[Federal Register Volume 79, Number 53 (Wednesday, March 19, 2014)]
[Proposed Rules]
[Pages 15282-15284]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-06041]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Part 170

RIN 0991-AB92


Voluntary 2015 Edition Electronic Health Record (EHR) 
Certification Criteria; Interoperability Updates and Regulatory 
Improvements; Correction

AGENCY: Office of the National Coordinator for Health Information 
Technology (ONC), Department of Health and Human Services.

ACTION: Proposed rule; correction.

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SUMMARY: This notice makes the following corrections to the proposed 
rule that appeared in the February 26, 2014 Federal Register entitled 
``Voluntary 2015 Edition Electronic Health Record (EHR) Certification 
Criteria; Interoperability Updates and Regulatory Improvements'': 
Corrects the preamble text and gap certification table for four 
certification criteria that were omitted from the list of certification 
criteria eligible for gap certification for the 2015 Edition EHR 
certification criteria; and provides information on inactive web links 
that appear in the proposed rule.

DATES: Comments on the proposed rule published February 26, 2014, at 79 
FR 10880, continue to be accepted until no later than 5 p.m. on April 
28, 2014.

FOR FURTHER INFORMATION CONTACT: Steven Posnack, Director, Federal 
Policy Division, Office of Policy and Planning, Office of the National 
Coordinator for Health Information Technology, 202-690-7151.

SUPPLEMENTARY INFORMATION: 

I. Background

    In FR Doc. 2014-03959, the proposed rule entitled ``Voluntary 2015 
Edition Electronic Health Record (EHR) Certification Criteria; 
Interoperability Updates and Regulatory Improvements'' (79 FR 10880) 
(hereinafter referred to as the 2015 Edition proposed rule), four 2015 
Edition EHR certification criteria were omitted from the list of 
certification criteria eligible for gap certification. There are also 
inactive web links included in the preamble. These errors are 
identified and corrected in this correction notice.

II. Summary of Errors

    We define ``gap certification'' at 45 CFR 170.502 as ``the 
certification of a previously certified Complete EHR or EHR Module(s) 
to: (1) [a]ll applicable new and/or revised certification criteria 
adopted by the Secretary at subpart C of [part 170] based on the test 
results of a NVLAP-accredited testing laboratory; and (2) [a]ll other 
applicable certification criteria adopted by the Secretary at subpart C 
of [part 170] based on the test results used to previously certify the 
Complete EHR or EHR Module(s)'' (for further explanation, see 76 FR 
1307-1308). Our gap certification policy focuses on the differences 
between certification criteria that are adopted through rulemaking at 
different points in time. This allows EHR technology to be certified to 
only the differences between certification criteria editions rather 
than requiring EHR technology to be fully retested and recertified to 
certification criteria that remain ``unchanged'' from one edition to 
the next and for which previously acquired test results are sufficient. 
Under our gap certification policy, ``unchanged'' certification 
criteria (see 77 FR 54248 for further explanation) are eligible for gap 
certification, and each ONC-Authorized Certification Body (ONC-ACB) has 
discretion over whether it will provide the option of gap 
certification.
    In the 2015 Edition proposed rule, we noted whether a proposed 2015 
Edition EHR certification criterion was ``eligible'' or ``ineligible'' 
for gap certification at the beginning of each section of the preamble 
that discussed each certification criterion. We also provided a table 
that cross-walked ``unchanged'' 2015 Edition EHR certification criteria 
to the corresponding 2014 Edition EHR certification criteria (79 FR 
10916, Table 4). In the preamble section for each certification 
criterion and in the gap certification table (Table 4), we omitted four 
certification criteria that are eligible

[[Page 15283]]

for gap certification because they are ``unchanged'' based on our 
description of what constitutes an ``unchanged'' criterion. These 
criteria are:
     For the inpatient setting only Sec.  170.315(a)(2) 
Computerized provider order entry--laboratory (79 FR 10887);
     Sec.  170.315(h)(1) Transmit--Applicability Statement for 
Secure Health Transport (79 FR 10914);
     Sec.  170.315(h)(2) Transmit--Applicability Statement for 
Secure Health Transport and XDR/XDM for Direct Messaging (79 FR 10914);
     Sec.  170.315(h)(3) Transmit--SOAP Transport and Security 
Specification and XDR/XDM for Direct Messaging (79 FR 10914).

In addition, some of the web links in the preamble have become inactive 
since the proposed rule was published.

III. Correction of Errors

    In FR Doc. 2014-03959 of February 26, 2014 (79 FR 10880), make the 
following corrections:
    1. On page 10887, first column, line 15, ``Ineligible.'' is 
corrected to read ``Eligible for the inpatient setting. Ineligible for 
the ambulatory setting.''
    2. On page 10914, second column, line 24, ``Ineligible'' is 
corrected to read ``Eligible.''
    3. On page 10914, second column, line 50, ``Ineligible'' is 
corrected to read ``Eligible.''
    4. On page 10914, third column, line 12, ``Ineligible'' is 
corrected to read ``Eligible.''
    5. On page 10916, Table 4--Gap Certification Eligibility for 2015 
Edition EHR Certification Criteria is revised to read as follows:

               Table 4--Gap Certification Eligibility for 2015 Edition EHR Certification Criteria
----------------------------------------------------------------------------------------------------------------
                        2015 Edition                                             2014 Edition
----------------------------------------------------------------------------------------------------------------
                                      Title of regulation                                  Title of regulation
        Regulation section                 paragraph             Regulation section             paragraph
----------------------------------------------------------------------------------------------------------------
Sec.   170.315(a)(1).............  Computerized physician     Sec.   170.314(a)(1)....  Computerized Provider
                                    order entry--medications.                            Order Entry.
Sec.   170.315(a)(2) Inpatient     Computerized physician
 setting only.                      order entry--laboratory.
Sec.   170.315(a)(3).............  Computerized physician
                                    order entry--radiology/
                                    imaging.
Sec.   170.315(a)(4).............  Drug-drug, drug-allergy    Sec.   170.314(a)(2)....  Drug-drug, drug-allergy
                                    interaction checks.                                  interaction checks.
Sec.   170.315(a)(6).............  Vital signs, BMI, &        Sec.   170.314(a)(4)....  Vital signs, BMI, &
                                    growth charts.                                       growth charts.
Sec.   170.315(a)(7).............  Problem list.............  Sec.   170.314(a)(5)....  Problem list.
Sec.   170.315(a)(8).............  Medication list..........  Sec.   170.314(a)(6)....  Medication list.
Sec.   170.315(a)(9).............  Medication allergy list..  Sec.   170.314(a)(7)....  Medication allergy list.
Sec.   170.315(a)(12)............  Drug-formulary checks....  Sec.   170.314(a)(10)...  Drug-formulary checks.
Sec.   170.315(a)(13)............  Smoking status...........  Sec.   170.314(a)(11)...  Smoking status.
Sec.   170.315(a)(14)............  Image results............  Sec.   170.314(a)(12)...  Image results.
Sec.   170.315(a)(16)............  Patient list creation....  Sec.   170.314(a)(14)...  Patient list creation.
Sec.   170.315(a)(18)............  Electronic medication      Sec.   170.314(a)(16)...  Electronic medication
                                    administration record.                               administration record.
Sec.   170.315(a)(19)............  Advance directives.......  Sec.   170.314(a)(17)...  Advance directives.
Sec.   170.315(b)(3).............  Electronic prescribing...  Sec.   170.314(b)(3)....  Electronic prescribing.
Sec.   170.315(c)(1)-(3).........  Clinical quality measures  Sec.   170.314(c)(1)-(3)  Clinical quality
                                                                                         measures.
Sec.   170.315(d)(1).............  Authentication, access     Sec.   170.314(d)(1)....  Authentication, access
                                    control, & authorization.                            control, &
                                                                                         authorization.
Sec.   170.315(d)(3).............  Audit report(s)..........  Sec.   170.314(d)(3)....  Audit report(s).
Sec.   170.315(d)(4).............  Amendments...............  Sec.   170.314(d)(4)....  Amendments.
Sec.   170.315(d)(5).............  Automatic log-off........  Sec.   170.314(d)(5)....  Automatic log-off.
Sec.   170.315(d)(6).............  Emergency access.........  Sec.   170.314(d)(6)....  Emergency access.
Sec.   170.315(d)(7).............  End-user device            Sec.   170.314(d)(7)....  End-user device
                                    encryption.                                          encryption.
Sec.   170.315(d)(8).............  Integrity................  Sec.   170.314(d)(8)....  Integrity.
Sec.   170.315(d)(9).............  Accounting of disclosures  Sec.   170.314(d)(9)....  Accounting of
                                                                                         disclosures.
Sec.   170.315(e)(3).............  Secure messaging.........  Sec.   170.314(e)(3)....  Secure messaging.
Sec.   170.315(f)(1).............  Immunization information.  Sec.   170.314(f)(1)....  Immunization
                                                                                         information.
Sec.   170.315(f)(3) #...........  Transmission to public     Sec.   170.314(f)(3) #..  Transmission to public
                                    health agencies--                                    health agencies--
                                    syndromic surveillance.                              syndromic surveillance
Sec.   170.315(f)(5).............  Cancer case information..  Sec.   170.314(f)(5)....  Cancer case information.
Sec.   170.315(g)(4).............  Quality management system  Sec.   170.314(g)(4)....  Quality management
                                                                                         system.
Sec.   170.315(h)(1).............  Transmit--Applicability    Sec.                      Transitions of care--
                                    Statement for Secure       170.314(b)(2)(ii)(A).     create and transmit
                                    Health Transport.                                    transition of care/
                                                                                         referral summaries.
Sec.   170.315(h)(2).............  Transmit--Applicability    Sec.                      Transitions of care--
                                    Statement for Secure       170.314(b)(2)(ii)(B).     create and transmit
                                    Health Transport and XDR/                            transition of care/
                                    XDM for Direct Messaging                             referral summaries.
Sec.   170.315(h)(3).............  Transmit--SOAP Transport   Sec.                      Transitions of care--
                                    and Security               170.314(b)(2)(ii)(C).     create and transmit
                                    Specification and XDR/                               transition of care/
                                    XDM for Direct Messaging                             referral summaries.
----------------------------------------------------------------------------------------------------------------
# If certified to the revised 2014 Edition version of this criterion after the effective date of the 2015
  Edition Final Rule. For further information on this distinction, please see the gap certification discussion
  under the ``Transmission to Public Health Agencies--Syndromic Surveillance'' in section III.A of this
  preamble.


[[Page 15284]]

Inactive Web Links

    Inactive web links included in the 2015 Edition proposed rule are 
identified on ONC's Standards and Certification Regulations page with 
an explanation and/or corrected link (http:[sol][sol]www.healthit.gov/
policy-researchers-implementers/standards-and-certification-
regulations).

    Dated: March 13, 2014.
Jennifer M. Cannistra,
Executive Secretary to the Department.
[FR Doc. 2014-06041 Filed 3-17-14; 11:15 am]
BILLING CODE 4150-45-P