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

[MacRumors]

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

 

[insomniac86]

Come on Australia, you can do it!

 

[johnyslats]

I’ll be trying the region trick as soon as it appears in the developer beta (UK)

 

[zorinlynx]

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?

 

[recoil80]

I'm afraid it will take ages before being approved in my country, but the feature is really cool I'd really like to give it a try

 

[bingeciren]

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?

 

[TheManOfSilver]

If people are interested, you can follow new Health Canada device approvals at the following RSS feed:
https://www.canada.ca/content/dam/hc-sc/migration/hc-sc/rss/dhp-mps/devices-instruments-eng.xml

 

[johnyslats]

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?

Nobody actually knows yet. Either that or it could well be baked in to watchOS 5.1 but will only be viewable if the region is US

 

[nnoble]

I

I’ll be trying the region trick as soon as it appears in the developer beta (UK)

I doubt UK (NHS) will sign up for this in a hurry, but I personally would welcome it. Take up of AW4 could be more subdued in countries were this key feature is not implemented.

 

[bingeciren]

I’ll be trying the region trick as soon as it appears in the developer beta (UK)

What is the region trick? How does it work?

 

[johnyslats]

What is the region trick? How does it work?

Well, take it with a pinch of salt but it may only work for those with GPS only (same model globally) models. Someone in an Apple store suggested it may appear by changing regions

 

[kiranmk2]

I
I doubt UK (NHS) will sign up for this in a hurry, but I personally would welcome it. Take up of AW4 could be more subdued in countries were this key feature is not implemented.

Don't think it's anything to do with the NHS - Apple will be trying to get EU approval at which point it will have been approved throughout the EU.

 

[bingeciren]

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.

 

[skinned66]

Definitely a huge value increase for the AW with this. I might finally consider it.

 

[adamski23]

Does the watch automatically know which wrist the watch is on or do you have to select it before performing the reading? Electrode position is vital in a proper readout. I'm also wondering how it will handle artifacts (i.e., non-cardiac electrical activity)?

While I understand apple's reasoning behind this (I think its cool also), in my honest opinion, there are significant downsides to having too much insight into one's physical health.

 

[Elian_Gonzalez]

One wonders if doctors in the US are prepared for a potential deluge of readings from their patients trying out the ECG feature.

 

[BuddyTronic]

Wonderful news! Glad Canada is going to approve this non-invasive ECG device quickly! Lives can be saved! Additionally, I am certain that it will be allowed as a health expense tax deduction now - particularly for those with pre-existing health conditions. That's a huge perk. Perhaps the wise health minister will be giving tax discounts to Apple Watch owners? Prevention, and encouraging healthy lifestyles is where it's at for Public Healthcare!

 

[bingeciren]

in my honest opinion, there are significant downsides to having too much insight into one's physical health.

Perfect toy for hypochondriacs

 

[BuddyTronic]

One wonders if doctors in the US are prepared for a potential deluge of readings from their patients trying out the ECG feature.

Not an issue I don't think.
[doublepost=1537453736][/doublepost]

Perfect toy for hypochondriacs

Indeed! Instead of my fat cousin complaining and telling me all the time about his non-existent heart condition, it will be verified that all he needs to do is get active and cut down on cheeseburgers!

 

[BvizioN]

Don't think it's anything to do with the NHS - Apple will be trying to get EU approval at which point it will have been approved throughout the EU.

If so, they better hurry up and do it before March 19.

 

[kstotlani]

However, the ECG app for watchOS 5 won't be available until later this year.

I hope this is delivered at least by end of the year unlike AirPower.

 

[twistedpixel8]

Don't think it's anything to do with the NHS - Apple will be trying to get EU approval at which point it will have been approved throughout the EU.

Which had better happen before the end of March 2019 or it will be down to the useless UK government who will debate it for 20 years.

 

[nnoble]

Which had better happen before the end of March 2019 or it will be down to the useless UK government who will debate it for 20 years.

True! And at 67 my heart will have stopped responding before the 20 years is up )

 

[chiccociolla]

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!

 

[twistedpixel8]

True! And at 67 my heart will have stopped responding before the 20 years is up )

Glass of red wine every evening and some light cardio exercise (and a sprinkling of genetic luck) may well see you to 100