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Review of digital clinical safety standards: DCB0129 and DCB0160

NHS England has commenced a review of digital clinical safety standards DCB0129 and DCB0160 to ensure they remain up-to-date, practical and aligned with the latest advancements in healthcare technology and clinical practice.

What are 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

Why this review is happening

We have committed to review the standards to ensure they remain practical for those that use them, and that they keep pace with the rapid technological advancements in healthcare IT.

Key reasons for the review include:




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


How you can get involved

Stage 1:  Focus groups around the DCB0160 standard will take place during June 2025.  The focus groups will support us to canvass opinion on the current sufficiency of the standard.

To register your interest in participating in a DCB0160 focus group, please complete our expression of interest form by 2 May 2025.

Focus groups on DCB0129 have now been completed.

Stage 2: The insights from the focus groups will shape proposed revisions to the DCB0129 and DCB0160 standards. The proposals will then be subject to a subsequent public consultation, providing additional opportunities for feedback.

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


Data (Use and Access) Bill

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.

 

Last edited: 10 April 2025 8:05 am