Have Wearables Blurred The Line?

CES in Las Vegas wasn’t all fun and games this year. Squished between 4K TV’s and odd looking VR headsets a new generation of niche wearables. Their function is less about fittness and more about health and that hasn’t gone unnoticed by the FDA.

The question isn’t will demand for wearables continue to grow. The question may concern the method and speed at which the FDA has moved to regulate them. As some have pointed out, the line between fittness and healthcare device is getting harder to see.


Wearables and HealthcareIf your device(s) records heart rate, sleep, glucose and blood pressure, is it really a fitness device? Or, is it a health care device for select users? The difference between the two may depend on whether it’s just you, or your doctor that’s using the data.




“With these devices, even though they’re not FDA-certified, we can glean a lot of information,”

Dr. David Rhew, the chief medical officer and head of healthcare and fitness at Samsung Electronics America- US News & World Report.

If wearable manufacturers are concerned about crossing over into a classification as health care device, they aren’t showing it.  Samsungs Heartwise smart watch and software is actually classified under “Healthcare” on their site. The home page goes on to explain that it’s part of a “home-based heart wellness program” and there is an actual feature called “cardiac rehab”. That sounds pretty clinical for a fitness program that you download at the “Play Store”.

Potential Benefits for Wearables

The Mayo Clinic’s Million Hearts Initiative reported in 2016 that participation rates in the US for CR- Cardiac Rehabilitation are a dismal 20-30%. It goes on to lay out a number of traditional initiatives that may help reverse these rates. If that trend can be reversed by non-traditional methods do the ends  justify the means? Dr. Rhew of SES pointed to an internal study that increased cardiac rehab rates to “around 80%” with the use of existing wearables technology. It’s an internal study so that’s a big “if”, but it poses an equally positive “what if”.

The Mayo Clinic estimates a 70% participation rate could save 25,000 lives and prevent 180,000 hospitalizations per year. What if the driving force behind wearable adoption for fitness could pay dividends in health? Like other less clinical applications, the appeal comes down to convenience. Consumer demand to track everything while demanding little or nothing in return…like routine office visits.

Obvious Concerns

Gartner is forecasting 340 million wearable devices in 2018, 1/3 of those related to user monitoring. That’s a lot of devices and even more device data being collected. What happens to that data when support, or the company itself vanishes? The article by Teena Maddox of Tech Republic does an excellent job of covering wearable data and privacy issues from hacking to exploitation.


Working on healthcare related applications is demanding. With piezo related projects the threshold for quality, accuracy and traceability is incredibly high. But, those requirements and responsibilities generally speaking are pretty clear.  What are the standards and responsibility for accuracy for consumer wearables that aren’t yet 510k approved? Again, does it come down to who’s relying on the data?

Half the Equation solved?

In an independent study by Stanford University on heart rate accuracy of wrist worn devices, they proved accurate within 5%!  That far exceeded study expectations, the target benchmark was 10%. The technology and performance in wearables might be outpacing the ability to define it’s place. It may also explain  why the FDA seems less concerned about wearable hardware and more focused on software. With it’s announcement of the  Digital Health Innovation Action Plan the path to FDA certification could be much shorter. The mHealth friendly move will allow companies to pre-certify to a set of standards. Then, submit comparatively little information on subsequent products with the assumption that company continues to meet those standards.

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