Clinical safety (DCB0129)
Building a DCB0129 clinical safety case for a health-IT product
How a manufacturer produces the DCB0129 clinical safety case, hazard log and Clinical Safety Officer sign-off that NHS deployment requires.
Illustrative example. This is a representative worked example of how we structure this kind of work — not a specific client engagement. It contains no client names, confidential information or achieved metrics. Real client work is confidential and shared only anonymised, with permission, under NDA.
The challenge
A manufacturer of a health-IT product has been told by an NHS trust that it cannot be deployed without a DCB0129 clinical safety case. The team understands their software but not the clinical-risk-management standard, and needs a safety case and hazard log that will withstand scrutiny — produced without stalling the product roadmap.
Approach
How the work is structured
Clinical safety is treated as an engineering discipline, not paperwork: hazards are identified from how the software is actually used, and each is traced to a control.
- Scope the clinical risk. Map the clinical workflow the software touches and where a failure, misuse or misunderstanding could reach a patient.
- Build the hazard log. Identify hazards, rate their clinical risk before and after controls, and record the mitigations — as a living document, not a one-off.
- Write the safety case. Assemble a structured, evidenced argument that the product is acceptably safe for its intended use.
- CSO governance. A suitably qualified Clinical Safety Officer owns the safety case and hazard log and provides accountable sign-off.
Result
What a good result looks like — and how it is measured
The deliverable is a defensible clinical safety case and maintained hazard log that a deploying organisation’s own safety officer (under DCB0160) can rely on.
- A complete hazard log with pre- and post-control clinical risk ratings
- A safety case argument traceable from intended use to evidence
- CSO ownership and accountable sign-off in place
- Artefacts a deploying trust’s DCB0160 process can build on directly
Transferability
Would this transfer to your setting?
A safety case is specific to a product’s intended use; broadening the claims or changing the workflow reopens the hazard analysis. The example shows the method, which transfers, rather than a set of hazards, which do not.
Answers
Clinical safety (DCB0129): frequently asked questions
Is this a real client engagement?
No — it is an illustrative worked example of the method. It names no client and reports no confidential information. Real safety-case work is confidential to the manufacturer and the deploying organisation.
What is the difference between DCB0129 and DCB0160?
DCB0129 is the manufacturer’s clinical-risk-management standard; DCB0160 is the deploying healthcare organisation’s. Both are needed for safe NHS deployment, and the manufacturer’s safety case feeds the deployer’s.
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