European Health Data Space (EHDS) – opportunities and challenges in relation to standardization – Danish perspective and measures Passed
Tuesday May 23, 2023 13:35 - 13:50 F2
Lecturers: Frederik Endsleff, Jeanett Fleron
Track: Nordic focus, 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.
Topic
Data and Information
Language
English
Seminar type
Pre-recorded + On-site
Objective of lecture
Orientation
Level of knowledge
Advanced
Target audience
Management/decision makers
Keyword
Innovation/research
Law, Judicial procedures
Government information
Conference
Vitalis
Lecturers
Frederik Endsleff Lecturer
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.
Jeanett Fleron Lecturer
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).