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Healthcare and FDA lawyer Michael H. Cohen spoke on telemedicine, mobile medical app (M-health) and wearable health tech legal issues at the Los Angeles County Bar Association's Healthcare Law [...]

The FDA's final Guidance for Industry and FDA staff on mobile medical apps continues to constrain industry development of new health apps. Like the draft mobile medical app FDA guidance, the [...]

The FDA now requires that mobile app developers create a cyber security plan and submit it to the FDA along with their mobile medical app / medical device submission.

The FDA's Mobile Medical App Guidance contains many nuanced definitions that determine whether your mobile app will likely be regulated by the FDA as a medical device.Recent clients have asked [...]