Published on in Vol 10 (2024)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/49811, first published .
Development of Interoperable Computable Phenotype Algorithms for Adverse Events of Special Interest to Be Used for Biologics Safety Surveillance: Validation Study

Development of Interoperable Computable Phenotype Algorithms for Adverse Events of Special Interest to Be Used for Biologics Safety Surveillance: Validation Study

Development of Interoperable Computable Phenotype Algorithms for Adverse Events of Special Interest to Be Used for Biologics Safety Surveillance: Validation Study

Ashley A Holdefer   1 , MS ;   Jeno Pizarro   1 , BBA ;   Patrick Saunders-Hastings   2 , PhD ;   Jeffrey Beers   1 , MD ;   Arianna Sang   1 , BA ;   Aaron Zachary Hettinger   3, 4 , MS, MD ;   Joseph Blumenthal   3 , BA ;   Erik Martinez   1 , MBA ;   Lance Daniel Jones   1 , MA ;   Matthew Deady   1 , BA ;   Hussein Ezzeldin   5 , PhD ;   Steven A Anderson   5 , PhD

1 IBM Consulting, Bethesda, MD, United States

2 Accenture Inc, Ottawa, ON, Canada

3 Center for Biostatistics, Informatics and Data Science, MedStar Health Research Institute, Columbia, MD, United States

4 Department of Emergency Medicine, Georgetown University School of Medicine, Washington, DC, United States

5 Center for Biologics Evaluation and Research, United States Food and Drug Administration, Silver Spring, MD, United States

Corresponding Author:

  • Hussein Ezzeldin, PhD
  • Center for Biologics Evaluation and Research
  • United States Food and Drug Administration
  • 10903 New Hampshire Avenue
  • Silver Spring, MD, 20993
  • United States
  • Phone: 1 2404028629
  • Email: Hussein.Ezzeldin@fda.hhs.gov