Certification Of EHR Systems - Tony Kenny


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Certification Of EHR Systems - Tony Kenny

  1. 1. Certification ofEHR Systems HISI 2011 1
  2. 2. FEED BACK FROM 2 EU PROJECTSEHR – Implemement analysed implementation experience in 10 countriesEHR - QTN evaluating the importance and possible impact of having well documented good quality and reliable EHR systems on the market and users. HISI 2011 2
  3. 3. 10 GOOD REASONS TO ADOPT EHR SOLUTIONS Re-usability of information Tracability - Reliability - Responsability Manag. Patient empowerment Improve record / practice management Improve care management Improve care through decision support, surveillance and… Improved cost efficiency of care To share information Store & Retrieval To access any time anywhere Level 1 Level 2 0 Level 3 5 Level 4 10Level 5 15 20 25 30 HISI 2011 3
  4. 4. Barriers to Adopting High Start-up Costs 12 High On-going Costs 11 Financial Return on Investment (ROI) Uncertainty 8 Lack of Financial Resources 2 Lack of computer skills of the physicians and/or Staff 10 Lack of technical training and support 9Primary barriers Complexity of the system 2 Technical Limitation of the system 2 Lack of Customizability 5 Lack of Reliability 3 Interconnectivity/Standardizat ion 8 Lack of computers/hardware 2 Time to select, purchase and implement the system 5 Time to learn the system 7 Time Time to enter data 6 More time needed per patient 8 Time needed to convert the records 2 HISI 2011 4
  5. 5. Barriers to Adopting Lack of belief in EHRs Psychological Need for control (loss of control or influence) Uncertainty about the vendor Lack of support from external parties Interference with doctor-patient Social relationship Secondary barriers Lack of support from other colleagues Lack of support from the management level Legal Privacy or security concerns Organizational size Organizational Organizational type Lack of support from organizational culture Change Process Lack of incentives Lack of participation Lack of leadership HISI 2011 5
  6. 6. EFFECTIVE USEEHR-Implement issued two concreterecommendations:• Application selection should be the subject of detailed user evaluation to ensure local processes; workflow and functional needs are taken into account.• Vendors selection must be the subject of a thorough due diligence process to ensure that both the EHR software and vendor organisation are fit for purpose. HISI 2011 6
  7. 7. EFFECTIVE USESelecting the most appropriate application from the correct vendor is a real challengeQuality assessment, labelling and certification of the systems can fulfil an important rolewhen procuring an application.They offer, considering the trustworthiness of the procedure, a guarantee of compliancewith standards, legal and user requirements, of course as far as they are tested againstpre-defined and comparable / similar criteria. HISI 2011 7
  8. 8. Effective Use• “There is a large gap between the postulated and empirically demonstrated benefits of eHealth technologies. In addition, there is a lack of robust research on the risks of implementing these technologies and their cost-effectiveness has yet to be demonstrated” HISI 2011 8
  9. 9. Reasons why a country might opt for certification Assured compliance to national rules and standards Increasing quality of the products through coherent and pre-tested 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 Increase compliance to user and use quality requirements Improve EHR ProcurementImproving the quality of the care by improving the quality of the content based on related criteria Validated privacy protection Stimulate competition on quality and reduce market fragmentation Improve market deployment and product development 0 2 4 6 8 10 12 14 16 18 Level 1 Level 2 Level 3 Level 4 Level 5 HISI 2011 9
  10. 10. Stakeholders• Health Authorities • Initiators • Enablers, Facilitators • Responsible • Delegation– Buyers– Health Professionals– Patients– Industry HISI 2011 10
  11. 11. Initiator IAFSupplier Authority Accreditation body Certification body Certificate Label CAB Product HISI 2011 11
  12. 12. Verification and Validation of Software• Verification attempts to answer to the question “is the software built right?”• Validation attempts to answer to the question “is the right software built?” HISI 2011 12
  13. 13. Approaches to Certification• EHR-QTN approach • Third party assessment • quality label • Self-assessment with an external audit • declaration of quality.• HITCH approach • LabelCert of products • Self-assessment with external audit• KITH approach • Self-declaration based on high level description of key requirements • Self-declaration based on formal, verifiable requirements HISI 2011 13
  14. 14. What Works best• Third party assessment is the most suitable procedure for the still immature market of EHR systems.• Comprehensive or progressive testing – The EuroRec Repository• Modular quality labelling and certification – Eurorec “baskets” of criteria HISI 2011 14
  15. 15. Related Issues• Quality labels and certificates are primarily national.• It is strongly recommended to start small”,• Impact of the Medical Devices Directive 2007/47/EC – The IEC 62304 standard • Applicable to eHealth and EHR systems? • The Canadian Experience • Difficult area• HISI 2011 15
  16. 16. Building blocks• EuroRec • 1.700 functional descriptive statements• IHE HISI 2011 16
  17. 17. Overlaps HISI 2011 17
  18. 18. Sustaining certification Functional assessment and “interoperability” assessment should be kept as distinct procedures. Develop quality assessment and certification as a “public service” with / without subcontracting. Costs should be supported by the product suppliers Organise cross border recognition of tested functions. Develop and support a common “language” across Europe to describe functional requirements enabling portability across Europe: European repository of nationally reusable statements publically available. Costs need to be supported by the health authorities. Functional assessment and “interoperability” assessment should be offered by on Health IT Quality Institute. Develop and support a common “language” to describe functional requirements in a comparable way: national repository of reusable statements publically available. Costs need to be shared between health authorities and the industry, industry e.g. paying the effective testing / assessment onlyIncrease economic viability of the suppliers by supporting the use of certified EHR systems and stimulating defragmentation of the market. Create a relation of trust and partnership between authorities, users and industry. 0 2 4 6 8 10 12 14 Level 1 Level 2 Level 3 Level 4 Level 5 HISI 2011 18
  19. 19. Conclusions• May be hard to see now• But its coming …• 4 Speed Europe HISI 2011 19
  20. 20. HISI 2011 20