Have you ever been in a US emergency room, especially a rural one? The regulations are stiff, but not necessarily rigid, as the law is not a theorem-proving system.
Disclaimer: I am not an MD, but I used to work in drug and medical device development, where the regs did have to be followed strictly to the letter, and became quite familiar with where flexibility was and was not).
(And I meant IDE -- device exemption -- not IND, which is a drug exemption).
