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2015-EE-IA-0100_ AGREEMENT No INEA/CEF/ICT/A2015/1156737 - final reports

Tervise- ja heaolu infosüsteemide keskus · 24. september 2021
Viit
6-2/3536-1
Registreeritud
24. september 2021
Dokumendi liik
Väljaminev kiri
Adressaat
Euroopa komisjon
Saabumis/saatmisviis
post
Funktsioon
6 Projektid ja E-teenuste juhtimine
Sari
6-2 Välisvahenditega seotud projektid ja hankedokumentatsioon
Toimik
6-217/207
Vastutaja
Liisa Lvova (TEHIK, E-teenuste juhtimise osakond, Tervise talitus)

Failid

  • 📎6-23536-1 24.09.2021 Väljaminev kiri.asice12846 KB

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eHealth Network Decision regarding go-live for the Estonia NCPeH with service eP A Adopted by the eHealth Network on 11.06.2019 eHealth Network Purpose of this document: On 13th of May 2019 the National Contact Point for eHealth (NCPeH) of Estonia, submitted to the secretariat of the eHDSI Member State Expert Group (eHMSEG) an application to 'go-live' for the service ePrescription – country A. The application was accompanied by the following supporting documentation: a signed declaration; test reports; and a draft Initial Audit report; and a list of the corrective actions taken by the NCPeH to address the recommendations. In accordance with the 'go-live procedure', the eHMSEG has evaluated the application. This document contains a summary of the evaluation and decision of the eHealth Network. Section 1 Executive summary The eHN decides that Estonia: Goes live with observations, provided that: 1. All recommendations of the Initial audit report Reference No: 2019-6841 have been satisfactorily addressed and that this has been verified by the auditors, before entering routine operations.  The NCPeH needs to submit a statement of the Auditors to the eHMSEG (via the secretariat) that all recommendations have been satisfactorily addressed. 2. The necessary conformance and functional tests were passed and that this has been confirmed by the Solution Provider before entering routine operations.  The NCPeH needs to submit a statement of the Solution Provider to the eHMSEG (via the secretariat) that the necessary conformance and functional tests were passed. The NCPeH can then enter routine operations without the need for further approval . Section 2.1 Main findings of the conformance and functional test reports The end-to-end functional testing aims to validate, from the user point of view, the process and the information provided by the eHDSI services to health professionals. It is expected to detect flaws or malfunctions in any step of the process, from the processing of the original document to its transfer and subsequent processing and display in the receiver country. The evaluation is carried out for all eHDSI services (Patient Summary and ePrescription/eDispensation) in an environment that intends to simulate normal operations as much as possible: e.g. a pharmacist dispensing a medicinal product or a physician in an emergency department providing care to a citizen from a different deploying country. The only difference with a real scenario is that only test data are used and no real patients are involved. In the Wave 2 Formal Pre-Preparatory Tests (February 2019) Estonia has undergone the tests for the specifications and services below:  Wave 2 specification for ePrescription service Country A - Formal PPT  Wave 2 specifications for ePrescription service Country B - Upgrade PPT The report submitted demonstrates that the NCPeH has passed the necessary conformance test. The functional tests report submitted demonstrate that the NCPeH should complete the tests with all the partners (in case they are available in the June 2019 test session). Section 2.2 Main findings of the Initial audit report 2 eHealth Network The initial audit of the NCPeH, against the readiness criteria checklist (version 1.2.1), took place from 25 to 26 March 2019. The scope of the audit covered the organisation of the NCPeH and its activities in relation to ePrescription Country A, including sub-contracted parties. The Initial audit report concluded that: “Insufficient adaptation of processes and documentation to the new [ePrescription country A] service requirements creates risks to the confidentiality, integrity and availability of patient data. The report contains recommendations to the Estonian NCPeH aimed at rectifying the shortcomings identified.” Section 2.3 Evaluation No further actions are required in relation to conformance testing. As the result of the functional testing, it is recommended that Estonia should complete the tests with all the partners (in case they are available in June 2019 test session). The Initial audit identifies fourteen non-compliances and contains recommendations to the NCPeH to address each of them. The following table provides an overview of these non-compliances and recommendations, and the corrective actions taken by the NCPeH to address the recommendations. 3 Non compliance Audit conclusions Recommendation Corrective action proposed by the NCPeH Self assessment document will be complemented accordingly (by the 15th of May The data controllers and data processors 2019). Data controllers (Population Register, To ensure that the data controllers and data for the eP-A service and their respective Estonian Medical Prescription Center, Register processors for the new eP-A service and responsibilities have not been of Medicinal Products, Health Information 1 their respective responsibilities are comprehensively identified. The Data System) and processors (Ministry of the comprehensively identified, in line with Protection Impact Assessment has not Interior, Estonian Health Insurance Fund, The incomplete readiness criterion C.9. been updated for the new eP-A service. Estonian Health and Welfare Information identification of data Systems Centre, Agency of Medicines, Ministry processors of cross-border of Social Affairs) will be specified. patient data, and the lack To ensure that the Patient Information of a patient information The Patient Information Notice for the Notice for the new eP-A service is 2 notice mean that the PIN will be published by the 15th of May 2019. new eP-A service is not yet available. available, in line with readiness criterion NCPeH cannot C.14. demonstrate its In addition to the notifying of the parties accountability towards its concerned we’ve done so far, we will include a stakeholders at national concrete list of digital distribution channels, and European Union level. While there is some preliminary To ensure that the dissemination plan for where we will publish informative articles. As information on the HWISC website, a the beneficiaries of the new eP-A service soon as we have exact information when and 3 dissemination plan for the beneficiaries is available, in line with readiness criterion what countries are going live (Estonia as eP-A) of the new eP-A service is missing. O.12. we may continue with our dissemination plan and produce different posters, information materials and publish digital banners (main focus). We will add separate annexes for testing, adding To ensure that the conformance testing The conformance testing process is not NCP-B Pre-Projectathon and references to the 4 process is documented, in line with documented. The lack of documented testing framework by the 15th of May 2019. Self readiness criterion T.21. processes undermines assessment plan will be updated. effective planning and To ensure that the process and the While the NCPeH is able to implement Service pass will be amended accordingly by monitoring, and creates associated NCPeH roles and the measurements required by the eHDSI the 15th of May 2019. Sending of the KPIs will risks to the availability of responsibilities to implement the 5 Monitoring Framework, the process and be specified and added references to monitoring the new eP-A service. measurements required by the eHDSI the associated NCPeH roles and framework, also roles and responsibilities will Monitoring Framework are documented, in responsibilities are not documented. be updated in service pass. line with readiness criterion O.11. eHealth Network Incident management does not To ensure that incident management is Jira will be amended in accordance with eHDSI distinguish between eP-B and eP-A aligned with the eHDSI Country Service 6 service desk guide, paragraph 2.3.1 by the 15th services. This is not in line with the Desk Guideline, in line with readiness of May. eHDSI Country Service Desk Guideline. criterion OS.8. Expected capacity is defined in the service pass (max 8 patients per day), but some formatting changes will be made to clarify the content. We To ensure that methods and procedures to will specify monitoring of our overall services Procedures to monitor service capacity monitor service capacity for the new eP-A and extract eP-A data from there. Daily 7 for the new eP-A service are not service are documented and in place, in monitoring will be in place (time of the query, documented nor in place. line with readiness criterion OS.21. how many prescriptions have been bought etc), checking for possible errors and notifying monitoring center. Amendments in service pass will be done by the 15th of June 2019. To ensure that the risks associated with the Although a Business Impact and a Risk Most of the risks included in the assessment are new eP-A service are clearly identified in Assessment have been performed, risks applicable for both, eP-B and eP-A, but 8 the Business Impact and Risk associated with the new eP-A service additional assessment will be ordered and Assessments, in line with readiness have not been identified. conducted by the end of June 2019. criterion IS.3. To ensure that the Business Continuity The Business Continuity Plan does not Plan includes requirements related to the Documents will be updated by the end of June 9 include requirements related to the new new eP-A service, in line with readiness 2019. eP-A service. The incomplete criterion IS.11. identification of risks, of To ensure that the Disaster Recovery Plan The Disaster Recovery Plan does not configuration items and of considers all assets which are specific for Disaster recovery plan will be amended by the 10 consider assets which are specific for the possible scenarios arising the new eP-A service configurations, in end of June 2019. new eP-A service configurations. from the new eP-A service line with readiness criterion IS.12. creates risks to the The NCPeH has interfaces with some confidentiality, integrity new external services required under the and availability of patient new eP-A service (e.g. Prescriptions To ensure that the NCPeH interfaces with data. Centre and Population Register) and new external services required under the there are some other eP-A related eP-A service, as well as other eP-A related Configuration management database will be 11 configuration items required under configurations required under OS.19, are updated by the end of June 2019. OS.19 (such as firewalls, Service managed through configuration Metadata Publisher and International management, in line with readiness criteria Patient Search Mask). However, these OS.19 and IS.14. are not managed through configuration management. 5 eHealth Network To ensure that policies for the processing Policies for the processing and and safeguarding of personally identifiable safeguarding of personally identifiable Helpdesk tickets notifications will be information related to the new eP-A 12 information related to the new eP-A categorized and only available to certain people. service are clearly established for the service are not clearly established for the Implementation done by the end of June 2019. Helpdesk, in line with readiness criterion Helpdesk. IS.20. Essential elements for the new eP-A To ensure that relevant NCPeH technical service (e.g. Service Metadata Publisher documentation (such as the ‘Estonian and Terminology Services Access Cross-Border eHealth Architecture’ and Manager Synchroniser) were missing in Update will be conducted in service pass by the 13 the "Teenuse pass") includes all the the ‘Estonian Cross-Border eHealth end of May 2019. The documentation of essential elements for the new eP-A Architecture’ document and the service service operations for eP-A service, in line with readiness criteria T.1 passport document ("Teenuse pass") processing activities is and T.2-1. provided to the audit team. incomplete. This creates To ensure that the ‘Dispensed Prescribed risks to the availability of The ‘Dispensed Prescribed Medicine’ Medicine’ workflow in the ‘Estonian the new eP-A service. workflow in the ‘Estonian Cross-Border Cross-Border eHealth Architecture’ Update will be conducted in service pass by the 14 eHealth Architecture’ document does not document accurately describes the data end of May 2019. accurately describe the data processing processing activities related to the eP-A activities related to the eP-A service. service, in line with readiness criterion T.12. 6 Section 3. Decision to go live for Estonia The eHN decides that Estonia: Goes live with observations, provided that: 1. All recommendations of the Initial audit report Reference No: 2019 -6841 have been satisfactorily addressed and that this has been verified by the auditors, before entering routine operations.  The NCPeH needs to submit a statement of the Auditors to the eHMSEG (via the secretariat) that all recommendations have been satisfactorily addressed. 2. The necessary conformance and functional tests were passed and that this has been confirmed by the Solution Provider before entering routine operations.  The NCPeH needs to submit a statement of the Solution Provider to the eHMSEG (via the secretariat) that the necessary conformance and functional tests were passed. The NCPeH can then enter routine operations without the need for further approval . eHealth DSI Member State Expert Group Decision regarding Estonia NCPeH to be authorised to start the Production Environment Testing with service PS A and PS B Having analysed the audit and Pre-Production Testing of Estonia. eHMSEG considers the following functional findings f-4, and f-6 have a medium impact on the eHDSI, and finding f-8 have low impact on the eHDSI. eHMSEG has determined these findings can be resolved during routine operations. There are two findings from the initial audit, on which the auditors concluded that no further requests for information or other follow-up actions are needed. The eHMSEG takes note on the fact, that EE have not finished the conformance tests with three partners, due to the exceptional situation, which was the outburst of the COVID -19 pandemic. Having said so, the eHMSEG decides that EE NCPeH is authorised to start the Production Environment Testing of service PS A and PS B. In addition, findings f-4, f-6 and f-8 do not prevent NCPeH from starting routine operations, provided that all the Production Environment Tests sessions are fulfilled and there are no further findings impeding the go-live after these tests. Adopted by the eHMSEG on 15.06.2021 eHealth Network Recommendation Report to Go Live for Estonia Drafted and adopted by eHMSEG on 23.10.2018 eHealth Network Purpose of this document: On 12/10/2018 the National Contact Point for eHealth (NCPeH) of Estonia, submitted to the secretariat of the eHDSI Member State Expert Group (eHMSEG) an application to 'go-live' for the service ePrescription – country B. The application was accompanied by the following supporting documentation: a signed declaration; test reports; and a follow-up audit report. In accordance with the 'go-live procedure', the eHMSEG has evaluated the application. This document contains a summary of the evaluation and recommendations to the eHealth Network. Section 1 Executive summary The eHMSEG recommends that Estonia: Goes-live, with observations, provided that all corrective actions identified have been taken and this has been verified by Auditors, before entering routine operations.  The NCPeH needs to submit a statement of the Auditors to eHMSEG (via secretariat) that all corrective actions have been implemented.  The NCPeH can then enter routine operations without need for further approval. Section 2.1 Main findings of the conformance and functional test reports The end-to-end functional testing aims to validate, from the user point of view, the process and the information provided by the eHDSI services to health professionals. It is expected to detect flaws or malfunctions in any step of the process, from the processing of the original document to its transfer and subsequent processing and display in the receiver country. The evaluation is carried out for all eHDSI services (Patient Summary and ePrescription/eDispensation) in an environment that intends to simulate normal operations as much as possible: e.g. a pharmacist dispensing a medicinal product or a physician in an emergency department providing care to a citizen from a different deploying country. The only difference with a real scenario is that only test data are used and no real patients are involved. The reports submitted demonstrate that the NCPeH has passed the necessary conformance and functional tests. Section 2.2 Main findings of the follow-up audit report The initial audit of the NCPeH, against the readiness criteria checklist (version 1.19), took place in March 2018. The scope of the audit covered the organisation of the NCPeH and its activities in relation to ePrescription Country B, including sub-contracted parties. A follow-up audit was carried out at the end of September 2018. The follow-up audit report concluded that: "The NCPeH organisation is well advanced in complying with the readiness criteria pertaining to the organisation, semantics and technical interoperability domains. Nevertheless, actions remain to be completed in the domains of contractual compliance, service operations and information security. The absence of a legal basis to operate in the cross-border exchange of health data means that the NCPeH organisation cannot demonstrate its accountability towards its stakeholders at national and European Union level. In the information security domain, the absence of a comprehensive log management system poses a risk to the confidentiality of the data exchanged in cross-border health services." 2 eHealth Network Section 2.3 Evaluation No further actions are required in relation to conformance and functional testing. The report of the follow-up audit identifies nine non-compliances and contains recommendations to the NCPeH to address each of them. The following table provides an overview of these non- compliances and recommendations, the proposed actions of the NCPeH for addressing them, and the opinion and rationale of the eHMSEG underpinning its recommendation to the eHealth Network, as shown in section 3 of this document. 3 Non compliance Audit conclusions Recommendation Corrective action proposed by the NCPeH 1 C.1 [critical]: Current legislation does The absence of a legal basis To ensure that the Health and Welfare The HWISC as well as the Ministry of Social not designate the HWISC as the national for the HWISC to operate as Information Systems Centre is designated Affairs, informed the audit team that (changes organisation responsible for exchanging an NCPeH in the cross-border by the national competent authority as the to) two pieces of legislation are under ePrescriptions with other Member States. exchange of ePrescriptions organisation responsible for the cross- preparation, both of which are needed to means that the organisation border exchange of health information empower the HWISC to fulfil its role in cannot demonstrate its pertinent to ePrescriptions, in line with exchanging ePrescription data with other EU accountability towards its readiness criterion C.1. Member States. The first of three readings of the stakeholders at national and legislation is due to take place in the Social EU level. Affairs Committee on 9 October. This legislation also identifies the responsible data controller and data processor referred to in the Data Protection Impact Assessment. The Ministry anticipates the legislation to become applicable on 13 November 2018. 2 C.4 [critical]: The HWISC is currently To ensure that there are contractual After the legislation referred to above will come not empowered to make contracts with arrangements in place with the national into force, the HWISC intends to make pharmacies for the cross-border health care organisations (pharmacies) for contracts with all 131 pharmacy activity licence exchange of ePrescriptions. the cross-border exchange of health holders for the cross-border exchange of information pertinent to ePrescriptions, in ePrescriptions. The signature of contracts may line with readiness criterion C.4. start after the third reading of the legislation referred to in Finding No 1 (i.e. in October), and HWISC expects to have signed all contracts by the end of December 2018. 3 OS.1 [critical]: The current service Although service operations To put in place the Service (Level) The HWISC expects the problem management management plan is at an advanced stage are largely ready for routine Management Plan, in line with readiness procedure to be completed by the end of but it does not address problem operations, shortcomings in criterion OS.1. October 2018. management. problem management and in 4 OS.21 [major]: Even if real time capacity the recovery procedure in case To put in place methods, procedures The HWISC expects to establish the business monitoring has been demonstrated and of disruption, may pose a risk and/or techniques to monitor and provide requirement for capacity by the end of the technical capacity of the system has to the availability of the adequate service capacity, in line with September 2018 and to complete the been identified as five simultaneous services. readiness criterion OS.21. configuration of the monitoring tools by the end users (due to NCPeH technical of October 2018. limitations), the business requirement for capacity has not been described, and the monitoring tools have not been configured accordingly. eHealth Network Non compliance Audit conclusions Recommendation Corrective action proposed by the NCPeH 5 OS.24 [major]: The HWISC does not To put in place a procedure to recover The HWISC expects that the procedure to have an approved procedure to recover back to normal operations in case of recover back to normal operations in case of back to normal operations in case of disruption, in line with readiness criterion disruption will be completed and approved once disruption. OS.24. the business impact plan, the risk assessment plan, the business continuity plan and the disaster recovery plan have been completed. They expect all these documents to be finalised by the end of November 2018. (See also Finding Nos 8 and 9.) 6 IS.6 [critical]: Even though the security The information security To ensure that no cross-border data could HWISC expects to document these safeguards controls relating to the trust models system is largely ready for be transmitted via their services to an by the end October 2018. applicable to the cross-border exchange routine operations. entity that either does not belong to or is of health data have been identified, the Nevertheless, there are gaps in not allowed within the Cross Border safeguards being implemented are not the system for collecting, eHealth Information System network, in documented. analysing, storing and line with readiness criterion IS.6. 7 IS.7 [critical]: The HWISC has not retaining audit trails and logs, To put in place an appropriate system of The HWISC expects to complete work to exhaustively identified: (a) the logs which pose a risk to the collecting, analysing, storing and retaining address these shortcomings by the end of generated by the NCPeH technical confidentiality and integrity of audit trails and logs, in line with readiness October 2018. gateway; (b) the security policies (access the data exchanged in cross- criterion IS.7. rights) applicable to each type of log. border health services. 8 IS.11 [major]: The business continuity To define service/business continuity The HWISC expects the business continuity plan has not yet been approved. (The risks associated with the requirements in a Business Continuity plan to be approved and implemented by the absence of the business Plan, in line with readiness criterion IS.11. end of November 2018. 9 IS.12 [critical]: The HWISC does not continuity plan, are mentioned To establish a Disaster Recovery Plan for The HWISC expects the current draft disaster have a disaster recovery plan for the in the conclusions for the the National Contact Point for eHealth recovery plan to be amended and approved by cross-border exchange of health data. Operations and services Technical Gateway and other critical the end of November once the business impact domain). services and resources, in line with and risk assessment plans are completed. (See readiness criterion IS.12. also Finding Nos 5 and 8.) 5 Section 3. Recommendations to go live for Estonia The eHMSEG recommends that Estonia: Goes-live, with observations, provided that all corrective actions identified have been taken and this has been verified by Auditors, before entering routine operations.  The NCPeH needs to submit a statement of the Auditors to eHMSEG (via secretariat) that all corrective actions have been implemented.  The NCPeH can then enter routine operations without need for further approval. PATIENT SUMMARY SERVICE Introduction A portal for cross-border Patient Summary (PS) exchange needs to be created. The portal is for national use and only in Estonian. The portal will be used only by doctors and the main workflow will be to identify a foreign person and view his / her Patient Summary. The primary purpose of electronic patient summary id to provide the healthcare professional (HP) with a data set of key health information at the point of care to deliver safe patient care during unscheduled care. The content of the PS is not the entire medical record, but the essential patient information to provide treatment. The portal is only used in desktop version. The project has been funded by the European Union. Main page without logging in The portal is only for logged in users. Therefore, only the login option is available on the front page of the portal. The doctor logs in Login is via Keycloak. In other words, the portal directs the user to Keycloak and this forwards to TARA, where authentication takes place. Keycloak and TARA are separate applications. After authentication, the user is authorized. This is done against the records of the Health Board. These are backend queries. In the design view, the user has a login button. The button directs it to other applications. When the user returns to the PS portal, the user is already authenticated and authorized. The portal displays possible countries If the user (doctor) is logged in, he/she will be taken to the front page of the logged in view. The user can: • See that he is logged in • Possibility to log out • Select the country whose patient is to be identified. By logging in, the portal offers possible countries whose patients can be identified. In the first stage, in addition to Estonia, the following countries will participate: Czech Republic, Portugal, Malta, Croatia, Luxembourg. It must be taken into account that all European countries can participate and the list of countries is inconclusive and increasing over time. The doctor identifies the patient Once the country is selected, the portal offers a different number of patient identification fields according to the selected country. For example, a Finnish patient can only be identified by personal identification code. For Austria, the patient is needed to identify the patient's ID, name, first name and date of birth. Fields can be mandatory or optional. Fields can have a required length (minimum and maximum length) or a required format. Examples: When starting the search, it is possible to mark the symbol "hädaolukord". This feature is indicated when the person is incapable of contact and failure to provide assistance endangers the person's life. If the patient is conscious, the purpose of use is “ravi”. When searching for a patient, usually only one patient comes up (but for some countries, depending on the search criteria, several patients may come up). Patients may not be found. An appropriate information will be given then. The doctor opens the Patient Summary If the patient is found, the user selects a specific patient and moves to the view of the patients “patient summary” (patient summary query is launched when the user clicks “vali”. The answer is a PS or an error message). The PS document display is already designed and cannot be changed/designed. The existing design opens in a portal window. When displaying the PS, it must be possible to see who is the subject and when the PS was created. It must also be possible to print the PS and open the original document. The original document is always in the patient's home language and in PDF format. The PS request may also give an error message or a warning message. In this case, the error code and descriptions are displayed. Possible error messages are: Condition and Severity Response Message Code Status The patient has not given consent to the requested Failure No Consent 4701 service. (ERROR) Country A requests a higher authentication trust Failure Weak 4702 level than assigned to the HP ( eg password- Authentication based login is not accepted for the requested operation). (ERROR) Either the security policy of the country A or a Failure Insufficient 4703 privacy policy of the patient (that was given in Rights country A) does not allow the requested operation to be performed by the HP (ERROR). No patient summary is registered for the given Success No Data 1102 patient. (WARNING) If PDF-coded patient summary is requested: Success Unsupported 4201 Country A does not provide the (optional) source Feature coded version of the patient summary (INFO) The query argument slots used by the service Failure Unknown 4202 consumer are not supported by the service Signifier provider. (ERROR) The requested encoding cannot be provided due Failure Transcoding 4203 to a transcoding error. (ERROR) Error The service provider is un- able to evaluate the Failure Unknown Filter 4204 given argument values (ERROR). Other Test subjects • 49406240016 Kati Piiriülene (27.a) • 38507220018 Toomas Piiriülene (36.a) • 49203030010 Mari Piiriülene-Läbu (29.a) HWISC Implementation of CEF project in Estonia Liisa Lvova Health and Welfare Information Systems Centre/Project Manager 10.2020 Initial plans for Patient Summary service ‣ 2019 July – analysis of datasets ‣ 2019 August – September – development of PS service ‣ 2019 September – October – testing the PS service and eHDSI Preparatory test event ‣ 2020 February – March - eHDSI Formal test event ‣ 2020 April - audit ‣ 2020 May - June – audit findings ‣ 2020 June - live Reality ‣ eHDSI Formal test event postponed to April and June ‣ Fixing the test event findings during summertime ‣ Audit postponed to autumn: ‣ 8 calls done via videoconference during the summer and autumn ‣ Grant agreement amendment ‣ Officially valid until the end of year ‣ Proposed an extension of 6 months Where we are right now? Where we are right now? ePrescription/eDispensation service Country Estonians abroad Foreigners in Estonia Finland 1. June 2020 21. January 2019 Croatia 31. August 2020 2. March 2020 Portugal 1. June 2020 Patient summary • Waiting for the final audit report • Already fixing the known findings • Patient Information Notice amendment and consent discussions New concept of the audit • Requirements driven approach (no more readiness criteria) • More like a security audit, but still all the aspects are covered The process: • ~2500 pages of documentation • Out of this ~ 600 requirements extracted Outcome: • Authentication, confidentiality, integrity and non-repudiation are central themes in requirements Some statistics Finland eP A – Estonia eP B Finland eP A – Estonia eP B Estonia eP A – Finland eP B Estonia eP A – Finland eP B Thank you for listening! Liisa Lvova [email protected] PIIRIÜLESE DIGIRETSEPTI TEENUSE KÄIVITAMINE Aleksandra Stupak– piiriülese terviseandmete vahetamise teenuse projektijuht Tervise ja Heaolu Infosüsteemide Keskus Tallinn 22. veebruar 2019 ETTEKANDE TEEMAD • Projekti ajakava • Statistika andmed • Projekti esimeses etapis osalevad riigid • Teenuse väljastamise võimalused • Portaali tutvustus • Hansasofti kasutamine • Korduma kippuvad küsimused Piiriülese retsepti PROJEKTI AJAKAVA • I etapp: Eesti realiseerib piiriülese digiretsepti väljamüügi teenuse (riik B teenus) – läks toodangusse – 21. jaanuar 2019 • II etapp: Eesti arendab digiretsepti väljastamise teenuse (riik A teenus), tehniline valmisolek selleks peab olema juuli 2019 • Testimisega on juba alustatud Statistika Eestis realiseeritud EL paberretseptide hulk suureneb iga aastaga • 2014. aastal realiseeriti Eestis 2492 EL retsepti • 2015. aastal realiseeriti Eestis 2647 EL retsepti • 2016. aastal realiseeriti Eestis 3374 EL retsepti • 2017. aastal realiseeriti Eestis 3716 EL retsepti • 2018.a IV kvartali andmed ei ole meil veel koos, aga kolme esimese kvartali jooksul realiseeriti 2989 retsepti • Kõige populaarsemad preparaadid : Vagifem, Malarone, Pradaxa, Victoza, Cialis, Xarelto Eesti ja Soome käivitasid teenus koos jaanuaris 2019 • Eestis saavad digiretsepti alusel osta ravimi välja Soome elanikud alatest 18. eluaastast • Skoobist on väljas: • Narkotilised ravimid • Psühotroopilised ravimid • Ekstemporaalsed ravimid Sellisel juhul retsepti üldse patsiendi retseptide nimekirjas on kirjas, et ei ole võimalik müüja (not dispensable), apteeker ei pea teadma piiranguid ja riikide erisusi. • Soodustused – piiriülese digiretseptiga patsient maksab alati ravimi eest välisriigis täishinna, kuid tal on võimalik oma koduriigis kindlustuse kaudu teha taotlus soodustuse raha tagasi saamiseks. • Asendamine kui ATC kood, annus või tugevus on erinev Välisriigi digiretsepti alusel ravimi väljastamiseks on kaks võimalust VÕIMALUS 1: INTEGREERIDA TEENUS APTEEGI INFOSÜSTEEMI • TEHIK-u poolt on loodud teenus, mis on võimalik kasutusele võtta apteegi infosüsteemis selleks, et ka piiriüleseid digiretsepte oleks võimalik pärida otse apteeker töölaualt. • Vajab apteegi infosüsteemis arendust, kuid teenus on loodud võimalikult sarnane retseptikeskuse teenusega, et vähendada apteegi infosüsteemi poolel töömahtu. Apotheka – Noom tarkvara –valmis Hansasoft – ei ole veel tehtud – kasutab valisrets.digilugu.ee portaali MISP2 - kasutab valisrets.digilugu.ee portaali PIIRIÜLESE DIGIRETSEPTI TEENUSE SISU VÄLISRIIGI ISIKU RETSEPTIDE PÄRIMINE EESTI APTEEKRI POOLT: 1. Identifitseeritakse välisriigi patsient esitatud isikut tõendava dokumendi alusel ning teostatakse IS abil päring patsiendi päritoluriigi 2. Soome puhul on kasutusel 2 isikut tõendavat dokumenti: Pass või ID kaart 3. Päringu vastuseks tagastatakse välisriigist patsiendi üldandmed (nimi, sugu, sünniaeg). • Apteekril on võimalik kontrollida tagastatud andmete vastavust dokumendil olevatele andmetele, mille eesmärk on veenduda, et tegemist on õige patsiendiga. Soome Pass Soome ID card Isikut tõendavast dokumendist on vaja leida soomlase isikukood – see on passis väljal nimetusega TUNNUS - KOD - CODE – CODE ja ID-kaardil väljal nimetusega TUNNUS – KOD - punasega on märgitud isikukoodi asukoht. Soome Pass Kui TUNNUS - KOD - CODE – CODE sisaldab, ainut 5 sümbolit, siis enne seda on vaja panna sünniaega, formaadis PPKKAA (ehk selle näidisel 211271-426U PIIRIÜLESE DIGIRETSEPTI TEENUSE SISU VÄLISRIIGI ISIKU RETSEPTIDE PÄRIMINE EESTI APTEEKRI POOLT: 1.Välisriigi retseptide nimekirja päring 2.Välisriigi retsepti detailsete andmete päring Retsepti detailsed andmed kuvatakse apteekrile tõlgituna eesti keeles (ATC kood, nimi, kogus, pakendite arv, ühiku tüüp jne). Lisaks tõlgitud andmetele on võimalik näha originaalkeeles retsepti PDF-i, kus teatud juhtudel võib olla täiendavat informatsiooni, mida ei olnud võimalik teises riigis struktureeritult retseptile lisada 3.Välisriigi retseptile ravimi müügiteate koostamine ja välisriiki tagasi saatmine Vastavalt edastatud müügiinfole muudetakse teise riigi retseptikeskuses retsepti staatus osaliselt või täielikult välja müüduks PIIRIÜLESTE TERVISEANDMETE PORTAAL Portaali avavaade (peale kasutaja sisse logimist): PIIRIÜLESTE TERVISEANDMETE PORTAAL Portaali avavaade PIIRIÜLESTE TERVISEANDMETE PORTAAL Portaali avavaade • Peale apteegi valimist avaneb pop-up aken. On vaja patsientidelt üle küsida, kas ta teab, kuidas Eestis töödeldakse tema andmeid? (Me säilitame kõik andmed logides 7 aastat probleemi lahendamiseks või statistika / uuringu tegemiseks) • Kui patsient annab andme töötlemiseks nõusolu (suuliselt), siis on võimalik ravimi väljamüügiga edasi minna • Kui patsient nõusolekut ei anna siis retsepti väljamüüki ei ole võimalik teostada. • Soomlastele on vaja eraldi anda nõusolekud, et nende andmed oleks nähtavaid välisriigis (https://www.kanta.fi/omakanta) – praegu juba 6000+ inimest andsid nõusolekut PIIRIÜLESTE TERVISEANDMETE PORTAAL Portaali avavaade (peale kasutaja sisse logimist): PIIRIÜLESTE TERVISEANDMETE PORTAAL Portaalis patsiendi päring PIIRIÜLESTE TERVISEANDMETE PORTAAL Portaalis patsiendi päring PIIRIÜLESTE TERVISEANDMETE PORTAAL Portaalis patsiendi retseptide nimekirja päring PIIRIÜLESTE TERVISEANDMETE PORTAAL Viga PIIRIÜLESTE TERVISEANDMETE PORTAAL LANTUS,ATC kood PIIRIÜLESTE TERVISEANDMETE PORTAAL LANTUS,ATC kood HS-is retsepti sisestuseks nupp „Paberretseptide sisestus“ HS-i retsepti sisestamine (punased – kohustuslikud väljad) HS-is teostage müük PIIRIÜLESTE TERVISEANDMETE PORTAAL Portaalis teavitus edukast väljamüügi teostamisest Küsimused - vastused •Kui Eesti kodanikul on ka Soome isikukood/patsiendi number, ja soovib Soomes välja kirjutatud retsepti Eestis välja osta. •Millist isikukoodi siis kasutada? V: Alati tuleb kasutada selle riigi isikukoodi, kus retsept välja kirjutati. Praegu tehniline lahendus ei luba kasutada Riik C koodi, kui piiriülene retsept oli välja kirjutatud Riigis A ja on soov seda välja osta Riigis B Küsimused - vastused Küsimused - vastused •Kui on vajalik ravimit osta lapsele, kas ostja on siis laps ise? (isikukood) V: Jah, selles ostja on laps ise. Siin on asjaolu, et esimeses etapis võivad osta ravimit välja Soome patsiendid alatest 18. eluaastast Küsimused - vastused Küsimused - vastused •Kas soomlaste jaoks nõusolek on vajalik ja kus seda on võimalik anda? •V: Jah, nõusolek on vajalik, kui see puudub, siis teile ei tagastatakse selle patsiendi andmeid ja on kirjas, et nõusolek puudub. •Teile tagastatakse veateade: FINNCP-0030 Teave puudub (Patsiendil puudub nõusolek kanta.fi portaalis või patsiendil pole kunagi olnud Soome digiretsepte) •Soomlaste jaoks see on võimalik teha: https://www.kanta.fi/omakanta Küsimused - vastused Küsimused - vastused •Milline riik lisaks Soomele saab veel Eestist piiriülese digiretsepti alusel ravimit välja osta? V: Teises etapis liituvad veel riigid – Küpros, Kreeka, Portugal – alatest juuli 2019. Küsimused - vastused Küsimused - vastused •Millal tekkib Eesti patsientidel võimalus digiretsepti alusel ravimeid välja osta välisriigis? V: 2019 aasta juulis. Eesti patsiendid saavad ravimeid välja osta digiretsepti alusel Soomes, Kreekas, Küprosel, Portugalis Küsimused - vastused Küsimused - vastused •Ostes digiretsepti alusel ravimi mõnes välisriigis, kas kehtivad Eestis kehtivad soodustused või siiski antud riigi soodustused, kust ravim välja ostetakse? V: Piiriülese digiretseptiga patsient maksab alati ravimi eest välisriigis täishinna, kuid tal on võimalik oma koduriigis teha taotlus, et soodustuse raha tagasi taotleda. Küsimused - vastused Küsimused - vastused •Missugused dokumendid on vajak, et saada ravimi hüvitist? V: Soome patsientide puhul on vaja trükkida välja müügiteatise pdf-i ( kus on see originaal retsepti välja kirjutatud ravim ja välja ostetud ravim) ja siis tšekk. Küsimused - vastused Küsimused - vastused •Kas piiriülese retsepti saab tühistada? V: Tühistada ei saa, esialgu on vaja kopeerida andmeid oma Infosüsteemi ja võtta patsiendilt raha, ja siis ainult „kinnitada“ välja müüki portaalis. Kui patsient mõtleb ümber või tal ei ole raha kaasas, siis viimane samm jääb tegemata ja retsept on väljastamata. Küsimused - vastused Küsimused - vastused •Kas ATC koodi saab muuta? V: ATC koodi muuta ei saa, see peab olema üldisemal tasemel, aga 2 viimast numbrit võib ära jätta, kui sama ATC koodi ei ole ja asendus on lubatud. Küsimused - vastused Küsimused - vastused •Portaal näitab retseptide sulgudes: «not dispensable» - kas see tähendab, et on mingi probleemid süsteemidega? V: Ei, see tähendab, et seda retsepti ei ole võimalik välisriigis realiseerida. Soomlased panid piiranguid. Põhjused, millest võib see teada olla tingitud: • Soome arst ei ole retseptile märkinud ravimi kogust, vaid on kirjutanud selle välja tingimuse „kehtib aasta“. • Retsepti välja kirjutades on Soome arst lisanud sellele märke „doctors fee“ ehk „arsti tasu“ ja sellisel juhul saab seda retsepti realiseerida teostades esimene ost Soomes. Peale esimese ostu realiseerimist koduriigis on võimalik seda edaspidi realiseerida ka piiriüleselt. https://www.kanta.fi/en/buying-prescription-medicines-abroad Küsimused - vastused Küsimused - vastused •Kui retsepti peal on kirjas „not dispensable“, aga patsient ikka tahab ravimit saada. Mida teha? V: Sellest tulenevalt soovitame Teil esimese asjana paluda patsiendil helistada oma arstile uue retsepti väljastamiseks, millele oleks märgitud ka ravimi kogus ja ei olnud pannud mingi piiranguid. Küsimused - vastused Küsimused - vastused •Kui on retseptil on 1400 tk tabletti, mitu tabletti on võimalik välja müüa? V: Välja müüa on võimalik nii palju, kui retseptil on välja kirjutatud. Kuid soomlaste jaoks on võimalik teha ka osalise välja müüki, ehk kui patsient soovib osta 30 tk tabletti, siis süsteem automaatselt arvutab mis arv on jäänud retseptil. Ja siis järgmine kord patsiendil on 1400 – 30= 1370 tk tabletti on jäänud. Küsimused - vastused Küsimused - vastused •Kui kaua tavaliselt kehtivad soome retseptid? V: tavaliselt kehtivad 2 aastat. Küsimused - vastused Küsimused - vastused •Mis formaadis on soome isikukood? V: Kui TUNNUS - KOD - CODE – CODE sisaldab, ainut 5 sümbolit, siis enne seda on vaja panna sünniaega, formaadis PPKKAA (kus PP on päev, KK on kuu, AA on sünniaasta) . Küsimused - vastused Küsimused - vastused •Veateate AUTH-006 – „Puudub Ravimiameti autoriseering!“ – Mis see tähendab? V:Apteek kasutati vale tegevuskohakoodi 2029. Selle koodi kehtivusaeg on möödas! Selle pärast tuli see veateade, et puudub terviseameti autoriseering. http://rkav.sm.ee/rkav/faces/pages/tegevuslubaForm/tegevusluba Haldus.jspx Apteegile on vaja võtta ühendust oma IT toega, ja siis küsida, et selle tegevuskohakood asendatakse süsteemi õige vastu. Kui see on tehtud siis saavad nad kasutada piiriülese digiretsepte. Küsimused - vastused Küsimused - vastused •Veateate AUTH-006 – ''puudub terviseameti autoriseering''– Mis see tähendab? V:Terviseameti registris apteekri töökoht on tühi või ei ole seost apteegiga. http://mveeb.sm.ee/Apteekrid/ Tööandja peab määrata töökoha, kus proviisor töötab, kui registris seda ei ole, siis piiriülest retsepti ei saa välja müüa Millised on Teie küsimused? Aitäh! Aleksandra Stupak [email protected] ÜLDKONTAKTID Uus-Tatari 25 10134 Tallinn Tel: 7943 900 E-mail: [email protected] Piiriülese digiretsepti teenuse ülevaade TEHIK-u kasutajatoele Katre Pruul August 2018 Eesmärk 1. Ülevaade projekti taustast 2. Ülevaade teenuse sisust 3. Piiriülese digiretsepti väljamüügi portaali tutvustus 4. Piiriülese teenuse kasutajatoe pakkumise detailid Projekti taust Projekt: „Piiriüleste digiretsepti ja haigusloo kokkuvõtte teenuste arendamine Eestis“ Projektil on kaks eesmärki: 1. Digiretsepti piiriülese teenuse arendamine eesmärgiga luua Eesti elanikele võimalus osta digiretsepti alusel ravimeid välja teistes Euroopa riikides ning Eesti apteekidele võimalus müüa digiretsepti alusel välismaalastele ravimeid. 2. Patsiendi haigusloo kokkuvõtte piiriülese teenuse arendamine eesmärgiga luua Euroopa riikide tervishoiutöötajatele võimalus pärida tervise infosüsteemist patsiendi haigusloo kokkuvõtet juhul, kui Eestist pärit patsiendil on tekkinud ravisuhe välisriigi tervishoiutöötajaga ja patsient on andmete edastusega nõus. Samuti arendada võimalus Eesti tervishoiutöötajal pärida välisriikidest pärit patsientide puhul päritoluriigi infosüsteemist välisriigi patsiendi haigusloo kokkuvõtet. Eestis realiseeritav projekt põhineb: • Eesti ja Soome peaministrite 2016. aasta mais allkirjastatud ühisdeklaratsioonil „Joint Declaration on an Initial Roadmap for Cross-border Data Exchange and Digital Services Between the Republic of Estonia and the Republic of Finland“ • Connecting Europe Facility (CEF) Euroopa Komisjoni kaasrahastuse saanud projektil Projekti organisatsioon Eestis TEHIK on antud projekti vaatest juhtiv organisatsioon ja riiklik kontaktpunkt (National Contact Point) Lisaks on projekti meeskonnas esindatud liikmed Ravimiametist ja Eesti Haigekassast Sotsiaalministeerium, koos esindajatega teistest seotud asutustest, moodustavad juhtrühma, mis vastutab kogu tervise-, sotsiaal- ja töövaldkonna piiriüleste teenuste strateegiliste otsuste tegemise eest Kontaktid TEHIK-us Katre Pruul (projektijuhi rollis) Monika Soosaar (kommunikatsioon) Artur Novek (teenuse arhitektuur) Kristjan Kukk (administraator) Tõnis Jaagus (üldiselt kõikide tervise valdkonna teenustega seoses) Projekti ajakava Projekti ajakava Eesti jaoks: 01.01.2017 - 31.12.2020 Esimene etapp: Eesti alustab retsepti vastuvõtja/väljamüüki teostava riigina 2018. aasta lõpus (riik B). Antud etapi tulemusena on võimalik Eestis välja osta Soome, Horvaatia ja Portugali elektroonilisi retsepte. Järgnevatel aastatel lisandub teisi riike Teine etapp: Eesti alustab retsepti väljastaja riigina (teise riiki väljamüümiseks edastamine) ning patsiendi haigusloo kokkuvõtte väljastaja ja vastuvõtja riigina 2019. aasta juunis Riikide live-i mineku ajakava I etapp (2018 lõpp) II etapp (2019 suvi) III etapp (2020 kevad) IV etapp (2021 kevad) Riik A (retsepti Riik B (retsepti Riik A Riik B Riik A Riik B Riik A Riik B päritoluriik) väljamüüja riik) Eesti x x Soome x x Horvaatia x x Portugal x x Rootsi x x Küpros x x Kreeka x x Itaalia x x Austria x x Ungari x x Iirimaa x Šveits x Poola x x Leedu x x Slovakkia x(?) Tšehhi x x Hispaania x x Riikide live-i mineku ajakava • Antud tabel võib aja jooksul muutuda, kuna riikidel on õigus teatud põhjustel oma ajakava muuta • Jooksvalt võib riike lisanduda vastavalt nende siseriiklikule valmisolekule ning rahastuse olemasolule • Andmevahetuse realiseerimine ei eelda Eestilt eraldi kokkulepete loomist kõikide riikidega – kasutusel on ühine platvorm, millega riigid saavad liituda vastavalt valmisolekule Live-i mineku protsess • Teenuste realiseerimise käigus on kohustus riikidel tõendada teenuste kvaliteetne rakendamine ning võimekus teenust jätkusuutlikult kõrgel tasemel pakkuda. Seetõttu on kohustus läbida riikide ülesed testimisüritused ning Euroopa Komisjoni poolne auditeerimine • Teenuste käivitamise aeg sõltub Euroopa Komisjonist, aga ka riikide võimekusest teenused ja kõik nendega seonduv realiseerida. Seetõttu on live-i mineku tähtaega ka juba 2 korda edasi lükatud (2018. a märts -> 2018. aasta juuni -> 2018. aasta lõpp) • Otsuse, millised riigid võivad teenuse käivitada, teeb Euroopa riikide esindajate kõrgetasemeline esinduskogu (eHealth Network) vastavalt testimise ning riigi vastutava organisatsiooni auditeerimise tulemustele • Esimeste otsuste tegemine riikide live-i mineku vaatest on hetkel planeeritud 13.novembril (eHealth Networki kohtumine) Digiretsepti piiriülese andmevahetuse eesmärgid Eestis • Tagada inimestele võimalus kasutada digiretsepte välismaal • Tõsta väliriigis kirjutatud retsepti alusel ravimite müüki Eestis • Tagada välisriigi retsepti eesti keeles kuvamine apteegis • Tagada põhjalikumad/kvaliteetsemad andmed väljamüügi teostamisel Teenuse protsess Nõusoleku olemasolu kontrolli eest vastutab riik A. Apteekrile kuvatakse eesti keelde tõlgitud retsept. Lisaks on võimalik vaadata originaalretsepti PDF-i. Väga reaalsed on ka juhud, kus patsiendile ei ole Patsient peab tasuma ravimi eest enne väljamüügi võimalik ravimit retseptile välja müüa, sest: teatise saatmist teise riiki. 1. Eesti ravimiturg on üsna väike ning kõik ravimid või Kui väljamüügiteatis on saadetud ja teise riigi poolt pakendi suurused ei ole saadaval aktsepteerimise sõnumiga vastatud, siis ei ole võimalik 2. Teatud asendamised ei ole piiriüleselt lubatud (nt väljamüüki enam tühistada (nt kui selgub, et patsiendil poolikute pakendite väljastamine) pole piisavalt raha, et ravimi eest tasuda). 3. Apteeker võib keelduda väljamüügist, kui retsept ei Juhul, kui tekib viga ning väljamüüki ei ole võimalik teostada, sisalda piisavalt infot siis tagastab apteek patsiendile raha. Piiriülese digiretsepti teenuse sisu Välisriigi isiku retseptide pärimine Eesti apteekri poolt: • Välisriigi patsiendi identifitseerimine vastavalt esitatud isikut tõendavale dokumendile ning vastavalt patsiendi vastava riigi isikukoodile päringu tegemine välisriiki • Välisriigist tagastatakse patsiendi üldandmed (nimi, sünniaeg jm.) • Apteekril on võimalik kontrollida tagastatud andmete vastavust dokumendil olevatele andmetele, et tagada, et tegemist on õige patsiendiga • Välisriigi retseptide nimekirja päring • Välisriigi retsepti detailsete andmete päring • Retsepti detailsed andmed kuvatakse apteekrile tõlgituna eesti keelde • Lisaks tõlgitud andmetele on võimalik näha originaalkeeles retsepti PDF-i, kus teatud juhtudel võib olla täiendavat informatsiooni, mida ei olnud võimalik teises riigis struktureeritult retseptile lisada • Välisriigi retseptile ravimi müügiteate koostamine ja välisriiki tagasi saatmine • Vastavalt edastatud müügiinfole muudetakse teise riigi retseptikeskuses retsepti staatus osaliselt või täielikult välja müüduks Patsiendi identifitseerimise päringu vastuse maksimaalne andmekoosseis Andmed Selgitus Patsiendi Patsiendi isikukoodi/identifikaatori alusel teeb apteeker ka päringu ning see isikukood/identifikaator on üks vastuse osast samuti Patsiendi eesnimi ja perekonnanimi Sugu Aadress Täiendavad patsiendi koodid Juhul, kui need on riik A poolt määratud, näiteks passi või juhiloa number, tervisekindlustuse number vms. Retseptide nimekirja päringu vastuse maksimaalne andmekoosseis Andmed Selgitus Retsepti pealkiri Vabatekst, mille sisu määrab riik A (nt „ePrescription“) Retsepti koostamise aeg Selgitus/kirjeldus Vabatekst, soovituslik info: ravimpreparaadi või toimeaine nimetus, ATC kood, ravimvorm, tugevus Retsepti koostaja nimi Retsepti number Unikaalne ID Piiriülese digiretsepti maksimaalne andmekoosseis Andmed Selgitus Dokumendi andmed Koostamise aeg, ID, pealkiri, konfidentsiaalsus patsiendile jm. Patsiendi andmed Patsiendi ID, aadress, kontaktid, nimi, sugu, sünniaeg, keel Patsiendi esindaja andmed Nimi, aadress, kontaktid Retsepti autori andmed Eriala, kood, nimi, aadress, asutus ja asutuse aadress ning kontaktid Retsepti number Ravimi nimetus Kui tegemist on pakendipõhise retseptiga. ATC kood ja nimetus Tõlgitakse Eesti keelde, kui antakse kodeeritult ning kui Eestis on vastav ATC kood kasutusel. Kui ei ole, siis kuvatakse apteekrile inglise keeles ning sellisel juhul ei ole võimalik ka väljamüüki teostada. Toimeainete nimetused Võivad olla välisriigi keeles, kui neil ei ole võimalik anda inglise keelseid nimetusi. Tugevus Ravimvorm Vastavalt loendile ning tõlgitakse eesti keelde. Pakendi tüüp Ühikute kogus Mitu ühikut on välja kirjutatud ravimi ühes pakendis. Pakendite arv Mitu pakendit on retseptiga välja kirjutatud. Annustamise andmed Näiteks ravimi võtmise algus/lõpukuupäev, intervall, annus, manustamise viis Täiendav vabatekstiline Vabatekst ning ei ole võimalik tõlkida. informatsioon apteekrile ja/või patsiendile Asendamise informatsioon Kas antud retseptiga välja kirjutatud ravimi asendamine on lubatud või mitte. Piiriülese väljamüügi teatise andmekoosseis Andmed Selgitus Dokumendi andmed Koostamise aeg, ID, pealkiri, konfidentsiaalsus patsiendile, viide retseptile, mille alusel väljamüük teostati jm. Patsiendi andmed ja Võetakse retseptilt. patsiendi esindaja andmed Väljamüügi teatise autori Apteekri andmed (nimi, kood), apteegi andmed (nimetus, registrikood, andmed aadress) Müügiteate ID Müügi kuupäev Väljastatud ravimi kood Ravimi nimetus Ravimvorm Pakendi maht ATC kood ja nimetus Toimeained ja nende tugevused Asendamise informatsioon Kas väljamüügiga teostati asendamine. Retseptil olnud andmed Võetakse retseptilt. väljakirjutatud ravimi kohta Piiriülese digiretsepti teenuse piirangud • Piiriülese digiretsepti saab välja osta ainult retsepti omanik, kuna teenusesse ei ole võimalik lisada eraldi väljaostja isikukoodi ning apteeker peab identifitseerima kohapeal retsepti omaniku • Soodustused – piiriülese digiretseptiga patsient maksab alati ravimi eest välisriigis täishinna, kuid tal on võimalik oma koduriigis kindlustuse kaudu teha taotlus soodustuse raha tagasi saamiseks. • Ravimite, mis on välja toodud EK direktiivi 2001/83/EC artikkel 71(2) (näiteks narkootilised ja psühhotroopsed ravimid), retsepte ning ekstemporaalsete ravimite (apteegis kohapeal valmistatavad ravimid, nt teatud kreemid) retsepte ei ole võimalik piiriüleselt elektrooniliselt välja müüa. • Riikidel on lisaks õigus rakendada täiendavaid piiranguid, mis retsepte ei ole võimalik erinevatel põhjustel välisriigis välja müüa. • Näiteks retseptid, mida ei ole võimalik struktureerituna edastada (toitesegud, toitelisandid, millel puudub ATC kood või tugevuse andmed) Sellistel juhtudel ei võimalda teenus apteekril seda retsepti väljastada või sellist retsepti üldse patsiendi retseptide nimekirjas ei kuvata (apteeker ei pea teadma piiranguid ja riikide erisusi) Piiriülese digiretsepti teenuse sisu Kasutuslugu, mis on teenuse skoobis: patsiendil, kes on riik A elanik, on digiretsept selles samas riigis (A) ning ta läheb riiki B, et seal digiretsept välja osta. Skoobis ei ole kasutuslood, kus: • Patsiendil riigist A on digiretsept riigist B ning ta soovib selle retsepti välja osta riigis A. • Patsiendil riigist A on digiretsept riigist B ning ta soovib selle retsepti välja osta riigis C. Piiriülese digiretsepti teenuse sisu Andmevahetuseks võetakse kasutusele Euroopa Komisjoni poolt hallatav andmevahetusplatvorm ning igas riigis on üks tehniline ja organisatsiooniline kontaktpunkt, läbi mille andmeid vahetatakse Tehniline lahendus realiseeritakse Euroopa Komisjoni rahastuse ning TEHIK omafinantseeringu abil: • Luuakse portaal, mis võimaldab piiriüleseid digiretsepte pärida ning väljamüüki teostada • Luuakse uued teenused ja sellega kõik eeldused selleks, et apteekide infosüsteemidel oleks võimalikult lihtne võtta kasutusele piiriüleste retseptide pärimine ja väljamüügi teostamine oma infosüsteemis Lõppkasutaja TEHIK-u poolt hallatav teenus Kesksed teenused (haldab Euroopa Komisjon) Seotud osapooled Eestis TEHIK (kogu teenuse toimimine, AAM-i teenus) Sotsiaalministeerium (sh piiriüleste juhtrühm, teenuse omanik) Ravimiamet (ravimiregister, ravimikäitlejate register) – võimaldab kasutada teenuses riigis müügiloaga ravimite registrist; võimaldab autentida piiriülest andmevahetusteenust kasutada sooviva apteekri asutust (apteeki), et sellel oleks olemas kehtiv tegevusluba; Farmaatsiaterminoloogia ekspertkomisjon - tagavad tõlked ning vastavustabelis MVC/MTC jaoks Terviseamet (proviisorite ja farmatseutide register) – võimaldab autentida piiriülest andmevahetusteenust kasutada soovivat apteekrit vastavalt tema apteekri koodile Apteegid – teenuse lõppkasutajad Apteekide infosüsteemide arendajad Riigi Infosüsteemi Amet – teenuses kasutatakse X-teed, andmevahetuses TEHIK-u ja apteekide vahel (juhul, kui apteegid kasutavad oma infosüsteemi integreeritud teenust). KA laivõrgu ja TESTA võrgu teenus SK ID Solutions AS – sertifitseerimisteenus Teenuse kasutuselevõtt Eesti apteekides Kohustus piiriülest digiretsepti tunnustada: • Eesti õigusruumi kohaselt peab olema apteek võimeline välja müüma ka piiriülest digiretsepti. • Väljamüügi otsus on apteekri teha – kui retseptil jääb midagi selgusetuks või tekib muu kahtlus, on apteekril õigus väljamüügi tegemisest loobuda. • Selleks, et apteekidel tekiks õiguslik alus piiriülest digiretsepti teenust kasutada, on vajalik teenuse kasutamise lepingu sõlmimine TEHIK-uga • Lepingud on plaanis sõlmida vaid apteekide juriidiliste esindajatega, mitte iga tegevuskohaga Edasised olulisemad tegevused projekti vaatest • Toodangukeskkonna ettevalmistamine • Lepingute sõlmimine apteekide juriidiliste esindajatega • Koostöö apteekide infosüsteemide arendajatega teenuse kasutuselevõtu osas, sh ühine testimine • Kordusauditeerimine 25-26.september 2018 • Sisend eHealth Networki otsuseks 23. oktoobril riikide ülesel projektijuhtide kohtumisel • Otsus live-i mineku osas 13. november • Koolitused apteekritele 2018. aasta lõpus, mis keskenduvad detailsemalt teenusest ülevaate andmisele, portaali kasutuse juhendamisele ning ühistele aruteludele • Plaanis on lisaks ette valmistada portaali kasutusjuhend ning üldisem piiriülese digiretsepti teenuse juhend apteekritele Piiriülese digiretsepti väljamüügi portaal Piiriüleste terviseandmete portaal • Portaal on realiseeritud varasema pilootprojekti epSOS raames riikide koostöös • TEHIK-u poolt on portaal integreeritud Eesti infrastruktuuri ning tehtud kohalikke väiksemaid täiendusi, nt: • Ühendamine autentimis- ja autoriseerimismooduliga (AAM) • Ühendamine farmatseutide ja proviisorite registriga ja ravimikäitlejate registriga • Lisatud võimalus otsida pakendeid ravimiregistrist (mitte otse ühendatud ravimiregistriga vaid kohaliku koopiaga) Portaali avavaade (peale kasutaja sisse logimist): Portaalis patsiendi päring Portaalis patsiendi retseptide nimekirja vaatamine Portaalis patsiendi retsepti vaatamine ja pakendi otsing Portaalis teavitus edukast väljamüügi teostamisest Kasutajatoe pakkumine piiriülese digiretsepti teenusele Erinevate riikide kasutajatugede ja Euroopa Komisjoni kasutajatoe suhtlus • Eesmärk tagada tugi erinevatele piiriülese terviseandmete andmevahetuse teenusega seotud osapooltele, et võimaldada jätkusuutlik teenuse pakkumine Peamised osapooled, kellele kasutajatuge on vajalik teenusega seoses pakkuda • Tervishoiutöötajad (apteekrid) ehk teenuse lõppkasutajad • Arendajad (nt apteegi infosüsteemi arendaja) • Patsiendid • Teise riigi kasutajatugi • Euroopa Komisjoni keskne kasutajatugi kaasatakse juhul kui probleem on seotud kesksete teenustega. Kui tegemist on kahe riigi vahelise probleemiga, siis keskset kasutajatuge ei teavitata. Suhtlus teise riigi kasutajatugede ja Euroopa Komisjoni keskse kasutajatoega käib inglise keeles Kasutajatoe ülesanded piiriülese teenuse vaatest Peamised ülesanded: • Intsidentide lahendamisega tegelemine (probleemi info vastu võtmine, vajadusel edasi suunamine jm) • Katkestuste info vastu võtmine keskselt või teise riigi kasutajatoelt ning selle info edastamine Eesti lõppkasutajatele (esimeses etapis apteekrid) • katkestuste teavituste väljasaatmine • Üldiste pöördumiste vastu võtmine ja vajadusel vastamine Teenuse juht peaks vastutama kasutajate pöördumistest tagasiside koondamise ning üldise analüüsi eest teenuse edasise parendamise vaatest. Selleks planeeritud regulaarsed kasutajate pöördumiste väljavõtted. Võimalikud pöördumised/intsidendid Intsidendid: - tehniline tõrge (tehniliste tõrgete kohta info, mis hõlmab kõiki teenuse osapooli; planeerimata katkestuste kohta info teise riigi/Euroopa Komisjoni kasutajatoelt) Teenindussoovid: - infopäringud (üldise info küsimine apteekide poolt seoses teenuse toimimisega ; üldise info küsimine patsientide poolt seoses teenuse toimimisega, nt mis riigist saab retsepte välja osta jm) - arendusettepanekud (igasugused täiendussoovid jm ettepanekud, mis ei lähe tehnilise tõrke kategooria alla) - liidestuslepingud (liidestuslepingutega seotud küsimused, tagasiside jm) - partnerite teavitus (kõik üldine info teiste riikide või Euroopa Komisjoni kasutajatugede poolt, mis edastatakse teadmiseks ja siseriiklikult jagamiseks, nt planeeritud katkestused) - üldine (kõik muu, mis ei lähe eelmiste punktide alla, nt kui kasutajatoe meilile satub mõni üldine teabepäring teenuse kohta vm) Näidisstsenaariumid 1. Planeeritud katkestus Eesti teenuses (nt korraline hooldus) a) teavitus teiste riikide kasutajatugedele miinimum 2 tööpäeva ette (üks üldine e-maili aadress plaanis luua) b) teavitus siseriiklikele lõppkasutajatele (apteekrid, apteegi infosüsteemide arendajad) 2. Probleem teenuse kesksete teenuste kasutamisel a) Kui ei ole Eesti poolel lahendatav, siis eskaleerimine Euroopa Komisjoni kesksele kasutajatoele 3. Planeerimata katkestus Eesti teenuses a) Juhul kui 30 min jooksul peale tuvastamist ei ole lahenenud, siis vajalik teavitada lõppkasutajaid (apteekrid, apteegi infosüsteemide arendajad) ning teiste riikide kasutajatugesid 4. Intsident/probleem seoses digiretsepti töövooga kahe riigi vahel a) Nt apteeker teavitab kasutajatuge, et saab vea, et teise riigi poolne teenus on maas või tekib tehniline tõrge väljamüügil b) Kui tegemist on kahe riigi vahelise teenuse probleemiga, siis on vajalik teavitada teist riiki, et nad saaksid omaltpoolt uurida Aitäh! TEHIK Piiriülene andmevahetus Tervise ja Heaolu Infosüsteemide Keskus September 2021 Piiriülene andmevahetus TEENUSED • Digiretsept • Patsiendi terviseandmete kokkuvõtte edastamine EESMÄRK • Hõlbustada terviseinfo liikumist ning võimaldada teha paremaid raviotsuseid • Parem ravikvaliteet ja patsiendi ohutus • Tagada patsiendile muretu elu Euroopas reisides • Ühtlustada riikide e-tervise teenused Piiriülene digiretsept • Digiretseptide ja väljamüügi andmete edastamine, mis võimaldab patsiendil välja osta talle välja kirjutatud ravimid teises, teenusega kaetud riigi apteegis ning edastada väljamüügi info patsiendi koduriigi retseptikeskusesse. • Apteekrile võimaldatakse teenusega retsept tõlgituna selle riigi keelde Patsiendi terviseandmete kokkuvõte • Teenus on mõeldud välisriigis terviseteenuse osutamisel paremate raviotsuste tegemiseks • Teenus võimaldab edastada patsiendi olulisemate meditsiiniliste andmete kokkuvõtte teise riigi tervishoiutöötajale ning kuvada need andmed tervishoiutöötajale kohalikku keelde tõlgituna, et tagada kvaliteetsem ja efektiivsem ravi, eriti erakorralises olukorras • Eesti terviseandmete kokkuvõte genereeritakse välisriigi päringu peale automaatselt TISis Teenuse omanik • Tunneb oma teenuseid ja nende protsesse • Kaasab TEHIKu algfaasis ning aitab TEHIKul skoopi hoida • Koostab läbimõeldud lähteülesande IKT teenuse jaoks • Teeb vajadusel eelanalüüse ja kujundab arengukavadest/seadusandlusest tellija vaate • Lähteülesande juures mõtleb läbi ka teenuse mõõdikud, KPId ja aruandluse • Aitab otsida rahastust ja planeerib koos ressursse • Agiilne arendusprotsess nõuab igapäevast panustamist tellija poolt • Juriidika/andmekogude põhimäärused täiendatud/RIHA Tegevused ‣Sisulised parandus- ja arendusettepanekud (spetsiifilised küsimused, teenuse kvaliteedi parandamine, parem terviklik lahendus) ‣Prioriteetide seadmine siseriiklikult (allergia, med seadmed) ‣Tagasiside kasutajatelt (apteegid, patsiendi, arstid) ‣Kliiniliste ekspertide tugi (Euroopa Komisjoni testimised, tõlked) ‣Kommunikatsioonitegevused ‣Teenuse järelevalve ‣KPId ‣10.09 koolituse tähtaeg Tänan, et võtsid aega kaasa mõtlemiseks! TEHIK Piiriülene andmevahetus Tervise ja Heaolu Infosüsteemide Keskus Detsember 2020 Piiriülese andmevahetuse eesmärk • Hõlbustada terviseinfo liikumist ning võimaldada teha paremaid raviotsuseid • Parem ravikvaliteet ja patsiendi ohutus • Tagada patsiendile muretu elu Euroopas reisides • Ühtlustada riikide e-tervise teenused • Projekt on rahastatud Euroopa Liidu poolt. Pilootprojekt • 2013 toimus esimene patsiendiinfo vahetus – Itaalia päris patsiendi terviseandmeid Eestist • Pilootprojekti tulemuste alusel oli tõestatud, et riigid on võimelised andmevahetust käivitama • Aga see tegevus oli projekti- ja õhinapõhine, kui raha lõppes sai ka õhin ka otsa. Piiriülese andmevahetuse esimesed tegevused • 2015. sügisel avati teenuste • Kokku rahastati 20 riigi käivitamiseks võimalus piiriülese andmevahetuse Euroopa Liidu vahenditest raha teenuste arendust: taotlemiseks • Digiretsept • Terviseandmete kokkuvõte • Eesti esitas taotluse ja sai positiivse otsuse 2016. aasta sügisel. Teenuste arenduse kogumaksumus on 500 000€, sellest 75% kaetakse EL vahenditest Kuidas tekib teenus? ‣Analüüs ja arendus (mis andmeid on üldse võimalik piiriüleselt edastada ja kuidas, seadusandluse muudatused, turvaaudit) ‣Euroopa Komisjoni testimine (2x aastas testitakse teiste liikmesriikidega nende valmimisjärgus olevaid teenuseid) ‣Euroopa Komisjoni audit (Komisjon viib läbi auditi, tagamaks loodud süsteemi vastavuse nõuetele) ‣Euroopa Komisjoni heakskiit (kui loodud lahendus vastab kõikidele nõuetele väljastatakse liikmesriigile luba toodangus testida) ‣Toodangu testimine (päris andmetega viiakse läbi testimised, tagamaks süsteemi toimivus) ‣Kommunikatsioontegevused ‣Teenuse LIVE Patsiendi terviseandmete kokkuvõte • Teenus on mõeldud välisriigis terviseteenuse osutamisel paremate raviotsuste tegemiseks • Teenus võimaldab edastada patsiendi olulisemate meditsiiniliste andmete kokkuvõtte teise riigi tervishoiutöötajale ning kuvada need andmed tervishoiutöötajale kohalikku keelde tõlgituna, et tagada kvaliteetsem ja efektiivsem ravi, eriti erakorralises olukorras • Eesti terviseandmete kokkuvõte genereeritakse välisriigi päringu peale automaatselt TISis Patsiendi terviseandmete kokkuvõte • Euroopa Komisjoni poolt hallatav keskne platvorm (OpenNCP) • Patsient annab/võtab enda terviseandmete edastamiseks nõusoleku (www.digilugu.ee) • Terviseandmete kokkuvõte on tõlgitud kohalikku keelde • Lisaks on võimalik vaadata originaalandmeid (patsiendi koduriigi keeles) Andmestik • Andmed patsiendi kohta • Andmed meditsiiniseadmete • Andmed patsiendi esindaja kohta kasutamise kohta • Andmed patsiendi kontaktisikute • Andmed teostatud protseduuride ja kohta operatsioonide kohta • Andmed patsiendi perearsti kohta • Andmed põetud haiguste kohta • Andmed haigusloo kokkuvõtte • Immuniseerimise andmed koostaja asutuse kohta (nimi, • Andmed eluliste näitajate kohta registrikood, aadress, telefon, e- • Andmed oluliste laboratoorsete post) uuringute kohta • Annustatud ja väljakirjutatud ravimite andmed, sealhulgas ravimi väljakirjutaja või manustaja andmed • Kaebuste loetelu Kasutusjuhud • Teenus on praegu ette nähtud kasutamiseks välisriigis hädaolukordades (emergency care) • Töögruppides käib arutelu kas ja kuidas teenus kasutusele võtta ka plaanilise ravi korral Tulevik • Üle-Euroopaline digiretsept ja patsiendi terviseandmete edastamine • Praegu tegeleme Euroopa Komisjoni auditi tulemustega • Planeeritud live: 2021 suvi Teenustega liitumise ajakva Terviseandmete kokkuvõte 2021: Luksemburg, Horvaatia, Tšehhi, Malta, Portugal, Küpros, Kreeka, Rootsi 2022: Ungari, Belgia, Holland, 2023: Austria, Läti 2024: Leedu, Soome Tänan, et võtsid aega kaasa mõtlemiseks! TEHIK Piiriülene andmevahetus Tervise ja Heaolu Infosüsteemide Keskus September 2020 Usume, et meie töö suudab säästa inimeste aega, et nemad saaksid keskenduda olulisele. Selleks loome nii inimesekeskseid teenuseid, et ükski inimene ei tunne, et ta kulutab riigiga suhtlemisel tarbetult aega. Me oleme IT-kompetentsikeskus, mis loob avaliku sektori IKT teenuseid nii töö-, tervise- kui ka sotsiaalvaldkonnas. Piiriülese andmevahetuse eesmärk • Hõlbustada terviseinfo liikumist ning võimaldada teha paremaid raviotsuseid • Parem ravikvaliteet ja patsiendi ohutus • Tagada patsiendile muretu elu Euroopas reisides • Ühtlustada riikide e-tervise teenused Pilootprojekt • 2013 toimus esimene patsiendiinfo vahetus – Itaalia päris patsiendi terviseandmeid Eestist • Pilootprojekti tulemuste alusel oli tõestatud, et riigid on võimelised andmevahetust käivitama • Aga see tegevus oli projekti- ja õhinapõhine, kui raha lõppes sai ka õhin ka otsa. Piiriülese andmevahetuse esimesed tegevused • 2015. sügisel avati teenuste • Kokku rahastati 20 riigi käivitamiseks võimalus piiriülese andmevahetuse Euroopa Liidu vahenditest raha teenuste arendust: taotlemiseks • Digiretsept • Terviseandmete kokkuvõte • Eesti esitas taotluse ja sai positiivse otsuse 2016. aasta sügisel. Teenuste arenduse kogumaksumus on 500 000€, sellest 75% kaetakse EL vahenditest Kuidas tekib teenus? ‣Analüüs ja arendus (mis andmeid on üldse võimalik piiriüleselt edastada ja kuidas, seadusandluse muudatused, turvaaudit) ‣Euroopa Komisjoni testimine (2x aastas testitakse teiste liikmesriikidega nende valmimisjärgus olevaid teenuseid) ‣Euroopa Komisjoni audit (Komisjon viib läbi auditi, tagamaks loodud süsteemi vastavuse nõuetele) ‣Euroopa Komisjoni heakskiit (kui loodud lahendus vastab kõikidele nõuetele väljastatakse liikmesriigile luba toodangus testida) ‣Toodangu testimine (päris andmetega viiakse läbi testimised, tagamaks süsteemi toimivuse) ‣Kommunikatsioontegevused ‣Teenuse lansseerimine Teenuse arendus 2017. aasta alguses algas arendus digiretsepti andmevahetuseks Tehti kokkulepped reeglite osas: • mida tohib müüa • mis tingimustel tohib ravimeid asendada • millised retseptid välisriigis näha on • kas ainult retsepti omanik saab ravimit osta • hüvitamine jne. • nõusoleku andmine andmete edastamiseks välisriiki Eesti retseptid Soomes Väljamüügid Soomes Apteek Müüke Vantaan IX Myyrmannin apteekki 200 Yliopiston apteekki Mannerheimintie 5 171 Yliopiston apteekki Töölö 76 Vuosaaren apteekki 60 Vantaan Hakunilan apteekki 50 Tuusulan I apteekki 49 Tikkurilan Ykkösapteekk 46 Walkiaskosken apteekki 45 Yliopiston apteekki Turku 42 Töölön apteekki 40 Soome retseptid Eestis Väljamüügid Eestis Apteek Müüke Nautica Keskuse Südameapteek 2 255 Apotheka Viru Keskuse Apteek 1 787 Kaubamaja Apteek 394 Laikmaa Apteek 350 Koduapteek Aia tn. 7, Tallinn 277 Sadmarketi Apteek 241 Pärnu Rüütli Apteek 225 Postimaja Apteek, Narva mnt 1. 223 Tallinn Port Arturi Apteek 170 Papiniidu Apteek 145 Kogemused Eesti: Soome: • OmaKanta (Soome • Apteekrid ei näe kõiki patsiendiportaal) nõusolek retsepte patsientide puudu retseptide nimekirjas • Ajastatud retseptid (soome (muudatus on juba arstid kirjutavad arenduses ja saadame konkreetseks ajaks mõeldud peatselt kõik patsiendi retsepte väga palju, nt ravim olemasolevad retseptid on kasutamiseks üheks välismaale) kuuks) Patsiendi terviseandmete kokkuvõte • Teenus on mõeldud välisriigis terviseteenuse osutamisel paremate raviotsuste tegemiseks • Teenus võimaldab edastada patsiendi olulisemate meditsiiniliste andmete kokkuvõtte teise riigi tervishoiutöötajale ning kuvada need andmed tervishoiutöötajale kohalikku keelde tõlgituna, et tagada kvaliteetsem ja efektiivsem ravi, eriti erakorralises olukorras Andmestik • Andmed patsiendi kohta • Andmed meditsiiniseadmete • Andmed patsiendi esindaja kohta kasutamise kohta • Andmed patsiendi kontaktisikute • Andmed teostatud protseduuride ja kohta operatsioonide kohta • Andmed patsiendi perearsti kohta • Andmed põetud haiguste kohta • Andmed haigusloo kokkuvõtte • Immuniseerimise andmed koostaja asutuse kohta (nimi, • Andmed eluliste näitajate kohta registrikood, aadress, telefon, e- • Andmed oluliste laboratoorsete post) uuringute kohta • Annustatud ja väljakirjutatud ravimite andmed, sealhulgas ravimi väljakirjutaja või manustaja andmed • Kaebuste loetelu Kasutusjuhud • Teenus on praegu ette nähtud kasutamiseks välisriigis hädaolukordades (emergency care) • Töögruppides käib arutelu kas ja kuidas teenus kasutusele võtta ka plaanilise ravi korral Tulevik Suur plaan: • Üle-Euroopaline digiretsept ja patsiendi terviseandmete edastamine • Praegu tegeleme järjepidevalt digiretsepti teenuse testimisega (kohe, kui mõni välisriik on enda lahenduse valmis saanud ja läbinud Euroopa Komisjoni auditi, saame testima hakata) • Hetkel testime Portugaliga Teenustega liitumise ajakva Digiretsept Terviseandmete kokkuvõte 2020-2021: 2020-2021: Rootsi, Tsehhi, Küpros, Kreeka, Poola Küpros, Prantsusmaa, Kreeka, Iirimaa, 2021-2022: Hispaania Leedu, Hispaania, Ungari, Itaalia 2021-2022: 2022-2023: Ungari, Itaalia, Holland, Sloveenia, Läti, Sloveenia 2022-2023: 2023-2024: Läti, Saksamaa, Slovakkia Bulgaaria 2023-2024: Leedu, Bulgaaria Tänan, et võtsid aega kaasa mõtlemiseks! European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility Guidelines for completing the individual financial statement Background information The purpose of these guidelines is to assist beneficiaries in presenting their individual financial statements. Any request for payment requires: 1) A technical report, containing the information needed to justify the declared costs. 2) A separately completed electronic excel version of the individual financial statements (i.e this XLS workbook) which includes the breakdown of the eligible costs for each beneficiary (including its affiliated entities and its implementing bodies) - article II.23 of the Grant Agreement (GA). 3) For mono-beneficiary grants; In addition to point 2) above, a scanned copy of the original stamped and signed form "1.General info" 4) For multi-beneficiary grants where a coordinator is designated: In addition to point 2) above, a consolidated financial statement, drawn up on the basis of the information provided by each beneficiary in its individual financial statement, certified by the coordinator; 5) When applicable, a Certificate on the Financial Statements (CFS) must be included with the individual Financial Statement (article II.23.2 of the GA). The CFS shall be drawn up in line with Annex VII of the GA and cover costs claimed by the beneficiary, any of its affiliated entities and/or implementing bodies. All the above-mentioned documents should be sent by email to the Agency functional mailbox mentioned in article 6.2 of the GA. In case of multi-beneficiary grants, it is the responsibility of the coordinator to submit the request for payment (article II.1.3 of the GA). Language and submission means All requests for payments, reports and financial statements must be submitted in the language specified in article 4.3 of the GA and only electronically. Submission of hard copies will not be considered. General information (form 1) Encoding information/data in the following worksheets Through-out the worksheets only white fields require the encoding of information/data. Period covered by the financial statement Reporting periods are detailed in article 4.1.1 of the GA. Only costs incurred within the reporting period are to be reported. Eligible costs Each beneficiary is responsible for declaring all the eligible costs incurred during the implementation of the action by the beneficiary itself, its affiliated entities and implementing bodies. To be eligible, costs must comply with the conditions of eligibility set out in Article II.19 of the GA: 1. Be incurred during the timeframe of the action (see article 2.2 of the GA) and in connection with the action; 2. Be indicated in the estimated overall budget of the action (Annex III of GA); 3. Be necessary for the implementation of the action; 4. Be identifiable, verifiable and recorded in the accounting records of the beneficiary; 5. Comply with the requirements of applicable tax and social legislation; 6. Be reasonable, justified and comply with the requirements of sound financial management, in particular regarding economy and efficiency. For further details on categories of eligible direct costs, please refer to article II.19.2.1. Indirect costs Flat rate set at 7% of the eligible costs declared in the individual Financial Statement (minus subcontracting costs and minus support to third parties (see article II.19.3 of the GA). Indirect costs are automatically calculated in form 3 and must not be declared as single cost item in form 2. Explanations about the detailed costs incurred (form 2) Drop-down menus and automatic calculations 1 Version: 27/04/2017 European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility Throughout the different worksheets, and where possible, drop-down menus and automatic calculations have been used to facilitate and standardise the encoding of information. Do not delete or modify any drop-down menus or automatic calculations. Beneficiary/implementing body/affiliated entity Please indicate the name of the beneficiary, its implementing body(ies) or affiliated entity(ies) claiming the costs. Short description of the cost claimed Provide a short description of the nature of the costs incurred in line with your accounting records. Please note that the Agency reserves the right to request the submission of supporting documents corresponding to individual cost items (article II.27). Personnel costs Personnel costs should be detailed per activity in line with the planning agreed under article I.4 of the GA (one line per activity). Supplier Please indicate the supplier of services, works and/or supplies. Insert one line for every accounting entry. When there is no supplier and the task was performed by your own personnel, please indicate this and add a clear description on the nature of the task in the “short description of the cost claimed” field . Date of the invoice Please insert the date indicated by the supplier on the invoice. When there is no invoice from the supplier (such as for tasks performed by your own staff or regulated by contracts etc.), please report the date of registering the cost in the accounting system. Unique Accounting number Please insert the unique number identifying the invoice in your accounting records. VAT (in EUR) VAT is an eligible cost only if it cannot be deducted or recovered by the beneficiary under the applicable national VAT legislation (article II.19.2.h of the Grant Agreement) and providing that the beneficiary is not specifically mentioned under Article 14 of the GA. Amount in EUR For the beneficiaries who have their general accounts in a currency other than euro, please indicate the amount in your national currency as recorded in the accounting system. The conversion of costs into euro shall be made in line with article II.23.4. of the GA. Please also refer to the "Guide to currency conversion to Euro" available on the Beneficiaries' Info Point for practical help. (https://ec.europa.eu/inea/en/connecting-europe-facility/useful-documents-and-forms) The calculated exchange rate should be indicated in the field "Calculated exchange rate". This rate will be used to automatically calculate the amount of the items claimed into EUR. INEA will reject cost claims in case of wrong currency conversion. In the event that an affiliated entity and/or implementing body has its general accounts in a currency different to that of the beneficiary please use separate tables per currency Overview of costs incurred by the beneficiary (form 3) This form provides an overview of costs incurred per category and is automatically completed based upon the information provided in sheet 2 (Details of costs incurred). If the costs incurred differ from the estimation provided in Annex III of the GA, please include a justification in the technical report (notably, section 2.4). The "Overview of costs incurred" form has been developed for projects with up to 12 activities. Should your project have more than 12 activities please contact the Agency through the functional mailbox mentioned in Article 6.2 of the Grant Agreement. Receipts (form 4) Beneficiaries shall report all the receipts linked to the action (see article II.25.3 of the GA). Receipts are any income generated by the action and/or financial contributions specifically assigned by the donors to the financing of the eligible costs of the action. The grant should not produce a profit for the beneficiaries (i.e. a surplus of the receipts over the eligible costs of the action). If you have any additional questions related to these guidelines and the template, please contact the Agency through the functional mailbox mentioned in Article 6.2 of the Grant Agreement. 2 Version: 27/04/2017 European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility Individual financial statement Period covered by this report (art. 4.1.1 From: 01.04.2018 To: 30.07.2018 of the GA) 1. GENERAL INFORMATION (to be filled in by each beneficiary) Grant Agreement (GA) Number INEA/CEF/ICT/A2015/1156737 Action number (art. 1 of GA) 2015-EE-IA-0100 Action title (art. 1 of GA) Estonian Health Insurance Fund Start date of the action (art. 2.2 of End date of the action (art. 2.2 of GA) 01.01.2017 30.06.2021 GA) Author of the individual financial statement Name Anett Lilleväli Position Chief specialist of pharmaceuticals and medical devices department Beneficiary's Legal Name Estonian Health Insurance Fund Beneficiary number as per GA 2 Telephone Nº +372 6 696 630 E-mail [email protected] Certification by the Beneficiary (only applicable if mono-beneficiary grant) Name Position Entity Telephone Nº E-mail The Beneficiary certifies that: 1) the information provided in the request for payment is complete, reliable and true (Article II.23.2); 2) the costs declared are real and eligible in accordance with the Agreement and that the request for payment is substantiated by adequate supporting documents that can be produced in the context of the checks or audits described in Article II.27; 3) in case of payment of the balance, all the receipts referred to in the GA Article II.25.3.2 have been declared. Date and Signature Stamp (optional) 1 Version: 27/04/2017 European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility 2. Details of the declared costs incurred by each beneficiary (article II.23.2) Action Number : 2015-EE-IA-0100 Beneficiary's Legal Name : Estonian Health Insurance Fund Indicate the currency of the general accounts used by the beneficiary (art. II.23.4) : EUR /EUR Calculated exchange rate 1,00000 Total direct costs claimed for all activities in EUR (including only eligible VAT) : 35 258,39 Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement Personnel costs May-June 2018, project 1 Personnel costs Estonia Health Insurance Fund management and analysis Estonia Health Insurance Fund 30.06.2018 6 288,83 0,00 6 288,83 Personnel costs May-June 2018, project 2 Personnel costs Estonia Health Insurance Fund management and analysis Estonia Health Insurance Fund 30.06.2018 6 139,11 0,00 6 139,11 Personnel costs May-June 2018, project 5 Personnel costs Estonia Health Insurance Fund management and analysis Estonia Health Insurance Fund 30.06.2018 5 390,45 0,00 5 390,45 Development of the Health services - developing the 1 Subcontracting Estonia Health Insurance Fund supplies main functionality to save the dispensation Intelsys OÜ 31.05.2018 6-2.9/33 5 290,00 0,00 5 290,00 information to Prescription Centre. 0056-0338 Development of the Health services - developing new controls in prescription centre prod environment 1 Subcontracting Estonia Health Insurance Fund supplies and in process integration server to use the cross Intelsys OÜ 30.04.2018 6-2.9/33 12 150,00 0,00 12 150,00 border services. 0056-0339 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 1 Version: 27/04/2017 European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 2 Version: 27/04/2017 European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 3 Version: 27/04/2017 European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 4 Version: 27/04/2017 European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 5 Version: 27/04/2017 European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility 3. Overview of costs incurred by the beneficiary Action Number: 2015-EE-IA-0100 Beneficiary's legal name: Estonian Health Insurance Fund If applicable, Claimed costs in EUR Cost category claimed costs in national currency (conversion to EURO ) (indicative amount) Personnel costs 17 818,39 17 818,39 Other costs 0,00 0,00 Subcontracting 17 440,00 17 440,00 Direct costs 35 258,39 35 258,39 Indirect costs (7%) 1 247,29 1 247,29 Total 36 505,68 36 505,68 If applicable, Claimed costs in EUR Activity Cost category claimed costs in national currency (conversion to EURO ) (indicative amount) 1 Personnel costs 6 288,83 6 288,83 1 Other costs 0,00 0,00 1 Subcontracting 17 440,00 17 440,00 2 Personnel costs 6 139,11 6 139,11 2 Other costs 0,00 0,00 2 Subcontracting 0,00 0,00 3 Personnel costs 0,00 0,00 3 Other costs 0,00 0,00 3 Subcontracting 0,00 0,00 4 Personnel costs 0,00 0,00 4 Other costs 0,00 0,00 4 Subcontracting 0,00 0,00 5 Personnel costs 5 390,45 5 390,45 5 Other costs 0,00 0,00 5 Subcontracting 0,00 0,00 6 Personnel costs 0,00 0,00 6 Other costs 0,00 0,00 6 Subcontracting 0,00 0,00 7 Personnel costs 0,00 0,00 7 Other costs 0,00 0,00 7 Subcontracting 0,00 0,00 8 Personnel costs 0,00 0,00 8 Other costs 0,00 0,00 8 Subcontracting 0,00 0,00 9 Personnel costs 0,00 0,00 9 Other costs 0,00 0,00 9 Subcontracting 0,00 0,00 10 Personnel costs 0,00 0,00 10 Other costs 0,00 0,00 10 Subcontracting 0,00 0,00 11 Personnel costs 0,00 0,00 11 Other costs 0,00 0,00 11 Subcontracting 0,00 0,00 12 Personnel costs 0,00 0,00 12 Other costs 0,00 0,00 12 Subcontracting 0,00 0,00 Direct costs 35 258,39 35 258,39 Indirect costs (7%) 1 247,29 1 247,29 Total 36 505,68 36 505,68 Total estimated CEF contribution 75% EU co-financing rate - to select from dropdown menu (without receipts) 27 379,26 75,00% 6 Version: 27/04/2017 European Commission CEF Telecom - Individual Financial Statement Innovation and Networks Executive Agency (INEA) Connecting Europe Facility 4. RECEIPTS (article II.25.3) - only applicable for the payment of the balance Action number : 2015-EE-IA-0100 Beneficiary's legal name : Estonian Health Insurance Fund Financing sources of the action (see article I.3 Amount of financial contribution to the action Comments on financing sources and II.25.3.2 of the G.A. ) eligible costs (EUR) 1. CEF - financing: 27 379,26 2. Beneficiary’s own resources: 9 126,42 3. State budget(s): 0,00 4. Regional/local budget(s): 0,00 5. Income generated by the action: 0,00 6. Other sources: 0,00 Total: 36 505,68 Attention: this is applicable only with the request for payment of the balance for each beneficiary. 7 Version: 27/04/2017 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility Guidelines for completing the individual financial statement Background information The purpose of these guidelines is to assist beneficiaries in presenting their individual financial statements. Any request for payment requires: 1) A technical report, containing the information needed to justify the declared costs. 2) A separately completed electronic excel version of the individual financial statements (i.e this XLS workbook) which includes the breakdown of the eligible costs for each beneficiary (including its affiliated entities and its implementing bodies) - article II.23 of the Grant Agreement (GA). 3) For mono-beneficiary grants; In addition to point 2) above, a scanned copy of the original stamped and signed form "1.General info" 4) For multi-beneficiary grants where a coordinator is designated: In addition to point 2) above, a consolidated financial statement, drawn up on the basis of the information provided by each beneficiary in its individual financial statement, certified by the coordinator; 5) When applicable, a Certificate on the Financial Statements (CFS) must be included with the individual Financial Statement (article II.23.2 of the GA). The CFS shall be drawn up in line with Annex VII of the GA and cover costs claimed by the beneficiary, any of its affiliated entities and/or implementing bodies. All the above-mentioned documents should be sent by email to the Agency functional mailbox mentioned in article 6.2 of the GA. In case of multi-beneficiary grants, it is the responsibility of the coordinator to submit the request for payment (article II.1.3 of the GA). Language and submission means All requests for payments, reports and financial statements must be submitted in the language specified in article 4.3 of the GA and only electronically. Submission of hard copies will not be considered. General information (form 1) Encoding information/data in the following worksheets Through-out the worksheets only white fields require the encoding of information/data. Period covered by the financial statement Reporting periods are detailed in article 4.1.1 of the GA. Only costs incurred within the reporting period are to be reported. Eligible costs Each beneficiary is responsible for declaring all the eligible costs incurred during the implementation of the action by the beneficiary itself, its affiliated entities and implementing bodies. To be eligible, costs must comply with the conditions of eligibility set out in Article II.19 of the GA: 1. Be incurred during the timeframe of the action (see article 2.2 of the GA) and in connection with the action; 2. Be indicated in the estimated overall budget of the action (Annex III of GA); 3. Be necessary for the implementation of the action; 4. Be identifiable, verifiable and recorded in the accounting records of the beneficiary; 5. Comply with the requirements of applicable tax and social legislation; 6. Be reasonable, justified and comply with the requirements of sound financial management, in particular regarding economy and efficiency. For further details on categories of eligible direct costs, please refer to article II.19.2.1. Indirect costs Flat rate set at 7% of the eligible costs declared in the individual Financial Statement (minus subcontracting costs and minus support to third parties (see article II.19.3 of the GA). Indirect costs are automatically calculated in form 3 and must not be declared as single cost item in form 2. Explanations about the detailed costs incurred (form 2) Drop-down menus and automatic calculations Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility Throughout the different worksheets, and where possible, drop-down menus and automatic calculations have been used to facilitate and standardise the encoding of information. Do not delete or modify any drop-down menus or automatic calculations. Beneficiary/implementing body/affiliated entity Please indicate the name of the beneficiary, its implementing body(ies) or affiliated entity(ies) claiming the costs. Short description of the cost claimed Provide a short description of the nature of the costs incurred in line with your accounting records. Please note that the Agency reserves the right to request the submission of supporting documents corresponding to individual cost items (article II.27). Personnel costs Personnel costs should be detailed per activity in line with the planning agreed under article I.4 of the GA (one line per activity). Supplier Please indicate the supplier of services, works and/or supplies. Insert one line for every accounting entry. When there is no supplier and the task was performed by your own personnel, please indicate this and add a clear description on the nature of the task in the “short description of the cost claimed” field . Date of the invoice Please insert the date indicated by the supplier on the invoice. When there is no invoice from the supplier (such as for tasks performed by your own staff or regulated by contracts etc.), please report the date of registering the cost in the accounting system. Unique Accounting number Please insert the unique number identifying the invoice in your accounting records. VAT (in EUR) VAT is an eligible cost only if it cannot be deducted or recovered by the beneficiary under the applicable national VAT legislation (article II.19.2.h of the Grant Agreement) and providing that the beneficiary is not specifically mentioned under Article 14 of the GA. Amount in EUR For the beneficiaries who have their general accounts in a currency other than euro, please indicate the amount in your national currency as recorded in the accounting system. The conversion of costs into euro shall be made in line with article II.23.4. of the GA. Please also refer to the "Guide to currency conversion to Euro" available on the Beneficiaries' Info Point for practical help. (https://ec.europa.eu/inea/en/connecting-europe-facility/useful-documents-and-forms) The calculated exchange rate should be indicated in the field "Calculated exchange rate". This rate will be used to automatically calculate the amount of the items claimed into EUR. HaDEA will reject cost claims in case of wrong currency conversion. In the event that an affiliated entity and/or implementing body has its general accounts in a currency different to that of the beneficiary please use separate tables per currency Overview of costs incurred by the beneficiary (form 3) This form provides an overview of costs incurred per category and is automatically completed based upon the information provided in sheet 2 (Details of costs incurred). If the costs incurred differ from the estimation provided in Annex III of the GA, please include a justification in the technical report (notably, section 2.4). The "Overview of costs incurred" form has been developed for projects with up to 12 activities. Should your project have more than 12 activities please contact the Agency through the functional mailbox [email protected]. Receipts (form 4) Beneficiaries shall report all the receipts linked to the action (see article II.25.3 of the GA). Receipts are any income generated by the action and/or financial contributions specifically assigned by the donors to the financing of the eligible costs of the action. The grant should not produce a profit for the beneficiaries (i.e. a surplus of the receipts over the eligible costs of the action). If you have any additional questions related to these guidelines and the template, contact the Agency through the functional mailbox HADEA-CEF- [email protected] Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility Individual financial statement Period covered by this report (art. 4.1.1 From: 01.01.2017 To: 30.06.2021 of the GA) 1. GENERAL INFORMATION (to be filled in by each beneficiary) Grant Agreement (GA) Number INEA/CEF/ICT/A2015/11S6737 Action number (art. 1 of GA) 2015-ΕΕ-ΙΑ-Θ1Θ0 Action title (art. 1 of GA) Deployment of Generic Cross Border eHealth Services in Estonia Start date of the action (art. 2.2 of End date of the action (art. 2.2 of GA) 01.01.2017 30.06.2021 GA) Author of the individual financial statement Name Liisa Lvova Position Project manager Beneficiary's Legal Name Health and Welfare Information Systems Centre Beneficiary number as per GA 1 Telephone Nº 7 943 943 E-mail [email protected] Certification by the Beneficiary (only applicable if mono-beneficiary grant) Name Position Entity Telephone Nº E-mail The Beneficiary certifies that: 1) the information provided in the request for payment is complete, reliable and true (Article II.23.2); 2) the costs declared are real and eligible in accordance with the Agreement and that the request for payment is substantiated by adequate supporting documents that can be produced in the context of the checks or audits described in Article II.27; 3) in case of payment of the balance, all the receipts referred to in the GA Article II.25.3.2 have been declared. Date and Signature Stamp (optional) 1 of 4 Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility 2 of 4 Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility 2. Details of the declared costs incurred by each beneficiary (article II.23.2) Action Number : 2015-ΕΕ-ΙΑ-Θ1Θ0 Beneficiary's Legal Name : Health and Welfare Information Systems Centre Indicate the currency of the general accounts used by the beneficiary (art. II.23.4) : EUR /EUR Calculated exchange rate : 1,00000 Click for GUIDE TO CURRENCY CONVERSION Total direct costs claimed for all activities in EUR (including only eligible VAT) : 410 126,79 Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement eHDSI OpenNCP Boot Camp Brussels, Aarne 1 Subcontracting HWISC services Roosi, 23-26.01.17 Casadeva OÜ 22.03.2017 1110 3-9/77-2 1 057,14 1 057,14 Development March 2017 - B side analysis, epsos web portal installation and testing, openNCP initial installation, translation service analysis and 1 Subcontracting HWISC services development, prescription portals interface with Industry62 OÜ 07.04.2017 1135 3-9/77-2 17 473,45 17 473,45 authentication services, session management in prescription portal, meetings Development April 2017 - A and B side analysis, 1 Subcontracting HWISC services prescription centre developments, API Industry62 OÜ 12.05.2017 1184 3-9/77-2 13 532,85 13 532,85 developments Development May 2017 - OpenNCP upgrade and support, meetings, CDA parser, country A analysis, 1 Subcontracting HWISC services pdf and health insurance fund questions, NCP_B Industry62 OÜ 09.06.2017 1255 3-9/77-2 9 903,35 9 903,35 adapter TC, country B additional questions and testing, creation of prescription centre interface Development June 2017 - projectathon support, AIS API database connector creation, OpenNCP hotfix, 1 Subcontracting HWISC services meetings, translation and prescription portal Industry62 OÜ 07.07.2017 1288 3-9/77-2 8 451,55 8 451,55 analysis, eHDSI patient information implementation Development July 2017 - documentation of API and 1 Subcontracting HWISC services prescription portal, API prescription list development Industry62 OÜ 25.08.2017 1339 3-9/77-2 1 348,10 1 348,10 Development August 2017 - gazelle validation class conflict, openNCP upgrade to 2.5.2.RC1, meetings, 1 Subcontracting HWISC services additional developments to prescription portal, Industry62 OÜ 06.09.2017 1347 3-9/77-2 8 088,60 8 088,60 openNCP audit questions, automatic validation errors Development September 2017 - upgrade to 1 Subcontracting HWISC services 2.5.2.RC2 , meetings, test event support and fixes Industry62 OÜ 04.10.2017 1374 3-9/77-2 2 592,50 2 592,50 Development October 2017 - Authorization cache, meetings, API upgrade, development of pharmacy 1 Subcontracting HWISC services connector authentication, test plan creation, testing Industry62 OÜ 10.11.2017 1422 3-9/77-2 12 288,45 12 288,45 and support, integration of a new epsos version Development November 2017 - upgarde to 2.5.2 RC 5, authentication of pharmacy IS, meetings, 1 Subcontracting HWISC services pharmacy API testing, adding xquery to the project, Industry62 OÜ 06.12.2017 1442 3-9/77-2 7 984,90 7 984,90 API CDA mock functionality development Development December 2017 - meetings, upgrade 1 Subcontracting HWISC services to 2.5.2, testing and support, prescription centre Industry62 OÜ 04.01.2018 1498 3-9/77-2 4 770,20 4 770,20 queries, art decor validation and API testing OpenNCP boot camp Brüssel 23.01-26.01.2017 2 Other costs HWISC services Kristjan Kukk (air ticket, travel insurance, accom.) CWT Estonia AS 18.01.2017 2018110294 669,53 669,53 OpenNCP boot camp Brüssel 23.01-26.01.2017 2 Other costs HWISC services Kristjan Kukk (daily allowance, travel expenses) HWISC 26.01.2017 T800-LK/6-K1 171,20 171,20 JAseHN 5.2 meeting, Berlin 30.01-01.02.2017 Mari 5 Other costs HWISC services Asser, Katre Pruul (air ticket, travel insurance, CWT Estonia AS 27.01.2017 2018110556 505,04 505,04 accom.) JAseHN 5.2 meeting, Berlin 30.01-01.02.2017 Mari 5 Other costs HWISC services Asser(daily allowance) HWISC 31.01.2017 T800-LK/8-K1 64,00 64,00 JAseHN 5.2 meeting ,Berlin 30.01-01.02.2017 Katre 5 Other costs HWISC services Pruul (daily allowance, travel expenses) HWISC 31.01.2017 T800-LK/9-K1 73,00 73,00 eHMSEG, Brüssel 22.02-23.02.2017 Katre Pruul 5 Other costs HWISC services (air ticket, travel insurance, accom.) WRIS AS 15.02.2017 289694-01 555,56 555,56 Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement eHMSEG, Brüssel 22.02-23.02.2017 Katre Pruul 5 Other costs HWISC services (daily allowance, travel expenses) HWISC 22.02.2017 T800-LK/19-K1 99,69 99,69 Stocholm 27-28.02.2017 Katre Pruul, Mari Asser, 5 Other costs HWISC services Artur Novek, Alvar Ristikivi( air ticket, travel CWT Estonia AS 10.02.2017 2 018 110 877 1 277,56 1 277,56 insuranse, accom) Stocholm 27-28.02.2017 Katre Pruul (daily 5 Other costs HWISC services allowance, travel expenses) HWISC 28.02.2017 T800-LK/11-K1 105,88 105,88 Stocholm 27-28.02.2017 Mari Asser (daily 5 Other costs HWISC services allowance, travel expenses) HWISC 28.02.2017 T800-LK/10-K1 105,88 105,88 Stocholm 27-28.02.2017 Artur Novek(daily 5 Other costs HWISC services allowance, travel expenses) HWISC 28.02.2017 T800-LK/12-K1 110,39 110,39 Stocholm 27-28.02.2017 Alvar Ristikivi (daily 5 Other costs HWISC services allowance, travel expenses) HWISC 28.02.2017 T800-LK/13-K1 122,55 122,55 Tartu travel ticket 08.03.2017 Katre Pruul, meeting 5 Other costs HWISC services Pharmacy Union HWISC 08.03.2017 T800-LK/24-K1 17,50 17,50 Tartu travel ticket 08.03.2017 Mari Asser, meeting 5 Other costs HWISC services Pharmacy Union HWISC 08.03.2017 T800-LK/23-K1 28,75 28,75 Semantic Boot Camp, Brüssel 14.03-15.03.2017 5 Other costs HWISC services Katre Pruul, Mari Asser ( air ticket, travel insuranse, Baltic Tours AS 15.03.2017 348 402-1 1 191,14 1 191,14 accom.) Semantic Boot Camp, Brüssel 14.03-15.03.2017 5 Other costs HWISC services Katre Pruul(daily allowance, travel expenses) HWISC 15.03.2017 T800-LK/27-K1 91,40 91,40 Semantic Boot Camp, Brüssel 14.03-15.03.2017 5 Other costs HWISC services Mari Asser(daily allowance, travel expenses) HWISC 15.03.2017 T800-LK/26-K1 125,28 125,28 Stocholm 04.05.2017 Katre Pruul, ( air ticket, travel 5 Other costs HWISC services insuranse, accom) Reisieksperdi AS 17.05.2017 TR17-1367 271,50 271,50 Stocholm 04.05.2017 Katre Pruul(daily allowance, 5 Other costs HWISC services travel expenses) HWISC 04.05.2017 T800-LK/42-K1 44,45 44,45 Meeting 29-30.05.2017, Deployment of Generic 5 Other costs HWISC services Cross Border eHealth Services in Estonia - service Saukas OÜ 30.05.2017 R-41 407,28 407,28 introduction to key stakeholders eHDSI - NCPeH Gateway Test Training 07- 2 Other costs HWISC services 08.06.2017 Kristjan Kukk, Bret Rand, ( air ticket, CWT Estonia AS 06.06.2017 20 181 103 852 1 940,46 1 940,46 travel insuranse, accom.) eHDSI - NCPeH Gateway Test Training 07- 2 Other costs HWISC services 08.06.2017 Kristjan Kukk (daily allowance, travel HWISC 08.06.2017 T800-LK/55-K1 113,24 113,24 expenses) eHDSI - NCPeH Gateway Test Training 07- 2 Other costs HWISC services 08.06.2017 Bret Rand (daily allowance, travel HWISC 08.06.2017 T800-LK/56-K1 96,34 96,34 expenses) Lissabon 19-21.07.2017 Mari Asser, Katre Pruul 5 Other costs HWISC services (daily allowance, travel expenses) CWT Estonia AS 14.07.2017 20 181 104 778 1 512,68 1 512,68 Lissabon 19-21.07.2017 Mari Asser(daily allowance, 5 Other costs HWISC services travel expenses) HWISC 21.07.2017 T800-LK/64-K1 124,70 124,70 Lissabon 19-21.07.2017 Katre Pruul (daily 5 Other costs HWISC services allowance, travel expenses) HWISC 21.07.2017 T800-LK/65-K1 110,80 110,80 Semantic Boot Camp, Brüssel 16.05-17.05.2017 5 Other costs HWISC services Katre Pruul(air ticket, travel insuranse, accom.) Baltic Tours AS 09.05.2017 350 906-1 502,74 502,74 Semantic Boot Camp, Brüssel 16.05-17.05.2017 5 Other costs HWISC services Katre Pruul(daily allowance, travel expenses) HWISC 17.05.2017 T800-LK/48-K1 85,85 85,85 Personnel costs 2017: Mari Asser, Katre Pruul,Artur 1 Personnel costs HWISC not applicable Novek, HWISC 25 146,97 25 146,97 Personnel costs 2017: Mari Asser, Katre Pruul,Artur 2 Personnel costs HWISC not applicable Novek, HWISC 4 423,47 4 423,47 Development January 2018 - fixing of Jenkins, API - dispensation submit development, UC143 - consent 1 Subcontracting HWISC services implementation, UC78 - patient identification Industry62 OÜ 06.02.2018 1521 3-9/77-2 7 466,40 7 466,40 implementation Development February 2018 - UC78 and UC84 implementation, consultation of pharmacy IS 1 Subcontracting HWISC services vendors, A side PDF example creation and testing, Industry62 OÜ 08.03.2018 1570 3-9/77-2 11 303,30 11 303,30 DB caching, API testing Development March 2018 - versioning 1 Subcontracting HWISC services implementation, API installation and tetsing Industry62 OÜ 04.04.2018 1594 3-9/77-2 4 199,85 4 199,85 Development April 2018 - adding value attribute to 1 Subcontracting HWISC services dispensation creation, testing, complete logging Industry62 OÜ 03.05.2018 1625 3-9/77-2 1 581,43 1 581,43 function Development May 2018 - Country B template fixes, 1 Subcontracting HWISC services country A tetsing, NI A prescription list and Industry62 OÜ 04.07.2018 1711 3-9/77-2 3 162,85 3 162,85 dispensation information development 2 Subcontracting HWISC services Security audit Clarified Security OÜ 27.06.2018 18073 3-9/864-1 6 400,00 6 400,00 Development June 2018 - authentication interface 1 Subcontracting HWISC services implementation consultation, meetings and support Industry62 OÜ 27.08.2018 1753 3-9/77-2 544,43 544,43 Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement Development July/August 2018 - meetings, fixes to 1 Subcontracting HWISC services NCP-A, upgrade and testing Industry62 OÜ 11.09.2018 1768 3-9/77-2 2 644,35 2 644,35 Development September 2018 - OpenNCP upgrade 1 Subcontracting HWISC services to 2.5.3 Industry62 OÜ 31.10.2018 1817 3-9/77-2 3 007,30 3 007,30 Development October 2018 - OpenNCP upgrade to 1 Subcontracting HWISC services 2.5.4, W2 testing support, documentation of logs Industry62 OÜ 02.11.2018 1824 3-9/77-2 3 759,13 3 759,13 2 Subcontracting HWISC services Security audit Security software OÜ 13.11.2018 18355 3-9/77-2 12 000,00 12 000,00 Development November 2018 - OpenNCP 2.5.4 1 Subcontracting HWISC services upgrade to OpenNCP 2.5.5, Wave2 testing and Industry62 OÜ 14.12.2018 1878 3-9/77-2 1 762,90 1 762,90 support Development December 2018 - OpenNCP upgrade 1 Subcontracting HWISC services to 2.5.5, wave live support, cache optimization, Industry62 OÜ 07.01.2019 1922 3-9/77-2 2 385,10 2 385,10 testing Brüssel 01.03-02.03.2018 Katre Pruul,( air ticket, 5 Other costs HWISC services travel insuranse, accom.) CWT Estonia AS 20.02.2018 20 191 101 184 400,63 400,63 Brüssel 01.03-02.03.2018 Katre Pruul(daily 5 Other costs HWISC services allowance, travel expenses) HWISC 02.03.2018 T800-LK/28-K1 84,29 84,29 Brüssel 03.04-04.03.2018 Katre Pruul(daily 5 Other costs HWISC services allowance) HWISC 04.03.2018 T800-LK/32-K1 64,00 64,00 eP/PS Cluster F2F meetings 11-14.04.2018 Katre 5 Other costs HWISC services Pruul (air ticket, travel insuranse, accom.) Baltic Tours AS 27.03.2018 362 602-1 595,84 595,84 eP/PS Cluster F2F meetings 11-14.04.2018 Katre 5 Other costs HWISC services Pruul (daily allowance, travel expenses) HWISC 11.04.2018 T800-LK/43 157,75 157,75 eHealth Member States Expert Group 18.04.2018 5 Other costs HWISC services Katre Pruul ( travel insurance) CWT Estonia AS 16.04.2018 20 191 102 775 11,51 11,51 eHealth Member States Expert Group 18.04.2018 5 Other costs HWISC services Katre Pruul (daily allowance, travel expenses) HWISC 18.04.2018 T800-LK/44-K1 55,20 55,20 eHealth Member States Expert Group 21.06- 5 Other costs HWISC services 23.06.2018 Katre Pruul (travel insurance, accom.) CWT Estonia AS 12.06.2018 20 191 104 210 285,74 285,74 eHealth Member States Expert Group 21.06- 5 Other costs HWISC services 23.06.2018 Katre Pruul (daily allowance, travel HWISC 23.06.2018 T800-LK/71-K1 119,45 119,45 expenses) eHMSEG Semantic Task Force 7th Face-to-Face 5 Other costs HWISC services meeting Aleksandra Stupak, Artur Novek 12-13-11- Baltic Tours AS 09.11.2018 370 040-1 1 045,49 1 045,49 2018 (air ticket, travel insurance, accom.) eHMSEG Semantic Task Force 7th Face-to-Face 5 Other costs HWISC services meeting Aleksandra Stupak 12-13-11-2018 (daily HWISC 13.11.2018 T800-LK/129-K1 81,28 81,28 allowance, travel expenses) eHMSEG Semantic Task Force 7th Face-to-Face 5 Other costs HWISC services meeting Artur Novek 12-13-11-2018 (daily HWISC 13.11.2018 T800-LK/131-K1 114,91 114,91 allowance, travel expenses) Tartu Aleksandra Stupak 14.11.2018, training of 2 Other costs HWISC services Pharmacy Union HWISC 14.11.2018 T800-LK/130-K1 78,60 78,60 13th eHealth Member State Expert Group 5 Other costs HWISC services Aleksandra Stupak 11-12.11.2018 Brüssel (air Baltic Tours AS 28.11.2018 370 673-1 115,65 115,65 ticket, travel insuranse, accom.) 13th eHealth Member State Expert Group 5 Other costs HWISC services Aleksandra Stupak 11-12.11.2018 Brüssel (daily HWISC 12.11.2018 T800-LK/144-K1 106,29 106,29 allowance, travel expenses) 1 Personnel costs HWISC not applicable Personnel costs 2018: Artur Novek, Katre Pruul, HWISC 2 484,34 2 484,34 Personnel costs 2018: Katre Pruul, Kristjan Kukk, 2 Personnel costs HWISC not applicable Jaanus Kari HWISC 19 842,56 19 842,56 3 Personnel costs HWISC not applicable Personnel costs 2018: Aleksandra Stupak HWISC 7 894,66 7 894,66 Personnel costs 2018: Katre Pruul, Aleksandra 5 Personnel costs HWISC not applicable Stupak HWISC 7 255,16 7 255,16 1 Subcontracting HWISC services Development January 2019 - dispensation pdf fixes Industry62 OÜ 04.03.2019 1972 3-9/77-2 6 559,03 6 559,03 Development February 2019 - Wave2 OpenNCP 1 Subcontracting HWISC services 3.0.0.RC1 and RC2, testing and support Industry62 OÜ 04.03.2019 1074 3-9/77-2 4 122,08 4 122,08 1 Subcontracting HWISC services Development April 2019 - regular meetings/standup Industry62 OÜ 02.05.2019 2045 3-9/77-2 207,40 207,40 Development June 2019 - PS analysis, 1 Subcontracting HWISC services peojectathon support, TSAM and units issues Industry62 OÜ 07.08.2019 2169 3-9/77-2 5 599,80 5 599,80 Development July 2019 - Testing support with 1 Subcontracting HWISC services Croatia, PS analysis Industry62 OÜ 03.09.2019 2197 3-9/77-2 466,65 466,65 Development August 2019 - test event outcome 1 Subcontracting HWISC services analysis, test event support and eP fixes Industry62 OÜ 06.09.2019 2213 3-9/77-2 2 281,40 2 281,40 Development December 2019 - userID fixes, NCP-A 1 Subcontracting HWISC services production time out issue, additional logging added, Industry62 OÜ 09.01.2020 2398 3-9/2058-1 1 625,00 1 625,00 pdf amendments Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement Development August- October 2019 - PS rules in Enterprise Architect and tetsing, PS service development and testing (codedResult_v1 ,immunization_v1 ,caregiver_v1 ,socialHistory_v1 1 Subcontracting HWISC services ,clinicalDocument_v1, activeProblem_v1 Industry62 OÜ 09.01.2020 2399 3-9/2058-1 44 020,60 44 020,60 ,medicalDevice_v1, Medication_v1, surgery_v1, section_surgery_v1, section_surgery_pdf_v1, vital_signs and allergy), rules in XQuery 2 Other costs HWISC services Production testing, patient prescription 2019 HWISC 25.01.2019 T800-3-10/23 8,68 8,68 2 Other costs HWISC services Pharmacists training HWISC 14.02.2019 T800-LK/19-K1 72,80 72,80 2 Other costs HWISC services Meeting with pharmacy managers (Euroapteek) HWISC 27.02.2019 T800-LK/29-K1 90,80 90,80 eHMSEG meeting Artur Novek 11.03.2019 ( travel 5 Other costs HWISC services insuranse) Baltic Tours AS 15.02.2019 372 805-1 2,77 2,77 eHMSEG meeting Artur Novek 11.03.2019 (daily 5 Other costs HWISC services allowance, travel expenses) HWISC 11.03.2019 T800-LK/48-K1 66,60 66,60 eHMSEG meeting Artur Novek, Liisa Lvova 16.05- 5 Other costs HWISC services 17.05.2019 (air ticket, travel insuranse, accom.) Baltic Tours AS 09.05.2019 375 411-1 790,01 790,01 eHMSEG meeting Artur Novek 16.05-17.05.2019 5 Other costs HWISC services (daily allowance, travel expenses) HWISC 17.05.2019 T800-LK/68-K1 123,68 123,68 eHMSEG meetingLiisa Lvova 16.05-17.05.2019 5 Other costs HWISC services (daily allowance, travel expenses) HWISC 17.05.2019 T800-LK/63-K1 120,84 120,84 eHDSI 2019 Technical/OpenNCP Boot-Camp Karli 5 Other costs HWISC services Grünberg 20.05.2019-24.05.2019 (air ticket, travel CWT Estonia AS 15.05.2019 20 201 105 901 1 020,55 1 020,55 insuranse, accom.) eHDSI 2019 Technical/OpenNCP Boot-Camp Karli 5 Other costs HWISC services Grünberg 20.05.2019-24.05.2019 (daily allowance, HWISC 24.05.2019 T800-LK/64-K1 187,78 187,78 travel expenses) Semantic Task Force meeting 24-26.09.2019 Krista 2 Other costs HWISC services Kärt (air ticket, travel insuranse, accom.) CWT Estonia AS 30.08.2019 202 011 014 323 698,40 698,40 Semantic Task Force meeting 24-26.09.2019 Krista 2 Other costs HWISC services Kärt (daily allowance, travel expenses) HWISC 26.09.2019 T800-LK/129-K1 122,28 122,28 16th Meeting of the eHealth DSI Member State 5 Other costs HWISC services Expert Group 16-17.10.2019 Liisa Lvova, Artur Baltic Tours AS 26.09.2019 379336-1 574,48 574,48 Novek (air ticket, travel insuranse, accom.) 16th Meeting of the eHealth DSI Member State 5 Other costs HWISC services Expert Group 16-17.10.2019 Artur Novek (daily HWISC 17.10.2019 T800-LK/150-K1 99,24 99,24 allowance, travel expenses) 16th Meeting of the eHealth DSI Member State 5 Other costs HWISC services Expert Group 16-17.10.2019 Liisa Lvova(daily HWISC 17.10.2019 T800-LK/157-K1 72,44 72,44 allowance, travel expenses) 2 Other costs HWISC services Production testing, patient prescription 2019 HWISC 31.12.2019 T800-3-10/5 13,53 13,53 Ketlin Kalle-Brackmann, E2E testing, 2019 and 2 Other costs HWISC services 2020 eHDSI test event HWISC 31.12.2019 TL 3-13/2040-1 68,24 68,24 eP/PS Cluster Face-to-Face Meeting 11-12.06.2019 5 Other costs HWISC services Liisa Lvova (air ticket, travel insuranse, accom.) Baltic Tours AS 04.06.2019 376189-1 592,74 592,74 eP/PS Cluster Face-to-Face Meeting 11-12.06.2019 5 Other costs HWISC services Liisa Lvova (daily allowance, travel expenses) HWISC 12.06.2019 T800-LK/93-K1 106,23 106,23 1 Personnel costs HWISC not applicable Personnel costs 2019: Artur Novek HWISC 1 441,28 1 441,28 3 Personnel costs HWISC not applicable Personnel costs 2019: Kristjan Kukk HWISC 880,82 880,82 Personnel costs 2019:Kristjan Kukk, Alexandra 4 Personnel costs HWISC not applicable Stupak HWISC 8 773,20 8 773,20 5 Personnel costs HWISC not applicable Personnel costs 2019:Liisa Lvova, Artur Novek HWISC 14 147,40 14 147,40 Development January 2020 - Upgrade OpenNCP 1 Subcontracting HWISC services and API 4.0.2, Jira tasks and fixes Industry62 OÜ 10.02.2020 2437 3-9/2058-1 6 207,50 6 207,50 Development February 2020 - Upgrade to 4.0.3 and testing, additional fixes, certificate renewal and 1 Subcontracting HWISC services testing, amendment of business rules, eP validation Industry62 OÜ 03.03.2020 2452 3-9/2058-1 7 150,00 7 150,00 error fixes Development March 2020 - prescription mock in production (for prod testing), PS pdf amendments, 1 Subcontracting HWISC services describing additional PS use cases, test event Industry62 OÜ 07.04.2020 2518 3-9/2058-1 6 175,00 6 175,00 support Development April 2020 - prod env support, PS 1 Subcontracting HWISC services fixes Industry62 OÜ 10.05.2021 2565 3-9/2058-1 1 105,00 1 105,00 Development May 2020 - WAVE 4 eHDSI Services 1 Subcontracting HWISC services and Artefacts, PS API discussions Industry62 OÜ 04.06.2021 2596 3-9/2058-1 715,00 715,00 Development June 2020 - X road client and server 1 Subcontracting HWISC services service renewal, OpenNCP upgrade to 4.1.0, Industry62 OÜ 06.07.2020 2654 3-9/2058-1 7 605,00 7 605,00 prescription list change Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement Development July 2020 - CDA fixes, API issues and 1 Subcontracting HWISC services fix Industry62 OÜ 11.08.2020 2692 3-9/2058-1 1 495,00 1 495,00 Development August 2020 - patient portal logs and 1 Subcontracting HWISC services consent, removal of epSOSCodeNoMedication, Industry62 OÜ 07.09.2020 2726 3-9/2058-1 1 365,00 1 365,00 units in terminology change Development September 2020 - patient portal log fixes, OpenNCP prod upgrade to next wave, 1 Subcontracting HWISC services postgre timeput issues, API upgrade, adding Industry62 OÜ 01.10.2020 2735 3-9/2058-1 7 312,50 7 312,50 package quantity Development October 2020 - pharmacy API soap request changes, dispensation discard development, eP-A number of packages prescribed 1 Subcontracting HWISC services not present in the Level 1 PDF, UI fixes, OpenNCP Industry62 OÜ 05.11.2020 2799 3-9/2058-1 7 865,00 7 865,00 upgrade to 5.1.0, enabling indicating dosage period length Development November 2020 - API upgrade, NCP- 1 Subcontracting HWISC services A adding additional testing resources, dose Industry62 OÜ 08.12.2020 2858 3-9/2058-1 975,00 975,00 translations issue Development December 2020 - syslog error fix, PS headings, dispensation discard use case description 1 Subcontracting HWISC services and development, PS portal, environment Industry62 OÜ 06.01.2021 2907 3-9/2058-1 11 765,00 11 765,00 developments, upgrades and tests 2 Other costs HWISC services Production testing, patient prescription 2020 HWISC 16.01.2020 T800-3-10/6 24,13 24,13 2 Other costs HWISC services Patient information notice translations Mill Tõlkebüroo OÜ 27.05.2020 24242 72,60 72,60 4 Personnel costs HWISC not applicable Personnel costs 2020 Liisa Lvova HWISC 1 722,86 1 722,86 2 Personnel costs HWISC not applicable Personnel costs 2020 Liisa Lvova HWISC 1 297,22 1 297,22 5 Personnel costs HWISC not applicable Personnel costs 2020 Liisa Lvova HWISC 6 992,80 6 992,80 1 Subcontracting HWISC services Development April 2021 - PS portal UI fixes Industry62 OÜ 06.05.2021 3062 3-9/2589-1 1 912,50 1 912,50 Additional patient summary risk analysis (European 2 Subcontracting HWISC services Commisions audit requirement) Security Software OÜ 14.04.2021 21114 3-9/2579-1 14 640,00 14 640,00 2 Other costs HWISC services Marleen Moritz, E2E testing, 2021 eHDSI test event HWISC 30.04.2021 42021 1-4/2671-1 96,34 96,34 Ketlin Kalle-Brackmann, E2E testing, 2021 eHDSI 2 Other costs HWISC services test event HWISC 30.04.2021 42021 1-4/2672-1 80,28 80,28 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility Amount of eligible VAT Activity Nº (in the currency of the (according to Amount Internal reference general accounts) Amount in EUR the cost Name of Beneficiary / Implementing Type of procurement contract Unique Accounting excluding VAT (in Cost Category Short description of the cost claimed Supplier Date of invoice of the procurement ( including eligible breakdown of Body / Affiliated Entity (services/supplies/works/not applicable) number the currency of the contract VAT is only eligible in VAT ) the grant general accounts ) agreement) accordance with Art. II.19.2.h and article 14 of the Grant Agreement 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 0,00 Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Individual Financial Statement Connecting Europe Facility 3. Overview of costs incurred by the beneficiary Action Number: 2015-ΕΕ-ΙΑ-Θ1Θ0 Beneficiary's legal name: Health and Welfare Information Systems Centre If applicable, Claimed costs in EUR Cost category claimed costs in national currency (conversion to EURO ) (indicative amount) Personnel costs 102 302,74 102 302,74 Other costs 18 946,46 18 946,46 Subcontracting 288 877,59 288 877,59 Direct costs 410 126,79 410 126,79 Indirect costs (7%) 8 487,44 8 487,44 Total 418 614,23 418 614,23 If applicable, Claimed costs in EUR Activity Cost category claimed costs in national currency (conversion to EURO ) (indicative amount) 1 Personnel costs 29 072,59 29 072,59 1 Other costs 0,00 0,00 1 Subcontracting 255 837,59 255 837,59 2 Personnel costs 25 563,25 25 563,25 2 Other costs 4 417,45 4 417,45 2 Subcontracting 33 040,00 33 040,00 3 Personnel costs 8 775,48 8 775,48 3 Other costs 0,00 0,00 3 Subcontracting 0,00 0,00 4 Personnel costs 10 496,06 10 496,06 4 Other costs 0,00 0,00 4 Subcontracting 0,00 0,00 5 Personnel costs 28 395,36 28 395,36 5 Other costs 14 529,01 14 529,01 5 Subcontracting 0,00 0,00 6 Personnel costs 0,00 0,00 6 Other costs 0,00 0,00 6 Subcontracting 0,00 0,00 7 Personnel costs 0,00 0,00 7 Other costs 0,00 0,00 7 Subcontracting 0,00 0,00 8 Personnel costs 0,00 0,00 8 Other costs 0,00 0,00 8 Subcontracting 0,00 0,00 9 Personnel costs 0,00 0,00 9 Other costs 0,00 0,00 9 Subcontracting 0,00 0,00 10 Personnel costs 0,00 0,00 10 Other costs 0,00 0,00 10 Subcontracting 0,00 0,00 11 Personnel costs 0,00 0,00 11 Other costs 0,00 0,00 11 Subcontracting 0,00 0,00 12 Personnel costs 0,00 0,00 12 Other costs 0,00 0,00 12 Subcontracting 0,00 0,00 Direct costs 410 126,79 410 126,79 Indirect costs (7%) 8 487,44 8 487,44 Total 418 614,23 418 614,23 Total estimated CEF contribution 75% EU co-financing rate - to select from dropdown menu (without receipts) 313 960,68 75,00% Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Consolidated Fin Statement Connecting Europe Facility Guidelines for completing the consolidated financial statement Background information The purpose of these guidelines is to assist the coordinator in presenting the consolidated financial statements that are to be submitted with the request for interim payments or payment of the balance. Any request for payment requires: 1) A technical report, containing the information needed to justify the declared costs; 2) A separately completed electronic excel version of the individual financial statements (i.e this XLS workbook) which includes the breakdown of the eligible costs for each beneficiary (including its affiliated entities and its implementing bodies) - article II.23 of the Grant Agreement (GA); 3) For multi-beneficiary grants where a coordinator is designated: In addition to point 2) above, a consolidated financial statement, drawn up on the basis of the information provided by each beneficiary in its individual financial statement, certified by the coordinator; 4) When applicable, the submission of a Certificate on the Financial Statements (CFS) with the individual Financial Statement (article II.23.2 of the GA). The CFS shall be drawn up in line with Annex VII of the GA and cover costs claimed by the beneficiary, any of its affiliated entities and/or implementing bodies; It is the responsibility of the coordinator to submit the request for payment (article II.1.3 of the GA) with all the above-mentioned documents by email to the Agency functional mailbox [email protected]. The coordinator shall certify that all the information provided in the request for payment is full, reliable and true. Language and submission means All requests for payment, reports and financial statements must be submitted in the language specified in article 4.3 of the GA and only electronically. Submission of hard copies will not be considered. General information (form 1) Encoding information/data in the following worksheets Throughout the worksheets only white fields require the encoding of information/data. Period covered by the financial statement Reporting periods are detailed in article 4.1.1 of the GA. Only costs incurred within the reporting period are to be reported. Explanations on the Consolidated Financial Statement (form 2) Drop-down menus and automatic calculations The worksheet contains automatic calculations to facilitate and standardise the encoding of information. Do not delete or modify any automatic calculations. Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Consolidated Fin Statement Connecting Europe Facility Beneficiary name Please indicate the name of the beneficiary as indicated in their individual financial statement. The consolidated financial statement has been developed for projects with up to 12 beneficiaries. Should your project have more than 12 beneficiaries please contact the Agency through the functional mailbox mentioned in Article 6.2 of the Grant Agreement Cost Categories (Personnel costs, Other, Subcontracting) The information provided in form "3. Overview of costs incurred" of each individual financial statement shall be copied per beneficiary. Total amount of receipts The coordinator shall report all the receipts linked to the action (see article II.25.3 of the GA). Receipts are any income generated by the action and/or financial contributions specifically assigned by the donors to the financing of the eligible costs of the action. Amount in EUR The consolidated financial statements must be submitted in EUR only. Total estimated CEF Contribution Select from the dropdown menu the EU co-financing rate as per article 3 of the GA. If you have any additional questions related to these guidelines and the template, contact the Agency through the functional mailbox [email protected] Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Consolidated Fin Statement Connecting Europe Facility Consolidated Financial Statement Period covered by this report From: 01.01.2017 To: 30.06.2021 (article 4.1.1 of the GA): 1. GENERAL INFORMATION (to be filled in by the Coordinator) Grant Agreement (GA) Number INEA/CEF/ICT/A2015/11S6737 Action number (art. 1 of GA) 2015-ΕΕ-ΙΑ-Θ1Θ0 Action title (art. 1 of GA) Deployment of Generic Cross Border eHealth Services in Estonia End date of the action: (art. Start date of the action: (art. 2.2 of GA) 01.01.2017 30.06.2021 2.2 of GA) Author of the consolidated financial statement Name Liisa Lvova Position Project Manager Coordinator's Legal Name Estonian Health and Welfare Information Systems Centre Telephone Nº +372 7943 900 E-mail [email protected] Certification by the Coordinator Name Katrin Reinhold Position Director General Entity Health and Welfare Information Systems Centre (HWISC) Telephone Nº +372 7943 900 E-mail [email protected] The Coordinator certifies that: 1) the information provided in the request for payment is full, reliable and true (Article II.23.2); 2) the costs declared are real and eligible in accordance with the Grant Agreement and the request for payment is substantiated by adequate supporting documents that can be produced in the context of the checks or audits described in Article II.27; 3) all the receipts (referred to in Article II.25.3.2) have been declared. Date and Signature of the Coordinator Signed digitally, 24.09.2021 Stamp (optional) Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Consolidated Fin Statement Connecting Europe Facility 2. Consolidated financial statement (aggregating all beneficiaries) Total estimated CEF contribution Beneficiary name Cost categories Amount (in €) per beneficiary without receipts (in €) Health and Welfare Information Systems Centre Personnel (HWISC) costs 102 302,74 313 960,68 Other costs 18 946,46 Subcontracting 288 877,59 Total DIRECT eligible costs (Article II.19.2): 410 126,79 INDIRECT costs (7% of direct costs): 8 487,44 TOTAL eligible costs: 418 614,23 Total amount of receipts: 418 614,23 Estonian Health Insurance Fund (EHIF) Personnel costs 17 818,39 27 379,26 Other costs 0,00 Subcontracting 17 440,00 Total DIRECT eligible costs (Article II.19.2): 35 258,39 INDIRECT costs (7% of direct costs): 1 247,29 TOTAL eligible costs: 36 505,68 Total amount of receipts: 36 505,68 Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Consolidated Fin Statement Connecting Europe Facility Total estimated CEF contribution Beneficiary name Cost categories Amount (in €) per beneficiary without receipts (in €) Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Consolidated Fin Statement Connecting Europe Facility Total estimated CEF contribution Beneficiary name Cost categories Amount (in €) per beneficiary without receipts (in €) Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Consolidated Fin Statement Connecting Europe Facility Total estimated CEF contribution Beneficiary name Cost categories Amount (in €) per beneficiary without receipts (in €) Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Personnel costs 0,00 Other costs Subcontracting Total DIRECT eligible costs (Article II.19.2): 0,00 INDIRECT costs (7% of direct costs): 0,00 TOTAL eligible costs: 0,00 Total amount of receipts: Total amount of eligible costs (in €) all beneficiaries 455 119,91 Total amount of receipts all beneficiaries (in €) 455 119,91 EU co-financing rate - to select from dropdown menu Version: May 2021 Health and Digital Executive Agency (HaDEA) CEF Telecom - Consolidated Fin Statement Connecting Europe Facility Total estimated CEF contribution Beneficiary name Cost categories Amount (in €) per beneficiary without receipts (in €) Total estimated CEF contribution 75% (without receipts) 75,00% 341 339,93 Version: May 2021 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. European Commission Interim / Final report Health and Digital Executive Agency (HaDEA) Connecting Europe Facility 1. INFORMATION ON THE ACTION Grant Agreement Nº INEA/CEF/ICT/A2015/1156737 Action Title (Art. 1 of GRANT AGREEMENT G.A.) UNDER THE CONNECTING EUROPE FACILITY (CEF) - TELECOMMUNICATIONS SECTOR Action number (Art. 1 of the G.A.) 2015-EE-IA-0100 Author of the report Name Liisa Lvova Position Project manager Coordinator's Legal Name Health and Welfare Information Systems Centre Telephone Nº +372 7 943 943 E-mail [email protected] 1 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. 2. IMPLEMENTATION OF THE ACTION1 2.1. Overall completion of the Action Planned Actual Start/End Completion3 Start/End date2 date 01/01/20 30/06/20 01/01/20 30/06/20 89,32% 17 21 17 21 2.2. Completion per activity/work package Title4 Planned Actual Start/End Completion Start/End date3 date Activity 1 Preparation and 01/01/20 31/01/20 01/01/20 31/01/20 100% Implementation 17 20 17 20 Milestone no Title3 Planned date3 Actual date Reached (Y/N) 1 Definition of the service 31/03/2017 31/03/2017 Y deployment plan with activities, milestones and tasks completed 8 Completion of the preparation 30/04/2021 30/04/2021 Y and implementation activity Title3 Planned Actual Start/End Completion Start/End date3 date Activity 2 Service Testing, Approval and 01/08/20 30/06/20 01/08/20 30/06/20 100% Deployment 17 21 17 21 Milestone no Title3 Planned date3 Actual date Reached (Y/N) 3 Compliance with the service 30/11/2017 10/10/2018 Y requirements and recommendations for ePrescription (as Country B). 6 Compliance with the service 31/03/2021 28/05/2021 Y requirements and recommendations for Patient Summary achieved. 1 For Interim report: please describe the completion of the action until the end of the reporting period as specified in the Grant Agreement. 2 As specified in Art. 2.2 of the Grant Agreement. 3 The completion of the Action and of each activity/work package should be indicated as a percentage. 4 As specified in the Grant Agreement. 2 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. Title3 Planned Actual Start/End Completion Start/End date3 date Activity 3 Operation 01/11/20 30/06/20 01/11/20 Not 80% 17 21 17 ended Milestone no Title3 Planned date3 Actual date Reached (Y/N) 5 Start of operation of 31/03/2018 21/01/2019 Y ePrescription (as country B) 7 Start of operation for the 30/06/2021 Not ended N Patient Summary 9 Completion of the 1st year of 31/03/2019 19/01/2020 Y operation of ePrescription (as country B) 10 Start of operation of 31/03/2019 01/06/2020 Y ePrescription (as country A) 11 Completion of operation activity 30/06/2021 30/08/2021 Y Title3 Planned Actual Start/End Completion Start/End date3 date Activity 4 Dissemination, Training and 01/04/20 30/06/20 01/04/20 Not 66,6% Support 17 21 17 ended Milestone no Title3 Planned date3 Actual date Reached (Y/N) 2 Planning of service 30/04/2017 30/04/2017 Y dissemination, education and training completed. It includes concrete actions, outcomes and responsibilities. 4 Definition of the service support 30/11/2017 30/11/2017 Y plan with responsibilities, workflow and stakeholders for Patient Summary and ePresciption completed 12 Completion of dissemination, 30/06/2021 Not ended N training and support activities Title3 Planned Actual Start/End Completion Start/End date3 date Activity 5 Governance and Management 01/01/20 30/06/20 01/01/20 30/06/20 100% 17 21 17 21 Milestone no Title3 Planned date3 Actual date Reached (Y/N) 3 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. 13 Completion of governance and 30/06/2021 30/06/2021 Y management activity 4 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. 2.3. Description of the implementation of the Action, including the actual status at the end of the Action (or of the reporting period) and possible deviations from the planned activities, and, if applicable, compliance with any relevant specific provisions as indicated in the Annex I of the GA Preparation and Implementation All the preparation and implementation activities were carried out by 31/01/2020. Tl.l. Plan and monitor progress towards services operation The initial planning of cross border ePrescription and patient summary started in the end of 2016 and beginning of 2017. A procurement was carried out to find a development partner, which also included a more detailed timetable for the implementation of the services. In addition, HWISC personnel got assigned to the project and joined the necessary eHDSI work groups. Necessary organizational processes were identified. T1.2. Design national architecture HWISC system architect Artur Novek created the first version for the proposed architectural scheme which was based mainly on ePSOS project, but at the same time focusing on the first wave of CEF project. In later steps the project description was added, functional and non-functional requirements etc. T1.3. Establish organizational requirements and procedures A steering committee was made, which included representatives from the Ministry of Social Affairs and other related government organizations (an overall steering committee for all cross-border services in health, labor and social field). The roles and responsibilities were agreed during the analysis of the implementation and describing the national architecture of the service (T1.2). All stakeholders were included in this step (eg Estonian Health Board, State Agency of Medicines, Information System Authority, pharmacies etc). All the needed organizational processes were described and agreed (eg incident, change and problem management). T1.4. Establish legal, security and privacy requirements and procedures Agreement between National Authorities or National Organisations responsible for National Contact Points for eHealth on the Criteria required for the participation in Cross-Border eHealth Information Services was signed in 2018. All the necessary statutes were updated by the Minisrty of Social Affairs and several DPIAs carried out. T1.5. Assure semantic interoperability of Patient Summary and ePrescription CDA development was outsourced from a competent software development company. The requirements, structure and documentation of the CDAs in our implementation are monitored by HWISC architects and data management analysts. We translated all MVC value sets into Estonian and transcoded only value sets that have corresponding national value set in use nationally. For transcodings we considered important that information loss would be minimal, therefore we didn’t transcode if national code system were with significantly higher granularity than eHDSi value set. For translations and transcodings we worked together with different experts and organizations depending on their domain of expertise. For the value sets related to medicines, we signed a collaboration agreement with State Agency of Medicine. For the value sets that represent more general medical domain, the translations and transcodings were conducted by different clinical experts and revised by national Competence Centre for Medical Terminology at National Institute for Health Development. More general/technical value sets were translated and mapped in-house. Also throughout the years we have been active in several eHDSI working groups: semantic, architecture, openNCP, eP and PS cluster T1.6. OpenNCP localisation implementation, integration and testing OpenNCP development, test (pre-live) and production environments were set up, configurated and connected to our national infrastructure and tested. This was mostly done by HWISC with some help from the procurement partner and Solution Provider team. Tl.7. Perform unit and integration testing OpenNCP testing environment was mostly tested with Finland at first, followed by Portugal and Croatia. This included testers from HWISC, following a test plan, that was created according to eHDSI needs. In addition, the processes for upgrade and testing of NCP were introduced to HWISC and taken into account while planning the resources. T2.1. Perform testing to assure quality of the service provision HWISC took part in eHDSI preparatory test events. OpenNCP needed to be up and running for this, also the agreed services had to be developed and available for testing. Terminology had to be translated, mapped and uploaded to central terminology services. Service Testing, Approval Deployment All the activities were carried out by 30/06/2021. 5 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. T2.2. Pre-Iive testing and Projectathon HWISC took part in eHDSI test events twice a year. In order to take part in those a timely upgrade for NCP was needed, also the update of terminology services. System administrator started with the configuration and security settings and the testers completed the necessary workflow tests, validated the results and uploaded them to Gazelle. This was followed by and end-2-end testing with the end users. After the test event, all the findings and observations were analysed and fixed. T2.3. Perform security audit During spring 2018, the first audit was carried out by the European Commission. HWISC prepared necessary documents and filled out the readiness criteria checklist, including all needed annexes to processes, legal aspects and security information. HWISC received the audit report with different findings, which were cleared by the autumn of 2018 and a confirmation from the auditors was received about the readiness for cross border ePrescription services (EE as eP B). Additional findings for EE as eP A were cleared during 2019 spring and summer. A remote audit for Patient Summary service was carried out in 2020 and findings were cleared in the beginning of 2021. T2.4. Preparation of country readiness approval processes Necessary documentation received from the auditors and test events was sent to eHDSI each time a new service go-live was requested. T2.5. Service deployment At first TESTA network connections were done. After this, opening of the X-road services was ordered. The ePrescription portal was configured and deployed and tsam sync performed, to get the mapped and translated terminology in use. In addition, an API is provided for the pharmacy software vendors. This has also been managed by HWISC system administrator. T2.6. Non-regression testing When eg a new release for NCP becomes available the procurement partner analyses and develops the new version, also performs non-regression tests. The changes are then implemented in the test environment and tested by HWISC. This is a manual testing procedure, and all the main workflows are being tested. If this is a whole new service, HWISC orders additional security testing to the new service, which is carried out by a third party. Operation eP services have received go-live decisions and patient summary service has received production environment testing decision by the end of 30/06/2021. T3.1. Service provision and monitoring HWISC deployed eP/eD as country B in January 2019 and as country A in July 2020. Patient summary service has been tested in production with other member states (eg Croatia, Luxembourg). eP/eD service is being monitored and provided to the users 24/7. In case of any interruptions the monitoring systems sends out automatic notifications to the project manager, monitoring specialist and system administrators. In addition, all the activities are monitored and displayed in Tableau software (number of queries, dispensations, patient searches etc). The same monitoring applies to patient summary service once its live. T.3.2. Service maintenance and change management For incidents, problems and change requests HWISC uses Jira environment. In case of any changes in the service, the new feature will be developed and tested in the development environment (based on a Jira ticket created by HWISC). After successful dev testing the same feature is delivered to the test environment, where it is also tested. All the changes and operations are recorded in Jira and included in the quality management quarterly reviews. T3.4. Service evaluation OpenNCP includes syslog, where patient data is stored. This is only accessible to the system administrator and system architect (based on a Jira ticket). Ministry of Social affairs has included the user satisfaction tasks to their work plan. So far interviews with the pharmacists have been carried out to identify any problems in the service and usability. During end-2-end testing, clinical experts have been included in validating different documents (CDAs, prescriptions data etc), in order to make any improvements in the service. Dissemination, Training and Support Most of the dissemination and training have been done by the end of 30/06/2021 (some patient summary activities are still ongoing). Support, by HWISC helpdesk, is being provided for the service 24/7. T4.1. An overall communication strategy HWISC has created and completed 3 different dissemination plans (one for eP B, eP A and PS). All of the plans have been approved by the auditors and carried out almost entirely (some activities from the PS plan are still in progress). T4.2. Stakeholder engagement Before the launch of the eP/eD service, HWISC carried out a seminar and several trainings for the pharmacists (in 2018 and 2019). 3 months after the eP/eD service go live, a questionnaire was forwarded to the pharmacists to gather 6 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. feedback. In addition, a constantly updated FAQ has been sent out to the pharmacies quarterly (tackling any new features and possible problems). In addition, HWISC has created different patient information notices and included them in the eHDSI communication pages. We have also created a demo for the healthcare providers, explaining how to use the patient summary service. A demo for the users is still in progress. T4.3. Citizen and end-users dissemination and motivation Whenever a new service or country goes live, HWISC gives out a press release, includes the information in the newspapers and different digital channels and information about this on their Facebook page. In addition, we usually organize at least a radio or television interview for the new services (eg in Terevisioon, a really popular show in the morning in TV). T4.4 Help desk and support Training of the helpdesk staff has been carried out in 2019 and 2020 (we are doing this yearly, 2021 is yet to come). All the tickets (HCPs, citizens etc) will be recorded in Jira and categorized, from there on a certain process follows (eg incident or problem management). HWISC has also created a service desk community in HWISC and shared their best practices and principles on how to manage cross border issues in helpdesk and how our actual helpdesk works. Governance and Management Governance and management tasks have been carried out by 30/06/2021. T5.1. Acting and reporting according to the eHDSI governance Estonia has been an active participant in all the eHDSI work groups from the beginning while contributing to different approaches, changes and proposals. HWISC has followed all the procedural policies, provided by the eHDSI and completed the development of the services based on their guidelines. T5.2. Management of national activities This was mainly done in the beginning of the project, while creating a steering committee, where the activities were agreed and roles assigned. 2.4. Conclusions on results of the Action, including the impact of the possible deviation on 1) the objectives of the action, 2) the completion of the planned activities and 3) the cost-breakdown Activity 1 According to the GA, total eligible costs for this activity were 240,848.8€, but the actual costs were 284,910.18. The main reason behind this was the fact that we had a new procurement each year and the cost of the development went up. All the personnel and short descriptions of the costs are described in the financial statement. Technically we didn’t have any workarounds in this step and everything is completed. Activity 2 According to the GA, total eligible costs for this activity were 98,528.7€, but the actual costs were 63,020.70€. Most of the costs were personnel costs and trainings, but also risk assessment and security audits. HWISC security audits cost less than initially planned (HWISC average security audit cost is 30,000€). Additional risk assessment was carried out based on audit findings, which wasn’t included in the initial work plan. Also, some translations were ordered. All the activities have been completed Activity 3 According to the GA, total eligible costs for this activity were 24,416€ and the actual costs were 8,775.48€. These were only personnel costs, and the operations part took fewer working hours than planned. Patient summary service is in production environment testing (PET) with other countries, hence the activity hasn’t been fully finished. The delay in going live is due to COVID-19 restrictions. Estonia couldn’t carry out end-2-end testing during lockdown and had to redo this part. In addition, the audit was held remotely over several months period (not in 1 week, as usually), which in turn resulted in getting the final audit report later than planned. Though Estonia has already completed PET we are waiting for the upgrade of NCP and with this comes an update of terminology catalogue. The situation is described more detailed in chapter 6. Activity 4 According to the GA, total eligible costs for this activity were 67,146€ but the actual costs were 10,496.06€. Since all the training was done by HWISC staff, then this activity also includes only personnel costs. Participations in different radio or TV shows didn’t cause any additional costs. Also carrying out the dissemination plan is purely HWISC personnel expense. HWISC still has some information work to carry out among HCPs and citizens about patient summary once the service is live, hence this activity hasn’t ended yet. Activity 5 7 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. According to the GA, total eligible costs for this activity were 62,102.8€ but the actual costs were 42,924.37€. This activity included all the travel costs, but since COVID-19 restrictions no travelling had happened since 2020. 8 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. 3. VISIBILITY OF UNION FUNDING What measures have been taken to publicize the Action, including EU funding (GA II.7.1)? We have included an EU logo in the portal used by pharmacists and patient summary portal used by HCP-s, indicating the funding: In addition, all the training materials included the EU funding information, also the articles in newspapers (all of them are in Estonian or Russian, eg https://www.ituudised.ee/uudised/2019/01/22/soome-digiretsepte-saab-ka-eestis-kasutada). For example, informational leaflet endings, where EU logo is included: 9 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. Information about the cross-border data exchange on Estonian HIF webpage: https://www.haigekassa.ee/kontaktpunkt/riiklik-kontaktpunkt HWISC web: https://www.tehik.ee/piiriulene-andmevahetus https://www.tehik.ee/piiriulene-patsiendi-terviseandmete-vahetus https://www.tehik.ee/piiriulene-digiretsept HIF web: https://www.haigekassa.ee/en/people/pharmaceuticals/digital-prescription (Patient summary page will be available after the service launch) In addition, different presentations that have been done over time have been included to the report (file Presentations.zip). 4. OTHER SOURCES OF EUROPEAN UNION FUNDS If applicable, provide information about other sources of EU funds (CEF, ERDF, Cohesion Fund, H2020, TEN, EEPR, EIPA, etc.) used for the action (including previous or subsequent phases not covered by the Grant Agreement). 10 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. 11 Health and Digital Executive Agency CEF Telecom Grant Agreement No: INEA/CEF/ICT/A2015/1156737. 5. COMPLIANCE WITH EU LEGISLATION Where relevant, provide information on the compliance with EU legislation regarding other matters (notably public procurement, competition, regulatory matters, etc…). There were no procurements below the EU threshold. All Estonian our procurements are based on Public Procurement Act (https://www.riigiteataja.ee/akt/101072017001?leiaKehtiv), which is in accordance with the requirements of the EU directive. All HWISC procurements are carried out electronically and can be found in the Procurement Register (https://riigihanked.riik.ee/rhr-web/#/). 6. COMPLIANCE WITH CORE PLATFORM AND POLICY OBJECTIVES Information on the compliance with the core service, including conformity with relevant technical specifications and alignment with the policy objectives of the Digital Service Infrastructure (as specified in the relevant CEF Telecom Work Programme). Included annexes: eHMSEG GoLive x2; PET decision About the patient summary GoLive: Estonia has already done production environment tests, but right now, all the countries in production are using a terminology catalogue MVC 3.1.1 (a 3.2.0 version hotfix has been issued, which includes COVID-19 vaccination information). Since Estonia can send immunization data to other countries, the transformation of patient summary fails due to missing information in 3.1.1. As most of the countries in production do not send immunization data this is not a critical issue and they do not need to update the 3.1.1 version to 3.2.0. The countries that do send immunization data (eg Estonia) the update of the MVC is necessary (and all the countries should use the same MVC in production, otherwise the service might not work). By now the countries in production still haven’t agreed on a date for the update of the MVC, since a mandatory update of MVC happens in October 2021 anyway and they do not see the point in preparing a 3.2.0 catalogue with the hotfix. As the MVC update happens on the 27th of October (after the NCP upgrade to W4), Estonia proposed to redo the PET tests in W4 with a new version of the MVC (which includes necessary immunization data) and go live in W4 in the beginning of November 2021. ANNEX: Financial statement 12
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