Office of Medical Policy

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FDA Launches Open Source Tool to Help Capture Data from Patients

Press Release | Food and Drug Administration | November 6, 2018

Today the U.S. Food and Drug Administration is announcing the MyStudies app, a new mobile technology to foster the collection of real world evidence via patients' mobile devices. Real world data can be collected from a variety of sources, such as electronic health records, claims and billing activities, and product and disease registries, as well as from patient-generated data including in home-use settings, or from data gathered from other sources, such as mobile devices. As part of the agency's work to foster greater opportunities around real world evidence, the FDA partnered with Kaiser Permanente on a pilot study to measure the functionality and engagement of the MyStudies app.

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