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Digital Front Door

DCB0129

DCB0129 compliance for digital triage — explained.

DCB0129 is the UK clinical risk management standard every health IT supplier must meet for NHS deployments — one of several compliance regimes TriageNix supports for health systems worldwide. This page explains what DCB0129 requires of a triage platform, what evidence healthcare buyers should ask for, and how TriageNix maintains DCB0129 compliance with each release.
Open safety case Governance FAQ
  • Live clinical safety case maintained per release
  • Hazard log with risk scoring, mitigation and residual risk
  • Named, registered UK Clinical Safety Officer (CSO)
  • Aligned with DCB0160 buyer-side obligations
  • Sharable evidence pack for ICB IG teams
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Releases under CSO sign-off
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Open critical hazards
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Evidence pack turnaround

What it is

DCB0129 is the NHS Data Coordination Board standard for clinical risk management in health software, applicable to UK deployments. It requires the manufacturer (TriageNix) to formally identify clinical hazards, mitigate them, and have a registered Clinical Safety Officer sign off each release. UK healthcare buyers are obliged under DCB0160 to obtain this evidence before deployment; buyers elsewhere receive the equivalent evidence pack for their national regime.

Who it's for

  • NHS information governance, clinical safety and IT teams evaluating suppliers
  • ICB digital transformation leads
  • Practice managers and GP IT leads
  • Procurement and DSPT assessors

How it works

    Step 1
    Hazard identification

    Clinical and engineering review of each new feature, route and edge case before merge.

    Step 2
    Risk scoring

    Severity × likelihood, with explicit mitigations and a residual-risk decision logged in the hazard log.

    Step 3
    CSO sign-off

    Registered UK CSO reviews the safety case and approves the release.

    Step 4
    Post-market surveillance

    Safety reports, near-miss reviews and per-release re-evaluation of the hazard log.

FAQ

What is DCB0129?

DCB0129 is the NHS Data Coordination Board standard (a UK-specific requirement) that requires manufacturers of health IT systems to apply clinical risk management — produce a clinical safety case, maintain a hazard log, and have a named Clinical Safety Officer (CSO) sign off each release. TriageNix applies equivalent clinical risk management discipline for health systems outside the UK.

Is DCB0129 mandatory?

Yes, for any health IT system deployed into the NHS in England. Buyers (hospitals, clinic groups, GP practices) are required by DCB0160 to obtain DCB0129 evidence from their supplier before go-live. Outside the UK, TriageNix maintains equivalent clinical risk management documentation for the applicable national regime.

What evidence does TriageNix provide?

A current clinical safety case report, hazard log, clinical risk management plan, CSO sign-off, and per-release safety review notes — sharable with your IG team under NDA before contract.

Who is your Clinical Safety Officer?

TriageNix has a named, registered UK Clinical Safety Officer responsible for sign-off across all deployments. CV and credentials are provided on request.

How does this map to DTAC and MHRA?

DCB0129 covers clinical safety. DTAC adds clinical safety, data protection, technical assurance, interoperability and usability. MHRA SaMD covers medical-device classification (Class IIa for risk-stratifying triage). TriageNix evidences all three.

Request the DCB0129 evidence pack

Available under NDA — typical turnaround under 48 hours for ICB and GP federation IG teams.

Open safety case Governance FAQ

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