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If they are used to store protected health information it’s the practice’s duty to make sure they comply with HIPAA regulations. So for example can’t leave that
by mygo 9y ago
If they are used to store protected health information it’s the practice’s duty to make sure they comply with HIPAA regulations. So for example can’t leave that file cabinet unlocked out in the front lobby.
When I was looking to make an app for a clinic they had to do a security review of the app. If the data wasn’t encrypted at rest it was a no-go. There are entire data companies sprouting out to address this issue. I think TrueVault is a Y-Combinator alum.
- nradov 9y agoYou missed the point. HIPAA security regulations are entirely separate from FDA medical device regulations.
- mygo 9y agoAah, gotcha. Well if the FDA medical device regulations don’t cover it, is there not still the possibility of some other regulation still effectively covering it? For example something like, the way my device functions may not be regulated but the use of my device by a medical provider is regulated.
- nradov 9y agoMost EMRs don't meet the legal definition of a medical device and nothing a provider does can change that. There are a variety of other regulations in this space. You'll have to be more specific about functionality to determine which rules apply.