Abstract Applications utilizing artificial intelligence (AI) have become a ubiquitous, indispensable part of modern life. This also applies to medicine where AI systems can support staff in decision-making processes and administrative tasks, but there is still uncertainty about the legality of their use. This review introduces examples from neuro-oncology, highlighting legal aspects and providing suggestions for the application of the Medical Device Regulation, the European Regulation on Artificial Intelligence (AI Act), the General Data Protection Regulation, and potential liability issues. AI systems for medical use are medical devices and high-risk AI systems that require the necessary certifications and entail strict requirements for clinical use. Since this may also apply to general AI tools if they are used for medical purposes other than their intended use cases, such use must be critically examined. However, the ultimate responsibility for using AI systems in a medical setting lies with the physicians, who need to be appropriately trained and made aware of the rules and regulations.
Agkatsev et al. (Thu,) studied this question.