Data used to categorize individuals for identification, records matching, and other purposes.

Data Element
Sex (Assigned at Birth)

Applicable Vocabulary Standard(s)

Applicable Standards

Birth sex must be coded in accordance with HL7 Version 3 (V3) Standard, Value Sets for AdministrativeGender and NullFlavor attributed as follows:

  • Female. F
  • Male. M
  • Unknown. nullFlavor UNK

Adopted at 45 CFR 170.207(n) 

Comment

Submitted by rmcclure on 2023-04-17

Use of "Sex" data element

Per the Gender Harmony Project as discussed and voted on 2023-04-17: There are many implementations that support both Sex Assigned at Birth and Sex.  The data element "Sex" as described by USCDI v4 does not have a clear definition and by choosing this general phrase USCDI does not directly align with the aspirations of the Gender Harmony Project. Yet, the Gender Harmony Project team acknowledges that "Sex" does have broad adoption and use for activities such as patient matching.  It is important that national policy continues to emphasize the importance and adoption of more specific and meaningful properties like Gender Identity and Sex Parameter for Clinical Use.  We recommend that ONC:
  • Retain the Sex USCDI Data Element in the near term.
  • Monitor the adoption of Sex Parameter for Clinical Use.
  • When industry adoption is sufficient, incorporate Sex Parameter for Clinical Use into USCDI.
  • After adopting SPCU, eventually retire Sex from USCDI.
The Gender Harmony Project did support the US Core decision to implement USCDI Sex using the Sex Assigned at Birth extension.

Submitted by yale-coredQMRoadmap on 2023-04-17

CMS-CCSQ/CDC Joint USCDIv4 Priority: Sex

CMS and CDC strongly support the ISWG and HITAC recommendation for USCDI v3 (on April 13, 2022) to include the HL7 Gender Harmony Project’s data elements related to Sex – Recorded Sex or Gender (RSoG) and Sex for Clinical Use (SFCU) in addition to the existing standards for capturing sex. Further specification of data elements related to the concept of sex is necessary to improve health equity, represent diversity, and improve care, specifically for historically vulnerable and/or underserved populations – all ONC stated priorities for USCDI v4. Sex for Clinical Use is critical because the appropriate sex value for an individual may differ for different procedures or tests. Likewise, Recorded Sex or Gender is critical because, depending on context, the value may change and not be the static value on an original birth certificate. These data elements allow the capture and exchange of more nuanced information, which is essential for proper care and will support patient care, care coordination, and quality measurement.

Submitted by nedragarrett_CDC on 2023-04-07

CDC's Consolidated Comment for USCDI v4

  • CDC-CMS Joint Priority
CMS and CDC strongly support the ISWG and HITAC recommendation for USCDI v3 (on April 13, 2022) to include the HL7 Gender Harmony Project’s data elements related to Sex – Recorded Sex or Gender (RSoG) and Sex for Clinical Use (SFCU) in addition to the existing standards for capturing sex. Further specification of data elements related to the concept of sex is necessary to improve health equity, represent diversity, and improve care, specifically for historically vulnerable and/or underserved populations – all ONC stated priorities for USCDI v4. For example, Sex for Clinical Use is critical because the appropriate sex value for an individual may differ for different procedures or tests. Likewise, Recorded Sex or Gender is critical because, depending on context, the value may change and not be the static value on an original birth certificate. These data elements allow the capture and exchange of more nuanced information, which is essential for proper care and will support patient care, care coordination, and quality measurement. These data elements were widely supported during USCDI v3 consideration and recommended by the ISWG and supported by HITAC
  • Comments from NACCHO: NACCHO supports addition of this data element. NACCHO recommends the use of the existing HL7 standard for sex.
  • Comments from CSTE: CSTE agrees with CDC. 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 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 EITHER Sex Assigned at Birth OR Sex for Clinical Use (a category that is based upon clinical observations typically associated with the  designation of male and female). The latter has been put forward by 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 may cause problems for members of the transgender community especially for those who 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).

Submitted by pwilson@ncpdp.org on 2022-09-30

NCPDP Comments

NCPDP recommends adding intersex (Definition: An individual born with any of several variations in sex characteristics, including chromosomes, gonads, sex hormones or genitals that do not fit the typical definitions of male or female) to “Sex (Assigned at Birth)” to align with the values NCPDP has defined.  By adding this additional value, this would allow providers to properly address patients and to be inclusive of all.

Submitted by rmcclure on 2022-09-30

"Sex" data element should be removed

While there is broad industry implementation of Administrative Gender and Sex assigned at birth (SAAB), there is also wide agreement that the meaning of these data elements requires conjecture and they can be dangerous if used when the meaning is unclear.  Recommendation:
  • Because the meaning around these concepts is unclear, we are supportive of removing ‘Sex assigned at Birth’ (as was done in USCDIv3).
  • We recommend removing ‘Sex’, and instead consider adding clarification that the concepts of Gender Identity and Sex for Clinical Use are well-defined replacements for ‘Sex’ and the ‘Sex assigned at Birth’.

Submitted by Svellanky on 2022-09-29

CMS-CCSQ Recommendation for Sex for USCDI v4

CMS repeats and supports the ISWG and HITAC recommendation for USCDI v3 (on April 13, 2022) to include the HL7 Gender Harmony Project’s data elements related to Sex – Recorded Sex or Gender (RSoG) and Sex for Clinical Use (SFCU) in addition to the existing standards for capturing sex. Further specification of data elements related to the concept of sex is necessary to improve health equity, represent diversity, and improve care, specifically for historically vulnerable and/or underserved populations – all ONC stated priorities for USCDI v4. For example, Sex for Clinical Use is critical because the appropriate sex value for an individual may differ for different procedures or tests. Likewise, Recorded Sex or Gender is critical because, depending on context, the value may change and not be the static value on an original birth certificate. These data elements allow the capture and exchange of more nuanced information, which is essential for proper care and will support patient care, care coordination, and quality measurement. These data elements were widely supported during USCDI v3 consideration and recommended by the ISWG and supported by HITAC. Maturity: These elements are classified as Level 2 by ONC. Current uses, exchange, and use cases: Elements related to sex 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 sex and gender information for quality measurement and continues to support Gender Harmony project efforts, reflected in this recommendation.

Submitted by nedragarrett_CDC on 2022-09-29

CDC's comment on behalf of CSTE for USCDI v4

 
  • CSTE agrees with CDC. 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 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 EITHER Sex Assigned at Birth OR Sex for Clinical Use (a category that is based upon clinical observations typically associated with the designation of male and female). The latter has been put forward by the HL7 Gender Harmony project
  1. http://www.hl7.org/implement/standards/product_brief.cfm?product_id=564
  2. http://www.hl7.org/documentcenter/private/standards/HL7_GENDER_R1_INFORM_2021AUG.pdf 
  • Sex assigned at birth as a term may cause problems for members of the transgender community especially for those who 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).

Submitted by nedragarrett_CDC on 2022-09-28

CDC-CMS Joint Priority Data Element for USCDI

CDC continues to recommend inclusion of this high priority data element in USCDI v4.  This element is also shared high priority item for CMS/CDC as outlined in our joint letter

Submitted by cmayo@med.umich.edu on 2022-09-11

Sex is not gender. We…

Sex is not gender. We recommend use of CDC definitions for sex at birth. This is a fixed value.   https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.113883.1.11.1   There are several standards systems in use for separately identifying gender. In the AAPM Operational Ontology for Radiation Oncology the HL7 Reference system is used.  http://hl7.org/fhir/2018May/codesystem-gender-identity.html   Other systems evaluated were  CDC https://phinvads.cdc.gov/vads/ViewValueSet.action?oid=2.16.840.1.113883.1.11.1 DICOM http://dicom.nema.org/medical/dicom/current/output/chtml/part16/sect_CID_7455.html#table_CID_7455 Health IT https://www.healthit.gov/isa/representing-patient-gender-identity LOINC https://loinc.org/76691-5/

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