Hiring guide · Clinical Safety Officer

How to hire a Clinical Safety Officer
for NHS digital health.

If your product needs DCB 0129, DTAC clinical safety evidence, SaMD risk management or NHS go-live sign-off, hire a Clinical Safety Officer early enough to shape the evidence - not just sign a document at the end.

DCB 0129Supplier-side safety evidence
DTACClinical safety section
ExternalCSO route for suitable scopes

Short answer

What should we look for?

Hire a registered clinician who is trained and competent in clinical risk management, understands NHS health IT standards, and has the authority to challenge release decisions. For DCB 0129, the Clinical Safety Officer needs enough product evidence to make a defensible residual-risk judgement.

Dr Chiho Song is an NHS clinician and contracted Clinical Safety Officer in England. For suitable digital health, SaMD and health IT suppliers, he can provide fixed DCB 0129 packages, independent CSO review, external named CSO support and post-go-live safety governance.


Hiring checklist

Check these before you book anyone.

This is the minimum due diligence before a supplier asks an external CSO to own clinical safety evidence.

1

Scope the product

Define intended use, users, patient group, setting, integrations, version, excluded uses and the clinical decisions the product affects.

2

Know the standard

Decide whether the work is supplier-side DCB 0129, deploying-organisation DCB 0160, DTAC clinical safety evidence, SaMD clinical safety, or a mix.

3

Check the person

The CSO should be a registered clinician with clinical risk management competence, not a generic compliance writer or detached signatory.

4

Check authority

An external CSO still needs access to evidence, product decision-makers, hazard review, unresolved issues and release governance.

5

Share evidence

Send current hazard log, CSCR, CRMF, testing, validation, workflow notes, incident history, DTAC evidence and the procurement timeline if available.

6

Agree the output

Be clear whether you need a fixed DCB 0129 package, independent review, named CSO retainer, change review or hourly post-go-live support.


Choose the route

Different hiring intents need different CSO cover.


What to send

Make the first email specific.

The fastest useful answer comes from a short product brief, not a vague request for "a CSO". Include the product URL or deck, intended use, users, clinical setting, target NHS organisation, decision deadline and whether the blocker is DCB 0129, DTAC, SaMD, an incident, a major change or a missing named CSO.

Do send product scope, timeline, current evidence, target NHS setting Do not send patient-identifiable data in the first enquiry Useful files hazard log, CSCR, CRMF, DTAC evidence map, validation notes

Cost

Budget before procurement pressure arrives.

For Dr Chiho Song's CSO services, the advertised prices are published so teams can decide quickly whether the route fits the stage and risk profile.

Fixed DCB 0129 package
£8,500

Defined pre-go-live package: hazard workshop, hazard log, Clinical Risk Management File, Clinical Safety Case Report, safety requirements, post-market surveillance plan and signed CSO release memo.

Full pricing detail
Post-go-live / ad hoc
£180/ hr

Safety reviews after launch, incident review, hazard log updates, major change sign-off, DTAC cross-walks and recurring governance meetings.

Named CSO retainer
£750/ mo+

Supplier-side named CSO support for suitable products where recurring governance, surveillance review and change triage are needed.


Enquiry

Ask for a CSO route, not just a signature.

If the product is suitable, I will tell you whether the fixed DCB 0129 package, independent CSO review, named CSO retainer, DTAC clinical safety support or another route makes sense. If the scope is not appropriate, I will say so.

Direct cs@csong.health Phone +44 7455 031153 Response usually a yes, no or referral with next steps
Hire a CSO enquiry

What needs clinical safety ownership?

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


Primary sources