Maternal mortality rates in the U.S. have climbed in recent years. Moreover, mortality rates are significantly higher for Black women and American Indian and Alaska Native American women than the rest of the population. Improving maternal health outcomes and eliminating disparities are ongoing priorities for the Department of Health and Human Services, reinforced by the Biden-Harris administration.

While progress has been made, there remain opportunities to improve the collection, linkage, and analysis of data collected at the point of care. Strengthening the quality of clinical data holds enormous potential for improving maternal health outcomes as well as supporting patient-centered outcomes research on the effectiveness of maternal healthcare services and interventions.

A key need is for better data standards in electronic health records to understand possible risk factors for maternal mortality and poor maternal and infant health outcomes. EHR data differ by clinical settings and data standardization across systems is essential for meaningful and unbiased use for research. Furthermore, data standards must be specific for maternal health to facilitate data linkages for a life span approach to women’s health that also includes their infants’ health.  

Data standardization, interoperability are critical to progress

EHRs collect a wealth of data that could be used by researchers to provide a more complete picture of the health and healthcare for pregnant women and mothers. Linking EHR data with other data – such as health insurance claims, social determinants of health, or mortality data creates a powerful resource for researchers to generate evidence about the clinical, social, and demographic factors that affect pregnancy outcomes for both mother and infants.

Data standardization brings data into a common format that allows for interoperability of health records, collaborative research, and large-scale analytics. Standardization is often a first and critical step in forming robust research datasets, and is especially important for studies on maternal health. Pregnant women and new mothers often see multiple providers—from an emergency room to primary care to their obstetrician-gynecologist—and their data are usually not aggregated into one consolidated record. Beyond aggregating data for one patient into one record, another difficult challenge is linking the clinical indicators and outcomes of mothers to their infants.

If maternal health data in EHRs were better standardized, researchers would have increased capacity to link these data with other data sources and pursue PCOR that examines critical questions about maternal and infant health such as: What social risk factors are associated with pregnancy induced hypertension or gestational diabetes? How do pre-pregnancy clinical factors and social risk factors impact pregnancy and longer-term maternal and infant health outcomes? How do medications and treatments during pregnancy impact maternal and infant health?

Achieving data standardization requires a collaborative approach

Establishing data standards requires a collaborative approach that brings together stakeholders at different points in the data life cycle. A portfolio of intradepartmental projects coordinated by HHS’ Office of the Assistant Secretary for Planning and Evaluation (ASPE) specializes in this kind of approach and is designed to build data capacity for conducting PCOR.

To improve maternal health data infrastructure, the Office of the Secretary’s Patient-Centered Outcomes Research Trust Fund (OS-PCORTF) has funded a series of projects that are designed to improve EHRs data for research on maternal health and pregnancy related conditions, outcomes, and procedures, and linking mothers with their infants:  

1. The National Institute of Health’s Eunice Kennedy Shriver National Institute of Child Health and Human Development project Severe Maternal Morbidity and Mortality EHR Data Infrastructure aims to improve the timeliness and comprehensiveness of maternal health data by developing a set of standard data elements for EHRs to be published for implementation in a FHIR implementation guide.
2. The Centers for Disease Control and Prevention's National Center for Birth Defects and Developmental Disabilities project MATernaL and Infant NetworK to Understand Outcomes Associated with Treatment for Opioid Use Disorder during Pregnancy (MAT-LINK) aims to establish a surveillance network to address the lack of national-level data on maternal, infant, and child health outcomes associated with treatments for opioid use disorder.
3. The CDC’s National Center for Health Statistics project Enhancing Surveillance of Maternal Health Clinical Practices and Outcomes with FQHCs' EHRs Visit Data aims to develop a nationally representative dataset on maternal health treatment and outcomes using EHRs from Federally Qualified Health Centers and linking to administrative data from the National Death Index and the Department of Housing and Urban Development.

To facilitate collaboration across these three projects, ASPE created a Maternal Health Consortium. In addition to the project leads, the Consortium includes representation from the Office of the National Coordinator for Health Information Technology.

ONC oversees the US Core Data for Interoperability, or USCDI, a standardized set of data classes and elements to facilitate interoperability. USCDI contains SDOH data elements, and the draft USCDI Version 3 contains a new data class on pregnancy status, both supporting exchange of data relevant to maternal health. The Consortium is also seeking input from the Health Resources and Services Administration on different maternal and child health program outcomes reported within their programs.

From its inception, the MH Consortium has facilitated knowledge sharing and collective work while actively engaging a range of federal, clinical, and public health partners to advance the standardization of data for research and PCOR on maternal health. Critically, the consortium has also engaged major EHR vendors to discuss their own approaches to standards and linkages. This provided important context on activities in the larger health ecosystem that informed the consortium’s approach to developing a FHIR implementation guide specifying longitudinal maternal and infant health information for research.

New implementation guide paves the way for better data, better research

The NICHD project developed a Longitudinal Maternal & Infant Health Information for Research Implementation Guide, while the MH Consortium facilitated a rapid and coordinated review cycle by seeking input from experts from federal agencies and private sector. This new guide paves the way towards a consolidated data infrastructure and marks an important milestone in capturing and making available more and better information about maternal health from pre-pregnancy to postpartum care and beyond as well as infant health through longitudinal linkages of mothers and their offspring.

In January 2022, the NICHD project tested the implementation guide at the Health Level Seven International FHIR Connectathon, and the feedback the project received helped identify and address gaps in the included standards. Additional tests will be conducted in at least one more Connectathon. The implementation guide will be then vetted through the formal HL7 balloting process in May 2022 and the anticipated time for publishing the standard is early 2023. This new guide will eventually support mapping maternal health data across several clinical areas and use cases. The first two use cases are: 1) pregnancy and subsequent death within a year of a pregnancy and 2) hypertensive disorders of pregnancy.

The development and future adoption of these standards throughout all EHRs mark progress in improving data capacity for maternal health and a step forward towards understanding better the risk factors and improving maternal health.

The MH Consortium is the catalyst for this progress. A group that includes researchers, multiple federal agencies, as well as involvement from multiple EHR vendors, has been critical in making the case for how much this kind of standardization will enhance maternal health research. 

While addressing the maternal mortality crisis is a long-term effort, advancing research is an important first step in better understanding the crisis and using a life span-approach when developing interventions. The implementation of these data standards will allow researchers to merge maternal and infant data elements across multiple EHR systems and create longitudinal record for the mothers as well as link those data to their children’s data. Ultimately, this will support patient-centered outcomes research on maternal and infant health, and improve their health outcomes thereof.

Violanda Grigorescu is senior health scientist in the Division of Healthcare Quality and Outcomes, Office of Health Policy in the Office of the Assistant Secretary for Planning and Evaluation at HHS.

She co-authored this article with Nahida Chakhtoura, Chief of the Pregnancy and Perinatology Branch, at the Eunice Kennedy Shriver National Institute of Child Health and Human Development; Juanita J. Chinn, Program Director in the Population Dynamics Branch at NICHD and Alison Cernich, Deputy Director at NICHD Scott R. Smith, Director of the Division of Health Care Quality and Outcomes in ASPE and Nancy DeLew, Associate Deputy Assistant Secretary for Health Policy in ASPE.