Incomplete and inconsistent capture of information about race and ethnicity in real-world data (RWD) limits a full understanding of the distribution, safety, and effectiveness of FDA-regulated products, which impacts the health of the public.

The Reagan-Udall Foundation for the FDA, in collaboration with FDA's Office of Minority Health and Health Equity, launched RAISE to elevate the capture and curation of race and ethnicity data in health care settings to ultimately improve the quality of health care and medical products.

Speaker Biographies

Workshop pre reads

View Meeting Summaries

AGENDA

Welcome 
        Speaker: Susan C. Winckler RPh, Esq, Reagan-Udall Foundation for the FDA

Welcome Remarks from FDA
        Speaker: Christine Lee-Flemming, PhD, PharmD, U.S. Food and Drug Administration
                       

Connecting the Dots
        Speaker: Carla Rodriguez-Watson, PhD, MPH, Reagan-Udall Foundation for the FDA

Presentations 

       The Gravity Project: The SDOH Data Standards Example of Tactics to Address Technical Challenges                   
        Sarah C. DeSilvey, DNP, FNP
        Director of Terminology, Gravity Project
        Yale/YNHH Center for Outcomes Research & Evaluation (CORE)- Project Lead, ASN measure
        Pediatric Faculty, Larner College of Medicine at the University of Vermont

        Progress, challenges, and incentives to adopting interoperability standards
        Ryan Argentieri           
        Deputy Director, Office of Technology
        The Office of the National Coordinator for Health Information Technology (ONC)

        Chinonye Onwunli
        Senior Policy Analyst and Branch Chief
        The Office of the National Coordinator for Health Information Technology (ONC)

         Yin & Yang: Challenges in data privacy & data sharing in the All of Us project
         Accenture Professor of Biomedical Informatics, Biostatistics, and Computer Science
         Vice Chair for Research Affairs Department of Biomedical Informatics
         Affiliated Faculty, Center for Biomedical Ethics & Society
         Vanderbilt University Medical Center

Moderated Discussion 
         Moderator: Lenel James, MBA 
                           FHL7, Business Lead – Health Information Exchange & Innovation
                           Market Solutions, Blue Cross Blue Shield Association

          Discussants:
          Workshop Champion: Bradley Malin, PhD
          Citizen Voice: La Keita D Carter, PsyD, LD
          Ryan Argentieri
          Sarah C. DeSilvey
          Chinonye Onwunli

Adjourn