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Scientific journal «Current problems of health care and medical statistics»
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LEGAL AND ETHICAL PROBLEMS OF IMPLEMENTATION OF ARTIFICIAL INTELLIGENCE AT THE PRE-MEDICAL STAGE IN MEDICAL ACTIVITIES INCLUDING OPHTHALMOLOGY

M.G. Sveredyuk1,2, V.S. Stupak3, M.V. Pshenichnov1
1. Federal State Institution “Eye Microsurgery Research and Development Center named after Acad. S.N. Fedorov Ministry of Health of Russia, Khabarovsk
2. Institute for Advanced Training of Healthcare Professionals, Ministry of Health of Khabarovsk Krai, Khabarovsk
3. Russian Research Institute of Health, Ministry of Health of the Russian Federation, Moscow
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Summary:
Relevance. Given the growing importance of artificial intelligence systems of new medical technologies, legal regulation of issues related to them is on the agenda both at the international and state level. At the same time, the use of new medical technologies is associated with medico-legal risks. The authors of the study analyze possible risks, including medico-legal risks, from the position of non-regulation in the legislation of such categories as legal capacity and tortability of artificial intelligence. The study analyzes the ethical and legal problems of the introduction of artificial intelligence systems in medical activities, taking into account the analysis of modern legislation in the field of health care. Purpose of the study. To analyze the legal norms of the Fundamentals of legislation on the protection of citizens' health in the Russian Federation, the Civil Code of the Russian Federation, the Criminal Code of the Russian Federation, regulating the legal aspects of civil rights objects, medical activity, legal responsibility in the support of medical technologies with the use of artificial intelligence, including ophthalmology. Materials and methods of research. A systematic review of the legislation of the Russian Federation, provisions, current normative legal acts at the federal and regional level, regulating legal relations in the field of health protection, in the support of medical technologies with the use of artificial intelligence, including ophthalmology, was conducted. The following methods were used in the work: logical method (when presenting all the material, forming recommendations, proposals and conclusions); method of system analysis; method of comparative jurisprudence; method of modeling; statistical method. Research results. Health care is one of the most promising areas for the introduction of artificial intelligence systems, however, it is necessary to provide for proper legal regulation. At present, there is no legal regulation of artificial intelligence systems in the provision of medical activities, the issues of the subject of liability in case of causing harm by artificial intelligence are not regulated. Among the legal problems of introduction of artificial intelligence, including in the field of healthcare, are: problems of determining responsibility for improper actions of artificial intelligence systems, related problems of proving in case of causing harm; problems of certification and licensing, including licensing of medical artificial intelligence systems; the presence of a large number of incompatible and expensive in operation medical information systems in the absence of industry standards; the complexity of creating a large medical Conclusions. Analyzing the above-mentioned provisions, the authors consider it advisable, when introducing artificial intelligence systems in medical activity, especially as an independent subject of legal relations, to conduct a comprehensive update of the current legislation, with the definition of the legal status, delictability and subjectivity of responsibility in the support of medical technologies, in order to prevent medical and legal risks, including in ophthalmology.
Keywords artificial intelligence, ophthalmology, medical activity, legislation, healthcare, medical and legal risk

Bibliographic reference:
M.G. Sveredyuk, V.S. Stupak, M.V. Pshenichnov, LEGAL AND ETHICAL PROBLEMS OF IMPLEMENTATION OF ARTIFICIAL INTELLIGENCE AT THE PRE-MEDICAL STAGE IN MEDICAL ACTIVITIES INCLUDING OPHTHALMOLOGY // Scientific journal «Current problems of health care and medical statistics». - 2025. - №2;
URL: http://www.healthproblem.ru/magazines?textEn=1634 (date of access: 01.07.2025).

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