Glossary, regulation and privacy
What is DCB0129?
DCB0129 is the information standard that requires manufacturers of health IT systems used in health and care in England to manage the clinical risk of their products. Its companion, DCB0160, places the matching duty on the organisations that deploy and use those systems.
Updated . Defined by the wai team for clinics, groups and health systems.
Also called DCB0129 clinical safety or DCB0160.
Why DCB0129 matters to a clinic
DCB0129 is published by NHS England under section 250 of the Health and Social Care Act 2012, and has been in effect since 1 July 2018.1 Its companion DCB0160 covers the deployment and use of the same systems.1
In practice an NHS body, or a clinic working with one, asks the supplier for its clinical safety case report and hazard log, and its own clinical safety officer reviews them for the local setting. Both sides of that work belong before the first patient, which is why it is worth starting early.
Questions
Does DCB0129 apply to private clinics?
DCB0129 applies to the manufacturer of health IT used in health and care in England. A private provider deploying the system takes on the DCB0160 side when it works within those settings, and many choose to follow it as good practice.
What is a clinical safety officer?
A registered clinician, trained in clinical risk management, who signs off the clinical safety work on each side, the manufacturer's under DCB0129 and the deployer's under DCB0160.
Sources
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