Resources
Standards and Specifications
| Resource |
Description |
URL |
| DCB 0129 specification and templates |
The full standard for manufacturers |
NHS Digital |
| DCB 0160 specification and templates |
The mirror standard for deploying organisations |
NHS Digital |
| NHS England Digital Clinical Safety Assurance |
Overview guidance covering both standards |
NHS England |
| DTAC specification and guidance |
National baseline criteria for NHS digital health technologies |
NHS Transformation Directorate |
| Standards review (DCB 0129/0160 v2) |
Information on the ongoing review towards version 2 |
NHS Digital |
Training
| Course |
Provider |
Format |
Cost |
| Essentials of Digital Clinical Safety |
NHS England / e-LfH |
E-learning |
Free for NHS staff; £35+VAT otherwise |
| Clinical Risk Management Programme |
NHS England / e-LfH |
E-learning (8 sessions) |
Free for NHS staff |
| Face-to-face Clinical Safety course |
NHS England |
One-day in person |
Varies (card payment required) |
Training portal: NHS Digital Clinical Safety Training
Guidance and Compliance
| Resource |
Description |
URL |
| AI and Digital Regulations Service |
Developer guidance on DCB 0129 compliance |
Digital Regulations |
| DTAC developer guidance |
How to use the DTAC as a developer |
Digital Regulations |
| NHS Applicability tool |
Helps determine if DCB 0129/0160 applies to your product |
Via NHS England step-by-step guidance |
Real-World Examples
| Resource |
Description |
URL |
| Concentric Health CSCR |
Publicly available Clinical Safety Case Report from a small healthtech company (digital consent) — good model for structure and tone |
Concentric Health |
| Concentric Health DTAC |
Example of DTAC evidence presentation including named CSO, registration details, and third-party risk coverage |
Concentric Health |
| HSSIB EPR thematic review |
Comprehensive investigation into patient safety issues associated with EPR systems — invaluable for hazard identification |
HSSIB |
| CDS API Clinical Safety Case Report |
Example of NHS programme-level CSCR with hazard workshop methodology |
NHS Developer |
| Tool |
Description |
URL |
| SafetyLogix |
Dedicated DCB 0129/0160 hazard log management tool — interactive risk matrix, collaboration, multiple export formats, training videos |
SafetyLogix |
| NHS Digital document templates |
Official templates for CRMP, Hazard Log, CSCR |
Available from NHS Digital Clinical Safety website |
CSO Consultancies
| Company |
Services |
URL |
| 8fold Governance |
CSO as a service, DCB 0129/0160 compliance, DTAC support, hazard workshops |
8foldgovernance.com |
| Safehand |
CSO consultancy, training, SafetyLogix tool, FAQ resources |
safehand.co.uk |
| AbedGraham Group |
CSO services, DCB 0129 compliance for large vendors, DTAC guidance |
abedgraham.com |
| Kaleidoscope Consultants |
CSO service for medtech and provider organisations, DCB 0129/0160 |
kaleidoscopeconsultants.com |
| Naq Cyber |
Combined clinical safety and cybersecurity compliance, DTAC support |
naqcyber.com |
| Acorn Compliance |
DTAC compliance, CSO support, evidence file building |
acorncompliance.com |
| Resource |
Description |
| HSSIB EPR thematic review (2025) |
Patient safety issues from EPR systems — real incident vignettes including weight-based medication errors, configuration risks |
| PSNet EHR primer (AHRQ) |
Overview of EHR safety issues including medication errors, usability, and interoperability |
| Pew Charitable Trusts: Ways to Improve EHR Safety (2018) |
Clinical test case methodology for EHR safety evaluation |
Last updated: February 2026. Standards are under active review — monitor NHS Digital for Version 2 publications.