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

A Roadmap towards comparable, standards based and reliable Certification of EHRs

Dr. Jos Devlies, EuroRec, Belgium

WoHIT 2012 - Copenhagen - EuroRec Session

2

IssuesWhy 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


3

Thematic

Network 2009-2012

8 May 2012


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 2012


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The Quality IssueMyers 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

8 May 2012

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


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Software Quality Standards

8 May 2012


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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 2012


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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

8 May 2012


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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

8 May 2012


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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

8 May 2012


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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

8 May 2012


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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

8 May 2012


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Quality Labelling and Certification

8 May 2012


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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

8 May 2012


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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

8 May 2012


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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

most

su

itab

le

pro

ced

ure

8 May 2012


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The Quality Assessment Process

Certification body

CAB

InitiatorIAF

Product

Supplier Authority

Accreditation body

Certificate

Label

8 May 2012


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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 2012


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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

8 May 2012


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EHR Quality Labelling and Certification in Europe

(based on EHR-QTN projects)

8 May 2012


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“National” Clinical Certification•Existing “national” certification

• Foreseen within 1-2 years

• Considered

8 May 2012


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Quality Labelling and Certification

Standards

8 May 2012


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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 =>

8 May 2012


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Applicable standards

Stakeholder Applicable ISO/IEC StandardAccreditation Body ISO/IEC 17011:2004

ISO 9000:2000ISO/IEC 17000:2004VIM:1993

Certification Body ISO/IEC Guide 65Conformity Assessment Body ISO/IEC 17025:2005

[1] General requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2004)- Quality management systems – Fundamentals and vocabulary (9000:2000)[2] Conformity assessment – Vocabulary and general principles (ISO/IEC 17000:200)[3] International vocabulary of basic and general terms in metrology (VIM:1993)[4] General requirements for bodies operating product certification systems (ISO/IEC Guide 65)[5] General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)

8 May 2012


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Main standard requirements

•Discretion and Confidentiality

•Impartiality

•Openness

•Distinct roles involved organisations

Independence

•Initial Documentation

•Rules of Evaluation

•Testing Documentation

Documentation of the process

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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


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Recommendationsby the EHR-QTN Consortium

8 May 2012


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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

8 May 2012

http://www.eurorec.org/

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Recommendations (summarised)

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.

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Recommendations (summarised)

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

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

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