• Matt Herren

Beyond Mobile - Wearable Health Tech is the Next BIG Thing


You may not have seen it coming, but there is a digital healthcare revolution underway in the form of wearable technologies—the synergistic confluence of mobile tech/devices and real-time data. IDTechEx predicts the wearable electronics business—broadly defined as a market that encompasses apparel, textiles, and devices—will grow from $14 billion this year to $70 billion by 2024. While this market includes products that are more fashion oriented (think smart clothing that can change color based on your mood or the occasion)—the majority of the wearable tech boom will be in the healthcare sector.

The Players

There is no shortage of corporate giants and upstarts vying for a piece of the action—tech innovators like Apple, Samsung, Intel, Google, AT&T, Microsoft, Oracle and Sun Microsystems; and seemingly disparate players such as pharma leader Novartis, sports apparel/footwear kings Adidas and Nike, and a raft of newcomers like Proteus Digital Health, IHealth Labs and Biosensics. All of them are scrambling to secure patent filings for disruptive wearable tech that increasingly blurs the line between consumer and health related technology.

The Products

The anticipated proliferation of these devices and new technologies will have a profound impact on our lives—from interactive smart watches/wristbands and passive textiles that monitor everything from heart rate, caloric burn-rate, weight, sleep statistics and body temperature to more sophisticated smart patches, ingestibles, injectables and implants that monitor vital bodily organs and (in the near future) deliver medications.

In addition to the more common fitness trackers (Fitbit, Jawbone UP3, Samsung Gear, MisFit, VivoSmart, and Smartband…among others)—here’s a list of some potential game-changing wearable health products:

  • Smart Diapers – disposable diapers with ability to detect Type 1 diabetes, urinary tract infection, and dehydration.

  • Zio-XT Patch – wearable patch that monitors heart rate and shares data with iRhythm app.

  • Cityzen Sciences – smart fabrics, apparel w/ micro sensors to monitor heart rate, speed, location and acceleration.

  • Acticheck Assure - emergency device that monitors and connects you to help when you need it.

  • OrCam - intuitive mobile device to assist the visually impaired.

  • Muse - brain fitness device and mobile app.

The commonality among all this technology is its ability to capture real-time, highly contextualized data and analytics that can be shared instantaneously with other mobile devices, and Internet connected platforms.

Collecting the data is the easier component in this new ecosystem—how the data is interpreted and put to meaningful use is the bigger question.

For the consumer, we will likely see a shift away from watches and bands that require user-interaction and input to more passive devices and smart wear that will provide a 360 degree view of our current—and predictive future—health.

From a healthcare perspective, wearable health tech has the ability to redefine the patient-physician relationship and usher in a new era of patient driven care.

Imagine your physician crunching your health data before you even arrive for an appointment, or remotely diagnosing a health condition without costly and time-consuming diagnostic tests.

The impact this will have on prevention and management of chronic diseases (diabetes, cancer, heart disease, arthritis, asthma) will be measured in enhanced patient outcomes, reduction in healthcare costs, and an increasingly healthier society. And with aging populations and life expectancy projected to continue to rise in most areas of the world—the demand for these tools will increase exponentially.

Regulation & Future Hurdles

In the U.S. – the Food & Drug Administration (FDA) recently proposed guidelines, for the fast growing wearable health tech market. While falling short of approving such devices, for the most part the FDA has taken a passive stance on products/devices that promote “general wellness”, are evidence based, and do not present much risk to users (think vitamins & supplements).

However, the FDA will actively investigate and regulate devices that make specific health claims to diagnose, treat and/or cure certain conditions (such as obesity, diabetes, heart disease). Again, the distinction is whether the device promotes wellness or promises to treat/cure. Likewise, any device that is ingested or injected will also fall into the latter category.

While the FDA’s guidelines seemingly bode well for much of the wearable market, the most pressing regulatory and legal hurdles—privacy & protection—are still a bit grey. The U.S. Department of Health & Human Services Office for Civil Rights enforces the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to protect confidentiality and security of healthcare information. But there is a significant gap between the legal requirements for health data collected for a consumer's personal use and that used as part of a relationship with a HIPAA covered entity such as a doctor or hospital.

A January 2013 HIPAA update attempted to address this issue by requiring software developers who build applications that track, store and share healthcare information with HIPAA covered entities to be compliant and meet the HIPAA Security Rule safeguarding health-related data. The update also redefined the definition of privacy breach, placing the onus on the business associates (any party that handles private health information such as an application developer or hosting party) to determine whether or not something should be reported as a breach. Therefore if a wearable device is hacked and health data is compromised then that would constitute as breach.

For its part, the Federal Communications Commission (FCC) has not directly delved into the privacy issue, but it has a lengthy track record of embracing and supporting the "acceleration and adoption of broadband-enabled health care solutions and the development of health-related technologies for all Americans".

Wearable health technology is still in its infancy and the regulatory agencies will continue to play catchup as the industry matures. But in the wake of recent global headlines of privacy breach—such as the U.S. government’s National Security Agency surveillance program, and media giant News Corp’s hacking of mobile phones—there is good reason to worry about who will gain access to this highly personalized health data. In the coming years, as privacy and security issues further impact consumer adoption of these services/devices, expect the FCC, HHS, FDA (and possibly the Supreme Court) to further flex their authority.

Regardless, the tsunami that is wearable health tech is coming and its projected hockey stick trajectory can only be compared to mobile’s meteoric rise.

#healthtech #wearables #healthcare #wellness

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