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Standards and Certification Regulations

ONC Regulations FAQs

  • I’ve identified that I am using two different EHR technologies to meet a single certification criterion (my document management system receives and displays summary records (45 CFR 170.306(f)(1)) and my EHR technology from EHR technology developer XYZ transmits summary records (45 CFR 170.306(f)(2)). Do both EHR technologies need to be certified?

  • My EHR technology is designed to receive demographic data from a registration system or a practice management system. The data from these other IT systems is then used by my EHR technology to demonstrate compliance with one or more certification criteria. Do these other IT systems that act as data sources to my EHR technology need to be certified?

  • 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?

  • If an EHR Module addresses multiple certification criteria (thus providing multiple capabilities), does it need to be tested and certified to the applicable privacy and security certification criteria as a whole or for each capability?

  • My hospital purchased a certified EHR Module that provides approximately 75% of the capabilities we need to meet the definition of Certified EHR Technology. The other 25% are provided by our own self-developed system(s).

  • I submitted a Complete EHR for certification, but it has not passed a test for one or more of the certification criteria. Can I request that the ONC-ATCB or ONC-ACB certify the EHR technology that I submitted as an EHR Module instead (i.e., certify only those capabilities that have been tested successfully)?

  • 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.

  • I currently use EHR version 1.3 which I purchased from EHR technology developer XYZ. EHR technology developer XYZ has informed me that it is not going to seek certification for EHR version 1.3. Can I seek certification for EHR version 1.3 or can I partner with a group of other health care providers that also use version 1.3 to split the cost of certification?

  • This FAQ has been archived and can be found in the Archived FAQs.

     

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  • If my EHR technology is capable of submitting batch files to an immunization registry using the applicable adopted standards, is that sufficient for demonstrating compliance with the certification criterion specified at 45 CFR 170.302(k) or170.314(f)(2) (adopted as part of the 2011 and 2014 Edition EHR certification criteria, respectively)?

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