Roadmap to a Sustainable Pan-European Certification of EHR Systems A deliverable of the European project EHR-Q TN

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1 Roadmap to a Sustainable Pan-European Certification of EHR Systems A deliverable of the European project EHR-Q TN François Wisniewski CRP Henri Tudor SANTEC, Luxembourg Regional Conference: EHR Systems Quality Labeling and Certification & EuroRec 2011 Annual Conference - Belgrade November 2011

2 Good reasons to generalise the use of EHR systems Top 5 of the consortium opinion: Enable a wider availability of health and care related data, accessible any time and any where. Improve cost efficiency of care avoiding double or unnecessary procedures and care consumption. Improve quality of care through decision support, surveillance and monitoring care, supporting operational processes. Enable appropriate documentation of the care. Improve interoperability and continuity of care through sharing of information. 2

3 Some quantifiable profits of the usage of EHR systems from the literature Increase adherence to guidelines, enhance disease surveillance, and decrease medication errors 1. Improvements in quality of care in the range of 12% to 20% 2. Enhancement of primary and secondary preventive health care delivery: influenza vaccination (12 to 18%), pneumococcal vaccinations (20 to 33%) and faecal occult blood testing (12 to 33%) 3. Reduce office visit times by 13% 4. 1 Shekelle Pg et al. Costs and benefits of health information technology. Evidence Report/Technology Assessment (Full Rep) Apr;(132): Balfour, D.C. et al. Health information technology - results from a roundtable discussion. Journal of managed care pharmacy JMCP 15, (2009). 3 Chaudhry B et al. Systematic review: impact of health information technology on quality, efficiency, and costs of medical care. Ann Intern Med May 16;144(10): Epub 2006 Apr Menachemi N, Brooks RG. Reviewing the benefits and costs of electronic health records and associated patient safety technologies. Journal of Medical Systems 2006 Jun;30(3):

4 Can any EHR meet these potential benefits? Essential requirements regarding functionality and user friendliness Fit for purpose. Sufficiently configurable to meet personal preferences Without errors, bugs and rigidity in use Effective and correct use of an EHR system by the user No sub-use of the system s potential Correct coding and structuring of the content of an EHR 4

5 Risks of using EHR systems Myers et al*. shows that adverse events are mainly manifested by: missing or incorrect data, data displayed for the wrong patient, chaos during system downtime system unavailable for use. Example of reported incidents in healthcare where 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:

6 Ricks of using EHR systems Software risk classes (Source: ISO/TS 25238:2007) -> Need a way to assess the quality of the EHR systems. 6

7 EHR certification in Europe Currently in place Austria, Belgium, Croatia, Denmark, Netherlands, Norway, Serbia In plan within 1 or 2 years Slovakia, Czech Republic, Italy In reflexion for later United Kingdom, Cyprus, Estonia and Ireland No decision country 7

8 Good reasons that can motivate a country to adopt EHR certification Top 5 of the consortium opinion: Assured compliance to national rules and standards Increasing quality of the products through coherent and pretested functionality Leverage exchange of health (care) related data and interoperability of systems Improved patient safety in care Have a reliable data source for secondary use 8

9 Impact of quality labelling and certification reported by the consortium Ongoing effect on the quality of the aspects of the systems covered by the certification through the suppliers adoption of a minimum clear functional requirements based on standards. Software solutions quality is uniform and better. Communication modules of solution are easier to buy (comparable, less specifications and discussions). Facilitate interoperability in selected areas on national level. The impact of the certification is increased when supported by a legal framework like in Serbia with the IT Rulebook. financial incentives promotion of the certified products to end-user customers (Health Pro) 9

10 Certification Strategy Market Driven: decided by the supplier Supplier driven: initiative by the supplier Procurement driven: the supplier needs to get a level of quality, of compliance with criteria as part of a procurement procedure. Public driven: enforced by law 10

11 Stakeholders Authorities -> a clear and consistent political commitment Health Authorities: Initiators, Enablers, Facilitators, Responsible, Delegation Regulatory Authorities: define requirements to be assessed Public Health Authorities: secondary users of the data from EHR Buyers: evaluate the compliance of the systems to their user needs Health Professionals: Users of EHR applications, Heterogeneous user group Patients: Beneficiaries, Users, Patient associations Industry: advisor, Suppliers of the systems 11

12 Roles of the Stakeholders Initiator IAF Supplier Authority Accreditation body Certification body Certificate Label CAB Product CAB (Conformity Assessment Bodies) IAF (International Accreditation Forum) 12

13 EHR-Q TN distinguishes the following certification procedures Certification procedure 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. Third party assessment by a CAB on requirements issued by an organisation not empowered by law or by regulation. 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. Self-assessment by vendor who performed testing on his own products and affirms that they conforming to a given set of requirements. Attestation granted Certificate Quality label No attestation but a quality mark on the product is allowed Declaration of quality 13

14 Verification and Validation of Software Verification = technical correctness of the software application or component of such an application. Verification attempts to answer to the question is the software built right? Validation = compliance of the application to the consumer s / user s functional expectations: does the application what it is expected to do and in a correct way? Validation attempts to answer to the question is the right software built? 14

15 Conditions needed to enable an EHR certification in a country Top 5 of the consortium opinion: 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 EHR (GP, ) Stimulate the use of certified EHR systems by offering services (improvement of administrative procedures) Initiate a cooperative platform involving all stakeholders to define overall quality criteria for the EHR 15

16 Conditions needed to reach sustainability of the EHR certification in a country Top 5 of the consortium opinion: 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 the effective testing / assessment only Develop and support a common language to describe functional requirements in a comparable way: national repository of reusable statements publically available. Functional assessment and interoperability assessment should be offered by on Health IT Quality Institute. 16

17 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 Accreditate a certification body Create advisory platforms with users and suppliers Select the standards to be used Preassessment 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 "restesting" sessions Distribute the "incentives" Update / upgrade of the criteria for future use 17

18 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) Preassessment 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 feasibility and appropriateness Assess the applications Document conformity or non conformity 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 18

19 Recommendations 1/4 Legal and regulatory framework Create and harmonise the legal and regulatory framework (Directive) 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. 19

20 Recommendations 2/4 Technical Framework It is highly recommended to strengthen the European scale pioneering initiatives (EuroRec / I.H.E) 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 as well as specialised in health informatics quality assessment. Quality labelling and certification process Third party assessment is the most suitable procedure for the still immature market of EHR systems. 20

21 Recommendations 3/4 Third party assessment offers most guarantees to the clients Mixed approaches are in use, self-assessment for a number of statements and third party assessment. This is the case in Belgium where previously tested criteria are self-assessed by the supplier, but still subject of ad random testing and validation. It is strongly recommended to start small, to evaluate the effectiveness of the scheme in place and the parties involved and to increase focus and requirements to be validated step by step. The incentivised model seems by far the most promising model to promote a more generalised used of certified systems, at least for self-employed healthcare professionals. The mandatory model may work in some countries with only employed healthcare professionals or only for employed healthcare professionals, though an incentive may be required for their employ 21

22 Recommendations 4/4 Regarding cross-border trans-european aspects Quality labels and certificates are primarily national. Strengthen national certification in order to improve average quality and to enable a second step Trans-European comparability and portability. The EuroRec statements facilitate yet cross-border and cross-domain functional certification of EHR systems. It would be pity not to use these opportunities. The IHE profiles are in principle country-independent and should be promoted as European Profiles for data-exchange. Promote equivalence of certificates across Europe by validating at European level the functional descriptive statements by 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. 22

23 Thank you François Wisniewski CRP Henri Tudor SANTEC,Luxembourg

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