HL7 Cross Paradigm Implementation Guide: Gender Harmony - Sex and Gender Representation, Edition 1
1.0.0 - release

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

Change Log

This log contains changes that are a result of the HL7 International ballot process for for all cross-paradigm gender harmony publications. The resolution of the community comments have been agreed and voted on by members of the following management and work groups: CDA Management Group, Financial Management, Orders and Observations, Patient Administration, Patient Care, Structured Documents, Terminology Infrastructure, Terminology Services Management Group, and V2 Management Group.

Changes applied to FHIR R5 Standard

Applied: Wording, formatting, and grammar corrections per FHIR-38861, FHIR-39197, FHIR-39201, FHIR-39202, FHIR-39204, and FHIR-39210
Applied: Removed the element “InternationalEquivalentRecordedSexOrGender” FHIR-38892, FHIR-39193, and FHIR-39527
Applied: Modified Definition of Specified and Null FHIR-38893
Applied: Added PractitionerRole as an allowed context for the GI extension FHIR-39195
Applied: Added general language referring implementers to GHP IG for specific guidance on how and when to use FHIR-39196
Applied: Updated gender-identity value set to use the codes from the source code system (SNOMED) directly instead of importing the NLM value set. FHIR-39198
Applied: Updated GI text FHIR-39202
Applied: Added “asked-declined” to GI value set FHIR-39238
Applied: Update the definition narrative for individual-genderidentity extension FHIR-39246
Applied: Modified display names in the value set to remove the “(finding)” parenthetical FHIR-39459
Applied: Changes to the guidance and wording in the Sex and Gender section, moving recommendations out of the FHIR base spec and into the GHP IG FHIR-39203
Applied: Modified RSG value set FHIR-39205 and FHIR-39237
Applied: Added clarification for RSG FHIR-39232, see also OTHER-2463
Applied: Change SFCU to SPCU FHIR-39219
Applied: Update the unknown code in the SFCU value set to be “unknown” from https://terminology.hl7.org/CodeSystem-data-absent-reason.html FHIR-39231
Applied: Clarified definition and display for “Specified” in SFCU values FHIR-39241
Applied: Update pronoun value set display text to the same as the LOINC code it represents FHIR-39676

Changes applied to the HL7 CDA® R2 Implementation Guide: Gender Harmony - Sex and Gender Representation, Edition 1 Implementation Guide

Completed: Removed the final HL7 CDA® R2 Implementation Guide: Gender Harmony - Sex and Gender Representation, Edition 1 PDF from this guide, the final document is published separately
Applied: Update CONF:4536-61 conformance verb from SHOULD to SHALL OTHER-2435
Applied: In the Gender Identity section added sentence to provide clarity around provenance OTHER-2465
Applied: In the Individual Pronouns section added sentence to provide clarity around provenance OTHER-2467
Applied: Removed the International Equivalent Recorded Sex or Gender data element OTHER-2469
Applied: Updated individual pronouns constraint CONF:4536-61, SHALL contain…code SHOULD be…OTHER-2475
Applied: Updated individual pronouns constraint CONF:4436-60 a OTHER-2476
Applied: Updated inconsistent conformance verb/cardinality: MAY contain 1..1 effective time OTHER-2477
Applied: Updated USG value set binding OTHER-2478
Applied: Improved sub-organization modularity for recorded sex and gender OTHER-2480
Applied: Added RSG Jurisdiction and Document Type observations value set bindings OTHER-2481
Applied: RSG Document Type sub-observation verb/cardinality mismatch corrected OTHER-2482
Applied: Updated typo in statusCode “complete” to “completed” OTHER-2483
Applied: Corrected RSG constraint CONF:4536-136 urn:oid OTHER-2485
Applied: Corrected RSG Xpath for reference narrative guidance OTHER-2486
Applied: Updated display name for LA29520-6 OTHER-2489
Applied: Fix broken links Gender Identity Core Concepts, Asked but Unknown and Other and harmonize the value set with THO ValueSet Gender Identity OTHER-2498 and OTHER-2499
Applied: Fix broken Pronoun links OTHER-2500
Applied: Clarified recorded sex and gender representation Observation: identifier urn:oid:2.16.840.1.113883.10.15.4 OTHER-2501
Applied: For consistency, removed RSG CONF:4536-141. It was Not included FHIR R5 or V2.9.1 OTHER-2504
Applied: Correction, added missing Act Relationship Types for RSG OTHER-2505
Applied: CDA Recorded Sex or Gender Patient Record Type, use Act reference/ExternalAct instead OTHER-2506 and OTHER-2508
Applied: Remove DateTime Template, use effectiveTime OTHER-2507
Applied: CDA Recorded Sex or Gender - Sex for Clinical Use SPRT actRelationshipType is “Has Support” OTHER-2510
Applied: In CDA, Change SFCU to SPCU based upon resolution of ballot comments OTHER-2470 and OTHER-2671
Applied: CDA Sex for Clinical Use - Unclear Sentence OTHER-2511
Applied: Update the conformance statement for observation.value.code at 2.3.13.a.v OTHER-2640
Applied: Updated gender null flavor instructions OTHER-2711

Changes applied to the V2.9.1 Standard

Applied: Wording, typos,broken links, and grammar corrections per V2-25385, V2-25386, V2-25387, V2-25420, V2-25423, V2-25424, V2-25442, V2-25446, V2-25452, V2-25458, V2-25487, and V2-25507,

Applied: Modified both OBX and 3 new segments, updated guidance V2-25412
Applied: Updated the descriptions of PID-8, GT1-9, and IN1-43 V2-25414 and V2-25506
Applied: Added guidance for name to use in section V2-25415
Applied: Added guidance in Chapter 1 clarifying updates to the underlying base are not expected to automatically be adopted by existing integrations V2-25418

Applied: Modified Table 0821 per V2-25425, V2-25434, FHIR-39459, V2-25447, and V2-25460

Applied: SFCU changed to SPCU, links provided to the Gender Harmony Implementation Guide V2-25427
Applied: Modified to table to include the final value set description in the FHIR value set V2-25436
Applied: Updated Table 824 in Chapter 2c to align with the FHIR RSG value set http://hl7.org/fhir/extensions/ValueSet-recorded-sex-or-gender-type.html V2-25438
Applied: Modified Table 0826 to align with https://build.fhir.org/valueset-doc-typecodes.html and changed the name of GSR-7 to SourceDocumentTypeForRecordedSexOrGender V2-25439 and V2-25454

Applied: Updated Table 0820 per V2-25441, V2-25459, and V2-25462

Applied: Updated chapter 2A - Control and Data Types Reference Range Administrative Sex Component for Gender Harmony per V2-25443 and V2-25518

Applied: Clarified that V2 will maintain the value set for Sexual Orientation directly, as that is not part of the Gender Harmony project. V2 will also maintain a value set of relevant gender-related LOINC codes for use in OBX-3. V2-25444
Applied: Removed element “InternationalEquivalent” V2-25453

Applied: Updated Table 0823 per V2-25463, V2-25465, and V2-25468

Applied: Corrected NK1 (removed SFCU) and added GSP and GSR V2-25471 and V2-25478

Applied: Moved the Gender Harmony segments to before PRT and after PD1, to align with the ordering defined in Chapter 3 V2-25473

Changes to this Cross-paradigm Implementation Guide

Changes applied across the Implementation Guide

Applied: Add links of a model acronym to the model heading for the element, to organizations, named specifications OTHER-2521
Applied: Added additional depth to the TOC OTHER-2526
Applied: Standardized the use of “Gender Harmony initial informative specification” when referring to initial specification OTHER-2570
Applied: Links to ValueSet and CodeSystems, binding strength definitions, and standardized ValueSet and datatype name capitalization OTHER-2574
Applied: Remove notes to balloters OTHER-2571, OTHER-2602, and OTHER-2604
Applied: Update SFCU to SPCU throughout the Gender Harmony IG and capitalized consistently OTHER-2414, OTHER-2671, and OTHER-2706,
Applied: Consistent capitalization of Gender Harmony OTHER-2580
Applied: Corrected footer published by OTHER-2523
Applied: The tab “History” was modified to Change Log OTHER-2592
Applied: Wording, typos, and grammar corrections per OTHER-2491
Applied: Added (shownav parameter) that inserts forward/backward navigation at top and bottom OTHER-2516

Changes applied to Home Page

Applied: Wording, typos, and grammar corrections per OTHER-2531, OTHER-2561, OTHER-2563, and OTHER-2565
Applied: Further explanation of ‘harmony’ in gender harmony OTHER-2594
Applied: Improved the readability and formatting of the In-scope section OTHER-2562 and OTHER-2528, Added links to the model page for GI, SPCU, RSG, Pronouns, NtU OTHER-2532
Applied: Updated the name of section 1.4.3 from Vendors to HIT System solution providers OTHER-2515
Applied: Updated to use the word ‘harmony’ to ‘harmonize’ OTHER-2594
Applied: Added links to DICOM and X12 OTHER-2564
Applied: Modified first sentence of the HIT System solution providers OTHER-2421
Applied: Improved the footnote notation using MD based footnote syntax OTHER-2560

Changes applied to Background Page

Applied: Minor wording, typos, and grammar corrections per OTHER-2533, OTHER-2535, OTHER-2536,OTHER-2566, OTHER-2568, OTHER-2537, and OTHER-2567

Changes applied to Model Page

Applied: Wording, typos, improved model display, and grammar corrections per OTHER-2411, OTHER-2420, OTHER-2480, OTHER-2492, OTHER-2494, OTHER-2519, OTHER-2572, OTHER-2573, OTHER-2575, OTHER-2576, OTHER-2577, OTHER-2578, OTHER-2581, OTHER-2582, OTHER-2585, OTHER-2597, OTHER-2625, and OTHER-2709
Applied: Changed field name from Jurisdiction to Issuer, added Definition, and put Cardinality on its own line OTHER-2586
Applied: Updated Source Field Name and Source Field Description OTHER-2587
Applied: Updated RSG model definition and other narrative OTHER-2463
Applied: Clarified terminology expectations for RSG OTHER-2557
Applied: Removed international equivalent references V2-25452
Applied: Confirmed removal of ICAO element and added explanation of change OTHER-2512
Applied: Updated GI usage note per OTHER-2539 and OTHER-2708
Applied: Updated UML Model with ballot changes OTHER-2707
Applied: Added links for minValueSets for SPCU, Pronouns, and Gender identity OTHER-2540
Applied: Clarified use of “sex or gender” OTHER-2532
Applied: Added section noting changes in the model when compared to original, conformed changes in bindings and provided links to binding strength definitions OTHER-2589
Applied: Added links to separate specifications OTHER-2569

Changes applied to Guidance, Design Considerations Page

Applied: Added new ribbon drop-down: Guidance, Place the Design Considerations page under ribbon entry, add new page “Implementer Considerations” OTHER-2472 and OTHER-2678
Applied: Added links, updated wording, typos, and made grammar corrections per OTHER-2541, OTHER-2542, OTHER-2543, OTHER-2546,
OTHER-2593, OTHER-2595, OTHER-2596, OTHER-2598, and OTHER-2599
Applied: Modified designated value sets in tables so they are represented consistently OTHER-2598
Applied: Removed TBD in RSG section OTHER-2600 and corrected the “Designated value set”
Applied: Updated RSG section to align with change in source document to be a concept domain (table 0826). Updated GSR field ids in RSG table for V2 after removal of International equivalent field OTHER-2479 and OTHER-2496
Applied: Modified text in the “Support zero to many instances” rows for GI and Pronouns OTHER-2422
Applied: Modified Name to Use table OTHER-2544 and OTHER-2674
Applied: Updated Gender Identity table to support notion of unknown OTHER-2556
Applied: Updated the CDA column of “Support notion of value = unknown” in SPCU table OTHER-2545
Applied: Updated the CDA column of ‘Support GH attribute = validity period, type = duration’ in the GI table OTHER-2577
Applied: Updated the V2 column of “Specific allowed set of values only” in teh SPCU table OTHER-2627
Applied: Modify table entries from “responsibility of template container” to the following row Define where element is available/appropriate for use. 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. OTHER-2676
Applied: Modified Pronouns section “Supports additional values (example) row OTHER-2589
Applied: Modified GI V2 binding section, added “Note: V2 requires a looser binding due to use of a structure that is used across other observations.” OTHER-2522

Changes applied to Guidance, Implementer Considerations Page

Applied: Added SPCU considerations OTHER-2558
Applied: Added new section Sex assigned at birth-focused Sex Parameter for Clinical Use OTHER-2452

Changes applied to Use Cases, DICOM PET Scan Use Case

Applied: Updated use case with changes from OTHER-2411, OTHER-2423, OTHER-2424, OTHER-2426, OTHER-2451, OTHER-2488, OTHER-2548, OTHER-2549,
OTHER-2601, OTHER-2603, and OTHER-2607,

Changes applied to Use Cases, Health Maintenance Lab Use Case Page

Applied: Updated SPCU code values and fixed heading hierarchy OTHER-2425

Changes applied to V2, V2 Gender Harmony Page

Applied: Updated wording, typos, and made grammar corrections per OTHER-2429, OTHER-2431, OTHER-2432, OTHER-2433, OTHER-2530, OTHER-2550, and OTHER-2551,
Applied: DICOM use case group has met with GH community and all open DICOM items were transitioned to DICOM supplement 233 OTHER-2454

Changes applied to CDA, CDA Gender Harmony Page

Applied: Remove notes to balloters OTHER-2571, OTHER-2602, and OTHER-2604
Applied: Update SFCU to SPCU throughout the Gender Harmony IG and capitalized consistently OTHER-2414, OTHER-2671, and OTHER-2706,

Changes applied to CDA, CDA Examples Page

Applied: Updated the NtU example per OTHER-2497 and OTHER-2436
Applied: Updated SPCU example to be more complete OTHER-2471
Applied: Updated the Gender Identity example to illustrate the correct usage of the templates OTHER-2464
Applied: Updated the Gender Identity example to include ASKU and OTH OTHER-2466
Applied: Removed the codeSystem=”NP” from the example OTHER-2487

Changes applied to FHIR, FHIR Guidance

Applied: Split design background into a new page, updated FHIR guidance with much more detail OTHER-2558
Applied: Added links, updated wording, typos, and made grammar corrections per OTHER-2411, OTHER-2428, OTHER-2616, OTHER-2617,
OTHER-2619, and OTHER-2629
Applied: Added guidance on the R4 backport extension for SPCU OTHER-2618 and OTHER-2620

Changes applied to FHIR, FHIR Design Background

Applied: Split design background into a new page, updated FHIR guidance with much more detail OTHER-2558
Applied: Updated wording, typos, and made grammar corrections per OTHER-2610, OTHER-2611, OTHER-2613, OTHER-2579,
OTHER-2525, and OTHER-2633
Applied: Moved ‘Avoids problems with changing normative content.” to the Advantages column in last two rows of table OTHER-2612
Applied: Added ServiceRequest and Procedure to SPCU context, clinical resource types OTHER-2615
Applied: Updated Backwards Compatibility for FHIR versions section OTHER-2618

Changes applied to Terminology

Applied: Added links, updated wording, typos, and made grammar corrections per OTHER-2409, OTHER-2457, OTHER-2458, OTHER-2459, OTHER-2553, OTHER-2557,
OTHER-2606, OTHER-2630, and OTHER-2641
Applied: Modified GI values to include FHIR DAR and V3 Null OTHER-2427
Applied: Modified Gender Identity section discussion around minimum value set for clarity OTHER-2636
Applied: Added additional guidance for RecordedSexOrGender OTHER-2637
Applied: Updated SPCU value references OTHER-2552

Changes applied to External Standards

Applied: Updated wording, typos, add links, and made grammar corrections per OTHER-2590 and OTHER-2609
Applied: Updated DICOM section to align with use of SPCU and final SPCU values OTHER-2608
Applied: Added LOINC section, arranged sections in alpha order OTHER-2710

Changes applied to Artifacts

Applied: Modified to list all IG artifacts as a ‘linked’ Title not separating the title from the url OTHER-2591
Applied: Modified reference to VSAC for UV value sets OTHER-2622