DTAC clinical safety · DCB 0129 evidence

The clinical safety evidence
DTAC will ask for.

Dr Chiho Song prepares and reviews the supplier-side DCB 0129 evidence behind the clinical safety section of NHS DTAC: named Clinical Safety Officer, hazard log, clinical risk management file, clinical safety case report and signed release memo.

Send a DTAC evidence enquiry → Read the DTAC guide
DTACClinical safety section
DCB 0129Supplier evidence
CSONamed clinician sign-off
Search intent

If DTAC has surfaced a clinical safety gap.

Many suppliers only discover DCB 0129 when an NHS buyer or assessor asks for DTAC clinical safety evidence. At that point, the request can look like a form question, but the underlying requirement is a real clinical risk management file for a defined product and release.

This page is the commercial route if the clinical safety section is the blocker. If the assessor specifically asked for a CSCR, hazard log or CRMF, use the Clinical Safety Case Report and hazard log page. If you need a full pre-go-live safety case, use the DCB 0129 consultant page. If you need ongoing named CSO support after launch, use the contract CSO page.

Evidence pack

What a credible DTAC clinical safety response needs.

The evidence has to match the product version, intended use and deployment context being assessed. A generic policy is not enough.

01

Named Clinical Safety Officer

A registered clinician trained in clinical risk management who is accountable for the safety case and residual-risk judgement.

02

Intended use and scope

Clear users, setting, patient group, supported decisions, exclusions, product version and deployment assumptions.

03

Hazard log

Credible clinical hazards, causes, controls, verification evidence, owners, initial risk and residual risk.

04

Clinical risk management file

The linked plan, hazard log, safety requirements, control evidence and change records behind the submission.

05

Clinical Safety Case Report

The structured argument that the evidence supports safe release for the defined product and context.

06

Release and monitoring

A signed release memo, post-market surveillance plan, incident process and change-review route after go-live.

How I help

From gap check to signed evidence.

Rapid gap review of your current DTAC clinical safety evidence DCB 0129 scope for the product, release and workflow being assessed Hazard workshop with product, clinical and engineering leads CSCR and CRMF prepared or repaired for submission Release memo signed where residual risk is acceptable Assessor response support if questions come back
Enquiry

Send the DTAC context.

Include the product, intended use, target NHS organisation, DTAC deadline and current clinical safety documents. I will tell you whether this is a small evidence-mapping job, a full DCB 0129 safety case, or not a fit.

Direct cs@csong.health Useful attachments current hazard log, CSCR, CRM plan, DTAC questions
DTAC clinical safety enquiry

What is the blocker?

Do not include patient-identifiable data. Your details are used to respond to this enquiry; read the privacy notice.

Primary sources

Check the official guidance.

This page is service information, not legal or regulatory advice. For formal decisions, use NHS England primary sources.

NHS England

DTAC guidance

Official Digital Technology Assessment Criteria guidance for buyers and suppliers.

Open source → NHS England

Clinical risk standards

Official DCB 0129 and DCB 0160 clinical risk management standards hub.

Open source → Guide

DTAC explained

A plain-English explanation of the 2026 DTAC form and evidence areas.

Read →