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Mobile Apps As Medical Devices

Posted on in FDA

The healthcare field is the latest in a group of industries that can say “There's an app for that!”. Some of these mobile applications are being scrutinized under the Food and Drug Administration since they can be considered medical devices. Officials from the FDA state that their primary interest in mobile medical applications are those whose “functionality could pose a risk to a patient's safety if the mobile app were to not function as intended.”

Earlier this year, the FDA released much-anticipated guidelines for mobile applications intended for use as medical devices. It's believed that there are more than 40,000 medical apps for smartphones linked to the healthcare industry.

The FDA is currently interested only in regulating those that carry major risks for patients, which they have classified into two different categories: those that serve as an accessory to an existing, regulated medical device and those that make a mobile platform into a medical device. Some examples of those that face the most scrutiny are those were doctors can make a diagnosis based on shared images and those that are used to locate irregular heartbeats.

Those medical apps left out of the fray will include tools for organizing health records, programs that allow patients to share symptoms with their medical providers, and applications to help manage conditions that are free of particular treatment plans or suggestions.

The increased focus on mobile applications seems to reflect a greater trend of awareness and involvement on the FDA's part when it comes to medical devices. This year the agency also released plans to track all medical devices with an identification system to issue recalls more quickly.

Defective medical devices can have serious consequences for patients. If you or a loved one has been hurt because of a defective medical device, you need the guidance of an Illinois personal injury attorney.

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