The safe and responsible adoption of ambient voice technologies (AI scribes) in clinical settings (WHC/2025/026)
Guidance to NHS Wales on the use of ambient voice technologies (AI scribes).
This file may not be fully accessible.
In this page
Details
Issue date:
4 August 2025.
Status:
Interim position.
Categories:
- Quality and safety.
- Delivery.
- Information technology.
- Science.
Title:
The safe and responsible adoption of ambient voice technologies ("AI scribes") in clinical and practice settings.
Date of expiry/review:
April 2026.
For action by:
- Chief executives of NHS Wales local health boards, trusts and special health authorities.
- All clinical network leads in NHS Wales.
- All digital directors in NHS Wales.
- All general practitioners and primary care leads in NHS Wales.
- All independent contractors providing NHS services, namely general practices, optometric, dental and community pharmacy practices.
- All executive directors of nursing.
- All primary care directors at NHS Wales local health boards.
- All medical directors, nurse directors, directors of therapy, directors of primary care and mental health NHS Wales.
Sender:
Helen Arthur
Director of Workforce and Organisational Development
Health, Social Care and Early Years Group
Welsh Government.
Welsh Government contacts:
Dr Rupa Chilvers
Deputy Director Life Science and Innovation
Health, Social Care and Early Years Group
Welsh Government.
Email: hss.aipolicy@gov.wales
The safe and responsible adoption of ambient voice technologies ("AI scribes") in clinical and practice settings
Dear colleagues,
This Welsh Health Circular provides an interim position on the introduction and use of artificial intelligence and machine learning in the form of ambient voice technologies (AVTs) in clinical and practice settings.
Audience
This circular applies to all NHS Wales clinicians, practitioners and teams, including independent contractors providing health services on behalf of the NHS in Wales, collectively referred to in this circular as "the NHS Wales health service provider(s)". It applies to those who are currently using, or considering the use of, AVTs in patient or public facing consultations.
This includes any clinical interactions that uses AI tools to transcribe or summarise clinician’s patient or service consultation notes. AVTs are essentially apps which use artificial intelligence and machine learning to transcribe conversations into written text. They can be used to create information about a health consultation or interaction in a templated format for clinicians and practitioners to use as part of an individual’s health record or for communication purposes including drafting letters.
The NHS Wales health service provider choosing to adopt AVTs must do so in line with current UK legislative and regulatory requirements, including those set out in guidance by the Medicines and Healthcare products Regulatory Agency (MHRA), where AI technologies and devices are classified by the MHRA as medical devices based on the features enabled and how it is used.
Interim position
The following information is provided to NHS Wales health service providers, in relation to the use of AVTs as an interim position. The requirements should be considered in line with the latest Government Digital Service AI playbook principles and in particular considering principles 2, 3, 4, 5 and 8 of the playbook in this context.
The following outlines the requirements governing the use of AVTs by NHS Wales on an interim basis.
AVTs should only be used for supporting summarisation of discussions and consultations
The level of detail for the summarisation should be tested in line with what is clinically appropriate and required as part of professional practice. AVTs should not be used as a decision support tool for clinical diagnosis or treatment plans (unless it is in a pre-agreed test environment or as part of research studies).
The NHS Wales health service provider must consult and seek approval of their respective clinical safety officers, Caldicott Guardians, senior information risk owners (SIRO), information governance and cyber leads to ensure that all legislative and safety considerations are in place prior to the use of the technologies in live clinical settings.
The use of speech recognition technology carries with it specific information rights considerations, which must be recorded through the DPIA process
NHS Wales health service providers as data controllers are accountable in relation to the requirement for them to comply with statutory and common law as well as applicable information standards and guidance from the information commissioner.
In circumstances where AVTs used by NHS Wales health service providers qualify as a medical device, the technology must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and evidence of MHRA approval must be sought
Current MHRA advice is that all AVT solutions that generate summarisation should be classified as at least a class 1 medical device, and in some cases as class 2. Where AVTs are used only for transcriptions and verbatim capabilities (such as a dictation tool), this is unlikely to fall into the category of a medical device.
All AVTs must not be used as autonomous tools and must be used as a human-in-command (HIC) tool operating under strict human supervision
The clinician or practitioner acting on behalf of the NHS Wales health service provider maintains full responsibility for the creation of the summaries in the way templates and equivalents are set up and validating outputs by AVTs prior to entry as part of patient or service record systems accordingly. The accuracy of the records remains the full responsibility of the clinician or practitioner, and this must be undertaken within the legal and professional scope for registered professionals.
All corporate NHS Wales health service provider level processes and procedures must be followed
As with any introduction of change in the way health care is provided and for the introduction of technology into practice (such as AVTs), all corporate NHS Wales health service provider level processes and procedures must be followed. This includes:
- information governance
- cyber security
- AI-specific processes
- identification and mitigation of clinical and technological risks
These will need to be reviewed and approved for the specific use case or set of use cases prior to use and application in clinical settings. AVTs should only be used within the scope of the approvals that are in place and the NHS Wales health service provider must ensure the devices meet the necessary regulatory approvals granted by the MHRA for use as medical devices. The necessary training for the safe introduction and use of such technologies and tools should be carried out in line with the usual NHS Wales health service provider processes and procedures.
The MHRA’s yellow card scheme should be used for reporting any adverse incidents arising from the use of AVTs
This is part of contributing to the UK system for reporting and monitoring safety concerns related to medical devices. In circumstances where an adverse incident or near miss has arisen, the appropriate safeguards and regulatory processes should be in place before recommencing the use of AVTs. This should follow usual continuous improvement, service improvement or service evaluation protocols, in line with safeguards for introducing changes in services where there are clearly defined performance metrics for accuracy, reliability, and ongoing monitoring. AVTs as technologies in themselves and as products that use generative artificial intelligence (AI) and large language models (LLMs) are subject to updates and changes. This may result in frequent changes and new functions unintentionally or through user-provided instructions and the underlying large language models. Processes should be in place for informing and updating user training on reviewing and revising outputs based on the learning, is essential as part of the safe and responsible use of AVTs.
The use of AVTs will need to be introduced with care and with consideration of patient and service-user needs and appropriate use of the technology
All people involved in the consultation or interaction must be advised ahead of using AVTs so that they can choose whether to proceed with, or without, the use of the technology. This should also include the opportunity to request the stopping and restarting the use of AVTs during the consultation or interaction. The NHS Wales health service provider must maintain transparency on how and where the AVTs are being used and how or if the use impacts on the provision of care. This is likely to be an area of further development as the capabilities for AVTs continue to evolve. It is important that NHS Wales health service providers follow the Algorithmic Transparency Recording Standard template to share information about how and why they are using these tools.
Ethical and responsible use of artificial intelligence across public sector workplaces
When using AVTs, the NHS Wales health service provider needs to consider the Workforce Partnership Council’s guidance on the ethical and responsible use of artificial intelligence across public sector workplaces. This may highlight areas of concern and uncertainty for clinicians or practitioners acting on behalf of the NHS Wales health service provider and these need to be considered and acted on accordingly.
It is important to only use AVTs as appropriate and effective to the care context
Clinicians and practitioners acting on behalf of the NHS Wales health service provider must consider inclusion and ensure the needs of diverse populations and communities paying particular attention to:
- speech recognition accuracy
- cultural and content sensitivity
- equitable access
- providing services in the preferred language choice
The benefits of using AVTs which have been described to assist with more natural and personable consultations, reduced administrative burden, and improved documentation must be balanced with transparency, consent and trust, particularly in communities that may already feel marginalised or underrepresented for the services being accessed.
Limitations of the technology and its ability to operate effectively in certain circumstances
When using AVTs in certain physical locations and settings, consideration should been given to the limitations of the technology and its ability to operate effectively in certain circumstances. For example, where the technology is not yet proven for use in locations, such as, with high levels of background noise, unreliable internet connections. Such factors will need to be considered as part of the organisational approvals.
Capturing and summarising interactions taking place in Welsh or other languages
The accuracy of AVTs for capturing and summarising consultations and interactions taking place in Welsh language or other languages is likely to differ based on the underlying technologies for speech recognition. This should be tested and considered as part of the approvals process and decisions taken accordingly.
Ensure that the tool is used in line with UK legislative and regulatory requirements
In all circumstances, it is the responsibility of the NHS Wales health service provider to ensure that all requirements set out in current UK legislative and regulatory requirements are met when using AVTs. It is the responsibility of the clinician or practitioner acting on behalf of the NHS Wales health service provider to ensure that the tool is used within the scope of the approvals.
If any of the requirements above are not in place or cannot be followed, the NHS Wales health service provider should immediately stop the use of AVTs in their service(s) and take appropriate steps to ensure compliance with usual NHS Wales processes and procedures.
The exception to the above rule is for projects that are in a testing stage or generating evidence to support professional development, training, research or service development on how best to use AVTs in NHS. For these projects, all the organisational approvals associated should be in place in line with regulations and information governance.
However, given that there will be continuous monitoring in place and that the AVTs are used alongside usual practices, a pro-innovation approach with proportionate controls and safeguards should be applied including for understanding for clinical risk which may be mitigated by the design of the test or evidence generation project.
Next steps
The Welsh Government is working closely with key stakeholders to ensure that detailed guidance is developed for areas where there are uncertainties on the effectiveness of AVTs or where there may be higher risk or increased potential to impact on quality of care.