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42 U.S.C. 1320d—1320d-9 and secs. 1104 and 10109 of Pub. L. 111-148, 124 Stat. 146-154 and 915-917.
65 FR 50367, Aug. 17, 2000, unless otherwise noted.
91 FR 14405, Mar. 24, 2026, unless otherwise noted.
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The Secretary adopts the following standards for the period on and after May 26, 2028:
(a) For transmissions described in § 162.2001, HL7 CDA Release 2: Attachment Implementation Guide: Exchange of C-CDA Based Documents, Release 2—US Realm, Version 2.1.0.1 September 2023 (incorporated by reference, see § 162.920).
(b) For transmissions described in § 162.2001(a)—
(1) HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume One—Introductory Material, August 2015 with 2019 June Errata (incorporated by reference, see § 162.920)
(2) HL7 Implementation Guide for CDA Release 2: Consolidated CDA Templates for Clinical Notes (US Realm) Draft Standard for Trial Use Release 2.1, Volume Two—Templates and Supporting Material, June 2019 (incorporated by reference, see § 162.920).
(c) For transmissions described in § 162.2001(a), the ASC X12N/06020X314—Additional Information to Support a Health Care Claim or Encounter (275) (incorporated by reference, see § 162.920).
(d) For transmissions described in section 162.2001(b) that pertain to § 162.2001(a) transmissions, the ASC X12N/006020X313—Health Care Claim Request for Additional Information (277) (incorporated by reference, see § 162.920).
(e) For transmissions described in § 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, Draft Standard for Trial Use, October 2014 (incorporated by reference, see § 162.920).