FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: EXPLORATION OF HEALTH LEVEL SEVEN FAST HEALTHCARE INTEROPERABILITY RESOURCES FOR USE IN STUDY DATA CREATED FROM REAL-WORLD DATA SOURCES FOR SUBMISSION TO THE FOOD AND DRUG ADMINISTRATION; ESTABLISHMENT OF A PUBLIC DOCKET; REQUEST FOR COMMENTS

WASHINGTON, April 23 -- Food and Drug Administration has issued a notice called: Exploration of Health Level Seven Fast Healthcare Interoperability Resources for Use in Study Data Created From Real-World Data Sources for Submission to the Food and Drug Administration; Establishment of a Public Docket; Request for Comments.

The notice was published in the Federal Register on April 23 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or the Agency) is announcing the establishment of a docket for public comments exploring the Health Level Seven (HL7) Fast Healthcare Interoperability Resources (FHIR) for submission of data collected from real-world data (...