What the research found
The MHRA, working with NHS England, published guidance clarifying that AI scribes ("ambient voice technology") used solely to transcribe, summarise clinical conversations or draft correspondence for a clinician to review are not regulated as medical devices, while any tool that supports diagnosis or treatment — or takes automated action such as placing an order without clinician review — is. The guidance doesn't change the underlying law; it's meant to remove ambiguity NHS organisations, suppliers and clinicians had been asking for as ambient scribing tools spread rapidly across the NHS.
A real-time test of the "clearance is not proof" point: this clears the low-risk administrative layer for faster adoption while explicitly keeping the higher-stakes diagnosis-and-treatment layer inside medical-device oversight — a risk-tiered line healthcare AI needs more of.