DCB0129 / DCB0160 Guidance
The two primary NHS England clinical risk management standards for health IT. Understanding both is essential for any organisation building or deploying digital health software in the UK.
Clinical Risk Management: its Application in the Manufacture of Health IT Systems
Audience: Health IT system manufacturers and developers
Requires manufacturers to establish a clinical risk management system, identify and assess clinical hazards during software development, and produce a Clinical Safety Case Report (CSCR) prior to release.
Key Documents
- Clinical Risk Management Plan
- Hazard Log
- Clinical Safety Case Report
Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems
Audience: NHS organisations and health system deployers
Requires deploying organisations to assess clinical risks introduced by deploying or integrating health IT systems into their clinical environment. Complementary to DCB 0129.
Key Documents
- Deployment Safety Assessment
- Local Hazard Log
- Clinical Safety Case
How DCSO Hub Helps
Hazard Library
Browse peer-reviewed hazards tagged by DCB clause to accelerate your Hazard Log population.
Community Q&A
Ask experienced CSOs for interpretation guidance on ambiguous DCB requirements.
Templates
Download community-contributed CSCR templates and Hazard Log spreadsheets.
Questions? Visit the Collaboration Hub or contact support.