FAQ: What is DCB 0160?
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SCCI 0129/0160 FAQFrequently Asked Questions DCB 0129/0160

What is DCB 0160?

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.

You can download the DCB 0160 standard and the accompanying guidance by visiting our webpage on how to find the standards.

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Related questions:

What is DCB 0129?
Are DCB 0129/0160 mandatory?
What’s involved in becoming compliant with the standards?
How long does it take to comply with the Standard?
If my product doesn’t make any clinical decisions, do I still need to comply?

Safehand provides expert consultancy services to manage clinical risk in health IT systems, maintain patient safety and comply with standards DCB 0129 and DCB 0160.