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FDA Session: Health IT at FDA
Session Chair(s)
Mitra Rocca, MSC
Associate Director, Medical Informatics, Office of Translational Science, CDER
FDA, United States
This session will focus on the status of health informatics at the FDA. Topics will include data standards for health care and clinical research, as well as use of EDC and EHRs in clinical research.
Learning Objective : Explain the Health IT activities at the FDA; Discuss the use of Health IT systems in clinical research; Discuss the results of one of the FDA-led initiatives focusing on the use of EHRs and other types of eSource in clinical investigations.
Speaker(s)
Health Information Technology at FDA
Mitra Rocca, MSC
FDA, United States
Associate Director, Medical Informatics, Office of Translational Science, CDER
Structured Sourcing of Clinical Data from EHRs
Adam L Asare, PHD
Quantum Leap Healthcare Collaborative, United States
Chief Data Officer