Question to the Department of Health and Social Care:

To ask His Majesty's Government what steps they are taking to ensure that local authorities using artificial intelligence to assess adult social care needs retain appropriate human oversight and safeguards for vulnerable people.

The National Commission into the Regulation of AI in Healthcare was established to bring together independent expertise and evidence to inform the Government’s development of a 'future ready’ regulatory framework for the use of artificial intelligence (AI) in healthcare.

Through its work, The National Commission has recommended that the Medicines and Healthcare products Regulatory Agency (MHRA) move to a more proportionate, lifecycle-based approach to regulation of AI products. This includes ensuring regulatory decisions are based on the risks and benefits of the specific device and introducing more ongoing, responsive post-market surveillance expectations and approaches, which will enable regulators to better detect and understand changes in safety and performance across the product lifecycle. The Commission also made a series of recommendations to further support clinical safety and governance, including requiring manufacturers to define the operational conditions needed for safe deployment of AI technologies, supporting providers to demonstrate the ‘AI readiness’ needed for safe deployment, and coordinated training of professionals to enable safe use. More information can be found in The National Commission’s recommendations report, a copy of which is attached. The Government will formally respond to those recommendations in the normal way in due course.

If an AI system providing real-time guidance during surgery meets the definition of a medical device, then the device would be required to comply with existing medical device regulations, including for safety and performance.