The response commits the government to developing a more agile, lifecycle-based regulatory system designed to support innovation while protecting patient safety and maintaining public trust.
The Medicines and Healthcare products Regulatory Agency (MHRA) has also opened applications for the third phase of its AI Airlock regulatory sandbox.
The changes will put greater emphasis on monitoring AI technologies throughout their working life rather than relying primarily on assessments carried out before a product reaches the market.
AI Airlock Phase 3 will test this approach in practice, with findings intended to shape future MHRA guidance and policy.
UK Health Innovation Minister James Fritch believes the move will be transformative for patients and the NHS: “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.”
Moving towards lifecycle regulation
The National Commission, whose recommendations were published on 10 September, concluded that the regulatory framework needs to evolve alongside AI technologies.
A central recommendation was to assess and monitor AI-enabled medical devices throughout their operational life. This would allow regulators and healthcare providers to better understand how products perform in real-world settings.
The government’s response commits to developing what it describes as a world-leading agile approach to AI device regulation. The intention is to allow patients to benefit from safe and effective AI more quickly, while ensuring safeguards can adapt as technologies change.
One of the first areas of work will focus on how regulators manage AI-enabled devices that change over time.
The MHRA will publish draft guidance by December 2026 on a new approach to managing modifications to AI-enabled medical devices as they adapt and improve.
The agency will also consult next year on how AI-enabled devices should be qualified and classified, addressing the first recommendation made by the National Commission.
AI Airlock enters its third phase
The regulatory changes to AI in healthcare will be supported by the next phase of AI Airlock, the MHRA’s regulatory sandbox for AI-enabled medical devices.
Following its pilot and second phase, the programme has secured three additional years of government funding. Phase 3 will concentrate specifically on post-market surveillance and lifecycle regulation, reflecting two of the central themes in the Commission’s recommendations.
The programme will work with developers, regulators and healthcare partners using real products and technologies. The aim is to explore how AI-enabled medical devices can be monitored and managed safely after deployment.
Evidence generated through the programme will contribute directly to the development of future MHRA guidance and policy.
Applications are now open to developers of eligible AI-enabled medical devices. A webinar for prospective applicants will be held on 22 October 2026 at 10:00, with the first group of innovators expected to be selected in November.
Professor Alastair Denniston, Chair of the National Commission, added: “I am delighted to welcome the government’s response to the National AI Commission, and its full acceptance of all our recommendations.
“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.
“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.”
Earlier access under closer oversight
The government’s response also outlines potential changes to how promising AI tools could enter the NHS.
Among the commitments is exploring staged authorisation pathways. These could allow suitable AI technologies to be introduced earlier under close supervision while additional evidence is collected from their use in real-world settings.
The approach reflects the broader shift towards regulation that can respond to technologies as they develop, rather than treating authorisation as a single assessment at one point in time.
The government has also committed to working with partners across the health system to strengthen patient involvement in decision-making.
Other areas include improving access to redress when standards of care fall below expectations and ensuring the benefits of AI are distributed fairly across communities, including underserved groups.
Implementation will continue across the health system
A newly established Programme Board will bring together work already taking place across government, the MHRA, NHS partners and the devolved authorities.
The board will oversee work across nine priority areas identified in the government’s response. A detailed implementation roadmap covering timelines and responsibilities for all 44 recommendations is due to be published by spring 2027, followed by regular progress updates.
The combined response and AI Airlock programme mark a move towards greater use of continuous, real-world evidence in the regulation of AI in healthcare.
Rather than relying predominantly on a product’s performance at a single point before deployment, the emerging framework is intended to account for how AI-enabled devices perform and change throughout their working life.
Alongside this, the government has committed to keeping patients informed about when AI is being used in their care.
With AI Airlock Phase 3 now open for applications and further regulatory guidance scheduled over the coming months, the next stage will focus on testing how this more continuous approach can work in practice while maintaining patient safety and public confidence.
Team Health Accessible
Health & Wellness Editorial Team
HealthAccessible editorial team delivers trusted, accessible, and evidence-based health information for everyone.
