US Core Implementation Guide, published by HL7 International / Cross-Group Projects. This is not an authorized publication; it is the continuous build for version 7.0.0-ballot). This version is based on the current content of https://github.com/HL7/US-Core/ and changes regularly. See the Directory of published versions
We have updated US Core to include the new U.S. Core Data for Interoperability (USCDI) v4 Data Elements and Classes that the Office of the National Coordinator (ONC) published in July of 2023:
For USCDI Encounter Identifier data element, no changes were needed because the US Core Encounter Profile already supports Encounter.identifier as a Must Support element.
For USCDI Facility Information data class and elements, the US Core Location Profile already supports Facility Name and has been updated to support Facility Identifier and Type. The US Core Immunization Profile has been updated to reference the US Core Location resource directly as a Must Support element, and the following US Core Profiles have been updated to indirectly reference the location/facility via US Core Encounter Profile as a Must Support element:
For USCDI Laboratory data class and elements, the US Core Laboratory Result Observation Profile already supports Result Unit of Measure data element for using UCUM for coded quantity units and has been updated to support Result Reference Range and Result Interpretation as a Must Support elements. The US Core Specimen Profile has been updated to support Specimen Identifier as a Must Support element, and Specimen Source Site and Specimen Condition Acceptability as Additional USCDI Requirements.
Implementers submitted over <N> trackers since the publication of US Core ver 6.0.0 and 6.1.0 We have addressed them and applied over <N’> changes listed below:
Tracker Status: SummaryJira IssueLink to Updated Content
Resolved - change required: RelatedPerson relationshiptype should have binding to FHIR value set RelatedPerson-relationshiptype FHIR-34755See Changes Here
Resolved - change required: Several Vital Signs missing from CapabilityStatement US Core Server page FHIR-34478See Changes Here
Resolved - change required: Confusing for commercial vendor. Reads very confusing. FHIR-30783See Changes Here
Resolved - change required: In most of the data elements – “Binding is from base FHIR and US Core Vital Signs” Need this to be one single combined listing FHIR-30780See Changes Here
The changes in this STU Update to US Core 6.0.0 have been reviewed by the public through the HL7 STU update process. The resolution of the community comments has been agreed to and voted on by the members of the HL7 International Cross-Group Projects work group.
The changes in this annual update to US Core have been reviewed and commented upon by the public through the January 2023 HL7 balloting process. The resolution of the community comments has been agreed to and voted on by the members of the HL7 International Cross-Group Projects work group.
What’s new in Version 6.0.0 of US Core:
Each update to a new version of US Core changes the US Core Profiles and conformance expectations. Implementers can find detailed comparisons between the FHIR artifacts in this 6.0.0 version of US Core and each previous major release on Changes Between Versions page. This section provides an overview of the significant changes in Version 6.0.0 of US Core.
New and updated resources to meet the U.S. Core Data for Interoperability (USCDI) v3 new Data Elements and Classes that the Office of the National Coordinator (ONC) published in July of 2022. This table summarizes the USCDI Data Classes and Data Elements and the corresponding US Core Profile(s).
The newUS Core Coverage Profile represent and access data related to an individual’s health insurance coverage for health care.
The profiles from version 5.0.1 have been renamed and re-scoped in this version to accommodate the USCDI Health Status/Assessments Data Classes.
The SDOH Assessments documentation has been rewritten and renamed to Screening and Assessments, reflecting its expanded coverage of Health Status/Assessments Data Elements including: Functional Status, Disability Status, and Mental/Cognitive Status in addition to SDOH Assessments.
Document the USCDI Requirement conformance category: Besides Mandatory and Must Support elements, the US Core Profile elements consist of USCDI Requirements elements for ONC Health IT Certification. This version clarifies the meaning and documents how it is communicated in the StructureDefinitions and on the profile pages
Expanded CapabilityStatement Narrative: Each US Core Profile contains references to other resources that it depends on or is related to. The CapabilityStatements narrative provides a table summarizing the Must Support references for US Core Profiles to help implementers understand their required capabilities.
Expanded documentation on the Terminology page: In addition to detailing the Code Systems unique to this guide, links all the Code Systems used in US Core are listed.
Introduce US Core SMART Scopes as a candidate requirements under consideration, and provide example for each Profile.
We continue our efforts to link terminology directly to the FHIR® Terminology Service for VSAC Resources (Value Set Authority Center (VSAC) where applicable and, as a result, align terminology between US Core and HL7 C-CDA.
Changes:
These changes are a result of over 150 January 2023 Ballot related trackers which are listed below:
Tracker Status: SummaryJira IssueLink to Updated Content
Applied: Remove html entities from examples FHIR-37474
Applied: Define the term Screening and Assessment FHIR-39938 See Changes Here](http://hl7.org/fhir/us/core/STU6/screening-and-assessments.html#introduction)
Applied: Clarify that Simple Observation Profile captures any sort of “simple” observations FHIR-39940See Changes Here
We have updated US Core to include the U.S. Core Data for Interoperability (USCDI) v3 Data Elements and Classes that the Office of the National Coordinator (ONC) published in July of 2022:
Applied: Health Insurance Information Using US Core to represent and access data related to an individual’s insurance coverage for health care.
Applied: The SDOH Assessments documentation has been rewritten and renamed to Screening and Assessments, reflecting its expanded coverage of Health Status/Assessments Data Elements. It documents how to use US Core Observation Screening Assessment Profile and the US Core Simple Observation Profile to represent and access health status and assessments, including: Functional Status, Disability Status, and Mental/Cognitive Status in addition to SDOH Assessments.
Several profiles from version 5.0.1 have been retired or renamed and rescoped in this version to accommodate the USCDI Health Status/Assessments Data Classes and as a result of implementer feedback. The Cross Version Comparisions Table summarized these significant revisions.
We continue our efforts to link terminology directly to the FHIR® Terminology Service for VSAC Resources (Value Set Authority Center (VSAC) - NIH) where applicable and, as a result, align terminology between US Core and HL7 C-CDA.
Implementers submitted over 70 trackers since the publication of US Core ver 5.0.0 and 5.0.1. We have addressed them and applied over 50 changes listed below:
Tracker Status: SummaryJira IssueLink to Updated Content
Applied: US Core Organization slice for CLIA does not list an HTA/THO approved external identifier system FHIR-36926See Changes Here
Applied: Remove effectiveDateTime invariant from Sexual Orientation and Simple Observation (aka Social History) Profiles FHIR-36932See Changes Here and See Changes Here
The changes in this errata to version 5.0.0 of US Core have been reviewed by the public through the HL7 errata process. The resolution of the community comments has been agreed to and voted on by the members of the HL7 International Cross-Group Projects work group.
Corrected Errata in Version 5.0.1 of US Core:
Tracker Status: SummaryJira IssueLink to Updated Content
Applied: Typos in Condition Profile URls FHIR-37585 See Changes:
The changes in this annual update to US Core have been reviewed and commented upon by the public through the January 2022 HL7 balloting process. The resolution of the community comments has been agreed to and voted on by the members of the HL7 International Cross-Group Projects work group.
What’s new in Version 5.0.0 of US Core:
New and updated resources to meet the U.S. Core Data for Interoperability (USCDI) v2 new Data Elements and Classes that the Office of the National Coordinator (ONC) published in July of 2021:
A Social Determinants Of Health (SDOH) guidance page on using US Core to represent and access SDOH Assessments, Goals, Interventions, and Problems/Health Concerns.
Applied: Update all occurrences of U.S. Core Data for Interoperability (USCDI) v1 to v2 or removed specific references to version. FHIR-34613For Example, See Change Here
Applied: Clinical Test Result Observation Profile Must Have needs to address the 3 slices for procedure, exam, and activity in the explanatory text FHIR-34753See Change Here
Applied: Clarify guidance for use of Patient.genderIdentity, Patient.birthsex, and pre-existing Patient.gender FHIR-34754See Change Here
Resolved - change required: List profiles by type and create table comparing Observation Profiles FHIR-34890 See Changes:
Applied: Change the query parameter value to be consistent with previous statement FHIR-35047See Change Here
Applied: Re-ordered sections in Downloads page and provide a zip file of schematrons FHIR-35064See Change Here
Applied: Split General Guidance page into 1) USCDI 3)General Guidance. Split Conformance Expectations into General Requirements and Must Support. Move General Guidance to General Requirements FHIR-35065 See Changes:
Applied: Clarify modeling of SDOH screening using Observations, Add QuestionnaireResponse profile as alternative screening instrument FHIR-35364 See Changes:
Applied: Change URL for CDT from http://ada.org/cdt to http://www.ada.org/cdt. FHIR-36861See Change Here
The Following Trackers Will be Applied in Future Version
Due external dependencies and publication tooling limitations, the application of these resolutions have been deferred.
Working with HL7 publishing to resolve these publishing issues:
Tracker Status: SummaryJira Issue Application Status
Resolved - change required: Patient Examples QA Errors: CDCREC code system in VSAC FHIR-30105 Manual code expansion and STU Note Present. Working with HL7 publishing to fix integration with VSAC.
Resolved - change required: valueset-simple-language.xml QA Error FHIR-30107 Working with HL7 publishing to fix.
Resolved - change required: Extensions used that are not defined in the scope FHIR-35775
Working with HL7 IG Authoring project to address these issues on IG readability:
Tracker Status: SummaryJira Issue Application Status
Resolved - change required: In most of the data elements – “Binding is from base FHIR and US Core Vital Signs” Need this to be one single combined listing FHIR-30780
Resolved - change required: AllergyIntolerance does not show constraint FHIR-34636
Resolved - change required: RelatedPerson relationshiptype should have binding to FHIR value set RelatedPerson-relationshiptype FHIR-34755
Applied: Care Team Member: Name, Identifier, Location, Telecom and Role See Change Here and Here and Here
Applied: Encounter: Diagnosis, Disposition, Location, Time, Type See Change Here
Applied: Problems: Date of Diagnosis and Date of Resolution See Change Here
Continued efforts to link terminology directly to the FHIR® Terminology Service for VSAC Resources (Value Set Authority Center (VSAC) - NIH) where applicable and as a result align terminology between US Core and HL7 C-CDA.
Addition of consolidated CSV and Excel File representations of Profiles to enable testers and analysts to review elements properties across profiles in a single table
Addressed and applied over 30 trackers submitted by implementers since the previous STU2 ballot for US Core ver 4.0.0:
Tracker Status: SummaryJira IssueLink to Updated Content
Applied: Make values in direct and birth sex extensions min=1 FHIR-26459 See Change:
Applied: US Core search page is not working FHIR-34028See Change Here - Coordination with HL7 IG publishing team to Correct
The Following Trackers Will be Applied Following this Ballot
Due external dependencies and publication tooling limitations, the application of these resolutions have been deferred.
Tracker Status: SummaryJira IssueLink to Updated Content
Resolved - change required: US Core Pulse Oximetry Profile noncomformant UCUM Unit for Oxygen Concentration FHIR-27845 - Awaiting FHIR-4b updates to update base FHIR Vitals Profile, STU Note Present
Resolved - change required: Patient Examples QA Errors: CDCREC code system in VSAC FHIR-30105See Change Here - Coordination with VSAC and IG publishing team to Correct and align Code System OIDS between FHIR, CCDA, and VSAC, Note To Balloters Present
Resolved - change required: valueset-simple-language.xml QA Error FHIR-30107See Change Here - Coordination with IG publishing team to Correct - Note To Balloters present
Resolved - change required: Display only differential invariants and terminology tables in Differential View FHIR-30780See Change Here - Coordination with HL7 IG publishing team to Correct
Resolved - change required: Confusing to reads invariants and terminology tables in Differential View FHIR-30783See Change Here - Coordination with HL7 IG publishing team to Correct
Resolved - change required: Wrong link to IG homepage from package manifest FHIR-33132See Change Here - Coordination with HL7 IG publishing team to Correct
The changes in this annual update to US Core have been reviewed and commented upon by the public through the January 2021 HL7 balloting process. The resolution of the community comments has been agreed to and voted on by the members of the sponsoring work group HL7 International Cross-Group Projects.
The key changes are summarized below:
New Conformance Expectations page
Defining different ways to implement and conform to US Core.
Clarification of the Must Support definitions as it relates to various FHIR elements such a choice datatype and references.
Publishing a set US Core Vital Signs independent of the FHIR core profile upon which it is based
US Core Vital Signs Profile
US Core Blood Pressure Profile
US Core BMI Profile
US Core Head Circumference Profile
US Core Body Height Profile
US Core Body Weight Profile
US Core Body Temperature Profile
US Core Heart Rate Profile
US Core Respiratory Rate Profile
Linking terminology directly to the FHIR® Terminology Service for VSAC Resources (Value Set Authority Center (VSAC) - NIH) where applicable:
US Core Value Set, VSAC Value Set, VSAC OID, extensional? 1. Detailed ethnicity, Detailed Ethnicity, 2.16.840.1.114222.4.11.877, No 1. OMB Ethnicity Categories, Ethnicity, 2.16.840.1.114222.4.11.837, Yes 1. US Core CareTeam Provider Roles, Care Team Member Function, 2.16.840.1.113762.1.4.1099.30, Yes 1. US Core Medication Codes (RxNorm), Medication Clinical Drug, 2.16.840.1.113762.1.4.1010.4, Yes 1. US Core Provider Specialty (NUCC), Healthcare Provider Taxonomy, 2.16.840.1.114222.4.11.1066, No 1. US Core Smoking Status, Smoking Status, 2.16.840.1.113883.11.20.9.38, Yes 1. US Core Vaccine Administered Value Set (CVX), CVX Vaccines Administered Vaccine Set, 2.16.840.1.113762.1.4.1010.6, Yes 1. US Core Common substances for allergy and intolerance documentation including refutations, Common substances for allergy and intolerance documentation including refutations, 2.16.840.1.113762.1.4.1186.8, No
Migrating to the standard set of HL7 FHIR IG templates for publishing. Although we strove to minimize the differences between this version and the previous versions of US Core, these changes are notable:
Additional Features include:
Addition of vocabulary and constraint tables to the profile pages
Addition of a summary table and to the profile page introduction
Addition of “Snapshot Table (Must Support)” Tab to profile views
Due to restrictions on customizable content, the full narrative text summaries of profiles is no longer available.
Addressing over 90 January 2021 Ballot related trackers resulting in the followed detailed changes.
Listed below are the resolved trackers for this version:
Applied: Clarify resource search requirements CapabilityStatements and provide guidance on search for multiple patients using Bulk data (FHIR-30787) See Changes:
We are working to fix these issues that may come up when using US CORE. We will correct them in a future version of the guide
Publishing
Resolved - change required:Confusing for commercial vendor. Reads very confusing. (FHIR-30783) proposal is to make the differential tab the default view, see publishing plans here timeline unknown.
Resolved - change required:In most of the data elements – “Binding is from base FHIR and US Core Vital Signs” Need this to be one single combined listing (FHIR-30780) proposal is to limit the terminology and invariants to view shown. see Zulip chat timeline unknown.
Resolved - change required:Why are there separate codes for USCoreVitalSigns and the Systolic.value and the diastolic value? (FHIR-30779) proposal is to work with publishing to “clean up” terminology and invariants to view shown. see: see Zulip chat timeline unknown.
Terminology
Resolved - change required: valueset-simple-language.xml QA error “Error from server: Language valuesets cannot be expanded as they are based on a grammar” (FHIR-30107) this error is still extant from prior version of US Core and has yet to be resolved. Work with publishing to fix and created STU note. see Zulip chat
Resolved - change required:imm-1.json NDC/CVX codes QA Error (FHIR-30104) Work with terminology server team to correct. see Zulip chat
Resolved - change required:Pulse Ox Example: observation-satO2-fiO2 (FHIR-27845) Proposed Jira ticket to resolve in base made an STU note that is technically not conformant with the base FHIR vital profile. See Zulip chat
The changes in this version have been voted on by the members of the sponsoring work group HL7 International Cross-Group Projects. This version addresses the following key issues:
Clarification of the Must Support definitions as it relates to:
Polymorphic datatypes, which of the possible types must be supported
Reference datatype (Reference, canonical) which of the target types must be supported
The vital signs profile in the Core Specification which profiles must be supported
New [Conformance Expectations] page
(see individual trackers below for details)
Publishing a set US Core Vital Signs independent of the FHIR core profile upon which it is based (see individual trackers below for details)
We are seeking to resolve several technical and policy glitches when using VSAC directly prior to publishing which include the requirement to log in using your own UMLS API Key requiring a current UMLS account to view the value sets. VSAC UMLS Licensing information.
To view the VSAC value set, use the link https://vsac.nlm.nih.gov/valueset/{OID}/expansion in your browser replacing the {OID} with the OID from the table below.
Enumerated (extensional) value sets can also be downloaded as a FHIR ValueSet resource. To do this, use the link https://cts.nlm.nih.gov/fhir/ValueSet/{OID} in your browser replacing the {OID} with the OID from the table below.
NOTE that the Code System value used in FHIR® Terminology Service for VSAC Resources for Race and Ethnicity (CDCREC) concepts does not align with historical and current usage of OIDs in C-CDA and US Core. This issue has not been resolved in time for publication of the ballot version of this guide. As a result validation errors may occur when validating against this version of the US Core Patient Profile. Feedback on which code system value to use is welcome.
US Core Value Set, VSAC Value Set, VSAC OID, extensional?
Detailed ethnicity, Detailed Ethnicity, 2.16.840.1.114222.4.11.877, No
Detailed Race, Race, 2.16.840.1.113883.1.11.14914, No
US Core CareTeam Provider Roles, Care Team Member Function, 2.16.840.1.113762.1.4.1099.30, Yes
US Core Medication Codes (RxNorm), Medication Clinical Drug, 2.16.840.1.113762.1.4.1010.4, Yes
US Core Provider Specialty (NUCC), Healthcare Provider Taxonomy, 2.16.840.1.114222.4.11.1066, No
US Core Smoking Status, Smoking Status, 2.16.840.1.113883.11.20.9.38, Yes
US Core Vaccine Administered Value Set (CVX), CVX Vaccines Administered Vaccine Set, 2.16.840.1.113762.1.4.1010.6, Yes
US Core Common substances for allergy and intolerance documentation including refutations, Common substances for allergy and intolerance documentation including refutations, 2.16.840.1.113762.1.4.1186.8, No
Migrating to the standard set of HL7 FHIR IG templates for publishing. Although we strove to minimize the differences between this version and the previous versions of US Core, these changes are notable:
Additional Features include:
Addition of vocabulary and constraint tables to the profile pages
Addition of a summary table and to the profile page introduction
Addition of “Snapshot Table (Must Support)” Tab to profile views
Due to restrictions on customizable content, the following features of prior versions are no longer available:
Full narrative text summaries of profiles NOTE: We are seeking feedback on whether to retain these full narrative text summaries for this guide (an example can be seen here by clicking on the “Text Summary” tab)*
Addressing over 95 outstanding trackers.
Trackers items and links to the updated content
listed below are the resolved trackers for this version:
Must Support Over Interpreted (FHIR-28375) Changes throughout the profiles – added conformance page See Change Here
Replace the US Core Update Allergy substances value set with VSAC reference (FHIR-29322) See Change Here
Change bindings from extensible to required for Condition.code value set: US Core Condition Category Codes Procedure.code value set: US Core Procedure Codes (FHIR-29563) See Changes Here:
Change binding for CareTeam.participant.role from NUCC to Care Team Member Function, replace the US Core Careteam Provider Roles Value Set with VSAC reference (FHIR-27769) See Change Here
Remove US Core Server Capability Statement requires support for HTTP status 410-deleted (FHIR-26597) See Change Here
This update addresses several technical corrections and errata and clarifications. They have been reviewed and voted on by the members of the HL7 International Cross-Group Projects WorkGroup who is sponsoring this errata release and reconciliation of the comments.:
Corrected US Core Pulse Oximetry Profile component.valueQuantity.code and component.valueQuantity.unit min from 0 to 1 to be consistent with the valueQuantity constraints within US Core (FHIR-27846)
review period comments Remove Provenance requirement from Medication, Location, Practitioner, PractitionerRole, and Organization and correct copy and paste error to Medication and Provenance searchType support in CapabilityStatement (FHIR-26840, FHIR-28161).
Correction on USCDI Table change “MedicationStatement” to “MedicationRequest” and remove references to MedicationStatement in the Medication Profile and CapabilityStatements (FHIR-26840).
In order meet the proposed *ONC U.S. Core Data for Interoperability** (USCDI) regulatory requirements for access to patient data, this STU Update of the US Core Implementation Guide has added new content. Structured Documents and the Argonaut Project Team have spent the last several months reviewing, testing and providing invaluable feedback on these and other topics including most notably:
1) A US Core Provenance Profile and Basic Provenance guidance on fetching Provenance for patient data.
2) Medication List Guidance for fetching a patient medications
3) Recasting the US Core Device profile into a US Core Implantable Device Profile
4) A US Core spO2 by US Core Pulse Oximetry Profile
5) Updated search to support requiring search by multiple statuses
6) Guidance when the source has no data
7) General guidelines and considerations for DSTU2 to R4 Conversion
8) Guidance for language support
9) Considerations for fetching data for multiple patients]
10) Future considerations for times offset and timezone guidelines
11) Future Considerations for writing and updating data
12) Update security pageto reflect current testing.
13) Clarify definition of MustSupport to reflect the intent that the server must be able to populate a MustSupport element in order to claim conformance to the profile.
14) Expanding bindings for Procedure and Condition codes for quality measures and other purposes.
These sections as well as several other clarifications, corrections and technical changes that are listed in the sections below have been reviewed and voted on by the members of the HL7 International Structured Documents WorkGroup who is sponsoring this STU Update comment period and reconciliation of the comments.
In order meet the proposed ONC U.S. Core Data for Interoperability (USCDI) regulatory requirements for access to patient data, this STU Update for Comment Version of the US Core Implementation Guide has added new content. The Argonaut Project Team has spent the last several months reviewing, testing and providing invaluable feedback on these and other topics including most notably:
1) A US Core Provenance Profile and guidance on fetching Provenance for patient data.
2) Guidance on fetching a patient’s medications
3) A US Core spO2 by Pulse Oximetry profile
4) Recasting the US Core Device profile into a US Core Implantable Device profile
5) Making server search requirements less opaque and requiring search by multiple statuses.
6) Guidance when the source has no data
7) General guidelines and considerations for DSTU2 to R4 Conversion
8) Guidance for language support
9) Considerations for Fetching data for multiple patients
10) Future considerations for times offset and timezone guidelines
These sections as well as several other clarifications, corrections and technical changes that are listed in the sections below have been reviewed and voted on by the members of the HL7 International Structured Documents WorkGroup who is sponsoring this STU Update comment period and reconciliation of the comments.
FHIR R4 version of US Core which added profiles for exchanging Clinical Notes, expanded search expectations, and updated guidance as a results of comments from balloters.