Last updated: 9/21/10 Page 3 of 20
In the “Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” Final Rule published on July28, 2010, the Secretary adopted the following implementation specifications at 45 CFR170.205(d)(2) for HL7 2.5.1 – Public Health Information Network HL7 Version 2.5 MessageStructure Specification for National Condition Reporting Final Version 1.0 and Errata and Clarifications National Notification Message Structural Specification. We believe that theseimplementation specifications may have been adopted in error because they only providedirection to public health agencies on how to report to the Centers for Disease Control and Prevention (CDC). Therefore, their adoption does not appear to either provide the appropriateor requisite implementation guidance for the adopted standard, HL7 2.5.1, or more importantly,to enable the user to “electronically record, modify, retrieve, and submit syndrome-based publichealth surveillance information…,” as required by the adopted certification criterion, 45 CFR170.302(l). Please clarify whether these implementation specifications are appropriate for theintended capability specified by the public health surveillance certification criterion at 45 CFR170.302(l)?
We have received numerous requests seeking clarification regarding these adoptedimplementation specifications. Based on additional discussions with various stakeholders, inputfrom public health agencies, and the CDC, and after further review of the implementationspecifications, we have determined that these implementation specifications were adopted inerror. As questioners correctly point out, the implementation specifications are not appropriatefor the intended capability specified by the adopted certification criterion. They provideguidance to public health agencies on the structure and methodology for using HL7 2.5.1 toreport Nationally Notifiable Conditions to CDC and do not provide additional clarity for howEHR technology would need to be designed to implement the adopted standard or enablecompliance with the capability identified in the certification criterion adopted at 45 CFR170.302(l).Accordingly, we anticipate issuing an interim final rule in the near future to remove theimplementation specifications adopted at 45 CFR 170.205(d)(2). We also intend to issuecompliance guidance to ONC-Authorized Testing and Certification Bodies to clarify how theymay continue to test and certify EHR technology in accordance with the related certificationcriterion until publication of the interim final rule removing “Public Health Information Network HL7 Version 2.5 Message Structure Specification for National Condition Reporting FinalVersion 1.0 and Errata and Clarifications National Notification Message StructuralSpecification.”