NHS-Ready AI Medical Scribe – Augnito Omni AI – Among First to Fully Meet New NHS England Ambient Voice Tech Guidelines
Augnito Omni AI approved by the NHS as one of the first AI Scribes to meet all regulations for adoption in GP Practices, Community Healthcare and Hospitals in UK
The Ambient Voice Technology (AVT) guidance, published by NHS England in April 2025 and updated at the end of that month, sets out a clear regulatory and governance framework to ensure AI tools used in patient care are secure, clinically validated, and properly risk-assessed. The guidance was released amid increasing interest in generative AI tools for clinical documentation, following national pilots across England and Scotland.
Augnito Omni AI meets all seven compliance categories detailed in the NHS guidance, including MHRA registration, data governance, clinical safety standards, procurement readiness, and local data hosting.
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MHRA Registered, Clinically Governed, and Fully DCB Compliant
Among the most critical components of the NHS’s framework is the requirement that any ambient AI solution with summarisation or generative functionality must be registered with the MHRA as a Class 1 medical device. Augnito Omni AI has already satisfied this classification - an important step which indicates that all generative outputs are subject to clinician review and oversight, not presented as autonomous clinical decision-making.
The solution is also compliant with DCB0129 and DCB0160 standards, which relate to clinical safety case documentation and risk assessment. Augnito has an appointed Clinical Safety Officer and maintains full records of its clinical risk management approach - now required for any digital health solution seeking integration into NHS environments.
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On NHS Frameworks and Ready for Immediate Deployment
From a procurement standpoint, Augnito Omni AI is available through several pre-approved NHS frameworks, including the NHS Commercial Solutions Framework (endorsed by NHS England as a recommended route to market), allowing NHS organisations to onboard the platform without new tenders or complex contract processes.
Industry observers note that this provides Trusts, Integrated Care Boards, and GP practices with a faster route to adopting AVT solutions that have already cleared regulatory hurdles.
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Data Privacy by Design
In accordance with NHS and UK GDPR regulations, Augnito processes all data on UK sovereign cloud infrastructure, with voice and text data fully encrypted and anonymised, with optional retention only within national borders.
This model addresses growing concerns among clinicians and digital governance leads about the use of global AI models that transmit or process sensitive data outside of the UK.
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UK-Trained Large Language Model (LLM)
One of the distinguishing features of Augnito’s solution is its proprietary large language model (LLM), which the company has trained using UK clinical datasets and with direct input from British healthcare professionals.
Unlike some AI providers that build on generalist internet-trained models (Such as Chatbots), Augnito’s domain-specific approach appears to offer greater clinical accuracy and fewer irrelevant or hallucinated suggestions — a key concern identified in the NHS’s AVT safety guidelines.
According to those familiar with the development process, UK clinicians were also closely involved in designing the user experience, ensuring that the platform aligns with NHS documentation workflows and doesn’t disrupt routine care.
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Governance-First Approach to Generative Suggestions
A core element of Augnito Omni AI’s architecture is its clinical documentation improvement (CDI) tool, which the company says includes rigorous safeguards to prevent unsupervised or misleading outputs. Suggestions are not drawn from public internet sources, but instead from clinician-approved guidance embedded within its UK-built model.
Importantly, no AI-generated content can be inserted into the clinical record without explicit clinician approval - a key requirement for maintaining Class 1 status under MHRA regulations. This puts Augnito in compliance with the NHS mandate that AI scribe solutions must support, not replace, clinical judgement.
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Enterprise-Grade Certifications and NHS Alignment
The platform is also certified to ISO27001, ISO9001, ISO14001, DSPT, UKCA, and Cyber Essentials Plus standards, offering reassurance to NHS IT and Information Governance teams evaluating the system’s security and resilience.
This suite of accreditations complements the NHS’s emphasis on risk mitigation, particularly as Trusts begin adopting more ambient and AI-driven technologies within high-risk clinical environments.
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A Roadmap to Class 2a - and a Sign of Things to Come
While already compliant with current NHS requirements, Augnito has confirmed it is now working towards becoming one of the first Class 2a AI medical scribe devices registered with the MHRA – a classification typically associated with more advanced clinical tools.
Although not yet required for AI scribing under current NHS guidance, this move would mark a step-up in assurance, involving more stringent clinical validation and post-market surveillance. Industry analysts believe this would signal the company’s intent to remain at the forefront of medical AI development in the UK and beyond.
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A Growing Global Client Base
Augnito’s reach is already international, with deployments across major hospital networks including:
• NHS Scotland, where NHS Lothian is reportedly set to become the first care board in the country to adopt an AI scribe platform using Augnito Omni AI
• Almoosa Healthcare Group, one of Saudi Arabia’s largest healthcare providers
• Apollo Hospitals, India’s largest hospital group
• Among many others
These implementations, particularly across public and private healthcare systems, are being closely watched by NHS leaders as they evaluate AVT tools that can scale across enterprise-level clinical environments.
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Early Access for NHS Sites
In a bid to accelerate adoption, Augnito has announced it is offering early onboarding rates to NHS organisations interested in evaluating or rolling out ambient scribing in 2025. Those familiar with the offer say it helps NHS sites reduce implementation costs while benefiting from regulatory compliance and localised model design from the outset.
“The onboarding process with Augnito Omni AI has been excellent – The Augnito team have been incredibly supportive, proactive, and always quick to respond. Their help navigating the DPIA and SSP processes has made what can often be a complex task feel straightforward and well supported” – Laura Rowlinson, Digital and Informatics Lead, NHS Lothian, Scotland (Edinburgh Region), June 2025.
DR JAM GAFAROV
Scribetech UK Ltd
+44 7860 351120
UKmarketing@scribetech.co.uk
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