TY - JOUR
T1 - Artificial intelligence tools in clinical neuroradiology
T2 - essential medico-legal aspects
AU - Hedderich, Dennis M.
AU - Weisstanner, Christian
AU - Van Cauter, Sofie
AU - Federau, Christian
AU - Edjlali, Myriam
AU - Radbruch, Alexander
AU - Gerke, Sara
AU - Haller, Sven
N1 - Open Access funding enabled and organized by Projekt DEAL. S.G.’s work was funded by the European Union (Grant Agreement no. 101057099). Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the Health and Digital Executive Agency. Neither the European Union nor the granting authority can be held responsible for them. S.G. also reports grants from the European Union (Grant Agreement no. 101057321), the National Institute of Biomedical Imaging and Bioengineering (NIBIB) of the National Institutes of Health (Grant Agreement no. 3R01EB027650-03S1), and the Rock Ethics Institute at Penn State University.
PY - 2023/7
Y1 - 2023/7
N2 - 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.
AB - 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.
KW - Artificial intelligence; Regulation; Clinical decision support; Privacy protection; Neuroradiology
UR - http://www.scopus.com/inward/record.url?scp=85158920197&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85158920197&partnerID=8YFLogxK
U2 - 10.1007/s00234-023-03152-7
DO - 10.1007/s00234-023-03152-7
M3 - Review article
C2 - 37160454
AN - SCOPUS:85158920197
SN - 0028-3940
VL - 65
SP - 1091
EP - 1099
JO - Neuroradiology
JF - Neuroradiology
IS - 7
ER -