Clarifications:
- For the public health certification criteria in § 170.315(f), health IT will only need to be certified to those criteria that are required to meet the measures the provider intends to report on to meet Objective: Public Health and Clinical Data Registry Reporting.
- For the functional requirements in § 170.315(f)(5)(i), a specific content exchange standard for electronic case reporting (eCR) is not required to meet this criterion. [see also 80 FR 62667]
- For the functional requirements in § 170.315(f)(5)(i), this criterion may be met through one of the following two ways:
- Documentation that sufficiently describes how the Health IT Module meets the functional requirements of the criterion.
- Documentation eCR implementation using the eCR Now Fast Health Interoperability Resources (FHIR®) application and the ability to meet paragraph § 170.315(f)(5)(i)(A) of this criterion. Note that this optional certification pathway using the eCR Now FHIR® application may require a different set of data elements than specified in § 170.315(f)(5)(i)(C)(2).
- For the time period up to and including December 31, 2025, Health IT Modules certified to § 170.315(f)(5)(i) may meet the requirements in § 170.315(f)(5)(i)(C)(2)(ii) using SNOMED CT® September 2015 Release or any later version. On and after December 31, 2025, Health IT Modules that wish to remain certified to 170.315(f)(5) must meet the requirements at 170.315(f)(5)(ii).
- Consistent with Executive Order (EO) 14168 and OPM guidance, Health IT Modules certifying and/or currently certified to certification criteria that cross-reference the USCDI standard at 45 CFR 170.213 are only required to demonstrate 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)|
- Further, these Health IT Modules are no longer required to support the following USCDI data elements for purposes of certification:
- Sexual orientation in USCDI version 4;
- Gender identity in USCDI version 4;
- Sex parameter for clinical use in USCDI version 5;
- Name to use in USCDI version 5;
- Pronouns in USCDI version 5.
- Consistent with Executive Order (EO) 14192, ASTP/ONC will not pursue enforcement activities for developers that do not comply with the adopted standards finalized in 45 CFR 170.315(f)(5), so long as the certified health IT remains conformant with either 45 CFR 170.315(f)(5)(i) or the requirements in (f)(5)(ii) as follows:
- (ii)(A) Consume and process case reporting trigger codes and identify a reportable patient visit or encounter based on a match with a trigger code value set (e.g., table).
- (ii)(B) Create a case report.
- (ii)(C) Receive, consume, and process a case report response.
- (ii)(D) Transmit a case report electronically to a system capable of receiving a case report.
- This means that, through December 31, 2025, developers can remain certified to (f)(5)(i), which only requires meeting the functional requirements of electronic case reporting. Starting January 1, 2026, all developers must be certified to (f)(5)(ii). Under enforcement discretion, they are not required to conform to one of the listed eCR standards, but they still must certify to the functional aspects of (f)(5)(ii). Review the Enforcement Discretion notice for more details.
