UK backs all health AI proposals in commission report
The UK government has said it will accept all 44 recommendations made in a recently published report on using AI tools in the NHS, including continual monitoring after deployment.
This morning, the government said that it was committing to publishing a full implementation plan by spring 2027, with a draft set of proposals scheduled for release before the end of the year.
Among the recommendations of the National Commission into the Regulation of AI in Healthcare report are staged authorisations for healthcare AIs – akin to the 'L plates' required for learner drivers – which would allow AIs to be tested in controlled environments before being rolled out more widely by the NHS.
Overall, it found that the current regulatory framework for healthcare AIs is inadequate in the UK, mainly because it was set up for conventional medical devices. By implementing the recommendations, the UK will adopt "a world-leading agile approach to AI device regulation that supports innovation while maintaining patient safety and public trust," said the government.
Also promised is a new approach to managing changes to AI-enabled medical devices as they evolve over time, moving towards a regulatory system that aims to maintain safety while supporting "timely access" to innovative devices.
Other commitments include exploring new staged authorisation pathways, allowing promising AI tools to be used in the NHS earlier under close supervision while further real-world evidence is gathered.
"This response shows that 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," said Prof Alastair Denniston, who led the review.
"Our approach to AI should be people-centred, and be underpinned by a regulatory system that is safe, fast, and trusted," he added.
Work at the UK regulator, the MHRA, will start next year on developing a framework to "qualify and classify" AI-enabled medical devices.
MHRA taking applications for new AI sandbox round
Alongside the government's announcement, the MHRA said it has opened a call for applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices, after getting funding for another three years.
The new phase will immediately implement the new regulation recommendations, with AI developers expected to work with regulators and healthcare partners to test how AI devices can be safely monitored and managed for post-market surveillance after they are deployed. Applications to participate in the third phase can be submitted straight away here, with selections due to be finalised in November.
A webinar for prospective applicants will take place on 22nd October.
"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," said the agency's chief executive, Lawrence Tallon.
"This is about making sure patients can benefit from safe, trusted AI more quickly, while never losing sight of the safeguards that maintain public confidence."
