The Medicines and Healthcare products Regulatory Agency has published guidance to clarify how the medical devices regulations apply to ambient voice technology in health and care.
MHRA notes that some AVT solutions qualify as a medical device and confirms some “AVT products that are intended solely for transcription, summarising of clinical conversations, drafting letters, or suggesting clinical codes for a clinician to review are not regulated as medical devices under the current framework”. The body goes on to recommend that “users of such AVT products should carefully consider what information and practices are needed to ensure safe deployment”.
AVT products that qualify as a medical device, cover the intended use to “support diagnosis, treatment or prevention, or take automated action such as placing orders without clinician review”. These technologies must meet relevant safety and performance requirements, MHRA stated.
The guidance highlights how AVT functionalities are considered in context of its specific intended purpose, risks, and benefits, and provides supporting examples of AVT products that are, and are not, medical devices.
Lawrence Tallon, chief executive officer, MHRA, commented to state: “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. We are setting out which functions of ambient voice technologies are deemed medical devices and which are not in order to remove ambiguity.”
Rob Thompson, chief digital, data and technology officer, NHS England, added: “We’ve worked closely with the Medicines and Healthcare products Regulatory Agency to develop this new guidance, which provides clarity for NHS organisations on how these tools should be assessed, introduced and managed. We’ll now begin rolling out the technology across the NHS safely, consistently and at scale so staff can spend more of their time where it matters most – with patients.”
Wider trend: Ambient voice technology
HTN was joined by a panel of experts from across the health sector for a focused webinar on the use of ambient scribe technology in NHS trusts. Panellists included Lauren Riddle, transformation programme manager at Hampshire and Isle of Wight Healthcare (HIoW); Ynez Symonds, CNIO at HIoW; Dom Pimenta, co-founder and CEO at Tortus AI; and Stuart Kyle, consultant rheumatologist and clinical lead for outpatient transformation at Royal Devon University Hospital. Our panel discussed the practicalities and considerations for ambient scribe implementations, from operating procedures and policies, integration and functionality, through to best practices around patient-practitioner interactions.
NHS England’s Transformation Directorate has published a list of 19 suppliers who have evidenced the criteria required to be part of its self-certified Ambient Voice Technology registry – “a national capability to support safe and effective scaling and adoption of AVT across the health and care system”. The 19 suppliers include 33n, Accurx, Anathem, Aprobrium (Lexacom), Beam Up, Corti, Dictate IT, eConsult, HealthOrbit AI, Heidi Health, Lyrebird Health, Microsoft Dragon, Optum (EMIS), Pungo t/a Joy, Scribetech, Tandem, Tortus, T-Pro, and X-On Health.
South East Coast Ambulance Service has launched a pilot of Tortus’s Ambient Voice solution in its emergency operations centres, looking to free-up clinician time to assist more patients. The tool listens in on conversations, transcribing spoken words into structured medical notes to be checked and approved. According to the trust, this is expected to reduce the amount of time taken by clinicians writing up notes following calls. Alongside the SECAmb pilot, due to run to February 2026, other ambulance services are also committed to testing the technology, including London Ambulance Service and South Western Ambulance Service.
