Joining the ranks of Google and Apple, online retail giant Amazon has met with the FDA, according to the agency's public calendar, according to a report in Modern Healthcare. Just why Amazon met with the FDA is still a matter for speculation.
Of the three companies, Google has been the most transparent about its meeting with the FDA. It announced on its blog in January that it had met with the agency about the smart contact lens being developed at Google-X, which is designed to noninvasively monitor blood glucose for people with diabetes using their tears. The prospect has been met with some skepticism, but Google's recently signed licensing deal with Novartis greatly decreases the chance that the technology is just vaporware.
Apple, meanwhile, met with the FDA at least twice -- once in 2010 to discuss "medical devices" and once in 2013 to discuss "mobile medical apps." It's most likely that the topic of discussion was Apple's Health app and HealthKit set of developer tools, and that the object was to avoid FDA regulation. Sure enough, this summer, the FDA added a description to its list of non-regulated apps which made it clear HealthKit would be exempt. It's important to remember that, like Apple, Amazon's meeting could just as easily be about avoiding the need for FDA clearance as about securing it.
In addition to the online retail business that launched it, Amazon is a newly-minted smartphone maker and longtime maker of the Kindle Fire tablet. Given the timing of the meeting and the Amazon Fire Phone's recent launch, one possible reason for the meeting is that Amazon is considering a HealthKit-like functionality for future updates of the device. Between HealthKit and Google Fit, it's starting to look like having a built-in aggregator for health and fitness data will be commoditized in the next generation of smartphones.
A lot of speculation has been around the idea that Amazon could be working on a wearable device for healthcare. Babak Parviz, the developer of Google Glass and one of the leads for the company's glucose-sensing contact lens project, recently left Google for Amazon. Though he spoke extensively about wearables at a recent Rock Health event, he was quiet on the question of Amazon's healthcare plans.
It's also possible, but less likely, that Amazon sees a future for its devices in the healthcare enterprise. Before the iPad secured its footing, the Kindle Fire had advocates among the mobile physician community. And as Darius Tahir points out in Modern Healthcare, Amazon's cloud service Amazon Web Services is HIPAA-compliant and already in use by a number of healthcare startups, especially cloud-based EHRs.
Finally, Amazon's meeting with the FDA could be tied into its core business of online retail. Amazon certainly doesn't need FDA clearance to sell consumer health devices -- products like Vitality Glowcaps, Beddit sleep tracker, and more have already been sold on Amazon.com. But if the company is turning its retail expertise toward the realm of curating or evaluating medical devices or apps, especially apps and devices that themselves are regulated, that might bring them close enough to regulation to seek a meeting with the FDA. Or the company could be meeting with the agency to discuss the reported sale of prescription medications on its platform by merchants located in other countries.
Any combination of these possibilities is possible, or even something totally new.
