What is a Clinical Safety Officer?
A Clinical Safety Officer is the clinician accountable for clinical risk management in a health IT system. In NHS digital health, the CSO turns product risk, clinical workflow and evidence into a defensible decision about whether residual clinical risk is acceptable.
Short answer
The CSO is the named clinical-risk owner.
A Clinical Safety Officer is a registered clinician with clinical risk management competence. The CSO is not just a document reviewer. They identify or challenge hazards, decide whether controls are clinically adequate, review evidence, and sign or approve the safety argument for a defined product release and use context. For who can hold the role, see the Clinical Safety Officer requirements guide.
For a supplier-side DCB 0129 scope, Dr Chiho Song can act as the Clinical Safety Officer for suitable NHS digital health, SaMD and health IT products. His work usually covers intended-use review, hazard workshop, hazard log, Clinical Risk Management File, Clinical Safety Case Report and signed release memo.
Responsibilities
What does a Clinical Safety Officer do?
The role is to make clinical risk explicit, controlled and defensible before the product is used in patient care.
Scope
Defines the clinical context
Clarifies intended use, users, patient group, care setting, workflow, dependencies, excluded uses and release boundary.
Hazards
Leads clinical hazard analysis
Identifies credible ways the system could contribute to harm, then records causes, controls, evidence, owners and residual risk.
Evidence
Builds the safety file
Reviews or prepares the hazard log, Clinical Risk Management File, safety requirements and Clinical Safety Case Report.
Challenge
Tests controls and assumptions
Challenges weak controls, missing verification, unsafe assumptions, workflow gaps, automation bias and evidence that does not match the released product.
Sign-off
Approves the release decision
Signs a CSO release memo or safety case only where residual clinical risk is acceptable for the defined use and context.
Maintenance
Keeps safety live after launch
Material changes, incidents, new integrations, new users and new deployment settings may require safety impact assessment and hazard log updates.
DCB 0129 and DCB 0160
Two standards, two accountability positions.
Supplier / manufacturer
DCB 0129 CSO
DCB 0129 is the manufacturer-side standard. It applies to organisations responsible for developing or maintaining health IT systems for use in England's health and care environment. The supplier CSO focuses on the product, release, intended use, hazards, controls and clinical safety case evidence.
DCB 0129 consultant →
Deploying organisation
DCB 0160 CSO
DCB 0160 is the deployment-side standard. It applies to the health or care organisation deploying, configuring and using the system. The deploying CSO focuses on the local workflow, implementation, configuration, training, local controls and operational use.
DCB 0129 vs DCB 0160 →
Outputs
What does the CSO produce or approve?
Clinical Risk Management Plan roles, scope, lifecycle and safety activities
Hazard Log hazards, causes, controls, owners, evidence and residual risk
Clinical Risk Management File the traceable evidence set
Clinical Safety Case Report the safety argument for release
Safety requirements controls and verification expectations
Release memo accountable go-live or no-go decision
When to appoint
Do not wait until procurement asks.
The CSO should be involved early enough to shape the product evidence and challenge clinical risk before design decisions become expensive to change.
Hiring
How to hire a CSO
What to check, what evidence to send and how to choose fixed DCB 0129, independent review or named CSO support.
Hiring guide → Provider selectionChoosing DCB 0129 support
Clinical accountability, CSCR quality, DTAC alignment and post-go-live governance checks before appointing support.
Selection guide → BudgetCSO cost and pricing
Published pricing for fixed DCB 0129 package, hourly post-go-live support and named CSO retainer.
See pricing →Need a Clinical Safety Officer?
Send the product, intended use, target NHS organisation, current evidence and timeline. You will get a clear route: fixed DCB 0129 package, independent review, named CSO retainer, referral or no-fit.