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

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.

Automated summary

Commercial AI-based software is being used in neuroradiology, making medico-legal issues related to Software as a Medical Device (SaMD) increasingly important. This article discusses medical malpractice liability, AI-based medical device regulation, and privacy protection in shared medical imaging data, focusing on the legal frameworks of the European Union and the USA. The intention is to provoke thoughts rather than provide comprehensive solutions, engaging clinical neuroradiologists in shaping the future of these topics.