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Standards and Certification Regulations

ONC Regulations FAQs

  • Does the ONC Health IT Certification Program (Program) account for instances in which a voluntary consensus standards organization (or steward) issues a correction to a standard or implementation specification after it has been adopted by ONC in a final rule? If so, how?

  • Will testing and certification for 45 CFR 170.314(g)(1) – “automated numerator recording” and 45 CFR 170.314(g)(2) – “automated measure calculation” continue to include use measures that are no longer included in the meaningful use criteria for EHR reporting periods in 2015 through 2017 as a result of CMS’s recent final rule (... Read more.

  • For certification to the 2014 Edition “data portability” certification criterion (45 CFR 170.314(b)(7)), must the EHR technology support a user’s ability to “batch” export all patients or is it permissible for this functionality to be limited to only a single C-CDA on a per patient basis?

  • What impact does the removal of the 2011 Edition EHR certification criteria and related standards, terms, and requirements from the Code of Federal Regulations (effective March 1, 2015) (79 FR 54447) have on the ONC Health IT Certification Program, health care providers, and health IT developers?

  • Are versions of the U.S. Edition of SNOMED CT® acceptable for the purposes of certifying EHR technology to 2014 Edition EHR certification criteria that include SNOMED CT® as a required standard? Further, is only the U.S. Edition of SNOMED CT® necessary for certification and not the International Release of SNOMED CT®?

  • 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?

  • Is a health care provider permitted by the HIPAA Privacy Rule to allow an ONC-ACB to conduct “in the field” surveillance on an EHR technology previously certified by the ONC-ACB, when protected health information (PHI) may be accessible to the ONC-ACB during the surveillance?

  • Does a certified Complete EHR or certified EHR Module need to be retested and/or recertified every time it is patched or updated?

  • What is the preferred language standard required for 2014 Edition Electronic Health Records (EHR) certification and is it possible for additional languages to be included in EHR technology that are not part of the standard?

  • What is the relationship between EHR certification and the annual CQM specification updates released by CMS?