Sex For Clinical Use

Context-specified SFCU data elements belong with specified class

We appreciate ONC's inclusion of the various context-specified SFCU data elements although it was our intent that they be data elements classified under the named data class used to define the context. We note that they are aggregated here (except clinical test). We would encourage ONC to consider following the recommendation noted above with the original submission and seek comments on this.

Change SFCU data class to specific SFCU data elements noted

SFCU is a context-dependent clinical sex value and should not be considered a USCDI Data Class unless the class exists only to aggregate the following data elements we suggest be created. We plan to submit a new specific SFCU data element for each of the following data classes: ·         Patent Demographics ·         Clinical Tests ·         Laboratory ·         Diagnostic Imaging ·         Procedures ·         Medications We understand that SFCU values have not been widely implemented in systems for data classes other than perhaps at the patient level (Patient demographics) because functionality needed for each of these data classes has been shoe-horned into the use of other general sex or gender values, such as sex assigned at birth, or administrative sex with the assumption that a unique value specific to one of these data classes could not occur. The only situation where this has been addressed is in occasions where Ask At Order Entry (AOE) values were collected, as has been discussed with COVID testing. Given that each use can be unique, each data class needs its own SFCU entry. It should be noted that SFCU is a context-focused summary sex categorization that has as a basis one or more discrete observations. The basis used is usually discrete organ inventory, hormone levels, or other direct physiological measurements that are often the “ideal” for driving clinical decisions, however this data may not be available, and when it is, there can be privacy considerations when exchanging this level of data in some contexts.  Our expectation is that contextual SFCU can often achieve similar outcomes to discrete organ inventory and other physiological measurements for many patients, with reduced privacy impact and provider documentation burden. Recommendation:

• The Gender Harmony project does not suggest and is not supportive of the exchange of context-independent SFCU.  We recommend removing SFCU as a data class so that the importance of the context is clear.
• Given that each context can be unique, and will have different levels of adoption in the industry, each existing data class (e.g., Laboratory, Medications) needs its own SFCU data element to clearly define the context of use, and to allow independent advancement as maturity of each contextual SFCU increases.
• Gender Harmony will submit separate ONDEC proposals as described above.