Legal Regulation of the Practical Use of Medical Artificial Intelligence Systems

In medical practice, a situation requires legal and bioethical justification when a doctor decides on the choice of treatment tactics based on data that becomes available due to the development of artificial intelligence systems and which he is unable to verify himself with a reasonable investment of time, material and other resources. The field under consideration is fundamentally different from the field of verification and administrative procedures for recognizing medical devices that comply with technical regulations, since it does not eliminate the question of to what extent a doctor can legally rely on data from artificial intelligence systems, if, for example, they are counterintuitive. The involvement of artificial intelligence systems cannot be recognized as a trivial evolution of diagnostic technologies that exceed human capabilities, since there are questions about the rotation of expert opinions in the protocol of medical research, as well as the procedure for resolving contradictions. The authors present a study of the legal regulation of the use of artificial intelligence systems in the field of medical diagnostics, based on the analysis of regulatory material, scientific literature, own medical and legal practice. Based on an interdisciplinary approach, integrative solutions to problematic issues aimed at improving regulatory framework in a relatively new area of legal relations in the field of health are proposed. The authors consider the criteria for evaluating the effectiveness of medical solutions and the conditions for the onset of civil liability

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