| Interoperability Standards Platform (ISP)

Data Element

Submitted By: Robert McClure / MD Partners, Inc. for HL7 Gender Harmony Project
Data Element Information
Rationale for Separate Consideration	A Sex For Clinical Use (SFCU) is intended to be a context-specific summarization of relevant clinical observations. The existing USCDI data class of SFCU that includes a general (context independent) SFCU data element is problematic because neither is context specific. A better approach is to have a context specific SFCU where the specific intended use is clear. While a “patient level” SFCU is only useful as a potential default value for use in situations where the clinical sex is needed, this type of value is currently most consistent with existing implementations. There is a need for other context specific SFCU data elements to clarify that SFCU can be included to support other data classes. Each of these unique data elements should be considered as a unique element representing a common approach. We expect industry maturity for SFCU to vary for different data classes. There is already some industry adoption of Patient SFCU. We expect Laboratory SFCU adoption may increase relatively quickly. SFCU for other data classes may require more investment by the industry to achieve maturity. Having separate data elements for the different contextual SFCUs allows the industry to advance the maturity of these contextual SFCU concepts independently.
Use Case Description(s)
Use Case Description	The Sex For Clinical Use categorization is intended to communicate the summary sex category (such as Male or Female) that would best align with the expected observations based upon the identified observation context used to determine the value. When male or female is not a proper categorization, then “Specified” is to be used to indicate that default behavior that is safe for both male and female populations should be used, or a provider should review treatment options individually with the patient. A Patient SFCU is a sex category that is intended to represent the proper sex categorization that can be applied in most situations, but particular situations, such as a mammogram screening, may require a context-specific SFCU.
Estimate the breadth of applicability of the use case(s) for this data element	Some systems (e.g., Epic) have implemented a sex for clinical use value at the patient level and that element aligns with this proposed data element. Most systems exchange a patient sex or gender value. Senders may consider that sex or gender value to be administrative, while some recipients may incorrectly assume that sex or gender value to be clinically relevant. Defining a specific data element for a clinical sex value reduces ambiguity and the risk or incorrect assumptions. We do note that this data element has not been widely implemented but is central to many use cases in clinical care and is expected to be necessary in any system that requires information on the clinical sex characteristics of a patient.
Link to use case project page	http://build.fhir.org/ig/HL7/fhir-gender-harmony/branches/main/health_maintanence_use_case.html
Healthcare Aims	Improving patient experience of care (quality and/or satisfaction) Improving the health of populations Improving provider experience of care
Maturity of Use and Technical Specifications for Data Element
Applicable Standard(s)	LOINC “Sex for clinical use” 99501-9 https://loinc.org/99501-9/ HL7 Patient SFCU extension: http://hl7.org/fhir/2022Sep/extension-patient-sexforclinicaluse.html http://hl7.org/fhir/2022Sep/extension-patient-sexforclinicaluse.html
Additional Specifications	Gender Harmony Logical model (http://www.hl7.org/implement/standards/product_brief.cfm?product_id=564) Gender Harmony Implementation Guide (http://hl7.org/xprod/ig/uv/gender-harmony/2022Sep/index.html) This guide provides an approach to representing context specific SFCU in CDA, V2, and FHIR.
Current Use	In limited use in production environments
Supporting Artifacts	There are systems, such as Epic, and other locally configured systems, such as at the Fenway Institute in Boston, that support an approach similar to Patient SFCU.
Extent of exchange	1
Supporting Artifacts	Epic currently supports exchanging a value that aligns with patient sfcu, but does this in a non standard way
Potential Challenges
Restrictions on Standardization (e.g. proprietary code)	No restrictions other than changing the perceived approach to this common element.
Restrictions on Use (e.g. licensing, user fees)	None
Privacy and Security Concerns	SFCU will likely contain information with privacy concerns. But it is our expectation that contextual SFCU could achieve desired clinical outcomes without revealing discrete organ inventory and other physiological measurements for many patients, but by not requiring those discrete observations, may have a reduced privacy impact and provider documentation burden.
Estimate of Overall Burden	Most systems will require updates to implement the SFCU element, differentiating it by context and previously recorded Sex information.
Other Implementation Challenges	Adoption of this element by governmental reporting systems.

ASTP Evaluation Details Each submitted Data Element has been evaluated based on the following criteria. The overall Level classification is a composite of the maturity based on these individual criteria. This information can be used to identify areas that require additional work to raise the overall classification level and consideration for inclusion in future versions of USCDI
Criterion #1 Maturity - Current Standards	Level 2 - Data element is represented by a terminology standard or SDO-balloted technical specification or implementation guide.
Criterion #2 Maturity - Current Use	Level 1 - Data element is captured, stored, or accessed in at least one production EHR or HIT module.
Criterion #3 Maturity - Current Exchange	Level 2 - Data element is electronically exchanged between more than two production EHRs or other HIT modules of different developers using available interoperability standards.
Criterion #4 Use Case(s) - Breadth of Applicability	Level 0 - Use cases apply to a limited number of care settings or specialties, or data element represents a specialization of other, more general data elements.
Evaluation Comment	This data element represents a component of an existing USCDI v5 Observations data element Sex Parameter for Clinical Use (SPCU). This data element encompasses multiple clinical contexts including patient level considerations of SPCU.

Comment

Submitted by rmcclure on 2023-04-17

Change name to Patient Sex Parameter for Clinical Use

After considerable discussion within the Gender Harmony Project, the SFCU element will be renamed to Sex Parameter for Clinical Use (SPCU) in the final HL7 standards to be published this year (V2.9.1, FHIR R5, CDA companion guide.) This means all the specific SPCU data elements should be renamed to align with this phrasing. In this case the name of this element should be Patient Sex Parameter for Clinical Use.