@Elizafox@vulpine.club I'd like to inform you that this does not apy to all medical IT.

For example, it might only apply to directly connected appliances used to monitor critical vitals.

I wish I could go i to more details, but existing NDAs prevent that.

Needless to say whilst some things might require certification as a medical product (i.e. questionnaires used for diagnostic purposes), most things don't and at the end of the day, common off-the-shelf FLOSS is the basis a lot of commercial SaaS in the medical sector relies on.

And no, there isn't much aside basic testing and insurance against mistakes in terms of gatekeeping.