1. A Roadmap towards comparable, standards based and reliable Certification of EHRs Dr. Jos Devlies, EuroRec, Belgium

2. Issues Why certification? Software Quality Standards Main tracks for quality labelling and certification Quality Labelling and Certification Standards State of the Art in Europe Recommendations 8 May 2012 2 WoHIT 2012 - Copenhagen - EuroRec Session

3. Thematic Network 2009-2012 8 May 2012 3 WoHIT 2012 - Copenhagen - EuroRec Session

4. The Quality Challenge eHealth and more specifically Electronic Health Record systems have an enormous potential to improve quality, accessibility and efficiency of care, provided they are: fit for purpose reliable, trustworthy and of sufficient quality; sharable and interoperable; used appropriately. Patients are too important to just suppose that EHR systems and other eHealth applications are trustworthy. 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 4

5. The Quality Issue Myers et al*. show that adverse events related to the use of EHR systems are mainly resulting from: missing or incorrect data; data displayed for the wrong patient; chaos during system downtime; system unavailable for use. “Bad Health Informatics can kill”: an overview of reported incidents in healthcare where a health information system was the cause or a significant factor : http://iig.umit.at/efmi/badinformatics.htmhttp://iig.umit.at/efmi/badinformatics.htm *Myers DB, Jones SL, Sittig DF, Review of Reported Clinical Information System Adverse Events in US Food and Drug Administration Databases, Applied Clinical Informatics 2011; 2: 63–74 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 5

6. Software Quality Standards 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 6

7. Are there quality standards for the EHR ? What kind of standards do we mean when addressing EHR Quality in Quality Labelling? Standards on data modelling. Standards on programming methodology. Standards about documenting the EHR application. Content related standards.. 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 7

8. Software Quality ISO 25010 “The quality of a system is the degree to which a system satisfies the stated and implied needs of its various stakeholders, and thus provide value”. Distinguishes: Quality in use Product quality 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 8

9. Effectiveness Efficiency Satisfaction UsefulnessTrustPleasureComfort Freedom from risk Economic risk mitigation Health and safety risk mitigation Environmental risk mitigation Context coverage Context completeness Flexibility 8 May 2012 9 WoHIT 2012 - Copenhagen - EuroRec Session

10. Functional Suitability Functional completeness Functional correctness Functional appropriateness Performance efficiency Time behaviourResource utilisationCapacity Compatibility Co-existenceInteroperability Usability Appropriateness recognisability LearnabilityOperability User error protection User interface aesthetics Accessibility 8 May 2012 10 WoHIT 2012 - Copenhagen - EuroRec Session

11. Reliability MaturityAvailabilityFault toleranceRecoverability Security ConfidentialityIntegrityNon-repudiationAccountabilityAuthenticity Maintainability ModularityReusabilityAnalysabilityModifiabilityTestability Portability AdaptabilityInstallabilityReplaceability 8 May 2012 11 WoHIT 2012 - Copenhagen - EuroRec Session

12. Functional Suitability Functional completeness Functional correctness Functional appropriateness Performance efficiency Time behaviourResource utilisationCapacity Compatibility Co-existenceInteroperability Usability Appropriateness recognisability LearnabilityOperability User error protection User interface aesthetics Accessibility 8 May 2012 12 WoHIT 2012 - Copenhagen - EuroRec Session

13. Quality Labelling and Certification 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 13

14. How to assess quality? Quality labelling and certification through professional third party assessment offers best chances for a comparable and reliable quality documentation of those systems. Addressing different domains: Functionality (incl. ability to produce ‘messages’) Data exchange (part of interoperability) Administrative and Billing aspects Use validation and Measurements Software Product as such 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 14

15. Tracks, Methods & Approaches Two Tracks : “Authority driven” versus “Market Driven” Public initiative / Supplier initiative For the market driven approach: by an independent organisation or by an industrial organisation Two Methods: third party assessment versus self- assessment Two main Approaches: system “Functionality” versus “Interoperability” testing National or even Regional Certification versus Cross- Border Quality Labelling 8 May 2012 15 WoHIT 2012 - Copenhagen - EuroRec Session

16. Procedures and kind of attestation Certification procedureAttestation granted Third party assessment by a CAB being a public authority or an organisation granted power by a public authority either by law or by regulation. Certificate Third party assessment by a CAB on requirements issued by an organisation not empowered by law or by regulation. Quality label Self-assessment with an external audit. Conformity assessment is done by the supplier and documented to a third party, being a public entity, a professional organisation or an industry federation. No “attestation” but a Quality Mark on the product is allowed Self-assessment by vendor who performed testing on his own products and affirms that they conform to a given set of requirements. Declaration of quality most suitable procedure 8 May 2012 16 WoHIT 2012 - Copenhagen - EuroRec Session

17. The Quality Assessment Process 8 May 2012 17 WoHIT 2012 - Copenhagen - EuroRec Session

18. 5 Good Reasons for National EHR Certification Assure compliance to national rules and standards. Increase quality of the products through coherent and pre-tested functionality. Leverage exchange of health (care) related data and interoperability of systems. Improve patient safety in care. Have a reliable data source for secondary use. 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 18

19. Cross-border Quality Labelling? There is no “authority driven” cross-border certification. The three “private” initiatives are indeed border- independent: EuroRec: independent, focus on EHR systems (functional and exchange as function) I.H.E.: industry driven, focus on testing the exchange and the technical interoperability Continua Health Alliance: industry driven, focus on devices content portability 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 19

20. EHR Quality Labelling and Certification in Europe (based on EHR-Q TN projects) 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 20

21. “National” Clinical Certification Existing “national” certification Foreseen within 1-2 years Considered 8 May 2012 21 WoHIT 2012 - Copenhagen - EuroRec Session

22. Quality Labelling and Certification Standards 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 22

23. The Quality Assessment Process ISO/IEC 17020 => <= ISO/IEC 17011 ISO/IEC 17025 => 8 May 2012 23 WoHIT 2012 - Copenhagen - EuroRec Session

24. Applicable standards StakeholderApplicable ISO/IEC Standard Accreditation BodyISO/IEC 17011:2004 ISO 9000:2000 ISO/IEC 17000:2004 VIM:1993 Certification BodyISO/IEC Guide 65 Conformity Assessment BodyISO/IEC 17025:2005 [ 1] [ 1] General requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2004) - Quality management systems – Fundamentals and vocabulary (9000:2000) [2] [2] Conformity assessment – Vocabulary and general principles (ISO/IEC 17000:200) [3] [3] International vocabulary of basic and general terms in metrology (VIM:1993) [4] [4] General requirements for bodies operating product certification systems (ISO/IEC Guide 65) [5] [5] General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005) 8 May 2012 24 WoHIT 2012 - Copenhagen - EuroRec Session

25. Main standard requirements Discretion and Confidentiality Impartiality Openness Distinct roles involved organisations Independence Initial Documentation Rules of Evaluation Testing Documentation Documentation of the process 8 May 2012 25 WoHIT 2012 - Copenhagen - EuroRec Session

26. Main standard requirements Involvement of all stakeholders Distinguish generic and domain specific Consider national / regional variants Content to be validated / tested Precise unambiguously the version of the SW Limit the validity to intended user group(s) Limit validity to region or country (if applic.) Limitations of Certificate or Label Pay attention to effective use to realise full added value Effective Use 8 May 2012 26 WoHIT 2012 - Copenhagen - EuroRec Session

27. Recommendations by the EHR-Q TN Consortium 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 27

28. Prerequisite “ If quality labelling and certification of EHR systems is to become generalised, then it needs endorsement at the highest competent levels e.g. by the EU Commission, the responsible Member States Ministries, the Healthcare Providers Organisations and the specialised industry.” See the Belgrade Declaration on www.eurorec.orgwww.eurorec.org 8 May 2012 28 WoHIT 2012 - Copenhagen - EuroRec Session

29. 1.Create and harmonise the legal and regulatory framework stimulating national and regional authorities to enforce the use of quality labelled and certified applications. 2.Certification bodies should be accredited and compliant to international standards, more precisely ISO 17020. 3.Strengthen the European scale pioneering initiatives (EuroRec / I.H.E.) in order to keep certification on the agenda and invest in maintenance and expansion of the actual descriptive statement and profiles. 4.Address the issue of personnel shortage in health informatics in general and more specifically in health informatics quality assessment. 8 May 2012 WoHIT 2012 - Copenhagen - EuroRec Session 29

30. 5.Third party assessment is the most suitable procedure for quality labelling and certification in the still immature market of the EHR systems. 6.The incentivised model seems the most promising, surely for self-employed healthcare professionals. 7.Promote equivalence of certificates across Europe by validating at European level both the functional descriptive statements of EuroRec and the IHE profiles. 8.Consider the possibility to create a cross-border “Register of Quality Labelled or Certified Clinical Software”, offering information about the products and documentation about the certification process. 8 May 2012WoHIT 2012 - Copenhagen - EuroRec Session 30