Governance

Clinical safety (DCB0129)

Last updated: 28 October 2026

TamRx will follow DCB0129 for clinical risk management. A Clinical Safety Officer will be appointed before any NHS deployment.

What DCB0129 is

DCB0129 is the NHS information standard for clinical risk management in the manufacture of health IT systems. It applies to organisations that develop and maintain health IT. Its companion standard, DCB0160, applies to the health and care organisations that deploy and use those systems.

Our planned approach

Clinical risk management starts during development, not at deployment. Our clinical safety documentation comprises:

• Clinical risk management plan setting out how clinical risk is identified, assessed and controlled, and who is responsible.
• Hazard log recording identified hazards, their causes and effects, risk ratings and the controls applied.
• Clinical safety case report presenting the evidence that risks have been reduced to an acceptable level.

Designed-in safety principles

• Evidence is shown, not hidden behind a single score.
• When the closest confirmed cases disagree, or no sufficiently similar case exists, the software reports insufficient evidence and defers to the clinician.
• The clinician remains responsible for every clinical decision.

Clinical Safety Officer

A suitably qualified and registered clinician will be appointed as Clinical Safety Officer before any NHS deployment, and will approve the safety case.

Supplier and deployment responsibilities

As the developer, TamRx is responsible for DCB0129. Any organisation deploying TamRx software in future will have its own responsibilities under DCB0160. Our safety documentation will be shared to support that work.

Reporting a safety concern

If you have a concern about the safety of anything we publish or demonstrate, email mounsif@tamrx.co.uk with "Safety" in the subject line. Please do not include identifiable patient information.