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

[jicon]

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.

 

[-C-]

Why can't they just enable it with a disclaimer "This is not legally a medical device." in the countries where it doesn't have approval as a medical device?

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.

 

[bingeciren]

Hi guys! I have a little question
I am a very happy owner of an AW2, but I am so thrilled for this new one that I am thinking about the upgrade.
Problem is: I live in italy. I Understand that the ECG feature will be released gradually worldwide, but there is one aspect not totally clear to me:
The "limitation" will be totally Software, not even HW?
I mean, for the LTE watch apple decided to avoid selling at all in some countries the model with the right specs..
I read here and there phrases like "ECG will be available only in models shipped in US for now", and I find them a little scaring
Do you agreee with me that it would be very strange to differentiate even the production of products? (I mean: produce an ECG-sensor-free model of AW4 for some countries?)
bye!

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.

 

[atikalz]

Apple says it is working with Health Canada to bring the Apple Watch Series 4's all-new ECG functionality to the Canadian market, according to MobileSyrup's Patrick O'Rourke. No timeframe was specified.

This likely means that Apple has submitted an application with Health Canada for clearance to sell the Apple Watch Series 4 with the ECG functionality enabled. Health Canada has similar requirements as the FDA in the United States for medical devices to be sold in the country.

In the meantime, Apple says the ECG functionality will be limited to the United States, where it has received clearance from the FDA. However, the ECG app for watchOS 5 won't be available until later this year.

Apple Watch Series 4 models include a new electrical sensor on the rear that's designed to take an electrocardiogram using Apple's ECG app, the built-in sensor, and the electrode built into the Digital Crown. This allows the Watch to display a single-channel ECG, similar to a Lead I ECG, according to the FDA.

To take an ECG reading from the Apple Watch, users will need to place a finger on the Digital Crown while wearing the watch. The reading is completed in 30 seconds, allowing users to determine whether their hearts are beating in a regular pattern or if there are signs of atrial fibrillation.

As a potentially life-saving feature, Apple surely wants the ECG functionality to be available in as many countries as possible, so it's likely the company is working with public health agencies in other countries too.

Via: iPhone in Canada

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

Don't let Germany fall like apple pay. Still not here.

 

[BuddyTronic]

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.

But is that an invasive device? Or completely passive like the ECG?

 

[TheManOfSilver]

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.

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.

 

[BuddyTronic]

Hi guys! I have a little question
I am a very happy owner of an AW2, but I am so thrilled for this new one that I am thinking about the upgrade.
Problem is: I live in italy. I Understand that the ECG feature will be released gradually worldwide, but there is one aspect not totally clear to me:
The "limitation" will be totally Software, not even HW?
I mean, for the LTE watch apple decided to avoid selling at all in some countries the model with the right specs..
I read here and there phrases like "ECG will be available only in models shipped in US for now", and I find them a little scaring
Do you agreee with me that it would be very strange to differentiate even the production of products? (I mean: produce an ECG-sensor-free model of AW4 for some countries?)
bye!

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.

 

[lunarworks]

It can now sense when you've been eating too much poutine.

 

[chiccociolla]

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.

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..

 

[recoil80]

Hi guys! I have a little question
I am a very happy owner of an AW2, but I am so thrilled for this new one that I am thinking about the upgrade.
Problem is: I live in italy. I Understand that the ECG feature will be released gradually worldwide, but there is one aspect not totally clear to me:
The "limitation" will be totally Software, not even HW?
I mean, for the LTE watch apple decided to avoid selling at all in some countries the model with the right specs..
I read here and there phrases like "ECG will be available only in models shipped in US for now", and I find them a little scaring
Do you agreee with me that it would be very strange to differentiate even the production of products? (I mean: produce an ECG-sensor-free model of AW4 for some countries?)
bye!

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?

 

[ryanwarsaw]

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?

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.

 

[CPPMaster]

How does the EKG functionality is enabled or disabled? Is it tied to the Apple ID? In other words if the watch is activated with a US Apple ID does the EKG becomes enabled but if it is activated with a non US Apple ID it is disabled?

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.

 

[Number-Six]

But is that an invasive device? Or completely passive like the ECG?

The freestyle libre has a needle, it's not completely passive.

 

[RodThePlod]

It can now sense when you've been eating too much poutine.

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...

 

[symphony]

My guess is that it will be tied to the Apple ID. That way a US citizen will be able to use it even if they happen to take a short trip to Canada, or to anywhere else in the world for that matter. Also, it makes no sense to geo-lock the watch based on the gps location as it may not work at indoors or during a flight for example.

We shall learn more about it as time goes on.

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.

 

[chiccociolla]

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...

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?

 

[RodThePlod]

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?

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.

 

[-C-]

No. But Apple Pay was/is 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.

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/

 

[Elijen]

Can anyone confirm that ECG works in other countries if US account is used for App Store?

 

[and 4096 others like this]

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...

 

[-C-]

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...

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.

 

[jicon]

The freestyle libre has a needle, it's not completely passive.

For the sensors, yes, applicator has a little needle. The reader (which the iPhone app can replace) is just an NFC scanner with software.

 

[danielceleste]

Why can't they just enable it with a disclaimer "This is not legally a medical device." in the countries where it doesn't have approval as a medical device?

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.

 

[and 4096 others like this]

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.

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.

 

[recoil80]

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.

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.