Resource hub
A working library for NHS digital clinical safety
Reference guides, analysis and the primary sources we work from — written for founders, product leads, quality managers and clinical safety officers who need to know what an NHS reviewer will ask, and why.
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By topic
DCB0129 for health IT manufacturers
Applicability, the clinical risk management lifecycle, hazard logs, safety case reports and the Clinical Safety Officer role.
Last reviewed 17 August 2026
DCB0160 for deploying organisations
What an NHS or care organisation has to do locally when it implements someone else's health IT system.
Last reviewed 17 August 2026
DTAC readiness, domain by domain
The five assessment areas, the evidence reviewers expect, and why packs most often stall on inconsistency.
Last reviewed 17 August 2026
The Clinical Safety Officer role
Registration, competence, authority, indemnity, and the difference between internal and fractional arrangements.
Last reviewed 17 August 2026
Building a clinical safety case
Structuring a safety argument that reflects the product as built and survives scrutiny from an NHS reviewer.
Last reviewed 17 August 2026
Clinical safety for AI-enabled products
AI-specific failure modes, meaningful human oversight, change management and post-deployment monitoring.
Last reviewed 17 August 2026
Digital mental health and neurodevelopmental products
Clinical safety and AI assurance for ADHD, autism, assessment and remote mental health platforms.
Last reviewed 17 August 2026
Primary sources
The guidance we work from
- Clinical risk management standards (DCB0129 and DCB0160)NHS England(opens in a new tab)
- Digital Technology Assessment Criteria (DTAC)NHS England(opens in a new tab)
- Software and artificial intelligence as a medical deviceMHRA(opens in a new tab)
- Guidance on AI and data protectionICO(opens in a new tab)
- Data Security and Protection ToolkitNHS England(opens in a new tab)
- NICE Evidence standards framework for digital health technologiesNICE(opens in a new tab)
External links are provided for reference. Always check the issuing body’s current version — guidance in this area changes, and evidence currency is what NHS reviewers scrutinise.
How to read this library
- Guides
- Reference explanations of a standard, role or process, kept under review.
- Analysis
- Our interpretation of how a requirement plays out in practice, with the uncertainty stated.
- Regulatory updates
- Changes to standards and guidance, and what they mean for suppliers.
- Primary sources
- The published material itself. Where we and the source disagree, the source wins.