The National Commission into the Regulation of AI in Healthcare has published its recommendations for how the UK's regulatory framework should evolve as AI becomes increasingly developed and used across healthcare.

Newton's Tree was pleased to contribute to the Commission's work, serving on an expert working group and taking part in the Commission's roundtable engagements.

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AI is transforming healthcare, but regulation must keep pace

AI has the potential to support earlier diagnosis, more personalised care, improved patient outcomes and better experiences for healthcare professionals, while helping the NHS and wider health system meet rising demand.

But AI can also evolve over time, perform differently across settings and patient populations, and depend on the environments in which it is used. The regulatory framework therefore needs to evolve with the technology.

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What the Commission heard

The Commission's recommendations have been shaped by evidence, expertise and extensive engagement. This has included input from its four expert working groups and wider research and engagement with patients and the public, healthcare professionals, healthcare organisations, industry, researchers, regulators and others across the health system.

The evidence showed strong support for the use of AI in healthcare, but that support is conditional rather than automatic. People want to know that AI can be used safely, fairly and transparently, with clear evidence of benefit, meaningful human oversight and accountability. Trust cannot simply be assumed. It must be earned.

This is consistent with findings from a public dialogue on AI-enabled ambient voice technologies (AVTs) that Newton's Tree commissioned earlier this year. Delivered independently by Hopkins Van Mil, the dialogue found that patients and the public expected national oversight, staff training, and ongoing monitoring of AI scribe accuracy and performance as these tools are rolled out across the NHS: the same themes of transparency, oversight and continuous monitoring emerging.

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The Commission's response

The Commission's central conclusion is that the regulation and assurance of AI in healthcare needs to become more proportionate, lifecycle-based and system-wide. Its vision is for a future framework that is Safe, Fast and Trusted: Safe in protecting patients and managing risk; Fast in enabling responsible innovation and timely access to beneficial technologies; and Trusted in giving confidence across the healthcare system.

The Commission's recommendations are organised around three connected areas of change.

1. Proportionate lifecycle regulation

This means having the right safeguards, at the right time, for the right level of risk. Regulatory requirements should reflect what a technology does, the benefits it could bring, the risks it presents and the level of uncertainty around it.

Safe, low-risk tools that support staff, improve services and patient care, should face lighter requirements, so those benefits are not unnecessarily delayed. However, products that have a greater effect on someone's health or care, or where there is greater uncertainty, would need stronger safeguards matched to their level of risk. Oversight must continue throughout the lifecycle, this means ensuring safety from the start but also continuing through deployment, monitoring, updating and ongoing learning from real-world use.

"What stands out from the MHRA's expert commission's work is how conditional public support for AI actually is. Newton's Tree monitors AI in live NHS deployments every day, and our experience is that performance can change once systems are in routine use. The Commission's emphasis on continuous, real-world monitoring throughout a device's lifecycle is therefore exactly right, and it positions the UK to lead the world in the safe adoption of AI in healthcare."
- Haris Shuaib, CEO, Newton's Tree

2. System-wide responsibility and safe management

This means recognising that keeping AI safe is a shared responsibility. Regulation alone cannot ensure the safe and effective use of AI. Manufacturers, healthcare providers, healthcare professionals, regulators and policymakers all have a role to play.

The future framework should support clearer responsibilities, stronger organisational readiness, appropriate workforce capability and effective governance. No one should be left responsible for something they cannot understand, control or act on.

3. Trust, transparency and predictability

This means recognising that trust must be earned. Patients and healthcare professionals need clear and accessible information about how AI is being used, alongside transparency, accountability and meaningful involvement so they can have confidence in the technologies supporting their care. Developers and manufacturers also need clearer and more predictable pathways through the regulatory system, helping them understand what is expected and giving them greater confidence to bring safe and beneficial technologies into healthcare responsibly.

"It has been encouraging to see the hard questions of our ecosystem being opened up during the Commission's work. NHS staff need guidance around liability, patients need their voices heard, and the environmental sensitivity of AI can't be ignored. This work is paramount if we are going to succeed."
-  Robin Carpenter, Head of AI Governance and Policy, Newton's Tree

The ambition is for the UK to become the best place in the world for innovators to build and test AI, for healthcare professionals to use it, and for patients to benefit from it in their care.

The government and the MHRA will now consider the Commission's recommendations, with a formal response to follow in due course.

Read the Commission's full report and recommendations here.

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