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ONC Regulation FAQs

#46 Question [2-14-046-1]

What does it mean under 45 CFR § 170.523(k)(1) to conspicuously include the specified information in all marketing materials, communications statements, and other assertions related to the Complete EHR or EHR Module's certification?

Answer: Section 170.523(k)(1) requires that ONC-ACBs ensure that Complete EHR and EHR Module developers conspicuously include certain information on their Websites and in all marketing materials, communications statements, and other assertions related to a Complete EHR or EHR Module's certification.  This information, in general, includes: a statement that the EHR technology has been certified by an ONC-ACB to meet certification criteria adopted by the Secretary; a HHS endorsement disclaimer; information an ONC-ACB is required to report to the National Coordinator under § 170.523(f) for the specific Complete EHR or EHR Module at issue; and any additional types of costs that an eligible professional (EP), eligible hospital (EH), or critical access hospital (CAH) would pay to implement a Complete EHR's or EHR Module's capabilities in order to attempt to meet meaningful use objectives and measures (excluding EHR technology self-developers).     

We established § 170.523(k)(1) in part based on our belief that more specific requirements concerning the representation and communication of a Complete EHR’s and EHR Module’s certified status would assist EPs, EHs, and CAHs with their purchasing decisions (see 76 FR 1304). When applying § 170.523(k)(1), ONC-ACBs should consider the following general principles:

  1. The requirements apply to all marketing materials, communication statements and other assertions related to the certification of a Complete EHR or EHR Module.  In general, this means if a banner, statement, or splash screen advertisement is not referencing the certified status of the product then § 170.523(k)(1) would not apply.  For example, if an EHR technology developer (“HEALTHYTECH”) has a 2014 Edition Complete EHR certification issued to its EHR technology, we would not expect an ONC-ACB to apply the requirements of § 170.523(k)(1) to a banner at a trade show stating “Come see HEALTHYTECH’s Amazing EHR.”
  2. When the marketing materials, communication statements and other assertions are related to the certification of a Complete EHR or EHR Module, then all the information must be conspicuously included (i.e., noticeable, legible and readily available).  For example, it would be unacceptable to provide the information in an illegibly small font size or only include some of the information in a brochure describing the EHR technology’s certified status.  

    However, in some limited cases where the context or medium would make it difficult to conspicuously include all of the information required by § 170.523(k)(1) (e.g., on a browser-based “splash screen” advertisement that only lasts for a few seconds), an ONC-ACB may deem it acceptable for an EHR technology developer to provide less of the information required by § 170.523(k)(1) so long as the EHR technology developer conspicuously indicates to its audience that the full information can be accessed through other means, such as a hyperlink/URL pointing directly to the full information. 

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