PHILADELPHIA, PA — (PRNewswire) — HealthVerity, Inc., the leader in Identity, Privacy, Governance, and Exchange (IPGE) for real-world data, today announced the launch of MOM, the Maternal Outcomes Masterset, a groundbreaking approach for generating novel insights around the impact of healthcare interventions for pregnant women and their babies. By accurately linking de-identified healthcare records of over 1.6 million pregnant women to their newborns, HealthVerity delivers a more comprehensive way for clinical researchers to study the patient journey from pre-pregnancy to birth and beyond, all in a HIPAA-compliant and privacy protected manner.
MOM was created to address a long-standing challenge for the healthcare industry, the lack of reliable evidence on drug safety during pregnancy. The COVID-19 pandemic highlighted this gap when patients and providers were faced with minimal data and uncertain guidance on whether expectant mothers should be vaccinated. The evidence gap exists largely due to the exclusion of pregnant women from clinical trials, as well as the scarcity of relevant retrospective data sources and pregnancy registries. According to draft guidance from the U.S. Food and Drug Administration, “pregnancy registry data is not sufficient to assess the safety of products during pregnancy. Other methods are needed to corroborate registry findings.” Furthermore, with the rate of maternal mortality climbing 18% in 2020, according to a new report by the Centers for Disease Control and Prevention (CDC), the Biden-Harris Administration has recently committed to a proposed maternity care quality hospital designation.
“In the Spring of 2020, as we were building a real-world evidence system for biopharma manufacturers and regulators to assess treatment approaches for COVID-19, it became clear to us that the market had very few reliable options to study the maternal journey, ” said Sandy Leonard, Senior Vice President of Partnerships and Real-World Data for HealthVerity. “We then began a year-long process that leveraged the HealthVerity IPGE platform to uniquely solve for the complex challenges of integrating broad-based clinical data on both mother and infant while also meeting the complex privacy requirements of HIPAA.”
Adoption of MOM among the clinical research community is advancing quickly, with SK Life Sciences and the CDC among a growing list of clients leveraging the masterset to advance maternal health outcomes research.
“We were looking for a better way to capture the full maternal health journey of pregnant women using anti-seizure medication”, said Sean Stern, Director of Health Economics and Outcomes Research for SK Life Sciences. “Through MOM, we’re able to crosswalk medical claims and pharmacy data for mom and baby, allowing us to see the relationship between mom and baby and gain more visibility into pregnancy health outcomes.”
MOM is unique in its ability to accurately household de-identified healthcare records of more than 1.6 million pregnant women with their newborns by leveraging key data sources within the nation’s largest ecosystem for healthcare data. Patient cohorts can be easily designated by researchers to explore key patient interactions, health equity and many more long-term objectives.
Key attributes that only MOM can deliver:
Purpose-built for pregnancy studies
MOM was designed to enable researchers to use longitudinal clinical data to follow mothers and their babies in tandem throughout their pregnancy journey, and beyond. The mom-baby linked data preserves critical data elements such as race, ethnicity, maternal age, birth events and pregnancy outcomes to enable novel pregnancy studies.
Regulatory quality, HIPAA-compliant, and research-ready
HealthVerity has solved a complex industry challenge of linking mom and baby data in a way that maintains the most critical data elements for pregnancy-related research while also meeting the most exacting standards of HIPAA. Because MOM is covered under HealthVerity’s third party expert determination, clients can begin data analytics work on day one.
Commercial and Medicaid data for more detailed analyses
MOM is sourced from over 150 U.S. healthcare payers, including both Commercial and Medicaid payers. Currently comprised of medical claims, pharmacy claims, enrollment data and lab results from the nation’s largest real-world data ecosystem, MOM enables access to more than five years of retrospective data, as well as prospective data options leveraging HealthVerity’s persistent identity resolution technology. EMR and hospital chargemaster data will be added in the months ahead.
Pharmaceutical manufacturers, payers, and government organizations have partnered with HealthVerity to solve some of their most complicated use cases through transformative technologies and real-world data infrastructure. The HealthVerity IPGE platform, based on the foundational elements of Identity, Privacy, Governance, and Exchange, enables the discovery of real-world data across the broadest healthcare data ecosystem, the building of more complete and accurate patient journeys and the ability to power best-in-class analytics and applications with flexibility and ease. Together with our partners, HealthVerity has built the modern way to data for the health insights economy. To learn more about the HealthVerity IPGE platform, visit www.healthverity.com.
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