2. Accreditation and Quality Labelling of EHRs in Europe The role of ProRec centres and the EUROREC Institute Dr. François MENNERAT Secretary General

3. ICT Expo, Dublin 2005-04-14 2 Fostering a harmonised implementation of high quality EHR systems Requires promotion, awareness and educational actions useful results of the PROREC initiative –a Support Action in the 4th Framework Programme –following the recommendations of the MEDIREC Concerted Action of the 3rd Framework Programme focusing on the promotion strategy for high quality EHRs the implementation of a quality labelling process has always been an explicit part of the mission assigned to the national ProRec centres

4. ICT Expo, Dublin 2005-04-14 3 Promotion strategy for high quality European Health Records "ProRec" stands for

5. ICT Expo, Dublin 2005-04-14 4 Registered non-for-profit organisations Established at the national level Gathering in a balanced way –solution providers –users Developing contacts with all other stakeholders (public authorities, etc.) ProRec centres

6. ICT Expo, Dublin 2005-04-14 5 Objectives of ProRec centres Identify, try and help solve issues opposing or slowing down the process of widely implementing and using high quality EHRs –secure, comprehensive, communicable, interoperable at the national level, as well as throughout Europe

7. ICT Expo, Dublin 2005-04-14 6 Rationale behind ProRec centres Take account of local specificity Act at ground level ("Bottom-Up") –think European (the mobile citizen, the market), –act locally (the needs) Bring together and involve field actors: –those who actually use EHRs as their professional tool, –together with those who provide the expected solutions

8. ICT Expo, Dublin 2005-04-14 7 Established Setting up Mature contacts First contacts The network of ProRec centres

9. ICT Expo, Dublin 2005-04-14 8 Fostering a harmonised implementation of high quality EHR systems In a second phase, the issue has been leveraged at EU level through the creation of the EuroRec Institute formed as a consequence of the WIDENET project –an Accompanying Measure under the 5th Framework Programme

10. ICT Expo, Dublin 2005-04-14 9 The EuroRec Institute The European Institute for Health Records A non-for-profit organisation Founded in 2002 by the first four ProRec centres (Belgium, Spain, France, and Bulgaria) Developing activities at the European level (principle of subsidiarity) Bound to become self-sustainable

11. ICT Expo, Dublin 2005-04-14 10 Fostering a harmonised implementation of high quality EHR systems In a third phase, the EuroRec Institute now aims at becoming one of the major players in the world for certification of EHR systems

12. ICT Expo, Dublin 2005-04-14 11 Definitions electronic health record (EHR) –repository of information regarding the health of a subject of care, in computer processable form ISO TR 20514:2004 "Health Informatics - EHR Definition, Scope, & Context"

13. ICT Expo, Dublin 2005-04-14 12 Definitions EHR system –set of components that form the mechanism by which electronic health records are created, used, stored, and retrieved Note: It includes people, data, rules and procedures, processing and storage devices, and communication and support facilities. ISO TR 20514:2004 "Health Informatics - EHR Definition, Scope, & Context"

14. ICT Expo, Dublin 2005-04-14 13 sets ambitious objectives to further deploy efficient eHealth systems at a national and regional level High quality Electronic Health Record systems (EHRs) acknowledged as a key to efficient eHealth services The e-Europe Action plan

15. ICT Expo, Dublin 2005-04-14 14 by helping the customers –i.e. the end users, the purchasers, and the decision makers find the relevant suppliers to fulfil their expectations by offering them access to an information –relevant –neutral, honest, based on explicit criteria –up-to-date A need to comfort the market

16. ICT Expo, Dublin 2005-04-14 15 Several Member States have initiated accreditation schemes for eHealth systems –Belgium, Ireland, Denmark, Germany, the Netherlands, etc. EHR systems a corner stone for eHealth systems Existing national initiatives

17. ICT Expo, Dublin 2005-04-14 16 These EHRs quality labelling and certification schemes differ –in their scope –by the legal framework under which they operate –in their policies –in their organisation –in the choice of quality conformance criteria for benchmarking –in their testing procedures –etc. Existing national initiatives

18. ICT Expo, Dublin 2005-04-14 17 to be countered by harmonisation efforts as soon as possible Therefore an urgent need to build on the work achieved so far and launch a European system for quality labelling and certification of EHR systems A risk of further fragmenting the market

19. ICT Expo, Dublin 2005-04-14 18 General objective –create an efficient, credible and sustainable mechanism Core objectives –define a Model with harmonised guidelines and procedures –incorporate the formal test plans into a Benchmarking Process Manual Quality labelling and certification of EHR Systems in Europe

20. ICT Expo, Dublin 2005-04-14 19 Fully worked out Business Plan State of the Art Report on existing EHRs Certification schemes Labelling Terminology and Functional Profiles for classification of EHRs to be certified; Model Certification Guidelines and Procedures Benchmarking Services Manual for EHRs Quality Labelling and Certification Inventory of Resources for EHR Interoperability –registers of Quality Conformance Criteria, EHR- Archetypes, XML schemes, Health Coding Systems, and relevant EHR Standards Quality labelling and certification of EHR Systems in Europe

21. ICT Expo, Dublin 2005-04-14 20 General principles Apply the "subsidiarity principle" Build on national experiences (Belgium, Ireland, etc.) Involve heavily national ProRec centres (and other contributors) Support new national initiatives European co-ordination Feasibility study granted by DG -Entr (about to start) Further support from the European Commission (DG- Entr, and DG-InfSo)

22. ICT Expo, Dublin 2005-04-14 21 –The EuroRec Institute is the overarching network of national ProRec centres –Its main mission being to promote high quality Electronic Health Record systems (EHRs) throughout Europe The EuroRec Institute will act as the co- ordinator of the process for quality labelling and certification The network of ProRec centres, wherein a wide variety of stakeholders are involved, will serve as an operational platform Organisational pattern

23. ICT Expo, Dublin 2005-04-14 22 Co-ordination with healthcare authorities through a collaboration with the eHealth ERA consortium and its European Health Care Authorities (HCA) / Ministries groups Both platforms (EuroRec and eHealth ERA) will assure the necessary bottom-up and top- down approaches for the adequate assessment of needs and for the optimal choice of methods Organisational pattern

24. ICT Expo, Dublin 2005-04-14 23 Conclusion The EuroRec Institute is now waiting for the green light The process is expected to start this year All stakeholders are already invited to prepare their useful contributions

25. ICT Expo, Dublin 2005-04-14 24 As well as for your questions! Thank you for your attention…