a european roadmap to quality in ehealth

A European Roadmap to Quality in eHealth

with focus on

EHR systems

OSOZ Conference, Warsaw, Dr. Jos Devlies

OSOZ Conference - Warszawa 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

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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.

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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: 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.

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http://iig.umit.at/efmi/badinformatics.htm


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

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Quality in use

Effectiveness

Effectiveness

Efficiency

Efficiency

Satisfaction

Usefulness

Trust

Pleasure

Comfort

Freedom from risk

Economic risk mitigation

Health and safety risk mitigation

Environmental risk mitigation

Context coverage

Context completeness

Flexibility

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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

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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

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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

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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

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OSOZ Conference - Warszawa 1317/5/2012

OSOZ Conference - Warszawa 1417/5/2012


A set in PolishGS001537.03 Każda wersja elementu rekordu medycznego ma datę i czas wprowadzenia danych.

GS001538.02 Każda wersja elementu rekordu medycznego umożliwia jednoznaczną identyfikację aktora wprowadzającego dane.

GS001539.02 Każde uaktualnienie elementu rekordu medycznego tworzy jego nową wersję.

GS001579.02 Każda wersja elementu rekordu medycznego posiada status, na przykład: aktywny lub bieżący, nieaktywny, historyczny lub poprzedni, zakończony, wycofany, zarchiwizowany.

GS001593.02 Usunięcie elementu rekordu medycznego skutkuje nową wersją tego rekordu, posiadającą status ,,usunięty”.

GS001594.02 Każda wersja elementu rekordu medycznego posiada osobę odpowiedzialną za zawartość tej wersji. Osoba odpowiedzialna za zawartość może być użytkownikiem lub stroną trzecią.

GS001595.01 Każda zmiana statusu elementu rekordu medycznego powoduje utworzenie nowej wersji tego elementu.

GS001598.02 Kompletna historia wersji dokumentu zdrowotnego może być zaprezentowana.

GS001601.04 System pozwala na wprowadzanie danych jako wolny tekst dla elementu rekordu medycznego.

GS001602.04 System pozwala wyspecyfikować że dane strukturalne są wymagane dla danego elementu rekordu medycznego.

GS001603.01 Dla Pacjenta element rekordu medycznego może być pozbawiony warunków

GS001617.01 Updates to a version of a health item "in progress" do not result in a new version of that health item.

GS001618.01 Każda wersja najmniejszego elementu rekordu medycznego może być podpisana przez jednego lub więcej użytkowników.

GS001619.02 System przechowuje identyfikator każdego użytkownika, użytkowników podpisujących wersję elementu rekordu medycznego.

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Translated Criteria

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FGS GPR Total

Bulgarian 348 92 440Croatian 966 179 1145Czech 158 0 158Danish 150 33 183Dutch 607 161 768Estonian 1686 179 1865French 530 98 628German 286 62 348Greek 201 42 243Hungarian 686 86 772Italian 344 144 488Lithuanian 416 95 511Polish 116 15 131Portugese 252 24 276Romanian 479 104 581Russian 19 0 19Serbian 351 60 411Slovakian 1694 179 1873Slovenian 204 47 251Spanish 1131 155 1286 10624 1755 12379


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

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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

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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

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The Quality Assessment Process

Certification body

CAB

InitiatorIAF

Product

Supplier Authority

Accreditation body

Certificate

Label

ISO/IEC 17020 =>

<= ISO/IEC 17011

ISO/IEC 17025 =>

National” Clinical Certification

•Existing “national” certification

• Foreseen within 1-2 years

• Considered


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.

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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 (€).

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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

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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 www.eurorec.org

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http://www.eurorec.org/


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

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What will the future bring?

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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

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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.

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Dziękuję za uwagę

Dank UMerci

Thank you

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a european roadmap to quality in ehealth

Documents

osoz conference warszawa14a

osoz conference warszawa13

osoz conference warszawa33

useproduct quality

wersj tego rekordu

health information system

use of ehr systems

computer systems