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Background: Cutting-edge digital technologies are being actively introduced into healthcare. The recent successful efforts of artificial intelligence in diagnosing, predicting and studying diseases, as well as in surgical assisting demonstrate its high efficiency. The AI’s ability to promptly take decisions and learn independently has motivated large corporations to focus on its development and gradual introduction into everyday life. Legal aspects of medical activities are of particular importance, yet the legal regulation of AI’s performance in healthcare is still in its infancy. The state is to a considerable extent responsible for the formation of a legal regime that would meet the needs of modern society (digital society). Objective: This study aims to determine the possible modes of AI’s functioning, to identify the participants in medical-legal relations, to define the legal personality of AI and circumscribe the scope of its competencies. Of importance is the issue of determining the grounds for imposing legal liability on persons responsible for the performance of an AI system. Results: The present study identifies the prospects for a legal assessment of AI applications in medicine. The article reviews the sources of legal regulation of AI, including the unique sources of law sanctioned by the state. Particular focus is placed on medical-legal customs and medical practices. Conclusions: The presented analysis has allowed formulating the approaches to the legal regulation of AI in healthcare.
Laptev et al. (Wed,) studied this question.