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DCB0160 - Clinical Risk Management in the Deployment of Health IT

Understanding DCB0160 and how it relates to DCB0129 for NHS health IT suppliers

DCB0160 is an NHS clinical risk management standard that applies to the deployment and use of health IT systems within healthcare organisations. It sits alongside DCB0129, which applies to system manufacturers and suppliers. While suppliers are generally not responsible for complying with DCB0160, understanding the standard is essential for supporting NHS customers, avoiding confusion, and ensuring smooth deployment.

How DCB0160 differs from DCB0129

DCB0160 and DCB0129 are closely related but apply to different parties and responsibilities.

DCB0129 (Supplier responsibility)

  • Applies to manufacturers and suppliers of health IT systems

  • Focuses on risks inherent in system design and functionality

  • Requires a named Clinical Safety Officer (CSO)

  • Produces supplier-level clinical safety artefacts

 

Learn more about DCB0129 compliance.

DCB0160 (Deployment responsibility)

  • Applies to healthcare organisations deploying systems

  • Focuses more on risks arising from local configuration and use

  • Requires local clinical safety governance processes

  • Also requires a named Clinical Safety Officer

  • Produces deployment-level safety documentation

 

Both standards are required to ensure end-to-end clinical safety, from system design through to real-world use.

Who does DCB0160 apply to?

DCB0160 applies to:

  • NHS trusts and foundation trusts

  • General Practices

  • Integrated Care Boards (ICBs) (if they are managing clinical safety for their area)

  • Any other healthcare organisations deploying clinical systems

 

These organisations are responsible for ensuring that clinical risks arising from local configuration, workflows, and use are properly managed. Suppliers are not responsible for DCB0160 compliance, but they play an important supporting role.

How DCB0129 and DCB0160 work together in practice

In practice:

  • DCB0129 addresses risks inherent in the system itself

  • DCB0160 addresses risks introduced by how the system is deployed and used

 

Information typically flows from supplier to healthcare organisation, including:

  • Clinical Safety Case Reports

  • Hazard logs and known risks

  • Assumptions, limitations, and intended use

 

Clear understanding of this handover is critical to avoid gaps or duplication. There is frequently a ‘handshake’ at some point where the DCB0129 material is provided to the deploying organisation for review and adding their specific configurations. The CSOs on both sides may play a part in expediting this.

Common misconceptions about DCB0160

“Suppliers need to be DCB0160 compliant”

Incorrect. Suppliers can support DCB0160 but are not responsible for compliance. The only caveat to that statement are suppliers who are also the deploying organisation (e.g. a healthcare service provider who has developed/deployed their own IT system). In that case a hybrid approach can be done to encompass all DCB0129 and DCB0160 requirements. 

“DCB0160 replaces DCB0129”

No. The standards are complementary and both are required in their respective contexts for end-to-end deployment of a solution.

“DCB0160 is optional”

DCB0160 is a mandated NHS standard for organisations deploying clinical systems. Clarifying these points early helps prevent procurement delays and unnecessary time and resource expenditure.

How suppliers can typically support DCB0160

While suppliers are not responsible for DCB0160, they commonly support NHS organisations by:

  • Providing the initial DCB0129 clinical safety documentation

  • Explaining system assumptions, limitations, and risks

  • Supporting local clinical safety assessments

  • Responding to assurance and governance queries

 

Suppliers with well-structured DCB0129 artefacts make DCB0160 compliance significantly easier for their customers. We also provide DCB0160 guidance documentation for your end-customers, ensuring as few hurdles as possible exist to deploying your technology. 

Interested in Other Services?

As leading Clinical Safety compliance experts we can support your organisation to navigate a range of technology and cybersecurity requirements.

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.

DCB0129 Support & Assurance

Practical support to help health IT suppliers achieve and maintain DCB0129 compliance, from documentation through to NHS assurance.

Clinical Safety Officer (CSO)

Independent Clinical Safety Officer services providing clinical oversight, governance, and sign-off required under DCB0129 for NHS-deployed digital health systems.

Where can DCB0160 cause challenges for suppliers?

Suppliers often encounter issues where:

  • Responsibility boundaries are unclear

  • NHS organisations request supplier-led DCB0160 activities

  • Clinical safety expectations differ between organisations

  • Documentation requirements are poorly defined

 

Understanding DCB0160 helps suppliers respond confidently and appropriately. We have deployed our DCB0129-compliant technologies in hundreds of different NHS scenarios so understand the market inside out. 

How AbedGraham supports clarity around DCB0160

While our primary focus is DCB0129 and supplier clinical safety, we support clients by:

  • Clarifying DCB0129 vs DCB0160 responsibilities

  • Ensuring DCB0129 artefacts support NHS deployment needs

  • Supporting discussions with NHS organisations where required

Our approach reduces friction and helps deployments progress smoothly. Our aim is for clinical safety to the done to the highest standard but also to not be the rate-limiting step in any procurement process.

 

Explore our DCB0129 compliance services.

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Book a Discovery Call

If your organisation needs incident response support, or wants to test its readiness, contact our consultants today.

What is DCB0160?

DCB0160 defines how clinical risk should be managed by healthcare organisations when deploying and using health IT systems.

The standard focuses on:

  • Safe configuration and implementation of systems

  • Integration into local clinical workflows

  • Ongoing clinical risk management during use

  • Local governance, oversight, and assurance

 

DCB0160 ensures that risks introduced by the local use of a system are identified and managed, even where the system itself is supplied by a third party.

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