National Commission into the Regulation of AI in Healthcare: Recommendations for a future regulatory framework

Key Findings

• — Recommendation 7 proposes an opt-in 'master file' approach for general-purpose platforms, foundation models and underlying technologies used by device manufacturers, and Recommendation 8 asks manufacturers to report product dependencies on underlying general-purpose models; the report names general-purpose models fine-tuned to serve as the basis of a medical device, such as a chatbot, as the case in point.
• — Recommendation 11 asks the MHRA to provide guidance on regulatory expectations for direct-to-consumer applications and wearables, including when such a product is a medical device and evidence expectations, recognising that consumers cannot rely on a health professional for risk controls.
• — Recommendations 19 and 22 propose a database or tool for sharing information on adverse incidents and enhanced enforcement mechanisms for the MHRA; Recommendation 6 covers predetermined change control plans.
• — Recommendations 35, 37 and 38 cover patient transparency about AI in care (with opt-out where possible or appropriate), public communication on safety concerns, and an 'AI sentiment census' run by DHSC and the devolved health departments.
• — The report distinguishes lower-risk uses (administrative, general wellbeing, low-risk clinical decision support) from higher-risk uses, and frames the whole healthcare system rather than the regulator alone as responsible for safe deployment.

Methodology Notes

Policy commission chaired by Professor Alastair Denniston with Professor Henrietta Hughes (Patient Safety Commissioner for England) as deputy chair; evidence from a call for evidence, public deliberation, engagement with seldom-heard groups, roundtables and working groups across the four UK nations (the companion 'Research, engagement and call for evidence findings' publication of 11 June 2026 carries the polling). Recommendations document with no primary study data. Full report PDF 119 pages (created 8 September 2026), plus easy-read and Welsh summaries; published on GOV.UK 10 September 2026 under the Open Government Licence. The UK government response, published by the MHRA on 6 October 2026 (42 pages), accepts all 44 recommendations, sets out four priority areas for the following year, and schedules further details on direct-to-consumer applications and wearables (Recommendation 11) and on Master Files for general-purpose models (Recommendation 7) for spring 2027.

Sources