Large language model generative AI chatbots require approval as medical devices. Comment from Stephen44026116 DrHughHarvey Tom Melvin erikvollebregt PaulWicks and colleagues.
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.
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