EHR Certification in Europe: steps towards harmonisation and interoperability

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19 November 2008. HISI - Dublin. 2. Overview. Importance of CertificationStatus on Certification in EuropeEuroRec Repository

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EHR Certification in Europe: steps towards harmonisation and interoperability

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1. EHR Certification in Europe: steps towards harmonisation and interoperability Dr. Jos Devlies Medical Director EuroRec

2. 19 November 2008 HISI - Dublin 2 Overview Importance of Certification Status on Certification in Europe EuroRec Repository & Tools EuroRec Seal EHR-QTN project 2009-2012 Conclusions

3. 19 November 2008 HISI - Dublin 3 Importance of Certification EHR systems are largely accepted as important tools for Safe care content: warning / surveillance systems safety: reliability / access management High Quality care: pro-active decision support / care pathways Effective care management: monitoring / outcome management Clinical Research: trials, vigilance, knowledge acquisition But how do you prove that a given system meets the quality and functional requirements in a way that their output can be considered as trustworthy? … certification of all applications processing patient data!

4. 19 November 2008 HISI - Dublin 4 Who wins from certification? Patient: quite obviously: safer/better care Health authorities: Enabling / guaranteeing that better care Possible to influence the product development: how to get otherwise a “wish” on the market / at the point of care? Care Professionals as users: Guarantee that a system fulfils it’s “promises” Suppliers / industry: Unambiguous specification of market – national requirements Market competition based on “quality issues”

5. 19 November 2008 HISI - Dublin 5 EHR Certification in Europe (1/4) Belgium: started 1999, first label 2002, a grant of 810€ for the users as important incentive, driven by health authorities, different professions, some signs of exhaustion: messaging and functionality.

6. 19 November 2008 HISI - Dublin 6 EHR Certification in Europe (2/4) Denmark: Since 2002 focusing on messaging in primary care. Some attempts in secondary care promoting a common basic structure (BEHR): mainly messaging, not on functionality. France: Haute Autorité de Santé has a program for certification of modules/applications for “electronically assisted prescribing”. Status: unclear. Difficult to get information on the status. Related to one single (main) functionality.

7. 19 November 2008 HISI - Dublin 7 EHR Certification in Europe (3/4) Ireland: initiated in 1994, reviewed in 1998 by the National GPIT group resulting in a new scheme in 2003 and in 2008. Certification on the basis of these criteria done in June – October 2008. 4 GP systems certified. Addressing the full application. By far the most advanced. Netherlands: first specification in late 80’s, first certifications in the 90’s (WCIA label for GP systems). Incentive included in standard annual fee per patient. Criteria ‘95 never implemented. Important reduction of vendors and absence of new incentives => stand still.

8. 19 November 2008 HISI - Dublin 8 EHR Certification in Europe (4) Norway: Started in 2005, focused on messages (now 25). Managed by KITH. Functionality only indirectly addressed, through the ability to produce messages. United Kingdom: First in 1993: GP Requirements for Accreditation, issued by NHS for Primary Care Systems. No accreditation for other areas. Except a procurement based process used by the NHS National Programme for IT. Other countries: no certification nor requirement specifications… as far as reported.

9. 19 November 2008 HISI - Dublin 9 EHR Certification outside Europe USA – CCHIT: functional testing started in 2006, addresses ambulatory and in-patient care, not-for-profit but initially heavily sponsored, only 29% of ambulatory practices are using an EHR,now also “incentive” approach: 700 M$ Canada: provincial initiatives, more practice management related – Canadian Infoway, Nov. 12, 2008: Richard Alvarez, president and CEO, Canada Health Infoway: "The launch of our new certification service will help the vendor community to develop new products accordingly, and provide buyers and users of those systems with some assurances the solutions are of high quality." Japan: no certification initiative identified Australia: no certification initiatives identified.

10. 19 November 2008 HISI - Dublin 10 Other quality assurance initiatives IHE – Integrating the Healthcare Enterprise: focus on sharing care related data, on communication and security standards, not on functionality of the EHR systems at the point of care. Based on “profiles” or “protocols” and using DICOM & HL7. Industrial Certification, e.g. Welch Allyn EHR Certification program

11. 19 November 2008 HISI - Dublin 11 Conclusions of the overview More (?) differences than commonalities: In domain / functionality: GP’s >< Hospitals In scope: messaging/interchange >< functions of the system as such In Legal Framework & Organisation (public / private) Content and formulation of the conformance criteria Criteria are defined each time, considering (main) domain of application, market reality and local “good” or “best” practice considerations. Need for harmonisation… and for Cross Border Certification (long term!)

12. 19 November 2008 HISI - Dublin 12 Main steps to harmonisation Consolidate the different approaches into a comprehensive common set of criteria. => EuroRec Repository and Certification Tools Increase awareness of certification throughout the Union => EHR-QTN – Thematic Network project Cooperation between authorities and certification bodies Start small … => EuroRec Seal 2008 => 2009 => 2010 => Repository of available resources for interoperability

13. EuroRec Certification Instruments

14. 19 November 2008 HISI - Dublin 14 EuroRec Repository Flow

15. 19 November 2008 HISI - Dublin 15 Fine Grained Statement Granular expression describing a single aspect or property of an EHR function or content element Purely “descriptive” statement. To be considered as a domain specific “linguistic expression”. They become criteria by adding attributes as mandatory/optional Indexed by means of a multi-axial indexing system. Nearby 1.400 FGS in the Repository. At present partially translated in up to 11 languages.

16. 19 November 2008 HISI - Dublin 16 Good Practice Requirements Fine Grained Statements are regrouped in “Good Practice Requirements”. Homogeneous sets of FGSs. Related to “Good Practice”… not necessarily “Best Practice”. Some of them are related to “existing practice” rather than to “good practice”. Centrally managed (user rights, authorship, national variants, translations, version management, indexing…). Exploitable by means of the EuroRec Tools. Used by the EuroRec Tools for retrieval of statements.

17. 19 November 2008 HISI - Dublin 17 EuroRec >< National statements Decomposed. Local aspects removed Reworded in a consistent way. Does not include “regulatory” or “good practice” options => Purely “descriptive” statement. => To be considered as a domain specific “linguistic expression”. Attributes as mandatory/optional are defined at usage level, within a given certification basket.

18. 19 November 2008 HISI - Dublin 18 HL7 Criteria & Statements

19. 19 November 2008 HISI - Dublin 19 EuroRec >< HL7 Profiles / Criteria As expected quite some similarities Fine Grained Statements ~ HL7 Conformance Criteria Good Practice Requirements ~HL7 Statements Main difference: The normative aspects are NOT included in the EuroRec descriptive statements Normative issues to be defined considering the domain of application when composing “baskets for certification”. Why? => Heterogeneity of the European Market Result: no duplication of profiles nor discussions on shall/should more flexibility

20. 19 November 2008 HISI - Dublin 20 A sample of Fine Grained Statements

21. 19 November 2008 HISI - Dublin 21 Translations

22. 19 November 2008 HISI - Dublin 22 Conclusion EuroRec Certification Use the “same” instruments to describe and to evaluate the EHR systems, available in all the languages of the union. Use “generic” statements, defined to be universally applicable/ used in different contexts. Specifications should be linked to identified certification sessions (in a given country, for identified types of applications and for defined session) Products meeting an increasing number of similar criteria will be – at least functionally – increasingly comparable.

23. 19 November 2008 HISI - Dublin 23 EuroRec Seal Seal granted across national borders to applications meeting a “base level” set of requirements. Certification can be done by any national authorised body, based on an agreement with EuroRec. by EuroRec at request of the industry for individual EHR products. Will favour progressive harmonisation of products across the union. Will enforce product quality all over the union.

24. 19 November 2008 HISI - Dublin 24 EuroRec Seal Content 20 criteria Generic ones (not related to specific or specialised functions) Independent from specific national regulatory aspects as e.g. funding Mainly focusing on the “trustworthiness of the content of an EHR”. Accessible on the web:

25. 19 November 2008 HISI - Dublin 25 EuroRec Seal 2008 Criteria (1/2)

26. 19 November 2008 HISI - Dublin 26 EuroRec Seal 2008 Criteria (2/2)

27. 19 November 2008 HISI - Dublin 27 EuroRec Seal Announcement Certification done by the GPIT group (National General Practice Information Technology Group) in Ireland has been recognised as compliant with the EuroRec Seal 2008 requirements. Four Irish GP Information Systems are the first to obtain the EuroRec Seal certificate: Complete GP, version 2.1, Complete GP, Mallow Health One, version 6, Health Ireland Partners, Arklow Helix Practice Manager, version 1, Helix Health, Dublin Socrates, version 1.5, Technical Ideas, Ballinoe Stigo

28. 19 November 2008 HISI - Dublin 28 EuroRec Seal Evolution Content of the Seal will be extended in 2009 From 20 to 40 criteria. Still mainly generic criteria. Some domain specific EHR content related topics. Direct certification of EHR systems “on demand” of the supplier Still limited to the EuroRec Seal criteria Increase cooperation with national certification centres. EuroRec Seal = Cross Border Certification EuroRec Seal = Gradual Harmonisation of applications

29. EHR-QTN Thematic Network on Quality Labeling and Certification of EHR Systems. 2009-2011

30. 19 November 2008 HISI - Dublin 30 EHR-QTN project - Objectives Main objective: prepare the health community across Europe for more systematic, comparable and large scale quality assurance and certification of e-Health products (with special emphasis on Electronic Health Record systems). By building a Network of interested and involved stakeholders around that theme! By improving the instruments developed in the Q-REC project. By promoting cooperation with third parties. Resulting in real certification on as much European Countries as possible.

31. 19 November 2008 HISI - Dublin 31

32. 19 November 2008 HISI - Dublin 32 EHR-QTN Main Tasks Validate and Customise the EuroRec criteria in 24 countries, focused on: Prescription and Medication Management Patient Summary services Inventory of legal issues. National coordination & educational meetings. Workshops to validate The EuroRec Repository. The tools for certification, product documentation and procurement. The procedures for EHR Quality Labelling and Certification. Annual EuroRec Conference.

33. 19 November 2008 HISI - Dublin 33 Conclusions (1/2) Harmonisation is phase 1 of interoperability. Interoperability will be the result of harmonisation not the other way around… Certification is a powerful weapon to increase that harmonisation: as you believe in, use it! Take advantage of the growing EuroRec repository and of the broadening certification scope (e.g. EHRs in other settings and other software applications) resulting from European investments

34. 19 November 2008 HISI - Dublin 34 Conclusions (2/2) Build a long term, incremental and consistent certification roadmap which is in harmony with your overall healthcare strategy and which aligns on European and International ones (cf. standards, coding systems ...). Professionalise the certification procedures. Do not forget to incentivise the use of certified EHR systems ...EuroRec is there to promote certification and to harmonise the approaches within Europe!

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