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
96 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
96 months ago
Exaggerate much?

No. Please tell us what you think the exaggeration is.
Score: 2 Votes (Like | Disagree)
steve333 Avatar
96 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
96 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
96 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
96 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)

Related Stories

studio buds family

Beats Studio Buds Debuting Today With Active Noise Cancellation, Stemless Design, and More for $150

Monday June 14, 2021 8:00 am PDT by
We've seen a lot of teasers about the Beats Studio Buds over the past month since they first showed up in Apple's beta software updates, and today they're finally official. The Beats Studio Buds are available to order today in red, white, and black ahead of a June 24 ship date, and they're priced at $149.99. The Studio Buds are the first Beats-branded earbuds to truly compete with AirPods...
youtube apple tv

YouTube Discontinuing 3rd-Generation Apple TV App, AirPlay Still Available

Wednesday February 3, 2021 3:09 pm PST by
YouTube is planning to stop supporting its YouTube app on the third-generation Apple TV models, where YouTube has long been available as a channel option. A 9to5Mac reader received a message about the upcoming app discontinuation, which is set to take place in March.Starting early March, the YouTube app will no longer be available on Apple TV (3rd generation). You can still watch YouTube on...
gradiente iphone white

Brazilian Electronics Company Revives Long-Running iPhone Trademark Dispute

Tuesday May 19, 2020 1:06 pm PDT by
Apple has been involved in a long-running iPhone trademark dispute in Brazil, which was revived today by IGB Electronica, a Brazilian consumer electronics company that originally registered the "iPhone" name in 2000. IGB Electronica fought a multi-year battle with Apple in an attempt to get exclusive rights to the "iPhone" trademark, but ultimately lost, and now the case has been brought to...
YouTube Picture in Picture Feature

YouTube Premium Subscribers Can Now Use iOS Picture-in-Picture: Here's How

Wednesday August 25, 2021 3:55 am PDT by
Google has rolled out picture-in-picture support as an "experimental" feature for YouTube premium subscribers, allowing them to watch video in a small window when the app is closed. If you're a premium YouTube subscriber looking to try out picture-in-picture, follow these steps: Launch a web browser and sign into your YouTube account at YouTube.com. Navigate to www.youtube.com/new. Scroll...
apple privacy

Apple Publishes FAQ to Address Concerns About CSAM Detection and Messages Scanning

Monday August 9, 2021 1:50 am PDT by
Apple has published a FAQ titled "Expanded Protections for Children" which aims to allay users' privacy concerns about the new CSAM detection in iCloud Photos and communication safety for Messages features that the company announced last week. "Since we announced these features, many stakeholders including privacy organizations and child safety organizations have expressed their support of...
apple screen time screen icons

Persistent Kids Finding Loopholes in Apple's Screen Time Limits

Tuesday October 15, 2019 9:44 am PDT by
Apple is currently engaged in a cat-and-mouse game with persistent kids looking to circumvent Screen Time restrictions, but the company has been receiving some criticism for not moving quickly enough to lock down some of the loopholes, reports The Washington Post. A few of the loopholes and ways for parents to shut them down are documented on the site Protect Young Eyes, while these and...
2012macpro

Apple Outlines Metal-Capable Cards Compatible With macOS Mojave on 2010 and 2012 Mac Pro Models

Monday September 24, 2018 3:26 pm PDT by
Apple's new macOS Mojave update is not compatible with mid-2010 and mid-2012 Mac Pros with stock GPUs, but it is supported on 2010 and 2012 Mac Pro models that have been upgraded with graphics cards that support Metal. Apple today shared a new support document that provides a list of graphics cards that are Metal-capable, which will be useful for 2010 and 2012 Mac Pro owners who want to...
bluetti eb70 main

MacRumors Giveaway: Win a Bluetti EB70 Portable Power Station and 200W Solar Panel

Friday September 3, 2021 11:13 am PDT by
For this week's giveaway, we've teamed up with MAXOAK to offer MacRumors readers a chance to win a Bluetti portable power station and an accompanying solar panel. Bluetti makes a range of portable power station options that are useful for camping, emergencies, power outages, off-grid living, and similar situations. The Bluetti EB70 is a solid middle of the road option that offers 716Wh and...
anker lightning cable mfi

Unwrap a New Apple Device? Stock Up on Extra Certified Lightning Cables for as Little as $6

Monday December 25, 2017 5:45 am PST by
If you unwrapped an Apple product today it likely came with one of the company's first-party Lightning cables, but having an extra on hand is always a good idea, so you can place it in other rooms in your house, in your car, or in a bag when you travel. For that reason, now's a good time to shop for third-party Lightning cables that are cheaper than Apple's own accessory, but still Made For...
ipad pro 10 5

Apple Discontinues 10.5-Inch iPad Pro Following Launch of Lower-Priced 10.5-Inch iPad Air

Monday March 18, 2019 6:09 am PDT by
Apple has stopped selling the second-generation 10.5-inch iPad Pro, originally released in June 2017, after launching a new 10.5-inch iPad Air today. The 10.5-inch iPad Pro had remained available from $649 following the release of 11-inch and 12.9-inch iPad Pro models in October 2018, but it has been replaced by the 10.5-inch iPad Air with a cheaper starting price of $499. The new iPad...