A Clinical Safety Officer
A named clinician who owns clinical risk.
A hazard log
Hazards, causes, controls and evidence.
A safety case
The argument that your product is safe to use.
A plan
How risk is managed through every release.
Clinical safety DCB 0129
DCB 0129
Clinical risk management for the people who build health IT.
- The NHS standard for manufacturers of health IT systems.
- A hazard log, a safety case and a named Clinical Safety Officer.
What the standard asks of you.
In Qyro, it is one thread.
Qyro Hazard Studio keeps each hazard tied to its control and its evidence.
HazardWhat could go wrong
CauseWhy it would
ControlWhat holds it
EvidenceProof the control works
Sign-offBy your Clinical Safety Officer
Your path to a signed safety case.
1ScopeWhat the product does
2HazardsWhat could go wrong
3ControlsHow each is held
4EvidenceProof it works
5Safety caseSigned off
6Each releaseReviewed again
Questions buyers ask.
Who needs DCB 0129?
Manufacturers of health IT systems used in health and care in England.
Do we need a clinician?
Yes. The standard requires a Clinical Safety Officer who is a registered clinician. Qyro can provide one.
How long does it take?
It depends on your product and on what already exists. The free readiness check shows where you stand, and we will give you a realistic date on a walkthrough.