Roadmap towards Sustainable Pan- European Certification of EHR System Synthesis of the deliverable of the European project EHR-Q TN

Transcription

1 Roadmap towards Sustainable Pan- European Certification of EHR System Synthesis of the deliverable of the European project EHR-Q TN François Wisniewski, Jos Devlies, Icíar Abad CRP Henri Tudor, Luxembourg EuroRec, Belgium Hospital Universitario de Fuenlabrada, Spain Med-e-Tel, 19 th April 2012, Luxembourg

2 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):

3 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 3

4 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:

5 Risks of using EHR systems Likelihood of occurrence of harm Degree of severity of harm to a patient Minor Significant Considerable Major Catastrophic Very high High Medium Low Very low Clinical risk acceptability matrix (Source: TS 29321:2008) -> Need a way to assess the quality of the EHR systems. 5

6 EHR certification in Europe Existing national Certification Foreseen within 1-2 years Considered No decision country 6

7 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 7

8 Impact of quality labelling and certification reported by the consortium Ongoing effect on the system s quality through conformity to a set of functional requirements, based on standards. Improved and consistent software quality. Improved, comparable and reliable procurement procedures. Facilitate interoperability in selected areas on national level. The impact of the certification is increased when supported by a legal framework (e.g. Serbia with the IT Rulebook). financial incentives for the users of certified systems. regulatory promotion of the certified products to end-user customers (Health Pro). 8

9 Certification Strategy Market Driven: decided by the supplier Supplier driven: initiative by the supplier requesting a quality label 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 or regulation 9

10 Roles of the Stakeholders Initiator IAF Supplier Authority Accreditation body <= ISO/IEC ISO/IEC => Certification body Certificate Label ISO/IEC => CAB Product CAB (Conformity Assessment Bodies) IAF (International Accreditation Forum) 10

11 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 11

12 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? 12

13 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 the legal framework 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 13

14 Three certification models Mandatory Certification Voluntary quality labelling & certification Incentivised 14

15 Three certification models (2) Mandatory Certification model Less efforts for consensus building with users and suppliers. Easier to implement a long term strategy for authority and for suppliers. Authority needs to have the means of its ambition. Defensive suppliers contesting interpretations of the criteria. May reduce competition and innovation. Voluntary quality labelling & certification model Based on a consensus between different stakeholders. Less contestation. Shared cost has more chance to be accepted. Long and stepwise approach with fastidious negotiations. Slower take-up and still some non-certified products on the market. Weakest partners may hamper progress. 15

16 Three certification models (3) Incentivised model -> Best of 2 worlds with the empowerment of the user. Involvement of all stakeholders Win-win for all stakeholders Important involvement of authorities granting incentives Important pre-assessment efforts. 16

17 Recommendations Legal and regulatory framework Create and harmonise the legal and regulatory framework Clarify the role of the Medical Device Directive 2007/47/EC regarding software development aspects Involvement of stakeholders Create an advisory platform involving all stakeholders to agree on content and feasibility of requirements. 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. 17

18 Recommendations (2) Technical Framework Strengthen the European scale pioneering initiatives (EuroRec / I.H.E) in order to keep certification on the agenda and invest in maintenance and expansion of the actual descriptive statements and profiles. Address the issue of personnel shortage in health informatics in general and more specifically in health informatics quality assessment. Quality labelling and certification 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 18

19 Recommendations: cross-border 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. Promote equivalence of certificates across Europe by validating at European level both the functional descriptive statements of EuroRec and the IHE profiles. Consider the possibility to create a cross-border Register of Quality Labelled or Certified Clinical Software, offering information about the products (complete EHR systems as well a software modules) and documentation about the certification process. 19

20 Thank you François Wisniewski CRP Henri Tudor SANTEC,Luxembourg