Clinical Safety Officer (CSO) Services for NHS Health IT Suppliers
Experienced Clinical Safety Officer support for DCB0129 and NHS digital assurance
The AbedGraham Group provides Clinical Safety Officer (CSO) services for organisations developing, supplying, or maintaining health IT systems used within the NHS. We can act as your named CSO under DCB0129, supporting proportionate clinical risk management and producing clear, defensible safety documentation. Our CSOs work closely with product, clinical, and governance teams to ensure clinical safety is embedded in delivery - not just bolted on at the end.
Discuss your product, deployment, or assurance requirements with an experienced CSO.
What is a Clinical Safety Officer?
A Clinical Safety Officer (CSO) is a suitably qualified clinician holding an active professional registration) responsible for overseeing clinical risk management activities for health IT systems.
Under DCB0129, the CSO:
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Provides clinical leadership for risk identification and mitigation
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Oversees the development of clinical safety documentation
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Ensures risks are assessed proportionately and transparently
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Signs off the Clinical Safety Case Report and other key artefacts
The CSO role is central to demonstrating that clinical risks associated with digital systems have been properly considered and managed.
Learn more about DCB0129 compliance and how the CSO role fits within it.
When do you need a Clinical Safety Officer?
You typically require a Clinical Safety Officer when:
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Supplying a health IT system to the NHS
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Deploying or scaling a digital product into clinical workflows
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Making significant functional or clinical changes to an existing system
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Responding to NHS procurement or assurance requirements
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Supporting ongoing compliance for a live NHS-deployed system
Many organisations engage a CSO too late, which can lead to reworking documentation, delays, or delayed or even failed procurements. Early CSO involvement almost always reduces risk and effort on your part.
What does a CSO actually do in practice?
While the CSO role is defined in the standards, its practical application is often misunderstood. In practice, our CSOs support:
Clinical hazard identification
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Reviewing system functionality and clinical workflows
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Identifying foreseeable clinical hazards and failure modes
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Supporting multidisciplinary risk workshops where appropriate
Risk assessment and mitigation
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Assessing severity and likelihood of clinical harm
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Defining proportionate mitigations (IT design, business process, training)
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Ensuring risks are tracked and reviewed
Creating and managing Clinical safety documentation
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Clinical Risk Management Plans (CRMPs)
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Hazard Logs
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Clinical Safety Case Reports (CSCRs)
Clinical governance and assurance
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Acting as the named CSO for DCB0129
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Providing clinical sign-off and assurance
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Supporting discussions with NHS organisations and assessors
Clinical Safety Officer services from AbedGraham
We provide flexible CSO services aligned to your organisation’s size, maturity, and risk profile.
How CSO support links to DCB0129 compliance
The Clinical Safety Officer role is a core requirement of DCB0129, but CSO input alone does not equal compliance. Effective CSO support must sit within a structured DCB0129 clinical risk management approach, including:
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Defined scope and intended use
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Systematic hazard identification
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Clear documentation and traceability
Our CSO services are therefore closely integrated with our wider DCB0129 compliance support.
Explore our full DCB0129 compliance services.
Common CSO challenges we help clients address
Organisations often come to us because:
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They are unsure who can act as CSO
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Internal clinicians lack time or experience in digital risk management
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CSO responsibilities are unclear or inconsistently applied
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Documentation exists but lacks defensible clinical oversight
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NHS feedback has raised concerns about clinical safety assurance
Our approach focuses on clarity, proportionality, and credibility.
CSO support for startups and smaller suppliers
Smaller organisations often worry that CSO and DCB0129 requirements will be overly burdensome. In reality:
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The standard allows for proportionate application
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CSO input can be scaled to risk and complexity
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Early guidance prevents unnecessary time and resource waste
We regularly support early-stage companies navigating NHS requirements for the first time.
Relationship between CSO, DCB0129 and DCB0160
While the CSO role is defined within DCB0129 (supplier responsibility), it interacts closely with DCB0160 (deployment responsibility). Clear boundaries and collaboration between supplier CSOs and deploying organisations are essential to avoid gaps in clinical risk ownership, prevent duplication of effort and support safe and timely deployments.
Read more about DCB0129 vs DCB0160 responsibilities.
Why Choose The AbedGraham for CSO Services?
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Deep experience in NHS clinical safety and assurance
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CSOs who understand both clinical risk and product delivery
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Proportionate, pragmatic approach
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Clear documentation that stands up to scrutiny
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Integrated support across CSO, DCB0129, and wider assurance
Interested in Clinical Safety?
As leading Clinical Safety compliance experts we can support your organisation to navigate a range of technology and cybersecurity requirements.