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Status Report IHE-Europe Certification Workgroup

Status Report IHE-Europe Certification Workgroup. Cor Loef, convener IHE-EU Certification Group. eHealth Solutions Quality Goals. Healthcare Authorities: Promote use of good quality eHealth solutions Provide comfort to the care providers and the patients

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Status Report IHE-Europe Certification Workgroup

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  1. Status Report IHE-Europe Certification Workgroup Cor Loef, convener IHE-EU Certification Group

  2. eHealth Solutions Quality Goals • Healthcare Authorities: • 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

  3. Quality Assurance: at which Level? Dutch Switch point example: National Switch Point Care Provider Care Provider Enterprise IT Enterprise IT GP summary GP summary

  4. Requirements before connecting to Dutch Switch point • Application (functional) Requirements • Features • Includes security, accuracy • 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

  5. 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

  6. Interoperability/Connectivity Experience • DICOM • Available commercial and public 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 • Web Technology consortia approach

  7. Concluding • There are many ways to assure quality of eHealth implementations • E.g. by providing “certified” tests, jury inspections, self-certification, etc. • Realize that products and interoperability specs are embedded in a context • Requiring specific ways of quality assurance

  8. IHE, testing and certification, improvement ideas (1) • [1]Introduce light-weight vendor-neutral field problem reporting process with feedback loop to IHE TF specifications and test tools. • [2]Connect-a-thon: make distinction between prototypes and products. • [3]Independent healthcare provider “jury” at Connect-a-thon. Have ISO certification of IHE Connectathon process. Contact recognized testing bodies and invite them to Connectathon. • [4]Introduction of test specifications in the IHE Technical Framework and Integration Profile development process. • [5]Formal review process by healthcare providers for the test specifications.

  9. IHE, testing and certification, improvement ideas (2) • [6]Improve the IHE test tools, by means of an Open Source development. • [7]Perform self-certification by vendors with the approved test specifications and tools. `[7b] : Validation of the tools by third party ? • [8]Vendor’s Marketing/Sales staff should know about and promote IHE quality testing process, based on easy to use tool given to them with technical stuff. • [9]List the features of the actors in IHE profiles, to facilitate the use of “building blocks” in National Healthcare IT Infrastructure projects, hospitals and others healthcare organizations • [10] : general glossary • [11] : process of maintenance of fixes to TF , CP process

  10. [2] : the result table with only products and impact to the CAT organization [3] : select third party ? Feedback [10] [11] [1] Connect-a-thon Implementation [8] Needs standards Technical Framework Tools for Connect-a-thon [9] [5] [6] [2] [4] [7b] [3] Feedback [4] : document of test plan/profile.actor [5] : Validation of the document [6] : Gazelle [7b] : validation of Gazelle by ISO (?) [10] : general glossary List of profiles, actors,standards… [11] : definition of the maintenance process [1] : reporting from user organizations to users cochairs, consolidation of the reports (to be defined) [8] : education sessions to users and vendors [9] : easy to use documents

  11. [1] Definition of an diagnostic report to give to user organizations to evaluate the quality of the integration: Process study Evaluation of the IHE workflow Differences ? Terminology Selected Profiles Actors, companies, transactions Others transactions Process of site test WHO Delay parameters Test plan (from IHE ?) Problem met Others concerns

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