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

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

  1. MacRumors macrumors bot


    Apr 12, 2001

    Earlier this month, Apple unveiled the Apple Watch Series 4 with a new electrocardiogram (ECG) feature that measures the electrical activity of your heartbeat, providing you with a heart rhythm classification that can be shared with your doctor. The feature isn't out yet, but it will be limited to Series 4 models in the United States later in 2018.


    Today, 9to5Mac shared a potential time window for the launch of the ECG feature in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) explains that the process starts by examining Apple's documentation surrounding the ECG feature and performing an audit of the quality assurance system.

    While this step doesn't appear to be lengthy, the proceeding steps could make the process longer. MHRA says it would require Apple to perform a new clinical investigation to judge the effectiveness of the ECG on Apple Watch, but Apple would likely not be able to use any of the data from the studies it's already completed because MHRA requires companies to notify the regulator in advance of a study.

    Once the study is submitted, MHRA has 60 days to approve it (which may become longer if the regulators have further inquiries for Apple), and then Apple can begin the study. These last few steps are what the MHRA say "could potentially add years" onto the debut of the ECG in the UK.
    Despite the potential for years-long approval, Apple may find ways to expedite this process. While the United Kingdom remains part of the European Union, it's possible that Apple could receive approval from a broader regulatory body and sidestep the MHRA's processes.

    In the United States, Apple has obtained de novo FDA clearance for the ECG feature in the Apple Watch Series 4 and the feature that can send a notification if an abnormal heart rate has been detected. However, FDA clearance is not the same as FDA approval and the FDA does not recommend that the ECG feature be used by those under 22 or those who have already been diagnosed with atrial fibrillation.

    The FDA warns that Apple's ECG app is not designed to replace traditional methods of diagnosis or treatment and is intended for informational use only.

    Elsewhere, Apple has said it is working with Health Canada to bring the ECG functionality to the Canadian market, although no timeline has been specified.

    Article Link: ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom
  2. CerebralX macrumors 6502


    Jun 28, 2013
    Looking for a place of freedom and rationality
    It makes sense. This is a very serious feature that needs to be thoroughly tested.
  3. markfc macrumors 6502a


    Sep 18, 2006
    Prestatyn, Wales, UK
    When it’s works in the UK, I’ll upgrade from my Nike Series 2.

  4. wubsylol macrumors 6502

    Nov 6, 2014
    This is a good thing. I am surprised the FDA allows it, even with the warning. People need to understand the limitations of the device; their lives literally may depend on it.
  5. Ifti macrumors 68020


    Dec 14, 2010
    Well that's the one useful feature I was tempted to buy the watch for, that I cant actually even use.
  6. kingjames1970 macrumors regular


    Mar 18, 2008
    Hampshire, UK
    Maybe being dim here - but could they not just have massive disclaimers saying the readings aren't regulated/approved and are advisory only? See a doctor etc.
  7. UKPoliticsGuy macrumors regular

    May 3, 2009
    Can you imagine the lines at NHS A&Es of hypochondriacs? No thank you!
  8. SteveJUAE macrumors 68030


    Aug 14, 2015
    Land of Smiles
    No surprise there NHS do not want someone running in for free checkups due to false alarms etc
  9. coldsweat macrumors 6502


    Aug 18, 2009
    Grimsby, UK
    Well that sucks - I still don't see why it actually needs full approval if it's only for informational purposes, but hey!
  10. Bornee35 macrumors 6502


    May 6, 2013
    Medicines and Healthcare products Regulatory Agency just want their palms greased. Europe is famous for waisting time via regulations. Nothing like log jamming a digital watch feature.
  11. Humdrumstick macrumors newbie

    Sep 17, 2018
    Maybe Apple will cut the price in the UK as a gesture of goodwill to us missing out on this feature....
  12. UKPoliticsGuy macrumors regular

    May 3, 2009
    or sponsor a few NHS heart units to cope with the people freaking out that they checked the ECG and it said 'low battery'.
  13. MrGimper macrumors 603


    Sep 22, 2012
    Andover, UK
    This isn't surprising.... TBH I have no need for the ECG and suspect the majority of people don't. I appreciate there are some totally legitimate situations where it would be great, but for most of us it's a cool gimmick to show your friends.

    The ECG wasn't part of my thought process when I upgraded from S2.
  14. Sasparilla macrumors 65816

    Jul 6, 2012
    Anything with health care is going to be slow - getting the approvals and tests, which as we've seen from Theranos are probably a good idea.

    I'm still surprised Apple got the FDA to allow it in the U.S. so quickly - although maybe that's been in the pipeline a long time.
  15. OllyW Moderator


    Staff Member

    Oct 11, 2005
    The Black Country, England
    You should make a visit to Edinburgh next year and enter this. :D
  16. johncarync macrumors regular


    Aug 2, 2005
    Cary, NC
    Surly a company with billions and billions of dollars, the life-saving stories that will appear when the feature is available elsewhere, and a large outcry from the UK citizens will speed up the approval process.
  17. applepuree macrumors 6502


    Aug 15, 2014
    Except this isn't the EU, its the UK they were talking about. Even if they could sidestep the UK regulations by getting in cleared by the EU, that type approval would probably be null and void when the UK leave the EU next march.

    Any word on when/if EU approval might come (specifically Germany)?
  18. buzzman macrumors member

    Aug 11, 2007
    I live in Switzerland and that could take a long time too here to be approved.
    I'm wondering if there will be some sort of OS flashing from the US version to my Swiss watch. Guess we have to wait.
  19. cmaier macrumors G5

    Jul 25, 2007
    It is unlikely that brexit would nullify it. They need to keep continuity and can’t just unwind everything that has been approved in the last several decades.
    --- Post Merged, Sep 27, 2018 ---
    It’s the same OS but will use location checks, assuming it is anything like what already happens for regional features.
  20. friednoodles Suspended

    Feb 4, 2014
    Why is everyone assuming Apple isn’t already months into this process like they were with the FDA?

    Pretty sure they already know what’s involved with getting regulatory approval in their main markets. It’s not like they woke up the day after the keynote and thought “oh, maybe we should start doing stuff for other authorities now, why didn’t we think of this earlier?”
  21. Spanky Deluxe macrumors 601

    Spanky Deluxe

    Mar 17, 2005
    London, UK
    Wait, so you can't even activate it in the UK for your own purposes? What about if you buy one in the US and then bring it over?
  22. Bornee35 macrumors 6502


    May 6, 2013
    Never said EU, just generalized Europe as a whole for waisting time on bureaucracy.
  23. Absrnd macrumors 6502a


    Apr 15, 2010
    I see 3 options:

    - Apple is able to speed up de process, and will be added to Euro watches this or next year.
    - it will never be released for Euro watches.
    - still be able to use it with a US account workaround :) (my hope)
  24. V.K. macrumors 6502a


    Dec 5, 2007
    Toronto, Canada
    This timeline is absurdly long. When I asked Health Canada on twitter they said that for a device like that they could approve an application very quickly, as quickly as 15 days. No reason why it should take years in UK.
  25. Khedron macrumors 65816

    Sep 27, 2013
    If you want to claim health benefits for a product the rest of the world requires you back up that claim. The USA only requires your product doesn't actively hurt the user.
    --- Post Merged, Sep 27, 2018 ---
    And half of that time is probably waiting for testing fees to clear. Just imagine how thorough a scientific study can be performed in a week.

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