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Mobile Health Technology: It's A Phone, It's An App, It's A…Medical Device?

Molly R. Berkery and Jed A. Roher | The National Law Review | August 18, 2016

As mobile health technology has proliferated, federal regulatory authorities have taken notice. In particular, over the last five years the U.S. Food and Drug Administration (FDA) has been honing its approach to mobile apps and has released a series of documents that provide helpful guidelines to developers of healthtech apps. In particular, the FDA sorts mobile apps into three buckets...

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