A person’s internal sense of being a man, woman, both, or neither.
Applicable Vocabulary Standard(s)
Applicable Standards
Gender Identify must be coded in accordance with SNOMED CT® and HL7 Version 3 Standard, Value Sets for AdministrativeGender and NullFlavor, attributed as follows:
Genderqueer, neither exclusively male nor female. 446131000124102
Additional gender category or other, please specify. nullFlavor OTH
Choose not to disclose. nullFlavor ASKU
Adopted at 45 CFR 170.207(o)(2)
Submitted By: A. Taylor
/ ONC
Data Element Information
Rationale for Separate Consideration
It is important for healthcare providers and staff to record patients’ administrative sex and gender identity separately and accurately. Although administrative sex may affect gender-specific care (e.g., mammograms), a patient's gender identity may also affect care and health outcomes. For example, transgender patients are known to face health disparities, and lack of adherence to preferred names and pronouns can lead to embarrassment and even discrimination in healthcare.
Use Case Description(s)
Use Case Description
Technical outcome – A user can record a patient’s gender identity according to HL7® FHIR R4, HL7® version 3, SNOMED CT®, and LOINC codes specified in the “standard(s) referenced” column. The user must be able to record whether the patient declined to specify gender identity. Note that while gender identity was included in the 2015 Edition “demographics” certification criterion and the 2015 Edition Base EHR definition, it was not included in the Common Clinical Data Set definition. This means that gender identity is not required to be exchanged using certain standards, only that systems enable a user to record, change, and access gender identity. [see also 80 FR 62619].
Estimate the breadth of applicability of the use case(s) for this data element
Users of the 572 certified health IT products, out of 901 total products certified to ONC's 2015 Edition, that successfully tested to the 170.315(a)(5) demographics certification criterion has the ability to record, change, and access gender identity data within these products.
This data element has been used at scale between multiple different production environments to support the majority of anticipated stakeholders
Extent of exchange
N/A
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)
While it is required under the 2015 Edition 170.315(a)(5) demographics certification criterion to be able to record, change, and access gender identity data, it is not required for exchange. One restriction may be the ability to restrict exchange based on patient consent by element.
Restrictions on Use (e.g. licensing, user fees)
None known
Privacy and Security Concerns
Potential concern due to limited capacity to capture and enforce patient consent by element across the industry at this time.
Estimate of Overall Burden
Already implemented for record, change, and access, but not for exchange.
Recommendation:Expand the Gender Identity data element definition to include the Gender Harmony Project’s minimum value set, with ISWG refinements.
Rationale:CMS supports the ISWG and HITAC recommendation included in the ISWG and HITAC recommendations on Draft USCDI v3 (April 13, 2022), Draft USCDI v4 (April 12, 2023), and Draft USCDI v5 (April 11, 2024). We recommend adding the following value set from the Gender Harmony Project to USCDI v6.
Gender Identity
Female
Male
Nonbinary
Unknown
USCDI defined values:
Additional gender category or other, please specify
CMS-CCSQ supports the ISWG and HITAC recommendation included in the ISWG and HITAC Recommendations on Draft USCDI v3 (April 13, 2022) and Draft USCDI v4 (April 12, 2023) for expanding the Gender Identity data element definition to include the Gender Harmony Project’s minimum value set, with ISWG refinements.
CMS supports the ISWG and HITAC recommendation for expanding the Gender Identity data element definition to include the Gender Harmony Project’s minimum value set, with ISWG refinements.
The additional values in the defined terminology work collectively with the sex data element to represent sex and gender diversity that supports improved care for vulnerable or underserved populations. The values for this data element are self-reported and not clinically determined, which allows for better representation of diversity.
Maturity: These elements are classified as Level 2 by ONC.
Current Standards:
CMS supports the ISWG recommended minimum value sets (https://www.healthit.gov/sites/default/files/facas/2022-04-13_IS_WG_Phase_1_Recommendations_Report_revised.pdf) from the Gender Harmony Project, along with the two USCDI values:
Female; Male; Nonbinary; and Unknown; Additional gender category or other, please specify; Choose not to disclose
HL7 Cross Paradigm IG: Gender Harmony – Sex and Gender Representation (https://build.fhir.org/ig/HL7/fhir-gender-harmony/branches/main/index.html)
Current uses, exchange, and use cases: Elements related to sex and gender are captured in nearly all clinical and administrative records and routinely exchanged as part of healthcare information exchange. As more appropriate and diverse terminology are standardized, the capture and exchange of the data must also keep pace to ensure appropriate and high quality of care.
CMS supports the ISWG and HITAC recommendation for expanding the Gender Identity data element definition to include the Gender Harmony Project’s minimum value set, with ISWG refinements. The additional values in the defined terminology work collectively with the sex data element to represent gender diversity that supports improved care for vulnerable and/or underserved populations. The values for this data element are self-reported and not clinically determined, which allows for better representation of diversity. The ISWG supported the expansion of the Gender Identity data element with the Gender Harmony Project’s minimum value set in addition to the two fields from USCDI that add critical data, for which CMS supports.
Maturity: These elements are classified as Level 2 by ONC.
Current uses, exchange, and use cases: Elements related to gender are captured in nearly all clinical and administrative records. The information is routinely exchanged as part of healthcare information exchange. As more appropriate and diverse terminology are standardized, the capture and exchange of the data must also keep pace to ensure appropriate and high quality of care. CMS also uses gender information for quality measurement and continues to support Gender Harmony project efforts, reflected in this recommendation.
While more work is needed to develop public health community consensus on the best way to collect and exchange data on gender identity, and there is variability in how these data are currently collected by health care as well as by health departments, CSTE supports the use of multiple questions to describe gender identity and sex, specifically Gender Identity and Sex for Clinical Use (a category that is based upon clinical observations typically associated with thedesignation of male and female).
This is the recommendation of the HL7 Gender Harmony project (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=564 http://www.hl7.org/documentcenter/private/standards/HL7_GENDER_R1_INFORM_2021AUG.pdf ). Sex assigned at birth as a term is controversial among members of the LGBTQ community and some individuals opt to correct or revise their sex on a birth certificate.
Values for gender identity should include male, female, nonbinary, exploring or questioning, another not listed (specify), choose not to disclose, and unknown. CSTE recommends that the terms transgender, female to male and transgender male to female be deprecated.
Values for sex for clinical use should include female, male, unknown, and something not listed (specify)
The AAPM Operational Ontology for Radiation Oncology ( https://aapmbdsc.azurewebsites.net) noted several systems for identifying gender. HL7 Reference system was recommended as the primary system.
Collecting SO/GI data is essential to providing high-quality, patient-centered care for transgender people. ONC has provided good leadership on the standardization of this content in USCDIv2. FQHCs are required to collect these data for all their patients and report them to HRSA so these data are well established and are imperative to the patient-centered provision of care.
SO/GI data can be collected in several ways:
Information can be obtained through patient portals and transmitted to an individual’s EHR. This approach is attractive because it puts the patient in charge of defining their own identity and needs.
Questions can be included on registration forms for all patients as part of the demographic section along with information about race, ethnicity, and date of birth.
Providers and their care team can ask questions during the patient visit, for instance, as part of a social or sexual-history discussion.
NACHC believes gender identity is a foundational component of patient identity. However, it is also associated with serious health inequity and health disparities. Furthermore, it is clinically relevant to several domains of sexual health, cancer risk, trauma and interpersonal violence, substance abuse and mental health risk factors.
We strongly support the requirement for gender identity data to be captured in a standardized way in EHRs to support patients’ identities, reduce health disparities and facilitate effective clinical risk that may be modified by sexual orientation. However, NACHC proposes the modification to the gender identity value set based on work from the Gender Identity Working Group at HL7.
Gender identity defined in USCDI v2 does not represent all different gender identities expressed by the community as a whole. There are additional gender identities that could not be categorized in any of the values existing in the current version. For example – there are community members identifying themselves as ‘Transgender’ rather than either ‘Male Transgender’ or ‘Female Transgender’. Similarly, there are additional categories that are presently represented by ‘other’ which accurately represents additional gender identities, as follows:
The "Optional Background Text / Cover Letter" field provides space for additional context or introductory information related to your comment.
If you wish to provide context, explanation, or an introduction to your comment, enter this information in the field labeled "Optional Background Text / Cover Letter." This is entirely optional and is most useful when submitting multiple related comments or when additional background would help reviewers understand your feedback.
If you are only commenting on a single data class or element, you may leave this field blank.
2. Select the Data Class
To specify which data class your comment addresses:
In the "Data Class" drop-down menu, select the appropriate data class you want to comment on.
If you are providing a general comment that is not specific to a data element, select "General" from the options. Comments with this designation will be displayed on the USCDI landing page.
Note that the Data Class field will automatically populate based on your current location in the platform:
If you are on a data class page, the field will be set to that specific data class
If you are on a data element page, the corresponding data class will be pre-selected
3. Select the Data Element
To specify which data element your comment addresses:
In the "Data Element" drop-down menu, select the specific data element you want to comment on.
The drop-down menu will display only the elements available under the data class you selected in the previous step.
You can use the search function within the drop-down to quickly locate a specific data element.
If you are commenting on the data class itself rather than a specific element, you may leave this field blank.
Note: Comments on a specific data element will appear on the respective data element page, while comments on a data class (without a specific element selected) will appear on the landing page for that data class.
Fig 1 The "Data Class" and "Data Element" dropdown menus allow users to specify the exact content they wish to comment on.
4. Optional: Propose New Data Class or Element
If you cannot find the appropriate data class or element for your comment:
Instead of clicking the "Comment On An Existing Data Class Or Element" button, click the adjacent button labeled "Propose a New Data Class or Data Element."
This will redirect you to the ONDEC (ONC New Data Element and Class) Submission System.
In the ONDEC system, follow the provided instructions to submit your proposal for a new data class or element.
Once your proposal is submitted through ONDEC, it will be reviewed separately from the commenting process.
Fig 2 The "Propose a New Data Class or Data Element" button redirects users to the ONDEC Submission System for proposing new data elements not currently available in the system.
5. Complete the Comment Form
Fill out the required fields in the comment form:
Subject: Enter a brief, descriptive title that summarizes your comment. This helps reviewers quickly understand the nature of your feedback.
Comment: In this field, provide the full details of your comment or feedback. Be as clear and specific as possible about your suggestions, concerns, or observations. Include any relevant details that support your position.
6. Optional: Add Additional Comments
If you need to comment on multiple data classes or elements:
After completing your first comment, click the link labeled "Comment on another data element" at the bottom of the form.
A new comment section will appear, allowing you to enter details for your additional comment.
For each additional comment, you must select the appropriate data class and data element from the drop-down menus.
Complete the Subject and Comment fields for your additional comment.
Repeat this process for each additional comment you wish to submit.
Fig 3 The "Comment on another data element" link enables users to create multiple comments addressing different elements within a single submission.
7. Optional: Upload Supporting Files
The platform allows you to upload supporting documentation to enhance your comment:
Locate the "File Upload" section at the bottom of the comment form.
Click to upload any files (such as PDFs or documents) that provide additional context, evidence, or clarification for your comment.
Important: If you have already entered your comments using the form fields, there is no need to upload duplicate content in PDF format. The file upload feature is intended for supplementary materials only. Please avoid uploading files that contain the same information already provided in your comment text.
Fig 4 The "File Upload" section permits users to attach supporting documentation that supplements their written comments.
8. Optional: Save and Exit
If you need to pause your work and return to complete your comment later:
Click the "Save and Exit" button at the bottom of the form.
Your comment will be saved as a draft that you can access and complete later.
When you return to the platform, you will see a red triangle with an exclamation mark next to the “Return to saved Comment” button, indicating that you have saved comments in draft status.
Click this button to continue working on your draft.
You will be taken to a review page where you can:
Select "Submit Comment" to officially submit your feedback.
Click "Edit" to return to the comment form and make changes
Select "Discard Draft" to delete the saved draft and start fresh
Fig 5 A red triangle with exclamation mark indicator appears next to the “Return to saved Comment” button when draft comments are saved in the system.
9. Review and Submit
Once you have completed your comment:
Click the "Review and Submit" button at the bottom of the form.
This will take you to a review screen displaying your comment(s) in full.
Review all information for accuracy and completeness.
On this review screen, you have three options:
Click "Submit Comment" to officially submit your feedback
Click "Edit" to return to the comment form and make changes
Click "Discard Draft" to delete the comment and start fresh
The review screen also includes a "Print" button that allows you to create a printed copy of your comments for your records.
If you choose to submit, your comment will be recorded in the system and made available for review by the appropriate stakeholders.
Fig 6 The review screen allows users to verify comment content and make any necessary modifications before final submission.
Submitted by rdillaire on
CMS-CCSQ Recommend enhancing the Gender Identity data element
Data Element: Gender Identity (USCDI v5)