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Key Health Informatics Initiatives at FDA

Key Health Informatics Initiatives at FDA


FDA's Office of Health Informatics spearheads the following initiatives:

  • openFDA uses cutting-edge technologies deployed on the Agency's public cloud computing infrastructure to make FDA's large, important publicly available data sets more easily accessible to researchers, web developers, and other members of the public in an open standard format.  >> More
  • Chillax provides options to the high cost of expanding and maintaining the internal high performance computing (HPC) infrastructure needed for Big Data analysis. >> More
  • The Global Substance Registration System. FDA is a key source for substance information that is precise to the molecular level for use internally and externally (where appropriate).  FDA’s Health Informatics program defines these substances, assigns unique identifiers (UNIIs), and collaborates with internal and external stakeholders worldwide to define requirements and provides content for the ISO compliant Global Substance Registration System (GSRS) currently in development at NIH.
  • Structured Product Labeling (SPL) is a document markup standard FDA has adopted as a mechanism for exchanging product and facility information.  Health Informatics facilitates the FDA Data Exchange Standards (E-list) change control board, provides subject matter expertise on the system and standard, and manages requirements and process change as governed by the board.  Health Informatics also maintains SPL Indexing Files for Pharmacologic Class, Substance, Product Concept, Biological Drug Substance, and Billing Units.
  • The FDA Data Standards Advisory Board (FDA DSAB) promotes developing and using voluntary consensus-based standards that define common data and enable sharing of this data internally and externally. The board is the decision-making body for participating in external standards bodies and for determining an FDA versus product center- or organization-specific decision.  
  • Vocabulary and Terminology Services helps FDA product centers and with standardizing medical, pharmaceutical, chemical, and other terminology that is relevant to data interchange.  Vocabulary and terminology services maintains over 85 different terminology standards and is the FDA terminology liaison and subject matter expert to key government and industry nomenclature and health information committees, such as USP expert committeesdisclaimer icon, HL7 committeesdisclaimer icon, andIHTSDO committeesdisclaimer icon, ONC/HealthIT.gov’s Federal Health Information Modeling (FHIM) workgroups.

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