FAQ: Are SCCI 0129/0160 mandatory?
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SCCI 0129/0160 FAQFrequently Asked Questions SCCI 0129/0160

Are SCCI 0129/0160 mandatory?

Yes. In 2014 the Secretary of State for Health confirmed in a Commons Debate that the SCCI (ISB) 0129/0160 standards are the means by which clinical safety requirements are addressed in health IT in England. However, unlike the Medical Device Directive, the standards are not currently enshrined in law. Failing to comply is not a criminal offence but can leave you in an indefensible position should your health IT product or implementation contribute to patient harm.

According to NHS England, NHS Trusts must only procure health IT systems which comply with SCCI 0129 standard. Then, the Trust must conduct SCCI 0160 activities to assure the implementation. Manufacturers who produce health IT systems which are not compliant will increasingly struggle to sell into the NHS. NHS Digital are gradually tightening the knot in this area and soon manufacturers will find it impossible to bring a product to market without having undertaken the work.

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Related questions:

What is SCCI 0129?
What is SCCI 0160?
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.