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FDA Releases Final Guidlelines for Mobile Health Apps

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By Phil Cohen

From weight loss monitoring and lung function measuring, thousands of health care apps have flooded the smartphone and tablet market. Until now, the healthcare app market has ran without much regulation. The Food and Drug Administration (FDA) released its final guidelines for healthcare app development this week.  According to the FDA, only a small portion of mobile health apps will be monitored.

The agency will focus on apps that could potentially harm consumers. Essentially, if the apps perform the same functions as medical devices, they will be subject to the same regulations as the medical devices they resemble. The majority of mobile health apps, including apps for weight loss and fitness, will not face any regulations.

“We have worked hard to strike the right balance, reviewing only the mobile apps that have the potential to harm consumers if they do not function properly,” said Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health.

According to the FDA, the healthcare apps subject to scrutiny are ones“intended to be used as an accessory to a regulated medical device–for example, an application that allows a health care professional to make a specific diagnosis by viewing a medical image from a picture archiving and communication system (PACS) on a smartphone or a mobile tablet; or transform a mobile platform into a regulated medical device–for example, an application that turns a smartphone into an electrocardiography (ECG) machine to detect abnormal heart rhythms or determine if a patient is experiencing a heart attack.”

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Phil Cohen

About the author

Philip Cohen is the founder and President of PRN Funding, LLC. PRN Funding is an extraordinarily focused niche player in healthcare funding. With years of…... Read More

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