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LegalText 42 U.S.C. § 1320d1 General requirements for adoption of standards us united_states_code code_section 42 THE PUBLIC HEALTH AND WELFARE 7 SOCIAL SECURITY 1320d1 42 U.S.C. § 1320d1 current 119-100 2026-06-26 official https://uscode.house.gov/download/releasepoints/us/pl/119/100/xml_usc42@119-100.zip /us/usc/t42/s1320d1 data/legal/raw/us/code/title-42/usc42.xml 9ca48b5f50151c27a81d4bec683b6899b352cb28cd26e291a7099ddd540a219a 644321055a08eb1f260a6a3e31ac157fa024756abf612a9fd6857e7e400cf24e dc408e7f4e6b3ce80ffd49ef6fd064c21b7a2baff5cc08c5a74309c3199a0759 2026-07-04 official
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42 U.S.C. § 1320d1 - General requirements for adoption of standards

Text

(a) Applicability Any standard adopted under this part shall apply, in whole or in part, to the following persons:

(1) A health plan.

(2) A health care clearinghouse.

(3) A health care provider who transmits any health information in electronic form in connection with a transaction referred to in section 1320d2(a)(1) of this title.

(b) Reduction of costs Any standard adopted under this part shall be consistent with the objective of reducing the administrative costs of providing and paying for health care.

(c) Role of standard setting organizations (1) In general Except as provided in paragraph (2), any standard adopted under this part shall be a standard that has been developed, adopted, or modified by a standard setting organization.

(2) Special rules (A) Different standards The Secretary may adopt a standard that is different from any standard developed, adopted, or modified by a standard setting organization, if—

(i) the different standard will substantially reduce administrative costs to health care providers and health plans compared to the alternatives; and

(ii) the standard is promulgated in accordance with the rulemaking procedures of subchapter III of chapter 5 of title 5.

(B) No standard by standard setting organization If no standard setting organization has developed, adopted, or modified any standard relating to a standard that the Secretary is authorized or required to adopt under this part—

(i) paragraph (1) shall not apply; and

(ii) subsection (f) shall apply.

(3) Consultation requirement (A) In general A standard may not be adopted under this part unless—

(i) in the case of a standard that has been developed, adopted, or modified by a standard setting organization, the organization consulted with each of the organizations described in subparagraph (B) in the course of such development, adoption, or modification; and

(ii) in the case of any other standard, the Secretary, in complying with the requirements of subsection (f), consulted with each of the organizations described in subparagraph (B) before adopting the standard.

(B) Organizations described The organizations referred to in subparagraph (A) are the following:

(i) The National Uniform Billing Committee.

(ii) The National Uniform Claim Committee.

(iii) The Workgroup for Electronic Data Interchange.

(iv) The American Dental Association.

(d) Implementation specifications The Secretary shall establish specifications for implementing each of the standards adopted under this part.

(e) Protection of trade secrets Except as otherwise required by law, a standard adopted under this part shall not require disclosure of trade secrets or confidential commercial information by a person required to comply with this part.

(f) Assistance to Secretary In complying with the requirements of this part, the Secretary shall rely on the recommendations of the National Committee on Vital and Health Statistics established under section 242k(k) of this title, and shall consult with appropriate Federal and State agencies and private organizations. The Secretary shall publish in the Federal Register any recommendation of the National Committee on Vital and Health Statistics regarding the adoption of a standard under this part.

(g) Application to modifications of standards This section shall apply to a modification to a standard (including an addition to a standard) adopted under section 1320d3(b) of this title in the same manner as it applies to an initial standard adopted under section 1320d3(a) of this title.

(Aug. 14, 1935, ch. 531, title XI, § 1172, as added Pub. L. 104191, title II, § 262(a), Aug. 21, 1996, 110 Stat. 2023.)

Notes

Editorial Notes

Prior ProvisionsA prior section 1172 of act Aug. 14, 1935, was classified to section 1320c21 of this title prior to the general amendment of part B of this subchapter by Pub. L. 97248.