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

Are DCB 0129/0160 mandatory?

Yes. There has been a great deal of debate in this area for some time but recently NHS Digital have confirmed that “Compliance with DCB0129 and DCB0160 is mandatory under the Health and Social care Act 2012.”

According to NHS England, NHS Trusts must only procure health IT systems which comply with DCB 0129 standard. Then, the Trust must conduct DCB 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 most manufacturers are finding it impossible to bring a product to market if they have not undertaken the work.

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Related questions:

What is DCB 0129?
What is DCB 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 DCB 0129 and DCB 0160.