Feasibility study being conducted for FDA to utilize HealthVerity electronic health record data for medical product safety surveillance
PHILADELPHIA, PA — HealthVerity, the leader in Identity, Privacy, Governance and Exchange (IPGE) for real-world data (RWD), announced that it entered into a feasibility study with the Food and Drug Administration’s (FDA’s) Sentinel Innovation Center, a national program led by Mass General Brigham and Harvard Pilgrim Health Care Institute that uses electronic health data for over 100 million people to monitor the safety of FDA-regulated drugs and other medical products.
Launched in 2008, the Sentinel Initiative has continued to grow and evolve, transforming the way researchers monitor the safety of FDA-regulated products and becoming the largest curated database in the world dedicated to medical product safety. In 2019, the Innovation Center was created as part of the Sentinel Initiative to explore methods for incorporating linked medical claims and electronic health record (EHR) data into the Sentinel System for 10 million lives within five years. EHR data provides more clinical detail than insurance claims and is expected to address current gaps in the Sentinel System’s capabilities.
HealthVerity was selected to participate in this undertaking. During the 14-month project, select EHR data from the vast HealthVerity data ecosystem, consisting of over 75 unique data sources representing more than 330 million de-identified patients, will be converted into the Sentinel Common Data Model, and evaluated to ensure the data is fit for purpose.
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.