Ambient voice technologies ("AVTs") are AI-enabled tools that automatically transcribe and document clinical conversations, and we are seeing a significant increase of these products on the UK market, including their active deployment across NHS settings.

NHS England has updated its guidance on AI-enabled ambient scribing products in health and care settings (Version 3, last updated 29 July 2026), alongside the launch of the NHS England Ambient Voice Technology ("AVT") Supplier Registry. Together, these developments establish a structured national framework for how NHS organisations will assess, procure, and deploy AI scribing tools, and set clear expectations for suppliers seeking to enter this market.

What the Registry is, and what it is not

The AVT Supplier Registry is a national self-certified registry providing NHS organisations with an accepted list of suppliers and a repository of supporting evidence to support and accelerate local procurement and assurance activities. Inclusion requires completion of the Digital Technology Assessment Criteria ("DTAC") assessment and Medicines and Healthcare products Regulatory Agency ("MHRA") registration as a medical device where applicable. Suppliers are also required to provide evidence of real-world benefit of their product in the NHS care setting proposed, and to demonstrate their approach to performance monitoring.

Being listed does not guarantee a contract and the Registry is not a commercial framework. NHS England does not endorse any of the suppliers listed and will only undertake preliminary completion checks against requirements and standards. Each NHS organisation remains responsible for its own procurement decisions in line with its own governance processes.

Is your product a medical device?

The single most important compliance question for ambient scribing suppliers is whether their product qualifies as a medical device under UK law. The answer turns on the intended purpose as defined by the manufacturer in their Instructions for Use, labelling, and promotional materials, and not simply on how the product functions in practice. A product meets the definition of a medical device when it has an intended purpose related to diagnosis, prevention, monitoring, treatment, or alleviation of disease. Importantly, to be listed on the AVT Supplier Registry, suppliers will generally need to be registered as a medical device.

Suppliers who have not yet undertaken a formal intended purpose analysis should treat this as an immediate priority, as medical device status triggers MHRA registration, risk classification, and post-market surveillance obligations. Manufacturers must also report serious incidents to the MHRA via the Yellow Card scheme.

The MHRA also published guidance on ambient voice technology-enabled products on 29 July 2026, available here, which sets out how existing medical device regulations apply to AVT products and includes a number of helpful examples. One example that may be particularly useful for suppliers is the following: a product that provides clinical conversation summaries but also presents users with an option to generate suggested diagnoses or follow-up and treatment options is a medical device, even where its labelling states it is intended only for administrative documentation. The MHRA makes clear that disclaimers alone will not establish non-device status where medical claims are made or implied elsewhere in labelling or promotional material. Critically, clinical safety requirements apply to all digital products intended for NHS use regardless of medical device status. The DCB0129 clinical safety standard requires suppliers of Health IT Systems to verify the safety of their products in England. NHS organisations are separately required to complete DCB0160 documentation, including a safety case, hazard log, and monitoring framework, and must ensure their supplier has completed the DCB0129. There is no compliance-free pathway.

Data compliance

On data compliance, suppliers and NHS organisations must comply with the Data Security and Protection Toolkit ("DSPT") and hold Cyber Essentials certification. Products must comply with the UK General Data Protection Regulation ("UK GDPR"), and NHS England has published separate Information Governance guidance including a Data Protection Impact Assessment ("DPIA") template to support organisations adopting ambient scribing products. Organisations should also be aware that patients have rights under UK GDPR Article 22 not to be subject to automated decision-making where the outcome produces a legal or similarly significant effect on them.

Further Considerations

Beyond the core compliance requirements above, suppliers should also consider Electronic Patient Record ("EPR") integration standards, such as Fast Healthcare Interoperability Resources ("FHIR"). Liability for AI-related claims in NHS settings remains complex and largely uncharted, and clear contractual arrangements that appropriately delineate responsibility are essential. Suppliers should also note that running a pilot does not exempt them from compliance, as pilots may only proceed where they are time-limited and are not used to bypass compliance requirements. Finally, AVTs carry a high potential for bias, and suppliers should be prepared to demonstrate performance across diverse patient populations, including across UK regional accents and dialects, those who speak English as a second language, and users affected by speech disorders or impairments.

Read the NHS England guidance here.

If you have questions about any of the compliance considerations set out in this article, or would like to explore how they apply to your products or services, please do not hesitate to get in touch with our team. Bird & Bird's Life Sciences and Technology practice has extensive experience advising AVT and digital health suppliers on regulatory, data, and commercial matters in the UK and across Europe.