Dancing with the FDA

How does the FDA look at and regulate mobile medical apps?

“The only way to make sense out of change is to plunge into it, move with it, and join the dance.”
Alan W. Watts

Yes we too are guilty of it! Getting involved with digital health projects that result in exciting new apps and treatment algorithms that help people manage their conditions and track their progress. Then, for some of these projects, we look at the data, and we become totally enthusiastic by the fact that it shows that our idea seems to be working and people are achieving the health results we were hoping for!!!
We want to scream to the world that we have a great solution that will change healthcare, and that everyone out there in the world should download our app (and every VC should pour money into our project) BUT… several hundred people downloading an app, using it, measuring their progress which shows significant improvements in their condition unfortunately does not meet the strict criteria of a controlled medical study, therefore we cannot legally make a marketing claim that our digital health app has proven medical benefits.

So what do we do at this point? Continue reading on www.healthwareinternational.com.

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