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Fitbit Inc

Take one Fitbit and call me in the morning

Mike Feibus
Special for USA TODAY

Will your doctor ever be able to prescribe a Fitbit to help monitor your condition? Thanks to a couple of recent policy moves by the Food and Drug Administration, that’s a little closer to reality. But it's still a long way off.

Fitbit tracks the users activity and provides data points such as distance traveled, calories burned and even how well the user slept.

Even with these policy steps, a lot has to change before smartwatches and fitness trackers – whether from Apple, Garmin, Samsung, Fitbit or anyone else – get integrated into your healthcare. That's because the wrist-worn wearables don’t come close to meeting the medical community’s strict definitions for accuracy in instrumentation.

Th problem is not so much with the wearable devices as it is with healthcare’s definition of accuracy.

I can almost hear the instrumentation purists snicker at that one. But think about this: how important can accuracy be when what we’re measuring – that is, us – varies so much? Let’s say, for example, that I scurried in late for my checkup last February, just minutes after downing an espresso shot during a rare visit to a coffee shop. For my August visit, though, I’m on time, relaxed and caffeine-free. The resulting readings my doctor sees might signal an improvement. When, in fact, the opposite could be true.

Given the choice, I’ll take the Fitbit. I’d rather hand my doctor an analysis drawn from thousands of heartrate readings recorded each day since the last time I saw her. Any variability the device might introduce would be muted by the sheer volume of samples. And then we could talk about the trends. Instead of two random data points.

Defining the role smartwatches, fitness trackers and other wearables play isn’t just a hypothetical issue. It’s an imperative. The country is racing against the clock to tame our $3-trillion-a-year medical bill before the aging Baby Boomers overwhelm the system. Toward that end, healthcare reform mandates doctors find ways to extend care beyond their office walls. And wearables offer a powerful option for monitoring patients and motivating them onto a healthier path.

The FDA is now accepting comments on a proposed opinion that could begin forging a path for remote monitoring devices like Fitbits to get cleared as medical devices. The proposed opinion, entitled Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, suggests a methodology for collecting data from devices that aren’t meant for a clinical setting.

In late July, the FDA issued a second opinion that gives device makers room to maneuver in the interim, while policymakers figure out how to incorporate tracker data into healthcare. In the opinion, entitled General Wellness: Policy for Low Risk Devices, the FDA essentially tells device makers that as long as they don’t claim to treat medical conditions, the agency would look the other way.

The FDA guidance is reminiscent of the decades-old “don’t ask, don’t tell” policy on gays in the military – but without any of the discriminatory undertones that made the Clinton Administration’s declaration so distasteful. It’s essentially how wearables makers have been coexisting with healthcare all along. But at least now the suppliers have confidence that they’ll stay clear of FDA scrutiny this way: claim only to promote wellness, and not treat conditions like high cholesterol or elevated blood pressure.

The new ruling is a source of some comfort for device makers, because the coexistence with healthcare has been rocky.

At the American Medical Association’s annual meeting in early June, Dr. James Madara, the AMA’s CEO, lashed out at wearables and other connected devices, calling them “the digital snake oil of the early 21st century.”

Just a couple weeks before Madara’s speech, researchers published a study that drove home his argument. The study, which was commissioned by plaintiffs in a class-action suit against Fitbit, found that the heartrate reported by the Fitbit Charge HR and the Surge were off by an average of 6.1 and 11.6 beats per minute, respectively. During periods of intense exercise, they were even more inaccurate.

The study, by the way, was based on readings taking during a single visit into the researchers’ lab by 43 subjects. In my experience, wearables get more accurate over time as the platforms’ intelligence comprehends our individual differences. When I tested the Charge HR and Surge last year, they took about five days to hone in on my heartrate during intense exercise.

We’ll always have the need for highly precise medical instrumentation. That’s not going to change. But we also need a second class of medical-grade for wearables and other remote-patient monitoring devices. And because they’re always watching, they offer insight that today’s medical equipment can’t. To really make these fitness trackers effective for patients, the FDA needs to do more than look the other way. It needs to set standards on how they can be used best.

I hope it happens soon – and for purely selfish reasons. Because if something is starting to go wrong with my body, I want to give my doctor every chance to find it. Don’t you?

Mike Feibus is principal analyst at FeibusTech, a Scottsdale, Ariz., market strategy and analysis firm focusing on mobile ecosystems and client technologies. Reach him at mikef@feibustech.com. Follow him on Twitter @MikeFeibus.

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