1 EHR-Q TN Main Conclusions & Recommendations Brussels, March 30 th 2012.

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EHR-QTN

Main Conclusions &Recommendations

Brussels, March 30th 2012

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Why certification?

Brussels, March 30, 2012

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Reasons for “Certification”

eHealth and more specifically Electronic Health Record systems have an enormous potential to improve quality, accessibility and efficiency of care, provided they are:

reliable, trustworthy and of sufficient quality;sharable and interoperable;used appropriately.

Quality labelling and certification through professional third party assessment offers best chances for a comparable and reliable quality documentation of those systems. Brussels, March 30, 2012

But there is a 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.

Examples of reported incidents in healthcare where a medical 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.

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

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Some EHR quality “statements”

1. Patients are too important to just suppose that EHR systems are trustworthy.

2. Patient data should not be locked into one system or application.

3. Patients essential data should be made available anywhere anytime to health professionals authorised to access them.

4. Patient has the right to request confidentiality of some data to be handled while taking full responsibility for that option.

5. Patients’ data accesses should be audit-trailed.


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A Norwegian statement…

A recent Norwegian statement is an important one and based on a large experience in certifying “messages” (certifying all kind of standards based data exchange).

The Norwegian Ministry of Health and Care Services stated that “EHR Quality will be difficult to reach unless certification of the EHR systems is made mandatory”.


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Not all EHR systems are good enoughSelecting the most appropriate application from the correct vendor is a real challenge => importance of assessing the systems’ quality.Comprehensive and correct use is another important factor =>

Importance of training the usersImportance of assessing the usersMotivation for incentives for the users.


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EHR Market: some considerationsVery fragmented as expected

May endanger quality of applications, though never proven.Not the privilege of the suppliers: also large number of “important stakeholders”.

There is no one single nor homogeneous provision of healthcare in Europe, neither within one country

Each profession needs a “different” application.Using the same application in several countries does not work.

There is some market “concentration”Concentration of ownershipNo concentration of applications, even when the same name is used in different countriesBrussels, March 30, 2012

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One of the project conclusions

The only approach that may work seems to be to increase harmonisation within diversity, offering more and more “similar” (not identical), functions based on the same basic functional and quality specifications.


10Brussels, March 30, 2012

Roadmap towards a sustainable pan-European certification of

EHR systems

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Verification versus Validation

Verification = technical correctness of the software application or component of an application. Verification attempts to answer the question “is the software built right (rightly)?” => medical device directive ?Validation = compliance of the application to the consumer’s / user’s functional expectations: is the application offering what it is expected to do? Validation attempts to answer the question “is the right software built?” => procurement and functional validation !


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Five areas for quality labelling and certification

Data exchange facilities (incl. IOP)Functionality (incl. some aspects of IOP)Administrative and billing facilitiesUse related measurements and validationSoftware development quality (out of scope, not specific for EHR systems)

=> Different expertise , different organisationsDublin, November 17-18

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Actual Status of Quality Labelling and Certification


Procedure 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

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Diversified reality

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-assessmentTwo main Approaches: system functionality versus “Interoperability” testingNational or even Regional Certification versus Cross-Border Quality LabellingBrussels, March 30, 2012

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Actual “National” Certification


• Existing “national” certification

• Foreseen within 1-2 years

• Considered

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Conditions enabling “national certification”

Consortium listed the top 5 enablers for a country wide certification:• Stimulate the use of certified EHR systems by creating

incentives (€).• Create a legal framework enabling to define quality

criteria for the EHR.• Initiate a cooperative platform involving all 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).

• Initiate a cooperative platform involving all stakeholders to define overall quality criteria for the EHR.


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Impact of “national” certification

Consortium listed the top 5 good reasons to adopt country wide 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.Brussels, March 30, 2012

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Actual “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 interoperabilityContinua Health Alliance: industry driven, focus on devices content portability


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Quality Requirements applicable to Quality Labelling and Certification


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Stakeholders & Functional Diagram - Applicable standards


Certification body

CAB

InitiatorIAF

Product

Supplier Authority

Accreditation body

Certificate

Label

ISO/IEC 17020 =>

<= ISO/IEC 17011

ISO/IEC 17025 =>

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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)

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Recommendations (about the process)


•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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Recommendations (about the process)


•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

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Towards more generalised and systematic Quality Labelling and Certification


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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.”


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Roll-out approaches

MandatoryEasier to implement a long term strategyOnly possible when the use of EHR is made mandatory

VoluntarySlower take-upImportant efforts in consensus building

IncentivisedThe best of two worlds with patient empowermentIncentives are not for free


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Improve the European DimensionHealthcare still a national competence.Dual approach only realistic one:

Extend the National Certification (deepening)Incremental upgrade of cross-border initiatives

Recognition of national certificates.European “incentives” for using certified systems.


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Recommendations


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Recommendations• Legal and regulatory framework

• Create and harmonise the legal and regulatory framework stimulating national or regional authorities to enforce the use of quality labelled and certified applications.

• Clarify the role of Directive 2007/47/EC regarding software development aspects, EHR functional aspects and Data-Exchange related issues

• Involvement of stakeholders• Certification bodies should be accredited and compliant to

international standards, more precisely ISO 17020.• Favour cooperation between all service providers active in

different areas of quality labelling and certification of EHR systems: administrative data exchange, clinical data exchange and system functionality.

• Create an advisory platform involving all stakeholders to agree on content and feasibility of requirements.


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Recommendations (2)• Technical Framework

• It is highly recommended to 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 statements and profiles.

• Address the issue of personnel shortage in health informatics in general and more specifically in health informatics quality assessment.

• Quality labelling and certification processThird party assessment is the most suitable procedure for the still immature market of EHR systemsIt is strongly recommended to start “small”, to evaluate effectiveness and to increase focus step by stepThe incentivised model seems the most promising, surely for self-employed healthcare professionals


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Recommendations: cross-borderStrengthen national certification in order to improve average quality and to enable in a second step the Trans-European harmonisation, improving comparability and portability of content. Promote equivalence of certificates across Europe by validating at European level both the functional descriptive statements of EuroRec and the IHE profiles. Consider the possibility to create a cross-border “Register of Quality Labelled or Certified Clinical Software”, offering information about the products (complete EHR systems as well a software modules) and documentation about the certification process. Brussels, March 30, 2012

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What could the future bring?


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Certification

Authority driven national certification will progress progressively:

because quality now becomes an issuebecause the authorities want to influence the products

There is nevertheless a risk that these efforts aren’t

coordinated and comparablere-usable outside country of certificationBrussels, March 30, 2012

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Conclusions

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.One-stop shopping regarding both data exchange and functionality quality labelling could boost the quality labelling and certification activities.


1 EHR-Q TN Main Conclusions & Recommendations Brussels, March 30 th 2012.

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Transcript of 1 EHR-Q TN Main Conclusions & Recommendations Brussels, March 30 th 2012.