Apple's VP of Health Says Apple Has 'Good' Relationship With FDA, Will Continue to Do Great Work in the Health Space

Discussion in ' News Discussion' started by MacRumors, Feb 22, 2019.

  1. MacRumors macrumors bot


    Apr 12, 2001

    Apple's VP of Health Dr. Sumbul Desai recently sat down for an interview with MobiHealthNews where she discussed Apple's health products, the company's relationship with the FDA, the success of the ECG feature on the Apple Watch, and more.

    On the topic of Apple's relationship with the FDA, Desai said that while Apple has a "good" relationship with the FDA, the FDA asked "hard questions" about the ECG feature in the Apple Watch, which received De Novo clearance in the U.S. ahead of its release.


    Apple gets no special treatment from the FDA and undergoes the same scrutiny any other company does.
    On the ECG feature, which was added in the Apple Watch Series 4 and is available in the U.S., Desai said that customer stories "have been amazing." Cook has gotten a "number of letters" from people who were able to detect atrial fibrillation and get help earlier than they might have otherwise been able to.

    Response from doctors has also been "pretty decent," but cardiologists are still working on the best way to handle that kind of data coming from patients.

    In response to a question about ECG and another new health feature, fall detection, being targeted to an older demographic that may not own the Apple Watch, but Desai says that these features can help everyone.
    Atrial fibrillation is also a condition that "affects everybody," and Apple has received positive responses from younger people diagnosed with the condition that were able to get help.

    Desai says that Apple is "very interested in the health space" and will "continue to do great work" in health. She agreed with Tim Cook's recent statement suggesting health is the area where Apple may ultimately have the greatest impact on mankind. Apple has a lot to share in the future, says Desai, and is still "in the first inning."
    Desai's full interview, which is worth reading for anyone interested in Apple's health initiatives, can be found over at the MobiHealthNews website.

    Article Link: Apple's VP of Health Says Apple Has 'Good' Relationship With FDA, Will Continue to Do Great Work in the Health Space
  2. Freida macrumors 68000

    Oct 22, 2010
  3. twocents macrumors regular


    Mar 31, 2016
    California, USA
    I'm just hopeful that while they focus on health, that they keep in mind that it shouldn't be a premium and inaccessible to a growing number of people. Same with privacy, you get what you pay for... but only if you can afford it. Apple is ultimately a business like any other though I hope they can continue their focus on intersecting technology with humanities / liberal arts
  4. scrapesleon macrumors 6502a


    Mar 30, 2017
  5. 69Mustang macrumors 604


    Jan 7, 2014
    In between a rock and a hard place
    It's great that Apple is focusing on the health aspects of tech. But if today's news about apps sharing customer data with Facebook isn't a warning, it definitely should be. Especially since a couple of those apps were health related.
  6. Firelock, Feb 22, 2019
    Last edited: Feb 23, 2019

    Firelock macrumors member


    Sep 7, 2012
    Dallas, Texas
    If any other company had gotten FDA approval for a wristwatch that serves as a portable ECG, their stock would have gone through the roof and the media would not stop talking about it. Apple does it and everyone yawns and asks, “where’s the innovation?”

    Edit: Should have said "clearance" instead of approval. Substance of the post still stands.
  7. MikeSmoke macrumors regular

    Mar 26, 2010
    Maryland USA
    I don’t think doctors as a rule are unethical money hungry people but I can be sure that more than a few, not to mention the big diagnostic equipment companies, are looking at the Apple Watch and thinking, uh-oh, I hope we can make it to retirement.
  8. Veinticinco macrumors 6502a


    Feb 25, 2009
    I wonder why that same "good relationship" isn't there with the European Commission or any individual member state health regulatory authority?

    Anyone expecting the S4 ECG-like feature to be made available outside of the US anytime soon, is an example of wishful thinking meets blatant misrepresentation.
  9. dannyyankou macrumors G3


    Mar 2, 2012
    Scarsdale, NY
  10. citysnaps macrumors 601

    Oct 10, 2011
    San Francisco
    To be fair, Apple has not received FDA approval for their ECG function.
  11. Macaholic868 macrumors 6502


    Feb 2, 2017
    Apple’s stock is already through the roof but I definitely agree that if it were any other company it would be more highly touted than it has been but I think as the data starts to emerge about how many lives it saves it will receive the attention it deserves. I’ve had a few episodes over the years where I felt like something wasn’t quite right with my heart but by the time I get to a doctor and get hooked up to an EKG it’s long since passed. We’re talking just a few minutes and it’s gone. When I heard about the feature I was so excited. Who knows. It might be nothing or it could save my life.
    Pretty freaking cool and well worth the money for the extra peace of mind.
  12. VictorTango777 macrumors 6502

    Oct 28, 2017
    If anything, doctors will be receiving more calls from self diagnosing internet patients saying "My watch tells me this", "My watch says that", etc. No different from the customer telling the genius at the Apple Store "My son is a computer engineer and he says you have to do X,Y,Z."
  13. s15119 macrumors 68000


    Nov 20, 2010
  14. dilbert99 macrumors 68020

    Jul 23, 2012
    I heard that Apple doesn't have the usual approval that people think about when related to medical devices. The approval that Apple has is less meaningful
  15. I7guy macrumors Core


    Nov 30, 2013
    Gotta be in it to win it
    The approval Apple got is "informational only", it's not a medical device. But the information seemingly spurs people to go to doctors, as appropriate, and get a sound medical opinion. The watch isn't supposed to render a medical diagnosis. But people are claiming the "information" spurred them to go to a doctor.
  16. now i see it macrumors 68040

    Jan 2, 2002
    Maybe because the Watch is usually crying wolf
  17. PearsonX macrumors newbie

    Nov 3, 2018
    "Response from doctors has also been "pretty decent," but cardiologists are still working on the best way to handle that kind of data coming from patients."

    A reliable wearable ECG tech has huge research potential, like gathering large scale population data on arrhythmias in an asymptomatic population. On the other hand the lion share of current data is from an at risk, or symptomatic population and as mentioned above it may not be the same rules that apply to these. In other words, if you apply a test to a low pre-test probability group, you increase the frequency of false positives.

    On the other hand its going to be a fantastic dataset to be abused as well, like using wearable data to assess health risk and increase health insurance. Imagine laziness being considered a pre-existing condition...

    BTW, FDA device approvals are much less regulated than drug approvals.
  18. lamina macrumors 68000


    Mar 9, 2006
    Buddy up with Health Canada and get the ECG functionality working on the Series 4 please.
  19. az431 Suspended


    Sep 13, 2008
    Portland, OR
    If Apple had obtained FDA approval its stock would indeed have gone through the rough. But it didn't, so there you go.
    --- Post Merged, Feb 22, 2019 ---
    The FDA did not approve anything. What Apple received was clearance to sell the device.
    --- Post Merged, Feb 22, 2019 ---
    The article (if you actually read it rather than just the headline) states "the company has received FDA clearance for both an atrial fibrillation-detecting algorithm and an ECG that will be built into the new Apple Watch Series 4"

    The headline is incorrect. The text of the article is correct. Approval and clearance are not the same thing.
    --- Post Merged, Feb 22, 2019 ---
    Who said it isn't there? A good relationship doesn't mean Apple can ignore laws, or that a country will look the other way when a company does.
    --- Post Merged, Feb 22, 2019 ---
    Apple's stock is down nearly 30% from its high and trading at barely 10 times earnings. That is most definitely not "through the roof." Toilet is more like it.
  20. BuddyTronic macrumors 6502a

    Jul 11, 2008
    The big message is that Apple brought us a kickass ECG function on their Apple Watch. It is an awesome piece of technology.

    Show me a better “watch” device and I’ll buy it for sure.

    As for the stock? Well let the chips fall where they may :) Check back in a couple years. AAPL is $171 today, two years from now you think AAPL will be in the toilet? :)
    --- Post Merged, Feb 22, 2019 ---
    No, it isn’t. It’s excellent.
  21. Romeo_Nightfall macrumors 6502


    Aug 8, 2018
    Come on! Thats not innovation = its one of the most unnecessary things ever = nearly no one needs it nor is happy with it.

    Health is a dead horse and completely unethical to do = You keep people unhealthy because they think now they can buy a ‚tool‘ to save them anyways
  22. GadgetBen macrumors 6502a


    Jul 8, 2015
    Fall detection goes off A LOT when I am playing soccer and I save a hard strike in goal. It's not easy to take your gloves off to prevent it from calling 999 mid match. Hope they can sort this.
  23. Black Belt macrumors 6502a

    Black Belt

    Jun 15, 2007
    If they manage to achieve a noninvasive glucosemeter, it will be truly revolutionary. Not just for diabetics (for which it would be life-changing!) but for fitness and diet as well. Having access to constant blood sugar levels with relation to diet will change everything and promote greater health.
  24. PlayUltimate macrumors regular


    Jul 29, 2016
    Boulder, CO
    You can turn it off.

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