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ONC Regulation FAQs

#28 Question [11-12-028-1]

Are ONC-ACBs required to certify 2014 Edition Complete EHRs to both of the mandatory certification criteria at 45 CFR 170.314(g)(1) and (g)(2)? Similarly, if EHR technology presented for certification as an EHR Module has been tested to satisfy a combination of the capabilities specified in 45 CFR 170.314(g)(1) or (g)(2),what certification criterion must an ONC-ACB indicate as the one to which the EHR technology is certified when the ONC-ACB submits its weekly certification data to ONC?

Answer:

Complete EHRs

EHR technology issued a 2014 Edition Complete EHR certification must be certified to § 170.314(g)(2) (“automated measure calculation”) as it is a mandatory certification criterion consistent with the 2014 Edition Complete EHR definition requiring certification to all mandatory certification criteria for a particular setting (ambulatory or inpatient). While § 170.314(g)(1) (“automated numerator recording”) is also designated as a mandatory certification criterion, a 2014 Edition Complete EHR is not required to be certified to the certification criterion (and therefore tested to the associated test procedure) because a 2014 Edition Complete EHR would have demonstrated capabilities beyond those included in § 170.314(g)(1) by being certified to (g)(2).

EHR Modules

Section 170.550(f)(1) requires ONC-ACBs to certify all EHR technology presented for certification as an EHR Module to be certified to § 170.314(g)(1) (“automated numerator calculation”) for each capability (for which certification is sought) that would support a meaningful use objective with a percentage-based measure. Additionally, as we indicated in the 2014 Edition EHR certification criteria final rule (77 FR 54186), ONC-ACBs can certify an EHR Module to either § 170.314(g)(1) or (g)(2). In issuing a certification to an EHR Module for either of these certification criteria, we wish to further explain the testing process and subsequent certification issued to an EHR Module because the preamble expressed in the final rule did not include this level of specificity.

#If EHR technology presented as an EHR Module is tested to:Then an ONC-ACB, when issuing an EHR Module certification, should report in its weekly certification data to ONC that:
1 170.314(g)(1) only 170.314(g)(1) only was certified
2 170.314(g)(2) only 170.314(g)(2) only was certified
3 A combination of 170.314(g)(1) & (g)(2) 170.314(g)(1) only was certified

For scenario #3, when an EHR Module is tested to some combination of 170.314(g)(1) and (g)(2), an ONC-ACB can only attribute to that EHR technology’s certification the fact that it had met 170.314(g)(1). This is so because, as we stated in the preamble, satisfying (g)(2) requires that an EHR Module presented for certification be capable of calculating all of the percentage-based MU measures for all of the capabilities it includes and that correlate to such percentage-based MU measures.

 

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