IoT
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Healthcare // Mobile & Wireless
Commentary
11/4/2014
09:06 AM
Mike Feibus
Mike Feibus
Commentary
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Health Wearables Going Big In 2015; Questions Loom

Tired of your uber-healthy co-workers crowing about their calorie intake and steps at the office? A new wave of health wearables might make you feel better -- if companies can clear the regulatory hurdles.

Mental Health Tools: From Office To Pocket
Mental Health Tools: From Office To Pocket
(Click image for larger view and slideshow.)

When it comes to wearables, 2014 will go down as the Year of Fitness. No question about that. And if things go the way that a wide swath of the industry hopes, then 2015 will go down as the Year of Healthcare. But there are many questions -- serious questions -- looming.

Indeed, for all the hardware and software suppliers, healthcare providers, drug makers, financial institutions, and others in the ecosystem now developing apps and devices to help manage care, there's a flock waiting on the sidelines to see whether existing players can navigate a minefield of regulatory obstacles that complicate an otherwise bright future.

Though the path might be muddy, the benefits of wearables for healthcare -- and the corresponding boon to the ecosystem -- are crystal clear. The market for wearables that are designed to manage healthcare has the potential to dwarf fitness with hundreds of billions of dollars in annual sales. The devices make it possible to record all sorts of vital statistics constantly, and physicians can use that stream of data to make quicker, more informed choices for care than they can today with only a few sets of results generated from office visits and bloodwork.

[The need for translation services has never been greater. Read Crowdsourcing Helps Patients, Doctors Speak The Same Language.]

The prospects and pitfalls of wearables for healthcare promise to be the overriding themes of this year's MEMS Executive Congress, an industry gathering that opens Wednesday in Scottsdale, Ariz. MEMS -- micro electromechanical systems -- are chips with built-in circuitry that sense and measure temperature, pressure, light, speed, direction, and other physical characteristics. They enable everything from measuring steps in fitness wearables to the automatic rotation feature in your smartphone.

Some of the early activity in managed care takes advantage of the stable of Fitbit, Jawbone, Samsung, and other wrist-worn fitness devices already available. New devices such as the Microsoft Band and the upcoming Apple Watch are helping as well to blur the line between fitness and health.

Health-oriented gadgets such as Sensoria's sensor socks are the next wave of wearables.
Health-oriented gadgets such as Sensoria's sensor socks are the next wave of wearables.

Take CareSpan, for example. The four-year-old startup has built an online healthcare service that makes it possible for patients in remote spots to get access to doctors for both emergency and chronic care. CareSpan is getting early traction at spots such as mining camps and Native American reservations.

Other startups are making healthcare-first devices. Three-year-old Sensoria plans to roll out in 2015 smart socks and other sensor-equipped clothing for both fitness and healthcare applications. And Force Impact Technologies (FIT) is readying a sensor-equipped mouth guard called FitGuard that measures the force of hits to the head. The device lights up when it detects enough force to cause a concussion. FIT is going the crowdfunding route to raise money for its first manufacturing run in part because it was having difficulty raising money from the venture community.

And there's the rub. Traditional funding sources are skittish about investing in wearables for healthcare before at least some of the myriad regulatory hurdles are settled. The Food and Drug Administration, for example, is weighing whether -- and, if so, how -- to regulate devices generating data that physicians use to make decisions. The FDA's also deliberating on how to enable physicians to prescribe "digital medicine." There are privacy laws including HIPAA to consider, especially when devices and services are paired with cloud-based processing and storage. Insurance coverage from Medicaid as well as private providers is another thorny issue.

Despite all the uncertainty, the pharmaceutical giants don't seem squeamish about jumping into healthcare devices. According to Qualcomm Life, a Qualcomm subsidiary that is helping to enable the drug makers in their efforts, the focus at this stage is more on stickables: patches that are paired with specific drugs to measure their efficacy. Other devices they're developing are connected devices that aren't even wearable, including pill boxes, inhalers, and injectors. Most of them rely on an app on the patient's smartphone to transmit the data from the devices.

There are many reasons why big pharma wants to take a leadership role. First and foremost, says Qualcomm Life, those companies understand that digital medicine is coming, regardless of whether they participate. Another big reason is that they can differentiate from generic suppliers by providing a complete health kit, rather than just a pill.

By this time next year, we'll really begin to notice wearables and other bio-sensing devices migrating from sporting goods stores to drugstore shelves. But it should be apparent by now that they'll be sitting alongside glucometers and blood-pressure machines. It'll be a while longer before they make their way behind the counter.

The owners of electronic health records aren't necessarily the patients. How much control should they have? Get the new Who Owns Patient Data? issue of InformationWeek Healthcare today.

Mike Feibus is principal analyst at TechKnowledge Strategies, a Scottsdale, Ariz., market strategy and analysis firm focusing on mobile ecosystems and client technologies. You can reach him at mikef@feibustech.com. View Full Bio
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freespiritny25
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freespiritny25,
User Rank: Ninja
11/14/2014 | 10:26:54 AM
Re: FDA Action Plan?
Wearables have been used in the medical community for decades, specifically in cardiac event tracking. Whether or not they are ever FDA approved, I can see these new products being tested for accuracy for several more years before the medical community will accept them as accurate.
Alison_Diana
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Alison_Diana,
User Rank: Author
11/5/2014 | 9:31:48 AM
Re: Accuracy?
I've thought the same thing. I mean, think about how often the good old scale is wrong! Don't know about you, but I can gain and lose pounds simply by choosing to use the scale at my doctor's office, the local Publix, or my bathroom scale! Now, any are fine if I only want to track whether I've lost or (gasp) gained weight. They do a decent job of monitoring a jump up or down of one or two pounds. But the actualy number itself? For that, I typically trust my doctor's digital scale... but i guess that could be wrong too!
MFeibus
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MFeibus,
User Rank: Strategist
11/4/2014 | 12:25:03 PM
Re: FDA Action Plan?
Good points. I'm not sure that anyone can say decisively, but I've heard predictions of a year for the FDA to weigh in, with the spector of subscriptions for digital subscriptions before the end of 2016.
MFeibus
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MFeibus,
User Rank: Strategist
11/4/2014 | 12:21:53 PM
Re: Accuracy?
Yep, and that's just one of many accuracy issues. For example, the best sensors are useless if the wearable isn't sitting on a good spot to take measurements.
Whoopty
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Whoopty,
User Rank: Ninja
11/4/2014 | 10:47:46 AM
Accuracy?
It's all well and good wearable makers bundled health tracking sensors into their products, but until doctors begin approving devices for legitimate medical purposes, they're largely redundant. There's no point in taking along six months of heart rate readings to your doctor only for them to not be able to consider it because the sensor in your budget wearable is a cheap one. Or because there is little context for the readings. 
Alison_Diana
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Alison_Diana,
User Rank: Author
11/4/2014 | 9:57:19 AM
FDA Action Plan?
Does anyone have any idea when the FDA will provide clearcut guidelines to developers of these devices? As you say, the creativity is there. Some clinicians are aboard and already 'prescribe' fitness trackers to overweight or diabetic patients. There are so many opportunities -- home health, telehealth, patient engagement, population management, pregnancy (especially teen or at-risk), etc. -- to use new and existing wearables that government roadblocks, while understandable to a point, are extremely frustrating. And not only to those who want to make money off them; they hold-up affects those whose lives might well be positively affected by tech that's ready to go.
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