Rebecca Wilson
Founder & Senior Clinical Governance Specialist
Clinical Safety Officer
Clinical Safety Officer (CSO) services for the NHS
A named, UK-registered Clinical Safety Officer on your DCB0129 or DCB0160 file, signing the Clinical Safety Case Report, chairing the Hazard Log, and answering NHS procurement, DTAC v2 and DSPT questions on your behalf.
What is a Clinical Safety Officer?
A Clinical Safety Officer (CSO) is a currently-registered UK clinician accountable for clinical risk management under NHS England's DCB0129 (manufacturers) and DCB0160 (deploying organisations) information standards.
Every NHS supplier and deploying organisation must have a named CSO. Without one you cannot pass DTAC v2, satisfy NHS procurement, or safely deploy clinical software into a trust, ICB, health board or GP federation.
DigiSafe provides fractional and retained CSOs drawn from GPs, hospital consultants, nurses, paramedics, pharmacists, occupational therapists and medical device specialists, matched to the clinical domain of your product.
What's included
- Named CSO on your DCB0129 or DCB0160 file, signed off by a UK-registered clinician
- Clinical Risk Management System (CRMS) written, reviewed and maintained
- Hazard Log built, chaired and kept live across product releases
- Clinical Safety Case Report authored and signed
- NHS procurement, DTAC v2 and DSPT questions answered on your behalf
- Monthly retainers from £999, no long lock-ins
What the CSO actually does, week to week
The CSO is not a rubber stamp. Under DCB0129 and DCB0160 they own a live process, not a document.
In practice that means running hazard identification workshops with your product and clinical teams, keeping the Hazard Log current, reviewing every material release, updating the Clinical Safety Case Report, and being the accountable clinician NHS procurement, information governance and clinical safety teams speak to.
- Author and maintain the Clinical Risk Management Plan
- Chair hazard identification and clinical review sessions
- Own the Hazard Log, hazards, causes, controls, residual risk
- Sign the Clinical Safety Case Report at each release
- Review incidents, near-misses and field safety notices
- Represent the organisation to NHS England, ICBs and trusts
CSO deliverables under DCB0129 and DCB0160
| Deliverable | DCB0129 (manufacturer) | DCB0160 (deployer) |
|---|---|---|
| Clinical Risk Management Plan | Required | Required |
| Hazard Log | Product hazards | Deployment hazards |
| Clinical Safety Case Report | Signed by CSO | Signed by deployer CSO |
| Named, registered CSO | Required | Required |
| Safety incident process | Required | Required |
| Change/release sign-off | Every material release | Every material deployment |
In-house vs fractional CSO, how to decide
Hire in-house when clinical safety is a full-time job, usually a multi-product manufacturer, a Class IIa/IIb medical device company, or a large NHS deploying organisation.
Use a fractional CSO when you need a named, registered clinician on the file but do not have enough clinical safety work to justify a full-time hire, the majority of UK digital health SMEs, start-ups, GP federations and smaller trusts fall here.
- Fractional CSO from £999/month, named clinician, no lock-in
- Retained CSO from £2,500/month, includes release reviews, DTAC v2 evidence and supplier due diligence responses
- Interim CSO cover when your in-house CSO leaves or goes on parental leave
- CSO training and mentorship if you want to bring the role in-house over time
Why DigiSafe
Every DigiSafe CSO is a currently-practising UK clinician. We do not sub-contract to overseas non-clinicians and we do not hand your file to a graduate account manager.
One senior CSO owns your file from kickoff to sign-off. We publish fixed pricing bands, respond to enquiries inside 24 hours, and run the CSO Training Academy, the largest public CSO course in the UK, so you always know what good looks like.
Frequently asked questions
What is a Clinical Safety Officer (CSO)?
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A Clinical Safety Officer is a currently-registered clinician (GMC, NMC, HCPC, GPhC or equivalent) accountable for clinical risk management under NHS England's DCB0129 (manufacturers) and DCB0160 (deployers) information standards. The CSO owns the Clinical Risk Management System, signs the Clinical Safety Case Report, chairs the Hazard Log and represents the organisation in NHS clinical safety conversations.
Who can be a Clinical Safety Officer?
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Only a clinician with current professional registration and appropriate training in clinical risk management. NHS England expects the CSO to be a registered doctor, nurse, pharmacist, paramedic, dentist, midwife or allied health professional who has completed formal CSO training (for example the NHS Digital Clinical Safety training or an equivalent accredited programme such as the DigiSafe CSO Training Academy).
How do you become a Clinical Safety Officer?
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Three things are required: (1) current UK clinical registration, (2) completion of an accredited CSO training course covering DCB0129 and DCB0160, and (3) practical experience of clinical risk management under supervision. DigiSafe's CSO Training Academy delivers the theory and pairs you with a working CSO for real-file mentorship.
Do I legally need a CSO to sell software to the NHS?
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Yes. NHS England requires a named CSO for any Health IT system used in clinical care. Without one you cannot pass DTAC v2, DCB0129 or the wider NHS supplier assurance, and NHS procurement will not sign off deployment.
Which deliverables is the Clinical Safety Officer responsible for approving?
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The CSO approves the Clinical Risk Management Plan, the Hazard Log, the Clinical Safety Case Report and any Safety Incident Management output. They also review and sign off release notes for material changes to the Health IT system.
Can I outsource the CSO role?
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Yes. Most start-ups, scale-ups and SMEs use a fractional or retained CSO instead of hiring in-house. DigiSafe provides GMC/NMC/HCPC-registered CSOs on monthly retainers from £999/month with no long lock-ins.
How much does a Clinical Safety Officer cost?
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In-house senior CSOs typically cost £90,000-£140,000 fully loaded. A DigiSafe fractional CSO on retainer starts at £999/month and scales with product size, most SME suppliers pay between £999 and £3,500/month for a fully-managed service.
How quickly can DigiSafe assign a CSO?
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Usually within 5 working days. We match you to a CSO with clinical experience relevant to your product (GP, nurse, paramedic, pharmacist, OT or medical device specialist) and start on your Clinical Risk Management Plan the same week.
What is the difference between a Clinical Safety Officer and a Safety Case Author?
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The CSO is the accountable clinician. The Safety Case Author writes the Clinical Safety Case Report, this can be the CSO or someone working under their direction. Only the CSO can approve and sign the file.
Related services
Talk to a Clinical Safety Officer
Book a free call with a DigiSafe CSO. We'll scope the work, timelines and cost, plain English, no jargon.
Direct clinical access
Meet the team, Clinical Safety Officers, DPOs & Medical Device Experts.
Multi-disciplinary lived experience across nursing, GP, paramedic, pharmacy, medical devices and data protection. Book a discovery call and we'll match you with the right expert.
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Dr. Lizzie Marston
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Sharon Fisher
Executive Assistant
Every engagement starts with a 15-min scoping call, a conflict-of-interest check, and a plain-English summary before you commit.