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Most EMR (electronic medical records) software isn't even regulated, though about 8-10 years ago there was a big todo about it coming down the line. Still hasn
by taborj 9y ago
Most EMR (electronic medical records) software isn't even regulated, though about 8-10 years ago there was a big todo about it coming down the line. Still hasn't happened. I would expect the EMRs to be regulated long before consumer apps.
- nradov 9y agoMost EMR vendors specifically design their products to not be medical devices. They simply store, display, and transmit patient charts. If the FDA was to regulate EMRs as medical devices then logically they would also have to apply the same rules to filing cabinets and fax machines.
- mygo 9y agoIf 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.