Source: http://thefederalregister.com/2010/10/13/2010-25683.html
Timestamp: 2018-09-22 20:21:19
Document Index: 336694626

Matched Legal Cases: ['art 170', 'art 170', 'ART 170', 'art 170', '§ 170', '§ 170', '§ 170', '§ 170']

Federal Register | Health Information Technology: Revisions to Initial Set of St
RIN 0991-AB76
SUMMARY: The Department of Health and Human Services (HHS) is issuing this interim final rule with a request for comment to remove the implementation specifications related to public health surveillance.
DATES: Effective Date:This interim final rule is effective October 13, 2010.
Comment Date:To be assured consideration, written or electronic comments must be received at one of the addresses provided below, no later than 5 p.m. on November 12, 2010.
ADDRESSES: *Federal eRulemaking Portal:Follow the instructions for submitting comments. Attachments should be in Microsoft Word, WordPerfect, or Excel; however, we prefer Microsoft Word.http://www.regulations.gov.
*Regular, Express, or Overnight Mail:Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Attention: Steven Posnack, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave., SW., Washington, DC 20201. Please submit one original and two copies.
*Hand Delivery or Courier:Office of the National Coordinator for Health Information Technology, Attention: Steven Posnack, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave., SW., Washington, DC 20201. Please submit one original and two copies. (Because access to the interior of the Hubert H. Humphrey Building is not readily available to persons without federal government identification, commenters are encouraged to leave their comments in the mail drop slots located in the main lobby of the building.)
Inspection of Public Comments:All comments received before the close of the comment period will be available for public inspection, including any personally identifiable or confidential business information that is included in a comment. Please do not include anything in your comment submission that you do not wish to share with the general public. Such information includes, but is not limited to: A person's social security number; date of birth; driver's license number; state identification number or foreign country equivalent; passport number; financial account number; credit or debit card number; any personal health information; or any business information that could be considered to be proprietary. We will post all comments received before the close of the comment period athttp://www.regulations.gov.
Docket:For access to the docket to read background documents or comments received, go tohttp://www.regulations.govor U.S. Department of Health and Human Services, Office of the National Coordinator for Health Information Technology, Hubert H. Humphrey Building, Suite 729D, 200 Independence Ave., SW., Washington, DC 20201 (call ahead to the contact listed below to arrange for inspection).
SUPPLEMENTARY INFORMATION: Acronyms ARRAAmerican Recovery and Reinvestment Act of 2009 CDCCenters for Disease Control and Prevention CFRCode of Federal Regulations EHRElectronic Health Record HHSDepartment of Health and Human Services HITHealth Information Technology HITECHHealth Information Technology for Economic and Clinical Health HL7Health Level Seven NAICSNorth American Industry Classification System OMBOffice of Management and Budget ONCOffice of the National Coordinator for Health Information Technology ONC-ATCBONC-Authorized Testing and Certification Body PHSAPublic Health Service Act RFARegulatory Flexibility Act RIARegulatory Impact Analysis UMRAUnfunded Mandates Reform Act of 1995 Table of Contents I. Background A. Legislative History B. Regulatory History 1. Initial Set of Standards, Implementation Specifications, and Certification Criteria for EHR Technology; Interim Final Rule 2. Initial Set of Standards, Implementation Specifications, and Certification Criteria for EHR Technology; Final Rule 3. Proposed Establishment of Certification Programs for Health Information Technology; Proposed Rule 4. Temporary Certification Program; Final Rule II. Discussion of the Interim Final Rule A. Public Health Surveillance Implementation Specifications B. Waiver of Proposed Rulemaking and Delay in Effective Date III. Response to Comments IV. Collection of Information Requirements V. Regulatory Impact Statement Regulation Text I. Background A. Legislative History
B. Regulatory History 1. Initial Set of Standards, Implementation Specifications, and Certification Criteria for EHR Technology; Interim Final Rule
On January 13, 2010, HHS published in theFederal Registeran interim final rule with a request for comment, which adopted an initial set of standards, implementation specifications, and certification criteria (75 FR 2014). The certification criteria adopted in that interim final rule established the required capabilities and specified the related standards and implementation specifications that certified electronic health record (EHR) technology would need to include to, at a minimum, support the achievement of meaningful use Stage 1 as proposed by CMS for eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs. (For consistency with subsequent regulatory changes, hereafter, references to “eligible hospitals” shall mean “eligible hospitals and/or critical access hospitals”.)
On July 28, 2010, HHS published in theFederal Registera final rule (75 FR 44590) to complete the Secretary's adoption of the initial set of standards, implementation specifications, and certification criteria, and to more closely align such standards, implementation specifications, and certification criteria with final meaningful use Stage 1 objectives and measures (the “Standards and Certification Criteria Final Rule”). The certification criteria adopted in that final rule establish the required capabilities and specify the related standards and implementation specifications that certified EHR technology will need to include to, at a minimum, support the achievement of meaningful use Stage 1 by eligible professionals and eligible hospitals under the Medicare and Medicaid EHR Incentive Programs. Complete EHRs and EHR Modules will be tested and certified according to adopted certification criteria to ensure that they have properly implemented adopted standards and implementation specifications and otherwise comply with the adopted certification criteria.
On March 10, 2010, under the authority granted to the National Coordinator for Health Information Technology (the National Coordinator) by section 3001(c)(5) of the PHSA as added by the HITECH Act, HHS published in theFederal Register(75 FR 11328) a rule proposing the establishment of two certification programs for purposes of testing and certifying health information technology. The first proposal would establish a temporary certification program whereby the National Coordinator would authorize organizations to test and certify Complete EHRs and/or EHR Modules. The second proposal would establish a permanent certification program to replace the temporary certification program. The permanent certification program included proposals that would separate the responsibilities for performing testing and certification, introduce accreditation requirements, establish requirements for certification bodies authorized by the National Coordinator related to the surveillance of Certified EHR Technology, and would include the potential for certification bodies authorized by the National Coordinator to certify other types of health information technology besides Complete EHRs and EHR Modules.
On June 24, 2010, HHS published in theFederal Registera final rule (75 FR 36158) establishing the temporary certification program for HIT (Temporary Certification Program). The Temporary Certification Program, established under the authority granted to the National Coordinator by section 3001(c)(5) of the PHSA, sets forth the process the National Coordinator will utilize to authorize organizations (ONC-Authorized Testing and Certification Bodies (ONC-ATCBs)) to test and certify Complete EHRs and/or EHR Modules to the certification criteria adopted by the Secretary in the Standards and Certification Criteria Final Rule. Once tested and certified, a Complete EHR or a combination of EHR Modules can be adopted by an eligible professional or eligible hospital to meet the definition of Certified EHR Technology as specified at 45 CFR 170.102 and used to help qualify for incentive payments under the Medicare and Medicaid EHR Incentive Programs.
II. Discussion of the Interim Final Rule A. Public Health Surveillance Implementation Specifications
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. (45 CFR 170.205(d)) Additionally, in response to public comment on the interim final rule published 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 MessageStructure Specification for National Condition Reporting Final Version 1.0 and the Errata and Clarifications National Notification Message Structural Specification. (45 CFR 170.205(d)(2)) We did not, however, adopt at that time implementation specifications for HL7 2.3.1.
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. They correctly point out that because these implementation specifications are inappropriate for the adopted standard and would likely frustrate achieving the capability specified in the adopted certification criterion at 45 CFR 170.302(l), testing and certifying in accordance with them would be wasteful and unproductive. 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 health care 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 (e.g.,patient's disposition status), specific indicators (e.g.,pulse oximetry, measured temperature), and age.
We ordinarily publish a notice of proposed rulemaking in theFederal Registerto provide a period for public comment before the provisions of the rule take effect in accordance with section 553(b) of the Administrative Procedure Act (APA) (5 U.S.C.553(b)). We also ordinarily provide a 30-day delay in the effective date of the provisions of a rule in accordance with section 553(d) of the APA (5 U.S.C. 553(d)). However, we can waive both the notice and comment procedure and the 30-day delay in effective date if the Secretary finds for good cause that a notice and comment procedure and a 30-day delay are impracticable, unnecessary, or contrary to the public interest, and incorporates a statement of the finding and the reasons in the final notice or rule that is issued.
In this regulatory framework, private organizations are provided the opportunity to apply to the National Coordinator for authorization as an ONC-Authorized Testing and Certification Body (ONC-ATCB). Once an organization is granted ONC-ATCB status and obtains authorization from the National Coordinator to test and certify Complete EHRs and/or EHR Modules, it will be subject, depending on the scope of its authorization, to the requirements specified at 45 CFR 170.445 (Complete EHR testing and certification) and/or 45 CFR 170.450 (EHR Module testing and certification). These provisions require ONC-ATCBs to test and certify Complete EHRs and/or EHR Modules to all applicable certification criteria adopted by the Secretary at subpart C of part 170. Consequently, an ONC-ATCB's failure to adhere to the testing and certification requirements of 170.445 and/or 170.450 could subject that ONC-ATCB to adverse action bythe National Coordinator in accordance with 45 CFR 170.465 (Revocation of authorized testing and certification body status). Because ONC-ATCBs are required to test and certify Complete EHRs and/or EHR Modules in accordance with all applicable certification criteria, including 45 CFR 170.302(l), and 45 CFR 170.302(l) requires that a Complete EHR or EHR Module would need to perform the specified capabilities in accordance with, in certain scenarios, the erroneously adopted implementation specification, the Complete EHR or EHR Module certified in accordance with those provisions would not be capable of fulfilling the fundamental requirements of syndromic surveillance, as explained above. Consequently, a Complete EHR or EHR Module that was developed in accordance with HL7 Version 2.5.1 and would otherwise meet all other applicable certification criteria could not be successfully certified until the removal of the implementation specifications adopted in error. We therefore believe that if left unchanged the erroneous adoption of these implementation specifications would significantly and adversely impact the ability of ONC-ATCBs from issuing, and EHR technology developers from receiving, certifications in a timely manner.
Because of the number of public comments we normally receive onFederal Registerdocuments, we are not able to acknowledge or respond to them individually. We will consider all comments we receive by the date and time specified in theDATESsection of this preamble, and, when we proceed with a subsequent document, we will respond to the comments in the preamble to that document.
We have examined the impacts of this interim final rule with comment as required by Executive Order 12866 on Regulatory Planning and Review (September 30, 1993, as further amended), the Regulatory Flexibility Act (RFA) (5 U.S.C. 601et seq.), section 202 of the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 1532) (UMRA), Executive Order 13132 on Federalism (August 4, 1999), and the Congressional Review Act (5 U.S.C. 804(2)).
For the reasons set forth in the preamble, 45 CFR subtitle A, subchapter D, part 170, is amended as follows: PART 170—HEALTH INFORMATION TECHNOLOGY STANDARDS IMPLEMENTATION SPECIFICATIONS, AND CERTIFICATION CRITERIA AND CERTIFICATION PROGRAMS FOR HEALTH INFORMATION TECHNOLOGY 1. The authority citation for part 170 continues to read as follows: Authority:
2. Section 170.205 is amended by revising paragraph (d)(2) to read as follows:
(2)Standard.HL7 2.5.1 (incorporated by reference in § 170.299).
3. Section 170.299 is amended by revising paragraph (g) to read as follows:
4. Section 170.302 is amended by revising paragraph (l) to read as follows:
§ 170.302 General certification criteria for Complete EHRs or EHR Modules.
(l)Public health surveillance.Electronically record, modify, retrieve, and submit syndrome-based public health surveillance information in accordance with the standard specified in § 170.205(d)(1) or § 170.205(d)(2).
Dated: October 6, 2010. Kathleen Sebelius, Secretary.