The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance clarifying how existing medical device law applies to ambient voice technology (AVT) products used in health and care settings in Great Britain.
The guidance was published in close partnership with NHS England (NHSE) and will support an ambition for the NHS to become the most AI-enabled health system in the world, giving developers, suppliers and NHS organisations the clarity needed to adopt AVT tools safely and with confidence.
AVT products, often referred to as AI scribes, are being used more frequently across the NHS to record and summarise conversations between clinicians and patients. This can save time on administrative tasks.
The new guidance says that 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.
However, 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.
Lawrence Tallon, Chief Executive Officer, MHRA said: “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.
“We are setting out which functions of ambient voice technologies are deemed medical devices and which are not in order to remove ambiguity. This will help to unlock faster uptake of lower risk tools that significantly reduce the burden of administrative work, such as transcribing or summarising conversations, in turn, giving clinicians more quality time focusing on patients.
“Crucially, where a product supports diagnosis or treatment, regulatory protections will still apply.”
Rob Thompson, Chief Digital, Data and Technology Officer, NHS England said: “AI notetaking tools are already showing real promise in reducing the administrative burden on frontline staff and freeing up more time for patient care, but the technology must be adopted with the right safeguards in place.
“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.”
