Cited by 208Artificial Intelligence in Healthcare and EducationHealthcare RegulationDigitalization, Law, and Regulation

Large language model AI chatbots require approval as medical devices

Gilbert, Stephen, Harvey, Hugh, Melvin, Tom, Vollebregt, Erik, Wicks, Paul·2023·Nature Medicine

Integrity signals

Registry

Crossref · 10.1038/s41591-023-02412-6

Cites

8 of 8 references verified0 citation errors · 0 not checkable

Statistics

Recomputing p-values needs the paper’s full text.

Claims the paper makes

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  • Healthcare is a uniquely demanding domain for XAI, where incorrect or biased decisions can directly impact patient outcomes and regulatory frameworks increasingly mandate algorithmic transparency.

    “Healthcare represents a uniquely demanding domain for explainable AI (XAI), where incorrect or biased decisions can directly impact patient outcomes and where regulatory frameworks increasingly mandate algorithmic transparency [7].”
  • The integration of foundation models in operable clinical software systems faces legal and regulatory challenges because these models require approval as medical devices.

    “Thirdly, the integration of such models in operable clinical software systems faces legal and regulatory challenges because these models require approval as medical devices26.”
  • Regulation of large language models is evolving and debated, including which contexts and intended uses qualify them as medical devices.

    “A particularly evolving and debated topic is the regulation of LLMs, and in which contexts and intended uses do they qualify as medical devices (191,192).”
  • The need for human oversight and validation is accentuated by the lack of professional guidelines or regulatory oversight within this field.

    “This need is accentuated by the lack of professional guidelines or regulatory oversight within this field23.”

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Authors
Gilbert, S., Harvey, H., Melvin, T., Vollebregt, E., & Wicks, P.
Affiliations
  • Else Kröner Fresenius Center for Digital Health (DE)
  • Trinity College Dublin (IE)
Corresponding author
Gilbert, Stephen
Venue
Nature Medicine
Published
2023-06-30
Volume
29
Issue
10
Pages
2396-2398
ISSN
  • 1078-8956 (ISSN-L)
  • 1546-170X
OpenAlex
W4382678522
Cited by
207
References
7
Citations by year
2026: 42 · 2025: 61 · 2024: 82 · 2023: 22
FWCI
8.38
Type
journal article
Language
en
Open access
closed
Locations
  • Nature Medicine (publishedVersion)
  • PubMed (publishedVersion)
Funders
Bundesministerium für Bildung und Forschung (16KISA100K)
Topics
  • Health Sciences › Medicine › Health Informatics › Artificial Intelligence in Healthcare and Education
  • Health Sciences › Health Professions › Health Information Management › Healthcare Regulation
  • Social Sciences › Law › Digitalization, Law, and Regulation
Keywords
large language models, AI chatbots, medical device regulation, regulatory approval, patient care, AI reliability

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