EUROPEAN STANDARDS OF LEGAL REGULATION OF THE USE OF ARTIFICIAL INTELLIGENCE IN MEDICINE AND THEIR IMPLEMENTATION IN UKRAINE

Abstract

In the article, the author conducts a comprehensive analysis of European standards for the legal regulation of the use of artificial intelligence in healthcare and determines the directions of their implementation in the legislation of Ukraine. The impact of the rapid development of algorithmic systems on the transformation of the provision of medical services, the organization of healthcare and the process of clinical decision-making is revealed. The author focuses on the legal challenges associated with ensuring patient safety, protecting personal data, adhering to the principles of transparency, non-discrimination and accountability of automated decisions, as well as determining the limits of responsibility of entities involved in the development and application of AI technologies, and emphasizes the importance of an interdisciplinary approach to understanding these problems. The paper analyzes the provisions of Regulation (EU) 2024/1689 (AI Act) as a system-forming act of the EU that introduces a risk-based regulatory model, and also reveals the significance of the Regulation on the European Health Data Space (EHDS) for forming a legal regime for accessing, processing and reusing medical data. The author characterizes the interaction of crosssectoral and sectoral acts of the EU (MDR, IVDR, HTAR) as a multi-level and complementary system that covers the entire life cycle of AI systems in medicine. Special attention is paid to the analysis of legal and regulatory challenges reflected in the European Commission report on the implementation of AI in the healthcare sector, in particular regarding ensuring trust, algorithmic transparency and quality control. The level of readiness of Ukrainian legislation for the implementation of artificial intelligence in the medical sector is studied through the prism of constitutional principles, sectoral regulation and acts of digital transformation. The author argues that despite the presence of constitutional guarantees for the protection of human life and health in Ukraine, there is no holistic regulatory model for the application of AI in medicine. The conclusions emphasize the need to form a systemically coordinated legal regime capable of combining innovative development with appropriate guarantees of patient safety, protection of human rights and effective management of digital medical resources.