questionText: 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.
answerText: 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, whi...
heading: NHS: Artificial Intelligence