FDA to Investigate Promising Mobile Medical Apps

by Sam Dean - Jul. 25, 2011Comments (3)

Many futurists, including tech-savvy forecasters such as Ray Kurzweil, have predicted that mobile phones and other mobile devices will increasingly serve medical purposes, even functioning as medical monitoring devices, as we noted in this post. The concept of the phone as pocket doctor may still be questionable for some people, since there are only limited applications in this space so far, but the concept holds much promise. After all, our phones and mobile devices are with us much more constantly than doctors are. Now, the U.S. Food and Drug Administration (FDA) is reportedly applying oversight to mobile medical apps. Is this a good thing?

According to I Programmer:

"The FDA has now drawn up a set of draft guidelines for reviewing a subset of medical mobile apps. It isn't planning to oversee all health apps - just those medical apps that could present a risk to patients if the apps don’t work as intended." 

According to the FDA's guidance documents:

"At this time, the FDA intends to apply its regulatory requirements solely to a subset of mobile apps that it is calling mobile medical applications or 'mobile medical apps."

Mobile developers have been picking up on medical apps for smartphones. When the iPhone 3.0 OS arrived, Apple demonstrated two new applications for the iPhone that monitor the glucose levels of the owners and monitor blood pressure. The idea is that iPhone owners who have diabetes or high blood pressure could have data on their physical status collected, and even automatically sent at regular intervals to a doctor. There are also many applications that are designed simply to help phone owners track health-related data.

Hopefully, the FDA will tread carefully as it begins to oversee this promising area of mobile app development. It would be ideal to see the open source development community dive into production of useful medical applications, and phone makers equip phones with simple health monitoring devices. Some early applications from the open source community are arriving. We've also written about open source applications aimed at medical and humanitarian aid before.

Too much oversight from the FDA could definitely put the kibosh on these emerging mobile health app trends.

Randy Clark uses OStatic to support Open Source, ask and answer questions and stay informed. What about you?


I don't think the FDA or the US Government will be able to keep up with the pace of innovation. With mobile technologies leaping to the forefront, it is going to take some serious thought leadership to be able to keep up with stuff like this. Also, how do you regulate apps that help you improve your stamina or other things, which, while not prescriptive, might lead you to heart issues!

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@ Jack, i agree on that. + it will be to much to handle.

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I think it will be a reality past 5-10 years.

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