Question [9-10-005-1]: I am an EHR technology developer. I have sought and achieved certification for the Complete EHR that I sell. The Complete EHR, however, is also designed to be sold in separate components so that I can offer my customers different prices based on the capabilities they seek to implement. Is it possible for me to sell components of my certified Complete EHR separately as certified EHR Modules, or do I need to seek testing and certification for each of the separate components that I plan to sell as certified EHR Modules?

Answer:

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 definition of a Complete EHR, nor would it have independently demonstrated that it can still properly perform capabilities for which certification is required in the absence of the capabilities with which it was previously certified as part of the Complete EHR. Additionally, the separate component(s) would not satisfy the requirements of 45 CFR 170.450(c) related to the privacy and security testing and certification of EHR Modules.

This concept is similar to our treatment of integrated bundles of EHR Modules. We clarified in the Temporary Certification Program final rule (75 FR 36191) that EHR Modules, once certified as part of a bundle, would not each separately inherit a certification just because they were certified as part of a bundle.

Therefore, EHR technology developers must have the separate components of a certified Complete EHR tested and certified as EHR Modules before the components may be sold separately as certified EHR Modules. Because ONC-ATCBs that are authorized to test and certify Complete EHRs are also, by default, authorized to test and certify all types of EHR Modules, such ONC-ATCBs are not precluded from issuing separate certifications for the separate components of a Complete EHR as EHR Modules at the same time the Complete EHR is presented for testing and certification, provided that the ONC-ATCB satisfies its responsibilities under 45 CFR 170.450 as well as other such responsibilities related to EHR Modules (e.g., 45 CFR 170.423 the Principles of Proper Conduct for ONC-ATCBs).

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