From: mHealthIntelligence
The FDA has unveiled an open-source app platform designed to help developers and researchers collect patient-reported mHealth data.
The federal agency in charge of regulating new mHealth technology is looking to include digital health data from consumers into the mix.
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“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.”
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