DCB0129
DCB0129 clinical safety roadmap — explained.
- Clinical safety case in development
- Hazard identification and risk review planned
- Clinical Safety Officer review planned
- Buyer-side DCB0160 considerations
- Evidence pack planned for future evaluation
What it is
Who it's for
- NHS information governance, clinical safety and IT teams evaluating suppliers
- ICB digital transformation leads
- Practice managers and GP IT leads
- Procurement and DSPT assessors
How it works
Clinical and engineering review planned for future releases.
Risk scoring and mitigation documentation planned.
Clinical safety review is planned before deployment.
Post-market surveillance to be established before deployment.
FAQ
What is DCB0129?
DCB0129 is a UK clinical risk management standard for health IT manufacturers. TriageNix is developing a clinical safety case in line with it.
Is DCB0129 mandatory?
UK healthcare buyers should assess the applicable clinical safety obligations before deployment. TriageNix has not completed its safety case.
What evidence does TriageNix provide?
A completed DCB0129 evidence pack is not yet available. Clinical safety work is in development.
Who oversees clinical safety?
A designated Clinical Safety Officer oversees development of the clinical safety case.
What is the DTAC and MHRA status?
MHRA registration, UKCA/CE marking, DTAC and DSPT have not been completed.
Request the DCB0129 evidence pack
The clinical safety case is in development; a completed evidence pack is not yet available.