The government has confirmed it will accept all 44 recommendations made by the National Commission into the Regulation of AI in Healthcare, which was published on 10 September. The government has also set out how these will be delivered across the UK.

Furthermore, the Medicines and Healthcare products Regulatory Agency (MHRA) is opening the call for applications for the third phase of AI Airlock, the regulatory sandbox for AI-enabled medical devices, with testing themes directly informed by the Commission’s recommendations.  

The reforms aim to ensure patients can benefit from safe, effective and trusted AI more quickly, while maintaining robust safeguards as technologies evolve.

The Commission found that the current regulatory approach must evolve for AI technologies by designing a more proportionate, lifecycle-based framework.

It also concluded 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. The AI Airlock Phase 3 will work 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.