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Standards and Certification Regulations

ONC Regulations FAQs

  • 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.

  • How will compliance to the ONC Applicability Statement for Secure Health Transport standard adopted at 45 CFR 170.202(a), and included in such certification criteria as “Transitions of Care” (45 CFR 170.314(b)(1) and (2)) be tested and certified with respect to header protection specified in RFC 5751 section 3.1 (more commonly referred to as “message wrapping”)?

  • In the 2014 Edition Standards and Certification Criteria Final Rule, ONC clarified that the two new SNOMED CT codes for smoking status “light tobacco smoker” and “heavy tobacco smoker” meant, respectively, fewer than 10 cigarettes per day and greater than 10 cigarettes per day. To which code should exactly 10 cigarettes per day be attributed?