[datenwolf]

> possibly this has changed recently but I don't think medical records software is subject to the same standards as medical device software (in Europe, at least).

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.

[kakoni]

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)

[datenwolf]

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.