FINAL RULE Issued: Temporary Certification Program for Health IT
Published in Federal Register on June 24, 2010
AGENCY: Office of the National Coordinator for Health Information
Technology, Department of Health and Human Services.
45 CFR Part 170
“Establishment of the Temporary Certification Program for Health
Information Technology; Final Rule” was published in the Federal Register on June 24, 2010, with excerpts below and links to html and PDF versions. ONC now estimates there may be as many as five ONC-ATCBs, up from the three estimated in the interim rule and that they will certify ”at most, approximately 205 Complete EHRs and/or EHR Modules under the temporary certification program.” Organizations for ATCB status may start applying July 1, 2010.
“SUMMARY: This final rule establishes a temporary certification program
for the purposes of testing and certifying health information technology. This final rule is established under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the Public Health Service Act (PHSA), as added by the Health Information Technology for Economic and Clinical Health (HITECH) Act. The National Coordinator will utilize the temporary certification program to authorize organizations to test and certify Complete Electronic Health Records (EHRs) and/or EHR Modules, thereby making Certified EHR Technology available prior to the date on which health care providers seeking incentive payments available under the Medicare and Medicaid EHR Incentive Programs may begin demonstrating meaningful use of Certified EHR Technology.”
II. Overview of the Temporary Certification Program
“The temporary certification program provides a process by which an organization or organizations may become an ONC-Authorized Testing and Certification Body (ONC-ATCB) and be authorized by the National Coordinator to perform the testing and certification of Complete EHRs and/or EHR Modules.
“Under the temporary certification program, the National Coordinator will accept applications for ONC-ATCB status at any time. In order to become an ONC-ATCB, an organization or organizations must submit an application to the National Coordinator to demonstrate its competency and ability to test and certify Complete EHRs and/or EHR Modules. An
applicant will need to be able to both test and certify Complete EHRs and/or EHR Modules. We anticipate that only a few organizations will qualify and become ONC-ATCBs under the temporary certification program. These organizations will be required to remain in good standing by adhering to the Principles of Proper Conduct for ONC-ATCBs. ONC-ATCBs will also be required to follow the conditions and requirements applicable to the testing and certification of Complete EHRs and/or EHR Modules as specified in this final rule. The temporary certification program will sunset on December 31, 2011, or if the permanent certification program is not fully constituted at that time, then upon a subsequent date that is determined to be appropriate by the National Coordinator.”
Analysis and Response to Public Comments: Overview
”This section discusses the 84 timely received comments on the Proposed Rule’s proposed temporary certification program and our responses. We have structured this section of the final rule based on the proposed regulatory sections of the temporary certification program and discuss each regulatory section sequentially. For each discussion of the regulatory provision, we first restate or paraphrase the provision as proposed in the Proposed Rule as well as identify any
correlated issues for which we sought public comment. Second, we summarize the comments received. Lastly, we provide our response to the comments, including stating whether we will finalize the provision as proposed in the Proposed Rule or modify the proposed provision in
response to public comment. Comments on the incorporation of the “recognized certification body” process, “grandfathering” of certifications, the concept of “self-developed,” validity and expiration of certifications, general comments, and comments beyond the scope of this final rule are discussed towards the end of the preamble.”
Several Excerpts About Increase Estimate to Five ONC-ATCBs
Different Levels of Preparedness
“As stated in the collection of information section, we estimate that each ONC-ATCB will incur the same burden and, assuming that there are 5 ONC-ATCBs, will test and certify, at most, approximately 205 Complete EHRs and/or EHR Modules under the temporary certification program.”
“In the Proposed Rule, we stated that we anticipated that there would be no more than 3 applicants for ONC-ATCB status. Based on the comments received, we now believe that there may be up to 5 applicants for ONC-ATCB status. In addition, we believe that up to 2 of these applicants will not have the level of preparedness that we originally estimated for all potential applicants for ONC-ATCB status.”
“In the Proposed Rule, we stated that we anticipated that there would be no more than 3 applicants for ONC-ATCB status. Based on the comments received, we now believe that there may be up to 5 applicants for ONC-ATCB status. In addition, we believe that up to 2 of these applicants will not have the level of preparedness that we originally estimated for all potential applicants for ONC-ATCB status.”
“As part of the temporary certification program, an applicant will be required to submit an application and complete a proficiency exam. We do not believe that there will be an appreciable difference in the time commitment an applicant for ONC-ATCB status will have to make based on the type of authorization it seeks (i.e., we believe the application process and time commitment will be the same for applicants seeking authorization to conduct the testing and certification of
either Complete EHRs or EHR Modules). We do, however, believe that there will be a distinction between applicants based on their level of preparedness. For the purposes of estimating applicant costs, we have divided applicants into two categories, “conformant applicants” and
“partially conformant applicants.” We still believe, after reviewing comments, that there will be three “conformant applicants” and that these applicants will have reviewed the relevant requirements found in the ISO/IEC standards and will have a majority, if not all, of the documentation requested in the application already developed and available before applying for ONC-ATCB status. Therefore, with the exception of completing a proficiency examination, we believe “conformant applicants” will only spend time collecting and assembling already developed information to submit with their application. Conversely, we believe that there will be up to two “partially conformant applicants” and that these applicants will spend significantly more time establishing their compliance with Guide 65 and ISO 17025.”
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For several interesting points in the rule, see John Halamka’s June 25, 2010 post in his Life as a CIO blog. He credits Robin Raiford for bookmarking the site, to whom–in serial form–this blog give credit as well.
