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  1. Office of Digital Transformation

Office of Health Informatics

Graphics depicting sources of health data


The mission of the Office of Health Informatics is to provide health informatics tools, solutions, and expertise that enhance, transform, and sustain FDA's ability to protect and promote the public health.

Major Functions
  • Develops and implements health initiatives, including data harmonization and data exchange standards, data science and analytics, open data, knowledge management, research and development, as well as big data initiatives and activities.
  • Captures, develops, coordinates, and promotes effective uses of informatics-based organizational knowledge.
  • Ensures a next-generation open source informatics platform that enables collaboration, fosters information-sharing, and provides analytic tools as regards the Precision Medicine Initiative.
  • Leads, researches, and implements enterprise informatics solutions in support of FDA's regulatory mission.
  • Ensures, coordinates, and sponsors standards-based electronic data submission, brokering, storage, retrieval, analysis, and knowledge dissemination.
  • Defines, advocates, and implements data exchange standards that are consistent with health information technology and the industry.
  • Implements harmonized controlled vocabularies and data.
  • Identifies and reviews electronic data sources (e.g. electronic medical records, data standards, and novel data sources) for FDA in collaboration with the Office of the National Coordinator (ONC), Centers for Medicare & Medicaid Services (CMS), and industry, among others.  
Key Initiatives

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