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PSS-1387 - Getting issue details... STATUS



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



Version

29

Modifier

Rob McClure

Modify Date

Oct 21, 2021 15:11

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

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

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

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),

2k. Conformance Facilitator

Graham Grieve

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.

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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

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

7e. CDA MG Approval Date

Oct 05, 2021

7f. FMG Approval Date

Oct 13, 2021

7g. V2 MG Approval Date

Oct 15, 2021

Version

28

Modifier

Caroline Macumber

Modify Date

Oct 21, 2021 15:04

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

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

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

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

7e. CDA MG Approval Date

Oct 05, 2021

7f. FMG Approval Date

Oct 13, 2021

7g. V2 MG Approval Date

Oct 15, 2021

Version

27

Modifier

Caroline Macumber

Modify Date

Oct 21, 2021 15:03

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Administration

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Security

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

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

7e. CDA MG Approval Date

Oct 05, 2021

7f. FMG Approval Date

Oct 13, 2021

7g. V2 MG Approval Date

Oct 15, 2021

Version

26

Modifier

Rob McClure

Modify Date

Oct 15, 2021 19:54

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Patient Administration

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

7b. Sponsoring WG Approval Date

Oct 14, 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

7e. CDA MG Approval Date

Oct 05, 2021

7f. FMG Approval Date

Oct 13, 2021

7g. V2 MG Approval Date

Oct 15, 2021

Version

25

Modifier

Rob McClure

Modify Date

Oct 15, 2021 19:12

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Patient Administration

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

7b. Sponsoring WG Approval Date

Oct 14, 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

7e. CDA MG Approval Date

Oct 05, 2021

7f. FMG Approval Date

Oct 13, 2021

Version

24

Modifier

Caroline Macumber

Modify Date

Oct 14, 2021 20:36

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Patient Administration

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

7b. Sponsoring WG Approval Date

Oct 14, 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

7e. CDA MG Approval Date

Oct 05, 2021

7f. FMG Approval Date

Oct 13, 2021

Version

23

Modifier

Rob McClure

Modify Date

Oct 14, 2021 14:47

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Patient Administration

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, HL7

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

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

7e. CDA MG Approval Date

Oct 05, 2021

7f. FMG Approval Date

Oct 13, 2021

Version

22

Modifier

Rob McClure

Modify Date

Oct 13, 2021 21:04

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Patient Administration

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, HL7

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

7c. Co-Sponsor 2 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

7e. CDA MG Approval Date

Oct 05, 2021

7f. FMG Approval Date

Oct 13, 2021

Version

21

Modifier

Caroline Macumber

Modify Date

Oct 08, 2021 18:53

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Patient Administration

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, HL7

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

7c. Co-Sponsor 2 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

7e. CDA MG Approval Date

Oct 05, 2021

Version

20

Modifier

Caroline Macumber

Modify Date

Oct 08, 2021 18:50

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2b. Co-Sponsor WG 2

Patient Administration

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, HL7

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

7c. Co-Sponsor 2 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

7e. CDA MG Approval Date

Oct 04, 2021

Version

19

Modifier

Lisa R. Nelson

Modify Date

Oct 07, 2021 15:26

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, HL7

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

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

7e. CDA MG Approval Date

Oct 04, 2021

Version

18

Modifier

Rob McClure

Modify Date

Oct 06, 2021 22:20

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, HL7

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

7c. Co-Sponsor 4 Approval Date

Sep 24, 2021

7c. Co-Sponsor 6 Approval Date

Sep 24, 2021

7c. Co-Sponsor 7 Approval Date

Oct 06, 2021

7e. CDA MG Approval Date

Oct 04, 2021

Version

17

Modifier

Rob McClure

Modify Date

Oct 06, 2021 22:17

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, HL7

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

7c. Co-Sponsor 4 Approval Date

Sep 24, 2021

7c. Co-Sponsor 6 Approval Date

Sep 24, 2021

7e. CDA MG Approval Date

Oct 04, 2021

Version

16

Modifier

Rob McClure

Modify Date

Sep 24, 2021 17:45

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, HL7

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

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

5b. Project Ballot Type

STU to Normative

5d. Joint Copyright

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)

6f. Stakeholders

Quality Reporting Agencies, Regulatory Agency, Standards Development Organizations (SDOs), Payors

6g. Vendors

EHR, PHR, Clinical Decision Support Systems, Lab

6h. Providers

Clinical and Public Health Laboratories, Healthcare Institutions (hospitals, long term care, home care, mental health)

6i. Realm

Universal

7a. Management Group(s) to Review PSS

CDA, FHIR, V2

7c. Co-Sponsor 4 Approval Date

Sep 24, 2021

7c. Co-Sponsor 6 Approval Date

Sep 24, 2021

Version

15

Modifier

Rob McClure

Modify Date

Sep 24, 2021 17:44

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 now proceeding to Normative directly or after being either Informative or STU?

No

2a. Primary/Sponsor WG

39

2b. Co-Sponsor WG

Patient Care

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 2 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 3 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 4 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2c. Co-Sponsor 5 Update Periods

at WGMs

2c. Co-Sponsor Level of Involvement

Request formal content review prior to ballot

2d. Project Facilitator

Rob McClure/Carol Macumber

2e. Other Interested Parties (and roles)

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

Kimberly Kenna (IBM)

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),

2k. Conformance Facilitator

Ioana Singureanu

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.

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. Perhaps if needed - 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

3i. HL7-Managed Project Document Repository URL:

https://confluence.hl7.org/display/VOC/The+Gender+Harmony+Project

3j. Backwards Compatibility

No

3l. Using Current V3 Data Types?

No

3m. External Vocabularies

Yes

3n. List of Vocabularies

SNOMED CT, LOINC, HL7

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

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?