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Standards and Certification Regulations

ONC Regulations FAQs

  • 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?

    Answer:

  • 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?

  • Can Surescripts’ version of the e-prescribing standard, NCPDP SCRIPT 8.1, called “SCRIPT 8.1E” be used to satisfy the 2011 Edition EHR certification criterion for electronic prescribing (45 CFR 170.304(b))?

  • Would an EHR technology that allows manual entry of problem, medication, or laboratory test data into an education search tool be able to satisfy the “other-than-Infobutton1 -enabled” capability required by the “patient-specific education resources”... Read more.

  • The clinical decision support and patient list creation certification criteria (45 CFR 170.314(a)(8) and 45 CFR 170.314(a)(14), respectively) require EHR technology to perform capabilities based on "demographics" data.

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