The puzzle of delivering medical apps and devices

As FDA gets closer to defining what personal devices and apps need approval, questions remain on how doctors should handle resulting data

The health care industry is abuzz about wireless sensors that can monitor patients outside the hospital, providing quick alerts before a medical crisis ensues, saving money and keeping patients from experiencing the worst conditions. There are even several efforts under way to create a medical tricorder à la the device made famous in the "Star Trek" series, with one contact-based "tricorder" device promised for later this year.

In the mobile industry, there's a growing list of health-oriented apps and sensors that regular individuals can buy, from pedometers like the Nike+ product line for iOS and heart-rate monitoring apps like Instant Heart Rate for Android to general wellness-tracking apps like Fitbit. We're getting medically wired both at the professional and consumer ends, with the lines blurring between what people do and what their providers do -- just as the work/home balance has become irrevocably blurred for so many businesses.

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These trends are raising tricky questions: Should consumer medical apps and devices be regulated by the Food and Drug Administration (FDA) like the ones hospitals use? Are they subject to the Obamacare national health care law's devices tax? Are doctors and health care providers liable for monitoring the data from the personal devices -- or for acting on that information if they do see it?

FDA oversight of health-oriented devices and apps to be highly focused
There's been a lot of uncertainty on the status of such medical devices and apps, as the FDA has deferred issuing its guidelines for two years. But this week, the FDA told Congress the broad outlines of its intended guidelines, to be issued by October:

  • The 2.3 percent excise tax on medical devices will not apply to iPhones, iPads, or other general-purpose mobile devices, nor to consumer health devices like glucose monitors and blood pressure readers -- the kinds you can pick up at a Walgreens, Target, or Kmart. The law never applied the tax to such consumer devices, but there's been a persistent rumor to the contrary for months. My best guess: This was disinformation released by the regulated medical devices industry, which is trying to get that tax repealed on the equipment sold to health care providers.
  • The FDA will not require approval of consumer mobile apps, nor of general-purpose mobile devices that might run medical apps. App stores are also not subject to regulation or approval. The FDA says what it calls "lifestyle app" will require no approval; such apps include personal health records systems, front ends to electronic health records (EHR) systems, pedometers and other tracking devices for various health metrics, medical encyclopedias and libraries, and prescription reminders.
  • The FDA will regulate and require approval for apps used for diagnosis of critical conditions such as cancer, for regulating drug delivery and other treatments, and for monitoring critical care factors such as blood oxyen levels.
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