SCCI 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 a mandatory requirement in England.
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.