Gender Harmony Project PSS

1a. Project Name Gender Harmony Project 1b. Project ID 1533 1c. Is Your Project an Investigative Project (aka PSS-Lite)? No 1d. Is your Project Artifact being Reaffirmed or proceeding to Normative directly after being either Informative or STU? No 1e. Today's Date 1f. Name of standard being reaffirmed 1g. Project Artifact Information 1h. ISO/IEC Standard to Adopt 1i. Does the standard include excerpted text from one or more ISO, IEC or ISO/IEC standards, but is not an identical or modified adoption? 1j. Unit of Measure 2a. Primary/Sponsor WG Vocabulary 2b. Co-Sponsor WG Patient Administration 2c. Co-Sponsor Level of Involvement Request formal content review prior to ballot 2b. Co-Sponsor WG 2 Patient Care 2c. Co-Sponsor Level of Involvement Request formal content review prior to ballot 2c. Co-Sponsor 2 Update Periods at WGMs 2b. Co-Sponsor WG 3 Financial Management 2c. Co-Sponsor Level of Involvement Request formal content review prior to ballot 2c. Co-Sponsor 3 Update Periods at WGMs 2b. Co-Sponsor WG 4 Structured Documents 2c. Co-Sponsor Level of Involvement Request formal content review prior to ballot 2c. Co-Sponsor 4 Update Periods at WGMs 2b. Co-Sponsor WG 5 Orders & Observations 2c. Co-Sponsor Level of Involvement Request formal content review prior to ballot 2c. Co-Sponsor 5 Update Periods at WGMs 2d. Project Facilitator Rob McClure/Carol Macumber 2e. Other Interested Parties (and roles) FHIR-I, HL7 Netherland (@Alexander Henket), HL7 Germany (@Kai U. Heitmann), HL7 Canada (@Kelly Davison), HL7 Australia (@Reuben Daniels), ISO TC 215 (@Beverly Knight), X12 (Kathy Shephard) , NCPDP (Margaret Weiker) and see https://confluence.hl7.org/display/VOC/Project+participants 2f. Modeling Facilitator Grahame Grieve 2g. Publishing Facilitator Graham Grieve 2h. Vocabulary Facilitator Rob McClure/Carol Macumber 2i. Domain Expert Representative Riki Merrick (O&O, V2), Lisa Nelson (CDA), Grahame Grieve (FHIR), Cooper Thompson (PA), Mary Kay McDaniel (FM), Celine Lefebvre (FM), 2j. Business Requirements Analyst 2k. Conformance Facilitator Graham Grieve 2l. Other Facilitators 2m. Implementers VA, DICOM, Epic, LabCorp 3a. Project Scope The original Gender Harmony project scope was, in summary, to achieve the following: 1. Identify the primary types of sex/gender classifications/uses that are currently needed for health data documentation and exchange The intent is to primarily represent actual user needs that reflects end user community needs including the international community. o Name and define these types. This class of things will, for now, be referred to as Sex-GenderTypes o include descriptions of the context of use for each Sex-GenderType. o If no real context of use can be identified then place the type on a to-do list and move on. Where agreement exists, link the context of use to existing clinical models/systems. o It is fine to identify existing model/systems that based on definition or existing allowed values, are linked to multiple sexy types. o Clarify the general context of use (write a definition) for the word “Sex” and the word “gender” o Pay particular attention to situations where a change in context of use may result in different sex or gender identity may change for the same person (IE: looks like a male but has female sex organs.) 2. Identify code/description/definition (ie, concepts, but not necessarily from an existing code system) to be used for each Sex-GenderType o While we may draw from a code system, this is not intended to restrict the process to use existing concepts. We’ll match things up later o Work to align with existing use and existing concepts, but not be hog-tied to them 3. Based on the context of use determined for the Sex-GenderTypes. Decide if the value set associated with the SexyType is “closed” or “open.” o CLOSED - no further concepts are to be used. This means any situation that doesn’t quite seem to fit one of the defined values would have to compromise and pick an existing value. o This means if we need to support Other or Unknown, we say that. (A so called null type) o OPEN - the defined set of concepts can be extended if the meaning that needs be sent is not in the provided value set. This is exactly equivalent to the FHIR Extensible binding strength. The expectation is that a concept from a different code system would be sent, and if that is not supported, then a text string. o If two Sex-GenderTypes are the same but one context needs to have a null, or needs to not be closed, that is a different context, so it’s a different Sex-GenderType. Phase 2: This Updated PSS defines additional objectives that was noted to be originally out of Scope but based on community feedback and Gender Harmony project group guidance, the informative document also included • The use of pronouns as a way of describing or addressing a person's sex or gender identity • Represented as a text attribute, the name that should be used when addressing or referencing the person. The following remained or were determined to be out of scope • Titles, Honorifics and/or Salutations: in accordance with an accepted practice or style (see Public Works and Government Services Canada, Translation Services Style Guide). Examples include Mr., Mrs., Ms., Mx, Doctor, Engineer, Captain, etc. • Defining or modeling the representation of patient sexual orientation, a future or future iteration of this group may convene separately to discuss such modeling. • Specific changes in standards to directly align with the proposed abstract model noted in this specification. In particular for HL7, enhancements to FHIR resources should be undertaken after consideration of this proposal. Some suggestions are provided in the Implementation Guidance section. • Representations of the provenance and qualifications needed for the collection of sex and gender identity information. Attachments 3b. Project Need The successful publication of the HL7 informative document entitled “Gender Harmony - Modeling Sex and Gender Representation, Release 1” was a critical step in providing the international community with a concise summary of the research around the impact of sex and gender on clinical care and a comprehensive description of the current state of sex and gender identity representation (or lack thereof) in both HL7 standards and various standard terminologies. Further, the HL7 informative document described, at a high level, how sex and gender are utilized in various health care related areas, including quality measurement, data analysis etc. Publication resulted in demands to implement changes in existing HL7 products to align with the recommended data model. This updated project scope statement adds the additional scope to support “Phase 2” of the project needed to meet the request to provide a guide that can be used by implementers to exchange V2, CDA (including C-CDA), and FHIR artifacts that are consistent with the Gender Harmony model. It is our plan to create a cross-paradigm Implementation Guide using whatever approach best suits the final product but if possible we intend to use the FHIR publishing process. Our intent is to describe the specific CDA templates, the specific profiles on FHIR resources, and updated V2 documentation required to align with the recommendations in the Gender Harmony informative document. If necessary we may also identify changes to a base specification. More specifically, 1. As a priority, the following are targeted for to support FHIR r5 (we may not complete this IG and the FHIR profiles in time for direct inclusion in r5): o Textual guidance improvements to the Patient Resource at section Patient Gender and Sex describing how to use existing resource elements where possible to align with the gender harmony ballot recommendations that do not require extensions or profiles. We may be able to get these textual improvements into r5 and maybe r4B. o New extensions or modification to extensions, or profiles on other resources (we assume Observations) where needed to fully represent: a. Gender Identity b. Sex for Clinical Use c. Recorded Sex or Gender d. Pronouns o We plan to investigate the ramifications of these changes to other resources related to Patient resource but may also provide profiles on related resources. o Examples for each of the above. 2. For V2 o We currently believe the changes needed are as follows. We need to determine what the best approach is for these regarding how to incorporate into v2.9 and support preadoption into earlier versions with the least impact on current implementations. a. Guidance on the use of PID-8 (Administrative Sex) b. Determination of the best approach for exchanging GH information in version 2. It is unclear at this point if this is best done using current 2.9 capabilities (OBX) or make changes that will require a new publication as determined by V2MG. c. Other changes as determined 3. Work with Structured Documents on any impact to CDA and C-CDA o FHIR Publication process to describe new templates, possibly an Organizer template, to support gender harmony. If there are any changes to existing templates, these will also be under consideration. We would like these changes to be ready for the upcoming new C-CDA publication. 4. Work with other SDOs who are currently engaged with the project such as DICOM, X12, NCPDP 3c. Security Risk No 3d. External Drivers Demand from numerous governmental agencies to implement the logical model with current and future HL7 standards. 3e. Objectives/Deliverables and Target Dates Phase I (Complete): January 2021 balloted informative document http://www.hl7.org/implement/standards/product_brief.cfm?product_id=564 BENEFITS: Describes an approach that can improve data accuracy for sex and gender information in health care systems Proposes independent consideration of sex and gender Phase II: A May 2022 Cross-paradigm Implementation Guide and potentially identify changes to a base specification. 3f. Common Names / Keywords / Aliases: Gender Harmony 3g. Lineage 3h. Project Dependencies 3i. HL7-Managed Project Document Repository URL: https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project 3j. Backwards Compatibility No 3k. Additional Backwards Compatibility Information (if applicable) 3l. Using Current V3 Data Types? No 3l. Reason for not using current V3 data types? 3m. External Vocabularies Yes 3n. List of Vocabularies SNOMED CT, LOINC, HL7 and others 3o. Earliest prior release and/or version to which the compatibility applies Jan 2021 Gender Harmony Informative Ballot 4a. Products FHIR Implementation Guide, FHIR Resources, V2 Messages – Administrative, V3 Documents – Clinical (e.g. CDA) 4b. For FHIR IGs and FHIR Profiles, what product version(s) will the profiles apply to? R5 4c. FHIR Profiles Version 4d. Please define your New Product Definition 4d. Please define your New Product Family 5a. Project Intent Implementation Guide (IG) will be created/modified 5a. White Paper Type Balloted Informative 5a. Is the project adopting/endorsing an externally developed IG? No 5a. Externally developed IG is to be (select one) 5a. Specify external organization 5a. Revising Current Standard Info 5b. Project Ballot Type STU to Normative 5c. Additional Ballot Info 5d. Joint Copyright No 5e. I understand I must submit a Joint Copyright Letter of Agreement to the TSC in order for the PSS to receive TSC approval. no 6a. External Project Collaboration Project membership includes representation from: DICOM, NCPDP, SNOMED, LOINC, ISO, US Department of Veterans Affairs, US Defense Health System, Canada Health Infoway, Fenway Health, US Office of the National Coordinator (ONC) 6b. Content Already Developed 6c. Content externally developed? 6d. List Developers of Externally Developed Content 6e. Is this a hosted (externally funded) project? 6f. Stakeholders Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors 6f. Other Stakeholders 6g. Vendors EHR, PHR, Clinical Decision Support Systems, Lab 6g. Other Vendors 6h. Providers Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health) 6h. Other Providers 6i. Realm Universal 7d. US Realm Approval Date 7a. Management Group(s) to Review PSS CDA, FHIR, V2 7b. Sponsoring WG Approval Date Oct 14, 2021 7c. Co-Sponsor Approval Date Oct 20, 2021 7c. Co-Sponsor 2 Approval Date Oct 04, 2021 7c. Co-Sponsor 3 Approval Date Oct 04, 2021 7c. Co-Sponsor 4 Approval Date Sep 24, 2021 7c. Co-Sponsor 5 Approval Date Oct 07, 2021 7c. Co-Sponsor 6 Approval Date Sep 24, 2021 7c. Co-Sponsor 7 Approval Date Oct 06, 2021 7c. Co-Sponsor 8 Approval Date 7c. Co-Sponsor 9 Approval Date 7c. Co-Sponsor 10 Approval Date 7e. CDA MG Approval Date Oct 05, 2021 7f. FMG Approval Date Oct 13, 2021 7g. V2 MG Approval Date Oct 15, 2021 7h. Architecture Review Board Approval Date 7i. Steering Division Approval Date 7j. TSC Approval Date