Applies to all applicable base regulatory and SVAP standards:
- Health IT Modules are not required to support patient-facing API-enabled “read” services for multiple patients for the purposes of this certification criterion.
- The clinical note text included in any of the notes described in the “Clinical Notes Guidance” section of a US Core Implementation Guide (IG) adopted in § 170.215(b)(1) must be represented in a “plain text” form, and it would be unacceptable for the note text to be converted to another file or format (e.g., .docx, PDF) when it is provided as part of an API response. The intent of this policy is to prohibit Health IT Modules from converting clinical notes from a “machine readable” format to a non-“machine readable” format (e.g., PDF). Clinical note text that originates from outside Health IT Modules should be exchanged using its original format. Additionally, “plain text” does not necessarily mean the FHIR® “contentType” “text/plain.”
- The US Core IG Profile “StructureDefinition-us-core-patient” element “name.suffix” is required for testing and certification in the Certification Program to meet the USCDI requirement to support the “Patient Demographics” Data Class: “Suffix” Data Element.
- A Health IT Module must support at least one Choice or Reference for US Core IG “must support” elements with multiple Choices or References, respectively.
- A Health IT Module must be conformant to the US Core IG for all Choices and References included in its standardized API, and cannot misrepresent Choices via the standardized API (e.g. a Health IT Module cannot transform “integer” values to “string” values).
- A health IT developer must document which US Core IG Choices and References are supported by their Health IT Module via public technical documentation to meet the requirements at § 170.315(g)(10)(viii) and the transparency conditions at § 170.404(a)(2).
- Information originating from the (g)(10)-certified Health IT Module must conform to the requirements included in the criterion, but legacy information and information from outside systems is not required to be mapped to the USCDI “Applicable Standards” and the US Core IG terminologies and value sets. However, health IT developers are encouraged to exceed the minimum requirements described in § 170.315(g)(10) to support the mapping of legacy information to the terminologies and value sets included in the USCDI and US Core IG where possible.
- In order to mitigate potential interoperability errors and inconsistent implementation of the Fast Healthcare Interoperability Resources (FHIR®) Bulk Data Access (Flat FHIR®) (v1.0.0: STU 1) standard, ONC assesses, approves, and incorporates corrections (errata) as part of required certification and testing to this criterion. Compliance with the following errata is necessary because the errata implements technical corrections and clarifications to the FHIR® Bulk Data Access (Flat FHIR®) (v1.0.0: STU 1) standard. There is a 90-day delay from the time the CCG has been updated with the ONC-approved errata to when compliance with the errata will be required to pass testing. Similarly, there will be an 18-month delay before a finding of an erratum’s absence in a Certified Health IT Module during surveillance would constitute a non-conformity under the Certification Program.
- Version: FHIR® Bulk Data Access (Flat FHIR®) (v1.0.1: STU 1). Effective for testing on October 25, 2021. Surveillance compliance date on January 27, 2023.
- Through the US Core Patch Process, the HL7® Cross-Group Projects Work Group (CGP WG) approves US Core “patches”, which are corrections for issues with the US Core implementation guide (US Core IG). US Core “patches” include corrections for issues such as ambiguous requirements and requirements incompatible with real world deployment. Similar to US Core “patches” are US Core “additional guidance”. US Core “additional guidance” approved by the CGP WG indicates guidance included in a newer version of the US Core IG as being relevant to a previous version of the US Core IG. Though US Core “patches” and “additional guidance” are not required for certification purposes (unless indicated in the Certification Companion Guide), health IT developers may optionally implement US Core “additional guidance” in their Health IT Module and still be conformant with § 170.315(g)(10) criterion requirements.
- More information regarding the US Core Patch Process and US Core “patches” and “additional guidance” approved by the CGP WG is available on the HL7® Confluence pages of US Core 'Patch' Process and Approved Patches and Additional Guidance.
- 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.
Applies to USCDI v1 and US Core 3.1.1 and SVAP approved standards US Core 4.0.0 (expires on January 1, 2026):
- The HL7® Cross-Group Projects workgroup, through the US Core 'Patch' Process ticket FHIR-40299, approved patching the US Core Patient Profile in US Core 3.1.1 and US Core 4.0.0. The USCDI data element “Patient Demographics: Previous Name” must be supported by including the capability to set the US Core Patient Profile element “Patient.name.use” to “old” or provide an end date in “Patient.name.period” element or support both. Additionally, the USCDI data element “Patient Demographics: Previous Address” must be supported by including the capability to set the US Core Patient Profile “Patient.address.use” element to “old” or provide an end date in “Patient.address.period” element or support both. Also, support for the US Core Patient Profile “Patient.address.period” element is not required for purposes of testing and certification.