Objective: To analyze the legal and ethical aspects of regulating artificial intelligence (AI) in medicine in key jurisdictions (United States, European Union, China, Russia), to identify regulatory gaps, ethical dilemmas and prospects for harmonization of standards. Material and methods. National and international regulatory documents (GDPR, AI Act, FDA, NMPA), scientific publications, clinical cases and regulatory initiatives (IMDRF, WHO) were reviewed. Methods for comparative legal analysis and systematization of ethical and legal norms were used. Results. Considerable differences in approaches to AI regulation were identified, including flexibility in the US, the ethical centricity in the EU, centralization in China and an emerging framework in Russia. Key issues were emphasized, such as algorithmic bias, AI transparency, responsibility, and the conflict between innovation and security. Conclusion. The harmonization of international standards, the introduction of dynamic regulation and the strengthening of interdisciplinary cooperation should be pursued to achieve a balance between innovation and the protection of patients' rights.
Korabelnikov et al. (Thu,) studied this question.