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Standards and Certification Regulations

ONC Regulations FAQs

  • The XDR/XDM for Direct Messaging v1.0 adopted at 45 CFR 170.202(b) specifies that the value of three attributes (i.e., DocumentEntry.uniqueId, SubmissionSet.sourceId, and SubmissionSet.uniqueId) should be a UUID URN (Universally Unique Identifier Uniform Resource Name).

  • What certification approaches would satisfy the 2014 Edition transitions of care certification criteria adopted at 45 CFR 170.314(b)(1) and (b)(2) as well as permit an eligible provider to have EHR technology that meets the Certified EHR Technology (CEHRT) definition? Please emphasize how the adopted transport standards fit in.

  • How many clinical quality measures (CQMs) must EHR technology be certified to in order to be issued a 2014 Edition Complete EHR certification?

  • Are ONC-ACBs required to certify 2014 Edition Complete EHRs to both of the mandatory certification criteria at 45 CFR 170.314(g)(1) and (g)(2)?

  • The 2014 Edition preferred language standard (45 CFR 170.207(g)) requires EHR technology to be capable of representing a patient’s preferred language in accordance with ISO 639-2 “limited” by ISO 639-1. What does “limited” or “constrained” by ISO-639-1 mean? Additionally, in some instances, there are ISO 639-2 languages that have both a (B) bibliographic code and (T) terminology code.... Read more.

  • Will ONC immediately enforce the new provisions in the Principles of Proper Conduct for ONC-ACBs (45 C.F.R. § 170.523) that require ONC-ACBs to report test results hyperlinks to ONC as well as ensure that EHR technology developers follow “price transparency” requirements?

  • For an eligible professional using EHR technology certified to the 2011 Edition, can the definition of Certified EHR Technology be met by combining EHR technology certified for an inpatient setting with EHR technology certified for an ambulatory setting?

  • For the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs, is an eligible professional or eligible hospital limited to demonstrating meaningful use in the exact way that EHR technology was tested and certified?

  • Could an interface that transmits lab results in HL7 message format between a hospital laboratory system and a physician’s EHR (presuming that the transmissions were occurring between two different legal entities) satisfy the certification criteria related to the exchange of key clinical information in 45 CFR 170.304(i) and 45 CFR 170.306(f)?

  • Do the 2011 Edition and 2014 Edition certification criteria pertaining to electronic prescribing, which reference certain content exchange standards (e.g., NCPDP SCRIPT 10.6), require that a Complete EHR or EHR Module be capable of electronically exchanging information with only external recipients (i.e., recipients that are not part of that legal entity) according to the appropriate... Read more.