10:55 AM
Nov 06, 2018
 |  BC Extra  |  Politics & Policy

FDA releases real-world data collection app

FDA released on Tuesday an open source code app that can be used to collect real-world data directly from patients, including from mobile devices.

The MyStudies app is a digital platform that users can adapt to collect data from a “variety of sources, such as electronic health records, claims and billing activities, product and disease registries, as well as patient-generated data including in home-use settings, as well as data gathered from other sources, such as mobile devices,” according to an FDA announcement. The app can be customized and used to administer questionnaires assessing patient-reported outcomes, symptom scales or patient reports of medication use.

“Our hope is that the collection of more real world data directly from patients, using a secure app, will lead to more efficient product development and assist with safety monitoring,” FDA Commissioner Scott Gottlieb said.

The release follows completion of a pilot study that FDA and Kaiser Permanente conducted. Sixty-four pregnant women from the Kaiser health plan used the app to report on health outcomes, including sleep patterns; medication use; chronic health conditions, such as asthma, anxiety and bipolar disorder; and acute health conditions, for example, cold, flu and headache, FDA reported.

MyStudies was developed by FDA scientists, Harvard Pilgrim Health Care Institute, LabKey Corp. (Seattle, Wash.) and Boston Technology Corp. (Malborough, Mass.).

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