But it gets really exciting when the “care about health” enters the area of medical therapy – raising compliance and affecting behaviour among people with medical conditions! Then the app becomes a “medical device”, since it’s an intervention. In that case major risks can occur, the app would most likely have to be regulated by the FDA – a simple “ok according to happtique” is not really up to snuff there, but I guess this will have to do until the FDA makes its mind up on how to treat this area – regulate it or not?

In the EU the guidance is pretty clear – if you sell to people with a disease, you are a medical product – but the regulations are cumbersome if you wish to follow the letter of the law.

Exiting topic, thanks for the article Mathew!

/Fredrik Debong