Regulation FAQs

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

ONC and CMS have received many questions related to this topic, which are reflected below. These responses are from both ONC and CMS.

Question 1: When new versions of CQM specifications are released by CMS, do EHR technology developers need to seek retesting/recertification of their certified Complete EHR or certified EHR Module in order to keep its certification valid?

ONC/CMS Response: No. The minimum version required for 2014 Edition… more

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?

The preferred language standard required for 2014 Edition EHR certification (adopted at 45 CFR 170.207(g)) is “ISO-639-2 alpha-3 codes limited to those that also have a corresponding alpha-2 code in ISO-639-1.”

For EHR technology certification purposes, EHR technology can be modified to include additional language codes beyond those identified in the adopted standard. We view the standard adopted for preferred language as the minimum amount of language codes that need to be supported… more

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

No. In general, modifications such as security patches, updates to “minimum standards” code sets1 (e.g., RxNorm, LOINC), CQM updates (i.e., FAQ #42, question 2), and other similar improvements to the version of an EHR technology listed on the Certified HIT Products List (CHPL… more

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?

Yes. Under the Office of the National Coordinator (ONC) HIT Certification Program rules at 45 CFR 170 Subpart E, ONC-ACBs are authorized to perform EHR technology certification on behalf of ONC. An ONC-ACB is also required as a condition of its accreditation and ONC-authorization to perform surveillance on the EHR technology it certifies to ensure the EHR technology continues to perform in an acceptable manner in the field. In this capacity, ONC-ACBs meet the definition of a “health… more

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?

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… more

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®?

Yes to both questions. The U.S. Edition of SNOMED CT® is now the official source of SNOMED CT® for use in US healthcare systems. Since its March 2013 release, it has been composed of:

  • The International Release of SNOMED CT®
  • The U.S. Extension to SNOMED CT®, a formal extension to the International Release containing US-specific content (concepts, descriptions, relationships, and history).

The September 2012 Release of the U.S. Extension to SNOMED CT® marked… more

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?
  1. ONC Health IT Certification Program
    1. ONC and NIST will archive the 2011 Edition Test Method (test procedures, tools and data). The Certified HIT Products List (CHPL) will maintain the 2011 Edition certified products in an active status until July 1, 2015, so that participants in HHS programs permitting the use of 2011 certified products (which also require a CMS EHR Certification ID) will be able to generate these IDs. Beginning in July 2015, these products will… 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?

To demonstrate compliance with this certification criterion, EHR technology must “enable a user to electronically create a set of export summaries for all patients in EHR technology formatted according to” the C-CDA standard (77 FR 54193). A set of export summaries for all patients must include multiple patients and cannot be satisfied by a user individually creating an export summary for each patient one-by-one.

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 (80 FR 62761), (80 FR 62785), (80 FR 62875)

No. These measures are no longer considered within the scope of these certification criteria and do not need to be tested in order to demonstrate compliance with either certification criterion (i.e., 2014 Edition; §170.314(g)(1) or (g)(2)). 

As a result, ONC-ACBs may issue new or updated certifications on the basis of this narrower testing scope. ONC has updated the 2014 Edition test procedure to reflect these policy changes. Additionally, for continuity purposes, this 2014 Edition… more

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?

Yes. In the event that the adopted version of the standard or implementation specification is corrected by a voluntary consensus standards organization (or steward) after it has been adopted by ONC in a final rule, ONC follows a specific approach to determine whether, even if not yet formally adopted by the Secretary, the correction(s) should be incorporated into the testing, certification, and surveillance of health information technology (health IT) to the adopted standard or… more

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