Rebecca Wilson
Founder, CEO & Director of Clinical Safety
AI assurance
AI assurance for NHS healthcare products
Clinical safety, DTAC v2, medical device and NHS SBS Healthcare AI Framework 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 bid on NHS SBS Healthcare AI Framework 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
- NHS SBS Healthcare AI Framework evidence pack
- 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.
What is the NHS SBS Healthcare AI Framework?
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The NHS SBS Healthcare AI Framework is a procurement route for AI products used in health and care. Suppliers must evidence clinical safety, information governance, medical device status, ethics and technical robustness to be listed.
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 NHS SBS AI framework bids?
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Yes, we've written clinical safety, DTAC and medical device evidence for multiple NHS SBS AI framework submissions.
Related services
Talk to a Clinical Safety Officer
Book a free call with a DigiSafe CSO. 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
Sharon Fisher
Executive Assistant
Every engagement starts with a free 20-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.