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A European Roadmap to Quality in eHealth

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Presentation on theme: "A European Roadmap to Quality in eHealth"— Presentation transcript:

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

2 OSOZ Conference - Warszawa
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 17/5/2012 OSOZ Conference - Warszawa

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Thematic Network 17/5/2012 OSOZ Conference - Warszawa

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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. 17/5/2012 OSOZ Conference - Warszawa

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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: *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. 17/5/2012 OSOZ Conference - Warszawa

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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 17/5/2012 OSOZ Conference - Warszawa

8 Quality in use Effectiveness Efficiency Satisfaction Freedom from risk
Usefulness Trust Pleasure Comfort Freedom from risk Economic risk mitigation Health and safety risk mitigation Environmental risk mitigation Context coverage Context completeness Flexibility 17/5/2012 OSOZ Conference - Warszawa

9 System/Software Product Quality (1/2)
Functional Suitability Functional completeness Functional correctness Functional appropriateness Performance efficiency Time behaviour Resource utilisation Capacity Compatibility Co-existence Interoperability Usability Appropriateness recognisability Learnability Operability User error protection User interface aesthetics Accessibility 17/5/2012 OSOZ Conference - Warszawa

10 System/Software Product Quality (2/2)
Reliability Maturity Availability Fault tolerance Recoverability Security Confidentiality Integrity Non-repudiation Accountability Authenticity Maintainability Modularity Reusability Analysability Modifiability Testability Portability Adaptability Installability Replaceability 17/5/2012 OSOZ Conference - Warszawa

11 Focus of Quality Labelling & Certification
Functional Suitability Functional completeness Functional correctness Functional appropriateness Performance efficiency Time behaviour Resource utilisation Capacity Compatibility Co-existence Interoperability Usability Appropriateness recognisability Learnability Operability User error protection User interface aesthetics Accessibility 17/5/2012 OSOZ Conference - Warszawa

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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 17/5/2012 OSOZ Conference - Warszawa

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A set in Polish GS Każda wersja elementu rekordu medycznego ma datę i czas wprowadzenia danych. GS Każda wersja elementu rekordu medycznego umożliwia jednoznaczną identyfikację aktora wprowadzającego dane. GS Każde uaktualnienie elementu rekordu medycznego tworzy jego nową wersję. GS Każda wersja elementu rekordu medycznego posiada status, na przykład: aktywny lub bieżący, nieaktywny, historyczny lub poprzedni, zakończony, wycofany, zarchiwizowany. GS Usunięcie elementu rekordu medycznego skutkuje nową wersją tego rekordu, posiadającą status ,,usunięty”. GS Każda wersja elementu rekordu medycznego posiada osobę odpowiedzialną za zawartość tej wersji. Osoba odpowiedzialna za zawartość może być użytkownikiem lub stroną trzecią. GS Każda zmiana statusu elementu rekordu medycznego powoduje utworzenie nowej wersji tego elementu. GS Kompletna historia wersji dokumentu zdrowotnego może być zaprezentowana. GS System pozwala na wprowadzanie danych jako wolny tekst dla elementu rekordu medycznego. GS System pozwala wyspecyfikować że dane strukturalne są wymagane dla danego elementu rekordu medycznego. GS Dla Pacjenta element rekordu medycznego może być pozbawiony warunków GS Updates to a version of a health item "in progress" do not result in a new version of that health item. GS Każda wersja najmniejszego elementu rekordu medycznego może być podpisana przez jednego lub więcej użytkowników. GS System przechowuje identyfikator każdego użytkownika, użytkowników podpisujących wersję elementu rekordu medycznego. 17/5/2012 OSOZ Conference - Warszawa

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Translated Criteria FGS GPR Total Bulgarian 348 92 440 Croatian 966 179 1145 Czech 158 Danish 150 33 183 Dutch 607 161 768 Estonian 1686 1865 French 530 98 628 German 286 62 Greek 201 42 243 Hungarian 686 86 772 Italian 344 144 488 Lithuanian 416 95 511 Polish 116 15 131 Portugese 252 24 276 Romanian 479 104 581 Russian 19 Serbian 351 60 411 Slovakian 1694 1873 Slovenian 204 47 251 Spanish 1131 155 1286 10624 1755 12379 17/5/2012 OSOZ Conference - Warszawa

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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 17/5/2012 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 17/5/2012 OSOZ Conference - Warszawa

19 Procedures and kind of attestation
Certification procedure Attestation 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 17/5/2012 OSOZ Conference - Warszawa

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

21 National” Clinical Certification
Existing “national” certification Foreseen within 1-2 years Considered

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. 17/5/2012 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 (€). 17/5/2012 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 17/5/2012 OSOZ Conference - Warszawa

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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 17/5/2012 OSOZ Conference - Warszawa

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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 17/5/2012 OSOZ Conference - Warszawa

27 What will the future bring?
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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 17/5/2012 OSOZ Conference - Warszawa

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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. 17/5/2012 OSOZ Conference - Warszawa

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Dziękuję za uwagę Dank U Merci Thank you 17/5/2012 OSOZ Conference - Warszawa


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