Enforcement Discretion and Certification Guidance

Dated: March 21, 2025

On January 20, 2025, President Donald J. Trump signed Executive Order (EO) 14168, “Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government.” Section 2 of EO 14168 establishes that it is the policy of the United States to recognize two sexes, male and female. Section 3 of EO 14168 further states that agencies shall remove all statements, policies, regulations, forms, communications, or other internal and external messages that promote or otherwise inculcate gender ideology, and shall cease issuing such statements, policies, regulations, forms, communications or other messages. The United States Office of Personnel Management (OPM) issued a memorandum, dated January 29, 2025, that provided initial guidance for EO 14168. Section 1(f) of the guidance directs agencies to withdraw any final or pending documents, directives, orders, regulations, materials, forms, communications, statements, and plans that inculcate or promote gender ideology.[1]

Consistent with EO 14168 and OPM guidance, the Assistant Secretary for Technology Policy (ASTP) and the Office of the National Coordinator for Health Information Technology (ONC) (collectively, ASTP/ONC) is exercising enforcement discretion and issuing certification guidance for the ONC Health IT Certification Program. Section 170.550 of Title 45 of the Code of Federal Regulations requires an ONC-Authorized Certification Body (ONC-ACB), when certifying Health IT Modules, to certify in accordance with the applicable certification criteria adopted in regulation.

  1. Under this enforcement discretion and certification guidance, ASTP/ONC will not take any enforcement action under 45 CFR 170.565 against an ONC-ACB based on non-compliance with 45 CFR 170.550 for certifying a Health IT Module that is presented for certification to a certification criterion or criteria in 45 CFR 170.315 that cross-references the United States Core Data for Interoperability (USCDI) version 3, where the Health IT Module:
    1. Does not demonstrate the capability to categorize data on individuals based on either or both of the following data elements:
      • sexual orientation; and
      • gender identity; or
    2. Only demonstrates the capability to categorize data on individuals for the sex data element in accordance with the following SNOMED CT® codes:
      • 248152002 |Female (finding)|; and
      • 248153007 |Male (finding)|.
  2. Additionally, under this enforcement discretion and certification guidance, ASTP/ONC will not take any enforcement action under 45 CFR 170.565 against an ONC-ACB based on non-compliance with 45 CFR 170.550 for certifying a Health IT Module that is presented for certification to the “patient demographics and observations” certification criterion (45 CFR 170.315(a)(5)), where the Health IT Module:
    1. Does not demonstrate conformance with any or all of the following data and observations in paragraph (a)(5)(i): sex parameter for clinical use, sexual orientation, gender identity, name to use, and pronouns; or
    2. Does not demonstrate conformance with any or all of the following paragraphs of (a)(5)(i): (D) (“sexual orientation”), (E) (“gender identity”), (F) (“sex parameter for clinical use”), (G) (“name to use”), and (H) (“pronouns”); or
    3. Only demonstrates, for conformance with paragraph (a)(5)(i)(C) (“sex”), that it can record sex in accordance with either the standard specified in § 170.207(n)(1) for the period up to and including December 31, 2025, or the following SNOMED CT® codes found in the standard specified in § 170.207(n)(2):
      • 248152002 |Female (finding)|; and
      • 248153007 |Male (finding)|.

Further, ONC will not exercise its direct review authority under 45 CFR 170.580 for any non-conformity, potential or actual, that arises solely from a Health IT Module not demonstrating the capabilities specified in (1)(a), (2)(a) or (2)(b) above; or for only demonstrating the limited specified capabilities in (1)(b) or (2)(c) above, for the relevant certification criteria requirements.

This enforcement discretion and certification guidance will remain in effect for twelve (12) months from the date of this notice or until the Department of Health and Human Services completes a regulatory action to revise the applicable regulations in compliance with EO 14168, whichever comes first. 

 

[1] “Gender ideology” as used here has the same meaning as defined in Section 2 of EO 14168.