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Onboarding of Commercial Electronic Health Record (EHR) Data Partners

    Basic Details
    Date Posted
    Status
    Complete
    Description

    The U.S. Food and Drug Administration (FDA) has tasked the Sentinel Innovation Center (IC) with establishing a query-ready, quality-checked distributed data network containing electronic health records (EHRs) for at least ten million lives that can leverage reusable analysis tools. To support this goal, the IC has identified two commercial Data Partners, HealthVerity and TriNetX, to convert their structured fields from linked EHR and claims data to the Sentinel Common Data Model 8.1 (SCDM). The IC will deploy quality metrics and quality control procedures to ensure EHR data from the Data Partners is reliably converted, and at least one Sentinel routine descriptive query in linked EHR-claims datasets from the Data Partners will be implemented. By the end of the performance period, the IC will have linked EHR-claims with structured data in the SCDM with quality checks in place and will be able to use these structured data assets to implement simple, descriptive queries. Ultimately, the transformation of structured data from these commercial Data Partners to the SCDM format will be a key first step for potential future incorporation of these Data Partners into the Sentinel Distributed Database (SDD), providing access to EHR-claims linked data for over ten million patients.

    Information
    Time Period
    November 01, 2022 - January 31, 2024
    Data Source(s)
    HealthVerity, TriNetX
    Workgroup Leader(s)

    Rishi Desai, MS, PhD; Mass General Brigham, Boston, MA

    Jeff Brown, PhD; TriNetX, Cambridge, MA

    Ruth Zimmerman, RN, MSN; HealthVerity, Philadelphia, PA

    Workgroup Member(s)

    Meighan Rogers Driscoll, MPH; Anjum Khurshid MD, PhD; Jennifer Lyons PhD, MPH; Elizabeth Siranosian; Dan Kiernan; Malcolm Rucker, MS; Christine Draper; Department of Population Medicine, Harvard Pilgrim Health Care Institute and Harvard Medical School, Boston, MA

    Sebastian Schneeweiss, MD, ScD; Mass General Brigham, Boston, MA

    Jeffrey Graham;  Michael Swartzbaugh; Steve Sison, MS; Sapna Rajupet; Emily Hoder; TriNetX, Cambridge, MA

    Erick Moyneur; Statlog, Ontario, Canada

    Jason Meyer; Tyler Folta; Rick Edwards; HealthVerity, Philadelphia, PA

    Mark Khayter, MS; Don Torok, MS; Ephir, Boston, MA

    Trish Bright, PhD, MSPH; Jose Hernandez, RPh, MPH, PhD; Office of Surveillance and Epidemiology, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD