Both standards ask the same question, “could this harm a patient?”, from two sides: the supplier's product and your practice's use of it.
- Whose job
- Supplier: DCB0129. Your practice: DCB0160.
- Who usually leads
- Each side's Clinical Safety Officer
- How often
- Every new tool, and every significant change
Side by side
Both are NHS information standards that are mandatory by law.12
DCB0129DCB0160Who it’s forThe manufacturer of the softwareThe organisation using it: your practiceWhat it coversRisks in the product itselfRisks in how you set it up and use itWho signsThe supplier’s Clinical Safety OfficerYour Clinical Safety OfficerWhat it producesTheir hazard log and safety case reportYour hazard log and safety case report
How they fit together
DCB0129The supplier
- Hazard log for the product
- Clinical safety case report
- Signed by their CSO
- Shared with you
DCB0160Your practice
- Read their documents
- Add your own local hazards
- Your safety case report
- Signed by your CSO
- Go live and keep watch
You can’t do good DCB0160 work without the supplier’s DCB0129 documents. They tell you what the supplier has already thought about, and what they expect you to manage locally.
What to ask the supplier
- Can you send your clinical safety case report and hazard log?
- Who is your Clinical Safety Officer?
- Which risks do you expect us to manage locally?
- How will you tell us about safety issues and updates?
For the whole process, with templates and a worked example, see clinical safety.
References
- DCB0129: Clinical risk management in the manufacture of health IT systems. NHS England standards directory
- DCB0160: Clinical risk management in the deployment and use of health IT systems. NHS England standards directory
Sources on this page last checked 6 November 2026.