Updates, Algorithm Transparency, and Information Sharing; Correction
| Published date | 07 March 2024 |
| Record Number | 2024-04785 |
| Citation | 89 FR 16469 |
| Court | Health Data, Technology, And Interoperability: Certification Program |
| Section | Rules and Regulations |
Federal Register, Volume 89 Issue 46 (Thursday, March 7, 2024)
[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]
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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.
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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
