HL7 Cross Paradigm Implementation Guide: Gender Harmony - Sex and Gender Representation, Edition 1, published by HL7 Terminology Infrastruture Work Group. This is not an authorized publication; it is the continuous build for version 1.0.0. This version is based on the current content of https://github.com/HL7/fhir-gender-harmony/ and changes regularly. See the Directory of published versions

Design Considerations

The discussion around gender harmony has been on-going for several years. This implementation guide is based on the logical Gender Harmony initial informative specification published in 2021 and the evolution of the Gender Harmony Project (GHP) team’s understanding of how sex and gender information is implemented currently and how it could be more effectively implemented in electronic healthcare systems. Based upon input from the community, the Gender Harmony project has defined (and prefers) implementing a model using extensions so that the added information is “close to user,” but it is clear that as an alternative users may choose to implement the information as observations in a manner similar to that found in the Gravity Project, for example Observation Recorded Sex Gender.

The table below lists design requirements considered by GHP for each Gender Harmony Model element and its implementation across the HL7 product families. Both the FHIR and V2 efforts chose to build sex and gender harmony model information into the core model – as FHIR extensions in FHIR and as a new segment in V2 – because the information processing requirements that those standards support benefit from this proximity. CDA does not have this constraint and prioritized ease of use and access to the artifacts, ultimately opting for the use of a clinical statement template as the most feasible approach.

Detailed design considerations for each HL7 product family are included in the appropriate sections in this IG.

Gender Identity

Logical Model Requirement	V2	FHIR	CDA
Distinct attribute available in specific places	GSP segment	Extension: https://hl7.org/fhir/extensions/StructureDefinition-individual-genderIdentity.html	Gender Identity Entry Template
Define where element is available/appropriate for use	As appropriate in the message structure	Patient, Person, RelatedPerson, Practitioner	All Open CDA Templates allow for using any other defined CDA Templates; The context and use of the «inserttemplatename» is driven by the template in which the template is contained.
Support zero to many instances	It is expected, but not required, that there be only one gender identity value for any time period even though the genderIdentity extension/segment can be repeated.	It is expected, but not required, that there be only one gender identity value for any time period even though the genderIdentity extension/segment can be repeated.	It is expected, but not required, that there be only one gender identity value for any time period even though the genderIdentity extension/segment can be repeated.
Value is coded and allows text	SOGI Concept Value (GSP-5), when SOGI Concept (GSP-4) = 76691-5^Gender Identity^LN with datatype Coded with Exceptions (CWE)	Datatype: CodableConcept (http://build.fhir.org/datatypes.html#CodeableConcept)	CD (CONF:4536-48)
Designated value set	GenderIdentity (http://terminology.hl7.org/ValueSet/gender-identity)	GenderIdentity (http://terminology.hl7.org/ValueSet/gender-identity)	GenderIdentity (http://terminology.hl7.org/ValueSet/gender-identity) (CONF:4536-48)
Support notion of value = “unknown”	UNK and asked-declined are in the Gender Identity value set	UNK and asked-declined are in the Gender Identity value set	UNK and asked-declined are in the Gender Identity value set
Supports additional values (extensible)	Example Binding Note: V2 requires a looser binding due to use of a structure that is used across other observations.	Preferred Binding	SHOULD (CONF:4536-48)
Support GH attribute = validity period, type = duration	Validity Range (GSP-6) with datatype Date Range (DR)	Datatype: Period (http://build.fhir.org/datatypes.html#Period)	effectiveTime/low and effectiveTime/high (CONF:4536-50)
Support GH attribute = comment, type = string	Comment (GSP-7) with datatype Text (TX)	Comment, datatype: string	text (CONF:4536-140)

Pronouns

Logical Model Requirement	V2	FHIR	CDA
Distinct attribute available in specific places	GSP segment	Extension: https://hl7.org/fhir/extensions/StructureDefinition-individual-pronouns.html	Pronoun Entry Template
Define where element is available/appropriate for use	As appropriate in the message structure	Patient, Person, RelatedPerson, Practitioner	All Open CDA Templates allow for using any other defined CDA Templates; The context and use of the «inserttemplatename» is driven by the template in which the template is contained.
Support zero to many instances	It is expected, but not required, that there be only one pronoun value for any time period even though the pronoun extension/segment can be repeated.	It is expected, but not required, that there be only one pronoun value for any time period even though the pronoun extension/segment can be repeated.	It is expected, but not required, that there be only one pronoun value for any time period even though the pronoun extension/segment can be repeated.
Value is coded and allows text	SOGI Concept Value (GSP-5), when SOGI Concept (GSP-4) = 90778-2^Personal pronouns - Reported^LN with datatype Coded with Exceptions (CWE)	Datatype: CodableConcept (http://build.fhir.org/datatypes.html#CodeableConcept)	CD (CONF:4536-61)
Designated value set	Pronouns (http://terminology.hl7.org/ValueSet/pronouns)	Pronouns (http://terminology.hl7.org/ValueSet/pronouns)	Pronouns (http://terminology.hl7.org/ValueSet/pronouns) (CONF:4536-61)
Support notion of value = “unknown”	Can be extended, since example binding	If unknown, no value would be sent	Asked but Unknown and Other  (CONF:4536-67)
Supports additional values (example)	Example Binding	Example Binding	MAY (CONF:4536-61)
Support GH attribute = validity period, type = duration	Validity Range (GSP-6) with datatype Date Range(DR)	Datatype: Period (http://build.fhir.org/datatypes.html#Period)	effectiveTime (CONF:4536-69)
Support GH attribute = comment, type = string	Comment (GSP-7) with datatype Text (TX)	Comment, datatype: string	Text (CONF:4536-72)

Name to Use

Logical Model Requirement	V2	FHIR	CDA
Support recording a Name to Use	Patient Name PID-5 applicable to ANY name, where datatype: Extended Person Name (XPN) is used and name type code (XPN.7) is valued ‘N’ Applicable to ANY name, where datatype: Extended (XCN) is used and name type code (XCN.10) is valued ‘N’	Resource.name using HumanName datatype, HumanName.use element	Record Target name
Support structured type = Name	Datatype: Extended Person Name (XPN)	Datatype: HumanName Element: HumanName.use set to value “usual”	Patient.name
Associate with person	XPN: Patient Name (PID-5), Next of Kin Name (NK1-2), Staff Name (STF-3), Guarantor Name (GT1-3), Payee Person Name (PYE-5), etc. XCN: Ordering Provider (ORC-12/OBR-16), Participating Person (PRT-5), Attending Doctor (PV1-7), Referring Doctor (PV1-8), etc.	Include in following Resources: Patient, Person, RelatedPerson, Practitioner	Patient.name
Support zero to many instances	[0..*]	[0..*]	[0..*]
Support GH attribute = validity period, type = duration	XPN.12 for start date with datatype Time Stamp (TS) XPN.13 for Expiration date with datatype Time Stamp (TS)	Datatype: Period	PersonName.validTime

Sex Parameter for Clinical Use

Logical Model Requirement	V2	FHIR	CDA
Distinct attribute available anywhere needed	GSC segment	Extension: https://hl7.org/fhir/extensions/StructureDefinition-patient-sexParameterForClinicalUse.html	Sex Parameter for clinical use Template
Define where element is available/appropriate for use	As appropriate in the message structure	All resources, though it is expected to be used primarily on clinical resources and enclosing contextual resources like Patient and Encounter.	All Open CDA Templates allow for using any other defined CDA Templates; The context and use of the «inserttemplatename» is driven by the template in which the template is contained.
Support zero to many instances	added as optionally repeating	With this cardinality the expectation is there will be a single instance of the extension, but there can be multiple instances of the extension for a single resource type (IE, multiple orders of the same resource type representing different tests that have different SPCU needs).	All Open CDA Templates allow for using any other defined CDA Templates; The context and use of the «inserttemplatename» is driven by the template in which the template is contained.
Value is coded	Sex Parameter for Clinical Use (GSC-4) with datatype Coded with Exceptions (CWE)	Datatype: CodeableConcept (http://build.fhir.org/datatypes.html#CodeableConcept)	value with @xsi:type=”CD” (CONF:4536-83)
Designated value set	Sex Parameter for Clinical Use (https://terminology.hl7.org/5.2.0/ValueSet-sex-parameter-for-clinical-use.html)	Sex Parameter for Clinical Use (https://terminology.hl7.org/5.2.0/ValueSet-sex-parameter-for-clinical-use.html)	Sex Parameter for Clinical Use (https://terminology.hl7.org/5.2.0/ValueSet-sex-parameter-for-clinical-use.html) (CONF:4536-83)
Support notion of value = “unknown”	Included in value set	Included in value set	Represented as a NULL value, not in the value set.
Specific allowed set of values only	Required binding	Required binding	SHALL binding
Support GH attribute = validity period, type = duration	Validity Period (GSC-5) with datatype Date Range (DR)	Datatype: Period	effectiveTime (CONF:4536-82)
Support GH attribute = comment, type = string	Comment (GSC-8) with datatype Text (TX)	Comment, datatype: string	text (CONF:4536-80)
Support assertion of linked clinical obs evidence for assignment	Evidence (GSC-7) with datatype Message Location (ERL)	SupportingInfo, datatype: CodeableReference (http://build.fhir.org/references.html)	entryRelationship (CONF:4536-101)
Support assertion of context for use: specific context (not modeled)	Context (GSC-6) with datatype Message Location (ERL)	The resource in which the extension is used	Guidance on nesting template under target or (for multiple targets) using Entry Reference
Support assertion of context for use: patient	Patient segment in the same message where the segment is used	The patient that is linked to the resource in which the extension is used	Guidance on including independent of entryRelationship

Recorded Sex or Gender

Logical Model Requirement	V2	FHIR	CDA
Distinct attribute available in specific places	GSR segment	Extension: https://hl7.org/fhir/extensions/ValueSet-recorded-sex-or-gender-type.html	Recorded sex or gender entry Template
Define where element is available/appropriate for use	As appropriate in the message structure	Patient, Person, RelatedPerson, Practitioner	All Open CDA Templates allow for using any other defined CDA Templates; The context and use of the «inserttemplatename» is driven by the template in which the template is contained.
Support zero to many instances	added as optionally repeating	0..* in each instance	All Open CDA Templates allow for using any other defined CDA Templates; The context and use of the «inserttemplatename» is driven by the template in which the template is contained.
Value is coded and allows text	Recorded Gender or Sex (GSR-4) with datatype Coded with Exceptions (CWE)	Datatype: CodableConcept	CE datatype
Designated value set to be used	AdministrativeGender (https://terminology.hl7.org/5.2.0/ValueSet-v3-AdministrativeGender.html) example binding	AdministrativeGender (https://terminology.hl7.org/5.2.0/ValueSet-v3-AdministrativeGender.html) example binding	` `MAY be selected from ValueSet AdministrativeGender (https://terminology.hl7.org/5.2.0/ValueSet-v3-AdministrativeGender.html) (HL7 V3) urn:oid:2.16.840.1.113883.1.11.1 (CONF:4536-89)
Additional representation of value using international equivalent	International Equivalent Sex Value (GSR-5) with datatype Coded with Exceptions (CWE)	Optional InternationalEquivalent element	translation (CONF:4536-95)
International equivalent value set	International equivalent element has been removed from the final publication	International equivalent element has been removed from the final publication	International equivalent element has been removed from the final publication
Support GH attribute = Source Field Name, Type = String	Source Document Field Type and or Label (GSR-5) with datatype Coded With Exception (CWE) using Original text (CWE.9)	sourceField, DataType: String	If a coded value is available (e.g., “76689-9 sex assigned at birth”) then record that in Observation.code, otherwise put provided description of the field in Observation.code.orginalText.
Support source field “type”, indicating the type or category of sex or gender that is recorded	Source Document Field Type and or Label (GSR-5) with datatype Coded With Exception (CWE)	Type, dataType: CodeableConcept	entryRelationship: Patient record type value with @xsi:type=”CD” (CONF:4536-136)
Source Type value set	SourceDocumentTypeForRecordedSexOrGender (Table 0826 User specified) Concept Domain	Recorded Sex or Gender Type (http://terminology.hl7.org/ValueSet/recorded-sex-or-gender-type) Preferred binding	Recorded Sex or Gender Type (http://terminology.hl7.org/ValueSet/recorded-sex-or-gender-type) urn:oid:2.16.840.1.113883.11.19757 (CONF:4536-136).
Support GH attribute = Document Record Description, Type = string	Document Type (GRS-6) with datatype Coded With Exception (CWE) with value set documentType; for string use using Original text (CWE.9)	Reference to document as sourceDocument(DocumentReference). Coding of class of document in codeableReference.	code=”92183-3” Document type (CONF:4536-119) value with @xsi:type=”CD” (CONF:4536-121) originalText (CONF:4536-122)
Support GH attribute = acquisition date, type = date	Acquisition Date (GSR-8) with datatype Date Time (DTM)	extension: acquisitionDate (dateTime)	code=”50786-3” Date of entry (CONF:4536-125) value with @xsi:type=”TS” (CONF:4536-128)
Support GH attribute = jurisdiction, type = string	Jurisdiction (GSR-7) with datatype Coded With Exception (CWE)	extension: jurisdiction (CodeableConcept), Jurisdiction ValueSet Extensible binding	code “77969-4” Jurisdiction code (CONF:4536-109) value with @xsi:type=”CD” (CONF:4536-113) originalText (CONF:4536-114)
Support GH attribute = validity period, type = duration	Acquisition Date (GSR-9) with datatype Date Range (DR)	Datatype: Period (http://build.fhir.org/datatypes.html#Period)	value with @xsi:type=”TS” (CONF:4536-128)
Support GH attribute = comment, type = string	Comment (GSR-10) with datatype Text (TX)	Comment, datatype: string	MAY contain zero or one [0..1] text (CONF:4536-91)