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ONC Regulation FAQs

#16 Question [09-10-016-2]

I’ve implemented EHR technology developer XYZ’s certified Complete EHR [or certified EHR Module] “E-HealthSystem” which has been certified to the 2011 Edition EHR certification criteria. The developer indicated that it’s making the necessary development changes and will, in the next year, present “E-HealthSystem” for Complete EHR certification to the 2014 Edition EHR certification criteria.

Scenario 1: I determined that E-HealthSystem needed to be reconfigured in order to connect with one of my patient registration systems so I made the necessary adjustments. Is it okay to make adjustments? If necessary, can I also reconfigure, in a similar manner, the next version of E-HealthSystem that will be certified to the 2014 Edition EHR certification criteria without compromising the certified status of my implementation of E-HealthSystem?

Scenario 2: EHR technology developer XYZ communicated to my organization that they relied upon a 3rd party software program “PatientInfoTracker 2.0” for the purposes of demonstrating compliance with the “generate patient lists” certification criterion specified at 45 CFR 170.302(i) in achieving E-HealthSystem’s certification. They’ve also informed me that they will rely on the same 3rd party program to meet the “create patient lists” certification criterion at 45 CFR 170.314(a)(14) as part of their Complete EHR certification to the 2014 Edition EHR certification criteria. I have already implemented, use, and would like to continue using “SuperListGenerator 7.0.” I have determined that I can reconfigure SuperListGenerator 7.0 to work with E-HealthSystem. Can I use SuperListGenerator 7.0 in lieu of PatientInfoTracker 2.0 without compromising the certified status of my implementation of E-HealthSystem now and potentially with the 2014 Edition version?

Answer:

With respect to Scenario 1, yes, you can reconfigure your implementation of E-HealthSystem without compromising its certified status, but you assume the risks associated with modifying a certified capability after it has been certified. You are also responsible for ensuring that the modifications do not adversely affect the performance of E-HealthSystem and, as a result, your ability to demonstrate meaningful use. We encourage eligible providers to use caution when modifying certified Complete EHRs or EHR Modules.

With respect to Scenario 2, no, you cannot use a different 3rd party program to perform a certified capability unless:

  • EHR technology developer XYZ already has a separate certification for E-HealthSystem that identifies SuperListGenerator 7.0 as a relied upon software program; or
  • You obtain certification for SuperListGenerator 7.0 as an EHR Module.

 

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