So
a) Class A, B, C in this context means safety class(=IEC62304?)
b) I was under the impression that EHR is not FDA regulated in US? (There was been lots of discussion about this though)
I'd have to look into my most recent seminar materials (we did only tangent on medical record software since this was focused on diagnostics and treatment devices) but as far as I recall, there was a slide that EHR software falls under FDA regulation; in contrast to EU law. Let me have a look at it tomorrow, when I'm in the office, where I placed the seminar stuff.