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Tuesday, June 20 • 4:00pm - 5:00pm
#268: FDA Session: Health IT at FDA

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Component Type: Session
Level: Intermediate
CE: CME 1.00; IACET 1.00; RN 1.00

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 Objectives

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.


Mitra Rocca, MSc


Health Information Technology at FDA
Mitra Rocca, MSc

Structured Sourcing of Clinical Data from EHRs
Adam L Asare, PhD

avatar for Adam Asare

Adam Asare

Chief Data Officer, Quantum Leap Healthcare Collaborative, United States
Adam Asare has over 15 years’ experience in academic and industry developing clinical and research information systems. He has a joint appointment as Chief Data Officer at Quantum Leap Healthcare Collaborative and Director of Information Technology for the UCSF Breast Care Clinic... Read More →
avatar for Mitra Rocca

Mitra Rocca

Associate Director, Medical Informatics, Office of Translational Science, CDER, FDA, United States
Mitra Rocca joined FDA in 2009 as the Senior Medical Informatician responsible for developing the health information architecture of the Sentinel System. She leads the FDA CDER Health Information Technology board and serves as the medical informatics expert at CDER. Prior to joining... Read More →

Tuesday June 20, 2017 4:00pm - 5:00pm CDT
N227b McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616
  01: Data-BigData-eHealth, Session