It's definitely part of medical treatment. Laws are changing to include "software medical devices" in health regulation. The FDA recently recognized this as a gap.
BTW I've worked with regulated software and it's not pretty. Just to update the firmware you have to fill out a ton of paperwork (because somebody died once after a firmware update and the firmware update was found to be the root cause). Regulation and review doesn't really make things tremendously safer, it just provides an audit chain so you can point at something when it does go pear-shape
BTW I've worked with regulated software and it's not pretty. Just to update the firmware you have to fill out a ton of paperwork (because somebody died once after a firmware update and the firmware update was found to be the root cause). Regulation and review doesn't really make things tremendously safer, it just provides an audit chain so you can point at something when it does go pear-shape