Meet every requirement for
DCB0129 with Assuric compliance software

DCB0129 is a mandatory clinical risk management standard in England, under section 250 of the Health and Social Care Act 2012, for manufacturers of health IT systems used in the NHS and adult social care.

DCB0129 and DCB0160 are overlapping clinical safety standards. DCB0129 applies to manufacturers or suppliers of digital health technologies or health IT systems. DCB0160 applies to the health and care organisations deploying them.

DCB0129 asks for three core documents: a clinical risk management plan, a hazard log and a clinical safety case report. All three are signed off by your Clinical Safety Officer, and they need to stay current as your product changes.

No. Templates designed by clinical safety officers give you the structure, and AI suggests hazards, causes and controls based on your product and its intended use, so your CSO is reviewing and deciding rather than starting from a blank page.

Link each control to evidence that it is in place and works, such as a design document, test result, training record or user guide, and record who verified it and when. Your clinical safety case report then summarises that evidence. In Assuric, every hazard opens to its causes, then its controls, then the document behind each control, so a reviewer clicks from the risk to the proof without asking you for a folder.

Yes. Controls are mapped once and reused across DTAC, DCB0160, ISO 14971 and IEC 62304, so evidence you create for DCB0129 is reused rather than recreated.

Yes. To comply with DCB0129 you must have a nominated individual acting as your CSO. They can be internal or external.

Your Clinical Safety Officer must be a suitably qualified and experienced clinician who holds current registration with an appropriate professional body and is knowledgeable in risk management and its application to clinical domains. They make sure your defined clinical risk management processes are followed, and they can be employed by you or provided through an outsourced arrangement.

Yes. One of our in-house CSOs is named on your project. They work with your team to become fluent in your product, request the documents they need, and approve your clinical risk management plan, hazard log and clinical safety case report. Your top management stays accountable for clinical risk management under DCB0129, and your CSO makes sure the process is followed and the documents are right.

You need to assess every change for its clinical safety impact, and update the hazard log and safety case where clinical risk changes. In Assuric, releases flag the hazards they affect, so your CSO reviews what changed rather than reopening the whole case.