ONC issues interim final rule to correct 'erroneous' EHR specs

The Department of Health and Human Services (HHS) Office of the National Coordinator for Health IT (ONC) has issued an interim final rule with a request for comment to remove the EHR implementation specifications related to public health surveillance.

The interim final rule, which was published in the Federal Register on Oct. 13, became effective the same day. Written or electronic comments will be accepted until Nov. 12.

“In the Standards and Certification Criteria Final Rule, we 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,” ONC stated. “Additionally, in response to public comment on the interim final rule published in January 2010, we adopted in the Standards and Certification Criteria Final Rule the following implementation specifications for HL7 2.5.1: Public Health Information Network HL7 Version 2.5 Message Structure Specification for National Condition Reporting Final Version 1.0 and the Errata and Clarifications National Notification Message Structural Specification. … We did not, however, adopt at that time implementation specifications for HL7 2.3.1.”

Since publication of the Standards and Certification Criteria Final Rule, some stakeholders had indicated these implementation specifications do not appear to be appropriate for implementing the adopted standard, HL7 2.5.1 for public health surveillance purposes, the document states.

“After further review of the implementation specifications and consultation with the Centers for Disease Control and Prevention (CDC), we have determined that these implementation specifications were adopted in error.”

The adopted implementation specifications provide direction 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 (HL7 2.5.1) or enable compliance with the capability identified in the certification criterion adopted,” ONC stated.

“Therefore, their adoption neither provides the appropriate or requisite implementation capability for the adopted standard, HL7 2.5.1, nor, more importantly, would enable the user to ‘electronically record, modify, retrieve, and submit syndrome-based public health surveillance information,’ as required by the adopted certification criterion.

“We have also heard from ONC-ATCBs as well as EHR technology developers that the erroneous adoption of these implementation specifications creates significant ambiguity and concern regarding whether these implementation specifications must be used for testing and certification.

“We understand further that while the erroneously adopted implementation specifications could be used to specify the structure and methodology for using HL7 2.5.1, their purpose is to facilitate the electronic exchange of de-identified Nationally Notifiable Conditions for notifiable disease reporting, which would not fulfill the fundamental requirements of syndromic surveillance. In contrast to notifiable disease reporting, where only data on patients with a notifiable disease diagnosis is sent to a public health agency, syndromic surveillance requires data from all patients that were seen in a healthcare setting. Moreover, syndromic surveillance requires data elements that the adopted implementation specifications do not address,” including a patient’s chief complaint, date/time of visit, severity of illness, specific indicators and age.

"The adoption of these implementation specifications also presents an unnecessary obstacle for EHR technology developers, who are currently faced with the dilemma of implementing HL7 2.3.1 (even though their customers may need HL7 2.5.1 to report to their state public health agency), or alternatively, HL7 2.5.1 according to the inappropriate implementation specifications, or unnecessarily to both standards, in order to seek certification. We believe that each of these alternatives places an unnecessary and unwarranted burden on EHR technology developers.”

Therefore, ONC said it is revising the certification final rule to remove these particular adopted implementation specifications, and also is removing the text “(and applicable implementation specifications)” to ease the unnecessary burden on ONC-ATCBs.

All comments received within the comment period will be posted at http://www.regulations.gov.

The complete text of the IFR can be found here.