Helping health IT suppliers achieve and maintain DCB0129 clinical risk compliance for NHS deployment
The AbedGraham Group provides specialist DCB0129 (DCB 0129) compliance support for organisations developing, supplying, or maintaining health IT systems used within the NHS. We help you interpret the standard, produce the required clinical safety documentation, and meet your obligations confidently and quickly.
Whether you need full end-to-end delivery, an outsourced Clinical Safety Officer (CSO), or support maintaining compliance over time, our consultants work as an extension of your team.
Book a discussion about your product, deployment, or assurance requirements.
What is DCB0129?
DCB0129 (sometimes written as DCB 0129) is an NHS England clinical safety standard that defines how clinical risk must be managed during the manufacture and deployment of health IT systems.
The standard applies to systems that:
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Support clinical decision-making
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Influence patient care pathways
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Capture, process, or present clinical information
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Are deployed within NHS organisations or NHS-commissioned services
DCB0129 focuses on ensuring that clinical risks introduced by digital systems are identified, assessed, mitigated, and managed throughout the system lifecycle.
In practice, this means health IT suppliers must be able to demonstrate that:
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Clinical hazards have been systematically identified
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Risks have been assessed and reduced to an acceptable level
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A suitably qualified Clinical Safety Officer (CSO) oversees this process
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Appropriate safety documentation is produced and maintained
Who needs to comply with DCB0129?
There is an NHS flowchart provided by NHS England online that gives a broad overview of the sort of products that may require DCB0129.
However, in brief, you are likely to require DCB0129 compliance if you are:
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A health IT supplier providing software to NHS organisations
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A digital health startup integrating with NHS clinical workflows
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A medical device software manufacturer (including Software as a Medical Device) if your product sits within an IT system
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A system integrator or platform provider hosting clinical functionality
DCB0129 is commonly required as part of:
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Formal procurement mechanisms with deploying healthcare organisations
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NHS onboarding and assurance processes (e.g. IM1, PDS, EPS)
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DTAC and wider clinical safety assessments
Common challenges with DCB0129
Many suppliers struggle with DCB0129 because:
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The standard is long and its constituent components sometimes different to understand
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There is confusion between DCB0129 and DCB0160 responsibilities
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CSO input is left too late in delivery
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There is confusion about whether the standard applies or not
A proportionate, experienced approach is essential — particularly for smaller suppliers and fast-moving product teams.
How AbedGraham supports DCB0129 compliance
We provide practical, proportionate DCB0129 consultancy aligned to your product, risk profile, and NHS deployment context. Our support includes:
End-to-end DCB0129 delivery
We take responsibility for:
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Clinical risk management planning
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Hazard identification and documentation
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All DCB0129 documentation development
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CSO oversight and sign-off
This is ideal for organisations needing full DCB0129 compliance support.
DCB0129 consultancy and advisory support
If you already have internal capability, we can provide:
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Independent review and gap analysis
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Targeted consultancy on specific risks or documents
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Support responding to NHS or assessor queries
Outsourced Clinical Safety Officer (CSO)
We can provide experienced Clinical Safety Officers on:
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End-to-end delivery of DCB0129 for suppliers
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A project basis for fixed encounters
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Fractional or retained arrangements
Our CSOs work hand-in-hand with development, clinical, and governance teams.
Typical DCB0129 timelines
While every system is different, indicative timelines for a single product company is usually in the first 3 months of engagement, although this depends on the existing documentation present and how pressing the procurement requirement is. We can always do our best to work around your sales timelines, however early engagement significantly reduces delivery risk and potential cost.
DCB0129 and DCB0160 – what’s the difference?
DCB0129 applies to manufacturers and suppliers of health IT systems and DCB0160 applies to healthcare organisations deploying and using those systems. If you are an entity that does aspects of both of those, you may need to cover both standards as part of the same product. While distinct, the two standards are closely linked, and clarity between responsibilities is essential to avoid gaps or duplication.
Learn more here about how DCB0129 and DCB0160 interact in practice.
Frequently asked questions
Why Work with The AbedGraham Group?
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Deep specialism in NHS clinical safety and assurance
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Proportionate approach aligned to real delivery contexts
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Experience supporting startups, established suppliers and multi-national corporations
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Clear, defensible documentation that stands up to scrutiny
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Consultants who integrate with your team, not slow it down
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We cover all aspects of DCB0129 provision from initial documentation, ongoing compliance and communication with other parties
Interested in Other NHS Requirements?
As leading NHS regulatory compliance experts we can support your organisation to navigate a range of NHS technology and cybersecurity requirements.
What does DCB0129 compliance actually involve?
Achieving DCB0129 compliance is not a tick-box exercise. It requires a structured clinical risk management approach that is proportionate to the system and its use.
Typically, compliance involves:
1. Appointment of a Clinical Safety Officer (CSO)
A suitably qualified Clinical Safety Officer must be responsible for overseeing clinical risk management activities and approving safety documentation.
2. Clinical risk management planning
This includes defining:
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Scope and intended use of the system
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Assumptions, constraints, and dependencies
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How clinical risks will be identified and managed
3. Hazard identification and risk assessment
You must identify clinical hazards arising from:
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System functionality
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Data flows and integrations
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User interfaces and workflows
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Foreseeable misuse
These hazards are assessed for severity and likelihood, with controls defined and tracked.
4. Production of safety documentation
Key artefacts commonly include:
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Clinical Risk Management Plan (CRMP)
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Hazard Log
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Clinical Safety Case Report (CSCR)
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A Safety Incident Management Log (SIML)
5. Ongoing maintenance
DCB0129 compliance must be maintained, not just achieved once. All proposed functionality changes, updates, incidents, and new deployments should all trigger reviews of the documentation and internal processes.