Problem: According to the 2021 Aspen Health Strategy Group report on “Reversing the U.S. Maternal Mortality Crisis”, 700 women die each year as the result of pregnancy or delivery complications, and 50,000 more face short-term or long-term health consequences because of pregnancy or labor. The U.S. has the highest maternal mortality rate of any high-income nation in the world (17.4 maternal deaths per 100,000 live births) according to The Commonwealth Fund. While rates of maternal mortality have been decreasing in other countries, they have been rising in the United States since 1987. Data are not standardized and data exchange in not interoperable across many settings, which impedes research on maternal morbidity, longitudinal maternal care, and associated impacts to infant and infant health. Scope: The team is creating a FHIR R4 implementation guide (IG) for the US Realm and based on US Core profiles where applicable. The IG will define patient metadata, including social determinants of health and associated clinical data, in support of research questions that explore the root causes for maternal/infant morbidity and mortality. The IG will focus on longitudinal maternal care, which includes antepartum (including pre-pregnancy), intrapartum, and postpartum care of a pregnant woman. The scope of this IG will define how, from which sources (e.g., electronic health records, research protocols), and when researchers will access data and will specify how to capture and link the maternal longitudinal record with the infant record(s). Specifically, this IG will include key data elements in a longitudinal record of a mother and child for two initial research use cases: • Pregnancy related deaths: This use case is focused on pregnant women who died within a year (365 days) of a pregnancy. The cause of death pathway may or may not include a pregnancy-related condition. • Pregnancy-induced hypertension (PIH): This use case focuses on women with a diagnosis of pregnancy-induced hypertension followed by a subsequent pregnancy. Purpose: The intent of this IG is to facilitate the capture of research data for predictive analysis, risk assessment, and retrospective research and to include data capture processes in FHIR resources based on a range of use cases that focus on: • risks for infants related to maternal exposure to medications taken during pregnancy • potential adverse maternal obstetric history impacts on infant outcomes • accessing relevant sensitive health information • retrospective population-based analysis of inherited disorders • creating structural relationships between: o maternal and infant records to effectively diagnose and treat otherwise fatal infant outcomes o maternal and birth records to maternal and infant death records o maternal and infant records in multiple disparate systems The establishment of a FHIR IG for research data that includes pregnancy, pregnancy outcomes, pregnancy-related conditions, co-morbidities, and procedures is essential for analyses of specific maternal and infant health conditions and treatments. This IG, harmonized across a broad set of use cases, will support mapping maternal data across health records from specialty care and linking mother and infant data. This will support researchers in identifying root causes of maternal mortality and pediatric developmental problems, including social determinants of health such as limited income, poor nutrition, lack of medical coverage, etc. The goal of the project is to create a method to standardize data for comparative analysis over time to improve health outcomes. During requirements gathering, we will be reviewing relevant implementation guides for existing standards: - US Core - Vital Records Common Profiles Library - Vital Records Birth and Fetal Death Reporting - Vital Records Mortality and Morbidity Reporting - Electronic Initial Case Report (eICR) within Electronic Case Reporting (eCR) - Supplemental Pregnancy templates for C-CDA - Birth Defects CDA/Draft FHIR CI - Birth Reporting DAM (extension of VR DAM). - IHE BFDR profiles ( https://www.ihe.net/uploadedFiles/Documents/QRPH/IHE_QRPH_Suppl_BFDR-E.pdf ) - NCHS Utah and Michigan SMART on FHIR app The project team will also review the Situational Awareness for Novel Epidemic Response (SANER) FHIR IG and will align and re-use Measure profiles where applicable recognizing there are differences such as: 1) The cohort is focused on pregnant mothers 2) The time frame is a longitudinal record view, rather than a situational awareness 3) The data source is not limited to an inpatient facility but includes data from diverse EHR systems during the longitudinal care of the mother and child. As the intended use of this data is for clinical research, the project will consider the appropriate de-identification of data and will review existing HL7 projects related to patient identity management such as Improving identity assurance and patient match quality through Interoperable Digital Identity and Patient Matching Capabilities. Resources: Aspen Health Strategy, “Reversing the U.S. Maternal Mortality Crisis” (April 22, 2021) https://www.aspeninstitute.org/publications/reversing-the-u-s-maternal-mortality-crisis/ The Commonwealth Fund, “Maternal Mortality in the United States: A Primer” (December 16, 2020) https://www.commonwealthfund.org/publications/issue-brief-report/2020/dec/maternal-mortality-united-states-primer Menard, M. Kathryn, et al. "Levels of maternal care." American journal of obstetrics and gynecology 212.3 (2015): 259-271. https://www.ajog.org/article/S0002-9378(14)02489-2/fulltext