What this is
DCB0129 — Clinical Risk Management: its Application in the Manufacture of Health IT Systems — is a clinical safety standard published under section 250 of the Health and Social Care Act 2012. It is mandatory for manufacturers of health IT systems used in the NHS.
The standard requires the manufacturer to operate a clinical risk management system, to maintain a Clinical Safety Case and Hazard Log for the product, and to appoint a suitably qualified Clinical Safety Officer to oversee the process.
Our status
Codara operates a clinical risk management system in conformance with DCB0129 and maintains a Clinical Safety Case and Hazard Log for the Codara platform.
- Clinical Safety Officer: Dr Anthony Cox (cso@codara.co.uk)
- Clinical Safety Case version: 4.2
- Last review date: 18 May 2026
The corresponding standard for the deploying NHS organisation is DCB0160. Codara provides the manufacturer's Clinical Safety Case to support customers' own DCB0160 obligations.
How it's verified
Clinical safety documentation is shared directly with customers under their own information governance and clinical safety processes.