Published by ETHOS | June 2025
The Current Regulatory Landscape
On 9th June 2025, NHS England issued a priority notification emphasising that all AVT solutions with AI summarisation features require MHRA Class 1 medical device status as a minimum. This represents a significant shift in how these technologies are regulated and underscores the importance of comprehensive clinical safety assurance.
This highlights a critical gap between technology adoption and regulatory compliance that organisations must urgently address.
Why Clinical Safety Expertise Matters
At ETHOS, our 15+ years of NHS and health sector experience has taught us that successful digital health implementations require more than just technical competence. They require deep understanding of clinical workflows, regulatory frameworks, and the complex interplay between technology and patient safety.
The Reality Check
Liability for using non-compliant AVT solutions sits squarely with the deploying organisation or individual clinicians. This makes professional clinical safety support not just advisable, but essential.
Key Risk Categories We’re Addressing
Through our analysis of hazard logs from leading AVT suppliers, we’ve identified several critical risk categories:
AI-Specific Risks
- AI Hallucinations: Systems generating false or misleading clinical information
- Algorithmic Bias: AI outputs that may disadvantage certain patient groups
- Over-reliance: Clinicians becoming too dependent on AI-generated content
Integration and Performance Risks
- System Unavailability: Critical downtime affecting patient care
- Data Migration Failures: Loss or corruption of clinical information
- Poor Interoperability: Systems that don’t integrate effectively with existing EPRs
Consent and Ethics Challenges
- Inadequate Consent: Patients unaware of AI processing of their data
- Transparency Issues: Unclear communication about AI involvement in care
The ETHOS Approach
Our methodology combines clinical expertise with regulatory knowledge to ensure safe, compliant implementations:
1. Comprehensive Risk Assessment
We don’t just tick boxes. Our team conducts thorough analyses that identify real-world risks specific to your organisation and patient population.
2. DCB 0160 Compliance Support
From Clinical Safety Officer provision to hazard log development, we ensure your implementation meets all mandatory requirements.
3. Ongoing Assurance
Technology evolves, and so do risks. Our post-implementation monitoring ensures continued safety and compliance.
Real-World Impact
One of our recent NHS trust clients was preparing to implement an AVT solution when our assessment revealed critical gaps in their consent management processes. By identifying and addressing these issues pre-implementation, we prevented potential data protection breaches and regulatory non-compliance that could have resulted in significant financial and reputational damage.
Looking Forward: The National Delivery Proposal
NHS England has announced that a national delivery proposal is in development to support standardised AVT rollout across England. This reinforces the importance of getting implementations right from the start, as organisations that establish good practices now will be better positioned for future national programmes.
Five Critical Questions Every NHS Organisation Should Ask
Before implementing any AVT solution, consider:
- Has your supplier provided valid MHRA medical device registration?
- Do you have a qualified Clinical Safety Officer appointed?
- Have you completed a comprehensive Data Protection Impact Assessment?
- Are your clinical teams trained on AI limitations and appropriate use?
- Do you have robust monitoring systems to detect AI performance issues?
If you can’t answer “yes” to all five questions, you’re not ready for safe implementation.
The Bigger Picture
AI technology in healthcare isn’t going away – and nor should it. When implemented safely and compliantly, AVT can genuinely transform clinical practice, reducing administrative burden and improving patient outcomes. The key is ensuring that enthusiasm for innovation doesn’t override fundamental safety principles.
As subject matter experts, we have a responsibility to ensure that the NHS’s adoption of AI technology is both transformative and safe. This requires professional expertise, not just technical capability.
How ETHOS Can Help
Whether you’re at the early stages of considering AVT implementation or dealing with compliance challenges in existing deployments, our team can provide:
- Independent Clinical Safety Officer services
- DCB 0129/0160 compliance assessment and documentation
- Risk assessment and hazard analysis
- Regulatory guidance and MHRA liaison
- Post-implementation monitoring and assurance
We believe in using standards and regulations as enablers, not barriers to innovation. Our approach ensures you can harness the benefits of AI technology while maintaining the highest standards of patient safety.
Get in Touch
If you’re considering AI Ambient Voice Technology implementation or need support with clinical safety assurance, we’d welcome the opportunity to discuss your requirements.
Contact ETHOS:
Phone: 07485 106 477
Email: [email protected]
Website: www.ethos.co.im
Address: 48 Queen Street, Exeter, United Kingdom, EX4 3SR
For more insights on digital health safety and compliance, follow ETHOS on LinkedIn and visit our website for regular updates.
