Regulation FAQs

Both the Physician Self-Referral Prohibition EHR Exception and the Anti-kickback EHR Safe Harbor regulations, at 42 CFR 411.357(w) and 42 CFR 1001.952(y), respectively, provide that software “is deemed to be interoperable if a certifying body recognized by the Secretary has certified the software within no more than 12 months prior to the date it is provided to the recipient.” The “recognition” of certification bodies process referred to in these regulations, as discussed in the Temporary… more

The certification criteria at 45 CFR 170.302(k) and 170.314(f)(2) do not specify, and are not intended to specify, when submissions should be made or the periodicity of the submissions. Consequently, submitting batch files to an immunization registry, provided that they are formatted according to the adopted standards referenced by the certification criteria at 45 CFR 170.302(k) and 170.314(f)(2), is not prohibited by these certification criteria and would be acceptable.

In response to your first question, yes, any individual health care provider, group of health care providers, other type of affiliation, or organization is permitted to seek to have EHR technology tested and certified. The Temporary Certification Program and ONC HIT Certification Program regulations do not specify who may seek testing and certification for EHR technology. However, we note that any party that seeks testing and certification for the EHR technology would typically assume the… more

Stand-alone, separate components of a certified Complete EHR do not derive their own separate certified status based solely on the fact that they were included as part of the Complete EHR when it was tested and certified. The separate component(s) would no longer meet the Complete EHR definition, nor would the separate component have independently demonstrated that it can still properly perform capabilities for which certification is required in the absence of the capabilities with which it… more

Yes, an ONC-ATCB or ONC-ACB that is authorized to certify Complete EHRs has the discretion to change the type of certification it would issue based on an EHR technology developer’s request. Whether the ONC-ATCB or ONC-ACB would choose to honor a request for a change, as well as any costs associated with a change, would depend upon the arrangement between the EHR technology developer and the ONC-ATCB or ONC-ACB. Along those lines, if an ONC-ATCB or ONC-ACB permits a developer or presenter to… more

Yes, you may seek testing and certification for only those systems that have not been certified as an EHR Module (in this case, the self-developed system), and no, you do not need to have the combination of certified EHR Modules certified again as a Complete EHR in order to meet the definition of Certified EHR Technology.

An EHR Module could provide a single capability required by one certification criterion or it could provide all capabilities but one required by the certification criteria for a Complete EHR. In other words, for example, we would call HIT tested and certified to one certification criterion an "EHR Module" and HIT tested and certified to nine certification criteria an "EHR Module," where ten certification criteria are required for a Complete EHR.

We now provide two different answers… more

Yes, this business practice is permitted. However, the ONC-ATCB or ONC-ACB that certified your Complete EHR is required to ensure that you adhere to the terms and conditions of the certification it issues, including communication of the information specified at 45 CFR 170.423(k) and 170.523(k), respectively. Thus, if you permit business partners/distributors to re-brand or rename your certified Complete EHR and represent that it has been certified, the ONC-ATCB or ONC-ACB that issued the… more

No, other IT systems that act as data sources and are not intended to perform required capabilities in accordance with adopted certification criteria do not need to be certified simply because they supply data to a Complete EHR or EHR Module. Obviously, if the other IT systems have not been developed to, and cannot, perform required capabilities in accordance with adopted certification criteria then certification of those other IT systems would not be available. For the purposes of… more

Yes, in order to possess EHR technology that meets the definition of Certified EHR Technology, both the document management system and the EHR technology from EHR technology developer XYZ together need to meet this certification criterion in its entirety. As a result, (assuming you are not implementing a certified Complete EHR) you could elect to seek testing and certification yourself for these two systems as an EHR Module or implement a certified EHR Module that meets this certification… more

It depends.

First, it depends on whether the EHR technology is being certified to the 2011 or 2014 Edition EHR certification criteria. Second, it depends on whether the EHR technology is designed to be used in an ambulatory setting or in an inpatient setting as we have adopted specific requirements for each setting to correspond to the correlated meaningful use requirements that eligible professionals (EPs), eligible hospitals (EHs), and critical access hospitals (CAHs) must satisfy… more

Yes, your data warehouse does need to be certified. However, only those capabilities that your data warehouse is intended to perform and for which certification is required would need to be tested and certified. Other capabilities that the data warehouse may also perform (e.g., benchmarking, research analytics) would not need to be tested and certified. Thus, if you plan to use a data warehouse to calculate and submit clinical quality measures to CMS or States for meaningful use, the data… more

Meeting the Certified EHR Technology definition can be achieved in numerous ways, including using EHR technologies that perform duplicative or overlapping capabilities (if that is what an eligible health care provider chooses to do) so long as those EHR technologies are certified. Consequently, an eligible health care provider could use both certified capabilities (e.g., CPOE) at the same time in two different sections/departments of its organization. The eligible health care provider would… more

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… more

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… more

The CEHRT definition can be found at 45 CFR 170.102 and applies to the calendar year (CY) for eligible professionals (EPs) and the fiscal year (FY) for eligible hospitals (EHs) and critical access hospitals (CAHs).

Before FY/CY 2014 (i.e., for the EHR reporting periods in 2011, 2012, and 2013)

An eligible provider can satisfy the CEHRT definition in any one of the following three ways:

1. The eligible provider possesses EHR technology certified to all… more

It depends. We recognize that the term “interface” has several different meanings depending on the context in which it is used, the IT infrastructure of which it is a part, and the capability it performs. Consequently, depending on various factors, an interface may or may not need to be certified.

“NO”

• The answer to your question would be “no,” if the interface provided a user with the ability to directly enter data to the public health agency/registry. In that… more

Yes, as discussed in the Initial Set of Standards, Implementation Specifications, and Certification Criteria Final Rule published in July 2010 (75 FR 44630), there is more than one way to demonstrate compliance with these certification criteria. For these certification criteria, Certified EHR Technology must be capable of generating two outputs to produce an electronic copy (i.e., a copy in human readable format and a copy as a CCD or CCR). If the Certified EHR Technology is capable of… more

Yes, it is possible for the action of “record” in this certification criterion to be implemented in different ways. The example in this question appears to be one possible way to demonstrate compliance with this certification criterion. Other possible methods could include a Complete EHR that accepts or retrieves raw data, analyzes the data, and then generates a report based on the analysis; a Complete EHR that separately tracks each capability with a percentage-based meaningful use measure… more

We consider “possession” of EHR technology certified to an edition of EHR certification criteria to be either the physical possession of the medium on which a certified Complete EHR, or certified EHR Module resides, or a legally enforceable right by an eligible health care provider to access and use, at its discretion, the capabilities of a certified Complete EHR or certified EHR Module. An eligible health care provider may determine the extent to which it will implement or use these… more