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Review
. 2023 Jul;65(7):1091-1099.
doi: 10.1007/s00234-023-03152-7. Epub 2023 May 9.

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

Dennis M Hedderich  1 , Christian Weisstanner  2 , Sofie Van Cauter  3   4   5 , Christian Federau  6   7 , Myriam Edjlali  8   9 , Alexander Radbruch  10 , Sara Gerke  11 , Sven Haller  12   13   14   15
Affiliations
Review

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

Dennis M Hedderich et al. Neuroradiology. 2023 Jul.

Abstract

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.

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Conflict of interest statement

Christian FEDERAU is working for AI Medical, yet there is no reference to this company in the current review article.

The other authors declare no conflict of interest related to the content of this review article.

Figures

Fig. 1
Fig. 1
Overview of risk classes and associated pathways for obtaining marketing authorization in the European Union or the USA
See this image and copyright information in PMC

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