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Large language model AI chatbots require approval as medical devices

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Chatbots powered by artificial intelligence used in patient care are regulated as medical devices, but their unreliability precludes approval as such.

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Acknowledgements

This work was supported by the German Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung, BMBF) through the European Union-financed NextGenerationEU program under grant number 16KISA100K, project PATH (Personal Mastery of Health and Wellness Data).

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Authors and Affiliations

  1. Else Kröner Fresenius Center for Digital Health, Technische Universität Dresden, Dresden, Germany

    Stephen Gilbert

  2. Hardian Health, Haywards Heath, UK

    Hugh Harvey

  3. School of Medicine, Trinity College, University of Dublin, Dublin, Ireland

    Tom Melvin

  4. Axon Lawyers, Amsterdam, The Netherlands

    Erik Vollebregt

  5. Wicks Digital Health, Advantage House, Stowe Court, Lichfield, UK

    Paul Wicks

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  1. Stephen Gilbert
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  2. Hugh Harvey
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  3. Tom Melvin
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  4. Erik Vollebregt
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  5. Paul Wicks
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Corresponding author

Correspondence to Stephen Gilbert.

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Competing interests

S.G. has or has had consulting relationships with Una Health GmbH, Lindus Health Ltd, Flo Health Ltd, Thymia Ltd and Ada Health GmbH; and holds share options in Ada Health GmbH. E.V. is a partner of Axon Lawyers. H.H. is owner and managing director of Hardian Ltd. T.M. is an unpaid advisory board member of Pumpinheart Ltd; was previously a senior medical officer in medical devices at the Health Products Regulatory Authority, Ireland; and was previously co-chair of the Clinical Investigation and Evaluation Working Group of the European Commission. P.W. is employed by Wicks Digital Health Ltd, which has received funding from Ada Health, AstraZeneca, Biogen, Bold Health, Camoni, Compass Pathways, Corevitas, EIT, Endava, Happify, HealthUnlocked, Inbeeo, Kheiron Medical, Lindus Health, MedRhythms, PatientsLikeMe, Sano Genetics, Self Care Catalysts, The Learning Corp, The Wellcome Trust, THREAD Research, United Genomics, VeraSci and Woebot. P.W. and spouse are shareholders of WDH Investments Ltd, which owns stock in BlueSkeye AI Ltd, Earswitch Ltd, Sano Genetics Ltd and Una Health GmbH.

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Gilbert, S., Harvey, H., Melvin, T. et al. Large language model AI chatbots require approval as medical devices. Nat Med 29, 2396–2398 (2023). https://doi.org/10.1038/s41591-023-02412-6

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