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ONC Regulation FAQs

#15 Question [09-10-015-2]

I am an EHR technology developer preparing my EHR technology for certification. I am relying on a 3rd party software program to demonstrate my compliance with a specific certification criterion. Does this 3rd party software program need to be independently certified?

Answer:

No, the 3rd party software program that your EHR technology relies upon does not need to be independently certified. In principle, when presenting your EHR technology to an ONC-ATCB or ONC-ACB you must be able to demonstrate that your EHR technology is in compliance with the certification criterion regardless of whether your EHR technology natively performs the specified capability or relies upon a 3rd party software program. Thus, in practice, if you rely upon a 3rd party software program to successfully demonstrate compliance with a certification criterion, the certification you are issued encompasses the 3rd party software program. In the context of relied upon software, we require ONC-ATCBs and ONC-ACBs:

  1. To include certain information about software that is relied upon when reporting your certification to the National Coordinator, which will result in your EHR technology’s entry on the Certified HIT Products List (45 CFR 170.423(h)(6) and 170.523(f)(6), respectively); and
  2. To ensure that you convey this information on your website and in all marketing materials, communications statements, and other assertions related to your EHR technology’s certification (45 CFR 170.423(k)(1)(ii)) and 170.523(k)(1)(ii), respectively).

 

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