United States Core Data for Interoperability USCDI Supporting

United States Core Data for Interoperability (USCDI) Supporting Implementation of the 21 st Century Cures Act ONC’s 3 rd Interoperability Forum Content Interoperability Track August 22, 2019

Creating Gender Harmony via HL 7 Accurately representing sex and gender identity in clinical systems Robert Mc. Clure, MD Partners, Inc. (consultant to NLM and ONC)

Problem Statement • F->M transgender patient presents for imaging and admit. Anatomic Female but undergoing hormone transition. Female Anatomy » Gender Identity = M » Sex for Imaging Use = F Female & Male Hormones » Sex for Lab = M or more complicated » Sex for clinical devices (for OR set-up) = F • Birth Sex, Administrative Sex, Gender are not consistently used or understood Female & Male Female Set-up 3

Project Approach • Gender Harmony HL 7® Project began Spring 2019 » Initiated by the need for Public Health reporting of gender/sex other than M – F – Added “X” = Non-binary to HL 7 code system Administrative Sex code system » This opened the door for tackling the larger problem of proper sex and gender data collection » Project has wide International, US Government, Clinical Domain, Vendor, LGBTQ, SDO, Provider involvement » Goal is to craft an Informative HL 7 Specification describing an approach to sex/gender data capture and use » Fortnightly web calls and HL 7 Confluence content site (http: //hl 7. me/GHP) 4

Current GH Project Thinking • Gender Identity = independent of legal gender identity, displayable, disclosed » • • Examples include Male, Female, Non-binary Legal Gender = may have more than one entry » Examples include legal gender - passport gender, legal gender - driver's license gender, legal gender - birth certificate sex » Qualified by a type and specified time frame, may require further qualification by jurisdiction » Administrative Sex / Administrative Gender – a legal gender type? Sex Phenotype = based on an observation » Examples include Male Pattern, Female Pattern, Other, Undisclosed, Unknown – Other – does not fit Male or Female Pattern -> Look for clinical observations – Unknown – not observable, e. g. , trauma case » Alternative name: Sex for Clinical Use 5

GH Alignment to USCDI Promotion Process Vetted for entry by HITAC, Public, & ONC Level 3 “USCDI” Updated by Stakeholders Classified by ONC Level 2 Level 1 Updated by Stakeholders Classified by ONC Comments Open Submission Nationwide Adoption Evidence of Impact/Use Specified and Pilot Tested/Prototype Use Novel Usage/Prepared for Testing Specified Implementation Guides Implementathons Connectathons Registries Integration into Current Standards C-CDA and FHIR, DICOM, SCT LOINC/ACLA Discussion Forum and working group participation. SDO or? 6

Questions? Gratefully acknowledge: • Co-chair Carol Macumber • The Gender Harmony Community @ONC_Health. IT @HHSONC 7

Questions? @ONC_Health. IT @HHSONC 8