Ranko Sovilj
PhD, Research Associate, Institute of Social Sciences, Belgrade, Serbia
Sanja Stojković Zlatanović
PhD, Senior Research Associate, Institute of Social Sciences, Belgrade, Serbia

Recent developments in the application of artificial intelligence (AI) in health care promise to solve many of the existing global problems in improving human health care and managing global legal challenges. In addition to machine learning techniques, artificial intelligence is currently being applied in health care in other forms, such as robotic systems. However, the artificial intelligence currently used in health care is not fully autonomous, given that health care professionals make the final decision. Therefore, the most prevalent legal issues relating to the application of artificial intelligence are patient safety, impact on patient-physician relationship, physician’s responsibility, the right to privacy, data protection, intellectual property protection, lack of proper regulation, algorithmic transparency and governance of artificial intelligence empowered health care. Hence, the aim of this research is to point out the possible legal consequences and challenges of regulation and control in the application of artificial intelligence in health care. The results of this paper confirm the potential of artificial intelligence to noticeably improve patient care and advance medical research, but the shortcomings of its implementation relate to a complex legal and ethical issue that remains to be resolved. In this regard, it is necessary to achieve a broad social consensus regarding the application of artificial intelligence in health care, and adopt legal frameworks that determine the conditions for its application.

Keywords: artificial intelligence (AI), health care, legal implications, regulation, protection.

Andonović, S. 2020. Strateško-pravni okvir veštačke inteligencije u uporednom pravu. Strani pravni život, 64(3), pp. 111-123.

Bailey-Wheaton, J. L. 2017. Artificial Intelligence in Healthcare – The Regulatory Envi­ronment. Health Capital Topics, 10(5), pp. 1-3.

Chowdhary, K. R. 2020. Fundamentals of Artificial Intelligence. India: Springer.

European Parliament. 2022. Artificial Intelligence in Healthcare – Applications, Risks, and Ethical and Societal Impacts. European Parliamentary Research Service: Scien­tific Foresight Unit (STOA).

Filipova, I. A. & Koroteev, V. D. 2023. Future of the Artificial Intelligence: Object of Law or Legal Personality? Journal of Digital Technologies and Law, 1(2), pp. 359-386.

Furhat Robotics, Social Robots in Healthcare. 2020. Available at: (20. 6. 2023).

Grand View Research, Artificial Intelligence Market Size, Share & Trends Analysis Report by Solution, by Technology (Deep Learning, Machine Learning), by End-use, by Region, and Segment Forecasts 2023 – 2030. Available at: (11. 6. 2023).

Guan, X., Ji, L. & Wang, R. 2016. Development of Exoskeletons and Applications on Rehabilitation. MATEC Web Conferences, 40, pp. 1-5.

Hildebrandt, M. 2019. Legal Personhood for AI? In: Hildebrandt, M. (ed.), Law for Com­puter Scientists, pp. 1-14.

Jiang, F. et al. 2017. Artificial intelligence in Healthcare: Past, Present and Future. Stroke and Vascular Neurology, 2, pp. 230-243.

Kamensky, S. 2020. Artificial Intelligence and Technology in Health Care: Overview and Possible Legal Implications. DePaul Journal of Health Care Law, 21(3), pp. 1-18.

Krainska, A. 2018. Legal Personality and Artificial Intelligence. Available at: (10. 6. 2023).

McCarthy, J. 2007. What Is Artificial Intelligence? Stanford: Stanford University – Com­puter Science Department, pp. 1-15. Available at: (17. 6. 2023).

Medicines & Healthcare Products Regulatory Agency. 2022. Government Response to Consultation on the Future Regulation of Medical Devices in the United Kingdom. Available at: (25. 6. 2023).

Milosavljević, N. 2023. Pojedini patentnopravni aspekti primene veštačke inteligencije. Pravo i privreda, 61(2), pp. 499-517.

Prlja, D., Gasmi, G. & Korać, V. 2021. Veštačka inteligencija u pravnom sistemu EU. Beograd: Institut za uporedno pravo.

Prlja, D., Gasmi, G. & Korać, V. 2022. Ljudska prava i veštačka inteligencija. Beograd: Institut za uporedno pravo.

Raposo, V. L. 2023. Artificial Intelligence, Fundamental Rights and Technological Devel­opment: Is There a Crowd in a Regulation? WAML Newsletter, June Issue, pp. 1-15.

Reddy, S. et al. 2020. A Governance Model for the Application of AI in Health Care. Journal of the American Medical Informatics Association, 27(3), pp. 491-497.

Rong, G. 2020. Artificial Intelligence in Healthcare: Review and Prediction Case Stud­ies. Engineering, 6, pp. 291-301.

Schneeberger, D., Stoger, K., & Holzinger, A. 2020. The European Legal Framework for Medical AI. In: Machine Learning and Knowledge Extraction. (LNISA, volume 12279). Springer, pp. 209-226.

Silva Rocha, E. et al. 2022. On Usage of Artificial Intelligence for Predicting Mortality During and Post-Pregnancy: A Systematic Review of Literature. BMC Medical Informatics and Decision Making, 22:234, pp. 1-17.

Sjeničić, M. 2011. Pravni aspekti transformisanja medicine iz reaktivne u prospektivnu P4-medicinu. Pravni život – časopis za pravnu teoriju i praksu, 60(9), pp. 425-438.

Solum, L. B. 1992. Legal Personhood for Artificial Intelligences. North Carolina Law Review, 70(4), pp. 1231-1287.

Sovilj, R. 2018. Uporednopravna analiza i izazovi regulisanja i finansiranja zdravstvenog osiguranja. Strani pravni život, 62(3), pp. 143-161.

Sovilj, R. 2023. Primena veštačke inteligencije u zdravstvenoj zaštiti – neka pravna pitanja. In: Mujović, H. (ed.), Aktuelnosti medicinskog prava – teorija, praksa i zakonodavstvo 4 (knjiga sažetaka). Beograd: Institut društvenih nauka, Novi Sad: Advokatska komora Vojvodine, pp. 14-17.

Vollers, N. & Dennis, A. 2023. AI Regulation in Healthcare: UK and EU Approaches. Availa­ble at: (24. 6. 2023).

Wojtczak, S. 2022. Endowing Artificial Intelligence with Legal Subjectivity. AI & Soci­ety, 37, pp. 205-213.

Legal sources

Proposal for a Regulation of the European Parliament and of the Council Laying Down Harmonised Rules on Artificial Intelligence (Artificial Intelligence Act) and Amend­ing Certain Union Legislative Acts, European Commission, Brussels, 21. 4. 2021. COM(2021) 206 final.

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC, Official Journal of the European Union, L 117.

Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Com­mission Decision 2010/227/EU, Official Journal of the European Union, L 117.

Download the article