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Google Fit and Apple iWatch Mobile Health Gadgets to face FDA

Jun 23 2014, 7:26am CDT | by , in News | Apple

Google Fit and Apple iWatch Mobile Health Gadgets to face FDA
Todd Hamilton

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Google Fit and Apple iWatch Mobile Health Gadgets to face FDA

As rumor has it, LA Lakers’ Kobe Bryant is testing Apple’s iWatch (a conclusion reached after Bryant was spotted at Apple’s Cupertino headquarters). Specifically, go the rumors, Bryant is testing the health and fitness capabilities of the device.

Whether or not Apple will roll out an iWatch this year and whether it will or will not have health and fitness capabilities road-tested by Bryant and other athletes is almost besides the point. Apple, obviously, is making a play for the health market one way or another as the debut of its iPhone app Health this month clearly shows.

Meanwhile, we will soon be getting a gander at “Google Fit”, a new health data tracking service. Forbes broke the story about the service, which will “collect and aggregate data from popular fitness trackers and health-related apps,” earlier this month. It will debut at Google I/O developers conference, Parmy Olson wrote—which is this week.

Without a doubt, the health and fitness mobile app category is heating up—finally. It was always primed to be a disrupted category but for some reason that never happened. In 2013, for example, Flurry points out that while the overall mobile app industry grew 115% in terms of average daily usage, the health and fitness category only grew 49%.

This year has been completely different, according to Flurry blog post that ran last week:

We are not even halfway through the year (and usage normally accelerates in the summer and during the holidays) and the growth in health and fitness app usage has been stunning. We have studied the usage of over 6,800 iPhone and iPad apps listed in the health and fitness category on Flurry’s platform and we have seen a 62% increase in usage of health and fitness apps over the past six months. This compares to 33% increase in usage, measured in sessions, for the mobile app industry in general. Growth in health and fitness is 87% faster than the industry, which is itself growing at an astounding rate.

So, mobile health and fitness’ big moment is finally here. Theoretically advertisers in this space should be popping the Champaign corks: not only is there burgeoning demand but Apple and Google, if nothing else, can be counted on to provide advertising opportunities around these devices, sooner or later.

And for some companies these opportunities will be wide open.

But for others—pharmaceutical and medical device makers—the window to take advantage of this space will probably creak painfully open in about, oh, ten or fifteen years if past performance by government regulators is any guide.

Last week—more than fifteen years after it promised that rules for “Internet communications” were “imminent” and more than five years after a public hearing on the subject–the U.S. Food and Drug Administration finally issued proposed guidelines for these companies to market their products on social media networks.

Generally, the proposal requires companies to post the both benefits and the main risks associated with a product. This can be done in any number of ways, including a hyperlink.

The FDA, though, seemed to be tone-deaf to the limits of social marketing, not to mention the expectation that above all Tweets should be brief and snappy.

It gave the example of a Tweet for hypothetical memory loss drug, NoFocus: “NoFocus for mild to moderate memory loss; may cause seizures in patients with a seizure disorder

Yes that “
mild to moderate” is necessary per the FDA–the guidelines call for companies being exact about the drug’s use.

And now there is new platform for which the FDA has eyes.

Last September, according to a blog post by Sheppard Mullin Richter & Hampton attorneys Stephanie Zeppa and Lauren Lewis issued its final guidance for developers of mobile medical applications used on smartphones and other mobile devices.

Now to be clear this regulation is aimed at the devices and apps’ medical use: as Zeppa and Lewis explain in another post, it appears that the “FDA will largely focus its enforcement attention on the functionality of the mobile applications and give greater consideration to those applications that the agency believes present ‘a greater risk to patients if they do not work as intended.’”

But presumably the FDA may feel it advisable to weigh in on advertising-related formats aimed at these devices with specific guidelines. And presumably those guidelines could take a very long time to be released.

We can count on ad tech providers to offer their own solutions, of course. Google, for example, a few years ago created a “FDA-Friendly” online pharma ad format that it said would address the agency’s risk-disclosure concerns. Bayer reportedly used it to market the birth-control pill Yaz.

But as strange as it sounds, the best relief may be coming from Congress. Zeppa and Lewis describe two bills introduced in the House and Senate that would limit the FDA’s powers to regulate mobile health devices.

When and whether those get passed, especially during an election year, remain to be seen. In fact, like the pharma industry waiting for social media guidance, I wouldn’t exactly hold my breath.


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