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

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Presentation on theme: "A European Roadmap to Quality in eHealth with focus on EHR systems OSOZ Conference, Warsaw, Dr. Jos Devlies."— Presentation transcript:

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

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 17/5/20122OSOZ Conference - Warszawa

3 Thematic Network /5/2012 OSOZ Conference - Warszawa 3

4 4

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. 17/5/20125OSOZ 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: *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. 17/5/20126OSOZ Conference - Warszawa

7 Software Quality ISO 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 17/5/2012OSOZ Conference - Warszawa7

8 Quality in use Effectiveness Efficiency Satisfaction UsefulnessTrustPleasureComfort Freedom from risk Economic risk mitigation Health and safety risk mitigation Environmental risk mitigation Context coverage Context completeness Flexibility 17/5/20128OSOZ Conference - Warszawa

9 System/Software Product Quality (1/2) Functional Suitability Functional completeness Functional correctness Functional appropriateness Performance efficiency Time behaviourResource utilisationCapacity Compatibility Co-existenceInteroperability Usability Appropriateness recognisability LearnabilityOperabilityUser error protection User interface aesthetics Accessibility 17/5/20129OSOZ Conference - Warszawa

10 System/Software Product Quality ( 2/2) Reliability MaturityAvailabilityFault toleranceRecoverability Security ConfidentialityIntegrity Non-repudiation AccountabilityAuthenticity Maintainability ModularityReusabilityAnalysabilityModifiabilityTestability Portability AdaptabilityInstallabilityReplaceability 17/5/201210OSOZ Conference - Warszawa

11 Focus of Quality Labelling & Certification Functional Suitability Functional completeness Functional correctness Functional appropriateness Performance efficiency Time behaviourResource utilisationCapacity Compatibility Co-existenceInteroperability Usability Appropriateness recognisability LearnabilityOperabilityUser error protection User interface aesthetics Accessibility 17/5/201211OSOZ 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 17/5/201212OSOZ Conference - Warszawa

13 17/5/201213OSOZ Conference - Warszawa

14 17/5/201214OSOZ Conference - Warszawa

15 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. 17/5/201215OSOZ Conference - Warszawa

16 Translated Criteria 17/5/ OSOZ Conference - Warszawa FGSGPRTotal Bulgarian Croatian Czech 1580 Danish Dutch Estonian French German Greek Hungarian Italian Lithuanian Polish Portugese Romanian Russian 190 Serbian Slovakian Slovenian Spanish

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 17/5/201217OSOZ 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 17/5/201218OSOZ Conference - Warszawa

19 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 17/5/ OSOZ Conference - Warszawa

20 The Quality Assessment Process ISO/IEC => <= 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. 17/5/201222OSOZ 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 (). 17/5/201223OSOZ 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 17/5/201224OSOZ 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 17/5/201225OSOZ 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 17/5/201226OSOZ Conference - Warszawa

27 What will the future bring? 17/5/201227OSOZ 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 arent – coordinated and comparable – re-usable outside country of certification 17/5/201228OSOZ 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. 17/5/201229OSOZ Conference - Warszawa

30 Dziękuję za uwagę Dank U Merci Thank you 17/5/2012OSOZ Conference - Warszawa30


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