ADMINISTRATIVE AND LEGAL INSTRUMENTS OF STATE REGULATION OF THE USE OF ARTIFICIAL INTELLIGENCE SYSTEMS IN THE SPHERE OF HEALTH CARE EUROPEAN EXPERIENCE AND PROSPECTS FOR UKRAINE

Abstract

The article is devoted to the study of administrative and legal instruments of state regulation of the use of artificial intelligence systems in the field of healthcare. The author justifies the relevance of the issue by the rapid expansion of the capabilities of algorithmic systems, which increasingly perform tasks that traditionally belonged exclusively to the competence of a doctor, in particular the interpretation of medical images and the formation of treatment recommendations. It is emphasized that this process is accompanied by gaps in legal support, in particular the lack of mechanisms for distributing responsibility between the developer, supplier and medical institution, as well as the uncertainty of procedures for controlling the safety of algorithmic solutions, the logic of which is variable and not subject to one-time verification. Within the framework of a review of scientific sources, the author analyzes the positions of foreign and domestic researchers on the value principles of the Artificial Intelligence Act and their structuring into public administration blocks, the delimitation of competence between the European Union and the member states regarding the regulation of artificial intelligence systems in national healthcare systems, the ratio of sectoral and horizontal approaches to regulation, as well as the problems of informed consent and digital asymmetry. Special attention is paid to domestic experience, in particular, pilot projects of the use of artificial intelligence in medical institutions of Ukraine, the functioning of the European Health Data Space and gaps in national legislation. Based on the results of the study, the author concludes that the administrative and legal regulation of artificial intelligence in healthcare should combine the product level of regulation with the organizational and managerial level of public administration, and legal guarantees of patient safety require the development of a medical data management infrastructure. It has been established that the situation in Ukraine is characterized by a gap between the pace of technology implementation and the lack of systemic regulatory support, and the EU riskoriented model has been identified as the most suitable benchmark for improving national legislation given the country’s European integration course.