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ONC Regulation FAQs

#09 Question [09-10-009-2]

I'm an EHR technology developer and I've had my Complete EHR certified. I work with business partners/distributors and permit them to sell my (unmodified) certified Complete EHR under their own brand/name/label. Is this business practice permitted? Is there anything that I should do or be aware of?

Answer:

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 certification for your Complete EHR may require you (consistent with Section 14 of Guide 65) to ensure that your business partners/distributors adhere to the requirements of 170.423(k) or 170.523(k) that apply to you. We encourage you to make arrangements with your business partners/distributors to ensure that they appropriately convey the information specified at 170.423(k) or 170.523(k), as applicable.

Additionally, ONC-ATCBs and ONC-ACBs are responsible for reporting to ONC a current list of the EHR technology that they have certified. Only EHR technologies reported by ONC-ATCBs and ONC-ACBs to ONC will appear on ONC’s “Certified HIT Products List (CHPL).” Therefore, if you are an EHR technology developer that expects to work with business partners/distributors that will re-brand or rename your certified Complete EHR and represent that it has been certified, we encourage you to work with your ONC-ATCB or ONC-ACB to identify (up front, if possible, or on an ongoing basis) the different names under which your certified Complete EHR may be distributed. Otherwise, those re-branded or renamed Complete EHR(s) will not appear on the CHPL.

An ONC-ATCB or ONC-ACB is permitted to report information to ONC related to re-branded or renamed Complete EHRs that it has certified. We would list the re-branded or renamed Complete EHR(s) on the CHPL using the same unique certification identification that is assigned to your certified Complete EHR.

 

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