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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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.