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Clinical Safety (DCB0129 / DCB0160)

Practice: Operations · Type: Standard · UK-specific

DCB0129 and DCB0160 are the NHS clinical-risk-management standards for manufacturers and deploying organisations of health IT, requiring a safety case and a nominated clinical safety officer. Celeredge assesses clinical-risk management against them from the client's own evidence.

Benefits​

  • Scored on the DCB0129 / DCB0160 standards' own scale — not a generic rubric.
  • Every score is traceable to the client's own evidence.
  • Gaps ranked by severity, ready to become the safety action plan.
  • A board-ready slide deck and a detailed report, generated automatically.
  • Re-runnable as the safety case matures, so readiness is tracked over time.

When to use it​

  • Assessing clinical-risk management for health IT against DCB0129 and DCB0160.
  • When manufacturing health IT and needing a DCB0129 safety case.
  • When deploying health IT into the NHS and needing DCB0160 compliance.
  • To check whether a clinical safety officer and safety case are in place and adequate.

What it assesses​

Celeredge scores the client's evidence against the standards' requirements, covering:

  • Clinical risk management system and process
  • Safety case and hazard log
  • Clinical safety officer role and governance
  • Manufacturer (DCB0129) and deployment (DCB0160) responsibilities

Expected output​

Per-requirement maturity scores on the standards' own scale. Each answer carries a confidence signal and citations back to the client's evidence, and gaps are ranked by severity. The run generates a board-ready slide deck and a detailed HTML report. See Maturity Scoring, Reports and Deck Studio.

How to use it in Celeredge​

  1. Collect evidence — see Evidence Collection.
  2. In Diagnose, select Clinical Safety (DCB0129 / DCB0160).
  3. Run it and watch it stream — see Running Assessments.
  4. Review answers with confidence and citations, then accept the ones you trust.
  5. Send gaps to Plan — see Gap Analysis.

FAQ​

What is Clinical Safety (DCB0129 / DCB0160)?​

DCB0129 and DCB0160 are the NHS clinical-risk-management standards for manufacturers and deploying organisations of health IT, requiring a safety case and a nominated clinical safety officer.

What does a Celeredge Clinical Safety assessment deliver?​

An evidence-based readiness assessment scored on the standards' own scale, with gaps ranked by severity and an auto-generated, board-ready slide deck and detailed report — every score traceable to the evidence behind it.

How does the assessment work?​

Clients upload their own evidence — policies, reports and data. An AI interviewer asks targeted follow-ups to fill anything missing, the platform scores against the framework, ranks the gaps, and generates the deliverables.

Celeredge runs an independent readiness and alignment review against this framework. It is not a certification audit and is not endorsed by the standard's owner. Framework and standard names are trademarks of their respective owners.