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CATEGORY 3 - USING INNOVATION, DATA, AND BREAKING DOWN ORGANIZATIONAL BARRIERS

ELAINE JOHANSON

Director, Health Informatics Staff

Office of Data, Analytics & Research

Office of Digital Transformation
U.S. Food and Drug Administration
U.S. Department of Health & Human Services

Elaine Johanson, Director of Health Informatics Staff (HIS) at FDA's Office of Data, Analytics, & Research (ODAR), is being recognized for playing a pivotal role in enhancing public service delivery through her leadership in several transformative initiatives.

Elaine has led the development of PrecisionFDA, a cutting-edge cloud-based computing environment that facilitates collaboration among over 6,000 users worldwide. This platform supports advanced analytics and AI research, particularly in precision medicine. It hosts numerous challenges and app-a-thons aimed at developing innovative solutions for regulatory science. These efforts have resulted in 11 FDA-coauthored publications and over 90 external scientific citations, highlighting its impact on scientific advancement.

Under Elaine's management, OpenFDA provides public access to critical FDA datasets, enabling transparency and fostering innovation in healthcare research. With over 10 million API calls per month, OpenFDA demonstrates its extensive use and value to researchers, healthcare professionals, and the public.

Elaine also oversees the Global Substance Registration System (GSRS), which catalogs more than 150,000 substances. This system streamlines information exchange and enhances regulatory efficiency, ensuring robust oversight of FDA-regulated products.

Additionally, Elaine manages the Common Data Model Harmonization (CDMH) platform on PrecisionFDA, facilitating the aggregation and analysis of real-world healthcare data. This platform supports clinical queries and contributes to public health research efforts.

Elaine's leadership and initiatives have significantly benefited the public by advancing AI and precision medicine, enhancing data accessibility through OpenFDA, and promoting data standardization critical for ensuring the safety and efficacy of FDA-regulated products. Her efforts have been recognized in FDA's modernization plans and healthcare technology agendas, underscoring her contributions to public health on a global scale.

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