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

Recommendations from the National Commission into the Regulation of AI in Healthcare, which was established to advise government on a future regulatory framework for AI in healthcare.

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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.