The Medicines and Healthcare products Regulatory Agency (MHRA) and NHS England have issued new guidance clarifying when Ambient Voice Technology (AVT) -- commonly known as AI scribes -- is regulated as a medical device.
The guidance is designed to remove regulatory uncertainty, helping NHS trusts safely adopt administrative AI tools to reduce paperwork and free up clinicians' time for patient care.
AVT products intended solely for transcription, clinical summarisation, letter drafting, or suggesting clinical codes for review are not regulated as medical devices.
Users of such AVT products should carefully consider what information and practices are needed to ensure safe deployment.
NHSE has issued guidance on the use of AVT products in health and care settings to assist those adopting ambient scribing products in England.
AVT products intended to support diagnosis, treatment or prevention, or that take automated action such as placing orders without clinician review, are regulated as medical devices and must meet the relevant safety and performance requirements.
Clinicians remain legally responsible for checking and verifying all AI-generated outputs before they are used in patient care. NHS boards and executive teams must also ensure that local governance, procurement, and staff training support safe deployment.
Lawrence Tallon, Chief Executive Officer, MHRA said that this guidance is an important step forward for the safe and confident adoption of AI in healthcare settings.
“NHS organisations, suppliers and clinicians have been asking for clarity on where the regulatory line sits for this high-growth and high-potential technology, and this guidance aims to provide it,” he added.
Haris Shuaib, NHS Consultant Clinical Scientist, Founder & CEO, Newton’s Tree, added, “For AI to deliver real impact in healthcare, organisations need clear rules and confidence to innovate and manage their own governance processes.”
He said the new guidance will provide clarity that will help the NHS adopt ambient voice technologies more consistently and at greater scale.
