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UK MHRA · UK · 9 Sep 2026 · Guidance

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

AI-generated summary

The UK MHRA's National Commission into the Regulation of AI in Healthcare has published recommendations for a future regulatory framework governing AI in healthcare. The Commission was established to advise government on regulating AI-enabled medical devices and addressing wider issues including accountability, transparency, and clinical governance. Its recommendations, developed through research, public engagement, and stakeholder consultation, aim to protect patients, enable innovation, and maintain public trust. A separate cross-government response will follow outlining how recommendations will be considered and implemented.

From UK MHRA

These reports contain the recommendations made by the National Commission into the Regulation of AI in Healthcare.

The National Commission into the Regulation of AI in Healthcare was established to advise government on a future regulatory framework for AI in healthcare. In doing so, it is considering not only the regulation of safe and effective software and AI-enabled medical devices but also wider issues such as accountability, transparency, clinical practice, organisational governance and system-wide level assurance. Its mission is to help ensure that patients can benefit from safe and effective AI technologies, support the government’s ambition to make the NHS the most AI-enabled healthcare system in the world, and establish a globally competitive regulatory environment that attracts investment and supports innovation.

The Commission’s recommendations are grounded in a research and engagement programme, including the Call for Evidence, public deliberation events, engagement with groups who are seldom-heard, professional and industry roundtables, specialist working groups and further engagement across government and the health system.

AI presents one of the most significant opportunities to improve healthcare in a generation. Realising that opportunity will require a regulatory and assurance framework that evolves alongside the technology itself: protecting patients, enabling responsible innovation and maintaining public trust. The Commission’s recommendations aim to provide a foundation for the Medicines and Healthcare products Regulatory Agency (MHRA), government and wider system partners to achieve that ambition.

A cross-government response will follow separately, setting out how government and system partners will consider and take forward the recommendations.

Excerpt from the official page. The original is authoritative.