This approach is an operational response to the DCB standard 0160: clinical risk management in the deployment and use of Health IT systems. It is a scaleable and flexible approach, which can be applied in one ward, one GP practice, one programme or across a whole system and which can support safe innovation at pace. It has been endorsed and adopted by the NHSE SW Digital Neighbourhood Teams Programme for AVT deployment in Primary Care.

The output is documentation that meets the requirement of the DCB Clinical Safety Case Report: a “physical document that summarises all the key elements of the Clinical Safety Case and references all supporting material in a clear, comprehensible and concise format.  It serves to communicate the Clinical Safety Case to the end users and Top Management but also where appropriate to other bodies such as regulators”