Recommendations on how regulation of AI in healthcare can be strengthened to support the UK’s ambitions for adopting innovation in a safe and transparent environment have been published.

The National Commission into the Regulation of AI in Healthcare today published its recommendations for a future regulatory framework.

Proposals include:

• Faster access to safe and effective AI via the MHRA introducing staged authorisations for new AI models similar to ‘L-plates’ for learner drivers.
• Continuous, real-world monitoring throughout a device’s lifecycle rather than a single, point-in-time approval for AI-enabled medical devices.
• Public access to safety information of specific AI-enabled medical devices, including any adverse incidents, to build trust.
• Tougher powers for the MHRA to protect patients, including enhanced enforcement powers when AI systems fall short of patient expectations.

Gerard Hanratty, Partner and Head of Health and Life Sciences at UK and Ireland law firm Browne Jacobson, said: “AI has significant potential to support the three big shifts set out in the 10-Year Health Plan – from sickness to prevention, hospital to community and analogue to digital. The UK is also uniquely placed to become a hotbed for rolling out novel technologies due to its cradle-to-grave records held by the NHS, a diverse population, and strong links between health information and the research community.

“However, for the UK to truly become a global leader in adopting AI within healthcare, it requires a strong regulatory environment that enables innovators to build and safely test AI, healthcare professionals to use, and patients to engage with it in their care. The Commission’s blueprint set out in this report provides the foundations for government to work with the MHRA in achieving this.

“The proposed L-plates-style staged authorisation model is a pragmatic and proportionate response to the genuine challenge of deploying adaptive technologies safely in real-world NHS settings. Equally important is the recommendation for continuous, lifecycle monitoring of AI-enabled medical devices, which reflects the reality that these are not static products. They evolve after deployment, and our regulatory frameworks must keep pace with that.

“NHS data is extraordinarily rich and holds genuine commercial value, but the question of how to share it internationally, with whom and on what terms remains unresolved at a systemic level – with public trust a central concern. The Commission's recommendation that patients should be able to easily access safety information about AI-enabled devices, and should know when AI is being used in their care, is a proportionate and necessary response to that challenge.

“Implementing these recommendations would support the UK’s ability to attract inward investment in healthcare. While the government frequently signals Britain is ‘open for business’ in this sector, the experience of trying to work within NHS procurement structures does not always reflect that message.

“In our white paper, Advancing inward investment into the UK health sector, we also suggested the creation of an ‘NHS front door’ to act as a centralised entry point for overseas investors to navigate the UK healthcare market.”