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From Issue #42 May 8, 2014

Wear and Tear

People are turning consumer tech into low-cost tools for medical measurement.

By Amy Westervelt Twitter icon 

Mimo Baby wearable baby monitor

Having survived a large and inoperable brain tumor, these days David Cohen1 is turning his attention to less critical health issues. Chief among them: he wants to find a way to deal with his sleep apnea without wearing a giant Storm Trooper-like mask to bed. He’d also like to get more exercise, despite experiencing peripheral neuropathy that makes it painful and potentially dangerous for him to physically exert himself. He recognizes his limitations: “I’m a sedentary, overweight person with health problems, living in the wake of cancer and its treatment.”

Sleep apnea is a common medical condition in which a sufferer has “one or more pauses in breathing (which can last from a few seconds or minutes and occur up to 30 times per hour), or shallow breaths, while you sleep,” as defined by the National Institute of Health.

The nonprofit National Sleep Foundation says 18 million adult Americans have sleep apnea, while the medical community suspects it’s actually far more. The disorder often goes undetected for years, but that doesn’t mean it’s harmless. Lack of oxygen caused by sleep apnea leaves people feeling tired throughout the day (NIH calls it the “leading cause of daytime tiredness”) and increases their risk of high blood pressure, heart attack, heart failure, stroke, obesity and diabetes. (Editor’s note: Chris Higgins digs into apnea in great depth in “Heavy Breathing,” Feb. 28, 2013, in which he discusses his and his father’s experiences with it.)

Cohen has been ignoring his sleep apnea for years. “I had a brain tumor. There were more acute health care issues to deal with,” he says. His primary physician, who runs a sleep institute, recognized the signs of apnea in Cohen and recommended a sleep study, which in turn opened up his insurance company’s wallet to pay for treatment. But none of the options — ranging from a mouth guard to a mask attached to a compressor — met Cohen’s needs.

The mouth guard is only 65 percent effective, and could cost $5,000 with his policy. A compressor (a CPAP, or continuous positive airway pressure) machine is much cheaper and highly effective, but “given everything else I’ve had going on, the last thing I need to introduce to the bedroom is a giant mask every night,” he says. “I’m pretty sure that would be worse for my marriage than the fact that I snore.”

Cohen opted to start with less-expensive, less-invasive options, but he was left with the problem of monitoring efficacy. Sleep studies are expensive, time-consuming, and only covered once a year with his policy.

When Cohen’s wife brought home a FitBit earlier this year, a light went off. “I can use it to monitor how much I sleep each night, and movement through the night, which gives me a decent indication of how many sleep apnea episodes I’m having,” he says, adding that the fact that the device may also motivate him to move more is a bonus.

The quantified health

Cohen is one of legions of people for whom the booming wearables market has provided low-cost, less obtrusive health monitoring beyond any intended use. Dozens of gadgets exist today to gather information about everything from the amount and quality of sleep to the number of steps someone takes in a day or their heart rate throughout the day. Smartphones have evolved to contain many of the sensors and communications technologies needed to collect that data, too, and new apps are being released every day to enable more and more biometric data collection.

Still, consumers are cobbling together their own monitoring systems, pairing multiple wearable gadgets with apps and anything else they can find to get the data they need to help deal with everything from sleep apnea to severe epilepsy to schizophrenia.

Dulcie Madden, co-founder and CEO of Rest Devices, began her career conducting clinical research on sleep apnea, where she says she met hundreds of people who had created their own wearables using a variety of consumer technologies. Today, Madden’s company makes the Mimo Baby wearable baby monitor, and she says she hears from parents on a regular basis who are using her company’s sensor-enabled onesie to monitor a premature baby’s vital signs, epileptic seizures, and respiratory distress. The product is designed to measure respiration, skin temperature, body position, and activity level.

Because wearables fall into the category of consumer electronics and not medical devices, they are not put through the seven years of clinical trials required for the average medical device to win FDA approval. That not only makes it quicker and easier for them to get to market, but also makes their cost far lower than medical devices.

“These parents, even though they know we are unregulated, and that this is a non-medical device, they want to use it for personal tracking,” Madden says. “There are people who are really hankering for something in this area, and those lines between medical devices and consumer products are going to get more and more blurred as wearable tech evolves.”

That’s good and bad, both for consumers and for wearable tech companies. These devices give people access to more biometric data, which could help them gauge how well a treatment is working or how bad a problem is, and share that information with their doctor. However, anytime a consumer repurposes a product, there’s the risk of something going wrong. With wearable tech at such an early stage — and growing so rapidly — one high-profile mishap could be a big problem for the entire industry.

“Being in a consumer industry that measures biometrics, which can be used in any number of areas, there’s always a chance there will be negative backlash,” Madden says. “We have to think smartly about the potential uses for products and how people will make it work, but it’s tough. There’s no way to prevent people from coming up with their own uses, and there’s no way to always plan for that.”

Madden says some parents also worry that there may be unforeseen health consequences to wearables, no matter what you’re doing with them. “It’s a new technology, and there aren’t any standards yet,” Madden says. “But we certainly believe that it’s safe, and when I explain to people that our onesie is only exposing their child to about one-tenth of the radiation that their iPhone or a standard audio baby monitor does, they usually feel okay about it.”

Mind craft

The industry is just beginning to look at the ethical and emotional implications of wearables. Via real-time feedback and, in some cases, peer pressure or competition, wearables are getting better and better at influencing behavior. That puts a lot of responsibility in the hands of designers — responsibility that goes far beyond even the privacy conversation that has dominated debates surrounding Google Glass.

“There are a lot of potentially really cool applications, but some of them require that someone along the way makes some big assumptions about social norms and how people should be reacting to or interpreting the world, and that comes down to a set of judgments,” Madden says. “Those have to be made by someone, and that’s a little unsettling because, again, this whole industry is totally unregulated.”

Regulation is likely to be a long way off. A handful of states (Delaware, Illinois, Missouri, New York, Maryland, West Virginia, New Jersey, and Wyoming) are considering legislation that would ban the use of wearables while driving, but that’s as far as any government body has gotten. Which is not necessarily a bad thing. Technology-specific laws are quickly outdated, and they can stifle innovation.

“It’s not that we need to stop people from designing wearable tech, or that there is anything bad about it, so much as that we need to better understand the potential impacts, both in order to mitigate some risks and to ensure that the benefits of wearables will be realized,” says M.A. Greenstein, founder of the George Greenstein Institute, a nonprofit dedicated to researching the intersection of culture and brain science.

Greenstein says her concern is that there has not been enough consideration of bioethics around wearables beyond privacy concerns, which could lead to either a breach of ethics, a consumer backlash, or both, leaving all of the potentially positive applications for wearable tech out in the cold.

In the meantime, people are continuing to experiment with wearable devices that fit their own needs. And because humans will be humans, they’re less worried about the potential pitfalls or any looming ethical concerns in the long term than they are about more immediate day-to-day issues.

Cohen sums it up simply: “I’m a 37-year-old man and my goal is just to feel as normal as possible.”

  1. His name has been changed to protect his privacy. 

An independent journalist based in Oakland, California, Amy Westervelt writes about health, technology, and the environment for a variety of publications, most recently The Wall Street Journal, Fast Company and Forbes.

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