2023
DOI: 10.1001/jama.2023.9651
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The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Models

Abstract: This Viewpoint discusses how regulators across the world should approach the legal and ethical challenges, including privacy, device regulation, competition, intellectual property rights, cybersecurity, and liability, raised by the medical use of large language models.

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Cited by 90 publications
(35 citation statements)
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“…Many areas of regulation lie outside the scope of this article, although there are several regulatory issues that are particularly important with respect to neurology and more broadly, medicine, that pertain to the technical and ethical challenges we raise. 19,47,48 Software as a medical device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF), as software that is not embedded within hardware and which performs medical tasks. Therefore, many medical LLMs would fall under this umbrella.…”
Section: Role Of Regulationmentioning
confidence: 99%
See 1 more Smart Citation
“…Many areas of regulation lie outside the scope of this article, although there are several regulatory issues that are particularly important with respect to neurology and more broadly, medicine, that pertain to the technical and ethical challenges we raise. 19,47,48 Software as a medical device (SaMD) is defined by the International Medical Device Regulators Forum (IMDRF), as software that is not embedded within hardware and which performs medical tasks. Therefore, many medical LLMs would fall under this umbrella.…”
Section: Role Of Regulationmentioning
confidence: 99%
“…Many areas of regulation lie outside the scope of this article, although there are several regulatory issues that are particularly important with respect to neurology and more broadly, medicine, that pertain to the technical and ethical challenges we raise. 19,47,48…”
Section: Technical and Ethical Challengesmentioning
confidence: 99%
“…We used images from peer-reviewed nuclear medicine journals, avoiding in-house patient data due to data privacy concerns with ChatGPT. 4 Yet, none of these images contained a color scale, and only 1 image indicated the patient orientation, leading to interpretation FIGURE 2. Examples of attempts to mark image findings.…”
Section: Discussionmentioning
confidence: 99%
“…3 Although ChatGPT is not designed for medical advice, unresolved concerns about data privacy, particularly for medical images, and legal liability remain. 4 Reports that ChatGPT is already being used by physicians to support their clinical work are mounting, 5 and other large language models dedicated to medical content are improving continuously. 6 Recently, ChatGPT has been updated with GPT-4V(ision), which can analyze uploaded images.…”
mentioning
confidence: 99%
“…The Viewpoint titled “The Challenges for Regulating Medical Use of ChatGPT and Other Large Language Models,” published on July 25, 2023, was corrected to fix the Funding/Support and Role of the Funder/Sponsor sections. “Dr Minssen also received support from the Horizon Europe project CLASSICA (grant 101057321)” was added to the Funding/Support section, and “the Horizon Europe project CLASSICA” was added to the Role of the Funder/Sponsor section.…”
mentioning
confidence: 99%