Clarifications:
- For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective 8: Public Health and Clinical Data Registry Reporting.
- Any health IT can be certified to this criterion if it can meet all the requirements of the criterion, which include context exchange and vocabulary standards. There is no specified transport standard or mechanism required for this criterion. Consequently, any additional products used to facilitate immunization data submission in the manner required by the public health agency are not required to be included as part of the certified EHR technology (CEHRT) implemented by eligible professionals, eligible hospitals, or critical access hospitals for those CMS programs requiring the use of CEHRT. Please consult the Centers for Medicare & Medicaid Services (CMS) regulations for more specific requirements for meeting the CEHRT definition. [see also 80 FR 62663]
- While no transport standard is required for this criterion, an expert panel convened by the CDC and the American Immunization Registry Association (AIRA) has recommended a SOAP-based standard for transport of immunization data. Developers have the discretion to decide which transport standard(s) to implement. [see also 77 FR 54240]
- CDC issued an addendum to the HL7® 2.5.1 Implementation Guide (IG) for Immunization Messaging (IM), Release 1.5. The addendum consolidates the IG IM Release 1.5 information that clarifies the conformance requirements, but does not specify additional substantive requirements. The addendum was adopted with the IG IM Release 1.5 for purposes of testing and certification to this criterion. [80 FR 62663]
- The criterion is not intended to specify when submissions should be made or the periodicity of the submissions. Consequently, submitting batch files to an immunization registry, provided that they are formatted according to the adopted standards referenced by this certification criterion, is not prohibited by this certification criterion and would be acceptable.
- The process for submitting immunization data often differs between public health agencies. ONC recommends developers work with the state or local immunization registry for guidance on how to submit the immunization data.
- ONC provides the following object identifiers (OIDs) to assist developers in the proper identification and exchange of health information coded to certain vocabulary standards.
- HL7® Standard Code Set CVX – Vaccine Administered OID: 2.16.840.1.113883.12.292
- National Drug Code Directory OID: 2.16.840.1.113883.6.69 [80 FR 62612]
- Health IT Modules can present for certification to a more recent version of the CVX – Vaccines Administered and National Drug Code Directory – Vaccine Codes code sets than outlined in regulation per ONC’s policy that permits certification to a more recent version of certain vocabulary standards.
- NIST published a “NIST Clarifications and Validation Guidelines” document, which can be used as a resource during validation testing for this criterion. It is available under “User Documentation” on the NIST Immunization Test Suite page and labeled “NIST Clarifications and Validation Guidelines.”
