Past, Current and Future Initiatives of EuroRec

1. Past, Current and Future Initiatives of EuroRec Prof. Dr. Georges DE MOOR EuroRec President

2. EuroRec is an independent not-for-profit organisation established in 2003. 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.

3. Organisational Issues: • - Adapt EuroRec’s Articles of Association (General Assembly Meeting,Nov.2009, Dublin) • Redefine EuroRec’s Global Business Plan

4. International Liaison: DG INFSO BT and TC 251 TC 215 IHTSDO

5. Trends in Health Systems The Old World Provider-focused Illness Site-of-care Episode Management Supply Management Solitary Decision Making Efficiency General care The New World Patient and family-focused Wellness Continuum of care Disease Management Demand Management Collaborative EBM Effectiveness Specialized care (from UHN, Toronto)

6. The care settings as starting points… In eHealth the technical landscape is so fast moving that the boundaries between tertiary, secondary and primary care settings, homecare settings and even body settings are fading away… … leading to a continuum of care (cf. health and wellness).

7. Electronic Health Record (EHR) All stakeholders across the world have recognized that the Electronic Health Record is: • a key tool in the provision of safe, high quality and effective care ; • and a critical factor for clinical research .

8. Trends in Electronic Health Record systems (EHR s) • Patient-centered (gatekeeper?) and longitudinal (life-long) records • Multi-disciplinary / multi-professional • Transmural and virtual • Structured and coded (cf. semantic interoperability) • Intelligent (cf. decision support) • Personalised • Predictive • More sensitive content (e.g. genetic data) • Integrative

9. Biosensors Biochips Environmental Data Genomic data Phenomic data Integrated Health Records Seeing the full picture of an individual’s health status (I. Iakovidis)

10. History of EU funded EuroRec Projects • 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) Interoperability • (Argos (FP7) (10-11) EU-US Collaboration)

11. Q-REC Rationale (Why Certification is Essential) • - To assure the quality of EHR systems: operabilityand patient safety! • Sharing of information requires a quality assessment of EHR products with a view to ensuringinteroperability with other systems (users) • - Certification of EHRs is essentialfor both the buyers and the suppliers to ensure that EHR systems are robust enough to deliver the anticipated benefits. • (EHR systems and related product quality (data portability and interoperability) are otherwise difficult to judge!)

12. QREC: Origin Several EU-member states (Belgium, Denmark, UK, Ireland,France …) have already proceeded since many years with (EHRs-) quality labelling and/or certification (more often in primary care)but these differin scope, inlegal framework under which they operate, in policies andorganisation, and perhaps most importantly in the quality andconformance criteriaused for benchmarking … These differences represent a richness but also a risk: therefore harmonisation efforts should help to avoid further market fragmentation in Europe

13. A few business cases for the quality criteria... • Ane-Health programmewishing to implement quality labelling or certification as to ensure consistent EHR system functionality regionally or nationally • A purchaserwishing to procure an EHR system module • Avendor/developerwishing to document his system or to (re-) develop an EHR system module or wishing to interface a given module of his system across multi-vendor systems

14. A growing number of strategic eHealth projects already are, or become certification-dependent, e.g.: • Administrative simplification • Electronic billing • Care pathways and disease management projects • Electronic prescription • Interaction with validated databases • Secure medical data exchange (summary records!) • Interoperability, operability and portability • ...

15. EuroRec Repository Flow

16. B1 Health care enterprises • B10 Long-term care (institution) • B11 General practice • B12 Secondary care (hospital) • B13 Tertiary care centre (specialist hospital) • B14 Domain specific • B15 Profession specific • B2 Secondary uses • B20 Research and knowledge discovery • B21 Education • B22 Health service and planning • B0 Generic or ubiquitous • B01 Regional healthcare network (specific distribution) • B02 Virtual or telehealth • B03 Personal health • B04 Community and home care • B05 Health, wellness and prevention • B06 Occupational health • B07 Public health • A0 EHR data (record) management • A00 EHR data entry • A01 EHR data analysis • A02 EHR data content • A03 EHR data structure • A04 EHR data display • A05 EHR data export/import • A09 EHR generic data attributes • A1 Clinical functions • A10 Clinical: medication management • A11 Clinical: long-term illness management • A12 Clinical: health needs assessment • A13 Clinical: care planning and care pathways • A14 shared care • A15 Clinical: alerts, reminders and decision support • A16 Clinical: workflow and task management • A17 Clinical: patient screening and preventive care services • A2 Administrative services • A20 Appointments and scheduling • A21 Patient consents, authorisations, directives • A22 Patient demographic services • A23 Certificates and related reporting services • A24 Patient financial and insurance services • A3 Care Supportive services • A30 Supportive care service requests (orders) • A31 Supportive care service reporting (results) • A32 Laboratory services • A33 Imaging services • A34 Diagnostic and therapeutic services (other): ECG/EEG etc. • A35 Pharmacy services • A4 Analysis and reporting • A40 Screening and preventive health • A41 Care setting reports • C3 Directory services • C30 Directory: patients • C31 Directory: personnel • C32 Directory: equipment • C33 Directory: health service directories • C34 Directory: service resources • C35 Third parties • C4 Profiling or authoring tool • C5 Documentation, support etc. • C6 EHR system functional component • C0 EHRS functional component • C1 EHRS infrastructure component • C10 EHRS Interoperability component • C11 Security management component • C2 Knowledge resources • C20 Knowledge: terminology • C21 Knowledge: ontology • C22 Knowledge: archetype • C23 Knowledge: template • C24 Knowledge: data set • C25 Knowledge: guideline • C26 Knowledge: algorithm Typology of Indexes • Multiple indexing of each statement to maximise the likelihood of finding • all relevant statements when searching via the indices • Business Functions(50 in 8 subcategories) • Care Settings(18 in 3 subcategories) • Component Types(18 in 4 subcategories) Business Functions Care Settings Component Types

17. EuroRec Statements

18. EuroRec Languages(non-exhaustive list) • English (default language) • Bulgarian • Danish • Dutch • French • German • Italian • Romanian • Slovakian • Slovenian • Serbian

19. Multilingual: statement 2265

21. Q-REC Approach EuroRec has installed a central repositoryof1500 « validated » quality criteriaand other relevant materials and has developed tools that can be used to harmonise certification, product documentation andprocurement specificationof EHR systems. EuroRec doesnot impose particular certification approachesor specific criteria on any interested party but wishes to foster, via appropriate channels, the progressive adoption of consistent and comparable approaches to EHR system quality labelling. EuroRec could therefor be considered as a service provider.

22. How to Manage Certification? EuroRec has Multiple Options: • Authority: Government(or mandated subcontr.) vs. Non Gov. • Self-certification by Industry (also an option!) • National based vs. Pan European (or joint, cf. specific/generic) • Mandatory vs. voluntary (with or without incentives) • Formal audit/testing vs. self-assessment(or pre-test assessment) • Scoring/rating scheme: pass/fail or more graded approach • Scheme review rate (1,2,…n year cycles) • Quality Assurance vs. Quality Improvement focus

23. Certification: a powerful weapon… New instruments Newfunctions 4 3 1 € 2 Pressure

24. In the US: increased momentum via Obama’s stimulus plan: Meaningful Use standards that HHS is developing under the American Recovery and Reinvestment Act (ARRA); • Meaningful Use: incentive payment from Medicare and Medicaid for physicians and hospitals using EHRs; • - Terms for Meaningful Use under development; • - Certification ! CCHIT is already starting 2 new certification programs with an eye toward helping providers earn federal subsidies starting in 2011! (criteria and test scripts published…) (incremental inspection program…).

25. Unveiling the EuroRec Seal To have a “base” level set of functions that can be accredited across Europe. This will greatly appeal to the supplier industry and allow for more early stage accreditation of systems across national boundaries. Harmonisation of the certification will favour harmonisation of products. Develop a strong, growing and profitable EHR supplier industry that can be competitive globally.

26. History of EU funded Projects • 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) Interoperability • Argos (FP7) (10-11) EU US Collaboration

27. EHR-Implementis 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 ruin implementation have been overlooked.

28. EHR-QTNis 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. The project fits with objective 1.6 of the 2nd Call for Proposals for the CIP-ICT PSP program: “Improving certification of e-Health products” EuroRec is offering its repository of quality criteria and its tools to facilitate the deployment of such certifications throughout Europe.

29. Poland Norway United Kingdom Austria Hungary Portugal Ireland Belgium Romania Bulgaria Italy Croatia Cyprus Czech Republic Serbia Denmark Slovakia Estonia Slovenia Luxembourg France Spain Germany Netherlands Greece EHR-QTN 28 Partners 24 Countries

30. EHR Q TN Activities • Validate and customise the EuroRec criteria (with a focus on on e- prescription and patient summaries) in 25 countries • Database of stakeholders (esp. EHRs vendors,incl.SMEs) • Inventory of legal issues regarding certification • Annual EHR-QTN International Conferences • In each of the 25 countries one workshop per year on: • Validation of EuroRec Repository and Criteria (Y1) • Tools for certification, product documentation & procurement (Y2) • Procedures for EHR Quality Labelling and Certification (Y3)

31. HITCH HealthcareInteroperabilityTesting and ConformanceHarmonization • Establish a deployable process for the Interoperability Conformance Testing of information systems in the field of Healthcare. • …where two different worlds interact with each other in a common project: • Technical Conformance Testing of Interoperability , ,and • Quality Labelling and Certification • ! CEN/CENELEC/ETSI • M403 – eHealth Interoperabillity / Phaze 2

32. Other New Areas of Interest of EuroRec • Semantic Interoperability: the EHR-content, ontologies, archetypes, templates, terminologies • Personal Health Records: andtheir 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

33. Value of Clinical Archetypes (D. Kalra) • Empowerment of healthcare professionals • enable clinical data sets and structures to be shared • Provide target knowledge representations for use by guidelines and care pathway systems • Decision support of physicians and intelligent coaching of patients • EHR entries identify the Archetypes used when the data were created, and/or to which they map • aids future interpretation, analysis, computation • contributes towards semantic interoperability

34. Archetypes / Detailed Clinical Models • to identify high quality archetypes which will have been developed elsewhere and to make them available to a broader community • to organize the involvement of clinicians via their official and authoritative associations (part of the 500 million Euro ELSA; to start a major experimental and clinically driven project for clinical content quality assurance embracing archetypes and terminology) • to develop formal methods of validatingthe design and content of archetypes • to develop a formal process of verification and certification for archetypes

35. Clinical Trials & Research Safety and Adverse Event Registers Marketing Knowledge Mgmt Platforms Healthcare Management Decision Support Systems Re-use of (medical) data Patient TRUST Clinician PHR EHR (EMR, EPR…) Privacy Enhancing Techniques Billing

37. 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 main interest: Comparative assessment of the EU and US approaches in the target area: “e-Health: interoperability and certification of Electronic Health Records”

38. EuroRec is at your service ! • Developing & maintaining a central repository with quality criteria • Developing tools: certification, procurement and product doc. • Providing guidance and assistance to all stakeholders • Assisting Authorities in introducing / adoptingcertification • Training and accreditation of surveyors(European level) • Set-up of certification session (incl. scenario scripting/operations) • Validation of clinical archetypes (clinical models) • Continous & total Q.A.of processes and procedures

39. Certification is a powerful weapon: use it! Continuity of certification should be guaranteed (this is for the matter credibility) Efficiency: do not (re-)invent the wheel Take advantage of the growing EuroRec repository and of the broadening certification scope (e.g. Certification of “EHRs in other settings” and of other eHealth applications) Align choices & strategies with European and International ones (cf. standards, clinical models and coding systems ...) Professionalize the certification procedures Build a long term, incremental and consistent certification roadmap which is in harmony with your overall healthcare strategy ...EuroRec is your partner and is at your service ! Some Conclusions

40. Thanks for listening! http://www.eurorec.org georges.demoor@ugent.be