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Profilbild för European Health Data Space (EHDS) – opportunities and challenges in relation to standardization – Danish perspective and measures

European Health Data Space (EHDS) – opportunities and challenges in relation to standardization – Danish perspective and measures Har passerat

Tisdag 23 maj 2023 13:35 - 13:50 F2

Föreläsare: Frederik Endsleff, Jeanett Fleron

Spår: Nordiskt fokus, Standardisering - Från storpolitik till vårdens vardag - nordiskt och professionsperspektiv

The European Union has high demands in terms of information security, the rights of the individual and is now also setting a very ambitious way forward with several European "data spaces", with the European Health Data Space as one of the first and significant, with fierce expectations regarding content and timing, including both primary and secondary use. The EU Commission seems to pursue a somewhat independent and self-determining approach, where Denmark from a standards perspective seeks influence in several ways, together with CEN TC 251, through EU projects and via related institutions, authorities, and fora, including regarding the text of the proposal. European interests, legislation and standards should complement each other, as with European harmonized standards, and where such standards (from Standard Development Organizations) rely on structured methodology, involvement, and voting, resulting in higher quality and democratic legitimacy.        


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Profilbild för Frederik Endsleff

Frederik Endsleff Föreläsare

Senior architect
Centre for IT and Medical Technology, the Capital Region of Denmark

Frederik Endsleff is employed at the Centre for IT and Medical Technology (CIMT), the Capital Region of Denmark, as a senior architect, MSc (E), MD, and has worked with health informatics since the mid-1990s. He is chairman of committee S-273 Health Informatics in Danish Standards since 2010, has been a member since 1999, actively involved in ISO/CEN standardisation and associate member of S-821 hosting the Danish HL7 Affiliate. He is also a member of the IT architecture council of the Danish Regions (RITA) and Member of the Advisory Committee on Standards and Architecture (RUSA) under the Danish Health Data Authority.

Profilbild för Jeanett Fleron

Jeanett Fleron Föreläsare

Senior Consultant
Danish Standards

Jeanett Fleron is sociologist and senior consultant. She works for Danish Standards to drive the development of European and international standards politically and commercially for the benefit of Danish companies, authorities and organizations.

She facilitates and leads the standardization areas: Medical Devices - Management & Quality (DS S-257/ISO TC 210), Biocompatibility & Clinical Documentation (DS S-258/ISO TC 194), Health Informatics (DS S-273/CEN TC 251/ISO TC 215) & Biotechnology (DS S-809/ISO TC 276).

She represents Danish Standard in CEN/Cenelec's Advisory Board for Healthcare Standards to the European Commission (ABHS) & the Danish Medicines Agency's Medical Devices Committee (UMU).