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ONC Regulation FAQs

#05 Question [09-10-005-2]

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 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 was previously certified as part of the Complete EHR. Therefore, EHR technology developers must have the separate components of a certified Complete EHR tested and certified as EHR Modules under the Temporary Certification Program or the ONC HIT Certification Program, as applicable, before the components may be sold separately as certified EHR Modules.

Similarly, components of a certified EHR Module do not derive their own certified status from being part of a certified EHR Module. Developers who seek to sell such components as certified EHR Modules must have them separately tested and certified under the Temporary Certification Program or the ONC HIT Certification Program, as applicable.

To read more about this policy, please see 77 FR 54266.

 

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