Digital Health Technology: A New Year and New FDA Guidance

January 19, 2018

Digital health technology encompasses a variety of innovative healthcare tools including clinical decision support (CDS) and patient decision support (PDS) technology. These terms are used loosely to cover everything from a proprietary algorithm recommending optimal cancer therapies for individual patients to an app that relies on published guidelines to encourage physical activity. Some digital health products stand alone while others are accessories to conventional medical devices. As companies from Apple and Google to garage start-ups look to enter the health technology space with a broad range of medical software innovations, there are many questions related to which products will be regulated by FDA as medical devices and to what degree.

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