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Summary: The FDA has chosen to only regulate medical apps that could be harmful to patients if they do not function properly. Regulated apps fall in one of two categories:
1. Apps that can be used as an “accessory to an already-regulated medical device”
2. Apps that “turn the smartphone into a medical device”
The FDA will not regulate the sale of these apps or have oversight of app distributors. Some examples of apps include SpiroSmart which uses a phone’s mic to measure breathing capacity, something important for those with diseases such as Cystic Fibrosis who have to spend thousands of dollars on a spirometer. Another app is a biosensor that people can use to test their food for allergens.

Think About:

1. How much of the diagnostic process will be done virtually as more applications are released into the market?
2. What issues arise with virtual diagnosis?
3. How much will these apps cost?
4. Will medical-device companies become more profitable if they work on applications? Or less profitable if fewer of their machines need to be purchased?

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