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A European Roadmap to Quality in eHealth

OSOZ Conference, Warsaw, Dr. Jos Devlies. A European Roadmap to Quality in eHealth. with focus on EHR systems. Topics addressed. The “Quality Issue” of Health Informatics Quality Standards Functional specifications Quality Labelling and Certification The Process

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A European Roadmap to Quality in eHealth

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  1. OSOZ Conference, Warsaw, Dr. Jos Devlies A European Roadmap to Quality in eHealth with focus on EHR systems

  2. Topics addressed • The “Quality Issue” of Health Informatics • Quality Standards • Functional specifications • Quality Labelling and Certification • The Process • Status of Certification in Europe • Some recommendations OSOZ Conference - Warszawa

  3. Thematic Network 2009-2012 OSOZ Conference - Warszawa

  4. OSOZ Conference - Warszawa

  5. 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. OSOZ Conference - Warszawa

  6. 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.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. OSOZ Conference - Warszawa

  7. 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 OSOZ Conference - Warszawa

  8. Quality in use OSOZ Conference - Warszawa

  9. System/Software Product Quality (1/2) OSOZ Conference - Warszawa

  10. System/Software Product Quality (2/2) OSOZ Conference - Warszawa

  11. Focus of Quality Labelling & Certification OSOZ Conference - Warszawa

  12. How to use the standard? • “.. as a checklist” • “characteristics used as a set when specifying or evaluating computer systems or software product quality” • => EuroRec Descriptive Statements • Functional EHR specifications • Multilingual • Generic as well as domain specific OSOZ Conference - Warszawa

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  15. A set in Polish OSOZ Conference - Warszawa

  16. Translated Criteria OSOZ Conference - Warszawa

  17. 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 OSOZ Conference - Warszawa

  18. 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 OSOZ Conference - Warszawa

  19. Procedures and kind of attestation most suitable procedure OSOZ Conference - Warszawa

  20. The Quality Assessment Process <= ISO/IEC 17011 ISO/IEC 17020 => ISO/IEC 17025 =>

  21. National” Clinical Certification

  22. 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. OSOZ Conference - Warszawa

  23. Enablers for National Certification • Create a legal framework enabling to define quality criteria for the EHR. • Initiate a cooperative platform involving all stakeholders to define overall generic quality criteria for the EHR. • Initiate a cooperative platform involving appropriate stakeholders to define domain / profession specific quality criteria for the different EHR settings (GP, secondary care, …). • Stimulate the use of certified EHR systems by offering services (e.g. simplification of administrative procedures). • Stimulate the use of certified EHR systems by creating incentives for the users (€). OSOZ Conference - Warszawa

  24. 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 OSOZ Conference - Warszawa

  25. 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.org OSOZ Conference - Warszawa

  26. Roll-out approaches • Mandatory • Easier to implement a long term strategy • Only possible when the use of EHR is made mandatory • Voluntary • Slower take-up • Important efforts in consensus building • Incentivised • The best of two worlds with patient empowerment • Incentives are not for free OSOZ Conference - Warszawa

  27. What will the future bring? OSOZ Conference - Warszawa

  28. Regarding Certification • Authority driven national certification will progress: • because quality now becomes an issue • because the authorities want to influence the products • There is nevertheless a risk that these efforts aren’t • coordinated and comparable • re-usable outside country of certification OSOZ Conference - Warszawa

  29. Conclusions • Quality needs to be an issue, based on ISO/IEC standards. (Standards should be available for free) • Market driven QL should be supported, independent and freely accessible. • Functional certification should be comparable and documented in the same way across borders by using an EHR functional descriptive language. Comparable national certification facilitates interoperability. OSOZ Conference - Warszawa

  30. Dziękuję za uwagę Dank U Merci Thank you OSOZ Conference - Warszawa

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