AMENDMENT N° 1 TO AGREEMENT No INEA/CEF/ICT/A2015/1156737

Ref. Ares(2020)7879617 - 22/12/2020 Agreement number: INEA/CEF/ICT/A2015/1156737 Modif. no 3 Amend. no 1 Action number: 2015-EE-IA-0100 Innovation and Networks Executive Agency Department C - Connecting Europe Facility (CEF) AMENDMENT N° 1 TO AGREEMENT No INEA/CEF/ICT/A2015/1156737 The Innovation and Networks Executive Agency (INEA) ("the Agency"), under the powers delegated by the European Commission ("the Commission"), represented for the purposes of signature of this amendment by the Head of Department C of the Agency, Andreas Boschen, on the one part, and 1. Health and Welfare Information Systems Centre (HWISC) Public Law Body Registration No 70009770 Uus-Tatari 25 10134 Tallinn Estonia VAT No , hereinafter referred to as “the coordinator”, represented for the purposes of signature of this amendment by Director, Katrin Reinhold and the following other beneficiaries: 2.Estonian Health Insurance Fund (EHIF) - established in Estonia duly represented by the coordinator by virtue of the mandate included in Annex IV of the above-mentioned grant agreement for the signature of this amendment, hereinafter referred to collectively as “the beneficiaries”, and individually as “beneficiary” for the purposes of this amendment where a provision applies without distinction between the coordinator or another beneficiary, on the other part, Having regard to the above-mentioned grant agreement concluded between the Agency and the coordinator on 16/12/2016, Whereas: (1) The coordinator has requested the Agency on 26/10/2020 to amend the above-  mentioned grant agreement for the following reason(s): Delays due to the impact of COVID-19 on the implementation of the Action. (2) The measures provided for in this amendment do not affect the award of the Union financial aid. HAVE AGREED AS FOLLOWS: Article 1 (1) Article 2.2 is replaced by the following article: "2.2 The action shall run from 01/01/2017 (“the starting date”) until 30/06/2021 (“the completion date”)". (2) Article 6.3 is replaced by the following article: "6.3 Communication details of the beneficiaries Any communication from the Agency to the beneficiaries shall be sent to the following addresses: For Health and Welfare Information Systems Centre: Liisa Lvova Project Manager Uus - Tatari 25, 10134 Tallinn, Estonia E-mail address: [email protected]" (3) Annex I shall read as follows: "ANNEX I DESCRIPTION OF THE ACTION ARTICLE I.1 – SCOPE AND OBJECTIVES OF THE ACTION The main objective of the Action is to prepare, test and deploy the cross-border Patient Summary and ePrescription services according to the best practices, and taking into account already available infrastructure and services in Estonia. Estonia is planning to implement cross border Patient Summary during the second quarter of 2021 (Country A and B) and ePrescription in first quarter 2018 (Country B) and first quarter 2020 (Country A). The two services will be deployed both as country of affiliation (Country A) and country of treatment/dispensation (Country B). The coordinator, the Health and Welfare Information Systems Centre (HWISC), is responsible for the Estonian central health information system (CHIS) and for the development of the eHealth services at the state level and will implement the Action in co- operation with the Estonian Health Insurance Fund (EHIF), responsible for ePrescription. The Action will allow cross-border eHealth services for Estonians travelling or working in Europe as well as for the citizens of other European countries travelling or working in Estonia. ARTICLE I.2 – LOCATION OF THE ACTION I.2.1 Member State(s): Estonia. I.2.2 EEA country(ies): not applicable. I.2.3 Third country(ies): not applicable. ARTICLE I.3 – ACTIVITIES I.3.1 Activities timetable Activity Activity title Indicative Indicative Milestone number start date end date number 1 Preparation and Implementation 01/01/2017 30/04/2021 8, 1 2 Service Testing, Approval and 01/08/2017 30/06/2021 6, 3 Deployment 3 Operation 01/11/2017 30/06/2021 11, 9, 7, 10, 5 4 Dissemination, Training and Support 01/04/2017 30/06/2021 12, 4, 2 5 Governance and Management 01/01/2017 30/06/2021 13 I.3.2 Activities description Activity 1: Preparation and Implementation This activity aims at designing national deployment plan and performing national preparatory and implementing activities towards the provision of cross-border eHealth services according to the Service Level Agreement (SLA) defined for operation. Already available national infrastructure will be taken into account. This activity will be broken down into the following tasks: T1.1. Plan and monitor progress towards services operation This task will comprise the following steps: - Formulate a detailed preparation and implementation plan; - Agree and adopt monitoring tools, in concordance with the other Member States participating in the eHealth initiative. T1.2. Design national architecture Analysis of the national architecture and ways to modify and connect it with the NCPeH will be performed. The analysis will provide an optimal solution for Estonia to connect the national architecture with the NCPeH, also specifying the National Connector and how to transform the Patient Summary and ePrescriptions into the EU friendly documents which would enable data exchange. T1.3. Establish organisational requirements and procedures Roles and procedures will be identified and assigned to the specific actors, including the involvement of the institutions relevant for provision of country A services and country B services. The organisational roles and procedures developed and used in the previous epSOS project will be taken into account. T1.4. Establish legal, security and privacy requirements and procedures It is foreseen that the eHealth Network will adopt a Multilateral Legal Agreement (MLA) in 2017 or 2018. The MLA, adopted by Member States, will govern the legal and security aspects. In case of delay of MLA adoption, Estonia and other Member States will adopt the Temporary Legal Agreement (TLA) and, if needed, will sign bilateral agreements. T1.5. Assure semantic interoperability of Patient Summary and ePrescription This task will consist in: - structuring and coding the clinical documents (in Health Level Seven (HL7) Clinical Document Architecture (CDA) Version 2 Level 3) according to the EC guidelines and the associated implementation guides; - translation and transcoding of the common terminologies defined in the Master ValueSet Catalogue (MVC) according to national requirements (Master Translation/Transcoding Catalogue: MTC). T1.6. OpenNCP localisation implementation, integration and testing The OpenNCP will be localized and implemented towards the national infrastructure and country B. The OpenNCP is centrally managed by the European Commission (EC), DG Santé in co-operation with the OpenNCP Community started in the epSOS project. T1.7. Perform unit and integration testing After unit tests, the OpenNCP localisation will be tested for national usage. The complete system will be deployed in the pre-live testing environment to perform technical and functional integration tests, according to the testing strategy jointly agreed in the OpenNCP Community, derived from the epSOS/EXPAND testing strategy. The integration and testing process will be repeated and fine-tuned for each wave, and every time a new OpenNCP release has to be adopted. Most of the tasks of this Activity will be subcontracted (analysis, developments and specialised expertise) Activity 2: Service Testing, Approval and Deployment The purpose of this activity is to test (nationally and internationally), to audit and provide evidence of the readiness level towards the provision of services. Tasks of the activity: T2.1. Perform testing to assure quality of the service provision Pre-production conformance tests will be performed and documented in order to be admitted to the Projectathon conformance and clinical testing (in compliance with the Conformance Gate). The pre-production environment will have to comply with the same security requirements as for the operational environment, including the adoption of the specified certificates for the VPN and security settings, the integration with the national pre-production testing (pre-PPT) infrastructure and the connection to the Central Configuration and Terminology Services. T2.2. Pre-live testing and Projectathon The NCPeH and the portal will be registered for the 2017 Project-a-thon as NCP-B, and for the 2018 Project-a-thon, as NCP-A for the ePrescription. The NCPeH and the portal will be registered for the 2020 Project-a-thon as NCP-A, NCP-B and Portal for the Patient Summary Service. End-to-end functional testing will be performed. The decision of participating in the 2021 Project-a-thon will be made by the beneficiaries in the course of the Action depending on the differences introduced by the adoption of the new EC guidelines for Patient Summary and ePrescription. T2.3. Perform security audit According to the process indicated in the Joint Action supporting the eHealth Network (JAseHN) organisational guidelines, the internal audit, focusing on legal, organisational and security aspects, will be performed to provide evidence of fulfilment of the requirements set by the Agreement and the organisational guidelines. Applying the security rules, the security audit will be repeated by external accredited auditors, six months after the start of the operational services. T2.4. Preparation of country readiness approval processes Objective evidence of the technical and semantic readiness (through the Project-a-thon test results), as well as the legal, organisational and security readiness (through the internal audit results) will be provided to the eHealth Network (or other designated body), in order to get the formal authorisation to start the cross-border eHealth services. This process will be repeated each time a new service is being prepared to enter into operation. T2.5. Service deployment The main steps to be performed within this task are: - implement the operational environment as for the servers, the security assets, the connection with the national infrastructure and the central configuration services; - deploy the NCPeH, the portal and the National Connector components; - configure the system towards the central configuration services and perform the synchronization of the Local Terminology Services. These operation steps will be performed each time a new service is being prepared to enter into operation. T2.6. Non-regression testing When the services have been deployed, the tests for non-regression, will be performed. These tests will be repeated for the deployment of new services or after the change management which implies the installation of NCPeH minor and major releases. The tasks of this Activity requiring specialised expertise, analysis and developments will be subcontracted. This will include external audit. Activity 3: Operation This activity aims at providing the cross-border eHealth services according to the Service Level Agreement (SLA) and pre-defined key indicators (i.e. performance and success). It will also include the maintenance of assets necessary to the provision of cross-border eHealth services, as well as change and risk management. Tasks of the activity: T3.1. Service provision and monitoring The approved and deployed services will be provided according to the release plan: - 2018: ePrescription country B; - 2019: ePrescription country A; - 2021: Patient Summary country A and B and ePrescription services will be aligned with the new EC guidelines. The cross-border services will be provided, in line with the specifications for seven days per week. Changes in the service levels will be discussed and agreed with the other Member States. Service and performance monitoring will be adopted to be able to intervene in case of performance degradation or service interruption. T.3.2. Service maintenance and change management A trouble ticketing process will be put in place to manage incidents, problems and change requests. The process to manage changes, specified during the epSOS project, will be applied. Any change in the operation environment will have to be first validated in the pre-production environment, according to the approved change management procedures. Major changes will require the application of specific non-regression tests. Changes may refer to semantic upgrades or changes in nationally used code systems or fixing in the Clinical Document Architecture (CDA) documents, software patches, minor or major OpenNCP releases. Operation and change management indicators will be collected and reported on a quarterly basis. T3.4. Service evaluation The evaluation process will follow three complementary approaches: - automatic data collection, programming and activating the specific OpenNCP component (always guaranteeing the privacy of the patient); - questionnaires, provided to the health professionals and patients, to assess the user satisfaction; - thorough evaluation sessions with domain experts, to assess the clinical validity and collecting indications for service / clinical documents improvements. Service evaluation results will be collected and reported on a semi-annual basis. The tasks of this Activity requiring specialised expertise and technical developments will be subcontracted. Activity 4: Dissemination, Training and Support This activity will raise awareness and demand among citizens and health professionals regarding the provision of cross-border eHealth services; it will orchestrate educational and training initiatives to empower and support end users as well as other Member States entering operation. The activity will put in place and make use of different communication channels: - Project Content Management System; - Project web portal, coordinated with the web portals of the other Member States; - Online training tools; - Social media and web channels. Tasks of the Activity: T4.1. An overall communication strategy will be defined and as far as possible aligned with the strategies of other Member States. T4.2. Stakeholder engagement including health professional dissemination, education and training To ensure proper stakeholder engagement, overall strategies and action roadmap will be agreed with the other Member States and implemented according to national specificities. The goal of these actions is to stimulate the triggering of the specific initiatives towards health professionals and citizens. Also, specific communication and educational sessions will be organised in order to inform and train the relevant health professionals. The training will not only teach how to use the system but it will also explain the differences in the Member States' approaches. T4.3. Citizen and end-users dissemination and motivation Specific mass communications and focused actions towards tourists, students and business travellers will be planned and put in place. Citizens will be made aware of their rights about cross-border care and about the availability of eHealth cross-border services (both in the home and in the visited countries). T4.4 Help desk and support The Help desk services will be set up and organised according to the typical three-level approach: - basic information to citizens and health professionals; - technical support to health professionals; - expert problem solving trouble tickets management. The service levels for the three help desk services will be discussed and agreed with the other Member States. Infrastructure and capacity of already available help desks for eHealth and health professionals in Estonia will be taken into account while planning and developing the help desk. Most of the tasks of this Activity requiring specialised expertise will be subcontracted. Activity 5: Governance and Management The aim of this activity is to establish a link and a binding channel with the eHealth DSI European governance structure, as well as the appropriate national management structure to assure the provision of cross-border eHealth services. Tasks of the activity: T5.1. Acting and reporting according to the eHDSI governance Estonia will participate and act according to the procedures defined by the eHealth DSI governance model. It will comply with the instructions and requests of the eHealth Operational Management Board (eHOMB) and eHealth Member State Expert Group (eHMSEG). It will also adopt the eHealth Network decisions regarding policies, guidelines and the approval to enter in operation with the eHealth cross-border services. T5.2. Management of national activities The beneficiaries will establish a governance and management structure to guarantee the execution of the proposed Action. ARTICLE I.4 – MILESTONES AND MEANS OF VERIFICATION Milestone Milestone description Indicative Means of number completion verification date 1 Definition of the service deployment plan 31/03/2017 Approved service with activities, milestones and tasks deployment schedule completed 2 Planning of service dissemination, 30/04/2017 Approved service education and training completed. It dissemination, includes concrete actions, outcomes and education and responsibilities. training schedule 3 Compliance with the service requirements 30/11/2017 Service Readiness and recommendations for ePrescription (as Statement for Country B). ePrescription approved by the eHealth Network 4 Definition of the service support plan with 30/11/2017 Approved service  responsibilities, workflow and stakeholders provision support for Patient Summary and ePresciption plan completed 5 Start of operation of ePrescription (as 31/03/2018 Issued Go-live country B) statement 6 Compliance with the service requirements 31/03/2021 Service Readiness and recommendations for Patient Summary Statement for Patient achieved. Summary approved by the eHealth Network 7 Start of operation for the Patient Summary 30/06/2021 Issued Go-live statement 8 Completion of the preparation and 30/04/2021 Submitted final implementation activity progress report on the preparation and implementation activity, containing Estonian requirements and recommendations 9 Completion of the 1st year of operation of 31/03/2019 Submitted service ePrescription (as country B) provision report 10 Start of operation of ePrescription (as 31/03/2019 Issued Go-live country A) statement 11 Completion of operation activity 30/06/2021 Submitted service provision report(s) 12 Completion of dissemination, training and 30/06/2021 Yearly reports on support activities dissemination, education and training, service provision and helpdesk performance 13 Completion of governance and 30/06/2021 Yearly reports on management activity governance and national activities management " Article 2 All the other provisions of the grant agreement shall remain unchanged. Article 3 The present amendment shall form an integral part of the grant agreement and it shall enter into force on the date on which it is signed by the last party. It shall take effect on 31/12/2020.  SIGNATURES For the beneficiary Health and Welfare For the Agency Information Systems Centre Katrin Reinhold Andreas Boschen Done at Tallinn, on Done at Brussels, on In duplicate in English. Electronically signed on 17/12/2020 11:42 (UTC+01) in accordance with article 11 of Commission Decision C(2020) 4482 Saatja: Katrin Reinhold </O=SOTSIAALMINISTEERIUM/OU=EXCHANGE ADMINISTRATIVE GROUP (FYDIBOHF23SPDLT)/CN=RECIPIENTS/CN=KATRIN REINHOLD97A> Saaja: Marika Vaher Teema: FW: Transmission of the signed Amendment n° 1 – Action n° 2015-EE-IA-0100 From: "[email protected]" <[email protected]> Date: Tuesday, 19. January 2021 at 11:18 To: Katrin Reinhold <[email protected]> Cc: Liisa Lvova <[email protected]> Subject: Transmission of the signed Amendment n° 1 – Action n° 2015-EE-IA-0100 INEA ref. Ares(2021)406596 <https://webgate.ec.testa.eu/Ares/document/show.do?documentId=080166e5d7eb5924&timestamp=1611046620150> – 18/01/2021 Dear Ms Reinhold, On behalf of Mr Hervé DUPUY, please find attached the electronic version of a letter and its annex regarding the signature of the Amendment n° 1 – Action n° 2015-EE-IA-0100. We kindly remind you that any communication addressed to the Agency shall be sent to the following address: European Commission Innovation and Networks Executive Agency (INEA) W910 Avenue du Bourget, 1 B-1140 Brussels Belgium Please note that this letter is sent to you by registered mail with acknowledgment of receipt. Best regards, ********************************************************************* European Commission Innovation and Networks Executive Agency (INEA) Tel: +32 (0)2 296 12 20 Fax: +32 (0)2 297 37 27 http://inea.ec.europa.eu <http://inea.ec.europa.eu/> Follow INEA on Twitter <http://www.twitter.com/inea_eu> and LinkedIn <https://www.linkedin.com/company/innovation-and-networks-executive-agency/> ! Check out our exciting new fully Digital 2020 CEF Telecoms Brochure <https://europa.eu/!pN69bC> ! <https://europa.eu/!pN69bC> P Printing of this email has a direct bearing on the Environment! Ref. Ares(2021)406596 - 18/01/2021 EUROPEAN COMMISSION Innovation and Networks Executive Agency Connecting Europe Facility (CEF) Department Unit C5 –CEF Telecommunications Brussels, INEA/C5/GT BY EMAIL Health and Welfare Information Systems Centre Katrin Reinhold Director Uus-Tatari 25, 10134 Tallinn Estonia Email: [email protected] Subject: Transmission of the signed Amendment n° 1 – Action n° 2015-EE-IA-0100 Dear Mrs Reinhold, Please find herewith amendment n° 1 to the Grant Agreement n° INEA/CEF/ICT/A2015/1156737 mentioned in subject, signed by INEA with a qualified electronic signature in line with the eIDAS Regulation. A copy of this amendment has been transmitted for information to the representative of the concerned Member State. Should you have any questions relating to the implementation of the amended Grant Agreement, you may contact Ms Georgia Tzenou at [email protected] who is the Project Officer in charge at INEA. I am looking forward to continuing the good cooperation with you and your services for the successful outcome of the Action. Yours sincerely, [e-Signed] Hervé DUPUY Head of Unit Encl.: Electronic version of Amendment n° 1 of the Grant Agreement INEA/CEF/ICT/A2015/1156737 Copy: Liisa Lvova ([email protected]) [email protected] Agence exécutive pour l'innovation et les réseaux /Uitvoerend Agentschap innovatie en netwerken, 1049 Bruxelles/Brussel, BELGIQUE/BELGIË - Tel. +32 22991111 ElectronicallyOffice: W910 signed on 01/126 18/01/2021 - Tel. 16:06 direct (UTC+01) line +32 2with in accordance 2990896 article 11 of Commission Decision C(2020) 4482 [email protected]