Apple Working With Health Canada to Bring Apple Watch Series 4's ECG Functionality to Canadian Market

Discussion in 'MacRumors.com News Discussion' started by MacRumors, Sep 20, 2018.

  1. jicon macrumors 6502

    Joined:
    Nov 29, 2004
    Location:
    Victoria, BC
    #26
    Waiting on Health Canada huh? I’m a skeptic on how long this may take.

    I started using something called an Abbott Freestyle Libre for checking interstitial glucose in early Spring. It comes with an NFC reader, real handy and all, but last year Abbott came out with the App. iPhone 7 or later can use built in NFC support to take readings. Available in the UK, and several other countries in the EU.

    Great. Bring it to Canada, Abbott. Not on the Canadian App Store. Allegedly it has been tied up for six months with Health Canada. Who knows when it may see a release.
     
  2. -C- macrumors regular

    -C-

    Joined:
    Jul 31, 2010
    #27
    Probably too much liability...if someone is harmed by a medical device on the market but not cleared through Heath Canada then they're looking at fines and lost sales on top of lawsuits.
     
  3. bingeciren macrumors 6502a

    bingeciren

    Joined:
    Sep 6, 2011
    #28
    I guess that the limitation is SW only, judging from the fact that even the US models don’t have it activated now. I believe it will be activated by releasing a new version of the watch OS, say 5.1, and that OS will only be available on the App Store of the country it is being released and not on the App Store of the other countries.
     
  4. atikalz macrumors regular

    atikalz

    Joined:
    Mar 22, 2016
    #29
    Don't let Germany fall like apple pay. Still not here.
     
  5. BuddyTronic macrumors 6502a

    Joined:
    Jul 11, 2008
    #30

    But is that an invasive device? Or completely passive like the ECG?
     
  6. TheManOfSilver macrumors regular

    TheManOfSilver

    Joined:
    Oct 26, 2004
    Location:
    Canada
    #31
    I agree. I think the hardware is the same everywhere, and the ability to take an ECG will be enabled in software. While the function may be present in a future watchOS update, they may simply release a standalone app, which will only be released on the App Store in markets where approvals or clearance have been obtained. This would also add an advantage of having a phone/tablet companion app that would allow for seeing a collection of ECG records.
     
  7. BuddyTronic macrumors 6502a

    Joined:
    Jul 11, 2008
    #32

    I am guessing that you can work around this issue by signing on to iTunes or whatever with country/region = "USA".

    You would naturally/normally do this if you moved to the USA, for example, and if you did this, then you would certainly be allowed to use the ECG functions of the Watch.
     
  8. lunarworks macrumors 65816

    Joined:
    Jun 17, 2003
    Location:
    Toronto, Canada
    #33
    It can now sense when you've been eating too much poutine.
     
  9. chiccociolla macrumors member

    Joined:
    Mar 11, 2016
    #34
    don't know if it is as simple as that..
    However, my doubt was simpler: Will I be ever able to use the ECG on a AW4 purchased in EU? Or maybe they will add the sensor in AW5 in EU market?
    I think we do all seem to agree that the answer (to the 1st question) is yes..
     
  10. recoil80 macrumors 68020

    Joined:
    Jul 16, 2014
    #35
    I think it is just software and they'll be able to add more countries with future watchOS updates. Otherwise you'd be able to use ECG in Italy if a friend is travelling to the US and bring you back an Apple Watch.
    Maybe it will be possible to try ECG in the future by setting a USA iCloud account

    Anyway yours is an interesting question and Apple should make that clear. What if a customer buys series 4 hoping to get ECG in some months or even in a year?
     
  11. ryanwarsaw macrumors 68020

    ryanwarsaw

    Joined:
    Apr 7, 2007
    #36
    Agreed it has to be software as they intend to roll out it worldwide in stages as they gain approval. It would be a huge mistake if it is a hardware limitation.
     
  12. CPPMaster macrumors member

    Joined:
    Jun 12, 2009
    Location:
    VA/USA
    #37
    The EKG functionality is not available yet, will be "soon" . Why ? I hope is not because Apple is afraid to have serious reviewers (serious = not these youtubers that does only good reviews because they get free stuff from Apple and a bad review means black list) will compare the functionality with the golden standard used on medical offices and conclude, "ops, is crap, sensors fails" and we have a EKGGATE, and people just hold on series 4 because that.
     
  13. Number-Six macrumors 6502

    Number-Six

    Joined:
    Jul 25, 2013
    #38
    The freestyle libre has a needle, it's not completely passive.
     
  14. RodThePlod macrumors 6502a

    RodThePlod

    Joined:
    Sep 7, 2005
    Location:
    London
    #39
    For some reason, I find that hilarious! :)

    Can't wait to have this functionality in the UK. Hopefully in the meantime, we'll be able to get around it by switching to the US store and downloading the app if that's the way Apple decide to implement.

    I'm thinking they won't even 'care' too much if people do this. Hopefully they take the view that as long as they've only made the app available in the App Stores of authorised countries, they've done what's necessary. If people then decide to get the app via non-standard means, that's up to them...
     
  15. melancholy macrumors 6502

    melancholy

    Joined:
    Aug 25, 2016
    #40
    I think it’ll be tied to region settings, which is the easiest to bypass. Apple News apps appears on iPhones when devices are set to US. I’m sure this is how ECG will appear because it is just an app like Apple News.

    TV app only appears if your Apple ID’s iTunes Store region is set to available countries like US, since these are tied to paid purchases.

    Apple Pay Cash is another service where it’ll only appear if you have an American card in wallet and/or your iCloud account is set to US.
     
  16. chiccociolla macrumors member

    Joined:
    Mar 11, 2016
    #41
    good point, but another simple question arises:
    was it possible in this way to use apple pay when was available only in US, even outside US?
     
  17. RodThePlod macrumors 6502a

    RodThePlod

    Joined:
    Sep 7, 2005
    Location:
    London
    #42
    No. But Apple Pay was/is a completely different beast as it doesn’t just rely on your phone or watch to work; It relies on the integration and support of the local banks.

    ECG reading is something quite different, and doesn’t rely on a massive back-end infrastructure to work.
     
  18. -C-, Sep 20, 2018
    Last edited: Sep 20, 2018

    -C- macrumors regular

    -C-

    Joined:
    Jul 31, 2010
    #43
    The ECG function makes it a class IIa medical device in the EU and that's an entirely different ballgame. I'd be willing to bet that the feature will be activated in the US and EU at the same time to avoid regulatory issues. A lot of smaller countries allow medical devices based on market clearance from those two regulatory bodies.

    Has anyone seen an EU version of the watch and is it now CE marked with a 4 digit notified body number?

    Edit; maybe they won't even make it available there since they have EU declarations of conformity for all the appropriate directives but not the medical device regulation...

    https://www.apple.com/euro/compliance/
     
  19. Elijen macrumors 6502

    Elijen

    Joined:
    May 8, 2012
    #44
    Can anyone confirm that ECG works in other countries if US account is used for App Store?
     
  20. and 4096 others like this macrumors member

    and 4096 others like this

    Joined:
    Jan 26, 2018
    #45
    I have a question - is there an institution in EU that can handle this and giving approval to Apple, so Apple could put ECG in every EU country at once? Or maybe Apple have to contact with institution separately in each country?z

    If first option is true, I would bet that ECG will be available in EU very soon...
     
  21. -C-, Sep 20, 2018
    Last edited: Sep 20, 2018

    -C- macrumors regular

    -C-

    Joined:
    Jul 31, 2010
    #46
    Yep, here's a nice flowchart for the process in the EU:

    https://www.slideshare.net/emergogroup/europe-ce-marking-for-medical-devices-under-new-mdr

    From the EU Medical Device Regulation "Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes is classified as class IIa".

    Once they go through that process they'll be allowed to apply the CE mark. They already apply the CE mark by itself for compliance they can self-certify but the medical device part is added on, requires a third party to confirm, and you'll know when you see four digits after the mark which indicates the notified body responsible for auditing them (among other things) for compliance with EU law....for example "CE 0123" is for TÜV SÜD.

    They can leverage most of the information already provided to the FDA.
     
  22. jicon macrumors 6502

    Joined:
    Nov 29, 2004
    Location:
    Victoria, BC
    #47
    For the sensors, yes, applicator has a little needle. The reader (which the iPhone app can replace) is just an NFC scanner with software.
     
  23. danielceleste macrumors regular

    Joined:
    Jun 16, 2012
    #48
    While medical device regulations are generally more lax (especially for the class this device falls in), they can’t do this for reasons similar to why a drug company can’t slap “this is not a legally approved drug” on a pill bottle and put it on store shelves.

    The function of a regulatory agency like Health Canada is to protect the public from potentially dangerous or ineffective products being made available to consumers. Part of their responsibility involves assessing the safety and effectiveness of a device, which includes details like user-facing information. For example, it’s likely that the exact wording of some of the arrhythmia notifications and the written interpretation of ECG data was submitted to the FDA. Even something that may seem trivial like this written messaging has an effect on how users respond to the device, and is therefore part of safety considerations.

    For those worried about the time it may take to get Health Canada approval, I wouldn’t worry too much: getting *de novo* approval with the FDA is exciting from a technical standpoint, I don’t imagine it’s nearly as rigorous as it would be to get Class III/IV approval (which is required for devices that people depend on for their lives). I don’t forsee much pushback or a “rejection” by Health Canada.
     
  24. and 4096 others like this macrumors member

    and 4096 others like this

    Joined:
    Jan 26, 2018
    #49
    Thank you for answer! So let's hope EU countries will got this feature soon. Then it will be time for me to upgrade my currently non-exist Apple Watch, to Apple Watch series 4.
     
  25. recoil80 macrumors 68020

    Joined:
    Jul 16, 2014
    #50
    It would be awful for a customer to buy a series 4, find out that finally his country approved the ECG but he bought it too early and doesn't have the feature. Terrible experience for the customer, and by hiding the feature in software achieve the same goal, you don't have it until it is approved.
     

Share This Page