FDA Unveils Open Source Code For Collecting Patient Data


The U.S. Food and Drug Administration on Tuesday released open source code for its MyStudies app to allow researchers to collect data provided by patients.


The FDA explained that after doing a pilot test, the MyStudies app isn’t what’s actually available in the Apple Store or Google Play. Instead, the agency has put open source code and technical documentation on GitHub that developers or researchers in hospitals and academic medical centers can use to customize and rename MyStudies for their own purposes.


Direct from the FDA: “MyStudies is designed to facilitate the entry of real-world data directly by patients, which can be linked to electronic health data supporting traditional clinical trials, pragmatic trials, observational studies and clinical trials. registers. ”


Apps and devices are everywhere. 2018 appears to be the year of the healthcare voice technology pilots. Medical data is exploding.

At the end of last month at the HIMSS Connected Health Conference in Boston, in fact, it became evident that the market is so inundated with apps, devices, wearable devices, and wellness tools. be that radical simplicity is needed, if only so that clinicians and consumers can better understand their option.

Despite all the technologies available, there is still no transparent way to link patient-generated health information to larger datasets.

The MyStudies code is not intended to fully solve this problem, nor is it something that many patients are likely to understand on their own. Indeed, it is too early to know how developers or researchers will use the code, but they now have the technological foundation to at least start integrating even small data sources.

And it’s the next phase of the digital transformation needed to enable promising trends in healthcare delivery such as population health and precision medicine.


The FDA stressed that the MyStudies code will continue to be open source so developers can improve it and make these changes to the community.

The software is also configurable for different health outcomes and therapeutic areas and has a partitioned data storage environment compliant with Federal Information Security Management Act and 21 CFR 11, which means it can be used in the monitoring of new investigational drugs.

“Additional open source code built on the Apple ResearchKit framework and the ResearchStack framework for Google’s Android operating system will be released in the coming calendar quarters,” the FDA wrote. “These improvements will simplify the setup for researchers and improve the experience for participants. “

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