Question to the Department of Health and Social Care:

To ask His Majesty's Government whether the new regulatory framework for AI and software as a medical device will define where medical liability will lie in cases where AI tools fail to perform as expected in the NHS.

On 26 September 2025, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the National Commission into the Regulation of AI in Healthcare (the National Commission).

The National Commission is an independent, non-statutory advisory group, responsible for advising the MHRA on the creation of a new regulatory framework for artificial intelligence (AI) products in healthcare, supporting our goal to make Great Britain the fastest and safest place to regulate AI and software as a medical device in the world. The Commission is looking into a range of topics relating to the regulation of AI in healthcare, including but not limited to Post-Market Surveillance, the role of different actors, developers, providers, and professionals throughout the adoption cycle of AI as a medical device, and the liability implications of AI technology.

The Commission will publish its recommendations for the new regulatory framework for AI in healthcare in Summer 2026.