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EHR-Q TN Final Review. Brussels, March 30 th 2012. Introduction of consortium and experts. Agenda. The partners EHR-Q TN : why was it needed? Overview of the Network Activities Investments done during the lifetime of the project Validation of the EuroRec Statements

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ehr q tn final review

EHR-QTNFinal Review

Brussels, March 30th 2012

agenda
Agenda
  • The partners
  • EHR-QTN: why was it needed?
  • Overview of the Network Activities
  • Investments done during the lifetime of the project
  • Validation of the EuroRec Statements
  • EHR Market Overview: main conclusions
  • Roadmap towards a sustainable pan-European certification of EHR systems
  • Recommendations from the Roadmap
  • Quality Labelling and Certification Procedures: the quality of the process
  • Conclusions and what brings the future?
  • Questions

Brussels, April 8, 2011

reasons for certification
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

some ehr quality issues
Some EHR quality issues
  • Patients are too important to just suppose that EHR systems are trustworthy.
  • Patient data should not be locked into one system or application.
  • Patients essential data should be made available anywhere anytime to health professionals authorised to access them.
  • Patient has the right to request confidentiality of some data to be handled while taking full responsibility for that option.
  • Patients’ data accesses should be audit-trailed.

Brussels, March 30, 2012

the quality challenge
The quality challenge

Myers et al*. show that adverse events 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.

why was such project needed
Why was such project needed?
  • Too many authorities not aware of the quality needs and related problems.
  • Even more authorities not effectively involved in quality labelling and certification.
  • Lack of awareness about what exists.
  • Existing initiatives not comparable with each other.
  • Cross-border quality assessment almost unexisting.

Brussels, March 30, 2012

overview of the network activities
Overview of the Network Activities
  • Dissemination & Awareness
    • Workshops
    • Annual EuroRec Conferences
  • Project Data
    • Consortium Meetings
    • Deliverables

Brussels, March 30, 2012

workshops
Workshops
  • In total 76 workshops
  • At least one per country
  • Agenda of the workshops:
    • Year 1: Communications from the Commission, Seal Level 1, Repository
    • Year 2: Validation of the EuroRec Statements
    • Year 3: Validation of procedures & roadmap for the countries with most chance of making progress

Brussels, March 30, 2012

overview workshops
Overview Workshops
  • Listed in the three Annual Reports and the Final Report
  • Reported in deliverables D1.4, D2.2, D3.2, D4-I, D4-II, D6.1a, D6.1b and D6.4

Brussels, March 30, 2012

workshops questions and suggestions
Workshops: questions and suggestions

Resulted in valuable comments and questions regarding:

  • Quality labelling and certification as such: need, quality & professionalism of the process;
  • The content of quality assessment;
  • The role of the (national) health authorities;
  • The use and appropriateness of the EuroRec Descriptive Statements;
  • The importance of functional testing.

Brussels, March 30, 2012

a norwegian statement
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”.

Brussels, March 30, 2012

eurorec conferences
EuroRec Conferences

Brussels, March 30, 2012

consortium meetings
Consortium Meetings

Brussels, March 30, 2012

deliverables
Deliverables

Brussels, March 30, 2012

investments
Investments
  • Improving functionality of the Repository.
  • Definition of EuroRec Seal Level 1 and 2.
  • Translations into 21 languages.
  • Validation workshops.
  • Setting-up effective quality labelling.

Brussels, March 30, 2012

functional tools investments
Functional Tools Investments
  • Extensionof the repository: secondary use of EHR data and lab reporting related issues.
  • Adding content-related functionality:
    • definition section
    • comments and interpretation
    • national variants
  • Adding maintenance functions to manage e.g. modifications in a multi-lingual environment

Brussels, March 30, 2012

eurorec seals
EuroRec Seals
  • EuroRec Seal Level 2 defined during the lifetime of the project
  • Basic sets of quality criteria
    • Addressing reliability, trustworthiness, authentication, access management and basic functionality
    • Comparable across borders and domains
  • Example of a “market driven” approach
  • Standardisation of the procedure (see further)
  • Products out of 7 different countries certified

Brussels, March 30, 2012

industrial testimonies
Industrial testimonies
  • “EuroRec Seal greatly helped to improve SW products.”
  • “Developers got clear guidelines about key features that are often neglected by end users.”
  • “Customers got additional assurance of software quality.”
  • “The Seal offers increased odds at foreign markets.”
  • “The EuroRec approach is very useful for new software (modules), new application design… giving ‘new ideas’.”

Brussels, March 30, 2012

translations 12 379 in total
Translations: 12.379 in total

Brussels, March 30, 2012

validation of the statements
Validation of the statements
  • Validation done
    • When translating the original statements
    • During the workshops
    • By the “clients”, software suppliers
  • Validation of the following aspects:
    • Formulation
    • Content
    • Technical correctness
    • Importance (for application quality)
    • Feasibility
  • Reported in deliverable D4.4

Brussels, March 30, 2012

effective quality labelling
Effective Quality Labelling
  • Documentation free available.
  • Seal request forms on the web.
  • Procedure validated against the applicable standards.
  • Partners involved (not only ProRec centres).

Brussels, March 30, 2012

ehr market overview summary
EHR Market Overview - Summary
  • 24 National market Overviews using a common template
  • Two Deliverables
    • Del. D3.1 Part I: Suppliers and Supplier Organisations: 1.005 supplier / product ID
    • Del. D3.2 Part II: Authorities and important stakeholders: 663 addresses
  • Detailed presentation: previous review

Brussels, March 30, 2012

ehr market some considerations
EHR Market: some considerations
  • Very 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 ownership
    • No concentration of applications, even when the same name is used in different countries

Brussels, March 30, 2012

one of the project conclusions
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.

Brussels, March 30, 2012

deliv d5 2 table of content
Deliv. D5.2 :Table of Content
  • Potential of the EHR: Why? Possible benefits? Barriers to adoption? Requirements?
  • Importance of Quality Labelling & Certification
  • Stakeholders and their role
  • State of Practice in Europe
  • Prerequisites for (sustainable) Quality Labelling & Certification
  • Main strategies regarding quality labelling and certification
  • Roadmap for certification at National Level
  • Cross-border Certification Roadmap
  • Cost of Certification & Business Definition
  • Risks and Remedies
  • EHR-QTN Recommendations

Brussels, March 30, 2012

introductory statement
Introductory statement

“Realising the potential health added and economic value linked to using an EHR system is not obvious.

It requires huge investments and a professional development environment.

It requires a permanent focus on “quality” at functional quality level and thus also regarding “interoperability”.

Quality should be documented in an objective, comparable and trustworthy way.”

Brussels, March 30, 2012

verification versus validation
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 !

Brussels, March 30, 2012

five areas for quality labelling and certification
Five areas for quality labelling and certification
  • Data exchange facilities (incl. IOP)
  • Functional (incl. some aspects of IOP)
  • Administrative and billing facilities
  • Use related measurements and validation
  • Software development quality (out of scope, not specific for EHR systems)

=> Different expertise , different organisations

Dublin, November 17-18

scope of ehr ql certification
Scope of EHR QL & Certification
  • Different expertise => Different organisations.
  • Our focus for Deliverable D6.2 is on
    • Functional testing, including some aspects of interoperability
    • Data exchange (message production and integration)
  • We will address how to “cooperate” later on.

Dublin, November 17-18

the use of ehr systems
The use of EHR systems
  • Consortium listed the top 5 good reasons to generalise the use of EHR systems.
  • A small literature survey proofs quantifiable profits.
  • There are nevertheless still barriers to EHR adoption:
    • by Healthcare Professionals
    • by IT providers
    • related to political and organisational factors

Brussels, March 30, 2012

not all ehr systems are good enough
Not all EHR systems are good enough
  • Selecting 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 users
    • Importance of assessing the users
    • Motivation for incentives for the users.

Brussels, March 30, 2012

impact of certification
Impact of 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

prerequisite
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.”

Brussels, March 30, 2012

stakeholders functional diagram
Stakeholders & Functional Diagram

<= ISO/IEC 17011

ISO/IEC 17020 =>

ISO/IEC 17025 =>

Brussels, March 30, 2012

kind of quality assessments
Kind of Quality Assessments
  • “Authority driven” versus “Market Driven”
    • Independent organisation / Industrial organisation
    • Public initiative / Supplier initiative
  • Third party assessment versus self-assessment
  • Comprehensive versus Modular
  • National / Regional versus Cross-Border
  • System functionality versus “Interoperability”
  • Generic versus Domain/Target Specific (LIS,…)

Brussels, March 30, 2012

procedure and kind of attestation
Procedure and kind of attestation

most suitable procedure

actual national certification
Actual “National” Certification

Brussels, March 30, 2012

actual cross border quality labelling
Actual “cross border” quality labelling
  • Not “authority driven”
    • There is no such an authority
    • No formal recognition of certificates across borders
  • Three “private” initiatives
    • 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

Brussels, March 30, 2012

one destination two itineraries
One Destination, Two Itineraries
  • Different and complementary approaches but always phased in a similar way:
    • Setting the framework & the decision to go for it
    • Pre-assessment: organisational context
    • Assessment: test related activities
    • Granting label or certificate

Brussels, March 30, 2012

conditions enabling national certification
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.

Brussels, March 30, 2012

roll out of quality labelling certification
Roll-out of Quality Labelling & Certification
  • Mandatory
  • Voluntary
  • Incentivised

Brussels, March 30, 2012

mandatory certification
Mandatory Certification
  • Advantages
    • Less important to consider feasibility. Less efforts required for consensus building with users and suppliers.
    • Easier to implement a long term strategy for authority and for suppliers.
  • Problems
    • Only possible when use of EHR is made mandatory.
    • Authority needs to have the means of its ambition.
    • Defensive suppliers contesting ‘interpretations’ of the criteria.
    • May reduce competition and innovation.

Brussels, March 30, 2012

voluntary quality labelling certification
Voluntary quality labelling & certification
  • Advantages
    • Based on a consensus between different stakeholders.
    • Less “contestation”.
    • Shared cost has more chance to be accepted.
  • Problems
    • Slower take-up and still non-certified products on the market. Risk that the actual results will falter.
    • Long and fastidious negotiations regarding requests from users and/or authorities.
    • Long and stepwise approach.
    • Weakest partners may hamper progress.

Brussels, March 30, 2012

incentivised model
Incentivised model
  • Best of two worlds… empowerment of the user.
  • Advantages
    • Involvement of all stakeholders
    • Win-win for all stakeholders
  • Problems
    • Important involvement of authorities granting incentives
    • Important pre-assessment efforts.

Brussels, March 30, 2012

functionality interoperability
Functionality & Interoperability

Brussels, March 30, 2012

cooperation ehealth quality institute
Cooperation: eHealth Quality Institute
  • To improve quality and efficiency of the processes
  • To align / link requirements formulation and documentation
  • To have full documentation available
  • To centralise information on “certified” applications and components
  • To invest in tools
  • To favour trans-European certification through recognition
  • To increase independence from providers and users

Brussels, March 30, 2012

european dimension
European Dimension ?
  • Healthcare remains national competence.
  • Dual approach only realistic:
    • Extended National Certification
    • Incremental upgrade of cross-border initiatives
  • Recognition of national certificates
  • European “incentives” for using certified systems

Brussels, March 30, 2012

recommendations from the roadmap
Recommendations from the Roadmap

Business aspects

Main Risks

Recommendations

Conclusions

Brussels, March 30, 2012

business definition
Business Definition
  • Defining and rolling-out a / ONE common business opportunity is very hypothetic:
    • Different approaches (authority driven versus market driven).
    • Different options and content (criteria) in the different countries.
    • Market driven initiatives each on a different track.
    • Impossible to receive information from the commercial initiatives.
  • Market potential for EuroRec and IHE described in Del. D5.2

Brussels, March 30, 2012

sustainability of national certification
Sustainability of national certification
  • Create a relation of trust and partnership between authorities, users and industry.
  • Increase economic viability of the suppliers by supporting the use of certified EHR systems and stimulating defragmentation of the market.
  • Costs need to be shared between health authorities and the industry, industry e.g. paying only the effective testing / assessment.

Brussels, March 30, 2012

sustainability of national certification1
Sustainability of national certification
  • Develop and support a common “language” to describe functional requirements in a comparable way: national repository of reusable statements publicly available.
  • Functional assessment and “interoperability” assessment should be offered by a recognised Health IT Quality Institute.

Brussels, March 30, 2012

main risks identified
Main Risks identified
  • Lack of any decision to go for quality labelling and certification.
  • Insufficient resources to invest in certification bodies, CABs and in favouring the use of certified EHR systems.
  • Market fragmentation due to national / regional healthcare delivery systems, regulations and the multi-professional and multi-lingual European reality => limited resources.

Brussels, March 30, 2012

main risks
Main risks
  • Nationally defined functional and data exchange related criteria to be avoided, when possible.
  • Actual cross-border health-IT is dominated by solution provider for “technical” departments and services. Insufficient to guarantee quality expressed in reliability, trustworthiness and appropriateness of the content.
  • Balkanisation and commercialisation.

Brussels, March 30, 2012

recommendations
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.

Brussels, March 30, 2012

recommendations 2
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.
    • Invest in maintenance and expansion of the actual descriptive statements and profiles towards more completeness and towards including more “domain- or profession-specific sets”.
    • Address the issue of personnel shortage in health informatics in general and more specifically in health informatics quality assessment.

Brussels, March 30, 2012

recommendations 3
Recommendations (3)
  • Quality labelling and certification process
    • Third party assessment is the most suitable procedure for the still immature market of EHR systems
    • It is strongly recommended to start “small”, to evaluate effectiveness and to increase focus step by step
    • The incentivised model seems the most promising, surely for self-employed healthcare professionals

Brussels, March 30, 2012

recommendations cross border
Recommendations: cross-border
  • Quality labels and certificates are primarily national. Strengthen 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. 
  • The EuroRec statements facilitate cross-border and cross-domain functional certification of EHR systems. It would be a pity not to use these opportunities. 
  • The IHE profiles are in principle country-independent and are used as European Profiles for data-exchange. 

Brussels, March 30, 2012

cross border recommendations
Cross-border recommendations
  • Promote equivalence of certificates across Europe by validating at European level both the functional descriptive statements of EuroRec and the IHE profiles. 
  • Enforce portability of quality assessment labels and certificates across the Union. 
  • 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

deliverable d6 2
Deliverable D6.2
  • Documents quality requirements / applicable standards to quality labelling and certification.
  • Describes the distinct roles of the initiator / authority, the certification body, the accreditation body and the conformity assessment body.
  • Describes in detail the assessment and the granting phase as described in the roadmap deliverable.

Brussels, March 30, 2012

applicable standards
Applicable standards

[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)

Brussels, March 30, 2012

a reminder
A reminder…

<= ISO/IEC 17011

ISO/IEC 17020 =>

ISO/IEC 17025 =>

Brussels, March 30, 2012

accreditation bodies
Accreditation Bodies
  • Standard (17011:2004) addresses
    • Legal responsibility
    • Structure
    • Impartiality
    • Confidentiality
    • Liabilityand Financing
    • Accreditation activities
    • General procedures (application, …)
    • Management of non-conformities
    • Internal audits…
    • Human resources
  • Describes the responsibilities of accreditation bodies, certification bodies and conformity assessment bodies

Brussels, March 30, 2012

certification bodies
Certification Bodies

ISO/IEC Guide 65 outlines the following aspects

  • General provisions
  • Organisational and operational aspects
  • Subcontracting
  • Quality system in place
  • Procedural aspects about granting, maintaining, extending, suspending and withdrawing a certificate
  • Internal audits
  • Documentation
  • Record keeping
  • Confidentiality
  • Specific quality criteria regarding the personnel

Brussels, March 30, 2012

certification bodies 2
Certification Bodies (2)

Other topics addressed in the ISO Guide

  • Way to deal with changes in certification requirements
  • Appeals
  • Procedures for complaints, appeals and disputes
  • Procedure for the certification application
  • How to prepare the evaluation
  • The evaluation itself
  • Decision making on the certification
  • Surveillance aspects
  • Use of licenses, certificates and other marks

Brussels, March 30, 2012

cab conformity assessment bodies
CAB – Conformity Assessment Bodies
  • ISO/IEC 17025:2005 General requirements for the competence of testing and calibration laboratories
  • Addresses 5 major topics
    • Scope of the standard
    • Normative references
    • Terms and definitions
    • Management requirements
    • Technical requirements

Brussels, March 30, 2012

actual status
Actual Status
  • Accreditation is “national” =>
    • cross-border activities are formally excluded
    • main issues still to be addressed:
      • Independence
      • Split between CB and CAB
  • National initiatives
    • Accreditation body seems to be active in France
    • Belgium, Serbia, Ireland… clear split CB/CAB
    • Other countries: authority defining scope, testing and granting the certificate

Brussels, March 30, 2012

assessment granting phase
Assessment & Granting Phase

Brussels, March 30, 2012

assessment phase
Assessment Phase
  • Test Bed (environment, test population, test patient)
  • Test Scenarios and Test Scripts
  • Assessment tools
  • Evaluation feasibility & appropriateness
  • Logistics, mainly the service agreement
  • Assess the application
  • Documenting conformity & non- conformity to the criteria

Brussels, March 30, 2012

granting phase
Granting Phase
  • Decision (by the certification body)
  • Motivation
  • Archive assessment documentation
  • Appeal and Retesting
  • Validity of Label or Certificate (version…)
  • Withdrawal of Label or Certificate
  • Preparing the future

Brussels, March 30, 2012

documenting actual certification
Documenting actual certification

The deliverable documents the authority driven national certification procedure(s) in

  • Austria
  • Belgium
  • Denmark
  • France
  • Ireland
  • Portugal
  • Serbia

Brussels, March 30, 2012

for each country we documented
For each country we documented
  • Who initiates / initiated the process of certification?
  • Legal or Regulatory context, if any
  • Domain addressed by the national certification
  • Is the certification compulsory, optional and/or incentivised
  • Involvement of different stakeholders
  • National scenario(s)
  • Effectively granting the Certificate
  • Appeal procedures
  • Possible contractual commitments related to the Quality Labelling and Certification

Brussels, March 30, 2012

documenting actual quality labelling
Documenting actual quality labelling

The deliverable documents the market driven cross-border quality labelling procedure(s) as implemented by:

EuroRec

I.H.E.

Continua Health Alliance

Brussels, March 30, 2012

for each initiative we documented
For each initiative we documented
  • Who initiates / initiated the process of certification?
  • Legal of Regulatory context, if any
  • Domains addressed by the quality label
  • Is there any incentive favouring the quality labelling?
  • Involvement of different stakeholders
  • Implemented scenario(s)
  • Effectively granting the Quality Label
  • Appeal procedures
  • Possible contractual commitments related to Quality Label or Certificate

Brussels, March 30, 2012

global comparison
Global Comparison

Global comparison made by the University of Victoria between:

  • The Certification Commission for Healthcare Information Technology (CCHIT) – United States
  • Department of Health and Human Services (HHS) – United States
  • ISO/IEC 15408 – The Common Criteria for Information Technology Security Evaluation
  • The European Institute for Health Records (EuroRec)
  • Health on the Net foundation (HON)
  • Canada Health Infoway (Infoway)
  • The Australian National E-Health Transition Authority (NEHTA)

Brussels, March 30, 2012

what has been compared
What has been compared?
  • Service category
  • Quality objectives(accountability, identifying purpose, consent, limiting collection, limiting use, disclosure, retention, accuracy, safeguards, openness, individual access, challenging compliance)
  • Focus of conformance assessment
  • Certification body (administration, independencde, impratiality, integrity, quality system, accreditation, complaints & appeal)
  • Methods and procedures
  • Certificate(assessment details, expiration, re-certification, warranty..)

Brussels, March 30, 2012

eurorec certification body
EuroRec : Certification Body

Brussels, March 30, 2012

hhs certificate related
HHS: Certificate related

Brussels, March 30, 2012

recommendations about the process
Recommendations (about the process)

Brussels, March 30, 2012

recommendations about the process1
Recommendations (about the process)

Brussels, March 30, 2012

what could the future bring
What could the future bring?

Brussels, March 30, 2012

certification
Certification
  • Authority driven certification will progress progressively:
    • because quality only now becomes an issue
    • because the authorities want to influence the products
  • There is a risk that these efforts aren’t
    • coordinated and comparable
    • re-usable outside country of certification

Brussels, March 30, 2012

quality labelling quality mark
Quality Labelling & Quality Mark
  • Border-independent and on initiative of the supplier
  • Quality Mark for products:
    • established practice and related business
    • not independent but it works
  • Quality Label
    • progress slowly (free to candidate for it)
    • (never) comprehensive
    • SMEs are a problem

Brussels, March 30, 2012

main risk
Main risk

Americanisation:

  • One single country
  • Rules issued endorsed by the authorities
  • Resources available to “influence” the market

Brussels, March 30, 2012

conclusions
Conclusions
  • The project clearly contributed to increased awareness about QL&C amongst specialised industry, health professionals and health authorities.
  • Certification is in the lift (> 10 countries)
    • In principle national and authority driven
    • Still fragmented and not (very) comparable
    • Covers functionality and data exchange

Brussels, March 30, 2012

conclusions1
Conclusions
  • Market driven QL is the current approach for cross-border quality assessment. This should be supported, independent and freely accessible.
  • Market driven QL services are offered mainly by three organisations addressing different aspects :
      • Functional quality of the (professional) applications
      • Ability to exchange (emit and receive) content
      • Portability (and safety) of device outcome

Brussels, March 30, 2012

conclusions2
Conclusions
  • Functional certification should be comparable and documented in the same way across borders by using an EHR functional descriptive language. Comparable national certification leads towards an increased harmonisation of the applications and facilitates interoperability.
  • One-stop shopping regarding both data exchange and functionality quality labelling could boost the quality labelling and certification activities.

Brussels, March 30, 2012

thank you
Thank You...

Brussels, March 30, 2012