Certification - one of the means to our Goal Kees Smedema Chairman COCIR Healthcare IT Committee Philips Medical Systems

“Quality” Goals Healthcare Authorities: Care Providers Patients Promote use of good quality eHealth solutions Provide comfort to the care providers and the patients Make sure that promised benefits are realized Care Providers Trust quality and functionality of eHealth solutions Patients Safety, quality of care, privacy Vendors Trust by Care Providers in products and solutions Improving market and market access COCIR/HINE Industry Session Kees Smedema, 9 Oct 2006, 2

Quality Assurance: at which Level? Dutch Switchpoint example: National Switch Point Care Provider Care Provider Enterprise IT Enterprise IT GP summary GP summary COCIR/HINE Industry Session Kees Smedema, 9 Oct 2006, 3

Requirements before connecting to Dutch Switchpoint Application (functional) Requirements Features Includes security, accuracy, recent Interoperability/Connectivity requirement Connectivity and message exchange with Switch point Implementation (quality) Requirements Security, authorization, availability, up-time, performance/response time, scalability, accuracy Management/Maintenance Requirements Management of connectivity, security, availability, actuality Test node is provided Pilot, no certification yet COCIR/HINE Industry Session Kees Smedema, 9 Oct 2006, 4

Questions Can we devise certification/quality schemes without having a clear idea about the context? Compare HIPAA: regulation for Institution, not for a product What Quality aspect are we talking about? Functionality Connectivity and interoperability Installation, Maintenance, operational use What is the best way to guarantee quality? 3rd party certification? Self certification, supported by a formal test process Provision of (open source) certified test scripts How can we make this process efficient and effective? Incentives to vendors and 3rd party Added value by involving users COCIR/HINE Industry Session Kees Smedema, 9 Oct 2006, 5

Interoperability/Connectivity Experience DICOM Available commercial DICOM test tools Cross-vendor testing During shows (RSNA,.. ) Within vendor labs Enormous market pressure to produce good products Very close community: you know who to call from “the other vendor” IHE Connect-a-thon and demo’s, public test-tools “integration statements” published by vendors Vendor community much wider COCIR/HINE Industry Session Kees Smedema, 9 Oct 2006, 6

IHE, testing and certification, some ideas Implement test scripts (open source) together with the technical specifications Formal review process for the test tools Connect-a-thon: make distinction between prototypes and products Independent “jury” at Connect-a-thon Do self-certification with the approved test-scripts Introduce light-weight problem reporting process with feedback loop to specifications and test tools. COCIR/HINE Industry Session Kees Smedema, 9 Oct 2006, 7

Concluding There are many ways to assure quality of eHealth implementations E.g. by providing “certified” tests Provide incentives and additional value when 3rd party certification is done for certain aspects E.g. testing by experienced users Independent bodies can be divorced from reality and their added value maybe very small or negative compared to the additional cost (cost-feedback loop!) Realize that products and interoperability specs are embedded in a context Requiring other ways of quality assurance COCIR/HINE Industry Session Kees Smedema, 9 Oct 2006, 8