While both standards focus on clinical safety, they apply to different organisations in the healthcare ecosystem. Here’s a breakdown of the key differences.
DCB0129
This standard is for the manufacturers and developers of health IT systems.
It requires them to have a robust clinical risk management process to ensure the software they build is safe before it is deployed.
Applies to creators of health software.
Focuses on safety during product development.
Requires a Clinical Safety Officer (CSO).
Ends with a Clinical Safety Case Report for the product.
DCB0160
This standard is for healthcare organisations (like GP practices, hospitals) that deploy and use health IT systems. It ensures they use this technology safely within a clinical setting.
Applies to users of health software.
Focuses on safety during implementation and use.
Requires a Clinical Safety Officer (CSO).
Ends with a Safety Case Report for the organisation.
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