Earlier quoted context omitted.
Genius move, take a crappy mobile game, call it a medical device and sell it for a price not even the best AAA games would ever dream to ask. Only the USA healthcare system could give life to such an abomination.
Nope, we have the same in Germany (and in the EU), called "digital health applications" (DiGA in German). These are smartphone apps with some medical claims, certified as medical devices and prescribed by doctors. They make about €120-€500 for 90 days. In some cases, these apps might be useful. But I think there are quite a few cash grabs in there, too.
But in 2017 the FDA launched the Digital Health Innovation Action Plan. So arguably the concept was born in the USA.