ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom

Discussion in 'MacRumors.com News Discussion' started by MacRumors, Sep 27, 2018.

  1. leebroath, Sep 27, 2018
    Last edited: Sep 27, 2018

    leebroath macrumors 6502a

    leebroath

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    Scotland
    #26
    Your Watch still has the ability to alert you to a decrease or increase in BPM

    Regardless of having this ECG ability on the watch, you should always contact your local doctor to have the above checked over, who will in-turn probably carry out their own ECG test on you anyway

    I’m not bothered about testing myself in the UK, as long as I get an early warning then this should help!
     
  2. centauratlas, Sep 27, 2018
    Last edited: Sep 27, 2018

    centauratlas macrumors 65816

    centauratlas

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    #27
    It is amazing that the UK government has to treat its citizens like babies who can't be trusted to make decisions for themselves. How about giving people the freedom to decide they want to use it or not? Sure, if they need to have a ton of disclaimers, go ahead.

    It isn't as if this is a defibrillator that is going to try and shock your heart back into rhythm, it is another tool that could potentially save someone's life by recording an ECG/EKG to show to their doctor later. It isn't perfect no doubt since it is an early version, but give people the freedom to choose for themselves whether to use it. I know plenty of people who are competent enough to understand the limitations.

    Talk about heavy-handed, paternalistic interference in people's lives.
     
  3. Khedron macrumors 65816

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    #28
    With this watch Apple was clearly putting its own marketing ahead of genuine interest in health. They withheld their applications in other countries because they didn't want the news of the feature leaking before they could start preorders.

    That was their decision, they can live with it.
     
  4. Bornee35 macrumors 6502

    Bornee35

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    #29
    Th
    They're not claiming any health benefits, and the technology isn't new. Its a single lead EKG. Anything less then 4 leads is a gimmick. It's just as inaccurate as your heart rate detection, it can vary up to +/- 10 BPM. There is a huge difference of semantics between can and will.
     
  5. trainwrecka macrumors 6502

    trainwrecka

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  6. venusboy macrumors regular

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    #31
    Because big pharma companies don’t have billions and billions of dollars? And people aren’t already waiting for life changing medecines currently under testing.

    Clinical trials take time. No way around it.
     
  7. Steve121178 macrumors 601

    Steve121178

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    #32
    It takes the local councils about 9 years to decide whether to resurface a damn road in this country. I'm sure ECG on Apple Watch will be approved just after Apple release the Apple Watch 17.
     
  8. Bornee35 macrumors 6502

    Bornee35

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    #33
    What trials? It's and EKG that logs data. The trials and data is already there.
     
  9. Khedron macrumors 65816

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    #34
    No one is preventing Apple from selling the watch in the UK. They are only prohibited from marketing it as a medical device with no evidence to back that up.
     
  10. recoil80 macrumors 68020

    Joined:
    Jul 16, 2014
    #35
    I'm not optimistic about the feature being release in EU before next Apple Watch is launched.
    I think I'll stick with my series 1 for another year and hopefully the ECG will be included into the AW I'll buy next fall, a discounted series 4 or a brand new 5.
     
  11. Khedron macrumors 65816

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    #36
    Preliminary studies suggest it is wildly inaccurate due to having a single lead rather than the standard 12.
     
  12. cmaier Suspended

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    California
    #37
    Source?
     
  13. nahkampfwombi macrumors member

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    Jan 7, 2016
    #38
    Well at least for me this is a huge feature.
    I'm not buying a smart-watch without such a feature.
    And I'm not even joking.

    I was so happy someone finally released such amazing stuff. Then again it's not allowed in GB/Germany/..

    Thanks for nothing. :-/
     
  14. Romeo_Nightfall macrumors 6502

    Romeo_Nightfall

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    #39
    Well thats what i blame the tech companies for , they have not transformed government world - especially here in europe. still the same ridiculous politicians who block everything.

    that said i find the ecg feature ridiculous , too - haha
     
  15. Bornee35 macrumors 6502

    Bornee35

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    #40
    Exactly similar to the Heart Rate feature, wildly inaccurate. Its a health feature, not a medical diagnostic. Apple isn't going to start emailing you prescriptions when the app goes off.
     
  16. Bornee35 macrumors 6502

    Bornee35

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    #42
    "For the ECG app, the FDA received data showing that the Apple Watch couldn’t classify about 1 in 10 rhythms. Of the rest, 98.3 percent of the time, people with atrial fibrillation were correctly detected as having it, while 99.6 percent of people were correctly identified as not having an AFib if they didn’t have one." apparently 99.6 percent correct is wildly inaccurate.
     
  17. Mac Fly (film) macrumors 65816

    Mac Fly (film)

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    #43
    And yet Paracetamol kills hundreds of people a year and they've no problem allowing the sale of that. And Aspirin only affective on a small portage or part thereof of people and doctors give it to everyone.
     
  18. Khedron macrumors 65816

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    #44
    https://www.apple.com/uk/apple-watch-series-4/health/

    This part in particular is very dangerous from Apple: "On alert. So you don’t have to be."
     
  19. cmaier Suspended

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    California
    #45
    Thanks.

    Doesn’t seem wildly inaccurate, though.

    “For the ECG app, the FDA received data showing that the Apple Watch couldn’t classify about 1 in 10 rhythms. Of the rest, 98.3 percent of the time, people with atrial fibrillation were correctly detected as having it, while 99.6 percent of people were correctly identified as not having an AFib if they didn’t have one.”
     
  20. Khedron macrumors 65816

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    #46
    I'm sure the UK will allow Apple to promote the watch if they make absolutely clear it is a gimmick.
     
  21. lkrupp macrumors 6502a

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    #47
    Apple, meet the healthcare lobby. Hello Apple, we see you’re trying to muscle in on our turf. Good luck with that.
     
  22. christophermdia macrumors 6502a

    christophermdia

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    #48
    This is not Apple's core expertise. They can make great products, but medical products educational or otherwise demand a rigorous process in order to gain clearance. ECG is a major addition and evaluator of health condition. As someone else here stated, these regulatory bodies do not want patients using this information for self diagnosis to then go and waste very very tight resources in their specific regions, especially the UK, which there are waiting lists months and months long to just see a doctor.

    to make it even more difficult, the EU is releasing more stringent requirements, even tougher than the FDA come May 2020. This will require that basically any medical device be monitored and tracked with documentation from a clinical coordinator to report the safety and efficacy of the product on an ongoing basis. If you cannot prove it in a clinical environment, they will deny further access to the market. As you get into regions like Japan and China, these regulations become tougher and tougher.

    The best way is to conduct a global clinical study in order to prove the validity of the claims. If you want China in the mix, this study needs to include a specific amount of asian population otherwise a separate study is required in China itself, with the only advantage is that it is manufactured in China and gives them a little head start in the process ...

    This is what I do for a living, and I have simpler things that I have released that give us headaches and take years to release, not to mention a DeNovo clearance in the US with FDA is actually quite rare and they are actually lucky to have even gotten that! I wouldn't be surprised if they have to have a pop up every time you activate the ECG to say that it is not a diagnosis and they should see their doctor if they have any concerns regarding their condition. etc ...

    Maybe I need to get a job with Apple
     
  23. Khedron macrumors 65816

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    Sep 27, 2013
    #49
    A 10% failure rate straight away (before you even consider false positives/negatives) seems wildly inaccurate as a medical device to me.
     
  24. Bornee35 macrumors 6502

    Bornee35

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    #50

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