Clinical Safety
Clinical Safety Officer (CSO) Services for NHS Health IT Suppliers
What is a Clinical Safety Officer?
A Clinical Safety Officer (CSO) is a clinician who holds an active professional registration (e.g. GMC) and who is responsible for overseeing clinical risk management activities for a health IT system.
Under DCB0129, the CSO:
- Provides clinical leadership for hazard identification, analysis and mitigation
- Oversees the development of the core clinical safety documentation required
- Signs off the Clinical Safety Case Report and other key artefacts
Learn more about DCB0129 compliance and how the Clinical Safety Officer role fits within it.
The CSO role is central to demonstrating that clinical risks associated with digital systems have been properly considered and managed.
When do you need a Clinical Safety Officer?
You typically require a Clinical Safety Officer when:
- Manufacturing and supplying a health IT system to the NHS
- Deploying a digital product into any clinical workflow
- Making significant functional or clinical changes to an existing system in a new release
- Responding to NHS procurement or assurance requirements
- Supporting ongoing compliance for a live system currently in the NHS
Many organisations look at clinical safety and a CSO requirement too late in the process, which can lead to rushed documentation and even failed procurements. Early review and CSO involvement almost always reduces time and resource requirements on your part for your end-customer deployments.
What does a CSO actually do in practice?
Hazard and hazard cause identification
- The review of system function, intended use, contra-indications and clinical workflows
- Identifying potential clinical hazards and failure modes
- Supporting multidisciplinary risk workshops
Risk assessment and mitigation
- Assessing the severity and likelihood of clinical harm for each hazard
- Defining proportionate mitigations (IT design, business process, training controls)
- Ensuring risks are tracked and reviewed on a regular basis
Creating and managing Clinical safety documentation
- Clinical Risk Management Plans (CRMPs)
- Hazard Logs
- Clinical Safety Case Reports (CSCRs)
Clinical governance and assurance
- Acting as the named CSO for DCB0129
- Providing clinical sign-off and assurance
- Supporting discussions with NHS organisations completing their DCB0160 documents
Clinical Safety Officer services from AbedGraham
Outsourced Clinical Safety Officer
We act as your named CSO, taking responsibility for:
- Oversight of clinical risk management activities
- Review and approval of the mandated documentation
- Ongoing support including future release sign-off and audit
Using a clinical safety provider is common (and accepted by the NHS) for startups and SMEs without the resource to hire an internal CSO.
Project-based CSO support
Ideal for:
- New product development or existing product change control
- Major system changes and mapping to existing or new hazards
- Specific NHS deployments and any locally required configurations
Our CSOs can provide bespoke input to help any barriers to procurement.
How CSO support links to DCB0129 compliance
The Clinical Safety Officer role is a mandatory requirement of the DCB0129 standard, but CSO input alone does not necessarily equate to formal compliance. An effective CSO role must sit within a formal DCB0129 clinical risk management approach (including all parts of the SDLC), including:
- Defined scope, intended use and contra-indications
- Hazard identification
- Clear documentation and traceability
Our Clinical Safety Officer 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:
- They are unsure who can act as a CSO
- Internal clinicians may lack time or have little experience in digital risk management
- The CSO responsibilities are unclear
- Internal documentation may exist but lacks defensible clinical oversight
- NHS or customer feedback has raised concerns about clinical safety assurance
Our approach to being a clinical safety provider 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:
- The standard allows for proportionate application based on the product
- CSO input can be scaled to risk and complexity
- Early guidance prevents unnecessary time and resource wastage
We regularly support early-stage companies navigating the applicable NHS requirements for the first time.
Relationship between CSO, DCB0129 and DCB0160
While the CSO role is defined within DCB0129, it interacts closely with DCB0160. 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. Although DCB0160 is not the responsibility of the manufacturer, assisting the deploying organisation as much as possible will help deployment timelines.
Read more about DCB0129 vs DCB0160 responsibilities.
Why Choose The AbedGraham Group for CSO Services?
- A trusted clinical safety provider with deep experience in NHS assurance for small and large companies
- CSOs who understand both clinical risk and commercial delivery
- A proportionate, pragmatic approach to risk assessment
- Clear, tried and tested, documentation that stands up to scrutiny
- Integrated support across CSO, DCB0129, and wider assurance
Interested in wider Clinical Safety services?
DCB0129 Overview
An introduction to DCB0129 clinical risk management for health IT suppliers, explaining when the standard applies, what compliance involves, and how suppliers meet NHS clinical safety requirements.
DCB0160 Guidance for Suppliers
Clear guidance on DCB0160 clinical risk management for deployment, helping suppliers understand responsibilities, support NHS customers, and avoid delays caused by role confusion.
Clinical Safety
Speak to a Clinical Safety Officer
If you need Clinical Safety Officer support as part of your DCB0129 requirements, we’d be happy to discuss your needs. Our UK Clinical Safety Officer consultancy is here to help - speak to an experienced CSO about your product and NHS assurance needs today.
Frequently asked questions
A Clinical Safety Officer needs to be a clinician with an active professional registration and experience in clinical risk management. All of our CSOs hold the experience required to operate in this space and manage over 100 products in the NHS every day.
No, the CSO can be internal or from a third-party organisation offering clinical safety services. What matters most is the quality of the process and the documentation produced.
Yes, absolutely. There is no constraint on a CSO providing services for multiple organisations - we find it leads to better results as they gain a wider understanding across many products, rather than just one or two.
CSO input is ideally maintained throughout the software development life cycle, from idea generation and product development through to go-live and post-market surveillance. We will help you map out the journey, develop the initial documentation, and maintain compliance from there.
Broadly speaking, yes. The Clinical Safety Officer should be involved in oversight of all major and minor updates, incident management (where patient care has been or could be compromised) and testing.
The CSO needs to be confident that all of the hazards have been identified, that they have been mitigated to an acceptable level, and that the wider incident management and change management processes are in place and allied to clinical safety provision. We will establish a cadence with your company to ensure this is all covered optimally.
Yes. As an experienced clinical safety provider and CSO consultant, we can act as your outsourced or named Clinical Safety Officer, taking on oversight of clinical risk management and signing off the clinical safety documentation required under DCB0129.
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