Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference Past, Current and Future Initiatives of EuroRec Prof. Dr. Georges DE MOOR EuroRec President

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD Current and Future Initiatives of EuroRec 2 EuroRec is an independent not-for-profit organisation established in Its main mission is to promote - as a federation of national ProRec centres (15 member countries and 7 new applicants) - the use of high quality Electronic Health Record systems (EHRs) in Europe. It therefore also supports certification by defining quality criteria.

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 3 - Adapt EuroRec’s Articles of Association (General Assembly Meeting,Nov.2009, Dublin) - Redefine EuroRec’s Global Business Plan Organisational Issues:

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 4 - MediRec (FP3) (94-95) (C.A.) Lisbon Declaration (Recom. 9) - ProRec (FP4) (96-98) (S.A.) Creation of first ProRec centres - Widenet (FP5) (00-03) (A.M) Creation of EuroRec - QRec (FP6) (05-08) (S.S.A.) Creation of Repository & Tools - EHR-Implement (FP6) (07-10) Strategic Recommendations - EHR-Q-TN (FP7) (09-12) (T.N.) Dissemination/Implementation - HITCH (FP7) (09-10) History of EU funded Projects

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 5 EuroRec has installed a central repository of validated quality criteria and other relevant materials that can be used to harmonise European quality labelling or certification, product documentation and procurement specification of EHR systems. EuroRec will not impose any particular certification model or any specific criteria on any member country but will foster, via accredited centres and other channels, the progressive adoption of consistent and comparable approaches to EHR system quality labelling (cf. several models ! and EuroRec seal). (today: criteria with translations in 18 languages).

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 6

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 7 - MediRec (FP3) (94-95) (C.A.) Lisbon Declaration (Recom. 9) - ProRec (FP4) (96-98) (S.A.) Creation of first ProRec centres - Widenet (FP5) (00-03) (A.M) Creation of EuroRec - QRec (FP6) (05-08) (S.S.A.) Creation of Repository & Tools - EHR-Implement (FP6) (07-10) Strategic Recommendations - EHR-Q-TN (FP7) (09-12) (T.N.) Dissemination/Implementation - HITCH (FP7) (09-10) History of EU funded Projects

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 8 EHR-Implement is collecting, analyzing and comparing broad scale Electronic Health Record implementations in European countries in order to provide best practice and strategic recommendations. In the past political, social and organizational aspects that can jeopardise implementation have been overlooked.

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 9 This project fits with objective 1.6 of the 2 nd Call for Proposals for the CIP- ICT PSP program: “Improving certification of e-Health products” EHR-Q TN is a Thematic Network project that prepares the health community across Europe (including also most Eastern European countries) for systematic and comparable quality assurance and certification of Electronic Health Record systems and other e-Health products. It is in the first place a dissemination project. EuroRec is offering its repository of quality criteria and its tools to facilitate the deployment of such certifications throughout Europe.

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD Current and Future Initiatives of EuroRec 10 EHR-Q TN 3 years 28 Partners 24 Countries 72 Workshops Austria Ireland United Kingdom Belgium Czech Republic Hungary Greece Germany France Estonia Denmark Bulgaria Croatia Cyprus Italy Luxembourg Netherlands Norway Poland Portugal Romania Serbia Slovakia Slovenia Spain

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 11 - Disseminating - Translating of validating existing criteria and tools - Defining the content of the EuroRec Seal 2010 (security; summary records; medication management and e- prescription) - Strengthening via the ProRec centres its liaisons with all stakeholders (including governments) - Conducting a market survey (a.o. database of vendors of EHR systems) - …

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 12 Healthcare Interoperability Testing and Conformance Harmonization Establish a deployable process for the Technical Conformance Testing of Interoperability of ICT systems for Health. …a project where two different worlds will interact with each other: - Technical Conformance Testing of Interoperability,,and - Quality Labelling and Certification ! CEN/CENELEC/ETSI M403 – eHealth Interoperabillity / Phaze 2 HITCH

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 13 - Semantic Interoperability: the EHR-content, ontologies, archetypes, templates, terminologies - Personal Health Records: and their interaction with Professional Health Records - Re-use of Electronic Health Record data: for research, clinical trials (and vice-versa! ) - EHRs and Pre-emptive care: genetic data to manage individual risk for potential diseases - Certification of other EHR-related systems: widening EuroRec’s scope - Collaboration at global level: e.g. between the EU and the US Other New Areas of Interest

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 14

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 15 - to identify high quality archetypes (detailed clinical models) which will have been developed elsewhere and to make them available to a broader community; including in the repository - in addition to “funtional “criteria -,criteria related to “content” - to organize the involvement of clinicians via their official and authoritative associations (cf. ELSA) - to develop formal methods of validating the design and content of archetypes - to develop a formal process of verification and certification for archetypes Validation of detailed clinical models

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 16 EHRs: Secondary Uses (examples) User / Clinician re-use Clinical Trial Safety and Adverse event Register EHR Decision Support Utilisation Review Marketing Billing t2t2 t4t4 t5t5 t6t6 t3t3 Knowledge Mgmt Platform t1t1 (de-identification) Patient

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 17

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 18 Pilot Projects: “ Transatlantic Methods for Handling Global Challenges in the European Union and United States ” RELEX/C1/2009/PP The general objective of the pilot projects is to promote mutual understanding and learning among EU and US policy researchers and policymakers on a number of challenges with a global dimension. EuroRec’s interest: Comparative assessment of the EU and US approaches in the target area “e-Health: interoperability and certification of Electronic Health Records”

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 19 Theme 1: Re-use of Clinical Care and of Clinical Trial Data Theme 2: Personal Health Systems, Personal Electronic Health Records and Professional Electronic Healthcare Records Theme 3: Towards Interoperability through Quality Labelling and Certification Theme 4: Semantic Interoperability: Terminologies and Classifications, Ontologies, Artefacts and Templates

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 20 - EuroRec is reinforcing its internal structure and is redefining its business plan. - EuroRec is further deploying certification services (one of its main missions) in Europe. - EuroRec is broadening the spectrum of its R&D activities hereby focusing on semantic interoperability (EHR content ). - EuroRec is striving to get to more convergence with other organisations at global level. SUMMARY

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 21 Thanks for listening!

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 22 08:30 – 09:00Registration Theme 1: Re-use of Clinical Care and of Clinical Trial Data 09:00 – 09:15Georges De Moor, EuroRec, BelgiumCurrent and Future Initiatives of EuroRec. 09:15 – 09:40Elaine Sawatsky, Canada Health System Use of Data: Secondary but Important. 09:40 – 10:00Selina Sibbald, Quintiles, United Kingdom Re-use of clinical care and of clinical trial data. A CRO point of view. 10:00 – 10:20Andreas Schmidt, Hoffman-La Roche, Switzerland (TBC) The possible impact of the re-use of EHR data. A point of view from the pharma industry. 10:20 – 10:45Discussion 10:55 – 11:30Break

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 23 Theme 2: Personal Health Systems, Personal Electronic Health Records and Professional Electronic Healthcare Records 11:30 – 12:00 Laurent Debenedetti – GIP-DMP, France Re-launching the French national project ‘DMP – Dossier Médical Personnel’ based on lessons learnt, local engagement and Concertation. 12:00 – 12:20 Discussion

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 24 Theme 3: Towards Interoperability through Quality Labelling and Certification 14:00 – 14:20Jos Devlies, EuroRec, Belgium The EuroRec Seal :20 – 14:40Richard Perkins, eClinical Forum, France EHR-CR, EHR compliant to clinical trial requirements. 14:40 – 15:10Discussion 15:10 – 15:40Break

Sarajevo, September 1, 2009 Georges De Moor, MD, PhD EuroRec 2009 Annual Conference 25 Theme 4: Semantic Interoperability: Terminologies and Classifications, Ontologies, Artefacts and Templates 15:40 – 16:10Ceusters Werner, Buffalo University, USA Post-hoc interpretation of mutually incoherent information models: the role and benefits of realism-based ontology. 16:10 – 16:40Dipak Kalra, City University, United Kingdom The contribution of archetypes towards semantic interoperability within national eHealth programmes. 16:40 – 17:30Michael Palmer, Commission, Europe Georges De Moor, EuroRec, Belgium Debate and Conclusions