Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing; Correction, 8546-8549 [2024-02519]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Office of the Secretary

[Federal Register Volume 89, Number 27 (Thursday, February 8, 2024)]
[Rules and Regulations]
[Pages 8546-8549]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-02519]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Parts 170 and 171

RIN 0955-AA03


Health Data, Technology, and Interoperability: Certification 
Program Updates, Algorithm Transparency, and Information Sharing; 
Correction

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

ACTION: Final rule; correction.

-----------------------------------------------------------------------

SUMMARY: This document corrects technical and typographical errors in 
the final rule entitled, ``Health Data, Technology, and 
Interoperability: Certification Program Updates, Algorithm 
Transparency, and Information Sharing'' that was published in the 
Federal Register on January 9, 2024, and has a stated effective of 
February 8, 2024.

DATES: As of February 8, 2024 the effective date of the final rule 
published on January 9, 2024 (89 FR 1192, FR 2023-28857), is corrected 
to March 11, 2024. The corrections in this document are effective on 
March 11, 2024.

FOR FURTHER INFORMATION CONTACT: Kate Tipping, Office of Policy, 
National Coordinator for Health Information Technology, 202-690-7151.

SUPPLEMENTARY INFORMATION:

I. Background

    In Federal Register document 2023-28857 (89 FR 1192) final rule 
entitled ``Health Data, Technology, and Interoperability: Certification 
Program Updates, Algorithm Transparency, and Information Sharing'' 
(HTI-1) (hereinafter referred to as the HTI-1 Final Rule), we 
identified certain technical and typographical errors following 
publication in the Federal Register on January 9, 2024. We summarize 
and correct these errors in the ``Summary of Errors'' and ``Corrections 
of Errors'' sections below.

[[Page 8547]]

II. Summary of Errors

A. Preamble Errors--DATES Section--Effective Dates of the Rule

    On page 1192, first column, bottom of the page, we erroneously 
included an effective date of 30 days after publication of the final 
rule in the Federal Register, when it should have been 60 days after 
publication of the final rule in the Federal Register. The 
Congressional Review Act (CRA) requires a 60-day delay in the effective 
date of a major rule from the date of publication in the Federal 
Register or receipt of the rule by Congress, whichever is later (5 
U.S.C. 801(a)(3)(A)). The rule was published in the Federal Register on 
January 9, 2024, and it has a stated effective date of February 8, 2024 
(89 FR 1192). The Congressional Record reflects that House and Senate 
received the HTI-1 Final Rule on January 10, 2024 (See 170 Cong. Rec. 
H105 (Jan. 11, 2024). Accordingly, we are correcting the effective date 
to March 11, 2024.
    Also on page 1192, first column, bottom of page, the incorporation 
by reference approval date should be the effective date of the final 
rule. The HTI-1 Final Rule stated that the incorporation by reference 
approval date was February 8, 2024 (89 FR 1192). Because we 
inadvertently included an erroneous effective date, the incorporation 
by reference approval date must also be corrected to March 11, 2024.

B. Preamble Errors--Part 171

1. Infeasibility Exception--Third Party Seeking Modification Use
    On page 1376, third column, middle of the page, we transposed the 
numbers and added an extra zero in a reference to the Code of Federal 
Regulations (CFR). We inadvertently added 54 CFR part 1600. We included 
the correct cross-reference to the regulatory text in a parenthetical. 
However, the reference to 54 CFR part 1600 should read ``45 CFR part 
160.''

C. Regulation Text Errors--Part 170--Health Information Technology 
Standards, Implementation Specifications, and Certification Criteria 
and Certification Programs for Health Information Technology

1. ONC Certification Criteria for Health IT
    On page 1429, third column, top of page, we inadvertently omitted 
amendatory text for Sec.  170.315. Within amendatory instruction 9 for 
Sec.  170.315, sub-instructions c. and f., we neglected to specify 
``introductory text'' for three references. Within sub-instruction c., 
paragraph (b)(2)(iii)(D) should read ``(b)(2)(iii)(D) introductory 
text'' and the reference to paragraph (b)(3) should read 
``(b)(3)(ii)(A) introductory text.'' Within sub-instruction f., 
paragraphs (e)(1)(i)(B)(1) and (2) should read ``(e)(1)(i)(B)(1) and 
(2) introductory text.'' Also on page 1429, third column, top of page, 
we inadvertently included an incorrect reference and omitted an 
italicization in sub-instruction h. The reference to paragraphs 
(g)(10)(v)(A)(1)(i) and (ii), (g)(10)(v)(A)(1)(B), (g)(10)(v)(A)(2)(i) 
and (ii) should read ``(g)(10)(v)(A)(1)(i) and (ii), 
(g)(10)(v)(A)(2)(i) and (ii), (g)(10)(v)(A)(B)''.
a. Transitions of Care
    On page 1430, middle column, top half of the page, we inadvertently 
referenced Sec.  170.207(n)(2) in Sec.  170.315(b)(1)(iii)(G)(3), Sex 
constraint. In the HTI-1 Proposed Rule (88 FR 23766), we proposed to 
remove the requirement in Sec.  170.315(a)(5)(i)(C) and Sec.  
170.315(b)(1)(iii)(G)(3) to code Sex according to the adopted value 
sets of HL7 Version 3 Value Sets for AdministrativeGender and 
NullFlavor as referenced in the value sets in Sec.  170.207(n)(1). We 
proposed instead to permit coding according to either the adopted value 
sets of HL7 Version 3 Value Sets for AdministrativeGender and 
NullFlavor as referenced in the value sets in Sec.  170.207(n)(1) until 
December 31, 2025, or in accordance with the standard in proposed Sec.  
170.207(n)(2) (89 FR 1220).
    In the HTI-1 Proposed Rule, we also proposed to update Sec.  
170.315(c)(4)(iii)(G) introductory text and (b)(1)(iii)(G)(3) to 
reference Sec.  170.207(n)(2) (89 FR 1225). In the HTI-1 Final Rule, we 
noted that, in the HTI-1 Proposed Rule regulation text in Sec.  
170.315(b)(1)(iii)(G)(3), we inadvertently included a reference to 
Sec.  170.213 (88 FR 23909) instead of including Sec.  170.207(n)(2) as 
discussed in our proposal (88 FR 23821). We finalized Sec.  
170.315(b)(1)(iii)(G)(3) without the proposed reference to Sec.  
170.213. We stated that we finalized Sec.  170.315(b)(1)(iii)(G)(3) to 
include a reference to Sec.  170.207(n)(2) to correct this error and to 
reference the most recent version of SNOMED CT U.S. Edition available 
at the time of this rule (89 FR 1225). In the HTI-1 Final Rule, we also 
finalized our proposal that the adoption of the code sets referenced in 
Sec.  170.207(n)(1) will expire on January 1, 2026, and that health IT 
developers can continue to use the specific codes in the current 
terminology standard through December 31, 2025, in order to provide 
adequate time for Health IT Modules certified to particular 
certification criteria to transition to the updated terminology 
standards (89 FR 1198). In the HTI-1 Final Rule, we finalized the 
timelines for the respective standards updates as proposed and stated 
our intent to allow the use of the standards for the criterion 
consistent with those dates (89 FR 1225). We further stated that 
developers of certified health IT with Health IT Modules certified to 
criteria that reference Sec.  170.207(n)(1) would be required to update 
those Health IT Modules to Sec.  170.207(n)(2) and provide them to 
customers by January 1, 2026 (89 FR 1298). Therefore, in this final 
rule correction we have added a reference to Sec.  170.207(n)(1) up to 
and including December 31, 2025, in Sec.  170.315(b)(1)(iii)(G)(3). 
Referencing Sec.  170.207(n)(1) in this manner is consistent with the 
rationale that Sex be coded according to the adopted value sets in 
Sec.  170.207(n)(1) until January 1, 2026; or coded according to the 
adopted standards in Sec.  170.207(n)(2), and consistent with what we 
proposed (88 FR 23766) and intended to finalize.
b. Electronic Prescribing
    On page 1430, third column, top of page, in Sec.  170.315(b)(3) we 
also inadvertently omitted five asterisks after paragraph 
(b)(3)(ii)(A). The text in (b)(3) should remain unchanged except for 
the revisions in (b)(3)(ii)(A).
2. Real World Testing
    On page 1434, first column, middle of page, in amendatory 
instruction 12 for Sec.  170.405, we neglected to specify 
``introductory text'' after paragraph (b)(2)(ii). The correct reference 
should say ``(b)(2)(ii) introductory text.''
3. Discontinuation of Year Themed Editions
    In the HTI-1 Final Rule, we finalized the discontinuation of year 
themed editions for ONC Certification Criteria for Health IT and 
renamed all certification criteria within the Program simply as ``ONC 
Certification Criteria for Health IT'' (89 FR 1206). In the HTI-1 
Proposed Rule (88 FR 23912, 23914), we proposed to remove and replace 
references to the 2015 Edition in Sec. Sec.  170.406(a)(5) and 
170.550(h)(1). In the HTI-1 Final Rule, we finalized the removal of 
year themed Editions as proposed and stated that we ``replaced 
references to the `2015 Edition' in Sec. Sec.  170.102, 170.405, 
170.406, 170.523, 170.524, and 170.550 (89 FR 1207). However, when 
removing the references to the 2015 Edition in the regulation text, we 
neglected to remove and replace the reference to the 2015 Edition

[[Page 8548]]

in Sec. Sec.  170.406(a)(5) and 170.550(h)(1). Because year themed 
editions have been discontinued, including the 2015 Edition, and 
because we proposed to remove and replace these references and stated 
that we finalized as proposed, in this final rule correction we have 
corrected Sec. Sec.  170.406(a)(5) and 170.550(h)(1) to replace the 
references to the 2015 Edition with references to ONC Certification 
Criteria for Health IT.

III. Waiver of Proposed Rulemaking, Comment Period, and Delay in 
Effective Date

    Under 5 U.S.C. 553(b) of the Administrative Procedure Act (APA), 
the agency is required to publish a notice of the proposed rulemaking 
in the Federal Register before the provisions of a rule take effect. In 
addition, section 553(d) of the APA mandates a 30-day delay in 
effective date after issuance or publication of a rule. Sections 
553(b)(B) and 553(d)(3) of the APA provide for exceptions from the 
notice and comment and delay in effective date requirements. Section 
553(b)(B) of the APA authorizes an agency to dispense with normal 
rulemaking requirements for good cause if the agency makes a finding 
that the notice and comment process are impracticable, unnecessary, or 
contrary to the public interest. In addition, section 553(d)(3) of the 
APA allows the agency to avoid the 30-day delay in effective date where 
such delay is contrary to the public interest and an agency includes a 
statement of support.
    We believe this final rule correction does not constitute a rule 
that would be subject to the APA notice and comment or delayed 
effective date requirements. This document corrects technical and 
typographical errors in the preamble and regulation text of the HTI-1 
Final Rule, but does not make substantive changes to the policies that 
were adopted in the HTI-1 Final Rule. As a result, this final rule 
correction is intended to ensure that the information in the HTI-1 
Final Rule accurately reflects the policies adopted in that document.
    In addition, even if this were a rule to which the notice and 
comment procedures and delayed effective date requirements applied, we 
find that there is good cause to waive such procedures and 
requirements. Undertaking further notice and comment procedures to 
incorporate the corrections in this document into the HTI-1 Final Rule 
would be contrary to the public interest because these corrections 
ensure the HTI-1 Final Rule complies with the CRA and do not change the 
policies laid out in the HTI-1 Final Rule. This final rule correction 
is intended solely to ensure that the HTI-1 Final Rule accurately 
reflects applicable law and the policies finalized in the HTI-1 Final 
Rule. Therefore, we believe we have good cause to waive the notice and 
comment and effective date requirements.

IV. Corrections of Errors

    In FR Doc. 2023-28857 appearing on page 1192 in the Federal 
Register of January 9, 2024, for the reasons stated above, the Office 
of the Secretary corrects the following:


0
1. On page 1192, first column, bottom of the page, correct the DATES 
section to read as follows:

DATES: Effective date: This final rule is effective on March 11, 2024.
    Incorporation by reference: The incorporation by reference of 
certain publications listed in the rule was approved by the Director of 
the Federal Register as of March 11, 2024.

0
2. On page 1376, third column, middle of the page, correct the 
reference to ``54 CFR part 1600'' to read ``45 CFR part 160.''

0
3. On page 1429, in the third column, instructions 9.c, 9.f and 9.h to 
section Sec.  170.315 are corrected to read as follows:

0
9. Amend Sec.  170.315 by:
* * * * *
0
c. Revising paragraphs (a)(12), (b)(1)(iii)(A)(1) and (2); 
(b)(1)(iii)(B)(2), (b)(1)(iii)(G) introductory text, (b)(1)(iii)(G)(3), 
(b)(2)(i) and (ii), (b)(2)(iii)(D) introductory text, and (b)(2)(iv), 
(b)(3)(ii)(A) introductory text, (b)(6)(ii)(B)(2), and (b)(9)(ii);
* * * * *
0
f. Revising paragraphs (e)(1)(i)(A)(1) and (2), and (e)(1)(i)(B)(1) and 
(2) introductory text, and adding paragraph (e)(1)(iii);
* * * * *
0
h. Revising paragraphs (g)(3) introductory text, (g)(6)(i)(A) and (B), 
(g)(9)(i)(A)(1) and (2), (g)(10)(i)(A) and (B), (g)(10)(ii)(A) and (B), 
(g)(10)(iv)(A) and (B), (g)(10)(v)(A)(1)(i) and (ii), 
(g)(10)(v)(A)(2)(i) and (ii), (g)(10)(v)(B), and (g)(10)(vi) and (vii).

0
4. On page 1430, starting in the second column, in amendatory 
instruction 9, in Sec.  170.315 correct paragraphs (b)(1)(iii)(G)(3), 
(b)(3)(ii)(A) introductory text, (g)(10)(v)(A)(1)(i) and (ii), 
(g)(10)(v)(A)(2)(i) and (ii), and (g)(10)(v)(B) to read as follows:


Sec.  170.315  [Corrected]

* * * * *
    (b) * * *
    (1) * * *
    (iii) * * *
    (G) * * *
    (3) Sex Constraint: Represent sex with the standard adopted in 
Sec.  170.207(n)(1) up to and including December 31, 2025; or with the 
standard adopted in Sec.  170.207(n)(2).
* * * * *
    (3) * * *
    (ii) * * *
    (A) Enable a user to perform the following prescription-related 
electronic transactions in accordance with the standard specified in 
Sec.  170.205(b)(1) and, at a minimum, the version of the standard 
specified in Sec.  170.207(d)(1) as follows:
* * * * *
    (g) * * *
    (10) * * *
    (v) * * *
    (A) * * *
    (1) * * *
    (i) Authentication and authorization must occur during the process 
of granting access to patient data in accordance with the 
implementation specification adopted in Sec.  170.215(c) and standard 
adopted in Sec.  170.215(e).
    (ii) A Health IT Module's authorization server must issue a refresh 
token valid for a period of no less than three months to applications 
using the ``confidential app'' profile according to an implementation 
specification adopted in Sec.  170.215(c).
* * * * *
    (2) * * *
    (i) Access must be granted to patient data in accordance with the 
implementation specification adopted in Sec.  170.215(c) without 
requiring re-authorization and re-authentication when a valid refresh 
token is supplied by the application.
    (ii) A Health IT Module's authorization server must issue a refresh 
token valid for a new period of no less than three months to 
applications using the ``confidential app'' profile according to an 
implementation specification adopted in Sec.  170.215(c).
    (B) Authentication and authorization for system scopes. 
Authentication and authorization must occur during the process of 
granting an application access to patient data in accordance with the 
``SMART Backend Services: Authorization Guide'' section of the 
implementation specification adopted in Sec.  170.215(d) and the 
application must be issued a valid access token.
* * * * *


Sec.  170.405  [Corrected]

0
5. On page 1434, first column, middle of page, in amendatory 
instruction 12 for Sec.  170.405 correct instruction 12.a to read as 
``a. Revising paragraphs (a) and (b)(2)(ii) introductory text; and''

[[Page 8549]]


0
6. Starting on page 1434, in the second column, redesignate 
instructions 13 through 22 as instructions 14 through 23.

0
7. On page 1434, in the second column, add a new instruction 13 and 
accompanying regulatory text to read as follows:

0
13. Amend Sec.  170.406 by revising paragraph (a)(5) to read:


Sec.  170.406  Attestations

    (a) * * *
    (5) Section 170.405 if a health IT developer has a Health IT 
Module(s) certified to any one or more ONC Certification Criteria for 
Health IT in Sec.  170.315(b), (c)(1) through (3), (e)(1), (f), (g)(7) 
through (10), and (h).

0
8. On page 1435, starting in the second column, correct newly 
redesignated instruction 17 and the accompanying regulatory text to 
read as follows:

0
17. Amend Sec.  170.550 by revising paragraphs (g) introductory text, 
(h)(1), and (m) introductory text to read as follows:


Sec.  170.550  Health IT Module certification.

* * * * *
    (g) Health IT Module dependent criteria. When certifying a Health 
IT Module to the ONC Certification Criteria for Health IT, an ONC-ACB 
must certify the Health IT Module in accordance with the certification 
criteria at:
* * * * *
    (h) * * *
    (1) General rule. When certifying a Health IT Module to the ONC 
Certification Criteria for Health IT, an ONC-ACB can only issue a 
certification to a Health IT Module if the privacy and security 
certification criteria in paragraphs (h)(3)(i) through (ix) of this 
section have also been met (and are included within the scope of the 
certification).
* * * * *
    (m) Time-limited certification and certification status for certain 
ONC Certification Criteria for Health IT. An ONC-ACB may only issue a 
certification to a Health IT Module and permit continued certified 
status for:
* * * * *

Elizabeth J. Gramling,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2024-02519 Filed 2-6-24; 8:45 am]
BILLING CODE 4150-45-P