Artificial intelligence tools in clinical neuroradiology: essential medico-legal aspects

Dennis Martin Hedderich (1) , Christian Weisstanner , Sofie van Cauter (2, 3, 4) , Christian Federau (5) , Myriam Edjlali (6, 7) , Alexander Radbruch (8) , Sara Gerke , Sven Haller (9, 10, 11)

1 TUM - Technische Universität Munchen - Technical University Munich - Université Technique de Munich
2 Department of Cardiology, Ziekenhuis Oost-Limburg, Genk
3 University Hospitals Leuven [Leuven]
4 UHasselt - Hasselt University
5 UZH - Universität Zürich [Zürich] = University of Zurich
6 END-ICAP - Handicap neuromusculaire : Physiopathologie, Biothérapie et Pharmacologies appliquées
7 Hôpital Raymond Poincaré (Garches) [GHU AP-HP Université Paris-Saclay]
8 University Hospital Bonn
9 Uppsala University
10 UNIGE - Université de Genève = University of Geneva
11 CUMS - Capital University of Medical Sciences [Beijing]

Commercial software based on artificial intelligence (AI) is entering clinical practice in neuroradiology. Consequently, medico-legal aspects of using Software as a Medical Device (SaMD) become increasingly important. These medico-legal issues warrant an interdisciplinary approach and may affect the way we work in daily practice. In this article, we seek to address three major topics: medical malpractice liability, regulation of AI-based medical devices, and privacy protection in shared medical imaging data, thereby focusing on the legal frameworks of the European Union and the USA. As many of the presented concepts are very complex and, in part, remain yet unsolved, this article is not meant to be comprehensive but rather thought-provoking. The goal is to engage clinical neuroradiologists in the debate and equip them to actively shape these topics in the future.

Keywords: Artificial intelligence; Regulation; Clinical decision support; Privacy protection; Neuroradiology

Domains: Neurons and Cognition [q-bio.NC]

Dennis Martin Hedderich, Christian Weisstanner, Sofie van Cauter, Christian Federau, Myriam Edjlali, et al.. Artificial intelligence tools in clinical neuroradiology: essential medico-legal aspects. Neuroradiology, 2023, 65 (7), pp.1091-1099. ⟨10.1007/s00234-023-03152-7⟩. ⟨hal-04191735⟩