LegalZoom Publishes “Health Apps as Medical Devices: What It Means for Consumers”

“Health Apps as Medical Devices: What It Means for Consumers” by healthcare, FDA & business lawyer Michael H Cohen was published by LegalZooom in its online legal headlines on Technology. The article analyzes legal issues, including FDA regulation, related to use of smartphones for healthcare technology. Michael notes:

In its Mobile Medical App Guidance, the FDA states that not all health-related apps are to be considered medical devices. In general, only apps that are used as an accessory to a regulated medical device or that transform a mobile platform into a regulated medical device are considered mobile medical apps and are, therefore, subject to FDA regulation.

The Cohen Healthcare Law Group represents medical device manufacturers, mobile app developers, and companies (whether start-ups or established, multinational corporations) who develop emerging technologies in the health, wellness and lifestyle markets. We provide FDA regulatory advice and corporate legal counsel to navigate the alphabet soup of government rules for our clients, whether they are dietary supplement manufacturers and distributors, or innovators in cosmetics, integrative care, anti-aging and functional medicine, telemedicine, robotics and nanotechnology, or other areas of the larger healthcare industry. Contact us, and let us know what legal and regulatory counsel you seek.

The Health Apps article concludes:

The line between medicine and health is blurring again, and you and your device are a part of the transformation.

Or to redo the famous Ghandi quote: “You are the change that the world wants you to be.”