Artificial intelligence

Abstract: The modern advancement of the healthcare system is characterized by the rapid integration of artificial intelligence technologies, which transforms approaches to diagnosis, treatment and management of medical institutions. At the same time, this process generates complex legal and ethical challenges related to the responsibility of medical professionals, the protection of personal data, and the use of automated systems in clinical decision-making. This study aims to provide a comprehensive analysis of the legal aspects of the implementation of artificial intelligence in healthcare, a comparison of regulatory approaches of the world’s leading jurisdictions, as well as the identification of directions for improving national legislation. The study uses regulatory legal acts of Ukraine, the European Union, the United States, Canada, and China, strategic documents of governments and international organizations, and applies methods of comparative jurisprudence, system analysis, and legal hermeneutics. It has been established that globally, various regulatory models of artificial intelligence have emerged: the risk-based European model, the decentralized approach of the United States, and the centralized system of China, while Canada combines federal and regional mechanisms. Ukraine is at the stage of forming an appropriate legal framework and requires its harmonization with European standards. The necessity of implementing the provisions of the European Artificial Intelligence Act, defining the legal status of medical AI systems, and introducing effective mechanisms of civil liability is justified. Taken together, these measures can ensure a balance between innovative development and protection of the rights of individuals and legal entities.

Keywords: artificial intelligence, medical law, digitalization, European Union, Artificial Intelligence Act, Medical Device Regulation, legal regulation, medical data, liability, cybersecurity

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