Question to the Department of Health and Social Care:

To ask the Secretary of State for Health and Social Care, whether the current in-development framework regarding the regulation of AI in healthcare will introduce a medical device classification for AI software requiring external assessment, and whether that will be coupled with statutory data-handling requirements governing access and use of patient data.

The Medicines and Healthcare products Regulatory Agency (MHRA) is currently undertaking a programme of regulatory reform for medical devices. This includes ensuring there is proportionate regulation of artificial intelligence (AI) as a medical device, which addresses the potential risks of these products without stifling their potential to transform healthcare.

On 26 September 2025, the MHRA announced the National Commission into the Regulation of AI in Healthcare (the National Commission).

The MHRA has established the National Commission as an independent, non-statutory advisory body to inform the development of a future regulatory framework for AI in healthcare. Its work recognises that AI technologies can challenge established regulatory approaches and is considering how regulation can evolve to support these technologies through more lifecycle-based and proportionate approaches to regulation, including device qualification and classification. The National Commission's role is to provide independent advice and recommendations, and it would not be appropriate to prejudge the content of its final recommendations. The National Commission is working with partners across the health system, including the Department and the Information Commissioner’s Office, to consider how emerging thinking on data protection and information governance should be reflected in the future regulation and governance of AI in healthcare.