🦺 Clinical Safety for HealthTech : DCB 0129/0160

Summary

• This guide unpacks the DCB 0129 standard, a mandatory clinical risk management requirement for digital health products intended for use within NHS England.
• It explains when DCB 0129 applies, what documentation is required, and the pivotal role of a Clinical Safety Officer (CSO) in ensuring safe product development.
• The standard aims to mitigate clinical risks posed by digital tools, especially those influencing real-time care decisions.

What this carousel covers

• The difference between DCB 0129 (developer responsibility) and DCB 0160 (implementer responsibility)
• Scenarios in which DCB 0129 applies—particularly for apps and platforms involved in diagnosis, monitoring, or care decisions
• Required documentation: Clinical Risk Management Plan, Hazard Log, and Clinical Safety Case Report
• The qualifications and responsibilities of the Clinical Safety Officer (CSO)

Key takeaways

• If your product influences clinical care or poses potential harm, DCB 0129 almost certainly applies
• Appointing a trained, registered CSO is non-negotiable for compliance
• The process demands structured risk assessment, transparent documentation, and collaborative validation with stakeholders
• Compliance with DCB 0129 is not only required—it’s foundational to building trust and entering the NHS market safely

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