Resources
Straight answers on NHS clinical safety and AI assurance
Short, honest explainers written for founders, product leads and quality managers who need to understand what NHS buyers will ask for — and why.
Guides
Start here
DCB0129 explained for manufacturers
What the standard asks of health IT manufacturers, the artefacts it produces, and how DCB0160 differs.
DTAC readiness, domain by domain
The five assessment areas, where suppliers commonly fall short, and how to prepare a coherent pack.
Clinical safety for AI-enabled products
Failure modes specific to AI, designing meaningful human oversight, and monitoring after deployment.
Primary sources
The guidance we work from
- NHS England — Clinical risk management standards (DCB0129 / DCB0160)(opens in a new tab)
- NHS England — Digital Technology Assessment Criteria (DTAC)(opens in a new tab)
- MHRA — Software and AI as a medical device(opens in a new tab)
- ICO — Guidance on AI and data protection(opens in a new tab)
External links are provided for reference. Always check the issuing body's current version — guidance in this area changes.