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 England and is a mandatory requirement in England and Wales.
Digital health technology can introduce as well as mitigate clinical risk. NHS England 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.
You can download the DCB 0160 standard and the accompanying guidance by visiting our webpage on how to find the standards.