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Overcoming regulatory barriers to the implementation of AI agents in healthcare

Nature Medicine (2025)Cite this article

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To facilitate the safe and effective implementation of autonomous artificial intelligence agents in healthcare, regulatory frameworks must evolve beyond static device paradigms to incorporate adaptive oversight and flexible pathways.

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Fig. 1: AI-enabled health applications by degree of autonomy and scope.
Fig. 2: Potential adaptations to current regulatory frameworks.

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Acknowledgements

During the preparation of this work, the authors used DeepL (DeepL SE), Grammarly (Grammarly, Inc.) and ChatGPT (in version GPT-4o; OpenAI, Inc.) to improve the grammar, spelling and readability of the manuscript. After using these tools and services, the authors reviewed and edited the content as needed and take full responsibility for the content of the publication.

J.N.K. is supported by the German Cancer Aid (DECADE, 70115166), the German Federal Ministry of Education and Research (PEARL, 01KD2104C; CAMINO, 01EO2101; TRANSFORM LIVER, 031L0312A; TANGERINE, 01KT2302 through ERA-NET Transcan; Come2Data, 16DKZ2044A; DEEP-HCC, 031L0315A; DECIPHER-M, 01KD2420A; NextBIG, 01ZU2402A), the German Academic Exchange Service (SECAI, 57616814), the German Federal Joint Committee (TransplantKI, 01VSF21048), the European Union’s Horizon Europe research and innovation program (ODELIA, 101057091; GENIAL, 101096312), the European Research Council (ERC; NADIR, 101114631), the US National Institutes of Health (EPICO, R01 CA263318) and the National Institute for Health and Care Research (NIHR, NIHR203331) Leeds Biomedical Research Centre. The views expressed are those of the author(s) and not necessarily those of the National Health Service, the NIHR or the Department of Health and Social Care. This work was supported by the European Commission under the Horizon Europe Program, as part of the project CYMEDSEC (101094218), and by the European Union. The views and opinions expressed are those of the authors only and do not necessarily reflect those of the European Union. Neither the European Union, nor the granting authorities, can be held responsible for them. Responsibility for the information and views expressed therein lies entirely with the authors. This work was supported by the German Federal Ministry of Education and Research (BMBF) as part of the Zunkuftscluster SEMECO (03ZU1210BA).

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Author notes

  1. These authors contributed equally: Jakob N. Kather, Stephen Gilbert.

Authors and Affiliations

  1. Else Kröner Fresenius Center for Digital Health, TUD Dresden University of Technology, Dresden, Germany

    Oscar Freyer, Sanddhya Jayabalan, Jakob N. Kather & Stephen Gilbert

  2. Department of Medicine I, University Hospital Dresden, Dresden, Germany

    Jakob N. Kather

  3. Department of Medical Oncology, National Center for Tumor Diseases (NCT), Heidelberg University Hospital, Heidelberg, Germany

    Jakob N. Kather

Authors
  1. Oscar Freyer
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  2. Sanddhya Jayabalan
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  3. Jakob N. Kather
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  4. Stephen Gilbert
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Corresponding author

Correspondence to Stephen Gilbert.

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Competing interests

O.F. has a leadership role and holds stock in WhalesDontFly GmbH, and has had consulting relationships with Prova Health Ltd. J.N.K. declares consulting services for Bioptimus, France; Panakeia, UK; AstraZeneca, UK; and MultiplexDx, Slovakia. Furthermore, he holds shares in StratifAI, Synagen and Ignition Lab (all in Germany); has received an institutional research grant by GSK; and has received honoraria by AstraZeneca, Bayer, Daiichi Sankyo, Eisai, Janssen, Merck, MSD, BMS, Roche, Pfizer and Fresenius. S.G. is an advisory group member of the Ernst & Young-coordinated “Study on Regulatory Governance and Innovation in the field of Medical Devices” conducted on behalf of the Directorate-General for Health and Food Safety of the European Commission. S.G. has or has had consulting relationships with Una Health GmbH, Lindus Health Ltd, Flo Ltd, Thymia Ltd, the FORUM Institut für Management GmbH, High-Tech Gründerfonds Management GmbH and Ada Health GmbH, and holds share options in Ada Health GmbH.

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Freyer, O., Jayabalan, S., Kather, J.N. et al. Overcoming regulatory barriers to the implementation of AI agents in healthcare. Nat Med (2025). https://doi.org/10.1038/s41591-025-03841-1

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