FDA open sources mobile app to collect patient-generated data

mobile app to collect patient-generated data

FDA open sources mobile app to collect patient-generated data

The Food and Drug Administration agency of the US recently introduced a new app MyStudies to collect real-world data for clinical studies and other research straight from patients using a mobile device.

A few days ago, the US Food and Drug Administration (FDA) announced the MyStudies app, which is an innovative mobile technology designed to collect the real world data including the EHR patient data, claims and billing information, and patient-generated health data through the mobile devices owned by the patients. It will allow the patients to submit their real-world data to the app using their mobile phones.

Researchers can then connect the collected data to other digital health information. The main goal behind launching this app is to improve drug development and to make the diversity of accurate health information available that can be used for clinical trials and studies to develop new treatments. The MyStudies app can be operated on both iOS and Android mobile operating systems. Both Google and Apple provide with an open-source tool to develop health research apps.

According to FDA Commissioner Dr. Scott Gottlieb, by capturing the real world data from a variety of sources, the whole new drug development process can be made more efficient and safe for the monitoring, and it will also help in bringing down the overall cost of product development.

During the development of the app, the researchers did a trial study of the app at Kaiser Permanente Washington Health Research Network. They used the app among pregnant women to study the use of medication and its effects. In the end, they reached on the conclusion that the MyStudies app had the all the compulsory technical, scientific and governance processes which are essential for wide-ranging use of the app in clinical researches.

As the researchers continue to work on this app, they are expecting the app to acquire much better skills along with a more user-friendly design features and incorporation with more data sources.

The complete research work was directed by David Martin, M.D., who is an associate director for real-world evidence in the Office of Medical Policy in the Center for Drug Evaluation and Research in FDA. It was done with a fund contribution made by the U.S. Department of Health and Human Services’ Patient Centered Outcomes Research Trust Fund.

The open source code which is the basis of the MyStudies app, and specifications for a protected patient data storage environment, were developed in association with Harvard Pilgrim Health Care Institute, LabKey, and Boston Technology Corporation.

Image credit: www.istockphoto.com

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