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

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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.

"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.

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

JosephAW

macrumors 68040
May 14, 2012
3,183
3,713
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.
 

Z400Racer37

macrumors 6502a
Feb 7, 2011
702
1,654
Ohhh the humanityyyyyy #### Where will we be without our lords telling us what is right???? or what is wrong???? #######
 

jayducharme

macrumors 68040
Jun 22, 2006
3,695
3,486
The thick of it
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.
 

usarioclave

macrumors 65816
Sep 26, 2003
1,447
1,506
The problem with BS like this is that they can't actually take a hands-on approach unless they decide to classify the watch as a medical device. He's basically saying "I'm reserving the right to change my stance" when actually he has no ability to take a stance.

His posturing, however, makes it sound like the FDA has actual authority, which they don't at this time. This is the crap that the government guys pull all the time. The press generally isn't smart enough to slap him down.
 

ThunderSkunk

macrumors 68030
Dec 31, 2007
2,998
2,575
Milwaukee Area
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.
 

PinkyMacGodess

macrumors 601
Mar 7, 2007
4,951
1,665
Midwest America.
The FDA has had pretty much the same response to everything...

I'd be in favor of killing it, or drastically decreasing its duties, and give those duties to a new agency that WILL act for the public's well being...

----------

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.
Can we give it a rest...

This thread is about the FDA, not your bigotry.
 

paul4339

macrumors 65816
Sep 14, 2009
1,404
666
...such as medical equipment? seriously i just thought fda was worried about what you ate.
oh heck yes, they have a huge scope ... medicine/pharma, medical equipment, vaccines, veterinary products and animal feed, etc -- they are mandated to protect public health.
 

lazyrighteye

macrumors 68000
Jan 16, 2002
1,960
757
Denver, CO
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.
Worthy of more than my up vote.
 

kdarling

macrumors P6
The problem with BS like this is that they can't actually take a hands-on approach unless they decide to classify the watch as a medical device. He's basically saying "I'm reserving the right to change my stance" when actually he has no ability to take a stance.
He's saying that if a device / app just wants to make general health recommendations or do general fitness tracking, that's fine and not considered a medical device.

On the other hand, he noted that "technology used for diagnosis, treatment and prevention will get a closer look," especially if it has a potential to cause harm if it gives mistaken advice.

Basically it's the same FDA stance they've had for years.
 

Urban Joe

Suspended
Mar 19, 2012
506
534
"If you have technology that's going to motivate a person to stay healthy, that's not something we want to be engaged in."

Yeah, no joke.
 
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