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Apple's December FDA Meeting Addressed 'Moral Obligation' for Health, Sensor Innovation, and Regulation

Last December, several Apple executives led by Senior Vice President of Operations Jeff Williams traveled to Washington, DC to participate in a meeting with Commissioner Margaret Hamburg and other representatives of the U.S. Food and Drug Administration (FDA).

While the topic of the meeting was listed only as "Mobile Medical Applications", speculation fueled in part by the presence of Michael O'Reilly had suggested that Apple might be laying some groundwork for the iWatch by having preliminary discussions with the FDA. At the time of the meeting, O'Reilly had only recently joined Apple after serving as Chief Medical Officer of pulse oximetry firm Masimo.

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Following disclosure of the December meeting, Apple Toolbox filed a Freedom of Information Act request with the FDA, asking for details on the meeting with Apple. After three months, the FDA has responded with a memo outlining the highlights of the meeting, and while the iWatch is unsurprisingly not addressed directly, it's clear that Apple is indeed looking to maintain a dialogue with the FDA as the company seeks to make an impact in health monitoring.

With regard to Apple's plans for health, company representatives thanked the FDA for guidance on mobile health apps and suggested that there may be a "moral obligation" to leverage this technology to improve human health but that care must be taken to make sure industry and regulators are on the same page.
Apple sees mobile technology platforms as an opportunity for people to learn more about themselves. With the potential for more sensors on mobile devices, Apple believes there is the opportunity to do more with devices, and that there may be a moral obligation to do more.

Sensors already exist on medical devices. For instance, Apple’s devices have cameras and accelerometers. There is still an opportunity to innovate, but Apple wants to make sure they are on the side of the FDA.
Discussions also centered around what aspects of health monitoring technology the FDA would regulate, with the FDA noting an emphasis on software being used to receive and calculate data rather than the more general hardware that would sense or display the data. Emphasis is also placed on how such health information is used, with uses considered educational or informational not being regulated while those considered diagnostic would be subject to FDA review.
Using the glucometer example, the glucometer may be unregulated if the intent is for a user to follow their blood sugar for the purposes of better nutrition. If the glucometer is marketed for diabetics, however, it would more likely be regulated as a medical device. FDA looks at how devices are actually used.
Apple's "Health" app for iOS 8, briefly introduced at WWDC last week, is Apple's first major step into this area, serving as a single location for users to either manually or automatically input various types of health data for tracking purposes.

While the lack of significant stage time for the feature at WWDC has led to some discussion of just how serious Apple is about its health initiative, the company may simply be waiting until it is ready to introduce the iWatch before making a bigger push with Health. With rumors of several types of biometric sensors being included the iWatch, it will likely serve as the core of Apple's health tracking initiative, with other accessories from third-party companies plugging into the system for more specialized tracking.

Top Rated Comments

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25 weeks ago
Wonder if they also told Apple that they need to backup user iHealth data to the iNSA cloud.
Rating: 3 Votes
25 weeks ago
My mind was just sort of blown… in the most contrived manner possible a tech company called "apple" will become certified by the Food and Drug Administration.

Ergo, the Apples I buy will be FDA approved.
Rating: 2 Votes
25 weeks ago
The FDA logo reminds me of something... But I can't place my finger on what...

Rating: 2 Votes
25 weeks ago
"Manually or Automatically" . . . lets hope they keep the manually option alive. I see moral obligation thrown in there. I wonder if they will some day feel morally obligated to force the sharing of this type of information . . you know, for your own good.
Rating: 2 Votes
25 weeks ago
The Fraud and Death Administration is beyond worthless.
BPA banned everywhere, thousands petition to have it banned, FDA instead spends their time raiding family farms for daring to sell fresh raw milk to their neighbors.

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This article taught me that the FDA does more than just monitor the safety of our foods and drugs. Thanks MacRumors!


They don't monitor squat. They get jobs from the companies they are supposed to be watching over after they leave the FDA.
The FDA, USDA, EPA are corrupt corporate tools, especially the USDA, which under Obama has basically become an arm of Monsanto.
Rating: 2 Votes
24 weeks ago

Exaggerate much?


No. Please tell us what you think the exaggeration is.
Rating: 2 Votes
24 weeks ago
Just a smart thing to do. Apple doesn't want to make something and get it pulled out by the FDA later. Ignorance is NOT bliss!
Rating: 1 Votes
24 weeks ago
*eyeroll*

Yes, the moral imperative to monitor the health of those of us who can afford an iPhone and a monthly plan of $130+/month. :rolleyes:

The FDA seems fundamentally broken under this administration. This week (http://www.forbes.com/sites/gregorymcneal/2014/06/09/fda-may-destroy-american-artisan-cheese-industry/), the FDA ruled that cheese can no longer be aged in wood. Where exactly is the problem they are trying to solve?

Also note: many beers, wines, meads, and liquors are aged in wooden containers. How long until the FDA addresses this "risk"?


To be fair, your analogy sucks; fementation vs. mold, and cheese doesn't kill bacteria... alcohol does.
Rating: 1 Votes
24 weeks ago

One bureaucratic ruling that might well be silly on its face, but hasn't even been enforced, being spun into a hysterical prediction of the destruction of food as we know it by those bad, bad people in the Obama administration, followed by a reductio ad absurdum argument of its other imagined implications. Other than that?


Exactly. You do indeed have a bunch of speculation there.

What facts do you have that the Forbes story is false? So far, all you've given us is conjecture.

What facts do you have that there is some actual risk from using wood? It's been done that way for hundreds if not thousands of years.

The bureaucrats at the FDA (as at other federal agencies) have little choice but to implement the laws as they are written.


You are confused. This is an order from the executive branch. If you think there is some new law they are now enforcing, you need to provide a reference.

If the problem is the law, which it appears to be, then the fix rests with Congress.


Again, you are confused. If you think there is some new law, you should tell us what law you're talking about.

We will see if Congress has any enthusiasm for addressing this


The Constitutional remedy that Congress has to address this overzealous activity is impeachment.

whether it will instead be treated as an opportunity for another political finger-pointing game.


That's exactly what you have done. :eek:

One more time: if you think there is some new law that the FDA is enforcing, you should have no problem telling us what law you're talking about.

To be fair, your analogy sucks; fementation vs. mold, and cheese doesn't kill bacteria... alcohol does.


Actually, you are misinformed. Both the creation of cheese and beer/wine/etc. are fermentation. You can read this piece (http://www.npr.org/2012/06/19/155305533/edible-fermentables-wine-beer-cheese-meat) to get educated from one of the world's experts on fermentation. If you read closely Katz's comments on cheese, you'll also learn why the risk is ludicrous.

To both of you: why doesn't France have a problem with aging cheese in wooden forms? Why doesn't Switzerland? WTF do these pencil pushers think they know that nobody else does?
Rating: 1 Votes
24 weeks ago

No. Please tell us what you think the exaggeration is.


One bureaucratic ruling that might well be silly on its face, but hasn't even been enforced, being spun into a hysterical prediction of the destruction of food as we know it by those bad, bad people in the Obama administration, followed by a reductio ad absurdum argument of its other imagined implications. Other than that?

The bureaucrats at the FDA (as at other federal agencies) have little choice but to implement the laws as they are written. If the problem is the law, which it appears to be, then the fix rests with Congress. We will see if Congress has any enthusiasm for addressing this, or whether it will instead be treated as an opportunity for another political finger-pointing game. Recent history makes forecasting the outcome a relatively trivial matter.
Rating: 1 Votes

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