1. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 The EuroRec Seal 2010 Dr. Jos Devlies, EuroRec Sarajevo, August 31 st 2009

2. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Why quality labelling and certification? Quality and efficiency of care depends on, beside the ability to exchange data and the professional expertise also on the use and intrinsic quality of the software “instruments”. What are the main “quality” requirements for an EHR? –Reliability and Trustworthiness of the application –Robust Functionality (does a system do what it has to do?) –Usability (user friendliness) How do you measure these quality requirements? –Evaluating the output (e.g. done by IHE) –Using and Testing the application => Quality assessment How does a user or procurer know that quality has been evaluated and that a system meets the criteria? => Certification

3. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 eHealth Quality Labelling Not at all limited to EHR system functional specifications as such Obviously also about data sharing, data exchange and semantic interoperability Even more…the complete “health infostructure” should be subject to quality assessment : archetypes, terminologies, ontology files etc…

4. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 What’s specific to the EuroRec approach? EuroRec is NOT defining what’s required in a given care environment. EuroRec offers content and tools to anyone who wants to define such requirements, e.g. for an ICU, for home care, for neonatology… No “shall” or “should”, only descriptive statements. This is an important difference with HL7. EuroRec offers tools to select customised sets of criteria. Advantage: –No need to agree on what is needed. –No need to define / redefine and to ballot new versions of the sets of criteria. –Is it possible to define a comprehensive set of requirements applicable cross- discipline and a fortiori cross border? There is no need to do so !!! National / regional and/or regulatory “authorities” can use the tools to select what’s important for them. EuroRec is NOT suggesting that these “professional profiles” aren’t important or valuable.

5. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Testing and Labelling Testing as such is another activity: a more technical “validation against well defined criteria” on the basis of use or test scenarios. Example: IHE is testing exchangeability of care related (also administrative) data, with (still) the main focus on syntactic issues. –Not defining the functionality of a system… other than validating the possibility to exchange data between systems. –The capacity to exchange is as such a function: one of the many functions of an EHR. –The capacity to exchange obviously impacts on the functionality.

6. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Other differences Neutrality – Independence –EuroRec is not defining what’s required: independent of authorities –Not representing important stakeholders –Other side of the picture: how to get this funded? Multilingual More a service provider: statements and tools to be used when labelling health information systems and artefacts…e.g. doing the compliance tests is (actually) not our main/first point of attention.

7. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 HITCH Healthcare Interoperability Testing and Conformance Harmonisation

8. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Requirements => Statements Decomposed from National Requirements. 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”.

9. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 HL7 Criteria

10. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 EuroRec Statements

11. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Statistics EuroRec Statements

12. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Multilingual: statement 2265

13. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 The EuroRec Seal. What? Why? A common/minimal basic set of criteria selected by “experts” to be committed in order to obtain the Seal. Goals of the Seal: –Not to define the “best” EHR system –Not the ambition to be “complete” –Additional to certification done locally where use context and local requirements can be taken into account Content of the Seal: –Addressing several “generic” issues such as reliability, trustworthiness and version management, confidentiality, access control, data entry and data display.

14. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Seal 2008 => Seal 2010 Seal 2008 had 20 very elementary functional requirements, addressing generic issues related mainly to reliability and trustworthiness of the applications, independent of the care setting. Composition of Seal 2008 available on the web site. Up to 125 candidate statements (out of +1.500) were selected extending scope to data entry and display as well as to access management and authentication. Still not at all specific for particular care settings. Voting form forwarded to EHR-Q TN members (25 countries, mainly ProRec centres). Form on the web… to be completed by “experts”.

15. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 GS003785.01 The system enables the user to select - for the practice - the preferred windowing as their "default". 2.67 GS002231.01 The systems enables to display selected policy statements to the user before logging in. 2.57 GS003757.02 The system enables local customisation of the placement of windows. 2.43 Lowest Scores Only 1 statement with less than 2,5 (50%)

16. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 GS002268.01Each user is uniquely and persistently identified. 4.87 GS002307.01Each patient and his EHR is uniquely and persistently identified within the system. 4.83 GS002265.01Each version of a health item has a user responsible for the effective data entry identified. 4.72 GS001538.01Each health item is uniquely and persistently associated with an identified patient. 4.73 GS001537.01Each version of a health item has a date and time of registration. 4.67 Highest scores All these statements were yet required for the Seal 2008. These are really essential requirements.

17. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Impact of a (cross-border) seal Average product quality increases each time a (new) labelling is performed based on increased requirements. Induces convergence at conceptual and structuring level without impacting diversity of applications. The more we have similar functions with the same attributes, the more convergence, the more harmonisation of the systems. Functional harmonisation (with different flavours!) is essential to realise real interoperability –Data exchange is validating “output”, on top of an application. –Exchangeability improves interoperability, but will not be the final solution to realise that interoperability.

18. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Conclusion 1 Cross border exchange (main focus of actual research) is only a first step towards interoperability. Even that first step and surely further and more performing interoperability requires “harmonisation” of the systems. That will take time… and progress will be realised with small steps. The EuroRec Seal is a good first step to that interoperability through harmonisation of the applications.

19. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Conclusion 2 There is no contradiction between the HL7, IHE and EuroRec activities. They are complementary. CCHIT is actually doing / coordinating the whole process of: –Defining what’s required (in cooperation with…) –Providing the tools and scenarios to test compliance –Doing the tests –Providing the certificates EuroRec remains an “independent” organisation

20. EuroRec Seal 2010 Dr. J. Devlies, ProRecSarajevo, August 31th 2009 Material on the web site… Web site: www.eurorec.orgwww.eurorec.org Seal 2008 composition Seal 2010 voting form Seal 2010 first results (50 candidate statements)