Re:Open source software for developing world hospitals
by kakoni on Friday December 04, 2015 @05:07PM
(#10679516)
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)
Re:Open source software for developing world hospitals
by datenwolf on Sunday December 06, 2015 @09:11AM
(#10685280)
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.
That is indeed the case (medical record software not being classified as a medical device software product in Europe). However medical record software has been added to also be covered some ISO 80xxx standard. However in the USA medical record software is considered a class B or even class C medical product by the FDA, depending on if the software is used just for record keeping or actively used for therapy planning.