Code of ethics for the use of artificial intelligence in the Russian Federation healthcare
https://doi.org/10.25881/18110193_2025_2_98
Abstract
The article discusses the process of development and approval of the first Code of Ethics of Artificial Intelligence (AI) application in the Russian Federation Healthcare. Against the backdrop of the active integration of AI technologies into medical practice (39 relevant medical devices have been registered), the emphasis is placed on the importance of establishing ethical standards that ensure the protection of patients' rights, increasing trust in technologies, and standardization processes. International approaches to AI ethics in healthcare (EU, USA, UK, Canada, Australia, China, India) are analyzed and the need to harmonize the domestic code with international initiatives is outlined. The stages of development of the document, in which employees of specialized departments of the Ministry of Health of Russia, chief freelance specialists and experts took part, as well as the structure and main provisions of the approved version of the Code are presented. The key principles emphasized include transparency, confidentiality, fairness, limited autonomy, oversight, and accountability of AI systems. The final version of the document was published in March 2025 on the Unified State Information System in Healthcare (EGISZ) portal after approval by the Interdepartmental Working Group under the Russian Ministry of Health. The Code is intended to serve as a foundation for the sustainable and safe implementation of AI in Russia's healthcare system.
About the Authors
J. I. KorolevaRussian Federation
PhD
Moscow
A. L. Khokhlov
Russian Federation
Academician of the RAS, DSc, Professor
Yaroslavl
O. R. Artemova
Russian Federation
Moscow
E. V. Kostina
Russian Federation
Moscow
T. V. Zarubina
Russian Federation
Corr. Member of the RAS, DSc, Professor
Moscow
References
1. Vankov V.V. Vnedrenie tekhnologii iskusstvennogo intellekta v zdravookhranenii. Fevral', 6-7, 2025; Moskva. Available at: https://www.itmportal.ru/resources/presentations/o-vnedrenii-tekhnologiy-iskusstvennogo-intellekta-v-subektakh-rossiyskoy-federatsii/ Accessed 28. 04. 2025. (In Russ.)
2. Vankov VV, Artemova OR, Karpov OE, et al. Results of the implementation of artificial intelligence in the russian healthcare. Medical Doctor and Information Technologies. 2024; 3: 32-43. (In Russ.) doi: 10.25881/18110193_2024_3_32.
3. Gusev AV, Artemova OR, Vasiliev YuA, et al. Integration of ai-based software as a medical device into russian healthcare system: results of 2023. National Health Care (Russia). 2024; 5(2): 17-24. (In Russ.) doi: 10.47093/2713-069X.2024.5.2.17-24.
4. Gusev AV, Artemova OR, Andrejchenko AE, et al. Formirovanie rynka programmnyh medicinskih izdelij v Rossijskoj Federacii v 2007-2024 gg.: prakticheskie rezul'taty. Nacional'noe zdravoohranenie. 2024; 5(3): 53-61. (In Russ.) doi: 10.47093/2713-069X.2024.5.3.53-61.
5. Khokhlov AL, Zarubina TV, Kotlovsky MYU, et al. Mechanisms for introduction of artificial intelligence in healthcare: new ethical challenges. Medical Ethics. 2024; 12(3): 4-10. (In Russ.) doi: 10.24075/medet.2024.018.
6. Koshechkin KA, Khokhlov AL. Ethical issues in implementing artificial intelligence in healthcare. Medical Ethics. 2024; 12(1): 12-19. (In Russ.) doi: 10.24075/medet.2024.006.
7. Amlaev KR, Dahkilgova KhT, Mazharov VN. The problems related to implementation of ai into health care system : a review. Problems of Social Hygiene, Public Health and History of Medicine. 2024; 32(4): 798-803. (In Russ.) doi: 10.32687/0869-866X-2024-32-4-798-803.
8. Pashkova NV, Vesnyanov MV. Ethical issues in using artificial intelligence technologies. Alma Mater (Vestnik Vysshey Shkoly). 2024; 1: 107-110. (In Russ.) doi: 10.20339/AM.01-24.107.
9. Alekseev AP, Alekseeva IYu. The status of ethical codes in the ethics of artificial intelligence. Information Society. 2024; 4:43-49. (In Russ.) doi: 10.52605/16059921_2024_04_43.
10. Ethics guidelines for trustworthy AI. European Commission, the High-Level Expert Group on AI. 8 April 2019. Available at: https://digital-strategy.ec.europa.eu/en/library/ethics-guidelines-trustworthy-ai Accessed 28. 04. 2025.
11. The EU Artificial Intelligence Act. Available at: https://artificialintelligenceact.eu/ Accessed 28. 04. 2025.
12. AMA Issues New Principles for AI Development, Deployment, and Use. Available at: https://www.ama-assn.org/system/files/ama-ai-principles.pdf Accessed 28. 04. 2025.
13. Artificial Intelligence and Machine Learning in Software as a Medical Device. FDA. 2023-10-20. Available at: https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-and-machine-learning-software-medical-device Accessed 28. 04. 2025.
14. Nuffield Council on Bioethics. Available at: https://www.nuffieldbioethics.org/ Accessed 28. 04. 2025.
15. Statement on EDI and Responsible AI. Available at: https://www.caiac.ca/en/node/502 Accessed 28. 04. 2025.
16. Discussion paper «Artificial Intelligence: Australia's Ethics Framework». Available at: https://www.csiro.au/en/research/technology-space/ai/AI-Ethics-Framework Accessed 28. 04. 2025.
17. Badmaeva MKh, Balchindorzhieva OB, Zolkhoeva MV. Artificial Intelligence Systems: Current Status and Future Development Prospects in China. Discourse-P. 2024; 21(3): 92–106. (In Russ.) doi: 10.17506/18179568_2024_21_3_92.
18. Ethical Guidelines for Application of Artificial Intelligence in Biomedical Research and Healthcare 2023. Available at: https://www.icmr.gov.in/ethical-guidelines-for-application-of-artificial-intelligence-in-biomedical-research-and-healthcare. Accessed 28. 04. 2025.
19. AI Alliance Network. Available at: https://a-ai.ru/?page_id=2867. Accessed 28. 04. 2025.
20. Kodeks etiki v sfere II v meditsine i zdravookhranenii. Al'yans v sfere iskusstvennogo intellekta. Available at: https://ethics.a-ai.ru/ethics-of-medicine/ Accessed 28. 04. 2025. (In Russ.)
21. Kodeks etiki v sfere II // Al'yans v sfere iskusstvennogo intellekta. Available at: https://ethics.a-ai.ru/ Accessed 28. 04. 2025. (In Russ.)
22. Regulatory considerations on artificial intelligence for health. // World Health Organization. 2023. Available at: https://www.aiunplugged.io/wp-content/uploads/2023/10/Regulatory-considerations-on-artificial-intelligence-for-health.pdf Accessed 28. 04. 2025.
23. Recommendation on the Ethics of Artificial Intelligence, 2021 Available at: https://www.unesco.org/ru/artificial-intelligence/recommendation-ethics Accessed 28. 04. 2025.
24. Web Application draw.io. Available at: https://www.drawio.com/ Accessed 28. 04. 2025.
25. Kodeks etiki primeneniya iskusstvennogo intellekta v sfere okhrany zdorov'ya. // Portal operativnogo vzaimodeistviya uchastnikov EGISZ. Mart. 2025. Available at: https://portal.egisz.rosminzdrav.ru/news/1001. Ссылка активна на 28. 04. 2025. (In Russ.)
Review
For citations:
Koroleva J.I., Khokhlov A.L., Artemova O.R., Kostina E.V., Zarubina T.V. Code of ethics for the use of artificial intelligence in the Russian Federation healthcare. Medical Doctor and Information Technologies. 2025;(2):98-106. (In Russ.) https://doi.org/10.25881/18110193_2025_2_98