NHS England issues guidance on Ambient Voice Technology Ensuring Safe and Assured Adoption of AI Scribes
- Lloyd Price
- 1 day ago
- 3 min read
Ensuring Safe and Compliant AI Scribe Technology in the NHS
NHS England has issued an urgent notification regarding the use of Ambient Voice Technology (AVT) solutions, also known as AI scribe technology, in clinical settings. While acknowledging the transformative potential of AVT for improving patient care and efficiency, the NHS is concerned about the widespread use of non-compliant solutions, posing significant risks to clinical safety and data security.
Key Directives for NHS Organisations
All NHS organisations, regardless of care setting, are mandated to ensure that any AVT solutions in use meet specified NHS standards. Non compliant solutions, whether procured through free trials or direct commissioning, are not permitted. The liability for using non-compliant solutions rests with the deploying organisation (eg. general practice or trust) or individual user.
Mandatory Requirements for AVT Adoption
To ensure compliance, NHS organisations must adhere to the following key points:
Avoid Non-Compliant Solutions: Do not use AVT solutions that do not meet NHS standards.
Medical Device Status: All AVT solutions that generate summarization must have at least MHRA Class 1 medical device status. Solutions aiming to produce generative diagnoses or management plans require at least MHRA Class 2a approval.
Risk Assessments: Providers must complete a clinical safety risk assessment and a Data Protection Impact Assessment (DPIA) as part of their legal responsibilities (DCB0160).
Supplier Compliance: It is the responsibility of NHS organizations to ensure AVT suppliers demonstrate compliance with core platform assurance requirements (e.g., DTAC, DSPT, Cyber Essentials Plus, end-to-end encryption, GDPR compliance). Suppliers are also responsible for translation accuracy.
Data Minimisation: Patient data from clinical sessions should be automatically deleted unless legally or operationally required, in line with UK GDPR and DPA 2018 principles.
System Integration: AVT solutions must integrate appropriately with existing IT infrastructure and electronic patient record systems to enable automated workflows.
Proven Benefits: Suppliers must provide evidence of real-world clinical validation within an NHS care setting, demonstrating benefits such as enhanced efficiency, reduced administrative burden, and improved patient care and data quality.
Economic Justification: Clear economic justification and workforce impact must be provided.
Immediate Required Actions
NHS organisations are instructed to immediately:
Pause, reject, or stop engagement with any AVT supplier that cannot meet the published assurance standards.
Pause or stop any implementation or use of AVT by an organisation or individual that cannot meet the published assurance standards.
Engage with their Integrated Care Board (ICB) and regional teams for assurance.
Future Developments
NHS England is developing a national delivery proposal to support the safe and compliant rollout of assured and standardised AVT solutions across England. Further communications regarding this initiative will be issued shortly.
It is essential for all NHS organisations to read the full guidance and consult with their ICB digital team before proceeding with any AVT solution.
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