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

Discussion in ' News Discussion' started by MacRumors, Jun 9, 2014.

  1. MacRumors macrumors bot


    Apr 12, 2001

    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.
    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.
    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
  2. edk99 macrumors 6502a

    May 27, 2009
    Wonder if they also told Apple that they need to backup user iHealth data to the iNSA cloud.
  3. AngerDanger macrumors 68030


    Dec 9, 2008
    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.
  4. phillipduran macrumors 65816


    Apr 30, 2008
    "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.
  5. pdaholic macrumors 6502a


    Jun 22, 2011
    This article taught me that the FDA does more than just monitor the safety of our foods and drugs. Thanks MacRumors!
  6. dwman macrumors 6502


    Nov 15, 2007
    San Francisco
    My wife is an FDA lawyer whose specialty happens to be medical devices. Wonder what she knows...;):D
  7. Parasprite macrumors 68000


    Mar 5, 2013
    The FDA logo reminds me of something... But I can't place my finger on what...

  8. Millah macrumors 6502a

    Aug 6, 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.
  9. Ralf The Dog macrumors regular

    May 1, 2008
    I wonder, will data on the iPhone will be regulated under HIPA?
  10. The Barron macrumors regular

    Mar 5, 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?
  11. Mac Fly (film) macrumors 65816

    Mac Fly (film)

    Feb 12, 2006
    iWatch, the first consumer medical device killed by the FDA.
  12. pacohaas macrumors 6502a

    Jan 24, 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.
  13. steve333 macrumors 6502a

    Dec 12, 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.


    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.
  14. MOFS macrumors 65816


    Feb 27, 2003
    Durham, 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.
  15. nick42983 macrumors 6502


    May 18, 2009
    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.
  16. timborama macrumors 6502

    Oct 12, 2011
    How nobel of them. But no obligation to pay the US taxes.
  17. apersona macrumors newbie

    Apr 26, 2011
    Let's all get down on our knees and join in with Butters.

    "Hey government, it’s 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"?
  18. SHNXX macrumors 68000

    Oct 2, 2013

    FDA bureaucracy is very very complicated.
  19. kdarling, Jun 9, 2014
    Last edited: Jun 10, 2014

    kdarling macrumors demi-god


    Jun 9, 2007
    First university coding class = 46 years ago
    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:

    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.
  20. SHNXX macrumors 68000

    Oct 2, 2013
    I think FDA approval for medical devices would add a lot of gravitas for apple's device or app if it goes through.
  21. HMI, Jun 9, 2014
    Last edited: Jun 13, 2014
  22. thisma macrumors member

    Sep 9, 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.
  23. SHNXX macrumors 68000

    Oct 2, 2013

    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.
  24. FloatingBones macrumors 65816


    Jul 19, 2006
    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"?
  25. perealb macrumors regular


    Oct 30, 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!

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