Legal implications of AI standard of care integration on patients’ informed consent: lessons from surgery

  • Bajwa, J., Munir, U., Nori, A. & Williams, B. Artificial intelligence in healthcare: transforming the practice of medicine. Future Healthc. J. 8, e188–e194 (2021).

    Google Scholar 

  • Bohr, A. & Memarzadeh, K. The rise of artificial intelligence in healthcare applications. In Artificial Intelligence in Healthcare (eds Bohr, A. & Memarzadeh, K.) 25–60 (Academic Press, 2020).

  • Moynihan, A. et al. New technologies for future of surgery in Ireland: An RCSI working Group report 2024. Surgeon 23, 120–132 (2025).

    Google Scholar 

  • Sauerbrei, A., Kerasidou, A., Lucivero, F. & Hallowell, N. The impact of artificial intelligence on the person-centred, doctor-patient relationship: some problems and solutions. BMC Med. Inform. Decis. Mak. 23, 73 (2023).

    Google Scholar 

  • Duffourc, M., Møllebæk, M., Druedahl, L. C., Minssen, T. & Gerke, S. Surgeons’ perspectives on liability for the use of artificial intelligence technologies in the United States and European Union: results from a focus group study. Ann. Surg. Open 6, e542 (2025).

    Google Scholar 

  • Park, H. J. Patient perspectives on informed consent for medical AI: a web-based experiment. Digit. Health 10, 20552076241247938 (2024).

    Google Scholar 

  • Iserson, K. V. Informed consent for artificial intelligence in emergency medicine: a practical guide. Am. J. Emerg. Med. 76, 225–230 (2024).

    Google Scholar 

  • Pallocci, M. et al. Informed consent: legal obligation or cornerstone of the care relationship? Int. J. Environ. Res. Public Health 20, 2118 (2023).

    Google Scholar 

  • Ng, I. K. Informed consent in clinical practice: old problems, new challenges. J. R. Coll. Physicians Edinb. 54, 153–158 (2024).

    Google Scholar 

  • Director, S. Does black box AI in medicine compromise informed consent? Philos. Technol. 38, 62 (2025).

    Google Scholar 

  • De Menech, C. Artificial intelligence and self-determination in medical field. Eur. J. Priv. Law Technol. 1, 164–180 (2022).

    Google Scholar 

  • World Health Organization. Ethics and governance of artificial intelligence for health: WHO guidance. https://iris.who.int/handle/10665/341996 (World Health Organization, 2021).

  • Pruski, M. AI-enhanced healthcare: Not a new paradigm for informed consent. J. Bioethical Inq. 21, 475–489 (2024).

    Google Scholar 

  • Mello, M. M., Char, D. & Xu, S. H. Ethical obligations to inform patients about use of AI tools. JAMA 334, 767–770 (2025).

    Google Scholar 

  • Cahill, R. A., Duffourc, M. & Gerke, S. The AI-enhanced surgeon—integrating black-box artificial intelligence in the operating room. Int. J. Surg. 111, 2823–2826 https://doi.org/10.1097/JS9.0000000000002309 (2025).

    Google Scholar 

  • Oliphant, K. Medical malpractice and compensation: comparative observations. In Medical Malpractice and Compensation in Global Perspective (eds Oliphant, K. & Wright, R.) 513–562 (Walter de Gruyter, 2013).

  • Borysiak, W. Concept of due care in medical law in a comparative perspective. Eur. J. Health Law 31, 1–26 (2023).

    Google Scholar 

  • Duffourc, M. & Gerke, S. Decoding US Tort Liability in Healthcare’s Black-Box AI Era: lessons from the European Union. Stanf. Tech. L. Rev. 27, 1–70 (2023).

    Google Scholar 

  • Raab, E. L. The parameters of informed consent. Trans. Am. Ophthalmol. Soc. 102, 225–232 (2004).

    Google Scholar 

  • Almekkawy, M. et al. Therapeutic systems and technologies: state-of-the-art applications, opportunities, and challenges. IEEE Rev. Biomed. Eng. 2, 325–339 (2019).

    Google Scholar 

  • Davis V. Nassau Ophthalmic Servs., P.C., 232 A.D.2d 358, 648 N.Y.S.2d 454 (1996).

  • BGH, judgment of 13-6-2006 – VI ZR 323/04 (OLG Frankfurt a.M.).

  • Johnson v. Jacobowitz, 65 A.D.3d 610, 884 N.Y.S.2d 158 (2009).

  • Mills v. Oxford University Hospitals NHS Trust, [2019] EWHC 936 (QB).

  • Snow v. Royal United Hospitals Bath NHS Foundation Trust, [2023] EWHC 42 (KB).

  • BGH, judgment of 22-09-1987 – VI ZR 238/86 (Karlsruhe).

  • Stover v. Association of Thoracic and Cardiovascular Surgeons, 635 A.2d 1047, 431 Pa.Super. 11 (1993).

  • OLG Cologne, judgment of 21.09.2011 – 5 U 188/10.

  • Bayley v George Eliot Hospital NHS Trust, [2017] EWHC 3398 (QB).

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