Article – FCC, FDA, ONC seek input on mHealth regs

I find the topic of this article interesting.

Here’s why…

  • We have had notebooks and netbooks on WiFi accessing Web-based and other types of applications deemed medical devices (e.g. PACS) for years. The essential difference between a tablet and a netbook is the keyboard. They pose the same risk as a client application platform.
  • If this is what regulators are worried about, wait til they get a load of the bigger billy goat coming across the bridge next …mobile apps are one thing, but what about a portal framework that aggregates patient data from distributed sources, in real-time? Imagine a screen where each discrete element of the patient record is managed in a different system. The values used to define and indicate normal and abnormal test results are from a public Web site. Where does the “medical device” start and end? Who is the “manufacturer” responsible if an issue arises? How do you manage the medical device labeling? With mobile, we are simply trying to figure out how to do what, in many cases, we do today, only now without a wire. …regulatory affairs folks are in for a world of change (or healthcare will fall ever farther behind the IT curve).

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