Legal Dimensions of Artificial Intelligence Use in the Healthcare Sector

Abstract

The article analyzes the legal dimensions of using artificial intelligence in the field of healthcare and identifies key gaps that hinder the development of an effective regulatory framework for the application of AI in medical practice in Ukraine.

The research methods are based on systemic, comparative-legal and formal-legal analysis, which made it possible to compare international and national approaches to regulating medical AI systems and to assess their compliance with the principles of safety, transparency and the protection of human rights.

The study reveals the insufficiency of the current regulatory framework, the lack of clear procedures for determining liability for AI-related errors, the absence of a defined legal status for developers and users of AI systems, as well as the unregulated nature of contractual relations in personalized medicine. It is demonstrated that international regulatory models rely on a risk-based approach and impose heightened safety requirements for high-risk systems, which should be taken into account when adapting Ukrainian legislation.

The conclusions emphasize that the use of artificial intelligence in healthcare generates significant legal challenges that are not yet adequately addressed by existing regulations. Despite the considerable potential of AI to improve the quality of medical services, the absence of a coherent legal model, comprehensive safety standards and liability mechanisms creates substantial risks for both patients and healthcare institutions. Responsible use of AI in healthcare is impossible without transparent algorithmic oversight and guarantees of human rights protection. The uncertain legal status of actors involved in the development and implementation of AI, together with the lack of norms governing contracts, quality standards, insurance and risk allocation, results in critical regulatory gaps. Further research should focus on clarifying the legal status of stakeholders involved in medical AI and on developing ethical and legal frameworks tailored to the healthcare sector.