Go Back   MacRumors Forums > News and Article Discussion > MacRumors.com News Discussion

Reply
 
Thread Tools Search this Thread Display Modes
Old Jun 9, 2014, 02:08 PM   #1
MacRumors
macrumors bot
 
Join Date: Apr 2001
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.

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.
Quote:
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.
Quote:
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.

Article Link: Apple's December FDA Meeting Addressed 'Moral Obligation' for Health, Sensor Innovation, and Regulation
MacRumors is offline   0 Reply With Quote
Old Jun 9, 2014, 02:14 PM   #2
edk99
macrumors 6502a
 
Join Date: May 2009
Location: FL
Wonder if they also told Apple that they need to backup user iHealth data to the iNSA cloud.
edk99 is offline   3 Reply With Quote
Old Jun 9, 2014, 02:16 PM   #3
AngerDanger
macrumors 65816
 
AngerDanger's Avatar
 
Join Date: Dec 2008
Location: doing the Dada Polka
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.
AngerDanger is offline   2 Reply With Quote
Old Jun 9, 2014, 02:17 PM   #4
phillipduran
macrumors 6502a
 
phillipduran's Avatar
 
Join Date: Apr 2008
Location: Iowa
"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.
__________________
That's "Geniuses," not Genii, genius.
To err, is PC.
phillipduran is offline   2 Reply With Quote
Old Jun 9, 2014, 02:25 PM   #5
pdaholic
macrumors 6502
 
Join Date: Jun 2011
This article taught me that the FDA does more than just monitor the safety of our foods and drugs. Thanks MacRumors!
pdaholic is offline   0 Reply With Quote
Old Jun 9, 2014, 02:35 PM   #6
dwman
macrumors 6502
 
Join Date: Nov 2007
Location: DC
My wife is an FDA lawyer whose specialty happens to be medical devices. Wonder what she knows...
__________________
2007 MBP 2.2 SR, 5.5G 30 GB iPod, 2ndG 4GB iPod Nano, 64 GB iPhone 6, 16GB iPad 2 3G
dwman is offline   1 Reply With Quote
Old Jun 9, 2014, 02:39 PM   #7
Parasprite
macrumors 65816
 
Parasprite's Avatar
 
Join Date: Mar 2013
The FDA logo reminds me of something... But I can't place my finger on what...

__________________
Has anyone, anywhere, ever actually used ~/Pictures/iPod Photo Cache/ for anything besides deleting or hiding it?
Parasprite is offline   2 Reply With Quote
Old Jun 9, 2014, 02:58 PM   #8
Millah
macrumors 6502a
 
Join Date: Aug 2008
I imagine Apple would like to steer FAR away from any product that requires FDA approval. Look at what the FDA is doing to the tobacco industry, doing everything they can to protect the lobbying Big Tobacco companies from emerging new TECHNOLOGY in the form of vaping. If vaping is any indication as to how the FDA handles an exploding technology market that is helping people, then you can guarantee Apple will be forced to make their health initiatives less-ambitious for fear of having to get FDA approval. The FDA takes years to approve even simple little variations, there's no way possible that they would be able to keep up with a fast paced, innovative technology field.

Sad that the potential for something to be a truly disruptive medical device will have to be reduced to an infotainment type device. I really hope Apple figures out a way to get the product they want out the door.
Millah is offline   1 Reply With Quote
Old Jun 9, 2014, 03:09 PM   #9
Ralf The Dog
macrumors regular
 
Join Date: May 2008
I wonder, will data on the iPhone will be regulated under HIPA?
Ralf The Dog is offline   0 Reply With Quote
Old Jun 9, 2014, 03:12 PM   #10
The Barron
macrumors regular
 
Join Date: Mar 2009
FDA's Blessing - Pros & Cons

True, government is usually a bad idea for any company, let alone, a non-medical one. However, I feel Apple may be doing the right thing here wanting to stay on the "right side" of government by seeking FDA's opinion on future technology e.g iWatch, etc. Why not?

Historically the FDA can be a make or break for any company wanting to market anything for U.S. citizens that has to do with our bodies. There's simply no way around other than develop, release & then pay the lawyers to fight until they've invested huge $ into a losing battle.

Just my 2 here. Opinions?
The Barron is offline   1 Reply With Quote
Old Jun 9, 2014, 03:35 PM   #11
Mac Fly (film)
macrumors 6502
 
Join Date: Feb 2006
Location: Ireland
iWatch, the first consumer medical device killed by the FDA.
Mac Fly (film) is offline   0 Reply With Quote
Old Jun 9, 2014, 03:51 PM   #12
pacohaas
macrumors 6502a
 
Join Date: Jan 2006
To the FDA a medical "device" doesn't even have to be a physical device. Apple could be trying to get their Health app certified as a software device.
pacohaas is offline   1 Reply With Quote
Old Jun 9, 2014, 05:05 PM   #13
steve333
macrumors regular
 
Join Date: Dec 2008
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.

----------

Quote:
Originally Posted by pdaholic View Post
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.
steve333 is offline   2 Reply With Quote
Old Jun 9, 2014, 05:19 PM   #14
MOFS
macrumors Demi-God
 
MOFS's Avatar
 
Join Date: Feb 2003
Location: Liverpool, UK
Any iDevice with FDA (or local equivalent) approval would be a lucrative coup for Apple, and a serious breakthrough in medical devices going mainstream. A mass sold iWatch with blood sugar meter for example would revolutionise diabetes management by introducing a mainstream portable innocuous device that many diabetics would love.
__________________
Be good
MOFS is offline   0 Reply With Quote
Old Jun 9, 2014, 05:22 PM   #15
nick42983
macrumors member
 
Join Date: May 2009
Location: California
How long before the government mandates that health data from iWatches and similar devices be stored "for your benefit" as a tie-in with ObamaCare? It'll start as a "voluntary" program with "incentives" for early adopters. If the NSA spying scandal is any indication, this data will be stolen and used against us. Who knows what back room, backdoor deals Apple will make if the FDA becomes a roadblock to their latest blockbuster product.
__________________
1.7 GHz i7 Macbook Air, 8GB RAM, 256GB
iPhone 4S 32GB
iPad Mini 16GB
nick42983 is offline   0 Reply With Quote
Old Jun 9, 2014, 06:03 PM   #16
timborama
macrumors member
 
Join Date: Oct 2011
How nobel of them. But no obligation to pay the US taxes.
timborama is offline   1 Reply With Quote
Old Jun 9, 2014, 06:16 PM   #17
apersona
macrumors newbie
 
Join Date: Apr 2011
Let's all get down on our knees and join in with Butters.

"Hey government, its me, Butters. I just want to say, well, thanks for watching over me and doing everything you do ..."

Haven't we had just about enough of the Watchers hoovering up every crumb of data we generate, all justified as being for "the common good"?
apersona is offline   0 Reply With Quote
Old Jun 9, 2014, 07:11 PM   #18
SHNXX
macrumors 6502a
 
Join Date: Oct 2013
Fascinating!

FDA bureaucracy is very very complicated.
SHNXX is offline   0 Reply With Quote
Old Jun 9, 2014, 07:57 PM   #19
kdarling
macrumors G4
 
kdarling's Avatar
 
Join Date: Jun 2007
Location: Device engineer 30+ yrs, touchscreens 23+.
Quote:
Originally Posted by Fresh Pie View Post
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.
The meeting details seem to indicate the reverse situation:

It sounds more like Apple was looking for guidance as to what they could do (and/or claim to do) WITHOUT requiring FDA approval.

For example, without FDA approval, they could not claim glucose monitoring for diabetics. They seemed to want guidance as to what kind of results they could present. Those of a purely educational or entertainment aspect do not require regulation.

As the meeting document said:

Quote:
"If the manufacturer advertises the device for an unapproved use of FDA sees a lot of off-label use that is potentially dangerous, FDA may regulate after the fact."

"Apple will work closely with FDA as they develop future products. The earlier FDA is involved and advising, the less likely that Apple would be caught by surprise later when they wish to release a new product, if that product must be regulated.
"

-FDA
The FDA also pointed out to Apple, that while the display format of information is not regulated, the software that measures the information would be regulated if it falls into a medical device category by acting as a diagnostic tool.

Last edited by kdarling; Jun 10, 2014 at 05:20 AM. Reason: spelling
kdarling is offline   1 Reply With Quote
Old Jun 9, 2014, 08:22 PM   #20
SHNXX
macrumors 6502a
 
Join Date: Oct 2013
I think FDA approval for medical devices would add a lot of gravitas for apple's device or app if it goes through.
SHNXX is offline   0 Reply With Quote
Old Jun 9, 2014, 09:07 PM   #21
HMI
macrumors 6502a
 
HMI's Avatar
 
Join Date: May 2012
.

Last edited by HMI; Jun 13, 2014 at 12:49 PM.
HMI is offline   0 Reply With Quote
Old Jun 9, 2014, 11:36 PM   #22
thisma
macrumors member
 
Join Date: Sep 2008
I want one

I hope very much that the iWatch has a glucometer. I don't have diabetes, but do want to know how my body reacts to food, exercise, stress, etc. so I can maintain better health. If I could monitor my blood sugar continuously all day and night long, then I would buy whatever can make that happen.
thisma is offline   0 Reply With Quote
Old Jun 10, 2014, 03:14 AM   #23
SHNXX
macrumors 6502a
 
Join Date: Oct 2013
Quote:
Originally Posted by thisma View Post
I hope very much that the iWatch has a glucometer. I don't have diabetes, but do want to know how my body reacts to food, exercise, stress, etc. so I can maintain better health. If I could monitor my blood sugar continuously all day and night long, then I would buy whatever can make that happen.

I don't think it's technically possible.

Non invasive glucose sensors have never been shown to work well and I don't see how apple's solution could be better.

My guess is that it will not include glucose sensor.
SHNXX is offline   0 Reply With Quote
Old Jun 10, 2014, 09:54 AM   #24
FloatingBones
macrumors 65816
 
FloatingBones's Avatar
 
Join Date: Jul 2006
Quote:
Originally Posted by The Barron View Post
Historically the FDA can be a make or break for any company wanting to market anything for U.S. citizens that has to do with our bodies. There's simply no way around other than develop, release & then pay the lawyers to fight until they've invested huge $ into a losing battle.
The FDA seems fundamentally broken under this administration. This week, 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"?
FloatingBones is offline   1 Reply With Quote
Old Jun 10, 2014, 10:23 AM   #25
perealb
macrumors regular
 
Join Date: Oct 2009
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!
perealb is offline   1 Reply With Quote

Reply
MacRumors Forums > News and Article Discussion > MacRumors.com News Discussion

Thread Tools Search this Thread
Search this Thread:

Advanced Search
Display Modes

Forum Jump

All times are GMT -5. The time now is 08:43 AM.

Mac Rumors | Mac | iPhone | iPhone Game Reviews | iPhone Apps

Mobile Version | Fixed | Fluid | Fluid HD
Copyright 2002-2013, MacRumors.com, LLC