Review of digital clinical safety standards: DCB0129 and DCB0160

Compliance with these standards is required under the Health and Social Care Act 2012. They provide essential requirements for manufacturers of health IT systems and healthcare providers in assessing and managing clinical risks to ensure the safety of digital solutions used across the NHS and adult social care services in England.

• DCB0129: Defines clinical risk management requirements for manufacturers of health IT systems
• DCB0160: Defines clinical risk management requirements for organisations that use health IT systems

We are actively seeking input from a range of stakeholders, including NHS professionals, IT manufacturers and those involved in digital risk assessment. This will support us to review the standards and ensure they remain effective in safeguarding patient safety and practical in their application.

Learn more about the NHS England Digital clinical safety strategy. 

The review will begin with DCB0129, focusing on clinical risk management requirements for IT manufacturers.

• Stage 1: Online focus groups will take place in February 2025. The focus groups will gather feedback from stakeholders across the NHS and beyond. This will support us to canvass opinion on the current sufficiency of the standard
• Stage 2: The insights from the focus groups will shape proposed revisions to DCB0129. The proposals will then be subject to a subsequent public consultation, providing additional opportunities for feedback

The review of DCB0160 will start later in 2025. You will be able to submit expressions of interest to participate in our DCB0160 focus groups via this webpage when we begin the process.

If you have any questions about the review of the standards, please feel free to contact us at [email protected]

DCB 0129 and 0160 are information standards relating to the risk management of health IT systems.  They sit alongside a suite of other information standards that promote safe, secure and compliant health IT systems which share data within the NHS and align closely with the forthcoming UK Data (Use and Access) Bill. 

This Bill seeks to modernise data governance by emphasising privacy, transparency, and innovation across sectors. Information standards combined with the Bill aim to balance efficient and safe use of data with patient confidentiality at its core and provides a clear framework for responsible health data use. Together, they support a data-driven, trust-based healthcare system.