FOI release

Department of Health and Social Care's response to your recent FOI request - Our ref:

Some or all of the information requested may not have been provided because we required clarification from the requester.

Case reference FOI2026/00971

Received 28 August 2026

Published 7 October 2026

Request

I am requesting from the MHRA’s viewpoint and records information to answer the following two questions, please: 1. I would like please to receive records of the policy decision making that went in to the MHRA's guidance issued online on 29th July 2026, concerning both public safety and government fiscal policy. 2. I would like in particular to understand how the UK Government funded research initiatives such as CERSI-AI and the outputs of the National Commission into the Regulation of AI in Healthcare have been considered and integrated in to the guidance, and any rationale of dismissing any findings for example in the CERSI-AI report on LLMs (which the MHRA sent contributing staff members) and the CERSI-AI and any MHRA internal initiative on borderline manual(s) regarding AI qualification and classification as a medical device.

Response

See attached

Documents

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