[chrisseaton]

> That is a very simple take on the quite complex situation that still differs in different states of the EU.

How complicated did you expect me to get in a HN comment?

But I believe it's fact - medical software that measures or calculates on an iPhone gives you a medical device, and a medical device needs to be regulated in the UK, EU, and most other places. I was on the team that did among the first work on regulating this properly.