Part of Applicability of DCB 0129 and DCB 0160
NHS Digital recommendation
Terms and definitions
Defined terms are presented between apostrophes.
NHS Digital recommends that DCB 0129 and DCB 0160 are adopted in all circumstances where 'Digital products' are developed or deployed to support health or social care services.
The standards represent best practice and provide a framework for 'Clinical risk management'. The application of risk will reduce the likelihood of harm outcomes.
The only exception to this recommendation would be in the context of software which is incorporated directly into a physical 'Medical device', for example software based drug dosing calculations 'Implemented' in an infusion pump.
In no circumstances do DCB 0129 or DCB 0160 supersede / replace the regulatory requirements associated with 'Medical devices'.
Last edited: 27 May 2022 9:49 am