FAQ: What is SCCI 0129?
Home / FAQ: What is SCCI 0129?

SCCI 0129/0160 FAQFrequently Asked Questions SCCI 0129/0160

What is SCCI 0129?

SCCI 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 is a mandatory requirement in England.

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 SCCI 0129 is supplemental to the requirements of the NHS Information Governance Toolkit.

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

Back to our FAQ Join our free Members Area for many more FAQs

Related questions:

What is SCCI 0160?
Are SCCI 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 SCCI 0129 and SCCI 0160.