On November 6, 2018, the United States Food and Drug Administration (FDA) announced a new app, the MyStudies app. The MyStudies app was created to “foster the collection of real-world evidence via patients’ mobile devices” and information will be collected from a variety of sources, including electronic health records, claims and billing activities, and product and disease registries. Information can also be collected from patient-generated data, including in home use settings or from other sources, including mobile devices.
The FDA previously partnered with Kaiser Permanente on a pilot study to measure the functionality and engagement of the MyStudies app. Based on the successful outcome of the study, the FDA is now releasing the open source code and technical documents that will allow researchers and developers to customize and use the FDA’s newly created MyStudies app to expand the diversity of health information available for clinical trials and studies, while directly capturing the perspective of patients. By providing the open source code, the agency is providing a tool that sponsors and developers can adapt to advance their specific clinical trial and real world evidence needs, while also remaining compliant with the FDA’s regulations and guidance for data authenticity, integrity and confidentiality.
The app came about through a directive from the Affordable Care Act of 2010 (ACA), which directed the Department of Health and Human Services (HHS) to build data capacity for patient-centered outcomes research through a Trust Fund of the same name. The key deliverable of the project is a mobile device application and patient data storage environment that can securely and transparently record the patient perspective and enable data linkage to the existing electronic health data in distributed or centralized studies, trials, or registries.
Some of the features of the app include: a secure data storage environment, with the ability to audit as necessary under 21 CFR Part 11 and the Federal Information Security Management Act; customizable and configurable for different therapeutic areas and health outcomes; and an open-source code so that software developers can improve its capabilities through time.
For example, the app will let patients securely enroll in and contribute data to traditional clinical trials, pragmatic trials, observational studies and registries. Sponsors then may be able to customize their apps to administer questionnaires assessing patient-reported outcomes, symptom scales or patient reports of prescription and over-the-counter medication use.
Open source code is being released for two versions of the app. One is built on Apple’s ResearchKit (iOS) framework, and the other is built on the open source ResearchStack framework, which runs on Google’s Android. (The original FDA-branded app is not currently in app stores because it was removed after being tested in a pilot study.) The open-source code will allow the app and patient data storage system to be reconfigured and rebranded by other organizations that conduct clinical research.