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- Title
Anna Haftenberger, Die Produkthaftung für künstlich intelligente Medizinprodukte – Eine Analyse der Anwendbarkeit und Eignung der europäischen Produkthaftungsrichtlinie 85/374/EWG.
- Authors
Handorn, Boris
- Abstract
The article "Anna Haftenberger, Product Liability for Artificially Intelligent Medical Devices - An Analysis of the Applicability and Suitability of the European Product Liability Directive 85/374/EEC" examines the applicability of the European Product Liability Directive 85/374/EEC to artificially intelligent medical devices. The author analyzes the challenges posed by the connectivity, autonomy, opacity, and complexity of new digital technologies. She also examines the concept of error in the directive and the assessment criteria for liability-relevant errors in AI-based medical devices. The author argues that existing liability rules provide adequate solutions and that new risks posed by AI can be addressed through judicial interpretation and legal development. However, the European legislator has proposed a revised product liability directive to cover further action needs. A new product liability directive is expected to come into force by 2024.
- Subjects
PRODUCT liability; MEDICAL errors; MEDICAL equipment; DIGITAL technology; NEW product development
- Publication
GesR: Gesundheitsrecht, 2024, Vol 23, Issue 4, p271
- ISSN
1610-1197
- Publication type
Article
- DOI
10.9785/gesr-2024-230417