FDA Taking 'Almost Hands-Off Approach' to Regulating Apple Watch and Similar Wearables

Monday March 30, 2015 6:21 AM PDT by Mitchel Broussard

As Apple and other companies create products capable of providing more and more detailed health-related information, the U.S. Food and Drug Administration has decided to give the companies creating these devices breathing room to manufacture the devices free, for the most part, from the scrutiny of the agency (via Bloomberg Business).

The FDA's associate director for digital health, Bakul Patel, noted that while the agency will be more lenient on devices aimed at simply improving the lifestyle of its customers, more health-invasive features, like a glucose monitor app on the Apple Watch, will continue to be reviewed by the FDA.

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"We are taking a very light touch, an almost hands-off approach," Patel, the FDA's associate director for digital health, said in an interview. "If you have technology that's going to motivate a person to stay healthy, that's not something we want to be engaged in."

The rule of thumb released in a few guidelines by the agency highlight that the FDA's focus will be on devices and software that are attempting to replicate, or mimic, the functionality of a medical service or device. Basic heart-rate and step-counting aspects of these wrist-worn devices will receive little-to-no regulation from the FDA.

Marketing will also be a factor for the agency, according to Patel. If a company is attempting to promote a product as being able to assist doctors in making medical decisions, "it will require more oversight." This is a concern not aimed currently at Apple's own Apple Watch and HealthKit, due to both's minimally invasive health-related functionality, but could become a concern in the future as Tim Cook himself echoed hopes of both platforms helping to pinpoint diseases and cancers in the near future.

"We have to be confident in what we are getting," Patel said. "The trajectory is there and all signals are headed that way, but by the same token the research and science should get us that confidence. It boils down to will it work or not."

"The FDA has a role to play for providing patients and consumers a level of confidence that they can use it," he said.

With a focus "only on the higher end of technology", Patel notes that the agency asks itself what kind of harm a user may face if the product fails, and uses that answer as a springboard into regulation of the product as a whole. The new laid-back angle is in stark opposition of how the tech world views the FDA, with most startups listing regulation by the agency as one of the biggest risks to a business "even when scrutiny is unlikely." Patel, and the FDA, knows of the issue and plans to hire new staff in assisting to "improve relations with technology companies" in the future.

Although the FDA's new lax approach to basic fitness-tracking will give companies more room to operate on their own terms, as technology for the smart wearables category moves forward, we'll no doubt see more and more glucose- and blood pressure-tracking applications in the future. Apple itself has met with the FDA several times in the past few years, with most recent discussions centering around the functions and regulations of the Apple Watch.

Related Roundups: Apple Watch, watchOS 6
Tag: FDA
Buyer's Guide: Apple Watch (Neutral)

Top Rated Comments

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66 months ago

Why would the FDA get involved since its neither food or drugs?

Are you being obtuse on purpose?

http://en.m.wikipedia.org/wiki/Food_and_Drug_Administration
Score: 9 Votes (Like | Disagree)
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66 months ago
Why would the FDA get involved since its neither food or drugs?
Score: 7 Votes (Like | Disagree)
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66 months ago

I'm generally pleased with Federal-anything taking a hands-off approach.


I'm all for the government looking out for consumers. Huge businesses are interested in profit first; that's the nature of capitalism. In that type of society, the government should be there to protect consumers from reckless or sloppy products that could cause harm. (And there have been plenty...)

Unfortunately, government has too often sided with big business in the past and citizen confidence has eroded. It's a matter of government organizations doing what they're supposed to do in a cost-effective manner.
Score: 6 Votes (Like | Disagree)
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66 months ago
I'm generally pleased with Federal-anything taking a hands-off approach.
Score: 5 Votes (Like | Disagree)
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66 months ago
Apple needs to follow this hands off approach as well and not get involved with political and state rights and focus on making good products.
Score: 4 Votes (Like | Disagree)
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66 months ago

Apple needs to follow this hands off approach as well and not get involved with political and state rights and focus on making good products.

Your want does not equal someone else's need.

Since Apple actually has holdings and employees in that state, it has a vested interest in that state being a stable part of the modern United States, observing whats left of the constitution, and not reverting to Bronze Age barbarian desert dweller culture as some kind of rogue nation state.

The FDA exists to endorse food & drug products and the sale thereof. Apple Watch is not a medical device and the FDA has no more grounds to approve or restrict it than they do your own finger, for its ability to check your pulse.


The day the FDA actually lifts a finger and quits blindly endorsing untested food technologies and the time honored tradition of pumping every single food product with a maximum amount of sugar & processing everything else until its nutritionally borderline poisonous garbage, & reviewing more than one out of ten thousand drugs for sale by the highest bidder while leaving everyone else to die horrible preventable deaths, their opinion might actually mean something other than just another thousand reasons to hate the government.
Score: 3 Votes (Like | Disagree)

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