Rebecca Wilson
Founder, CEO & Director of Clinical Safety
AI assurance
AI assurance for NHS healthcare products
Clinical safety, DTAC v2, medical device and ISO 42001 and EU AI Act evidence, end-to-end assurance for AI products used in NHS clinical care.
What NHS AI assurance covers
AI in healthcare touches every part of the NHS assurance stack, clinical safety (DCB0129/0160), DTAC v2, medical device regulation, information governance, ethics, bias and post-market monitoring.
DigiSafe brings all of it under one roof, so AI suppliers can meet ISO 42001 and EU AI Act expectations and land trust deployments without evidence gaps.
Our AI assurance package
- DCB0129 clinical safety file with AI-specific hazards (bias, drift, hallucination, explainability)
- DCB0160 deployer file for trusts rolling out AI
- DTAC v2 completion
- Medical device classification, technical file and UKCA/MHRA pathway
- ISO 42001 and EU AI Act readiness
- Post-market model monitoring and drift management plan
- Ethics and equity impact assessments
Frequently asked questions
What is AI assurance in the NHS?
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AI assurance is the process of demonstrating that an AI-enabled health product is safe, effective, ethical and compliant, across clinical safety (DCB0129/0160), data protection, medical device regulation, bias/fairness, transparency and post-market monitoring.
Do you cover ISO 42001 and the EU AI Act?
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Yes. We help you set up an ISO 42001 AI management system and prepare for the EU AI Act, alongside clinical safety, medical device regulation and DTAC v2, so one partner covers your whole AI compliance picture.
Do AI products need DCB0129?
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Yes, any AI used in NHS clinical care needs DCB0129 (manufacturer) and, on deployment, DCB0160 (deployer). AI-specific hazards (bias, drift, hallucination, explainability) must be in the hazard log.
Is an AI product also a medical device?
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Usually yes, if it informs a clinical decision. It will need classification under UK MDR, a technical file, ISO 13485/IEC 62304 alignment, UKCA marking and MHRA registration.
Can DigiSafe support AI and ambient scribe suppliers?
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Yes. We write clinical safety, DTAC and medical device evidence for AI and ambient voice technology products used in NHS care.
Related services
Talk to an Expert
Book a free call with a DigiSafe expert. We'll scope the work, timelines and the right partnership, plain English, no jargon.
Direct clinical access
Meet the team, Clinical Safety Officers, DPOs & Medical Device Experts.
Multi-disciplinary lived experience across nursing, GP, paramedic, pharmacy, medical devices and data protection. Book a discovery call and we'll match you with the right expert.
Suzanne Ash
Medical Device and Compliance Lead
Stacey Dudley
Chief Operating Officer
Steve Robson
Senior CSO, Nurse
Dr Lizzie Marston
Senior CSO, GP
Mona Kapinga
Senior CSO, Pharmacist
Matthew Olsson
Senior CSO, Lead Trainer, Paramedic
Zara Mahmood
CSO, Occupational Therapist
Dr Stephen Eberwein
CSO, GP
Shell Mcvey
Business Support Manager
Every engagement starts with a free 20-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.