FAQ: Do health apps need to comply with SCCI 0129?
Home / FAQ: Do health apps need to comply with SCCI 0129?

SCCI 0129/0160 FAQFrequently Asked Questions SCCI 0129/0160

Do health apps need to comply with SCCI 0129?

Whether the application is built for a desktop system or as an app, if the product can influence care delivery then SCCI 0129 applies. In other words, it’s the ability for the system to impact care which determines SCCI 0129 applicability not the technology.

There are an increasing number of organisations (including the NHS itself) who will review and endorse health apps with the intention of identifying those which are high quality, safe and effective. If the functionality within the app falls within scope of SCCI 0129, it is necessary to comply to demonstrate to these organisations that the product is safe.

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Related questions:

What is SCCI 0129?
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.