The FDA launched a new app designed to enable the easy collection of real world evidence in the form of EHR (electronic health record) patient data, claims and billing information as well as patient-generated health data via patients’ mobile devices. Called MyStudies, this app supports real world evidence from a variety of sources for utilization in clinical trials and observational studies that may help inform future regulatory decisions. Scott Gottlieb of the FDA noted “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.”
The FDA partnered with Kaiser Permanente to execute a pilot study determining the capabilities and effectiveness of the app. The FDA is releasing the open source code and technical documentation to support researchers and health technology professionals to customize and tailor the app to fill specific needs.
The app is flexible and can be customized to allow patients to securely contribute EHR data or patient generated health data to clinical trials, pragmatic trials, observational studies and registries. The FDA has made the app open source, encouraging ongoing improvement. The code is being released for Apple’s ResearchKit (iOS) framework as well as for ResearchStack framework running on Google’s Android. This move by the FDA aligns nicely with other initiatives such as Apple’s Health Records EHR data viewer released in early 2018. As reported by EHR Intelligence writer Kate Monica, more than 80 health systems have joined the Health Records beta program supporting patient health information accessibility.