FDA unveils open source code for collecting patient data

Researchers can customize and rebrand the agency’s MyStudies App for their own clinical trials or observational studies.

By Tom Sullivan

November 07, 2018

09:01 AM

Screesnshots of FDA's MyStudies App. Source: FDA.

The U.S. Food and Drug Administration on Tuesday posted open source code for its MyStudies App to enable researchers to collect patient-provided data.

WHY IT MATTERS

FDA explained that after going through a pilot test, the MyStudies App is not what’s actually available in the Apple Store or Google Play. Rather, the agency put open source code and technical documentation on GitHub that developers or hospital and academic medical center researchers can use to customize and rebrand MyStudies for their own purposes.

ON THE RECORD

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

THE BIGGER TREND

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

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Late last month at the HIMSS Connected Health Conference in Boston, in fact, it became evident that the market is so flooded with apps, devices, wearables and wellness tools that what’s needed is radical simplicity, if only so clinicians and consumers can better grasp their options.

Despite all the technologies available, there is not yet a seamless way to tie patient-generated health information into larger datasets.

The MyStudies code is neither intended to solve that problem entirely nor is it something many patients are likely to pick up on their own. Indeed, it’s too early to know how developers or researchers will use the code but they now have the technological underpinning to at least start integrating even small data sources.

And that’s the next phase of digital transformation necessary to enable promising care delivery trends such as population health and precision medicine.

WHAT COMES NEXT

FDA pointed out that the MyStudies code will continue to be open source so developers can improve upon it and contribute those changes back to the community.

The software is also configurable for varying health outcomes and therapeutic areas and has a partitioned data storage environment in compliance with the Federal Information Security Management Act and 21 CFR 11 meaning it can be used in Investigational new Drugs oversight.

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