Certification Criteria Compliance Dates Enforcement Discretion Notice

Dated: November 24, 2025

On October 1, 2025, through November 12, 2025, the Assistant Secretary for Technology Policy (ASTP) and the Office of the National Coordinator for Health Information Technology (ONC) (collectively, “ASTP/ONC”) experienced a lapse in appropriations. ASTP/ONC has determined that this lapse in appropriations impacted the ability of entities to comply with certain regulatory requirements.

In the Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information Sharing (HTI-1) Final Rule (89 FR 1192), ASTP/ONC made updates to the ONC Health IT Certification Program (Certification Program), including new and updated standards, implementation specifications, and certification criteria in 45 CFR Part 170, including establishing a new baseline version of the United States Core Data for Interoperability (USCDI). The HTI-1 Final Rule required that for all certification criteria in § 170.315, a health IT developer with a Health IT Module certified to any revised certification criterion, as defined in § 170.102, shall update the Health IT Module and shall provide such update to their customers in accordance with the dates identified for each revised certification criterion and applicable standard (89 FR 1307, 1429). This requirement to “update” and “provide” such updated technology is described in § 170.402(b)(3).

For each of the certification criteria listed below, the HTI-1 Final Rule required updates by January 1, 2026.[1]

  • The “patient demographics and observations” criterion in § 170.315(a)(5);
  • The “family health history” criterion in § 170.315(a)(12);
  • The “transitions of care” criterion in § 170.315(b)(1);
  • The “clinical information reconciliation and incorporation” criterion in § 170.315(b)(2);
  • The “care plan” criterion in § 170.315(b)(9);
  • The “decision support interventions” criterion in § 170.315(b)(11);
  • The “clinical quality measures (CQM) - filter” criterion in § 170.315(c)(4);
  • The “view, download, and transmit to 3rd party” criterion in § 170.315(e)(1);
  • The “transmission to immunization registries” criterion in § 170.315(f)(1);
  • The “transmission to public health agencies – reportable laboratory tests and values/results” criterion in § 170.315(f)(3);
  • The “transmission to cancer registries” criterion in § 170.315(f)(4);
  • The “consolidated CDA creation performance” criterion in § 170.315(g)(6);
  • The “application access – all data request” criterion in § 170.315(g)(9); and
  • The “standardized application programming interface (API) for patient and population services” criterion in § 170.315(g)(10).

Given the lapse in appropriations, health IT developers’ ability to certify their Health IT Modules to these revised criteria was substantially impacted. During the entirety of the lapse in appropriations, the ASTP/ONC website was unavailable, including access to testing tools and other resources. Additionally, ASTP/ONC staff were unavailable to provide operational or program support for ONC-ACBs, ONC-ATLs, and health IT developers. Therefore, ASTP/ONC is exercising the following enforcement discretion:

  1. ASTP/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 developer not complying with the January 1, 2026 compliance date for required updates to Health IT Modules certified to the certification criteria listed above. ASTP/ONC will also not exercise its direct review authority under 45 CFR 170.580 with respect to a developer with Health IT Module(s) certified to the certification criteria listed above and the requirements to “update” and “provide,” per 45 CFR 170.402(b)(3), their health IT certified to those criteria, until March 1, 2026.
  2. ASTP/ONC will not, prior to March 1, 2026, initiate an 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 listed above where the health IT developer has not completed required updates by January 1, 2026.

This enforcement discretion will be in effect beginning January 1, 2026, and will remain in effect until March 1, 2026. Health IT developers with Health IT Modules certified to the criteria listed above will, in effect, have through February 28, 2026, to complete updates required under the HTI-1 Final Rule to those criteria.

ID:EDN2025.06


 

[1] For additional information on required updates for certification criteria, please see https://www.healthit.gov/topic/certification-ehrs/onc-certification-criteria-health-it-regulatory-update-deadline.