FOI release

Copy of CERSI-AI report to MHRA

This request was refused in part, so we didn't provide some of the information the requester asked for. This may include information where we can neither confirm nor deny that we hold it.

Case reference FOI2026/00849

Received 1 August 2026

Published 17 September 2026

Request

Dear FOI Team, Under the Freedom of Information Act 2000, I am requesting a copy of the following information held by the Medicines and Healthcare products Regulatory Agency (MHRA): The report "Regulating Large Language Models in Healthcare: Expert and Multi-Stakeholder Perspectives," authored by the CERSI-AI team and workshop attendees (including Dr Joe Alderman and Professor Alastair Denniston), submitted to MHRA and/or the National Commission into the Regulation of AI in Healthcare. A draft version dated January 2026 (Version 2026-01-15) is known to exist; please provide this version and/or any later or final version, whichever you hold. If any part of this information is withheld under an exemption, please specify which exemption(s) are relied upon, and where the exemption is qualified, provide your public interest balancing reasoning, as required under the Act. MHRA's guidance on the regulatory status of AVT products, published 29 July 2026, represents a regulatory decision that has already been made and published. Any research, findings or analysis that related specifically to that decision are not, in my view, protected by an ongoing-deliberation rationale, since that particular deliberation has concluded. I look forward to your response within the statutory 20 working days.

Response

See attached

Documents

This is Medicines and Healthcare products Regulatory Agency's response to a freedom of information (FOI) or environmental information regulations (EIR) request.

You can browse our other responses or make a new FOI request.