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DCB0129 and DCB0160 are the NHS clinical safety standards for health IT systems. DCB0129 applies to manufacturers of health IT software (like Medflow Dynamics), and DCB0160 applies to deployers (such as GP practices and trusts). Both require a documented Clinical Safety Case Report and Hazard Log maintained by an appointed Clinical Safety Officer.
DCB0129 and DCB0160 are clinical safety standards published by NHS Digital (now NHS England) in 2018 under section 250 of the Health and Social Care Act 2012. They are the binding standards for clinical risk management of health IT systems used in the NHS.
DCB0129 — Clinical Risk Management: its Application in the Manufacture of Health IT Systems — applies to organisations that build health IT software. It requires the manufacturer to apply a structured clinical risk management process throughout the software development lifecycle, document hazards and mitigations in a Hazard Log, and produce a Clinical Safety Case Report signed off by a named Clinical Safety Officer (CSO) who is a registered clinician.
DCB0160 — Clinical Risk Management: its Application in the Deployment and Use of Health IT Systems — applies to deploying organisations such as GP practices, NHS trusts, and ICBs. It requires the deployer to do its own local clinical risk assessment of how the software is being used in its specific context, also documented and signed off by a CSO.
Together, DCB0129 and DCB0160 form the clinical safety chain that sits underneath any NHS health IT system. Medflow Dynamics maintains a DCB0129 Clinical Safety Case Report for each AI feature, with hazards specific to AI (incorrect mapping, hallucinated content, missed gaps, stale references) explicitly assessed and mitigated.
Any organisation that manufactures, develops, or modifies health IT software for use in the NHS. This includes commercial software suppliers, in-house NHS development teams, and organisations adapting existing tools for NHS use.
Any organisation deploying health IT systems within an NHS context — GP practices, NHS trusts, ICBs, community providers, and others. The deploying organisation must do its own local clinical risk assessment, separate from the manufacturer's DCB0129 work.
A Clinical Safety Officer (CSO) is a named, registered clinician (doctor, nurse, pharmacist, etc.) who owns clinical risk management for a health IT system. The CSO must have completed appropriate training in clinical risk management and is accountable for the Clinical Safety Case Report and Hazard Log under DCB0129/DCB0160.
Medflow Assure is built around the standards on this page. Book a walkthrough to see how it works in practice.
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