The Government has asked the Medicines and Healthcare products Regulatory Agency (MHRA) for an update on its approach to implementing the AI Regulation White Paper.

In an open letter from the departments for Science, Innovation and Technology, and of Health and Social Care, the MHRA is asked to outline their strategic approach to AI in the healthcare sector and the steps they are taking to implement the White Paper.

Please see our previous post explaining the UK’s approach to AI regulation set out in the White Paper.

Under the UK approach, regulators will govern the development and use of AI within their specific sectors, without a dedicated AI regulator or general overarching AI legislation (as opposed to the EU's approach with the cross-sector EU AI Act). 

The joint letter requests that the MHRA publishes an update by 30 April 2024 outlining:

  • how AI applies within MHRA’s regulatory responsibilities for medicines and medical devices
  • the steps they are taking to adopt the principles detailed in the White Paper
  • a summary of issued and proposed guidance on how organisations should comply with those principles
  • how they are assessing and managing risks posed by AI to the medicines and healthcare products sector
  • collaborations and overlaps with the responsibilities of other regulators
  • their capabilities and any shortcomings in how they can address AI risks in the sector
  • the initiatives they are implementing in the next 12 months

Any response by MHRA will build on previous updates linked to regulation of software and AI as a medical device. The MHRA first published a roadmap for regulation of AI in October 2022, with several updates since culminating in a timeline for new medical device regulations being issued in January 2024. 

The MHRA have also been preparing their AI-Airlock. This “regulatory sandbox” will be a controlled NHS environment that will allow technology which may not be compatible with existing trial techniques to be tested prior to market approval. It is expected to launch in mid-2024.

If you would like to discuss any issues relating to the regulatory framework surrounding Health Tech and the use of AI, please contact a member of our Health Tech team. 

This article was written by Rory Trust and Jacob Hall.