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

2. Brussels, March 30, 2012 2 Introduction of consortium and experts

3. 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, 2011 3

4. Brussels, March 30, 2012 4

5. EHR-Q TN : Why certification? Why the project? Brussels, March 30, 2012 5

6. 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 6

7. 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, 2012 7

8. 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 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.

9. 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 9

10. Overview of the Network Activities Brussels, March 30, 2012 10 Dissemination & Awareness Workshops Annual EuroRec Conferences Project Data Consortium Meetings Deliverables

11. 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 11

12. 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 12 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 -6677767767672 National Workshops Reported / Announced 4413428104212476

13. 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 13

14. 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, 2012 14

15. EuroRec Conferences Brussels, March 30, 2012 15 EHR-Q TN EuroRec (Annual) Conferences 1 EuroRec Conference 2009, Sarajevo, Bosnia & Herzegovina August 30-31, 2009 2 EuroRec Session at WoHIT 2010, Barcelona, Spain March 17, 2010 3EuroRec Conference 2010, Tallinn, EstoniaJune 18, 2010 4 EuroRec Session at WoHIT 2011, Budapest, Hungary May, 12, 2011 5 Regional Conference on EHR Systems Quality Labelling and Certification, Belgrade, Serbia November 21-22, 2011

16. Consortium Meetings Brussels, March 30, 2012 16 EHR-Q TN Consortium Meetings 1Prague, Czech Republic, Kick-OffFebruary 17-18, 2009 2Sarajevo, Bosnia-HerzegovinaAugust 31, 2009 3Dublin, IrelandNovember 17-18, 2009 4Tallinn, EstoniaJune 17, 2010 5Sofia, BulgariaDecember 9-10, 2010 6Lisbon, PortugalJune 17-18, 2011 7Nicosia, CyprusDecember 2, 2011

17. Deliverables Brussels, March 30, 2012 17 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 2Yes05.11.2009 D1.2 Documentation for the workshops1EuroRecRC 2Yes05.11.2009 D1.3EHR-Q TN website1EuroRecRP2Yes05.11.2009 http://ehrqtn.eurorec.org/ http://www.eurorec. org D1.4 Report on Workshops 1 - 61EuroRecE/RC6Yes05.11.2009Workshops 1 to 3 reported D2.1 Documentation for the second set of National Workshops 2EuroRecRC9Yes18.02.2010 D2.2 Report on National Workshops 7 - 19 7 to 19 2EuroRecEC12Yes26.02.2010Workshops 4 to 21 reported D2.3 Report on the Annual EuroRec Conference2EuroRecEC12Yes15.02.2010 D2.4 First Annual Project Report2EuroRecRP12Yes03.03.2010 D3.1 EHR Market Overview – Suppliers3EuroRecRP15Yes30.12.2010 D3.1 EHR Market Overview - Stakeholders3EuroRecRP15Yes01.12.2010 D3.2 Report on the National Workshops3EuroRecEC18Yes04.11.2010Workshops 22 to 27 reported D4.1 Report on the National Workshops (2 parts)4EuroRecEC24Yes07.03.2011 09.03.2011 Workshops 28 to 44 reported D4.2 Report on the Second Annual EuroRec Conf.4EuroRecEC21Yes16.03.2011 D4.3 Second Annual Project Report4EuroRecRP24Yes16.03.2011 D4.4 Validation of EuroRec Statements and EuroRec Use Tools 4EuroRecRC22Yes15.03.2011 D4.5 Documentation for the third set of National Workshops 4EuroRecRC22Yes24.03.2011 D5.1 Report on the National Workshops5EuroRecEC30NoMerged with Deliverable D6.1 D5.2 Roadmap towards Sustainable Pan- European Certification of EHR systems 5EuroRecRP30Yes11.11.2011 D6.1 Report on the National Workshops (2 parts)6EuroRecEC36Yes08.02.2012Workshops 45/76 reported D6.2 Report on the validation of the quality labelling and certification procedures and scenarios 6EuroRecRP36Yes14.02.2012 D6.3 Translated EuroRec Statements Report (2 parts) 6EuroRecRC33Yes05.03.2012 D6.4 Report on the Third Annual EuroRec Conference 6EuroRecEC36Yes30.12.2011 D6.5 Third Annual Report6EuroRecRP36Yes05.03.2012 D6.6 Final report6EuroRecRP36Yes10.03.2012

18. Investments during the lifetime of the project Brussels, March 30, 2012 18

19. 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 19

20. 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 20

21. 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 21

22. 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 22

23. Translations: 12.379 in total Brussels, March 30, 2012 23

24. Validation of the EuroRec Repository and of the Descriptive Statements Brussels, March 30, 2012 24

25. 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 25

26. Setting-up effective quality labelling Brussels, March 30, 2012 26

27. 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 27

28. EHR Market Overview : main conclusions Brussels, March 30, 2012 28

29. Brussels, March 30, 2012 29

30. 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 30

31. 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 31

32. 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 32

33. Brussels, March 30, 2012 33

34. Brussels, March 30, 2012 34 Roadmap towards a sustainable pan- European certification of EHR systems

35. 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, 2012 35

36. 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 36

37. 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 37

38. 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 38

39. 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 39

40. 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 40

41. 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 41

42. 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 42

43. 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 43

44. Stakeholders & Functional Diagram Brussels, March 30, 2012 44 ISO/IEC 17020 => <= ISO/IEC 17011 ISO/IEC 17025 =>

45. 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 45

46. 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

47. Actual “National” Certification Brussels, March 30, 2012 47 Existing “national” certification Foreseen within 1-2 years Considered

48. 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 48

49. 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 49

50. 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

51. 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 51

52. 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

53. Roll-out of Quality Labelling & Certification Mandatory Voluntary Incentivised Brussels, March 30, 2012 53

54. 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 54

55. 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 55

56. 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 56

57. Functionality & Interoperability Brussels, March 30, 2012 57

58. 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 58

59. 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 59

60. Recommendations from the Roadmap Brussels, March 30, 2012 60 1.Business aspects 2.Main Risks 3.Recommendations 4.Conclusions

61. 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 61

62. Budget for maintaining infrastructure Brussels, March 30, 2012 62 Budget for completion of the translation of the actual repository Number of languages Cost per language Total Completing actual sets of translations2015.000300.000 New Languages520.000100.000 Coordination and Consistency Management255.000125.000 525.000 Supporting integration of national specific variants Defining the national variants and translating them305.000150.000 Coordination and Consistency Management302.50075.000 225.000 Annual Maintenance Costs Number of languages Cost per language Total Maintenance of the translated statements255.000125.000 Coordination and Consistency Management252.50062.500 187.500 Expanding the repository to be more comprehensive (3.000 statements) Central Repository Maintenance and Expansion225.000 Translating to the different languages2515.000375.000 600.000

63. 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 63

64. 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 64

65. 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, 2012 65

66. 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, 2012 66

67. 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 67

68. 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 68

69. 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 69

70. 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 70

71. 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 71

72. Quality Labelling and Certification Procedures : the quality of the process Brussels, March 30, 2012 72

73. 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 73

74. Applicable standards Brussels, March 30, 2012 74 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)

75. A reminder… Brussels, March 30, 2012 75 ISO/IEC 17020 => <= ISO/IEC 17011 ISO/IEC 17025 =>

76. 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, 2012 76

77. 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 77

78. 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 78

79. 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 79

80. 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 80

81. Assessment & Granting Phase Brussels, March 30, 2012 81

82. 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 82

83. 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 83

84. 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 84

85. 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 85

86. 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 86

87. 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 87

88. 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 88

89. 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 89

90. EuroRec : Certification Body Brussels, March 30, 2012 90

91. HHS: Certificate related Brussels, March 30, 2012 91

92. Recommendations (about the process) Brussels, March 30, 2012 92 Discretion and Confidentiality Impartiality Openness Distinct roles involved organisations Independence Initial Documentation Rules of Evaluation Testing Documentation Documentation of the process

93. Recommendations (about the process) Brussels, March 30, 2012 93 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

94. What could the future bring? Brussels, March 30, 2012 94

95. 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 95

96. 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 96

97. Main risk Americanisation: One single country Rules issued endorsed by the authorities Resources available to “influence” the market Brussels, March 30, 2012 97

98. 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 98

99. 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 99

100. 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 100

101. Brussels, March 30, 2012 101 Thank You...