By: Jonathan C. Young, PhD, MS, CIP, CCRP Senior Research Regulatory Operations Analyst Rush University Medical Center
Abstract: The use of mobile medical devices in clinical research is increasing significantly. This article provides an overview of regulations and guidance related to mobile medical devices including mobile apps. Possible risks and controversy that may arise from the use of mobile medical devices and how to improve submissions to institutional review boards for research involving mobile medical devices are also discussed. Examples of institutional review board review of real studies involving mobile medical devices at Rush University Medical Center are provided.
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