Frequently Asked Questions DCB 0129/0160

What is DCB 0129?

DCB 0129 is the clinical risk management standard which manufacturers of health IT systems and apps need to comply with. The standard is governed by NHS Digital and compliance 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 manufacture health IT systems and apps undertake a formal risk assessment and evidence the measures which have been put in place to mitigate risk. Proactively demonstrating that a product is safe helps to protect from litigation and visibly demonstrates best-practice to customers.

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.

Note that DCB 0129 is supplemental to the requirements of the NHS Data Security and Protection Toolkit.

You can download the DCB 0129 standard and the accompanying guidance by visiting our webpage on how to find the standards.

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Related questions:

What is DCB 0160?
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.