Mobile healthcare apps are big business. An estimated 500 million smartphone users worldwide will be using them by 2015.
In response to the growing industry, the U.S. Food and Drug Administration (FDA) recently released its plan to regulate medical healthcare apps.
The new rules will not impact tools that allow you to look up the symptoms of the flu or track your weight loss goals from the convenience of your smartphone. Rather, they will focus exclusively on healthcare apps that function as medical devices.
According to the FDA, the agency will apply the same risk-based approach it uses to assure safety and effectiveness for other medical devices. However, many apps will not fall under the purview of the new regulations. The FDA will only regulate mobile apps that meet the regulatory definition of “device” and that:
Are intended to be used as an accessory to a regulated medical device, or
Transform a mobile platform into a regulated medical device.
The FDA also intends to exercise enforcement discretion over certain mobile applications that satisfy the regulatory definition of a “device” but pose minimal risk to patients and consumers. Examples include apps that: help patients self-manage a condition without providing specific treatment suggestions; provide patients with simple tools to organize and track their health information; and enable patients and providers to interact with electronic health record systems. Manufacturers of these mobile apps will not be required to undergo the premarket review process or register their apps with the FDA.
The FDA’s decision is good news for the medical technology industry. Given the prior lack of clarity on how the agency would regulate apps, many companies had delayed plans to jump into the action. And, given the popularity of apps, it is also good news for us patients.
If you have any questions about the FDA policy or would like to discuss the legal issues involved, please contact me, Dan Brecher, or the Scarinci Hollenbeck attorney with whom you work.
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FDA Plan Goes Easy on Healthcare Apps
Author: Dan Brecher
Mobile healthcare apps are big business. An estimated 500 million smartphone users worldwide will be using them by 2015.
In response to the growing industry, the U.S. Food and Drug Administration (FDA) recently released its plan to regulate medical healthcare apps.
The new rules will not impact tools that allow you to look up the symptoms of the flu or track your weight loss goals from the convenience of your smartphone. Rather, they will focus exclusively on healthcare apps that function as medical devices.
According to the FDA, the agency will apply the same risk-based approach it uses to assure safety and effectiveness for other medical devices. However, many apps will not fall under the purview of the new regulations. The FDA will only regulate mobile apps that meet the regulatory definition of “device” and that:
Are intended to be used as an accessory to a regulated medical device, or
Transform a mobile platform into a regulated medical device.
The FDA also intends to exercise enforcement discretion over certain mobile applications that satisfy the regulatory definition of a “device” but pose minimal risk to patients and consumers. Examples include apps that: help patients self-manage a condition without providing specific treatment suggestions; provide patients with simple tools to organize and track their health information; and enable patients and providers to interact with electronic health record systems. Manufacturers of these mobile apps will not be required to undergo the premarket review process or register their apps with the FDA.
The FDA’s decision is good news for the medical technology industry. Given the prior lack of clarity on how the agency would regulate apps, many companies had delayed plans to jump into the action. And, given the popularity of apps, it is also good news for us patients.
If you have any questions about the FDA policy or would like to discuss the legal issues involved, please contact me, Dan Brecher, or the Scarinci Hollenbeck attorney with whom you work.
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