1 EHR-Q TN Final Review Brussels, March 30 th 2012

Brussels, March 30, 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 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,

Brussels, March 30,

EHR-Q TN : Why certification? Why the project? Brussels, March 30,

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,

Some EHR quality issues 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. Brussels, March 30,

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: *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? 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,

Overview of the Network Activities Brussels, March 30, Dissemination & Awareness Workshops Annual EuroRec Conferences Project Data Consortium Meetings Deliverables

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,

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, Q1 4/09 Q2 7/09 Q3 10/9 Q4 1/10 Q5 4/10 Q6 7/10 Q7 10/10 Q8 1/11 Q9 4/11 Q10 7/11 Q11 10/11 Q12 1/12 Tot. National Workshops Planned National Workshops Reported / Announced

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,

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). T he 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,

EuroRec Conferences Brussels, March 30, EHR-Q TN EuroRec (Annual) Conferences 1 EuroRec Conference 2009, Sarajevo, Bosnia & Herzegovina August 30-31, EuroRec Session at WoHIT 2010, Barcelona, Spain March 17, EuroRec Conference 2010, Tallinn, EstoniaJune 18, EuroRec Session at WoHIT 2011, Budapest, Hungary May, 12, Regional Conference on EHR Systems Quality Labelling and Certification, Belgrade, Serbia November 21-22, 2011

Consortium Meetings Brussels, March 30, EHR-Q TN Consortium Meetings 1Prague, Czech Republic, Kick-OffFebruary 17-18, Sarajevo, Bosnia-HerzegovinaAugust 31, Dublin, IrelandNovember 17-18, Tallinn, EstoniaJune 17, Sofia, BulgariaDecember 9-10, Lisbon, PortugalJune 17-18, Nicosia, CyprusDecember 2, 2011

Deliverables Brussels, March 30, T ABLE 1. D ELIVERABLES Del. no. Deliverable nameWP.Lead participantNature (i)Dissemination level (ii) Due delivery date Deli-veredActual / Forecast delivery dateComments D1.1 Kick-Off Meeting1EuroRecEC 2Yes D1.2 Documentation for the workshops1EuroRecRC 2Yes D1.3EHR-Q TN website1EuroRecRP2Yes org D1.4 Report on Workshops EuroRecE/RC6Yes Workshops 1 to 3 reported D2.1 Documentation for the second set of National Workshops 2EuroRecRC9Yes D2.2 Report on National Workshops to 19 2EuroRecEC12Yes Workshops 4 to 21 reported D2.3 Report on the Annual EuroRec Conference2EuroRecEC12Yes D2.4 First Annual Project Report2EuroRecRP12Yes D3.1 EHR Market Overview – Suppliers3EuroRecRP15Yes D3.1 EHR Market Overview - Stakeholders3EuroRecRP15Yes D3.2 Report on the National Workshops3EuroRecEC18Yes Workshops 22 to 27 reported D4.1 Report on the National Workshops (2 parts)4EuroRecEC24Yes Workshops 28 to 44 reported D4.2 Report on the Second Annual EuroRec Conf.4EuroRecEC21Yes D4.3 Second Annual Project Report4EuroRecRP24Yes D4.4 Validation of EuroRec Statements and EuroRec Use Tools 4EuroRecRC22Yes D4.5 Documentation for the third set of National Workshops 4EuroRecRC22Yes D5.1 Report on the National Workshops5EuroRecEC30NoMerged with Deliverable D6.1 D5.2 Roadmap towards Sustainable Pan- European Certification of EHR systems 5EuroRecRP30Yes D6.1 Report on the National Workshops (2 parts)6EuroRecEC36Yes Workshops 45/76 reported D6.2 Report on the validation of the quality labelling and certification procedures and scenarios 6EuroRecRP36Yes D6.3 Translated EuroRec Statements Report (2 parts) 6EuroRecRC33Yes D6.4 Report on the Third Annual EuroRec Conference 6EuroRecEC36Yes D6.5 Third Annual Report6EuroRecRP36Yes D6.6 Final report6EuroRecRP36Yes

Investments during the lifetime of the project Brussels, March 30,

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,

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,

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,

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,

Translations: in total Brussels, March 30,

Validation of the EuroRec Repository and of the Descriptive Statements Brussels, March 30,

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,

Setting-up effective quality labelling Brussels, March 30,

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,

EHR Market Overview : main conclusions Brussels, March 30,

Brussels, March 30,

EHR Market Overview - Summary 24 National market Overviews using a common template Two Deliverables Del. D3.1 Part I: Suppliers and Supplier Organisations: supplier / product ID Del. D3.2 Part II: Authorities and important stakeholders: 663 addresses Detailed presentation: previous review Brussels, March 30,

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,

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,

Brussels, March 30,

Brussels, March 30, Roadmap towards a sustainable pan- European certification of EHR systems

Deliv. D5.2 :Table of Content 1.Potential of the EHR: Why? Possible benefits? Barriers to adoption? Requirements? 2.Importance of Quality Labelling & Certification 3.Stakeholders and their role 4.State of Practice in Europe 5.Prerequisites for (sustainable) Quality Labelling & Certification 6.Main strategies regarding quality labelling and certification 7.Roadmap for certification at National Level 8.Cross-border Certification Roadmap 9.Cost of Certification & Business Definition 10.Risks and Remedies 11.EHR-Q TN Recommendations Brussels, March 30,

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,

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,

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

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

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,

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,

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,

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,

Stakeholders & Functional Diagram Brussels, March 30, ISO/IEC => <= ISO/IEC ISO/IEC =>

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,

Procedure 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

Actual “National” Certification Brussels, March 30, Existing “national” certification Foreseen within 1-2 years Considered

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,

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,

Roadmap for Certification: national level Setting the Framework Convince the authorities to take the decision to go for quality labelling and certification Create the legal framework Accredit a certification body Create advisory platforms with users and suppliers Select the standards to be used Pre- assessment Phase Select and prioritise functions / processes to be assessed Negotiate feasibility with suppliers and users Formulate verifiable quality criteria Create appropriate documentation regarding each of the criteria and the procedure Manage Q & A and "interpretations" Select CAB (Conformity Assessment Body) Assessment Phase Define "test population" Define "test scenario's" Development of assessment tools Evaluate test scenario's on feasibility and appropriateness Install logistics (inscription, financial aspects,..) Assess the applications Document conformity or non conformity to the criteria Granting & Maintaining the Label / Certificate Decide on granting or not granting the label or certificate Document motivation and archive assessment documentation Enable "appeal" and "retesting" sessions Distribute the "incentives" Update / upgrade of the criteria for future use

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,

Cross-border Certification Roadmap Setting the Framework Create or recognise an institute or organisation to grant labels to EHR applications Create contractual context governing the quality labelling platform and processes Create advisory platforms with users and suppliers to gather domain expertise Elaborate and validate internal quality procedures, compliant with standards (ISO 17020) Pre- assessment Phase Select and prioritise functions / processes to be assessed (set of criteria / IHE profiles) applicable across Europe Consider feasibility with suppliers and users Create appropriate documentation regarding each of the criteria and the testing procedure Manage Q & A and "interpretations" Select CAB (Conformity Assessment Body) Assessment Phase Install logistics (inscription, financial aspects,..) Define "test scenario's" Develop assessment tools Evaluate test scenario's on feasability and appropriatness Assess the applications Document comformity or non confirmity to the individual criteria or to the profile Granting & Maintaining the Label / Certificate Decide on granting or not granting the label or certificate Document motivation and archive assessment documentation Enable "appeal" and "restesting" sessions

Roll-out of Quality Labelling & Certification Mandatory Voluntary Incentivised Brussels, March 30,

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,

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,

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,

Functionality & Interoperability Brussels, March 30,

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,

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,

Recommendations from the Roadmap Brussels, March 30, Business aspects 2.Main Risks 3.Recommendations 4.Conclusions

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,

Budget for maintaining infrastructure Brussels, March 30, Budget for completion of the translation of the actual repository Number of languages Cost per language Total Completing actual sets of translations New Languages Coordination and Consistency Management Supporting integration of national specific variants Defining the national variants and translating them Coordination and Consistency Management Annual Maintenance Costs Number of languages Cost per language Total Maintenance of the translated statements Coordination and Consistency Management Expanding the repository to be more comprehensive (3.000 statements) Central Repository Maintenance and Expansion Translating to the different languages

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,

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,

Main Risks identified 1.Lack of any decision to go for quality labelling and certification. 2.Insufficient resources to invest in certification bodies, CABs and in favouring the use of certified EHR systems. 3.Market fragmentation due to national / regional healthcare delivery systems, regulations and the multi-professional and multi-lingual European reality => limited resources. Brussels, March 30,

Main risks 4.Nationally defined functional and data exchange related criteria to be avoided, when possible. 5.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. 6.Balkanisation and commercialisation. Brussels, March 30,

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 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,

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,

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,

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,

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,

Quality Labelling and Certification Procedures : the quality of the process Brussels, March 30,

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,

Applicable standards Brussels, March 30, StakeholderApplicable ISO/IEC Standard Accreditation BodyISO/IEC 17011:2004 ISO 9000:2000 ISO/IEC 17000:2004 VIM:1993 Certification BodyISO/IEC Guide 65 Conformity Assessment BodyISO/IEC 17025:2005 [ 1] [ 1] General requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2004) - Quality management systems – Fundamentals and vocabulary (9000:2000) [2] [2] Conformity assessment – Vocabulary and general principles (ISO/IEC 17000:200) [3] [3] International vocabulary of basic and general terms in metrology (VIM:1993) [4] [4] General requirements for bodies operating product certification systems (ISO/IEC Guide 65) [5] [5] General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2005)

A reminder… Brussels, March 30, ISO/IEC => <= ISO/IEC ISO/IEC =>

Accreditation Bodies Standard (17011:2004) addresses Legal responsibility Structure Impartiality Confidentiality Liability and 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,

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,

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,

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,

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,

Assessment & Granting Phase Brussels, March 30,

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,

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,

Documenting actual certification The deliverable documents the authority driven national certification procedure(s) in Austria Belgium Denmark France Ireland Portugal Serbia Brussels, March 30,

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,

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,

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,

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 – 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,

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,

EuroRec : Certification Body Brussels, March 30,

HHS: Certificate related Brussels, March 30,

Recommendations (about the process) Brussels, March 30, Discretion and Confidentiality Impartiality Openness Distinct roles involved organisations Independence Initial Documentation Rules of Evaluation Testing Documentation Documentation of the process

Recommendations (about the process) Brussels, March 30, 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

What could the future bring? Brussels, March 30,

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,

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,

Main risk Americanisation: One single country Rules issued endorsed by the authorities Resources available to “influence” the market Brussels, March 30,

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,

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,

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,

Brussels, March 30, Thank You...