The UK Government is backing reforms to AI healthcare regulation, with a new lifecycle-based approach and the launch of the third phase of the MHRA’s AI Airlock regulatory sandbox.
The UK government has confirmed it will accept all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare and has set out how they will be delivered across the UK. Alongside the response, the MHRA is opening the call for applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices, with testing themes directly informed by the Commission’s recommendations.
A new approach to regulating AI in healthcare
The Commission concluded that the current regulatory approach must evolve for AI technologies by designing a more proportionate, lifecycle-based framework.
The recent response commits the UK to developing a world-leading, agile approach to AI device regulation that supports innovation while maintaining patient safety and public trust. The reforms aim to ensure patients can benefit from safe, effective and trusted AI more quickly, while maintaining robust safeguards as technologies evolve.
One of the Commission’s central conclusions was that AI-enabled medical devices should be assessed and monitored throughout their working life to better understand true performance, instead of over-relying on one-time assessments.
AI Airlock Phase 3 puts this principle into practice immediately, working with developers, regulators and healthcare partners to test how AI devices can be safely monitored and managed for post-market surveillance after they are deployed, generating insights, evidence and solutions that will directly inform future MHRA guidance and policy. Applications are now open for developers of eligible AI-enabled medical devices, with a webinar for prospective applicants taking place on 22 October.
Among the first steps set out, the MHRA is also committed to issue draft guidance by December 2026 on a new approach to managing changes to AI-enabled medical devices as they adapt and improve over time, moving towards a regulatory system that is designed to maintain safety while supporting timely access to innovative devices. The MHRA will also begin next year by consulting on how to qualify and classify AI-enabled devices, the first recommendation of the National Commission.
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. A full implementation roadmap, setting out timelines and responsibilities across all 44 recommendations, will be published by spring 2027, with regular progress updates to follow.
In addition, the Government has 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 communities, including underserved groups.
AI Airlock Phase 3: Applications open today
The MHRA is opening applications for the third phase of AI Airlock, its regulatory sandbox for AI-enabled medical devices. Following a successful pilot and Phase 2 programme, AI Airlock has secured three years of additional government funding.
Phase 3 will focus specifically on post-market surveillance and lifecycle regulation. Working with real products and technologies, the programme brings together innovators, regulators and healthcare partners to explore how AI-enabled medical devices can be monitored and managed safely throughout their working life, generating evidence and insights that will directly inform future MHRA guidance and policy.
Health Innovation Minister James Frith said: “We want all patients to benefit from the life-saving potential of AI, with the confidence that it is safe, effective and properly overseen. 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, but we are acting now by accepting in full all 44 recommendations of the Independent Commission, 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.”
Lawrence Tallon, the MHRA’s Chief Executive, said: “The independent National AI Commission, led by NHS doctors, 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. I am pleased that the Government is accepting its recommendations in full, whilst setting out a clear plan and oversight structure to deliver them.
“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. 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.”
Professor Alastair Denniston, Chair of the National Commission, said: “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. 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.”
What happens next?
The newly established Programme Board will convene with work already under way across government, the MHRA, NHS partners and the devolved authorities on the ten priority areas set out in the response. A full implementation roadmap will follow by spring 2027. AI Airlock Phase 3 applications are now open and the first wave of innovators will be selected in November 2026. A webinar will be held for prospective applicants on 22 October.
