Clinical safety
We manage clinical risk in our products under DCB0129, the NHS standard for manufacturers of health IT. Our Clinical Safety Officer, a practising doctor, leads this work and signs off our clinical safety cases.
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What DCB0129 and DCB0160 are
DCB0129 and DCB0160 are NHS information standards published under section 250 of the Health and Social Care Act 2012.
- DCB0129
- For manufacturers of health IT. It covers how the maker identifies, assesses and controls clinical risk in what it builds.
- DCB0160
- For organisations that deploy and use health IT. It covers the same work from the deploying organisation's side.
Prime Assist has a clinical safety case under DCB0129, signed off by our Clinical Safety Officer.
Our Clinical Safety Officer
Dr Humzah Jessa is a practising doctor and our Clinical Safety Officer. [TO CONFIRM: professional registration body and number]
Our clinical risk management process
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Identifying hazards
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Assessing risk
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Putting controls in place
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Keeping the hazard log
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The clinical safety case report and sign-off
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Monitoring after deployment
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Assessing the safety impact of every change
Supporting deploying organisations
Organisations that deploy our products, or AI scribes and agents from other suppliers, keep their own clinical safety case under DCB0160. We help them write it and keep it current.
See clinical safety for AI you deployReport a clinical safety concern
[TO CONFIRM: the dedicated route, what to include, and how quickly we respond]
Medical device status
[TO CONFIRM from the regulatory assessment]