The FDA recently joined the digital healthcare wave with its MyStudies app, a tool that is designed to collected patient generated health data (PGHD) to assist in conducting and developing clinical trials. The app will collect evidence from users’ mobile devices to increase the diversity of information available for researchers in clinical experiments as well as other healthcare research.
Following the success of their pilot study partnered with Kaiser Permanente, the FDA has made the decision to release the open source code and documents researchers need to develop their own customized MyStudies apps.
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These users can adapt the app to fit their personal clinical trial and patient-evidence needs, while still complying to the FDA’s regulations regarding integrity, data authenticity, and confidentiality. MyStudies allows patients to securely contribute data to and enroll in various trials and studies, expanding researchers reach for participants with the use of smartphones and easy accessibility. Among the features these researchers can analyze are patient-reported outcomes and self-reports of prescription and over-the-counter drug use.
“There are a lot of new ways that we can use real world evidence to help inform regulatory decisions around medical products as the collection of this data gets more widespread and reliable,” said FDA Commissioner Scott Gottlieb in a statement. “Better capture of real world data, collected from a variety of sources, has the potential to make our new drug development process more efficient, improve safety and help lower the cost of product development.”
The MyStudies app strives to provide meet patient centered needs. It collects patient information from electronic-health records, claims, patient portal, and registries for products and diseases. In addition, these patients can also provide their patient generated health data from wearable devices like the Apple Watch, remote monitoring devices, various other apps, and their own medical record-keeping.
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“If done right, it can also help make sure doctors and patients are better informed about the clinical use of new products, enabling them to make more effective, efficient medical choices,” Gottlieb explained. “This will ultimately help us achieve better outcomes, and safer and more efficient use of expensive technology.”
Though the FDA-branded app was removed from app stores after their pilot study, their open source code is being released for two versions of the MyStudies app, one designed for Apple’s ResearchKit framework, commonly seen as iOS, and Google’s Android ResearchStack framework.
In their statement regarding the MyStudies app, the FDA lists important features of the app to be:
“The data storage environment is secure and supports auditing necessary for compliance with 21 CFR Part 11 and the Federal Information Security Management Act, so it can be used for trials under Investigational New Drug oversight.
The app is configurable for different therapeutic areas, and health outcomes, which reduces software development hurdles for non-FDA users.
The data storage environment is partitioned to support multi-site trials or “distributed database” studies.”
Read the full FDA statement here.
The digital tool is designed to enhance patient data gathering, drug development and safety monitoring. #digitalhealth #medtech https://t.co/Azcx1CQ72S
— Healthcare Analytics News (@HCA_News) November 14, 2018
Sources: Patient Engagement HIT, Health IT Analytics, FDA
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