The puzzle of delivering medical apps and devices

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.

[ Also on InfoWorld: The rough road to reliable data exchange among EHRs • Patient engagement will be tough task for health tech • The iPad revolution is coming to a hospital near you • iPads have won the hospitals, but Android may win the patients. | Subscribe to InfoWorld’s Consumerization of IT newsletter today. ]

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.

Currently, the FDA reviews about 20 apps a year, a small portion of its medical device review. Officials don’t expect to see that number skyrocket, as the apps involved are typically part of specialty care systems that are reviewed by the FDA, rather than stand-alone apps.

The FDA approach shouldn’t mean that anything goes for the “lifestyle” devices and apps it doesn’t require be approved. The FDA has said it will monitor noncritical apps, intervening if it sees dangerous results, just as it does for nonmedical substances such as food additives and herbal remedies.

Tricky questions as to how to formally handle patient-generated health data Where there’s not likely to be such certainty is the data that such “lifestyle” devices and apps generate. Such self-monitoring dovetails nicely with the wellness movement that forms the basis of the behavioral shift for both providers and patients advocated in the Obamacare rules, especially those around patient engagement and reduction of preventable illnesses.

People are likely to be encouraged to pay more attention to their health metrics, from body mass index to calories burned, from blood pressure to heart rate, from nutrition ratios to allergy-free or pain-free days. Mobile devices and apps will make that self-monitoring easier.

But medical providers will be very leery of such data, even if they provide a space for it in their patient health portals. The data’s accuracy and provenance are both unknown, so acting on it could be risky. Then again, so could not acting on it (plausibly a form of negligence). Plus, bringing such data into the formal medical record makes it permanent — health records may not be deleted — so any bad data could be perpetuated.

Health care providers and consultants I’ve spoken with suggest that such data will be treated informally, just like patients’ self-reported conditions and readings during in-person, phone, and email consults. If a patient shares the information with a provider, the provider can decide whether to do formal tests to confirm what the patients’ personal data implies. The trick will be to keep patients educated about the limitations of their self-monitoring while not discouraging it, says Justin Steinbman, vice president of marketing at GE Health: “After all, it facilitates better conversations.”

This article, “The puzzle of delivering medical apps and devices,” was originally published at InfoWorld.com. Read more of Galen Gruman’s Smart User blog. For the latest business technology news, follow InfoWorld.com on Twitter.