- The federal agency in charge of regulating new mHealth technology is looking to include digital health data from consumers into the mix.
The US Food and Drug Administration has unveiled an open-source mHealth app called MyStudies “to foster the collection of real world evidence via patients’ mobile devices.” Officials say the connected health platform will improve the development of new mobile health technologies by giving developers and researchers a direct link to the patients who would be using the technology.
“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,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “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.”
“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,” he added. “This will ultimately help us achieve better outcomes, and safer and more efficient use of expensive technology.”
Federal officials used healthcare experts from both sides of the country to create the platform.
Backed by a grant from the US Department of Health and Human Services’ Patient Centered Outcomes Research Trust Fund, FDA officials led by David Martin, MD, associate director for real world evidence in the Office of Medical Policy in the FDA’s Center for Drug Evaluation and Research, worked with the Harvard Pilgrim Health Care Institute, LabKey and the Boston Technology Corporation to create the open-source code framework. The app was then tested in a pilot study launched by California-based Kaiser Permanente.
Along with patient-reported data from mobile devices and telehealth programs, the app can draw information from other sources, such as electronic health record platforms, product and disease directories and claims and billing activities.
It also enables secure data storage that complies with 21 CFR Part 11 and the Federal Information Security Management Act audits, required for studies under Investigational New Drug oversight.
This digital platform enables developers to adapt our technology to advance new ways to access and use data collected directly from patients - with the necessary controls in place to ensure patient privacy,” Gottlieb said. “Our hope is that the collection of more real world data directly from patients, using a secure app, will lead to more efficient product development and assist with safety monitoring.”
Gottlieb envisions healthcare providers using the app in clinical drug trials, where they could customize the platform to send out surveys assessing “patient-reported outcomes, symptom scales or patient reports of prescription and over-the-counter medication use.”
Officials said the app code will eventually be modified for use on both Apple’s ResearchKit and Google’s Android ResearchStack platforms.