Rebecca Wilson
Founder & Managing Director
What is DCB0160?
DCB0160 is the NHS England information standard for deploying organisations. If you roll out any Health IT system into NHS clinical care, you must run a Clinical Risk Management System and produce a signed Deployment Clinical Safety Case Report.
It sits alongside DCB0129: the supplier evidences the product; you evidence safe deployment into your workflows, populations and environments. Both are required.
DigiSafe acts as your named deployer CSO, or supports your in-house CSO with templates, workshops and sign-off cover.
Our DCB0160 package
- Named deployer CSO on retainer
- Deployment Clinical Risk Management Plan
- Deployment Hazard Log, workflow, environment and population risks
- Deployment Clinical Safety Case Report, signed by a UK-registered CSO
- Change and release reviews for every material update
- In-house CSO mentorship via CSO Training Academy
What DCB0160 requires from a deploying organisation
DCB0160 sets four requirements: a Clinical Risk Management System, a named CSO, hazard identification across the deployment lifecycle, and a signed Deployment Clinical Safety Case Report.
Crucially it is not a one-off assessment at go-live. DCB0160 requires the deployer to keep the safety case current across upgrades, configuration changes, workflow changes and incidents.
- Named, UK-registered CSO on the deployer side
- Deployment Clinical Risk Management Plan for your organisation
- Deployment Hazard Log, configuration, workflow, environment, population
- Deployment Clinical Safety Case Report signed at go-live and on material change
- Post-live safety incident process feeding back into the Hazard Log
- Change control that triggers a CSO review before releases go live
DCB0129 vs DCB0160, who does what
| Responsibility | DCB0129 (supplier) | DCB0160 (deployer) |
|---|---|---|
| Prove the product is safe by design | Yes | No |
| Prove the product is safe here, with our patients | No | Yes |
| Named CSO | Supplier's CSO | Deployer's CSO |
| Hazard Log covers | Product hazards | Deployment hazards |
| Signs the CSCR | Supplier CSO | Deployer CSO |
| Owns post-market clinical safety | Supplier | Deployer for local incidents |
Who DCB0160 applies to
Any organisation deploying a Health IT system into NHS clinical care needs DCB0160 evidence. That includes:
- NHS trusts and foundation trusts
- Integrated Care Boards (ICBs) and Integrated Care Systems
- Health boards (Wales, Scotland, Northern Ireland equivalents)
- GP practices, PCNs and GP federations
- Community, mental health and ambulance trusts
- Independent providers delivering NHS-commissioned care
- NHS-hosted CSUs and shared service organisations
Our DCB0160 package for NHS deployers
- Named deployer CSO on retainer, UK-registered clinician
- Deployment Clinical Risk Management Plan tailored to your organisation
- Deployment Hazard Log, workflow, environment and population risks
- Deployment Clinical Safety Case Report, signed by a UK-registered CSO
- Change and release reviews for every material update
- In-house CSO mentorship via the CSO Training Academy
Frequently asked questions
What is DCB0160?
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DCB0160 is the NHS England information standard (Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems) that requires deploying organisations, trusts, ICBs, health boards, GP federations, primary care networks and independent providers, to run a Clinical Risk Management System when they roll out any Health IT system into clinical use.
Who is responsible for DCB0160?
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The deploying organisation, not the manufacturer. If you are an NHS trust, ICB, health board, GP federation or independent healthcare provider rolling out software, DCB0160 is your obligation, even if the supplier is fully DCB0129 compliant.
What documents does DCB0160 require?
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A Deployment Clinical Risk Management Plan, a Deployment Hazard Log covering workflow / environment / population risks, and a Deployment Clinical Safety Case Report, all signed off by a named, currently-registered Clinical Safety Officer employed or retained by the deploying organisation.
Do I need DCB0160 if the supplier already has DCB0129?
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Yes. Their DCB0129 file evidences the product; your DCB0160 file evidences safe deployment into your specific clinical environment, workflows and patient populations. Both are required and neither substitutes for the other.
Can DigiSafe act as our deployer CSO?
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Yes. We provide named DCB0160 CSOs on retainer for NHS trusts, ICBs, health boards, GP federations and independent providers. We can also train your in-house CSO through the CSO Training Academy.
How long does DCB0160 take?
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A first-pass DCB0160 file is typically 3-6 weeks depending on system complexity, existing local risk assessments, and stakeholder availability for hazard workshops.
Do primary care networks and GP federations need DCB0160?
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Yes. Any organisation deploying a Health IT system into NHS clinical care is a deploying organisation under DCB0160, regardless of size. Primary care networks, GP federations and independent providers delivering NHS services all fall in scope.
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