As of 2025, Ukraine lacks clear regulations governing the use of artificial intelligence in the economic activities of healthcare institutions. Meanwhile, in recent years, the European Union has adopted several legal acts that regulate the use of artificial intelligence for medical purposes.

The purpose of this article is to analyse the key provisions of EU law related to medical artificial intelligence, with a view to their further integration into Ukrainian legislation. To achieve this purpose, the following objectives are set: to examine recent developments in EU law related to medical AI, to determine their relationship with other legal norms, and to identify the shortcomings that Ukraine should consider during the adaptation process.

The relevance of the study is determined by both the increasing practical use of artificial intelligence in Ukrainian healthcare and the absence of precise national legal regulation in the field of AI. As part of its obligations to the European Union, Ukraine will be once required to implement European approaches to AI into its national legislation. Timely adaptation of these approaches may help mitigate challenges related to workforce shortages and limited resources in the healthcare system.

In the course of the research, the authors employed the following methods: the system analysis and synthesis method (to examine the structure of European regulation and identify pathways for integrating relevant norms into Ukrainian legislation); the comparative legal method (to contrast the legislation of Ukraine and the EU concerning AI regulation); the formal-logical method (to ensure a consistent and reasoned examination of normative provisions of European acts on AI in healthcare); and the hermeneutic method (to interpret specific legal terms and norms in the field of medical AI regulation).

The authors compared the AI Act with other European instruments, including the Medical Device Regulation (MDR), the In Vitro Diagnostic Regulation (IVDR), the European Health Data Space Regulation (EHDS), the General Data Protection Regulation (GDPR), and the Council of Europe Framework Convention on Artificial Intelligence. These instruments establish a multi-level model of legal regulation of AI in the field of medicine. In this context, Ukraine must ensure not only legal adaptation but also the development of national methodological guidelines for practitioners, following the best practices of the European Commission.

The research findings demonstrate that the European approach to regulating artificial intelligence in healthcare is based on a multi-level model (AI Act, MDR, IVDR, EHDS, GDPR, and the Council of Europe Framework Convention on Artificial Intelligence). This model integrates requirements for safety, transparency, data protection, and innovative development.

Particular importance is attached to the AI Act’s provisions for classifying AI systems by risk levels, establishing mandatory requirements for high-risk medical applications, and strengthening supervision throughout all stages of their lifecycle. At the same time, the MDR and IVDR remain relevant, as they provide the mechanism for a single conformity declaration, while the EHDS ensures patients’ rights to access and reuse medical data.

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