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.

apple_fda_logos
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

(View all)
Avatar
83 months ago
Wonder if they also told Apple that they need to backup user iHealth data to the iNSA cloud.
Score: 3 Votes (Like | Disagree)
Avatar
83 months ago

Exaggerate much?


No. Please tell us what you think the exaggeration is.
Score: 2 Votes (Like | Disagree)
Avatar
83 months 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.

----------

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.
Score: 2 Votes (Like | Disagree)
Avatar
83 months ago
The FDA logo reminds me of something... But I can't place my finger on what...

Score: 2 Votes (Like | Disagree)
Avatar
83 months 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.
Score: 2 Votes (Like | Disagree)
Avatar
83 months 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.
Score: 2 Votes (Like | Disagree)

Top Stories

New Photos Offer Better Look at iPhone 12 Color Options

Tuesday October 20, 2020 2:34 am PDT by
As we wait for the iPhone 12 review embargo to lift later today, more pictures are circulating of the devices in real-world lighting conditions, providing a better look at the different colors available. Leaker DuanRui has shared images on Twitter of the iPhone 12 in white, black, blue, green, and (PRODUCT)RED. The black and white colors are similar to the iPhone 11 colors, but the other...

iPhone 12 Pro in Graphite and iPhone 12 in Blue Shown Off in Unboxing Videos

Monday October 19, 2020 8:20 am PDT by
While the iPhone 12 Pro does not launch until Friday, we now have an early unboxing video of the device courtesy of Twitter account DuanRui, providing a closer look at the shiny new flat-edge design and sleek Graphite color option. Ben Geskin re-uploaded the unboxing video to YouTube, which we've embedded below: Geskin has also uploaded an unboxing video of the iPhone 12 in Blue: ...

Apple Releases iPadOS and iOS 14.1 With Multiple Bug Fixes Ahead of iPhone 12 Launch

Tuesday October 20, 2020 10:06 am PDT by
Apple today released iOS and iPadOS 14.1, the first major updates to the iOS and iPadOS 14 operating system updates that were released in September. iOS and iPadOS 14.1 come a week after Apple released the golden master versions of the updates to developers. The iOS 14.1 update can be downloaded for free and it is available on all eligible devices over-the-air in the Settings app. To access...

Watch: iPhone 12 and iPhone 12 Pro Unboxing Videos and First Impressions

Tuesday October 20, 2020 6:05 am PDT by
Apple's embargo has lifted for iPhone 12 and iPhone 12 Pro reviews. In addition to our detailed review roundups for each device, we've rounded up over a dozen unboxing videos and first impressions below. iPhone 12 in Blue on left and iPhone 12 Pro in Pacific Blue on right via Engadget Key new features of the iPhone 12 and iPhone 12 Pro include a flat-edge design, 5G support, a much faster A14 ...

Gold Version of iPhone 12 Pro Apparently Has a More Fingerprint Resistant Stainless Steel Frame

Tuesday October 20, 2020 11:56 am PDT by
iPhone 12 Pro reviews hit the web today, and one of the more interesting tidbits came from TechCrunch's Matthew Panzarino, who revealed that the Gold version of the device apparently has a more fingerprint resistant coating applied to the stainless steel frame. From his review:Most of the iPhone 12 Pro finishes still use a physical vapor deposition process for edge coating. But the new gold...

Photographer Austin Mann Tests the iPhone 12 Pro's Camera

Wednesday October 21, 2020 4:14 am PDT by
Travel photographer Austin Mann usually performs an in-depth review of new iPhone models to test their camera performance in real-world scenarios. To test Apple's new iPhone 12 Pro, Mann traveled to Glacier National Park, Montana. Mann focused on some of the biggest camera upgrades with the iPhone 12 Pro, including the upgraded Wide lens, Ultra Wide Night mode, and LiDAR autofocus, across a...

iPhone 12 Pro Max Has Smaller 3,687 mAh Battery According to Regulatory Filing

Tuesday October 20, 2020 8:48 pm PDT by
Apple's new iPhone 12 Pro Max is equipped with a 3,687 mAh battery, which is around 7% less capacity than the 3,969 mAh battery in the iPhone 11 Pro Max, according to a regulatory filing published by TENAA, the Chinese equivalent of the FCC. The regulatory filing, spotted by MacRumors, also lists the iPhone 12 Pro Max with 6GB of RAM as seen in benchmark results last week. Apple has filed ...

5G Drains iPhone 12 Battery 20% Faster Than 4G in Benchmark

Wednesday October 21, 2020 3:17 am PDT by
After the first reviews for the iPhone 12 and iPhone 12 Pro emerged yesterday, a new report by Tom's Guide reveals the extent of battery life reductions when using 5G. The report outlines a test wherein the iPhone surfs the web continuously at 150 nits of screen brightness, launching a new site every 30 seconds until the battery drains. Interestingly, the test was run on an iPhone 12 and...

Hands-On With Apple's iPhone 12 and 12 Pro MagSafe Cases

Tuesday October 20, 2020 1:33 pm PDT by
Apple's iPhone 12 and 12 Pro are launching this Friday, and ahead of that release date, Apple is shipping out various accessories like the MagSafe charger and MagSafe cases. Yesterday we took a look at the MagSafe charger, and today our MagSafe case came in the mail, so we thought we'd take another look at the charger to see how it works with the case and just how strong the case magnets are. S ...

Reliable Leaker Suggests AirTags 'Coming Soon' in Two Different Sizes

Tuesday October 20, 2020 1:53 am PDT by
Apple's rumored AirTags Bluetooth tracking devices could launch imminently and will be available in two size options, based on new tweets from cryptic-but-reliable leaker L0vetodream. In typical enigmatic style, the leaker first tweeted this morning that a "big one" and a "small one" are "coming soon," but withheld what they were referring to. However that was followed an hour later with the ...