable decisions must be brought against the European Commission (not against the granting authority; see also Article 22). ARTICLE 44 — ENTRY INTO FORCE The Agreement will enter into force on the day of signature by the granting authority or the coordinator, depending on which is later. SIGNATURES For the coordinator For the granting authority [--TGSMark#signature-998429731_75_210--] [--TGSMark#signature-service_75_210--] 67  Associated with document Ref. Ares(2023)6408726 - 21/09/2023 ANNEX 1 EU4Health Programme (EU4H) Description of the action (DoA) Part A Part B Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 DESCRIPTION OF THE ACTION (PART A) COVER PAGE Part A of the Description of the Action (DoA) must be completed directly on the Portal Grant Preparation screens. PROJECT Grant Preparation (General Information screen) — Enter the info. Project number: 101129187 Project name: Estonia towards MyHealth@EU Project acronym: EST-2-MyHealth Call: EU4H-2022-DGA-MS-IBA2 Topic: EU4H-2022-DGA-MS-IBA-3 Type of action: EU4H-PJG Service: HADEA/A/01 Project starting date: first day of the month following the entry into force date Project duration: 36 months TABLE OF CONTENTS Project summary ......................................................................................................................................................3 List of participants .................................................................................................................................................. 3 List of work packages .............................................................................................................................................4 Staff effort ............................................................................................................................................................... 8 List of deliverables ..................................................................................................................................................9 List of milestones (outputs/outcomes) .................................................................................................................. 16 List of critical risks ............................................................................................................................................... 20 2 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 PROJECT SUMMARY Project summary Grant Preparation (General Information screen) — Provide an overall description of your project (including context and overall objectives, planned activities and main achievements, and expected results and impacts (on target groups, change procedures, capacities, innovation etc)). This summary should give readers a clear idea of what your project is about. Use the project summary from your proposal. The objective of this project will be to: - ensure stable operations of the deployed MyHealth@EU services, more especially the Patient Summary service by bringing it to a new platform, which will enable a more reliable service and create better opportunities for any updates in the future; - improve the national allergy related data exchange standards to ensure allergy data for Patient Summary, which is currently incomplete. LIST OF PARTICIPANTS PARTICIPANTS Grant Preparation (Beneficiaries screen) — Enter the info. Number Role Short name Legal name Country PIC 1 COO MSAE SOTSIAALMINISTEERIUM EE 998429731 1.1 AE TEHIK TERVISE JA HEAOLU INFOSÜSTEEMIDE EE 895885405 KESKUS 3 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 LIST OF WORK PACKAGES Work packages Grant Preparation (Work Packages screen) — Enter the info. Work Work Package name Lead Beneficiary Effort Start End Deliverables Package No (Person- Month Month Months) WP1 Management and coordination 1 - TEHIK 5.42 1 36 D1.1 – Project guide D1.2 – Governance participation report WP2 Dissemination, training and support 1 - TEHIK 5.42 1 36 D2.1 – Communication and dissemination strategy plan D2.2 – MS Service Dissemination, Education and Training Plan D2.3 – MS Service Dissemination, Education and Training Monitoring Report (Midterm) D2.4 – MS Service Dissemination, Education and Training Monitoring Report (Final) D2.5 – Project Website WP3 Evaluation and sustainability 1 - TEHIK 4.00 1 36 D3.1 – Evaluation and sustainability plan D3.2 – Mid-term evaluation and sustainability report D3.3 – Final evaluation and sustainability report D3.4 – Specific action-level indicators WP4 Maintenance and development 1 - TEHIK 39.82 1 36 D4.1 – eHMSEG decision M12 D4.2 – eHMSEG decision M24 D4.3 – Service improvement report D4.4 – Service operation and maintenance plan D4.5 – Service operation and maintenance report 4 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Work package WP1 – Management and coordination Work Package Number WP1 Lead Beneficiary 1. TEHIK Work Package Name Management and coordination Start Month 1 End Month 36 Objectives This WP aims to adequately manage and coordinate this project and it will have the following specific objectives: 1. To provide technical, scientific, financial and administrative management and support 2. To guide the efforts of the partners for the achievement of milestones 3. To provide a project management guide in close collaboration with other WP activities, that includes procedures for project management as well as for quality assurance 4. To monitor progress to avoid deviations 5. To communicate with HaDEA and DG SANTE 6. To comply with the HaDEA rules regarding financial, legal and administrative issues 7. To organize coordination meetings on a regular basis 8. Participation in the European MyHealth@EU governance framework and activities The project coordination core tasks will not be delegated to TEHIK in the description of WP1. Description Tasks (T) T1.1 - Participation in the European MyHealth@EU governance framework and activities - Continuous participation in the European MyHealth@EU governance framework and activities in accordance with the procedures defined by the eHealth DSI governance model (including by complying with eHOMB and eHMSEG instructions and requests). T1.2 - Consortium Operating Procedures Definition - MSAE and HWISC will develop a project guide for project management and quality assurance (by month 3), which will be the basis for managing the project throughout its lifecycle. It will also be a point of reference for all members and stakeholders. It will include administrative information as well as guidelines for financial reporting and presentating the standards for deliverables and reports to HaDEA. T1.3 - Coordination of the project management - Coordination and management of administrative and financial matters and providing support in administrative field to partners. Monitoring project progress, preparation of reports and communication with HaDEA services for coordination. T1.4 Consortium meeting - Foreseen are the following meetings: - Kick-off meeting: introduction and official start of project (by month 2) - Regular meetings to review progress and address any issues (monthly) - Closing event: final event summarizing all outcomes and benefits (by month 36) T1.6 - Legal management Deals with legal issues related to the project, focusing on the Grant Agreement and the Consortium Agreement implementation as well as supporting partners in legal issues. Work package WP2 – Dissemination, training and support Work Package Number WP2 Lead Beneficiary 1. TEHIK Work Package Name Dissemination, training and support Start Month 1 End Month 36 Objectives This WP aims to disseminate information on the project deliverables and progress to contribute the establishment of the health data access body. Dissemination activities will be carried out both internally and externally and knowledge 5 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 as well as experiences will be shared among all relevant stakeholders and partners. The methodologies will support the transparency and visibility of results and ensure the access to detailed and up-to-date information and communication platforms. Specific objectives of the WP2: ▪ Raise awareness and demand among health professionals regarding the provision of cross-border eHealth services ▪ Raise awareness of citizen of the cross-border eHealth services Description T2.1 - Communication and dissemination Communication strategy and its execution with reports, includes project content management system. T2.2 - Health professional dissemination and education - Health care professionals should continuously be informed of the availability of eHealth cross-border services and all necessary aspects of using the service (for example, the differences among the Member States approaches to consent management, ways of creating the Patient Summaries and clinical implication of these differences). A dissemination plan will be composed to analyse the necessary dissemination, education and training activities. T2.3 - Citizen dissemination and motivation - Citizens should continuously be made aware of their rights about cross- border care and about the availability of eHealth cross-border services (for example about the consent for cross-border data exchange) and about the activated Points of Care in the visited Countries. Focus during the current action will be on the following communication channels: - Keeping the information up-to-date on the Project Web Portal, co-ordinated with the Web Portals of the other Member States if needed - Social Media and web channels A dissemination plan will be composed to analyse the necessary dissemination, education and training activities. Work package WP3 – Evaluation and sustainability Work Package Number WP3 Lead Beneficiary 1. TEHIK Work Package Name Evaluation and sustainability Start Month 1 End Month 36 Objectives WP3 aims to guarantee a high impact through both internal and external consultation in order to support the projects overall aims, focusing on the process as whole as well as individual work packages and tasks. WP3 will evaluate the quality of the project and ensure that the outputs are effective, innovative and fit for purpose. Specific aims: Coordination and monitoring the implementation of the project according to the foreseen schedule and providing high quality deliverables in due time to describe the status of the activities undertaken during the project. Coordination and monitoring the sustainability progress of the tasks delivered Description T3.1 Evaluation and sustainability plan - Designing and writing the evaluation and sustainability plan that includes a baseline evaluation; success criteria; indicators; metric; timing and responsibilities as well policy and technical recommendations and sustainability action plans where applicable. T3.2 Mid-term evaluation report - Designing and writing the mid-term evaluation report for the project. This will assess the intended outcomes, outputs and success indicators half-way at the project (month 6-18) T3.3 Final evaluation report - Designing and writing the final evaluation report, that will be built on the mid-term evaluation report and final evaluations. 6 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Work package WP4 – Maintenance and development Work Package Number WP4 Lead Beneficiary 1. TEHIK Work Package Name Maintenance and development Start Month 1 End Month 36 Objectives WP4 aim is to ensure stable operations of the deployed MyHealth@EU services, more especially the Patient Summary service by bringing it to a new platform, which will enable a more reliable service and create better opportunities for any updates in the future. Specific objectives of the WP4: Implement upgrades to the new versions of MyHealth@EU artefacts adopted by the eHMSEG Perform annual upgrade testing Implement the necessary improvements to the cross-border service and national e-health exchange standards to ensure the data availability on Patient Summary and stable operations of the service Description T4.1 Implement upgrades to the new versions of MyHealth@EU artefacts adopted yearly by the eHMSEG and participate in Annual Upgrade Pre-Production Testing - Estonia will annually implement the new versions of MyHealth@EU artefacts and undergo Annual Upgrade Pre-Production Testing. The testing will result in receiving an Outcome Summary report and eHMSEG decision to continue the NCPeH routine operations (according to Procedure 6). T4.2 Data availability, alignment with eHN guidelines and other service improvements - Estonia will work on the improvement of data availability in relation to the cross-border eHealth services and thorough that seek further alignment with the updated eHN guidelines adopted at European level (allergy section on Patient Summary). A large rare disease related value set will be translated to ensure that the values on Patient Summary are displayed in Estonian (to a possible amount as described in section 1.2). To ensure the continuous stable operations of the deployed MyHealth@EU services, especially Patient Summary service, a platform update will be made and the Patient Summary service will be described as a microservice. T4.3 Planning and reporting on service operation and maintenance - Estonia will define upfront its current needs and foreseeable expenditures in relation to daily operations, provision of customer support, software updates, hardware costs and costs for staff involved in the NCPeH operations and report on effective expenditure at the end of the project. Relevant update of service operation plan will also be performed in the context of this task. 7 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 STAFF EFFORT Staff effort per participant Grant Preparation (Work packages - Effort screen) — Enter the info. Participant WP1 WP2 WP3 WP4 Total Person-Months 1 - MSAE 2.07 2.07 1.00 2.07 7.21 1.1 - TEHIK 3.35 3.35 3.00 37.75 47.45 Total Person-Months 5.42 5.42 4.00 39.82 54.66 8 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 LIST OF DELIVERABLES Deliverables Grant Preparation (Deliverables screen) — Enter the info. The labels used mean: Public — fully open ( automatically posted online) Sensitive — limited under the conditions of the Grant Agreement EU classified —RESTREINT-UE/EU-RESTRICTED, CONFIDENTIEL-UE/EU-CONFIDENTIAL, SECRET-UE/EU-SECRET under Decision 2015/444 Deliverable Deliverable Name Work Lead Beneficiary Type Dissemination Level Due Date No Package (month) No D1.1 Project guide WP1 1 - TEHIK R — Document, report PU - Public 3 D1.2 Governance participation report WP1 1 - TEHIK R — Document, report PU - Public 35 D2.1 Communication and dissemination strategy WP2 1 - TEHIK R — Document, report PU - Public 3 plan D2.2 MS Service Dissemination, Education and WP2 1 - TEHIK R — Document, report PU - Public 16 Training Plan D2.3 MS Service Dissemination, Education and WP2 1 - TEHIK R — Document, report PU - Public 27 Training Monitoring Report (Midterm) D2.4 MS Service Dissemination, Education and WP2 1 - TEHIK R — Document, report PU - Public 36 Training Monitoring Report (Final) D2.5 Project Website WP2 1 - TEHIK DEC —Websites, patent PU - Public 1 filings, videos, etc D3.1 Evaluation and sustainability plan WP3 1 - MSAE R — Document, report PU - Public 5 D3.2 Mid-term evaluation and sustainability WP3 1 - MSAE R — Document, report PU - Public 20 report D3.3 Final evaluation and sustainability report WP3 1 - MSAE R — Document, report PU - Public 36 D3.4 Specific action-level indicators WP3 1 - TEHIK R — Document, report SEN - Sensitive 36 9 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Deliverables Grant Preparation (Deliverables screen) — Enter the info. The labels used mean: Public — fully open ( automatically posted online) Sensitive — limited under the conditions of the Grant Agreement EU classified —RESTREINT-UE/EU-RESTRICTED, CONFIDENTIEL-UE/EU-CONFIDENTIAL, SECRET-UE/EU-SECRET under Decision 2015/444 Deliverable Deliverable Name Work Lead Beneficiary Type Dissemination Level Due Date No Package (month) No D4.1 eHMSEG decision M12 WP4 1 - TEHIK R — Document, report PU - Public 12 D4.2 eHMSEG decision M24 WP4 1 - TEHIK R — Document, report PU - Public 24 D4.3 Service improvement report WP4 1 - TEHIK R — Document, report PU - Public 35 D4.4 Service operation and maintenance plan WP4 1 - TEHIK R — Document, report PU - Public 1 D4.5 Service operation and maintenance report WP4 1 - TEHIK R — Document, report PU - Public 35 10 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Deliverable D1.1 – Project guide Deliverable Number D1.1 Lead Beneficiary 1. TEHIK Deliverable Name Project guide Type R — Document, report Dissemination Level PU - Public Due Date (month) 3 Work Package No WP1 Description Word/PDF document in EN . Project guide will describe the operational management procedure. Deliverable D1.2 – Governance participation report Deliverable Number D1.2 Lead Beneficiary 1. TEHIK Deliverable Name Governance participation report Type R — Document, report Dissemination Level PU - Public Due Date (month) 35 Work Package No WP1 Description Word/PDF document in EN Deliverable D2.1 – Communication and dissemination strategy plan Deliverable Number D2.1 Lead Beneficiary 1. TEHIK Deliverable Name Communication and dissemination strategy plan Type R — Document, report Dissemination Level PU - Public Due Date (month) 3 Work Package No WP2 Description Word/PDF document in EN/EST The strategy will define specific communication and dissemination activities, key stakeholders, their main topics and means to reach them. Deliverable D2.2 – MS Service Dissemination, Education and Training Plan Deliverable Number D2.2 Lead Beneficiary 1. TEHIK Deliverable Name MS Service Dissemination, Education and Training Plan Type R — Document, report Dissemination Level PU - Public Due Date (month) 16 Work Package No WP2 Description Word/PDF document in EN 11 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Deliverable D2.3 – MS Service Dissemination, Education and Training Monitoring Report (Midterm) Deliverable Number D2.3 Lead Beneficiary 1. TEHIK Deliverable Name MS Service Dissemination, Education and Training Monitoring Report (Midterm) Type R — Document, report Dissemination Level PU - Public Due Date (month) 27 Work Package No WP2 Description Word/PDF document in EN Deliverable D2.4 – MS Service Dissemination, Education and Training Monitoring Report (Final) Deliverable Number D2.4 Lead Beneficiary 1. TEHIK Deliverable Name MS Service Dissemination, Education and Training Monitoring Report (Final) Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP2 Description Word/PDF document in EN Deliverable D2.5 – Project Website Deliverable Number D2.5 Lead Beneficiary 1. TEHIK Deliverable Name Project Website Type DEC —Websites, patent Dissemination Level PU - Public filings, videos, etc Due Date (month) 1 Work Package No WP2 Description TEHIK will add project info and updates to their website, under existing webpage regarding cross-border-data-exchange: - Estonian: https://tehik.ee/piiriulene-andmevahetus - English: https://tehik.ee/en/cross-border-data-exchange Deliverable D3.1 – Evaluation and sustainability plan Deliverable Number D3.1 Lead Beneficiary 1. MSAE Deliverable Name Evaluation and sustainability plan Type R — Document, report Dissemination Level PU - Public Due Date (month) 5 Work Package No WP3 Description 12 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Word/PDF document in EN. The evaluation and sustainability plan has been submitted to the Portal Deliverable D3.2 – Mid-term evaluation and sustainability report Deliverable Number D3.2 Lead Beneficiary 1. MSAE Deliverable Name Mid-term evaluation and sustainability report Type R — Document, report Dissemination Level PU - Public Due Date (month) 20 Work Package No WP3 Description Word/PDF document in EN. The evaluation and sustainability report has been submitted to the Portal Deliverable D3.3 – Final evaluation and sustainability report Deliverable Number D3.3 Lead Beneficiary 1. MSAE Deliverable Name Final evaluation and sustainability report Type R — Document, report Dissemination Level PU - Public Due Date (month) 36 Work Package No WP3 Description Word/PDF document in EN. The evaluation and sustainability report has been submitted to the Portal Deliverable D3.4 – Specific action-level indicators Deliverable Number D3.4 Lead Beneficiary 1. TEHIK Deliverable Name Specific action-level indicators Type R — Document, report Dissemination Level SEN - Sensitive Due Date (month) 36 Work Package No WP3 Description For monitoring purposes there is deliverable “Specific action-level indicators”. In this deliverable we will report on the latest version of the KPIs as defined in the MyHealth@EU Monitoring Framework. The description refers to the call document (ex. Report on specific action-level indicators, as defined in the call document). Dissemination level Sensitive due to the nature of data. Deliverable D4.1 – eHMSEG decision M12 Deliverable Number D4.1 Lead Beneficiary 1. TEHIK Deliverable Name eHMSEG decision M12 Type R — Document, report Dissemination Level PU - Public Due Date (month) 12 Work Package No WP4 13 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Description Word/PDF document in EN Deliverable D4.2 – eHMSEG decision M24 Deliverable Number D4.2 Lead Beneficiary 1. TEHIK Deliverable Name eHMSEG decision M24 Type R — Document, report Dissemination Level PU - Public Due Date (month) 24 Work Package No WP4 Description Word/PDF document in EN Deliverable D4.3 – Service improvement report Deliverable Number D4.3 Lead Beneficiary 1. TEHIK Deliverable Name Service improvement report Type R — Document, report Dissemination Level PU - Public Due Date (month) 35 Work Package No WP4 Description Word/PDF document in EN Deliverable D4.4 – Service operation and maintenance plan Deliverable Number D4.4 Lead Beneficiary 1. TEHIK Deliverable Name Service operation and maintenance plan Type R — Document, report Dissemination Level PU - Public Due Date (month) 1 Work Package No WP4 Description Word/PDF document in EN Deliverable D4.5 – Service operation and maintenance report Deliverable Number D4.5 Lead Beneficiary 1. TEHIK Deliverable Name Service operation and maintenance report Type R — Document, report Dissemination Level PU - Public Due Date (month) 35 Work Package No WP4 Description 14 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Word/PDF document in EN 15 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 LIST OF MILESTONES Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) 1 Kick-off meeting – fixed date and agenda WP1 1-TEHIK Description - Definition of the date and agenda of 1 a meeting aimed at launching the project. Means of Verification - Date and agenda of the kick-off meeting fixed 2 Governance Participation WP1 1-TEHIK Description - Governance participation, including 35 the activities undergone at European level concerning the governance of service maintenance Means of Verification - Deliverable - Project Guide 3 Communication and dissemination strategy WP2 1-TEHIK Description: Communication strategy is 3 compiled and its execution with reports, includes project content management system. Means of verification: Deliverable - Communication and dissemination strategy plan 4 Planning of MS Service Dissemination, WP2 1-TEHIK Description: Service dissemination, education 16 Education and Training and training schedule with activities, milestones and tasks. It provides a prospective vision on the tasks to be made in order to create awareness and prepare users towards the use of services. Means of verification: Deliverable - MS Service Dissemination, Education and Training Plan 5 Reporting of MS Service Dissemination, WP2 1-TEHIK Description: Mid-term progress report on the 27 Education and Training Monitoring education and training activity, containing MS (Midterm) Service Dissemination, Education and Training Monitoring. Means of verification: Deliverable 16 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) - MS Service Dissemination, Education and Training Monitoring Report (Midterm) 6 Reporting of MS Service Dissemination, WP2 1-TEHIK Description: Final progress reporting on the 36 Education and Training Monitoring (Final)) education and training activity, containing MS Service Dissemination, Education and Training Monitoring would be included in the overall evaluation report foreseen under WP1. Means of verification: Deliverable - MS Service Dissemination, Education and Training Monitoring Report (Final) 7 Draft evaluation and sustainability plan WP3 1-MSAE Description: The evaluation and sustainability 3 available plan draft with indicators for the project and each WP will be available for the consortium, EC and public Means of verificaiton: Draft has been circulated for comments and amending, resulting in Evaluation and sustainability plan 8 Draft mid-term evaluation and sustainability WP3 1-MSAE Description: The evaluation and sustainability 18 report is available report draft with assessment of the project and each WP will be available for the consortium, EC and public Means of verification: Draft has been circulated for comments and amending, resulting in Mid-term evaluation and sustainability report 9 Draft final evaluation and sustainability report WP3 1-TEHIK Description: The evaluation and sustainability 34 available report draft with the final assessment of the project and each WP will be available for the consortium, EC and public Means of verification: Draft has been circulated for comments and amending, resulting in Final evaluation and sustainability report 17 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) 10 Decision on continuation of routine WP4 1-TEHIK Description: Annual decision taken by eHMSEG, 12 operations M12 based on the Outcome Summary report provided by the Solution Provider Means of verification: Deliverable eHMSEG decision M12 11 Decision on continuation of routine WP4 1-TEHIK Description: Annual decision taken by eHMSEG, 24 operations M24 based on the Outcome Summary report provided by the Solution Provider Means of verification: Deliverable eHMSEG decision M24 12 Reporting on service improvements WP4 1-TEHIK Description: Reporting will include a description 35 of the performed improvements affecting data availability and other service improvements. Means of verification: Deliverable Service improvement report 13 Translation of the Orphanet rare disease WP4 1-TEHIK Description: Translation of the Orphanet rare 35 nomenclature disease nomenclature (ORPHAcode) as a new value set, which has been added to the MyHealth@EU Master Valueset Catalogue. Means of verification: Deliverable Service improvement report 14 Upgrades implemented to the new versions of WP4 1-TEHIK Description: Implement upgrades to the new 35 MyHealth@EU artefacts adopted yearly versions of MyHealth@EU artefacts adopted yearly by the eHMSEG and participate in yearly formal and upgrade test events. Means of verification: deliverable Service improvement report 15 Patient Summary service platform updates WP4 1-TEHIK Description: Bringing Patient Summary service 35 by to a new platform, which will enable a more reliable service and create better opportunities for 18 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Milestones Grant Preparation (Milestones screen) — Enter the info. Milestone Milestone Name Work Package No Lead Beneficiary Means of Verification Due Date No (month) any updates in the future. Means of verification: Deliverable Service improvement report 16 Planning of service operation and WP4 1-TEHIK Description: Operation and maintenance plan 1 maintenance will include current needs and foreseeable expenditures related to daily operations, provision of customer support, software updates, hardware costs and costs for staff involved in the NCPeH operations. It will also include a description of the planned data quality improvements and other service improvements. Means of verification: Deliverable Service operation and maintenance plan 17 Reporting on service operation and WP4 1-TEHIK Description: Reporting will include effective 35 maintenance expenditure covering daily operations, provision of customer support, software updates, hardware costs and costs for staff involved in the NCPeH operations. Means of verification: Deliverable Service operation and maintenance report 18 Project webpage update WP2 1-TEHIK Description: TEHIK website's relevant webpage 36 is being updated during the project. Means of verification: Project webpage has been updated according to the Communication and dissemination strategy plan 19 Report on specific action-level indicators WP3 1-TEHIK Description: During the project KPIs are being 36 monitored and reported as MyHealth@EU Monitoring Framework requires Means of verification: report is made on the latest version of the KPIs as defined in the MyHealth@EU Monitoring Framework 19 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 LIST OF CRITICAL RISKS Critical risks & risk management strategy Grant Preparation (Critical Risks screen) — Enter the info. Risk Description Work Package Proposed Mitigation Measures number No(s) 1 Progress starting too late and the project resulting in WP1 Previous work has been done during the preparation of the poor delivery and project outcome (Likelihood: low, Project. General management procedures have been Impact: high) designed to detect any deviation from the initial plan and an experienced and robust management team will lead the project. The kick-off meeting has been carefully designed to coherently launch all the simultaneous activities. 2 Deliverables or official notifications to HADEA WP1 The coordinator will keep abreast of the ongoing work, promote mutual sharing of updates submitted late (Likelihood: low, Impact: low) within the consortium and provide guidance to the consortium members in order to avoid delays. Responsibilities and procedures will be clearly defined and implemented by partners under the coordinator’s, WP leaders’, task leaders’ supervision. The coordinator will also check the status of any deliverable to be sent to HaDEA 15 days before the deadline. Any delay will be communicated and justified beforehand, indicating the actual date of submission. 3 Financial deviations/ Budget issues that do not allow WP1 The budget has been carefully designed, discussed and agreed with all partners. A financial for activities to be carried out (Likelihood: medium, manager will lead the evaluation and monitoring of the use of resources and its justification Impact: medium) by all partners. 4 WP members do not deliver inputs to other WPs in WP3, WP4, WP2, Coordination and constant monitoring carried out by WP1 will help prevent this issue. time (Likelihood: high, Impact: low) WP1 Attention will also be paid to building a strong relationship and trust among project members. This can be reached, for example, by means of face-to-face meetings that will take place during the project. 5 Holidays, personal issues, COVID-19 pandemic WP3, WP4, WP2, WP members make sure that they have a person in their team who can cover, at least partly, or any other health issues that cause some WP WP1 their participation in the project. WP leaders and task leaders create back-up contact lists for members to be missing for a certain period of time having replacements in place. (Likelihood: low, Impact: low) 6 Reports and deliverables do not meet required WP3, WP4, WP2, Presence of an independent quality reviewer that is external to the core team and who has standards of written English and/or presentation, WP1 20 Project: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Critical risks & risk management strategy Grant Preparation (Critical Risks screen) — Enter the info. Risk Description Work Package Proposed Mitigation Measures number No(s) data visualization, clarity (Likelihood: low, Impact: extensive professional experience in drafting reports for the EC and national authorities is low) seeked; Strong collaboration with WP2 needs to be held 7 Problems with (sub)contracting due to delays in WP4 Preparing conditional (public) procurement and/or framework contracts (public) procurement (Likelihood: medium, Impact: high) 8 Difficulty in setting up meetings, mainly due to WP3, WP4, WP2, WP team members will make all efforts to adjust other commitments and ensure the presence unavailability of all relevant parties in any given WP1 time (Likelihood: low, Impact: low) 9 Losing leadership over outsourced activities WP4 Communication will be crucial to deliver outputs of the desired quality within the desired (Likelihood: low, Impact: high) timeframe. High-quality handover of partial tasks and monitoring must be carried out, in order to avoid losing quality and timeliness. 10 A key expert unexpectedly leaves the team WP3, WP4, WP2, Project managers create possible back-up lists of experts in their within their Competent (Likelihood: medium, Impact: medium) WP1 Authorities/Affiliated Entities, so that another expert can be promptly involved if needed until a new person is hired. 11 Stakeholder fatigue, lack of incentive with encaging WP4 The CA and AE will ensure that communication with stakeholders is efficient and respects with the consortium or providing feedback. the stakeholders time and effort. As such web-based tools will be used to enable engagement (Likelihood: high, Impact: high) at times most convenient, and incentives such as acknowledgment of contributions will be considered were necessary. 21 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 TECHNICAL DESCRIPTION (PART B) COVER PAGE Part B of the Application Form must be downloaded from the Portal Submission System, completed and then assembled and re-uploaded as PDF in the system. Page 1 with the grey IMPORTANT NOTICE box should be deleted before uploading. Note: Please read carefully the conditions set out in the Call document (for open calls: published on the Portal). Pay particular attention to the award criteria; they explain how the application will be evaluated. PROJECT Project name: [Estonia towards MyHealth@EU] Project acronym: [EST-2-MyHealth] Coordinator contact: [Jaanika Merilo], [Ministry of Social Affairs Estonia] TABLE OF CONTENTS TECHNICAL DESCRIPTION (PART B) .......................................................................................................................... 1 COVER PAGE ............................................................................................................................................................. 1 1. RELEVANCE ........................................................................................................................................................... 2 1.1 Background and general objectives .................................................................................................................... 2 1.2 Needs analysis and specific objectives ............................................................................................................... 3 1.3 Complementarity with other actions and innovation — European added value .................................................... 4 2. QUALITY ................................................................................................................................................................. 5 2.1 Concept and methodology .................................................................................................................................. 5 2.2 Consortium set-up............................................................................................................................................... 5 2.3 Project teams, staff and experts .......................................................................................................................... 6 2.4 Consortium management and decision-making................................................................................................... 7 2.5 Project management, quality assurance and monitoring and evaluation strategy ................................................ 8 2.6 Cost effectiveness and financial management .................................................................................................... 8 3. IMPACT ................................................................................................................................................................... 9 3.1 Impact and ambition ............................................................................................................................................ 9 3.2 Communication, dissemination and visibility...................................................................................................... 10 3.3 Sustainability and continuation .......................................................................................................................... 10 4. WORKPLAN, WORK PACKAGES, ACTIVITIES, RESOURCES AND TIMING ..................................................... 12 4.1 Work plan ......................................................................................................................................................... 12 Subcontracting ................................................................................................................................................. 13 Timetable ......................................................................................................................................................... 15 5. OTHER .................................................................................................................................................................. 17 5.1 Ethics ................................................................................................................................................................ 17 5.2 Security............................................................................................................................................................. 17 6. DECLARATIONS ................................................................................................................................................... 17 #@APP-FORM-EU4H@# #@PRJ-SUM-PS@# [This document is tagged. Do not delete the tags; they are needed for the processing.] 1 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 1. RELEVANCE 1.1 Background and general objectives Background and general objectives Describe the background and rationale of the project. How is the project relevant to the scope of the call? How does the project address the general objectives of the call? What is the project’s contribution to the priorities of the call? The main objective of this application is to support Estonian efforts to be part of a secure peer-to-peer Member States government’s network allowing the exchange of medical documentation through the MyHealth@EU infrastructure (also known as eHealth Digital Service Infrastructure/eHDSI). MyHealth@EU is the infrastructure built by the Member States and the Commission to enable the secure cross-border exchange of elements of patients’ Electronic Health Records, such as: • Patient Summary, • ePrescriptions, • Original Clinical Documents, • Medical images and medical imaging reports, • Laboratory results, • Hospital discharge reports. MyHealth@EU is intended to serve as a main building block of the European Health Data Space for the primary use of health data. Currently, it is an operational infrastructure defined in the Commission Implementing Decision 2019/1765 of 22 October 2019 under the Cross-Border Healthcare Directive and embedded where relevant in the Member States national law. The infrastructure is being deployed by most of the Member States and is already operational in more than 10 Member States, including Estonia. It provides a secure way to enable access to citizens’ health data when they are abroad. Currently, the services deployed in Estonia at the NCPeH are Patient Summary (in routine operations since August 2022) and ePrescriptions (in routine operations since January 2019).1 Estonia is in progress of major update to national Health Information System, which means that old national e-health services are being moved to a new platform as microservices. Under this objective, the Patient Summary service will also be brought to the new platform as a microservice which, in addition to being a more reliable service, will also allow to make continuous upgrades easier. Also Patient Summary will be updated with missing allergies and intolerances section. The Member States cooperation on MyHealth@EU paves the way to reach the following general objectives: 1) Enable seamless cross-border care and secure access to patient health information between European healthcare systems. 2) Contribute to patient safety by reducing the frequency of medical errors and by providing quick access to patient health information, as well as by increasing the accessibility of a patient's own prescriptions, also when abroad. 3) Provide medical personnel with life-saving information in emergencies and reduce the repetition of diagnostic procedures. Additionally, services provided by MyHealth@EU are significantly contributing to the Pillar 1 and Pillar 2 of the Commission Communication on digital transformation in health and care, which are: firstly, citizens' secure access to their health data, also across borders and secondly, personalised medicine through shared European data infrastructure. Health technology is considered critical to the Digital Single Market. The Digital Single Market Strategy seeks to provide the essential interoperability and standardisation in the health area, including eHealth and telemedicine. 1 https://www.HWISC.ee/piiriulene-patsiendi-terviseandmete-vahetus 2 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 1.2 Needs analysis and specific objectives Needs analysis and specific objectives Describe how the objectives of the project are based on a sound needs analysis in line with the specific objectives of the call. What issue/challenge/gap does the project aim to address? The objectives should be clear, measureable, realistic and achievable within the duration of the project. For each objective, define appropriate indicators for measuring achievement (including a unit of measurement, baseline value and target value). The objective of this project will be to ensure stable routine operations and necessary further development of the already operational NCPeH. Currently, the services deployed at the NCPeH are Patient Summary (in routine operations since August 2022) and ePrescriptions (in routine operations since January 2019). Under the proposed action, the NCPeH will: - Ensure stable operations of the deployed MyHealth@EU services, more especially the Patient Summary service by bringing it to a new platform, which will enable a more reliable service and create better opportunities for any updates in the future. Estonia is currently in progress of major update to national Health Information System, which means that old national e-health services are being moved to a new platform as microservices. Under this objective, the Patient Summary service will also be brought to the new platform as a microservice which, in addition to being a more reliable service, will also allow to make continuous upgrades easier. - Improve the national allergy related data exchange standards to ensure allergy data for Patient Summary, which is currently incomplete. New national FHIR based standards will be created according to dataset, which will be agreed on between different national stakeholders. This will enable all Estonian health care providers to implement the new standards and start providing allergy related information to the National Health Information System (ENHIS). As Patient Summary is automatically composed of the data in ENHIS, it will also enable the necessary information in the Patient Summary service. The allergies and intolerances data section is considered part of the basic sections meaning that it must be present in a Patient Summary document. The missing data in this section for an Estonian Patient Summary is currently evaluated as finding and is in need for improvement. - Implement upgrades to the new versions of MyHealth@EU artefacts adopted yearly by the eHMSEG and participate in yearly formal and upgrade test events. - Translation of the Orphanet rare disease nomenclature (ORPHAcode) as a new value set, which has been added to the MyHealth@EU Master Valueset Catalogue. This would allow to display the information coming from other NCPeH in Estonian to Estonian health care professionals. The translation will be done in collaboration with Estonian rare diseases expert centre. The value set is currently planned to be translated in possible amount as, according to rare disease experts, not all codes can be translated/are reasonable to be translated. Out of scope for this proposed action, but perhaps an effect of it is that the translation of ORPHAcode nomenclature would create an opportunity to move forward with the implementation of using the codes in national health data exchange in the future, which would allow for this information to be added to Patient Summary as well. MyHealth@EU Key Performance Indicators will be used for measuring achievement of the action. All indicators listed below are for Estonia only (not for the entire MyHealth@EU). The following Key Performance Indicators will be used for measuring achievement of the action: - Numbers of yearly upgrades - Three annual upgrades are planned under the proposed action according to the MyHealth@EU upgrade process. - Numbers of yearly formal and upgrade test events participation - Three annual formal and upgrade test events are planned under the proposed action. An Outcome Summary Report and 3 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 a decision to continue routine operations is provided by eHealth Member States Expert Group (eHMSEG) after the test events. - Number of sections to include structured data added to Patient Summary to align with eHealth Network Guidelines and MyHealth@EU specifications - Under the proposed action, one additional section will include coded and structured data according to the MyHealth@EU data exchange specifications. - Number of new code systems translations performed – One new code system added to the MyHealth@EU Master Valueset Catalogue will be translated to Estonian under the proposed action. The project will report on the latest version of MyHealth@EU Key Performance Indicators and the other action-level indicators specified in the call document #@COM-PLE-CP@# 1.3 Complementarity with other actions and innovation — European added value Complementarity with other actions and innovation Explain how the project builds on the results of past activities carried out in the field and describe its innovative aspects. Explain how the activities are complementary to other activities carried out by other organisations. Illustrate the European dimension of the activities: trans-national dimension of the project; impact/interest for a number of EU countries; possibility to use the results in other countries, potential to develop mutual trust/cross-border cooperation among EU countries, etc. Which countries will benefit from the project (directly and indirectly)? Where will the activities take place? The proposed action directly supports the freedom of movement of European citizens between Member States by facilitating the delivery of emergency medical care to citizens when they are in a Member State that is not their country of affiliation. Free movement of persons is one of the fundamental rights of EU citizens. This right is used to a large extent and, in order to implement it, citizens need to be able to ensure the portability of their previous history, be it contributions to unemployment benefits or pensions, medical insurance or medical history. In 2020, Among the EU citizens of working age, 3.3 % resided in an EU country other than that of their citizenship. Both Regulation (EC) No 883/2004 on the coordination of social security systems and the Directive 2011/24/EU on the application of patients' rights in cross-border healthcare allow for cross border healthcare and reimbursements, both in case of planned and unplanned care. The initial deployment and first Member States implementation of MyHealth@EU was supported by the European Union, through Connecting Europe Facility Telecom Programme. In 2015-2020, both the Commission and 25 Member States have received financial support to develop, deploy and operate the system for the cross-border exchange of health data. However, the Member States prioritized the cross-border exchange of health data much earlier. From 2007-2013 the Commission supported the Member States implementation of the epSOS large scale project, which have developed the specifications and software (OpenNCP), which was further refined and implemented at national level in MyHealth@EU. So far there are more than 10 Member States in routine operations with MyHealth@EU services, and almost all other Member States (+Norway and Iceland) are expected to join by 2025. Estonia has deployed the cross-border services under MyHealth@EU and is an active governance member. Estonia has also participated in other EU projects/collaborations, which have all contributed to MyHealth@EU, e.g. the abovementioned large scale piloting project epSOS and X-eHealth to develop the specifications for additional cross-border services, which have contributed enormously to the cross- border services under MyHealth@EU. Estonia has its members in the European governance bodies, which are responsible for governing MyHealth@EU. Those are: 4 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 - The eHealth Network (eHN), which steers the policy relevant to MyHealth@EU. It decides on the admission of an NCPeH to join the Cross-Border eHealth Information Services, and on the continued participation. It meets twice a year, once in the 2nd quarter and once in the 4th quarter. - The eHealth DSI Member State Expert Group (eHMSEG) is a group of project managers responsible for setting up and managing the NCPeH in their countries. The eHMSEG coordinates the technical and organisational implementation of the NCPeH to ensure that they are fully interoperable The eHMSEG provides advice to the eHealth Network on core elements and provides a link to building of the national elements. The eHMSEG is duly informed and consulted on solutions for MyHealth@EU, and contributes to the lifecycle of the MyHealth@EU core services. The eHealth Network and the eHMSEG have set up subgroups and task forces to facilitate discussions and decision-making on relevant questions. Estonia has participated in the following subgroups and task forces to support and further develop the European cooperation: - MyHealth@EU Technical workgroup and its subgroups (including OpenNCP Community) – current participation - MyHealth@EU Semantic Task Force – current participation - ePrescription Cluster – current participation - Patient Summary Cluster – current participation - New use cases workgroup – current participation - eHN Semantic subgroup – current participation - eHN Technical interoperability subgroup – current participation #§COM-PLE-CP§# #§PRJ-OBJ-PO§# #§REL-EVA-RE§# #@QUA-LIT-QL@# #@CON-MET-CM@# 2. QUALITY 2.1 Concept and methodology Concept and methodology Outline the approach and methodology behind the project. Explain why they are the most suitable for achieving the project’s objectives. The proposed action will follow the existing guidelines of MyHealth@EU in regards to implementing new versions of the artefacts, testing and upgrading. The national improvements will be made according to the national development process and Patient Summary will be updated, taking into account that any major updates in the service will require passing the testing phase before it can be released. The value set translation will be carried out in collaboration with the experts to ensure the quality of translations. The project team will continue to participate in relevant eHMSEG governance structures and task forces to be informed and to contribute to the MyHealth@EU artefacts new versions. The project will be coordinated by Ministry of Social Affairs Estonia (MSAE) (Competent Authority) and Estonian Health and Welfare Information Systems Centre (TEHIK) (Affiliated Entity and also responsible for maintaining the NCPeH for Estonia). #§CON-MET-CM§# #@CON-SOR-CS@# 2.2 Consortium set-up Consortium cooperation and division of roles (if applicable) Describe the participants (Beneficiaries, Affiliated Entities and Associated Partners, if any) and explain how they will work together to implement the project. How will they bring together the necessary expertise? How will they complement each other? 5 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 In what way does each of the participants contribute to the project? Show that each has a valid role and adequate resources to fulfil that role. Note: When building your consortium you should think of organisations that can help you reach objectives and solve problems. The Estonia’s application is composed by MSAE and TEHIK experts who have been working in the field of eHealth and MyHealth@EU services. The project will be led by mainly by the TEHIK project manager who will coordinate and participate in the WP 1, 2, 3 and 4 administrative coordination work together with jointly supporting project manager role from MSAE who is supporting TEHIK Project Manager on the administrative part relating to communication with EC. Also giving wider scope perspective to the project from the Ministry side. To make sure that the planned developments and maintenance works are carried out according to the project plan there will be separate project manager for the allergy and platform development part who will work closely together with the team in WP4. For empowering collaboration and engagement to the project, the team will have regular meetings and project managers will keep sight on the tasks and deliverables. 2.3 Project teams, staff and experts Project teams and staff Describe the project teams and how they will work together to implement the project. List the staff included in the project budget (budget category A) by function/profile (e.g. project manager, senior expert/, junior expert, trainers/teachers, technical personnel, administrative personnel etc. — use the same profiles as in the detailed budget table, if any) and describe briefly their tasks. Provide CVs of all key actors (if required). Name and Organisation Role/tasks/professional profile and expertise function Role: Project manager Katre Pruul, TEHIK Katre is currently working in the role of cross-border ePrescription and project manager Patient Summary service manager in Estonia and is the Estonian representative in eHMSEG. She has a background in working with semantic aspects and data interoperability standards in Estonian National Information System. She has contributed to other international projects/collaborations such as X-eHealth, eHAction consortium for future eHDSI use cases and the development of a Common Semantic Strategy. Role: Project manager (MSAE side) Jaanika Merilo, MSAE Position: Special Advisor project manager Summary: Jaanika is since March 2023 Special Advisor in Ministry of Social Affairs of Estonia responsible for innovation and international co-operation in eHealth and social services. Jaanika is a representative of Estonia in European Commission workgroup of European Health Data Space and national contact-point in eHealth Network. She is also responsible for international co-operation and projects and co-operation with private sector to support innovation. Role: Project Manager for platform development (managing T.4.2 Andre Lehis, TEHIK subcontract S.1.2 new platform development) project manager Project Manager for allergy development (managing T.4.2 Greete Mõttus TEHIK subcontract S.1.2 allergy standard development) Artur Novek, TEHIK Role: IT architect technical personell Mr. Artur Novek is IT Architect at Estonian Health and Welfare Information Systems Centre. His main task is to manage Estonian National Health Information System (ENHIS) and its bound components architecture. Artur has been working 20 years to deliver 6 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 eHealth solutions, starting as a programmer at software vendor. In 2008 he joined Estonian eHealth Foundation to build up ENHIS. Role: Administrator Jeremin Freed TEHIK Jeremin is an application administrator in TEHIK. He is the main Meister, administrator for the cross-border ePrescription and Patient Summary technical services for Estonian NCPeH. He also has previous experience in personell working as an application administrator. In addition to cross-border service administration, he is a secondary administrator for TEHIK's various microservices, for example the new generation health information system UpTIS. Role: Tester Ingrid Hanst, TEHIK Ingrid has been working as a software tester in private sector for over technical 10 years. Since the beginning of 2022 she has been working in personell TEHIK, being a tester for cross-border ePrescription and Patient Summary as well as for several other ehealth services. She has also participated the eHDSI formal test event in 2022. Kerli Linna, TEHIK Role: Data standardisation analyst technical personell Jelizaveta TEHIK Role: tester for platform development and allergy in T4.2 Vavilkina, technical personell Hedvig Soone, TEHIK Role: Business analytic technical personell Outside resources (subcontracting, seconded staff, etc) If you do not have all skills/resources in-house, describe how you intend to get them (contributions of members, partner organisations, subcontracting, etc.). If there is subcontracting, please also complete the table in section 4. In relation to implementing upgrade of the artefacts, work in regards to updating the platform of the existing service and translation service, subcontracting will be used as these skills are not present in TEHIK. Subcontracting will be done according to national public organisations procurement rules. Experts (if applicable) Explain if national and/or international experts will be nominated by national authorities to support the project implementation. Describe the specific professional and technical expertise and experience of each proposed expert and their contribution to the project implementation. Provide CVs (if required). Minimum requirements: • Qualification: A level of education which corresponds to a Bachelor's degree. • Professional experience: At least 4 years of proven experience in XXX • Other skills: ability to work in English (minimum B2 level) Insert text 2.4 Consortium management and decision-making 7 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 Consortium management and decision-making (if applicable) Explain the management structures and decision-making mechanisms within the consortium. Describe how decisions will be taken and how regular and effective communication will be ensured. Describe methods to ensure planning and control. Note: The concept (including organisational structure and decision-making mechanisms) must be adapted to the complexity and scale of the project. The management structure of this project has been designed to best respond the needs to update and maintain the MyHealth@EU services from Estonian side. Coordination role and management of the WP-s 1-4 is fulfilled by TEHIK with some support of MSAE. TEHIK will ensure the implementation of best practices and suitable policies for sustainable project results and it will respect traditional and accepted project management standards and principles. Each work package and each task planned within each work package has a time schedule which needs close monitoring and careful evaluation, this will be established through and effective internal communication. Management activities are focused not only on executing the project but also for ensuring the sustainability after the project deadline. The Steering Committee will be created as an operational body including project managers, relevant department or team leaders, subcontractor representatives (if applicable), and the WP leaders, as a decision-making body taking care of the daily running of the project, with prerogatives regarding minor updates and effort/budget re-assignment, as well as conflict resolution. Each SC member can participate to the SC meetings with one or more representatives. #§CON-SOR-CS§# #@PRJ-MGT-PM@# 2.5 Project management, quality assurance and monitoring and evaluation strategy Project management, quality assurance and monitoring and evaluation strategy Describe the measures planned to ensure that the project implementation is of high quality and completed in time. Describe the methods to ensure good quality, monitoring, planning and control. Describe the evaluation methods and indicators (quantitative and qualitative) to monitor and verify the outreach and coverage of the activities and results (including unit of measurement, baseline and target values). The indicators proposed to measure progress should be relevant, realistic and measurable. The project approach requires that the tasks of the maanagement and coordination (WP1) is strongly interconnected with the evaluation and sustainability (WP3) and dissemination, training and support (WP2). The maintenance and development (WP4) recieves input from all other WP-s. These WPs are interdependent in several ways: an output from one task can become the input for another task from the same or another WP. This implies that there is a need not only to apply clear and straightforward project management methodologies, but also to establish effective communication and coordination between WP leaders and task leaders. In the project management the project managers will look over different aspects to support the work of all WPs and people involved, as well assure quality of the processes. Taking into account methodologies and strategies created within WPs for the specific project and the risk assessment derived from the possible risks identified in section 2.7. #§PRJ-MGT-PM§# #@FIN-MGT-FM@# 2.6 Cost effectiveness and financial management Cost effectiveness and financial management Describe the measures adopted to ensure that the proposed results and objectives will be achieved in the most cost-effective way. Indicate the arrangements adopted for the financial management of the project and, in particular, how the financial resources will be allocated and managed within the consortium. Do NOT compare and justify the costs of each work package, but summarize briefly why your budget is cost effective. 8 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 Cost-effectiveness and financial management is the key for the progress of this project. TEHIK and MSAE financial department will be included in coordination of the project and resources. This supports the adequate use of resources. Project coordinators in collaboration with task leaders will take relevant action for keeping and reporting financial data according to the Grant Agreement and communication means will be used to keep all participators updated. For maximising cost-effectiveness, the financial contributions are carefully communicated, defined and shared. #§FIN-MGT-FM§# #@RSK-MGT-RM@# 3. IMPACT 3.1 Impact and ambition Impact and ambition — Progress beyond the state-of-the-art Define the short, medium and long-term effects of the project. Who are the target groups? How will the target groups benefit concretely from the project and what would change for them? Does the project aim to trigger change/innovation? If so, describe them and the degree of ambition (progress beyond the status quo/state-of-the-art). The cross-border services that have been put in place primarily target the following actors: • EU citizens including Estonians; • health professionals; • Estonia’s competent authority and affiliated entity First, all the European citizens (including Estonians) are the beneficiaries of the planned action. As all citizens are using healthcare services in their countries of affiliation, the data are electronically captured in the national, regional and local databases. In line with the targets of the European Health Data Space, the action will enable availability of this data in another Member State when the citizens are travelling or moving their residence. Following the establishment of the NCPeH, addition of further services in the future becomes more straightforward, enabling the extension of the cross-border infrastructure to further data categories of the full electronic health record. Secondly, the action affects health professionals, who are the direct users of the electronic health record systems. The connection of these systems to the NCPeH enables the availability of relevant health data when patients use the services of different healthcare providers in different Member States. Health professionals will be able to rely on the availability of data provided by them if the patient is using healthcare services abroad, increasing the importance and impact of their work on documenting healthcare encounters. The availability of MyHealth@EU services and corresponding new IT tools will, in the medium term, change their way of working and enable new medical processes. In the longer term, this solution will be popularized among health professionals and integrated with the hospital information systems. Finally, MSAE and TEHIK are the ones impacted by the implementation of the proposed action in the short term. Estonia is currently planning implementation efforts related to the European Health Data Space, including updating and maintaining the MyHealth@EU infrastructure for the primary use of electronic health data. The MS governments are responsible for enabling the resources necessary to set up and connect the NCPeH to their national infrastructures as well as its maintenance. At the same time, the government bodies are responsible for legal aspects of the project implementation. The relevant Patient Information Notices have to be drafted and made available to all citizens. The governments must make sure that their systems, including the connections to MyHealth@EU, follow the General Data Protection Regulation. Current project ensures that the cross-border services that have been put in place in Estonia, are continuously upgraded according to the MyHealth@EU artefacts and tested with other countries to ensure the quality of the services by improving the national allergy related data exchange standards additionally for allergy data for Patient Summary, which is currently incomplete. As well as to ensure the national 9 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 platform of the service is efficient. Efficiency is ensured by stable operations of the deployed MyHealth@EU services, more especially the Patient Summary service by bringing it to a new platform, which will enable a more reliable service and create better opportunities for any updates in the future. The Patient Summary service will also be brought to the new platform as a microservice which, in addition to being a more reliable service, will also allow to make continuous upgrades easier. #§IMP-ACT-IA§# #@COM-DIS-VIS-CDV@# 3.2 Communication, dissemination and visibility Communication, dissemination and visibility of funding Describe the communication and dissemination activities which are planned in order to promote the activities/results and maximise the impact (to whom, which format, how many, etc.). Clarify how you will reach the target groups, relevant stakeholders, policymakers and the general public and explain the choice of the dissemination channels. Describe how the visibility of EU funding will be ensured. The objective of the communication and dissemination activities will be to raise awareness and demand among citizens and health professionals regarding the provision of cross-border eHealth services, offer educational and training initiatives to empower and support end-users as well as other MS entering operation. Citizens should also be made aware of their rights about cross-border care and about the availability of eHealth cross-border services in term of actions to be done while still at home, to enable the use of these eHealth services (i.e. consent signature) and about the activated points of care in the visited countries. As the cross-border ePrescription and Patient Summary services are already in routine operations in Estonia and the main communication, dissemination and training was already performed during the project, focus during the current action will be on continuously raising the awareness of both health care professionals and citizen of the cross-border e-health services. The main communication channels used could be: - Keeping the information up-to-date on websites, co-ordinated with the websites of other Member States if needed - Social Media, web channels, press releases (upon opening service with new country for example) - Direct contact to health care providers via mailing lists if needed An overall communication strategy will be defined and as far as possible aligned with the other Member States. #§COM-DIS-VIS-CDV§# #@SUS-CON-SC@# 3.3 Sustainability and continuation Sustainability, long-term impact and continuation Describe the follow-up of the project after the EU funding ends. How will the project impact be ensured and sustained? What will need to be done? Which parts of the project should be continued or maintained? How will this be achieved? Which resources will be necessary to continue the project? How will the results be used? Are there any possible synergies/complementarities with other (EU funded) activities that can build on the project results? The proposed action will support the maintenance of the National Contact Point for eHealth (NCPeH) in Estonia. The NCPeH is a unique national gateway enabling the cross-border exchange of medical documentation. To get the positive decision from the eHealth Network to start the routine operations, the NCPeH needed to undergo the set of tests and compliance check. One of the compliance check criteria is to prove that the NCPeH has a national legal mandate for the cross-border exchange of data. Getting this mandate at national level makes NCPeH the part of national infrastructure with clearly established 10 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 responsibilities. This process was put in place to ensure the legal and operational sustainability of the NCPeH responsible for the data exchange. After the development and deployment, the maintenance of the NCPeH has been ensured. In this context, an operational compliance check (OCC) will need to be undertaken 3 years after the start of the routine operations (for ePrescription service the OCC took place in 2022 and for Patient Summary service the OCC is planned in 2025). In addition, the NCPeH will continue to take part regularly in test sessions, including in the context of the annual upgrade and before starting new exchanges with additional countries for a specific service. Since the ePrescription service has been operational in Estonia for more than 3 years, Estonian NCPeH has been successfully sustaining and continuing routine operations after the initial project grant duration. The maintenance (including operational compliance check, annual upgrades and necessary further improvements) has also been ensured over time. After the proposed action grant duration, the funding for maintenance and routine operation for the cross- border services will be ensured nationally as it has been previously. #§SUS-CON-SC§# 11 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 #@WRK-PLA-WP@# 4. WORKPLAN, WORK PACKAGES, ACTIVITIES, RESOURCES AND TIMING 4.1 Work plan Work plan Provide a brief description of the overall structure of the work plan (list of work packages or graphical presentation (Pert chart or similar)). Work Package 1: Management and coordination T1.2 Consortium Operating Procedures Definition T1.3 Coordination of the project management T1.4 Consortium meeting T1.6 Legal management 12 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 Work Package 2: Dissemination, training and support T2.1 Communication and dissemination T2.2 Health professional dissemination and education T2.3 Citizen dissemination and motivation Work Package 3: Evaluation and sustainability T3.1 Evaluation plan T3.2 Mid-term evaluation report T3.3 Final evaluation report Work Package 4: Maintenance and development Implement upgrades to the new versions of MyHealth@EU artefacts adopted yearly by the eHMSEG and participate in Annual Upgrade Pre-Production T4.1 Testing T4.2 Data availability, alignment with eHN guidelines and other service improvements T4.3 Planning and reporting on service operation and maintenance Subcontracting Subcontracting Give details on subcontracted project tasks (if any) and explain the reasons why (as opposed to direct implementation by the Beneficiaries/Affiliated Entities). Subcontracting — Subcontracting means the implementation of ‘action tasks’, i.e. specific tasks which are part of the EU grant and are described in Annex 1 of the Grant Agreement. Note: Subcontracting concerns the outsourcing of a part of the project to a party outside the consortium. It is not simply about purchasing goods or services. We normally expect that the participants have sufficient operational capacity to implement the project activities themselves. Subcontracting should therefore be exceptional. Include only subcontracts that comply with the rules (i.e. best value for money and no conflict of interest; no subcontracting of coordinator tasks). 13 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 Work Package No Subcontract No Subcontract Description Estimated Costs Justification Best-Value-for-Money (continuous Name (including task number and (EUR) (why is subcontracting (how do you intend to numbering linked (subcontracted BEN/AE to which it is necessary?) ensure it?) to WP) action tasks) linked) WP4 S1.1 T4.1 Technical tasks 327 500 euros Development service is The subcontracting will (developments) in regards always procured in be made according to to implementing the new TEHIK’s projects. national procurement versions of artefacts and rules and regulations, any changes to the which takes also into services will be provided account the best-value- by a subcontractor. for-money aspect upon choosing the subcontractor. WP4 S1.2 T4.2 PS new platform 403 500 euros Development service is The subcontracting will development always procured in be made according to subcontracting and TEHIK’s projects. national procurement national allergy data rules and regulations, exchange standard which takes also into creation related account the best-value- development for-money aspect upon subcontracting. choosing the subcontractor. WP4 S1.3 T4.2 Translation 20 000 euros Translation service is The subcontracting will subcontracting; always procured in be made according to TEHIK’s projects. national procurement rules and regulations, which takes also into account the best-value- for-money aspect upon choosing the subcontractor. Other issues: TEHIK and Ministry of Social Affairs do not have the necessary IT development or translation competences in house and thus subcontracting is necessary. This is also how the national IT projects in TEHIK are If subcontracting for the project goes beyond 30% of the total performed. The procurements are done according to national procurement rules and regulations. eligible costs, give specific reasons. 14 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 Subcontracting a service, for which competencies are not available in-house, will be more efficient than recruiting new people in-house for the tasks for only the project period. As the procurement rules and procedures are in place, there are more possibilities to ensure the quality of the outcome (the subcontractors will probably have more different resources available in addition to developers, for example system analysts, testers). The project is focusing on the technical improvement of the existing services, which means that the major part of the budget also forms of this. Timetable Timetable (projects of more than 2 years) Fill in cells in beige to show the duration of activities. Repeat lines/columns as necessary. Note: Use actual calendar years and quarters. In the timeline you should indicate the timing of each activity per WP. You may add additional columns if your project is longer than 6 years. YEAR 2023 YEAR 2024 YEAR 2025 YEAR 2026 YEAR 2027 YEAR 2028 ACTIVITY Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q Q 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 1 2 3 4 Task 1.1 - Participation in the European MyHealth@EU governance framework and activities Task 1.2 - Consortium Operating Procedures Definition Task 1.3 - Coordination of the project management Task 1.4 - Consortium meeting Task 1.5 - Legal management 15 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 Task 2.1 - Communication and dissemination Task 2.2 - Health professional dissemination and education Task 2.2 - Citizen dissemination and motivation Task 3.1 - Evaluation and sustainability plan Task 3.2 - Mid-term evaluation and sustainability report Task 3.3 – Final evaluation and sustainability report Task 4.1 - Implement upgrades to the new versions of MyHealth@EU artefacts adopted yearly by the eHMSEG and participate in Annual Upgrade Pre-Production Testing Task 4.2 - Data availability, alignment with eHN guidelines and other service improvements Task 4.3 - Planning and reporting on service operation and maintenance #§WRK-PLA-WP§# 16 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 #@ETH-ICS-EI@# 5. OTHER 5.1 Ethics Ethics If the Call document contains a section on ethics, describe ethics issues that may arise during the project implementation and the measures you intend to take to solve/avoid them. Insert text #§ETH-ICS-EI§# #@SEC-URI-SU@# 5.2 Security Security If the Call document contains a section on security, describe security issues that may arise during the project implementation and the measures you intend to take to solve/avoid them. Indicate if there is need for EU classification of information (Decision 2015/444) or any other specific security measures. Insert text #§SEC-URI-SU§# #@DEC-LAR-DL@# 6. DECLARATIONS Higher funding rate (if applicable) YES/NO Do you fulfil the conditions set out in the Call document for a higher funding rate? YES If YES, explain and provide details. According to the indications provided by HaDEA, countries whose GNI per inhabitant is less than 90% of the EU average can apply for exceptional utility. Estonia’s GNI index is below 90% of the average. Double funding Information concerning other EU grants for this project Please note that there is a strict prohibition of double funding from the EU budget YES/NO (except under EU Synergies actions). We confirm that to our best knowledge neither the project as a whole nor any parts YES of it have benefitted from any other EU grant (including EU funding managed by authorities in EU Member States or other funding bodies, e.g. EU Regional Funds, EU Agricultural Funds, etc). If NO, explain and provide details. We confirm that to our best knowledge neither the project as a whole nor any parts YES of it are (nor will be) submitted for any other EU grant (including EU funding managed 17 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 by authorities in EU Member States or other funding bodies, e.g. EU Regional Funds, EU Agricultural Funds, etc). If NO, explain and provide details. Financial support to third parties (if applicable) If in your project the maximum amount per third party will be more than the threshold amount set in the Call document, justify and explain why the higher amount is necessary in order to fulfil your project’s objectives. Insert text #§DEC-LAR-DL§# 18 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 LIST OF PREVIOUS PROJECTS List of previous projects Please provide a list of your previous projects for the last 4 years. Participant Project Reference No Period (start Role Amount Website (if any) and Title, Funding and end (COO, (EUR) programme date) BEN, AE, OTHER) H2020-SC1-DTH-2018-2020 Health and 1.09.2020 – joint 44 188 https://www.x- / H2020-SC1-DTH-2019-2, Welfare 30.11.2022 action ehealth.eu/ X-eHealth: eXchanging Information electronic Health Records Systems ina commom framework’ Centre — ‘X-eHealth Connecting Europe Facility Health and 01.01.2017 – direct 369 782 https://www.tehik. 2014-2020 CEF TELECOM Welfare 31.12.2020 grant ee/projektid?field_c CALLS FOR PROPOSALS Information ategory_value=All& 2015CEF-TC-2015-2. Systems page=2 Deployment of Generic Centre Cross Border eHealth Services in Estonia. AGREEMENT No INEA/CEF/ICT/A2015/1156 737 HISTORY OF CHANGES PUBLICATION VERSION CHANGE DATE 1.0 15.04.2021 Initial version (new MFF). 2.0 01.06.2022 Consolidation, formatting and layout changes. Tags added. 3.0 04.09.2023 On page 2 - the Project Summary section removed as it is already in SYGMA. Correction of the acronym of the Health and Welfare Information Systems Centre from HWISC to TEHIK throughout the document. On page 4 – added sentence: The project will report on the latest version of MyHealth@EU Key Performance Indicators and the other action-level indicators specified in the call document On page 6-7 - change of coordinator contact from Katre Trofimov to Jaanika Merilo and update of some TEHIK team member names and/or role descriptions. Second project manager added for TEHIK to have separate project managers on new platform development and allergy standard development. Data analyst role changed to business analytic which is needed instead. On page 9 - risk management section has been removed as it is already in SYGMA. On page 12 - the workplan work packages descriptions have been removes, as they are entered in SYGMA. On page 14 - Subcontracting explanation completed. On page 15 - Task 4.3 added to timetable. 19 Call: [Project 101129187 – EST-2-MyHealth] — [EU4H-2022-DGA-MS-IBA2] Associated with document Ref. Ares(2023)6408726 - 21/09/2023 EU Grants: Description of the action (DoA) — Annex 1 On page 19 – list of annexes removed 20  a Associated with document Ref. Ares(2023)6408726 - 21/09/2023 DETAILED BUDGET TABLE (ACTION GRANTS) Project number: 101129187 05.09.2023 18:44 Project acronym: EST-2-MyHealth Participant short name: MSAE Participant PIC: 998429731 ATTENTION: This table should be filled out one per participant (beneficiary, affiliated entity) ATTENTION: This table may ONLY contain eligible costs (i.e. costs that comply with the eligibility rules of the grant agreement that is part of your call documents). At proposal stage and during grant preparation, it should contain estimated costs/income. Costs must be estimated in EUR. ATTENTION! List each budgeted cost item ONLY once in this table, for the main WP. ATTENTION! White cells mean that you are required to enter data. Blue cells are calculated automatically. ACTION GRANT BUDGET TABLE (PER PARTICIPANT) PROJECT COSTS A. Personnel costs Costs (actual or unit costs) Time Rate Total Also working for other work ! monthly rates allowed for budgeting because simpler to establish the approximate costs; cost reporting will have to (months/other of work on (amount) (EUR) packages? YES/NO and which Description of project role/activities/responsibilities Type of rate the action) be done according to MGA (usually daily rates) (monthly/other) WP a b c=a*b WORK PACKAGE 1 MANAGEMENT AND COORDINATION A.1 Employees (or equivalent) Supporting TEHIK Project Manager on the administrative part relating to communication with EC. Giving wider Project managers monthly 3 500,00 2,07 7 245,00 YES, WP 2,3,4 scope perspective to the project from the Ministry side Other [category 1] monthly 0,00 0,00 0,00 Total employees (or equivalent) 7 245,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 7 245,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT A.1 Employees (or equivalent)  Supporting TEHIK Project Manager on the administrative part relating to communication with EC. Giving wider Project managers monthly 3 500,00 2,07 7 245,00 YES, WP 1,3,4 scope Associated perspective with documenttoRef. the project from the Ministry Ares(2023)6408726 side - 21/09/2023 Other [category 1] monthly 0,00 0,00 0,00 Total employees (or equivalent) 7 245,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 7 245,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY A.1 Employees (or equivalent) Supporting TEHIK Project Manager on the administrative part relating to communication with EC. Giving wider Project managers monthly 3 500,00 1,00 3 500,00 YES, WP 1,2,4 scope perspective to the project from the Ministry side Other [category 1] monthly 0,00 0,00 0,00 Total employees (or equivalent) 3 500,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 3 500,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT A.1 Employees (or equivalent) Supporting TEHIK Project Manager on the administrative part relating to communication with EC. Giving wider Project managers monthly 3 500,00 2,07 7 245,00 YES, WP 1,2,3 scope perspective to the project from the Ministry side Other [category 1] monthly 0,00 0,00 0,00 Total employees (or equivalent) 7 245,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00  Total natural persons under direct contract and seconded persons 0,00 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 7 245,00 Total personnel (all WPs) 25 235,00 B. Subcontracting costs Also used for other work Costs packages? Description of subcontracted project tasks/activities (actual costs) YES/NO and which WP WORK PACKAGE 1 MANAGEMENT AND COORDINATION 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT 1 [Subcontract short name] 0,00 2 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 Total subcontracting (all WPs) 0,00 C. Purchase costs C.1 Travel and subsistence Costs Description (e.g. international/not international; place of Costs (unit cost) (actual costs) Also part of other work activity/destination; number of days; number of persons packages? (speakers, personnel and participants whose costs are Amount per Total YES/NO and which WP covered); transport means; average price per person; Number of units unit ( EUR) subsistence costs/daily allowances) WORK PACKAGE 1 MANAGEMENT AND COORDINATION Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT Total travel costs for this WP 0,00  Total accommodation costs for this WP 0,00 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 Total travel costs (all WPs) 0,00 Total accommodation (all WPs) 0,00 Total subsistence (all WPs) 0,00 Total travel and subsistence (all WPs) 0,00 C.2 Equipment WORK PACKAGE 1 MANAGEMENT AND COORDINATION C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT C.2.1 Purchase (depreciation/full cost) Costs (actual costs)  Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed Associated with document Ref. Ares(2023)6408726 - 21/09/2023 WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00  ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 Total equipment (all WPs) 0,00 C.3 Other goods, works and services WORK PACKAGE 1 MANAGEMENT AND COORDINATION Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00  Total goods, works and services for this WP 0,00 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 Total goods, works and services (all WPs) 0,00 Total purchase costs (all WPs) 0,00 D. Other cost categories D.1. Financial support to third parties WORK PACKAGE 1 MANAGEMENT AND COORDINATION Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00  0,00 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 Total D.1 (all WPs) 0,00 Total other cost categories (all WPs) 0,00 E. Indirect costs Costs (flat-rate) Total estimated direct costs (on which indirect cost flat-rate is based, 25 235,00 see GA eligibility article) ALL WORK PACKAGES Flat-rate (%) 7% ATTENTION! Check that the rate is in line with the call conditions. Put 0% if you receive an EU Operating Grant and are not eligible to charge indirect costs” Total indirect costs 1 766,45 Total indirect costs 1 766,45 TOTAL COSTS PARTICIPANT 27 001,45  Associated with document Ref. Ares(2023)6408726 - 21/09/2023 PROJECT INCOME EU CONTRIBUTION (GRANT) Amount (EUR) Total costs 27 001,45 Single Funding rate (%) 80% ATTENTION! Enter funding rate from the call conditions. Maximum EU contribution #REF! Requested EU contribution 21 601,15 ATTENTION❗ In order to avoid rounding issues, please request 1 cent less than the maximum EU contribution. EU CONTRIBUTION 21 601,15 REVENUES AND CONTRIBUTIONS BY THIRD PARTIES Revenues Income generated by the action Amount Description of the income (type of generated income and (EUR) number of users, etc) ALL WORK PACKAGES Estimated income generated by the action 0,00 Total income generated by the action 0,00 Revenues 0,00 In-kind contributions by third parties In-kind contributions by third parties Amount Description of the contribution (type of contribution, (EUR) donor, purpose etc) ALL WORK PACKAGES Estimated in-kind contributions by third parties 0,00 Total in-kind contributions 0,00 In-kind contributions 0,00 Financial contributions by third parties Financial contributions by third parties Amount Description of the contribution (type of contribution, (EUR) donor, purpose, etc) ALL WORK PACKAGES Estimated financial contributions by third parties 0,00 Total financial contributions 0,00 Financial contributions 0,00 TOTAL REVENUES AND CONTRIBUTIONS BY THIRD PARTIES 0,00 OWN RESOURCES Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Amount (EUR) Own resources 5 400,30 OWN RESOURCES 5 400,30 TOTAL INCOME PARTICIPANT 27 001,45  a Associated with document Ref. Ares(2023)6408726 - 21/09/2023 DETAILED BUDGET TABLE (ACTION GRANTS) Project number: 101129187 26.02.2023 23:36 Project acronym: EST-2-MyHealth Participant short name: TEHIK Participant PIC: 895885405 ATTENTION: This table should be filled out one per participant (beneficiary, affiliated entity) ATTENTION: This table may ONLY contain eligible costs (i.e. costs that comply with the eligibility rules of the grant agreement that is part of your call documents). At proposal stage and during grant preparation, it should contain estimated costs/income. Costs must be estimated in EUR. ATTENTION! List each budgeted cost item ONLY once in this table, for the main WP. ATTENTION! White cells mean that you are required to enter data. Blue cells are calculated automatically. ACTION GRANT BUDGET TABLE (PER PARTICIPANT) PROJECT COSTS A. Personnel costs Costs (actual or unit costs) Time Rate Total Also working for other work ! monthly rates allowed for budgeting because simpler to establish the approximate costs; cost reporting will have to (months/other of work on (amount) (EUR) packages? YES/NO and which Description of project role/activities/responsibilities Type of rate the action) be done according to MGA (usually daily rates) (monthly/other) WP a b c=a*b WORK PACKAGE 1 MANAGEMENT AND COORDINATION A.1 Employees (or equivalent) TEHIK Project Manager on the administrative part relating Project managers monthly 5 000,00 3,35 16 750,00 YES, WP 2,3,4 to communication with EC and SMAE + managing the TEHIK team. Other [category 1] monthly 0,00 0,00 0,00 Total employees (or equivalent) 16 750,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 16 750,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT A.1 Employees (or equivalent) TEHIK Project Manager on the administrative part relating Project managers monthly 5 000,00 3,35 16 750,00 YES, WP 1,3,4 to communication with EC and SMAE + managing the TEHIK team.  Other Associated with document Ref. Ares(2023)6408726 - 21/09/2023 [category 1] monthly 0,00 0,00 0,00 Total employees (or equivalent) 16 750,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 16 750,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY A.1 Employees (or equivalent) TEHIK Project Manager on the administrative part relating Project managers monthly 5 000,00 3,00 15 000,00 YES, WP 1,2,4 to communication with EC and SMAE + managing the TEHIK team. Other [category 1] monthly 0,00 0,00 0,00 Total employees (or equivalent) 15 000,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 15 000,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT A.1 Employees (or equivalent) TEHIK Project Manager on the administrative part relating to communication with EC and SMAE + managing the Project managers monthly 5 000,00 6,35 31 750,00 YES, WP 1,2,3 TEHIK team. Leader of task T4.1 and S1.1. 2 Project Managers, both 4PM per person. 1 Project Manager for platform development (managing T.4.2 Project managers monthly 5 000,00 8,00 40 000,00 NO subcontract S.1.2 new platform development) and 1 Project Manager for allergy development (managing T.4.2 subcontract S.1.2 allergy standard development) TEHIK tester for task T4.1 Technical personnel monthly 5 000,00 2,10 10 500,00 NO TEHIK administrator T4.1 Technical personnel monthly 5 000,00 1,50 7 500,00 NO TEHIK IT architecht for T4.2 Technical personnel monthly 5 000,00 5,00 25 000,00 NO TEHIK standardizer for T4.2 Technical personnel monthly 5 000,00 8,00 40 000,00 NO TEHIK business analytic for T4.2 Technical personnel monthly 5 000,00 2,80 14 000,00 NO TEHIK tester for platform development and allergy in T4.2 Technical personnel monthly 5 000,00 4,00 20 000,00 NO Other  [category 1] monthly 0,00 0,00 0,00 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Total employees (or equivalent) 188 750,00 A.2 + A.3 Natural persons under direct contract and seconded persons Select a staff category monthly 0,00 0,00 0,00 Other [category 1] monthly 0,00 0,00 0,00 Total natural persons under direct contract and seconded persons 0,00 A.4 SME owners and natural person beneficiaries without salary SME owners/natural person beneficiaries without salary daily 0,00 0,00 0,00 Total SME owners and natural person beneficiaries without salary 0,00 Total personnel for this WP 188 750,00 Total personnel (all WPs) 237 250,00 B. Subcontracting costs Also used for other work Costs packages? Description of subcontracted project tasks/activities (actual costs) YES/NO and which WP WORK PACKAGE 1 MANAGEMENT AND COORDINATION 1 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT 1 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY 1 [Subcontract short name] 0,00 Total subcontracting for this WP 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT S1.1 Technical development subcontracting 327 500,00 S1.2 Technical development subcontracting 403 500,00 S1.3 Technical translation subcontracting 20 000,00 Total subcontracting for this WP 751 000,00 Total subcontracting (all WPs) 751 000,00 C. Purchase costs C.1 Travel and subsistence Costs Description (e.g. international/not international; place of Costs (unit cost) (actual costs) Also part of other work activity/destination; number of days; number of persons packages? (speakers, personnel and participants whose costs are Amount per Total YES/NO and which WP covered); transport means; average price per person; Number of units unit ( EUR) subsistence costs/daily allowances) WORK PACKAGE 1 MANAGEMENT AND COORDINATION Total travel costs for this WP 0,00  Total accommodation costs for this WP 0,00 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT Total travel costs for this WP 0,00 Total accommodation costs for this WP 0,00 Total subsistence costs for this WP 0,00 Total travel for this WP 0,00 0,00 Total travel costs (all WPs) 0,00 Total accommodation (all WPs) 0,00 Total subsistence (all WPs) 0,00 Total travel and subsistence (all WPs) 0,00 C.2 Equipment WORK PACKAGE 1 MANAGEMENT AND COORDINATION C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement  Total rental and leasing 0,00 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Total equipment for this WP 0,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY C.2.1 Purchase (depreciation/full cost) Costs (actual costs) Depreciation Rate of use for the Also part of other work method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT C.2.1 Purchase (depreciation/full cost)  Costs (actual costs) Depreciation Rate of use for the Also part of other work Associated with document Ref. Ares(2023)6408726 - 21/09/2023 method (e.g. Number of months action (100% or Total Description of tasks/activities for which the equipment is Price packages? YES/NO and which 36 month or 60 allocated to the action less if used also for (EUR) needed WP month) other purposes) a b c d e =(c/b *d) * a 1 [Equipment short name] 0,00 0 0,00 0% 0,00 2 [Equipment short name] 0,00 0 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total depreciation 0,00 C.2.2 Rental and leasing (rate of use/full cost) Costs (actual costs) Rate of use for the Also part of other work action (100% or Total Description of tasks/activities for which the equipment is Monthly rent/fee Number of months of use for the action packages? YES/NO and which less if used also for (EUR) needed WP other purposes) a b c d= a*b*c 1 [Equipment short name] 0,00 0,00 0% 0,00 2 [Equipment short name] 0,00 0,00 0% 0,00 ATTENTION! Can be used only if full cost option in the grant 3 [Equipment short name] 0,00 0,00 agreement Total rental and leasing 0,00 Total equipment for this WP 0,00 Total equipment (all WPs) 0,00 C.3 Other goods, works and services WORK PACKAGE 1 MANAGEMENT AND COORDINATION Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 5 000,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 5 000,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00  2 Bank fees (pre-financing guarantee) 0,00 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT Costs Also part of other work Description of tasks/activities for which the goods/services (actual costs) packages? YES/NO and which are needed; types of goods services needed; how much WP Consumables 0,00 Conferences, seminars, workshops, trainings & events 0,00 Information & publications 0,00 Other expenses 1 IPR costs 0,00 2 Bank fees (pre-financing guarantee) 0,00 3 Audit fees (CFS) 0,00 4 Project evaluation 0,00 [5 short name other] 0,00 [6 short name other] 0,00 Total goods, works and services for this WP 0,00 Total goods, works and services (all WPs) 5 000,00 Total purchase costs (all WPs) 5 000,00 D. Other cost categories D.1. Financial support to third parties WORK PACKAGE 1 MANAGEMENT AND COORDINATION  Also used for other work AssociatedDescription with document Ref. Ares(2023)6408726 - 21/09/2023 Costs of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 2 DISSEMINATION, TRAINING AND SUPPORT Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 3 EVALUATION AND SUSTAINABILITY Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 WORK PACKAGE 4 MAINTENANCE AND DEVELOPMENT Also used for other work Costs Description of support scheme (estimated number of Financial support to third parties packages? recipients; maximum amount per recipient) (actual costs) YES/NO and which WP [Support scheme short name] 0,00 [Support scheme short name] 0,00 0,00 Total other cost category D.1 for this WP 0,00 Total D.1 (all WPs) 0,00 Total other cost categories (all WPs) 0,00 E. Indirect costs Costs (flat-rate) Total estimated direct costs (on which indirect cost flat-rate is based, 993 250,00 see GA eligibility article) ALL WORK PACKAGES Flat-rate (%) 7% ATTENTION! Check that the rate is in line with the call conditions. Put 0% if you receive an EU Operating Grant and are not eligible to charge indirect costs”  Total indirect costs 69 527,50 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Total indirect costs 69 527,50 TOTAL COSTS PARTICIPANT 1 062 777,50 PROJECT INCOME EU CONTRIBUTION (GRANT) Amount (EUR) Total costs 1 062 777,50 Single Funding rate (%) 80% ATTENTION! Enter funding rate from the call conditions. Maximum EU contribution 850 222,00 Requested EU contribution 850 221,99 ATTENTION❗ In order to avoid rounding issues, please request 1 cent less than the maximum EU contribution. EU CONTRIBUTION 850 221,99 REVENUES AND CONTRIBUTIONS BY THIRD PARTIES Revenues Income generated by the action Amount Description of the income (type of generated income and (EUR) number of users, etc) ALL WORK PACKAGES Estimated income generated by the action 0,00 Total income generated by the action 0,00 Revenues 0,00 In-kind contributions by third parties In-kind contributions by third parties Amount Description of the contribution (type of contribution, (EUR) donor, purpose etc) ALL WORK PACKAGES Estimated in-kind contributions by third parties 0,00 Total in-kind contributions 0,00 In-kind contributions 0,00 Financial contributions by third parties Financial contributions by third parties Amount Description of the contribution (type of contribution, (EUR) donor, purpose, etc) ALL WORK PACKAGES Estimated financial contributions by third parties 0,00  Total financial contributions 0,00 Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Financial contributions 0,00 TOTAL REVENUES AND CONTRIBUTIONS BY THIRD PARTIES 0,00 OWN RESOURCES Amount (EUR) Own resources 212 555,51 OWN RESOURCES 212 555,51 TOTAL INCOME PARTICIPANT 1 062 777,50  DETAILED BUDGET TABLE (ACTION GRANTS) Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Project number: 101129187 Project acronym: EST-2-MyHealth Participant short name: MSAE Participant PIC: 998429731 CONSOLIDATED COSTS PER WORK PACKAGE (PER PARTICIPANT) COSTS PER WORK PACKAGE A.1 Employees C. Purchase costs D. Other cost categories A.2 + A.3 Natural persons B. Subcontracting E. Indirect costs under direct contract and A.4 SME owners costs Total seconded persons C.1 Travel and C.3 Other goods, D.1 Financial support to C.1 Travel C.1 Accommodation C.1 Subsistence C.2 Equipment subsistence work and services third parties e = flat-rate * (a1 + a2 + a3 + a5 + b [+ a1 - a2 a3 b c1 c1a c1b c1c c2 c3 d1 c1] + [c1a + c1b + c1c] + c2 + c3 + d1 + d2 + d3 + d4 + d5 + d6) WP1 MANAGEMENT AND COORDINATION 7 245,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 7 245,00 WP2 DISSEMINATION, TRAINING AND 7 245,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 7 245,00 SUPPORT WP3 EVALUATION AND SUSTAINABILITY 3 500,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 3 500,00 WP4 MAINTENANCE AND DEVELOPMENT 7 245,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 7 245,00 TOTAL COSTS PARTICIPANT 25 235,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 1 766,45 27 001,45  DETAILED BUDGET TABLE (ACTION GRANTS) Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Project number: 101129187 Project acronym: EST-2-MyHealth Participant short name: TEHIK Participant PIC: 895885405 CONSOLIDATED COSTS PER WORK PACKAGE (PER PARTICIPANT) COSTS PER WORK PACKAGE A.1 Employees C. Purchase costs D. Other cost categories A.2 + A.3 Natural persons B. Subcontracting E. Indirect costs under direct contract and A.4 SME owners costs Total seconded persons C.1 Travel and C.3 Other goods, D.1 Financial support to C.1 Travel C.1 Accommodation C.1 Subsistence C.2 Equipment subsistence work and services third parties e = flat-rate * (a1 + a2 + a3 + a5 + b [+ a1 - a2 a3 b c1 c1a c1b c1c c2 c3 d1 c1] + [c1a + c1b + c1c] + c2 + c3 + d1 + d2 + d3 + d4 + d5 + d6) WP1 MANAGEMENT AND COORDINATION 16 750,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 5 000,00 0,00 21 750,00 WP2 DISSEMINATION, TRAINING AND 16 750,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 16 750,00 SUPPORT WP3 EVALUATION AND SUSTAINABILITY 15 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 15 000,00 WP4 MAINTENANCE AND DEVELOPMENT 188 750,00 0,00 751 000,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 939 750,00 TOTAL COSTS PARTICIPANT 237 250,00 0,00 751 000,00 0,00 0,00 0,00 0,00 0,00 5 000,00 0,00 69 527,50 1 062 777,50  DETAILED BUDGET TABLE (ACTION GRANTS) Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Project number: 101129187 Project acronym: EST-2-MyHealth ATTENTION! Delete columns that do not apply for your grant. CONSOLIDATED COSTS PER WORK PACKAGE (PROJECT) PROJECT COSTS PER WORK PACKAGE A.1 Employees D. Other cost C. Purchase costs A.2 + A.3 Natural categories B. Subcontracting E. Indirect costs persons under direct A.4 SME owners costs D.1 Financial contract and seconded C.1 Travel and C.3 Other goods, persons subsistence C.1 Travel C.1 Accommodation C.1 Subsistence C.2 Equipment works and services support to third Total parties e = flat-rate * (a1 + a2 + a3 + a5 + b [+ a1 - a2 a3 b c1 c1a c1b c1c c2 c3 d1 c1] + [c1a + c1b + c1c] + c2 + c3 + d1 + d2 + d3 + d4 + d5 + d6) MSAE TOTAL COSTS PARTICIPANT 25 235,00 1 766,45 27 001,45 (Proposal Step) TOTAL COSTS PARTICIPANT 0,00 (Grant Preparation Step) TEHIK TOTAL COSTS PARTICIPANT 237 250,00 751 000,00 5 000,00 69 877,50 1 063 127,50 (Proposal Step) TOTAL COSTS PARTICIPANT 0,00 (Grant Preparation Step)  Grant Agreement number: 101129187 — EST-2-MyHealth — EU4H-2022-DGA-MS-IBA2 EU4H Ref. Associated with document MGAAres(2023)6408726 — Multi & Mono:-v1.1 21/09/2023 ANNEX 2 ESTIMATED BUDGET FOR THE ACTION Estimated eligible1 costs (per budget category) Estimated EU contribution2 Direct costs Indirect costs EU contribution to eligible costs Maximum B. Total costs Maximum EU D. Other cost Requested EU grant amount6 A. Personnel costs Subcontracting C. Purchase costs E. Indirect costs 3 Funding rate %4 categories contribution5 contribution costs A.1 Employees A.4 SME owners B. Subcontracting C.2 Equipment C.3 Other goods, D.1 Financial E. Indirect costs (or equivalent) and natural person C.1 Travel and subsistence works and support to third beneficiaries services parties A.2 Natural persons under direct contract Travel Accommodation Subsistence A.3 Seconded persons Forms of funding Unit7 or Unit7 or Unit7 or Actual costs Unit costs7 Actual costs Actual costs Actual costs Actual costs Flat-rate costs8 actual costs actual costs actual costs e = flat-rate * (a1 + a3 + b + f=a+b+ a1 a3 b c1a c1b c1c c2 c3 d1 U g = f * U% h m c1a + c1b + c1c c+d+e + c2 + c3 + d1) 1 - MSAE 25 235.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 1 766.45 27 001.45 80 21 601.16 21 601.14 21 601.14 1.1 - TEHIK 237 250.00 0.00 751 000.00 0.00 0.00 0.00 0.00 5 000.00 0.00 69 527.50 1 062 777.50 80 850 222.00 850 222.00 850 222.00 Σ consortium 262 485.00 0.00 751 000.00 0.00 0.00 0.00 0.00 5 000.00 0.00 71 293.95 1 089 778.95 871 823.16 871 823.14 871 823.14 1 See Article 6 for the eligibility conditions. All amounts must be expressed in EUR (see Article 21 for the conversion rules). 2 The consortium remains free to decide on a different internal distribution of the EU funding (via the consortium agreement; see Article 7). 3 Indirect costs already covered by an operating grant (received under any EU funding programme) are ineligible (see Article 6.3). Therefore, a beneficiary/affiliated entity that receives an operating grant during the action duration cannot declare indirect costs for the year(s)/reporting period(s) covered by the operating grant, unless they can demonstrate that the operating grant does not cover any costs of the action. This requires specific accounting tools. Please immediately contact us via the EU Funding & Tenders Portal for details. 4 See Data Sheet for the funding rate(s). 5 This is the theoretical amount of the EU contribution to costs, if the reimbursement rate is applied to all the budgeted costs. This theoretical amount is then capped by the 'maximum grant amount'. 6 The 'maximum grant amount' is the maximum grant amount decided by the EU. It normally corresponds to the requested grant, but may be lower. 7 See Annex 2a 'Additional information on the estimated budget' for the details (units, cost per unit). 8 See Data Sheet for the flat-rate. Page 1 of 1  Associated with document Ref. Ares(2023)6408726 - 21/09/2023 ANNEX 2a ADDITIONAL INFORMATION ON UNIT COSTS AND CONTRIBUTIONS SME owners/natural person beneficiaries without salary See Additional information on unit costs and contributions (Annex 2a and 2b) Travel and subsistence See Additional information on unit costs and contributions (Annex 2a and 2b) 1  Associated with document Ref. Ares(2023)6408726 - 21/09/2023 ANNEX 4 EU4H MGA — MULTI + MONO FINANCIAL STATEMENT FOR [PARTICIPANT NAME] FOR REPORTING PERIOD [NUMBER] 1 2 Eligible costs (per budget category) EU contribution Revenues Direct costs Indirect costs EU contribution to eligible costs Total requested EU Income generated by the Total costs Requested EU contribution action A. Personnel costs B. Subcontracting costs C. Purchase costs D. Other cost categories 2 3 4 E. Indirect costs Funding rate % Maximum EU contribution contribution A.4 SME owners and C.3 Other goods, works and D.X Financial support to A.1 Employees (or equivalent) natural person B. Subcontracting C.1 Travel and subsistence C.2 Equipment E. Indirect costs services third parties beneficiaries A.2 Natural persons under direct contract Travel Accommodation Subsistence A.3 Seconded persons Forms of funding Actual costs 5 Actual costs 5 5 5 Actual costs Actual costs Actual costs 6 Unit costs Unit or actual costs Unit or actual costs Unit or actual costs Flat-rate costs e= f= a1 a3 b c1a c1b c1c c2 c3 d1a flat-rate * (a1 + a3 + b + c1a + U g = f*U% h m (i) n a+b+c+d+e c1b + c1c + c2 + c3 + d1a) XX – [short name beneficiary/affiliated entity] The beneficiary/affiliated entity hereby confirms that: The information provided is complete, reliable and true. The costs and contributions declared are eligible (see Article 6). The costs and contributions can be substantiated by adequate records and supporting documentation that will be produced upon request or in the context of checks, reviews, audits and investigations (see Articles 19, 20 and 25). For the last reporting period: that all the revenues have been declared (see Article 22). i Please declare all eligible costs and contributions, even if they exceed the amounts indicated in the estimated budget (see Annex 2). Only amounts that were declared in your individual financial statements can be taken into account lateron, in order to replace costs/contributions that are found to be ineligible. 1 See Article 6 for the eligibility conditions. All amounts must be expressed in EUR (see Article 21 for the conversion rules). 2 If you have also received an EU operating grant during this reporting period, you cannot claim indirect costs - unless you can demonstrate that the operating grant does not cover any costs of the action. This requires specific accounting tools. Please contact us immediately via the Funding & Tenders Portal for details. 3 See Data Sheet for the reimbursement rate(s). 4 This is the theoretical amount of EU contribution to costs that the system calculates automatically (by multiplying the reimbursement rates by the costs declared). The amount you request (in the column 'requested EU contribution') may be less. 5 See Annex 2a 'Additional information on the estimated budget' for the details (units, cost per unit). 6 See Data Sheet for the flat-rate.  Associated with document Ref. Ares(2023)6408726 - 21/09/2023 ANNEX 5 SPECIFIC RULES ETHICS (— ARTICLE 14) Ethics Actions involving activities raising ethics issues must be carried out in compliance with: - ethical principles and 1 - applicable EU, international or national law, including Directive 2005/28 and 2 Regulation 536/2014 . The beneficiaries must pay particular attention to the principle of proportionality, the right to privacy, the right to the protection of personal data, the right to the physical and mental integrity of a person, the right to non-discrimination, the need to ensure protection of the environment and high levels of human health protection. Before the beginning of an action task raising an ethical issue, the beneficiaries must have obtained all approvals or other mandatory documents needed for implementing the task, notably from any (national or local) ethics committee or other bodies such as data protection authorities. The documents must be kept on file and be submitted upon request by the coordinator to the granting authority. If they are not in English, they must be submitted together with an English summary, which shows that the documents cover the action tasks in question and includes the conclusions of the committee or authority concerned (if any). INTELLECTUAL PROPERTY RIGHTS (IPR) — BACKGROUND AND RESULTS — ACCESS RIGHTS AND RIGHTS OF USE (— ARTICLE 16) List of background The beneficiaries must, where industrial and intellectual property rights (including rights of third parties) exist prior to the Agreement, establish a list of these pre-existing industrial and intellectual property rights, specifying the rights owners. The coordinator must — before starting the action — submit this list to the granting authority. 1 Commission Directive 2005/28/EC of 8 April 2005 laying down principles and detailed guidelines for good clinical practice as regards investigational medicinal products for human use, as well as the requirements for authorisation of the manufacturing or importation of such products (OJ L 91, 9.4.2005, p. 13). 2 Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (OJ L 158, 27.5.2014, p. 1). 1  Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Rights of use of the granting authority on results for information, communication, dissemination and publicity purposes The granting authority also has the right to exploit non-sensitive results of the action for information, communication, dissemination and publicity purposes, using any of the following modes: - use for its own purposes (in particular, making them available to persons working for the granting authority or any other EU service (including institutions, bodies, offices, agencies, etc.) or EU Member State institution or body; copying or reproducing them in whole or in part, in unlimited numbers; and communication through press information services) - distribution to the public in hard copies, in electronic or digital format, on the internet including social networks, as a downloadable or non-downloadable file - editing or redrafting (including shortening, summarising, changing, correcting, cutting, inserting elements (e.g. meta-data, legends or other graphic, visual, audio or text elements extracting parts (e.g. audio or video files), dividing into parts or use in a compilation - translation (including inserting subtitles/dubbing) in all official languages of EU - storage in paper, electronic or other form - archiving in line with applicable document-management rules - the right to authorise third parties to act on its behalf or sub-license to third parties, including if there is licensed background, any of the rights or modes of exploitation set out in this provision - processing, analysing, aggregating the results and producing derivative works - disseminating the results in widely accessible databases or indexes (such as through ‘open access’ or ‘open data’ portals or similar repositories, whether free of charge or not. The beneficiaries must ensure these rights of use for the whole duration they are protected by industrial or intellectual property rights. If results are subject to moral rights or third party rights (including intellectual property rights or rights of natural persons on their image and voice), the beneficiaries must ensure that they comply with their obligations under this Agreement (in particular, by obtaining the necessary licences and authorisations from the rights holders concerned). Access rights for the granting authority, EU institutions, bodies, offices or agencies and national authorities to results for policy purposes The beneficiaries must grant access to their results — on a royalty-free basis — to the granting authority, other EU institutions, bodies, offices or agencies, for developing, implementing and monitoring EU policies or programmes. Such access rights are limited to non-commercial and non-competitive use. 2  Associated with document Ref. Ares(2023)6408726 - 21/09/2023 The access rights also extend to national authorities of EU Member States or associated countries, for developing, implementing and monitoring their policies or programmes in this area. In this case, access is subject to a bilateral agreement to define specific conditions ensuring that: - the access will be used only for the intended purpose and - appropriate confidentiality obligations are in place. Moreover, the requesting national authority or EU institution, body, office or agency (including the granting authority) must inform all other national authorities of such a request. Access rights for third parties to ensure continuity and interoperability Where the call conditions impose continuity or interoperability obligations, the beneficiaries must make the materials, documents and information and results produced in the framework of the action available to the public (freely accessible on the Internet under open licences or open source licences). COMMUNICATION, DISSEMINATION AND VISIBILITY (— ARTICLE 17) Communication and dissemination plan The beneficiaries must provide a detailed communication and dissemination plan, setting out the objectives, key messaging, target audiences, communication channels, social media plan, planned budget and relevant indicators for monitoring and evaluation. Additional communication and dissemination activities The beneficiaries must engage in the following additional communication and dissemination activities: - present the project (including project summary, coordinator contact details, list of participants, European flag and funding statement and project results) on the beneficiaries’ websites or social media accounts - for actions involving publications, mention the action and the European flag and funding statement on the cover or the first pages following the editor's mention - for actions involving public events, display signs and posters mentioning the action and the European flag and funding statement - upload the public project results to the EU4Health Project Results platform, available through the Funding & Tenders Portal . SPECIFIC RULES FOR CARRYING OUT THE ACTION (— ARTICLE 18) Durability Unless exempted by the granting authority, the beneficiaries must commit to continue to use and maintain after the end of the action equipment bought and eligible at full cost, for activities pursuing the action’s objectives. Such equipment must be used for these purposes — for at least five years after the end of the action (see Data Sheet, Point 1) or until the end of its economic lifespan (i.e. until it has been fully depreciated) — whichever is earlier. 3  Associated with document Ref. Ares(2023)6408726 - 21/09/2023 Specific rules for blending operations When implementing blending operations, the beneficiaries acknowledge and accept that: - the grant depends on the approved financing from the Implementing Partner and/or public or private investors for the project - they must inform the granting authority both about the approval for financing and the financial close — within 15 days - the payment deadline for the first prefinancing is automatically suspended until the granting authority is informed about the approval for financing - both actions will be managed and monitored in parallel and in close coordination with the Implementing Partner, in particular: - all information, data and documents (including the due diligence by the Implementing Partner and the signed agreement) may be exchanged and may be relied on for the management of the other action (if needed) - issues in one action may impact the other (e.g. suspension or termination in one action may lead to suspension also of the other action; termination of the grant will normally suspend and exit from further financing and vice versa, etc.) - the granting authority may disclose confidential information also to the Implementing Partner. 4  Digitally sealed by the European Commission Date: 2023.09.21 18:30:26 CEST This electronic receipt is a digitally signed version of the document submitted by your organisation. Both the content of the document and a set of metadata have been digitally sealed. This digital signature mechanism, using a public-private key pair mechanism, uniquely binds this eReceipt to the modules of the Funding & Tenders Portal of the European Commission, to the transaction for which it was generated and ensures its full integrity. Therefore a complete digitally signed trail of the transaction is available both for your organisation and for the issuer of the eReceipt. Any attempt to modify the content will lead to a break of the integrity of the electronic signature, which can be verified at any time by clicking on the eReceipt validation symbol. More info about eReceipts can be found in the FAQ page of the Funding & Tenders Portal. (https://ec.europa.eu/info/funding-tenders/opportunities/portal/screen/support/faq) Commission européenne/Europese Commissie, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111