ONC Issues Standards and Certification Final Rule Correction for EMRs
The Office of the National Coordinator for Health Information Technology (ONC) published an interim final rule in the Oct. 13 Federal Register to correct a recently detected error in the “Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology” Final Rule, published in the July 28 Federal Register.
In the final rule, the secretary adopted two content exchange standards for electronic submission to public health agencies for surveillance and reporting: Health Level Seven (HL7) versions 2.3.1 and 2.5.1. Since then, the ONC has received numerous requests for clarification regarding the adopted implementation specifications.
“After further review of the implementation specifications, we have determined that these implementation specifications were adopted in error. As questioners correctly point out, the implementation specifications are not appropriate for the intended capability specified by the adopted certification criterion. They provide guidance to public health agencies on the structure and methodology for using HL7 2.5.1 to report Nationally Notifiable Conditions to CDC and do not provide additional clarity for how EHR technology would need to be designed to implement the adopted standard or enable compliance with the capability identified in the certification criterion adopted at 45 CFR 170.302(l),” the ONC said in response to a question posted on its FAQ webpage.
The interim final rule with comment period, “Health Information Technology: Revisions to Initial Set of Standards, Implementation Specifications, and Certification Criteria for Electronic Health Record Technology,” removes the implementation specifications adopted at 45 CFR 170.205(d)(2). The ONC also intends to issue compliance guidance to ONC-Authorized Testing and Certification Bodies (ONC-ATCBs) to clarify how they may continue to test and certify EHR technology in accordance with the related certification criterion.
Written and electronic comments must be received by the ONC no later than Nov. 12.