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AGs Weave Themselves Into Patchwork of Digital-Health Regs

There are more than 165,000 mobile health applications available for download in Appleā€™s App Store or Google Play. This number will likely keep rising, and a body of federal and state regulators, including state attorneys...more

Software as a Medical Device: FDA Releases Draft Guidance

Companies that develop software that functions as a medical device should be aware that the Food and Drug Administration (FDA) has issued draft guidance that, once finalized, will classify the endless variety of Software as a...more

A New Tool for Health App Developers to Navigate a Crowded Regulatory Field

As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more

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