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A Systematic Review of the Current Legal Position of eHealth Standards in Norway

Authors:
Marianne Lodvir Hemsing

Keywords: Health Technology; Medical Software; Standards; Policy in Digital Health.

Abstract:
This systematic review investigates how Norwegian courts engage with technical standards and European Conformity (CE) marking in legal disputes involving eHealth and medical software. Although European regulation increasingly relies on harmonised standards, a systematic screening of 36 legal decisions from the national case-law database Lovdata Pro (2015–2025) found only five cases referencing either standards or CE-marking, and in none were these references determinative. Standards appeared as supportive background at best, and CE-marks were invoked as compliance signals rather than legal authority. These findings suggest that, unless legally “activated” via regulation or contract, technical standards play little role in litigation. The study offers a legal baseline ahead of European Health Data Space (EHDS) rollout and provides recommendations for improving the enforceability of standards in Norway.

Pages: 45 to 50

Copyright: Copyright (c) IARIA, 2025

Publication date: October 26, 2025

Published in: conference

ISSN: 2519-8491

ISBN: 978-1-68558-312-5

Location: Barcelona, Spain

Dates: from October 26, 2025 to October 30, 2025