To ask His Majesty's Government what steps they are taking to regulate the use of artificial intelligence in healthcare, particularly in relation to AI-ECG risk estimation.
Answered on
11 November 2024
The Department has invested £9.3 million to bolster the safety of artificial intelligence (AI) in health and care, and to ensure the regulatory pathway is clear for both developers and adopters. Ensuring technologies are safe is a top priority, and through this funding the Department has supported the launch of regulatory projects such as the AI and Digital Regulation Service and the AI Airlock.
AI-electrocardiogram (ECG) risk estimation technologies are classified as medical devices. The Medicines and Healthcare products Regulation Agency (MHRA), an arm’s length body of the Department, is responsible for regulating medical devices and ensuring their safety, efficacy, and performance. AI-ECG risk estimation tools will need to go through the relevant regulatory approvals and register with the MHRA prior to being placed on the market.