Advancing Diverse Representation in Clinical Trials and Research

HealthVerity offerings support the call for action by the Committee on Improving Representation of Women and Underrepresented Minorities in Clinical Trials and Research.

HealthVerity IPGE changes the world for researchers

The Inside Story Behind MOM, the Maternal Outcomes Masterset

In the Spring of 2021, HealthVerity was in the midst of assembling a powerful and comprehensive dataset to serve the detailed needs of Pharmaceutical Manufacturers pursuing vaccine and antiviral therapies for COVID-19. The mounting list of study requirements was generally satisfied by the breadth of de-identified data available in the company’s ecosystem, but one segment of the market was particularly difficult to study - Mothers and their pregnancy journeys. As we further explored this challenge with our clients, it became readily apparent that the issue was far larger than COVID. In fact, the market had very few reliable options to study the maternal journey let alone 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. So began nearly a year of extensive research on data privacy techniques, payer claims data, lab data and inpatient data to better understand the clinical attributes that would best answer some of the healthcare industry’s most difficult questions, including the recent increase in maternal death rates in the US.

In support of this work, HealthVerity further validated that current methods for data capture for use cases such as post-marketing requirements (PMRs) for new therapies are incredibly difficult to fulfill, and pregnancy registries alone rarely gather enough information to drive better maternal health outcomes. In fact, the FDA Postapproval Pregnancy Safety Studies Guidance for Industry said it best: “Pregnancy registries generally are not sufficient by themselves to assess the safety of products during pregnancy.”

Our own data journey led to the ideation and creation of the Maternal Outcomes Masterset (MOM) to address the challenges of providing a more insightful and thorough means of understanding the impact of pharmaceutical products and healthcare services on the status of pregnant women and their babies. HealthVerity has built a better way for healthcare stakeholders to study a more comprehensive patient journey for moms and babies from pre-pregnancy to prenatal care to birth by synthesizing householded data from the most desired sources, all in a HIPAA-compliant, privacy protected package.

We invite you to read about why MOM is groundbreaking in its approach and how HealthVerity can enable its partners and clients to generate the regulatory quality research that only a masterset can deliver.

Why everyone needs MOM in their lives

MOM was designed to allow researchers to use de-identified clinical data to follow mothers and their infants in tandem through the term of their pregnancy journey, and beyond. Through proprietary, HIPAA-compliant techniques, MOM enables a wide range of use cases, including many of the most difficult studies to pursue. The masterset links over 1.5 million pregnant women to their newborns while delivering critical elements from medical claims, pharmacy data, lab data and inpatient data.

In comparison, traditional maternal health outcomes resources such as registries can be expensive to compile and take years to complete, and in many cases, failing to even enroll enough patients. Approaches that rely on retrospective data sources often find that the data is too narrow or lacks critical details such as race,ethnicity or month of death. In cases when sufficient data is available, it may not offer enough flexibility for analytics, or may not be interoperable with complementary datas sources. Furthermore, manually crosswalking all of these data sources for analytics means having to accurately link a mother’s data to her newborn which can be difficult in many circumstances.

With all of these challenges, we set out to ensure a better relationship between you and MOM. HealthVerity designed MOM to make it easy to leverage the nation’s broadest sources of healthcare data to study mothers and their infants with a deeper context around the data. MOM includes race and ethnicity attributes for nearly all patients, plus, maternal age and year of birth, pregnancy outcomes with diagnosis codes for birth events and other outcomes such as maternal or infant death — all interoperable, HIPAA compliant, and research-ready.

MOM knows best, or so we’re told

We built MOM from the ground up to ensure that it included the core data elements and privacy-protecting attributes that your research demands. In fact, here’s a few ways that MOM stands apart from other legacy datasets on the market.

Commercial and Medicaid representation: Existing pregnancy data sources are usually limited to commercial claims data. MOM offers vast Commercial health plan coverage as well as Medicaid within the master set, yielding a far more representative overview of the population. This provides for a more inclusive dataset and allows for more detailed analyses. In addition, HealthVerity will continue to evolve MOM as we add new data sources to the nation’s largest data ecosystem for healthcare and consumer data, thus supporting even more extensive and insightful projects.

Analytics agnostic: MOM enables data independence in that data meeting your unique inclusion and exclusion criteria is delivered directly to your secure FTP or to your analytics partner of choice for both retrospective and prospective elements. This unparalleled access to data contrasts with most pregnancy registries that require a built-in analytics provider. MOM offers flexibility both now and in the future.

HIPAA certified and de-identified from day one: HealthVerity has applied advanced techniques to reveal more of the maternal/infant journey but to ensure that MOM meets the most exacting standards of HIPAA. Because MOM is covered under HealthVerity’s third party certification, clients can begin work on the underlying data on day one and avoid any lengthy HIPAA review. Most comparable datasets for maternal health are not pre-certified and often limit attributes that HealthVerity has been able to leverage expert determination to achieve.

Trust MOM for the best advice for Real World Data

By enabling wider access to richer datasets, MOM makes it easy for you to discover pathways to improved health outcomes. You can leverage MOM to:

Challenge the status quo for synthesizing data on pregnant women and their babies. Because clinical interventional studies do not typically include pregnant patients, many studies rely on passive data collection to understand the potential impact of a drug or other treatment on pregnant women or newborns. MOM is a unique solution that enables better understanding of outcomes via larger populations (over 1.5 M mother/baby combinations) as well as racially diverse populations.

Enable rich data without exposing patient identity through date shifting. MOM retains relative date of service for most healthcare events but shifts dates randomly to within +/- 45 days of index event (pregnancy resolution). All transactions relative to the index event is date shifted by the same random base date to retain the integrity of the timeline. MOM also implements the same date shifting for the newborn to ensure an aligned patient story while ensuring the privacy of the patient. De-identifying and date shifting the patient data allows payers and providers to explore events that impact health outcomes while keeping patient anonymity.

Complete post-marketing requirements and improve the development lifecycle is with MOM to simplify efforts for life sciences. The masterset helps refine how to select an ideal patient population for study, what types of analysis can add value to clinical trials and how to properly position efforts around drug labeling. MOM offers ideal inputs across the entire continuum.

MOM is here for you

We invite you to begin your MOM journey with HealthVerity. This groundbreaking approach to answering the most challenging questions regarding the maternal lifecycle is just one call away. Let us show you what MOM can do for you today.

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