[Federal Register Volume 88, Number 52 (Friday, March 17, 2023)]
[Proposed Rules]
[Page 16392]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2023-05489]



[[Page 16392]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Office of the Secretary

45 CFR Parts 160 and 162

[CMS-0053-CN]
RIN 0938-AT38


Administrative Simplification: Adoption of Standards for Health 
Care Attachments Transactions and Electronic Signatures, and 
Modification to Referral Certification and Authorization Transaction 
Standard; Correction

AGENCY: Office of the Secretary, Department of Health and Human 
Services (HHS).

ACTION: Proposed rule; correction.

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SUMMARY: This document corrects technical and typographical errors that 
appeared in the proposed rule published in the Federal Register on 
December 21, 2022, entitled ``Administrative Simplification: Adoption 
of Standards for Health Care Attachments Transactions and Electronic 
Signatures, and Modification to Referral Certification and 
Authorization Transaction Standard.''

DATES: The comments due date remains March 21, 2023.

FOR FURTHER INFORMATION CONTACT: Geanelle G. Herring, (410) 786-4466 
and Christopher Wilson, (410) 786-3178.

SUPPLEMENTARY INFORMATION:

I. Background

    In FR Doc. 2022-27437 of December 21, 2022 (87 FR 78438), there 
were several technical and typographical errors in the regulations text 
that are identified and corrected in this correcting document.

II. Summary of Errors

    On page 78453, in the section of the proposed rule that describes 
the documents that would be incorporated by reference, we inadvertently 
omitted language regarding the HL7 Implementation Guide for CDA Release 
2: Digital Signatures and Delegation of Rights, Release 1 that we 
proposed to adopt as the electronic signature standard. Including this 
implementation guide in the list of documents to be incorporated by 
reference would align the section with discussion on page 78451, which 
specifies that the aforementioned implementation guide would be 
incorporated by reference. This correction does not introduce a new 
document for incorporation by reference, but, rather, ensures that the 
proposed incorporation by reference section of the proposed rule 
identifies all the documents proposed for incorporation by reference. 
We correct this error in section III. of this document (see item 1).
    On page 78468, we note the following:
     In the regulations text for Sec.  162.2002, we 
inadvertently omitted paragraph (f) that identifies the electronic 
signature standard we proposed to adopt. We also inadvertently omitted 
Sec.  162.920(e)(4), which would specify the incorporation by reference 
of the implementation guide that would be adopted for the proposed 
electronic signature standard specified in Sec.  162.2002(f). Adding 
these references would conform the regulations text to the policies 
proposed on pages 78449 and 78450 where we describe how the term 
``electronic signature'' would be defined, identify the specific 
electronic signature standard we would adopt, and specify that we would 
adopt the electronic signature standard at Sec.  162.2002(f). These 
corrections do not introduce new policy proposals in this document, 
but, rather, conform the regulations text to the policies that were 
clearly proposed and intended to be reflected in the regulations text. 
We correct these errors in section III. of this document (see items 
2.a. and 1.b.(2)).
     In the regulations text for Sec.  162.2002(e)(2), we made 
an inadvertent typographical error by referencing the wrong citation. 
We mistakenly referenced 45 CFR 1302(e)(2) rather than 45 CFR 
162.1302(e)(2). We correct this error in section III. of this document 
(see item 2.b.(1).).

III. Correction of Errors

    In FR Doc. 2022-27437 of December 21, 2022 (87 FR 78438), make the 
following corrections:

0
1. On page 78453
0
a. Second column, first full paragraph:
    (1) Lines 11 and 12, the phrase ``Errata; and (3) HL7 
Implementation'' is corrected to read ``Errata; (3) HL7 
Implementation''.
    (2) Last line, the phrase ``with Errata.'' is corrected to read 
``with Errata; and (4) HL7 Implementation Guide for CDA Release 2: 
Digital Signatures and Delegation of Rights, Release 1.''
0
b. Third column, after the first partial paragraph, the text is 
corrected by adding a paragraph to read as follows:
    ``The HL7 Implementation Guide for CDA Release 2: Digital 
Signatures and Delegation of Rights, Release 1 provides a standardized 
method of applying Digital Signatures to CDA documents. The standard 
provides for multiple signers, signers' declaration of their role, 
declaration of the purpose of the signature, long-term validation of 
the Digital Signatures, and data validation of the signed content.''.
0
2. On page 78468, in the second column, correct Sec.  162.920 by adding 
paragraph (e)(4) to read as follows:


Sec.  162.920   [Corrected]

* * * * *
    (e) * * *
    (4) HL7 Implementation Guide for CDA Release 2: Digital Signatures 
and Delegation of Rights, Release 1 October 2014; IBR approved for 
Sec.  162.2002(f).
0
3. On page 78468, in the third column, correct Sec.  162.2002 by:
0
a. In paragraph (e)(2), correcting the reference ``45 CFR 1302(e)(2)'' 
to read ``45 CFR 162.1302(e)(2)'' and
0
b. Adding paragraph (f).
    The addition reads as follows:


Sec.  162.2002   [Corrected]

* * * * *
    (f) For transmissions described in Sec.  162.2001(a), where a 
health care provider uses an electronic signature, the HL7 
Implementation Guide for CDA Release 2: Digital Signatures and 
Delegation of Rights, Release 1 (incorporated by reference, see Sec.  
162.920).

Elizabeth J. Gramling,
Executive Secretary to the Department, Department of Health and Human 
Services.
[FR Doc. 2023-05489 Filed 3-15-23; 8:45 am]
BILLING CODE 4120-01-P