Artificial Intelligence Technologies in Reproductive Health Care in Russia and Foreign Countries: Ethical and Legal Possibilities

This article presents the ethical and legal opportunities of using artificial intelligence (AI) in reproductive medicine. A review of domestic and international scientific studies allows us to highlight regulatory opportunities, patient rights, and formulate proposals for improving legal regulation in key areas, including the assessment of biological material for assisted reproductive technologies (ART) and embryos, embryo selection, and predicting the outcomes of in vitro fertilization (IVF). Objective. To present the potential for legal regulation of the use of artificial intelligence in reproductive medicine at the national level in Russia and in foreign jurisdictions, to substantiate the insufficiency of current legislative regulation, and to propose directions for harmonizing legal approaches. Materials and methods. The study is based on an analysis of international and Russian regulatory legal acts and standards. Methods include system analysis, comparative legal analysis, and doctrinal method. Results. The fragmentary nature of legal regulation of AI use in Russian medicine without standardization methods was revealed. Various regulatory strategies in foreign jurisdictions are presented, ranging from the risk-oriented approach of the European Union to the product-oriented system of the United States and the innovation sandboxes of the United Kingdom. It has been established that the distribution of legal liability for errors in the use of AI in medicine between the physician, the medical organization, and the software developer remains a key unsolved issue. Conclusion. Proactive regulatory action at the national level, enshrining the «human-in-the-loop» principle, as well as the creation of compensation mechanisms that consider international experience in regulating artificial intelligence, both in the use of medical devices and in institutional oversight in the reproductive sector, are needed.