What’s happened 

The Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on how existing medical device regulations apply to AI-enabled ambient voice technology used in health and care settings in Great Britain. 

Often known as AI scribes, these tools can record and transcribe conversations between clinicians and patients and use them to produce clinical notes, summaries and correspondence. 

The guidance confirms that tools used solely to: 

• transcribe clinical conversations  

• summarise conversations  

• draft correspondence  

• recommend clinical codes for review by a healthcare professional  

are not classed as medical devices under current regulations. 

However, different rules apply when the technology goes beyond administrative support. 

AI scribing products intended to support diagnosis, treatment or disease prevention, or to take automated action without clinician review, are regulated as medical devices and must meet the relevant safety and performance requirements. 

The guidance does not introduce new legislation. It explains how existing medical device regulations apply to this technology. 

NHS England has published separate supporting guidance to help NHS organisations assess, procure and introduce ambient scribing products. 

Why this matters to members 

AI scribes are increasingly being used across healthcare to reduce the administrative work involved in documenting consultations. 

The new guidance provides greater clarity for podiatrists and healthcare organisations using or considering these tools about when medical device regulations apply. 

Importantly, using an AI scribe does not transfer professional responsibility to the technology. 

Clinicians remain responsible for reviewing and checking AI-generated transcripts, summaries, clinical codes and correspondence before they are used as part of patient care. 

NHS England also advises healthcare organisations to have appropriate governance, staff training, procurement processes and clinical oversight in place. 

The MHRA advises organisations to keep the functionality of AI scribing products under review. Adding new functions, particularly those that support clinical decisions, could change how a product is classified. 

Links and references 

• MHRA: MHRA clarifies regulatory status of ambient voice technologies used in the NHS 

• NHS England: Guidance on the use of AI-enabled ambient scribing products in health and care settings