Updates, Algorithm Transparency, and Information Sharing; Correction, 16469-16470 [2024-04785]

Agencies

• DEPARTMENT OF HEALTH AND HUMAN SERVICES
• Office of the Secretary
• Health Data, Technology, and Interoperability: Certification Program

[Federal Register Volume 89, Number 46 (Thursday, March 7, 2024)]
[Rules and Regulations]
[Pages 16469-16470]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04785]


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

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: 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 technical and typographical errors following publication in 
the Federal Register on January 9, 2024. We first published a notice 
correcting certain errors on February 8, 2024 (89 FR 8546). In this 
document, we summarize and correct additional errors in the ``Summary 
of Errors'' and ``Corrections of Errors'' sections below.

II. Summary of Errors

A. 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, within amendatory 
instruction 9 for Sec.  170.315, sub-instruction h., paragraph ``(g)(3) 
introductory text'' should read paragraph ``(g)(3)(i).''
    On page 1432, third column, halfway down the page, we inadvertently 
added the language, ``User-centered design processes must be applied to 
each capability technology includes that is specified in the following 
certification criteria: paragraphs (a)(1) through (5), (9) until the 
criterion's expiration date, and (14), and (b)(2), (3), and (11) of 
this section.'' to paragraph (g)(3) when the language should have been 
added to paragraph (g)(3)(i). While we had erroneously proposed (88 FR 
23746, 23911) and then finalized the revision to paragraph (g)(3), we 
had intended to revise paragraph (g)(3)(i). This fact is evident by our 
discussion of revising the provision actually found in paragraph 
(g)(3)(i) to include the ``DSI'' certification criterion (45 CFR 
170.315(b)(11)) in the preambles of the proposed (88 FR 23787) and 
final (89 FR 1256) rules. Paragraph (g)(3) only contains the title of 
the certification criterion (safety-enhanced design) and not the 
language referenced in preamble and specifically included in paragraph 
(g)(3)(i). Therefore, when we discussed revising the substance of 
paragraph (g)(3) to ``apply to the new certification criterion proposed 
in Sec.  170.315(b)(11) as well,'' (88 FR 23787), we believe it was 
evident we intended to refer to (g)(3)(i), since there were no 
substantive requirements in paragraph (g)(3) that could be revised. We 
received no substantive feedback on the proposal (89 FR 1256) and then 
erroneously finalized the revised provision in (g)(3) rather than 
(g)(3)(i).
2. Insights Condition and Maintenance of Certification
    On page 1434, third column, beginning at the bottom half of the 
page, in Sec.  170.407, and ending in the first column of page 1435, we 
inadvertently included incorrect paragraph designators (i) within 
paragraphs (a)(3)(iv), (v), (vi) and (vii). The (i) in these paragraphs 
should be deleted. We also inadvertently included the word ``of'' after 
the word ``distinct'' and

[[Page 16470]]

before ``certified health IT'' in paragraph (a)(3)(iv)(i), which should 
be removed.

B. Regulation Text Errors--Part 171--Information Blocking

    On page 1437, third column, in amendatory instruction 22, we add 
subpart D. In subpart D, after the table of contents, we erroneously 
included the authority for the subpart, which is the same authority as 
for part 171 and all subparts under part 171, and was already included 
in amendatory instruction 17 on page 1435. Therefore, ``Authority: 42 
U.S.C. 300jj-52; 5 U.S.C. 552.'' under subpart D table of contents 
should be removed.

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 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 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 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:
    1. On page 1429, in the third column, top of page, instruction 9.h 
to Sec.  170.315 is corrected to read as follows:

0
9. Amend Sec.  170.315 by:
* * * * *
0
h. Revising paragraphs (g)(3)(i), (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
2. On page 1432, in the third column, in amendatory instruction 9, in 
Sec.  170.315 correct paragraph (g)(3) by removing the text following 
the paragraph heading and adding paragraph (g)(3)(i) to read as 
follows:


Sec.  170.315  [Corrected]

* * * * *
    (g) * * *
    (3) Safety-enhanced design. (i) User-centered design processes must 
be applied to each capability technology includes that is specified in 
the following certification criteria: paragraphs (a)(1) through (5), 
(9) (until the criterion's expiration date), and (14) and (b)(2), (3), 
and (11) of this section.
* * * * *

0
3. On page 1434, in the third column, beginning at the bottom half of 
the page, in amendatory instruction 13, in Sec.  170.407, correct 
paragraphs (a)(3)(iv), (v), (vi) and (vii) to read as follows:


Sec.  170.407  [Corrected]

    (a) * * *
    (3) * * *
    (iv) Use of FHIR in apps through certified health IT. If a health 
IT developer has a Health IT Module certified to Sec.  170.315(g)(10), 
then the health IT developer must submit responses on the number of 
requests made to distinct certified health IT deployments that returned 
FHIR resources, number of distinct certified health IT deployments 
active at any time, the number of distinct deployments active at any 
time that returned FHIR resources in response to API calls from apps 
connected to certified health IT, including stratifying responses by 
the following:
    (A) User type;
    (B) FHIR resource; and
    (C) US Core Implementation Guide version.
    (v) Use of FHIR bulk data access through certified health IT. If a 
health IT developer has a Health IT Module certified to Sec.  
170.315(g)(10), then the health IT developer must submit responses for 
the total number of FHIR bulk data access requests completed through 
the certified health IT, and the number of distinct deployments of the 
certified health IT active at any time overall, and by whether at least 
one bulk data download request was completed.
    (vi) Immunization administrations electronically submitted to 
immunization information systems through certified health IT. If a 
health IT developer has a Health IT Module certified to Sec.  
170.315(f)(1), then the health IT developer must submit responses for 
the use of certified health IT to electronically send immunizations 
administered to immunization information systems (IIS), including 
stratifying responses based on the following subgroups:
    (A) IIS; and
    (B) Age group.
    (vii) Immunization history and forecasts through certified health 
IT. If a health IT developer has a Health IT Module certified to Sec.  
170.315(f)(1), then the health IT developer must submit responses for 
the use of certified health IT to query immunization history and 
forecast information from immunization information systems (IIS), 
including stratifying responses based on the following subgroup:
    (A) IIS.
    (B) [Reserved]
* * * * *

Subpart D [Amended]

0
4. On page 1437, in the third column, in amendatory instruction 22, 
correct subpart D by removing the authority.

Elizabeth J. Gramling,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2024-04785 Filed 3-6-24; 8:45 am]
BILLING CODE 4150-45-P