Accenture

The Accenture Trust Centre makes available Clinical Safety Case Reports and Hazard Logs. These documents provide assurance that each release or update of the Health IT System has been assessed for clinical safety and is compliant with NHS Digital standards.

DCB0129 is a mandatory NHS clinical risk management standard for manufacturers of health IT systems. DCB0129 requires all developers and manufacturers of digital health systems used in NHS funded care in England to put a robust clinical risk management system in place. This includes appointing a Clinical Safety Officer (CSO), maintaining a hazard log, conducting risk assessments, and producing a Clinical Safety Case Report to demonstrate the product is safe for clinical use. Compliance is a legal obligation under the Health and Social Care Act 2012 and is required for market access and procurement by NHS bodies. For example, if a digital health company builds a new electronic patient record system to be used in NHS hospitals, it must follow DCB0129. This involves documenting all potential clinical risks, how they are managed or mitigated, and ensuring that a qualified CSO signs off on all safety casework before the software can go live. Without DCB0129 compliance, NHS organisations cannot legally implement the system, making DCB0129 fundamental to safe, effective health technology deployment in the NHS.

DCB0129 compliance is important because it ensures that digital health and IT products used in NHS in England are clinically safe, effectively manage risk, and meet legal and regulatory requirements. DCB0129 provides a systematic framework for manufacturers to identify, assess, and mitigate clinical risks associated with digital health technologies throughout their lifecycle. Compliance is mandatory under the Health and Social Care Act 2012 and is a requirement for NHS procurement. Without DCB0129, digital health products cannot be deployed in the NHS or be considered safe for clinical use. The standard mandates robust risk management, oversight by a Clinical Safety Officer, and thorough documentation, all aimed at reducing harm to patients, building trust for clinicians, and supporting high standards of care.

NHS England (NHSE) is the body that produces and governs information standards such as DCB0129. The Data Alliance Partnership Board (DAPB), overseen by NHSE, is responsible for formally approving the standards under Section 250 of the Health and Social Care Act 2012.

A clinical safety case report is a structured document that presents the evidence and arguments showing a digital health system is acceptably safe for clinical use, in accordance with NHS standards such as DCB0129. The clinical safety case report (CSCR) summarises how hazards associated with the digital health solution have been identified, assessed, and managed throughout the product lifecycle. This report draws on supporting documents like a hazard log and risk assessments, explaining how risks are reduced to acceptable levels, what controls are in place, and including sign-off from a Clinical Safety Officer. The CSCR is essential for providing assurance to key stakeholders that the product’s safety has been rigorously and transparently evaluated. Producing and maintaining a current clinical safety case report is a mandatory requirement for DCB0129 compliance.