Clinical safety for
every product and deployment

DCB0129 applies to manufacturers of health IT systems used in NHS care. It requires clinical risk management throughout development, a hazard log, a clinical safety case report and a named Clinical Safety Officer. DCB0160 applies to the health and care organisations that deploy and use those systems, who assess the risks of their own local deployment, building on the manufacturer’s DCB0129 documentation. Assuric supports both, so suppliers and deploying organisations can work from the same hazards and evidence.

Any company that makes health IT software used in health and care in England, including the NHS, such as patient apps, clinical decision support, EPR modules and AI tools. DCB0129 is a mandatory information standard under the Health and Social Care Act 2012, and NHS buyers check it as part of DTAC, so a supplier without a DCB0129 safety case will struggle to get through NHS procurement.

Yes. Both DCB0129 and DCB0160 require a named Clinical Safety Officer: a clinician registered with a professional body, such as the GMC, NMC or HCPC, and trained in clinical risk management. The CSO oversees your clinical risk management process, reviews hazards and controls, and signs off the safety case. If you do not have one in-house, our fractional CSOs can act as your named CSO, working inside your Assuric workspace.

A clinical safety case report sets out the argument that your system is safe to use: the system description, the hazards identified, the controls in place, the residual risk and the Clinical Safety Officer’s conclusion. In Assuric, the report is generated from your live hazard log, so it stays current with each release.

Each hazard should record its causes, its potential effect on patients, the initial risk rating from severity and likelihood, the controls that reduce it, the evidence that those controls work, the residual risk, an owner and a status. Assuric links each hazard to its controls and evidence, with a risk matrix you can configure to suit your organisation.

Yes. A comprehensive onboarding and migration service comes as standard. Our team imports all your existing hazard logs, clinical safety case reports and other clinical safety documentation, from spreadsheets, documents or another tool, and maps them against the relevant requirements, so nothing has to be rewritten. Assuric AI can also import seamlessly from your existing evidence and spreadsheets, so new records come across without manual re-entry.

Yes. AI tools used in NHS care fall under DCB0129 and DCB0160 like any other health IT system. If your software is also a medical device, you will also need risk management to ISO 14971 for UK MDR. Assuric links the two, so the same hazards and controls feed both your DCB0129 safety case and your ISO 14971 risk file.