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Large language model AI chatbots require approval as medical devices

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

DOI 10.1038/s41591-023-02412-6

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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
ORCID: Gilbert, Stephen
Harvey, Hugh
Melvin, Tom
Wicks, Paul
Venue: Nature Medicine
Publisher: Springer Science and Business Media LLC
Published: 2023-06-30
Volume: 29
Issue: 10
Pages: 2396-2398
ISSN: 1078-8956 (ISSN-L)
1546-170X
DOI: 10.1038/s41591-023-02412-6
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
Licence: www.springernature.com/gp/researchers/text-and-data-mining (tdm)
www.springernature.com/gp/researchers/text-and-data-mining (vor)
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 › Medicine › Public Health, Environmental and Occupational Health › 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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