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

edk99 Avatar
108 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)
FloatingBones Avatar
108 months ago
Exaggerate much?

No. Please tell us what you think the exaggeration is.
Score: 2 Votes (Like | Disagree)
steve333 Avatar
108 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)
Parasprite Avatar
108 months ago
The FDA logo reminds me of something... But I can't place my finger on what...

Score: 2 Votes (Like | Disagree)
phillipduran Avatar
108 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)
AngerDanger Avatar
108 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)

Popular Stories

iOS 16

Apple Releases iOS 16.0.2 With Bug Fixes for iPhone 14 Pro Camera Vibration, Copy/Paste Issue and More

Thursday September 22, 2022 1:04 pm PDT by
Apple today released iOS 16.0.2, addressing a number of bugs that iPhone 14 owners have been experiencing since the new devices launched. iOS 16.0.2 comes two weeks after the launch of iOS 16, and it follows iOS 16.0.1, an update made available to iPhone 14 owners on launch day. The update is available for all iPhones that are capable of running iOS 16. The iOS 16.0.2 update can be...
apple watch series 7 aluminum colors yellowbg

Don't Want the Apple Watch Ultra or Series 8? Amazon Has Record Low Prices on Series 7 Models This Week

Friday September 23, 2022 6:56 am PDT by
The Apple Watch Series 8 and Apple Watch Ultra are now available to purchase, but if you aren't interested in these updates you can save a lot of money on Series 7 models right now on Amazon. Note: MacRumors is an affiliate partner with Amazon. When you click a link and make a purchase, we may receive a small payment, which helps us keep the site running. The best deals are on cellular...
Dynamic Island For Android Users Feature

Android App Copying iPhone 14 Pro's Dynamic Island Released on Play Store

Thursday September 22, 2022 7:57 am PDT by
A copycat version of the iPhone 14 Pro's Dynamic Island has arrived on Android's Google Play Store in the form of an app called "dynamicSpot." The app, still in beta, offers customers several different experiences at the top of their smartphones. In its current form, dynamicSpot offers playback control for songs, timers, battery status, and more features coming soon, according to the app's...
maxresdefault

Video Review: Four Days With the iPhone 14 Pro Max

Wednesday September 21, 2022 7:49 am PDT by
Apple on Friday released the new iPhone 14 models, and MacRumors videographer Dan picked one up on launch day. He's been using the iPhone 14 Pro Max non-stop since it came out, and over on the MacRumors YouTube channel, has shared his initial thoughts on the day-to-day experience with the latest iPhone. Subscribe to the MacRumors YouTube channel for more videos. Dan's mini review highlights...
14 vs 16 inch mbp m2 pro and max feature 1

New 14-Inch and 16-Inch MacBook Pros Reportedly Launching Later This Year

Friday September 23, 2022 7:08 am PDT by
Apple plans to release new MacBook Pro models in the fourth quarter of 2022, according to supply chain publication DigiTimes. The report does not mention specific models, but it very likely refers to the next-generation 14-inch and 16-inch MacBook Pros given that the 13-inch model was already updated earlier this year. There has been uncertainty surrounding the timing of new 14-inch and...
facebook meta

Meta Sued Over Tracking iPhone Users Despite Apple's Privacy Features

Thursday September 22, 2022 5:12 am PDT by
Meta is facing a new proposed class action lawsuit that accuses it of tracking and collecting the personal data of iPhone users, despite features and policies made by Apple which are meant to stop that same type of tracking. In August, it was revealed that with the Facebook and Instagram apps, Meta can track all of a user's key taps, keyboard inputs, and more, when using the in-app browser....
AirPods Max 2022 Colors

Ten Things AirPods Pro 2 Tell Us About AirPods Max 2

Saturday September 24, 2022 1:00 am PDT by
Upon the release of the second-generation AirPods Pro, the AirPods Max became the oldest current-generation AirPods product still in Apple's lineup. Introducing several new features like Adaptive Transparency and the H2 chip, the second-generation AirPods Pro may provide some of the best indications yet of what to expect from the second-generation AirPods Max. Almost two years later, rumors...
new airpods pro ear tips

Apple Explains Why Second-Generation AirPods Pro Ear Tips Are Incompatible With Original AirPods Pro

Thursday September 22, 2022 3:12 pm PDT by
Apple today explained why the new silicone ear tips for the second-generation AirPods Pro are not officially compatible with the original AirPods Pro. In an updated support document, Apple said the original AirPods Pro ear tips have "noticeably denser mesh" than the second-generation ear tips. Apple did not provide any additional details, but the mesh density could result in acoustical...
AirPods Pro Second Generation 2 Pairing Feature 1

AirPods Pro 2 Engravings Appear in iOS During Pairing and Connecting

Friday September 23, 2022 9:40 am PDT by
Customers who personalize their second-generation AirPods Pro charging case with an engraving will now have that engraving reflected directly on iOS as they pair and connect their AirPods Pro. Apple allows customers to personalize their AirPods Pro charging case with a special engraving that can include select emojis and Memojis. Unlike before, starting with the second-generation AirPods...