AI in healthcare set for major regulatory shake-up across the NHS

The UK’s National Commission into the Regulation of AI in Healthcare has called for a major rethink of how the NHS regulates artificial intelligence.

They argue that patients should be able to benefit from new technologies more quickly without compromising safety or public trust.

The independent Commission, established by the Medicines and Healthcare products Regulatory Agency (MHRA) in September 2025, has published a series of recommendations following a year-long investigation involving more than 12,000 patients, members of the public, clinicians, healthcare leaders, technology developers and industry representatives.

Its findings point to broad public support for AI in healthcare, but with clear conditions. People want robust safety standards, meaningful human oversight and greater transparency about when AI is being used in their care.

The Commission says its proposed regulatory changes are designed to meet those expectations while making the UK a more attractive environment for developing and deploying medical AI.

Professor Alastair Denniston, NHS consultant and Chair of the National Commission into the Regulation of AI in Healthcare, commented: “We innovate because we believe tomorrow’s healthcare can be better than today’s.

“But any new innovation – including AI – needs to earn its place and earn our trust. These technologies need to show that they are safe, effective and bring benefits to patients, staff and the wider NHS, without leaving people behind.

“Over the past year we have heard from more than 12,000 people, including patients, carers, clinicians and the technologists building AI tools. One message came through clearly: people are open to AI improving their care, but only if it is safe, overseen by humans, and if they know when it is being used.

“These recommendations are designed to make that trust possible, so that the UK can lead the world not just in developing AI for healthcare, but in showing how it can be regulated and used responsibly.”

Building confidence around healthcare AI

AI is already being used within NHS services for a range of clinical and administrative tasks.

Existing applications include technologies that can help identify serious conditions such as strokes and skin cancers at an early stage. AI-powered voice tools are also being used to reduce administrative workloads and give clinicians more time to focus on patients.

However, AI’s rapid development creates a regulatory challenge. Conventional medical-device approval processes are largely designed around products that remain relatively stable once authorised. AI systems can behave differently as they are updated, adapted or exposed to new real-world data.

The Commission argues that regulation needs to reflect this changing landscape rather than treating approval as a one-off event.

A new route from testing to NHS use

One of its central proposals is a system of staged authorisation for new AI models.

The approach would be comparable to the restrictions placed on learner drivers. Rather than moving immediately from development to unrestricted clinical use, promising AI systems would initially operate under tighter controls, closer supervision and clearly defined safeguards.

Performance and safety could then be assessed in real-world healthcare environments before the technology progressed towards broader authorisation.

The aim is to balance two competing risks: allowing potentially valuable AI innovations to reach patients too slowly, while avoiding premature deployment of systems that have not been adequately tested.

If adopted, the model could allow the UK to offer patients earlier access to emerging AI technologies while retaining regulatory oversight during their initial deployment.

Monitoring would continue after approval

The Commission also wants regulation to extend throughout the operational life of AI-enabled medical devices.

Rather than relying primarily on evidence gathered before a product enters the NHS, regulators would continuously monitor technologies once they are in real-world use.

That could become increasingly important as AI systems are modified and updated. Ongoing surveillance would give the MHRA greater visibility over how products perform in practice and allow potential problems to be identified and addressed more rapidly.

The recommendation reflects a fundamental shift in how regulators view AI: not as a finished product that can be approved once, but as technology that may require continuing scrutiny.

Giving patients more information

Transparency is another major theme running through the recommendations.

The Commission says members of the public should have an accessible way to find information about individual AI-enabled medical devices, including their safety record and any reported adverse incidents.

Such a system could build on existing MHRA approaches for communicating information about medicines, giving patients a clearer picture of how particular AI technologies have performed.

The Commission’s public engagement also found that people want to know when AI is involved in their healthcare. Its recommendations therefore call for a proportionate approach to informing patients as AI becomes more deeply integrated into NHS services.

Stronger powers for the regulator

The Commission has further recommended giving the MHRA stronger enforcement powers.

The intention is to ensure that regulators can intervene decisively when AI systems fail to meet expected safety or performance standards, rather than relying solely on voluntary compliance or retrospective action.

The government and MHRA will now consider the recommendations before issuing a formal response.

The outcome could help determine whether the UK can resolve one of the central challenges surrounding AI in healthcare: how to accelerate access to potentially transformative technology while ensuring patients remain protected when that technology enters the consulting room.