Comment Re:We no longer regulate ads and mail order produc (Score -1) 254
If the app impacts diagnosis in any way it is no longer just an app, it's a medical device, and subject to regulation.
This doesn't even begin to speak to patient data stored locally in an app and current HIPAA regulation.
The DSM-IV, which is simply a list of diagnostic criteria for psychiatric disorders, is available in e-book format as an "app". Is that app a medical device? What about a paper copy of the DSM-IV that I carry around in my pocket? Is that a medical device, too?
The DSM-IV is more than just an app, and it would be impossible to argue that it is not subject to regulation. In fact, were such regulation introduced to medical apps, would you not agree that the mental health aspects would be regulated, and that a large basis of this regulation would be based on the DSM-IV?
Despite its flaws, it is still one of the benchmarks in psychiatric medicine, and would undoubtedly be a foundation for the regulation of psychiatry apps were such regulation to be introduced.
