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ChatGPT and Bard are Large Language Models (LLMs) that are currently directed to provide general information to the public and make no medical claims, but this could change as other LLMs come online.
UK MHRA says that LLMs with a medical purpose would require fulfillment of appropriate clinical evidence requirements and may be regulated as a medical device under the UK’s Medical Device Regulation 2002 (as amended),
LLMs that are developed for, or adapted, modified or directed toward specifically medical purposes are likely to qualify as medical devices. Additionally, where a developer makes claims that their LLM can be used for a medical purpose, this again is likely to mean the product qualifies as a medical device.
SOURCE:
- Large Language Models and software as a medical device. MHRA MedRegs Blog. 3 March 2023 [archive]
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