DCB 0160 is the clinical risk management standard which NHS organisations need to comply with when they implement health IT systems. The standard is governed by NHS Digital and is mandatory under the Health and Social care Act 2012
Digital health technology can introduce as well as mitigate clinical risk. NHS Digital requires that organisations who implement health IT systems undertake a formal risk assessment and evidence the measures which have been put in place to mitigate risk.
To comply with the standard, organisations needs to undertake a formal risk assessment on the product and produce three documents summarising the outcome; the Clinical Risk Management Plan, Hazard Log and Clinical Safety Case Report. The risk assessment needs to be carried out before a system goes live. The documentation then needs to be kept up to date during live service.