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.