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The doctor-led National Commission into the Regulation of AI in Healthcare provided 44 recommendations for its safe adoption in the NHS.
As previously reported by Healthcare Today, the National Commission into the Regulation of AI in Healthcare has concluded that the current regulatory approach must evolve for AI technologies by designing a more proportionate, lifecycle-based framework.
The government’s acceptance of the doctor-led Commission’s 44 recommendations commits the UK to developing a world-leading, agile approach to AI device regulation to support innovation, while maintaining patient safety and public trust.
Alastair Denniston, NHS consultant ophthalmologist, professor of regulatory science and innovation and chair of the National Commission, said he was “delighted” with the government’s response. “This shows that the government has listened, not just to the Commission, but to the more than 12,000 patients, clinicians and members of the public who shaped our recommendations.”
He added that the government’s response is a “welcome confirmation that it is committed to the Commission’s guiding principles, namely that our approach to AI should be people-centred, and be underpinned by a regulatory system that is safe, fast and trusted”.
MHRA’s shift in practice
One of the Commission’s key conclusions was that AI-enabled medical devices should be assessed and monitored throughout their working life to better understand their true performance, instead of over-relying on one-time assessments.
To assist with this, the Medicines and Healthcare products Regulatory Agency (MHRA) will put its AI Airlock Phase 3 into practice immediately. Working with developers, regulators and healthcare partners, the MHRA will test how AI devices can be safely monitored and managed for post-market surveillance after they are deployed. This will generate insights, evidence and solutions, it said, that will directly inform future MHRA guidance and policy.
“The regulatory challenges being prioritised by AI Airlock Phase 3 is an early sign of that shift in practice, putting the lifecycle-based approach we recommended into action from day one,” said Denniston.
In addition, the MHRA has committed to issuing draft guidance by December 2026 on a new approach to managing changes to AI-enabled medical devices as they adapt and improve over time. This will move the regulatory system towards one that is designed to maintain safety while supporting timely access to innovative devices, the MHRA said.
The regulator will also begin next year by consulting on how to qualify and classify AI-enabled devices. This was the Commission’s first recommendation.
“Led by NHS doctors, the independent Commission has given us a clear and ambitious blueprint for how we make the UK the best place to get AI products to patients safely, quickly and in a way that maintains public trust,” said Lawrence Tallon, the MHRA’s chief executive. “The MHRA’s AI Airlock is already opening its doors to more innovators who want to help us understand how these technologies can be implemented and monitored safely throughout their working life.”
NHS to harness the best technologies
Other commitments set out as part of the government’s priority areas include exploring new staged authorisation pathways, and allowing promising AI tools to be used in the NHS earlier under close supervision while real-world evidence is gathered.
A full implementation roadmap, setting out timelines and responsibilities across all 44 recommendations, will be published by spring 2027, with regular updates to follow, the government said.
It has also committed to working with partners across the health system to strengthen patient engagement in decision-making, improve access to redress where standards of care fall below expectations, and ensure the benefits of AI are shared fairly across all patient communities, including underserved groups.
“We want all patients to benefit from the life-saving potential of AI, with the confidence that it is safe, effective and properly overseen,” said James Frith, the government’s health innovation minister. “We also want to see the NHS harness the best new technologies to give patients faster, better care and give staff more time to focus on patients. But innovation must never come at the expense of patient safety.
“This will be a continually evolving process as the technology itself develops,” Frith added, “but we are acting now by accepting in full all 44 recommendations, which will provide a foundation to embrace the opportunities AI brings while putting strong safeguards, transparency and public confidence at the heart of its use”.
