Changing Your Apple Watch or iPhone's Region Won't Enable ECG App Outside of United States

[lartola]

I am pretty sure they weren't THAT specific; but since the VAST majority of customers purchase a product IN the country they LIVE, I would imagine they simply didn't think to instruct personnel to make SURE they followed that "rule".

Apple has never instructed personnel to verify the status of anyone who enters one of their store and buys a product there, nor do they need to as most of those people probably live in the country anyway. Online orders are a different animal, since they do require a shipping address in the country website where you're ordering from. Nonetheless, I think they overdid it this time with the restriction. They are trying to cover the sun with one finger.

 

[MacsRuleOthersDrool]

Apple has never instructed personnel to verify the status of anyone who enters one of their store and buys a product there, nor do they need to as most of those people probably live in the country anyway. Online orders are a different animal, since they do require a shipping address in the country website where you're ordering from. Nonetheless, I think they overdid it this time with the restriction. They are trying to cover the sun with one finger.

I think they just played the "Better safe than sorry" with a zillion different policies regarding "medical device claims" across the zillion countries that could EASILY simply place an EMBARGO on ALL Apple Watches.

Remember, they really don't have much experience in navigating these kinds of "Agency Approvals" in all those countries. I think some of the Posters that opined that perhaps Apple is waiting for some "history" in the U.S. to accumulate to help bolster their Medical Device Applications in those other Countries.

 

[Cmd-Z]

Remember, they really don't have much experience in navigating these kinds of "Medical Agency Approvals" in all those countries.

Fixed that for you, as Apple is quite familiar with regulatory/compliance issues for safety, environment, etc.

 

[Azathoth123]

Why not? Bloody rules and regs

He answered his own question!

This is really interesting (don't get me wrong as I'm pleased its working for you), from a legal standpoint surely Apple is in breach of UK regulations because technically you are using a health device in the UK that has no regulatory approval in UK?

I doubt that the authorities in any country would be willing to incur the risk of turning off a foreign visitor’s medical device, even if they could. They’d basically have to hack your phone and watch which would normally be illegal. Say it’s the iOS installer that checks the watch serial number then installs the ECG app. Once the app is installed, there’s no ‘switch’ to turn the app off, it’s either there or it isn’t.

I believe a previous post was correct about it, you can bring it in but you can’t sell it, at least sell commercially. No doubt that there will be robust black/grey market.
[doublepost=1544229150][/doublepost]

And if you cannot be transparent with your customers who are largely not experts in the devices, and your own staff in your stores are lying to said customers...well, i suspect you like feeling superior to all those dilweeds huh.

First off, I apologize for the off-putting remark, it was maybe a poor choice of humor.

Do you have any citable example of Apple Store staff lying to customers? As opposed to say, a misunderstanding on either party’s part? Now that would be post-worthy.

 

[lartola]

I did exactly that. I bought my series 4 in the USA and now I just need to find a way to somehow use ECG here in Germany. My settings are anyhow all set to USA, even I am living in Germany.

I tried to use my "USA VPN Wireless" which I do use to stream "HULU" on my AppleTV, but looks like that is still not enough. I guess I have to temporarily switch to my "US AppleID" on the iPhone and re-pair my watch with the US AppleID. I guess that is the only way.

I do really wonder if even a US citizen can only use ECG when actually being in USA territory?
So can you as US citizen perform an ECG during your vacations in Europe or anywhere outside of US ????

They can use it outside the US too, the feature doesn’t turn off based on GPS location. Once it’s enabled, it is there for good.

 

[Solver]

That doesn’t necessarily mean they haven’t taken action. The last thing they want is for a submission to be rejected. Perhaps the FDA data plus “real world” results will help with submissions in other countries.

My first app submitted to Apple was rejected because it would save too many temporary files in a user’ backup. I made changes on the app and it got rejected again for some different reason. I made more changes and it was finally accepted. This took just over two months. That’s two years government time.

 

[Azathoth123]

They can use it outside the US too, the feature doesn’t turn off based on GPS location. Once it’s enabled, it is there for good.

I suspect that this is correct. I think that the iOS installer checks, and if the installer is happy you get the app. But hey, I’ve been wrong before. I can through limited experience, say that whatever mechanism they use has to be pretty simple. Don’t overthink it.

I also don’t believe that they can, or would, give you functionality, then take it away without your approval based on location. Boy what a sueball waiting to happen lol.

 

[scrapesleon]

Disappointed but not surprised

 

[drhatta]

Apple today released watchOS 5.1.2, which enables the ECG app on Apple Watch Series 4 models. However, as Apple made clear, the ECG app is currently only available in the United States and its territories of Puerto Rico, Guam, and the U.S. Virgin Islands, preventing it from being used internationally at this time.

Many software features on Apple devices are initially limited to the United States, but international users have often been able to simply change their iPhone or Apple Watch region to the United States to gain access.

That's not the case with the the ECG app on the Apple Watch Series 4, though, as it only functions on models purchased in the United States. Those who live in and bought an Apple Watch in Canada, the UK, or elsewhere abroad can't use the region-switching trick to enable the ECG app -- it doesn't work.

Note that the ECG app requires an Apple Watch Series 4 with watchOS 5.1.2, paired with an iPhone 5s or newer with iOS 12.1.1.

Both the ECG app and irregular heart rhythm notifications are regulated features on the Apple Watch. Both features have been granted De Novo classification by the FDA for users 22 years and older in the United States. Apple says people already diagnosed with atrial fibrillation should not use the app.

It's unclear when the ECG app will expand to additional countries, but Apple Watch Series 4 models sold internationally do have the necessary electrical heart sensor. Apple is likely in the process of gaining clearance for the ECG app in other countries, but it has yet to comment on wider availability.

Article Link: Changing Your Apple Watch or iPhone's Region Won't Enable ECG App Outside of United States

[doublepost=1544235419][/doublepost]It wasn’t made clear during the presentation or any of Apple’s ad that this feature is not available outside US made Watch 4. Just got mine yesterday and very disappointed now

 

[Azathoth123]

[doublepost=1544235419][/doublepost]
It wasn’t made clear during the presentation or any of Apple’s ad that this feature is not available outside US made Watch 4. Just got mine yesterday and very disappointed now

I don’t understand this comment with respect to the cited article above.

It appears that Apple very clearly stated that it was a US only feature.

 

[lartola]

I don’t understand this comment with respect to the cited article above.

It appears that Apple very clearly stated that it was a US only feature.

I do. Apple stated ECG would be available to US users only, but not that it would be available on US hardware only, which is NOT the same. Restricting ECG based on region settings like Apple did in the past with other features such as apple pay, TV or News was more than enough to achieve the goal of ECG being available to US users only while they wait for approval in other countries. No matter what Apple or anyone else says to justify the nasty move, there was no absolute need for Apple to restrict the availability of ECG based on where the hardware was purchased and to annoy so many customers outside the US by doing that. None. They’re just being a.....es.
[doublepost=1544239280][/doublepost]

I suspect that this is correct. I think that the iOS installer checks, and if the installer is happy you get the app. But hey, I’ve been wrong before. I can through limited experience, say that whatever mechanism they use has to be pretty simple. Don’t overthink it.

I also don’t believe that they can, or would, give you functionality, then take it away without your approval based on location. Boy what a sueball waiting to happen lol.

Well in this case I commented based on evidence. People have reported in many forums including this one that they could use ECG while physically located outside the US just as long as they bought their apple watch there. Not even the iphone as some tech websites say, just the watch. And even with the region set to countries other than the US.

 

[drhatta]

I do. Apple stated ECG would be available to US users only, but not that it would be available on US hardware only, which is NOT the same. Restricting ECG based on region settings like Apple did in the past with other features such as apple pay, TV or News was more than enough to achieve the goal of ECG being available to US users only while they wait for approval in other countries. No matter what Apple or anyone else says to justify the nasty move, there was no absolute need for Apple to restrict the availability of ECG based on where the hardware was purchased and to annoy so many customers outside the US by doing that. None. They’re just being a.....es.
[doublepost=1544239280][/doublepost]
Well in this case I commented based on evidence. People have reported in many forums including this one that they could use ECG while physically located outside the US just as long as they bought their apple watch there. Not even the iphone as some tech websites say, just the watch. And even with the region set to countries other than the US.

Yes lartola. I couldn’t have said it well like you had . Thank you

 

[KPOM]

I do. Apple stated ECG would be available to US users only, but not that it would be available on US hardware only, which is NOT the same. Restricting ECG based on region settings like Apple did in the past with other features such as apple pay, TV or News was more than enough to achieve the goal of ECG being available to US users only while they wait for approval in other countries. No matter what Apple or anyone else says to justify the nasty move, there was no absolute need for Apple to restrict the availability of ECG app based on where the hardware was purchased and to annoy so many customers outside the US by doing that. None. They’re just being a.....es.
[doublepost=1544239280][/doublepost]
Well in this case I commented based on evidence. People have reported in many forums including this one that they could use ECG while physically located outside the US just as long as they bought their apple watch there. Not even the iphone as some tech websites say, just the watch. And even with the region set to countries other than the US.

I believe they said it would be available “in the US” first. Apple geofences other features based on serial number and place of purchase (e.g no eSIM in China, required apps in India, no disabling of camera shutter in Japan). Perhaps their lawyers advised them to do so with this feature to avoid import bans. Customs agents are unlikely to target individuals returning from personal trips to the US with small quantities for personal use, but they may reject bulk shipments if users can overcome the restriction can by updating internal settings.

Unlike News, Apple Pay, etc. active ECG changes the regulatory classification of a device. It is no longer simply a mobile communications and computing device, but is now a “medical device” subject to a whole different set of regulatory restrictions. Technically, individuals may be violating local laws by bringing back Apple Watches purchased in the US, but that’s not Apple’s problem, and again, customs agents likely won’t harass individuals bringing back small quantities not intended for resale.

 

[lartola]

I believe they said it would be available “in the US” first. Apple geofences other features based on serial number and place of purchase (e.g no eSIM in China, required apps in India, no disabling of camera shutter in Japan). Perhaps their lawyers advised them to do so with this feature to avoid import bans. Customs agents are unlikely to target individuals returning from personal trips to the US with small quantities for personal use, but they may reject bulk shipments if users can overcome the restriction can by updating internal settings.

Unlike News, Apple Pay, etc. active ECG changes the regulatory classification of a device. It is no longer simply a mobile communications and computing device, but is now a “medical device” subject to a whole different set of regulatory restrictions. Technically, individuals may be violating local laws by bringing back Apple Watches purchased in the US, but that’s not Apple’s problem, and again, customs agents likely won’t harass individual bring back small quantities not intended for resale.

Historically, when Apple says a new feature will be available "in the US first" or "in the US only" they don't mean literally on US soil. The wording is poorly chosen (maybe purposely), but Apple actually just means that the new feature will be available first or only to US based customers whether or not they are physically located in the US when it comes out. Just as long as the customers are US based. That's how Apple has always handled the regional availability of all new features and services involving support or approval from a third party: based upon the region selected, not based upon the actual physical location of the device or where the hardware was purchased (i.e., using the region setting, not the GPS or Model/serial number). But your argument as to why they didn't do that this time kinda makes sense.

 

[Ennox]

If a jailbreak is able to get me this feature, I am willing to take the risk.

 

[kklaus]

Well, this kind of stuff making me crazy. Been with Apple for a long time and with the price increases has been harder and harder to keep up. Last year I went with the 8+ instead of the 10 to save money and this year the first time I skipped getting a new phone. This is one of the reasons I upgraded my Apple Watch 0 to the 4 this year - I live in Germany, though, and wasn't expecting to be cut out when the ECG was made available. Little frustrations like this add up (I know this one thing isn't necessarily huge, but Siri frustrates me CONSTANTLY) and the soaring prices have me looking hard at other products lately. When the time comes to upgrade this phone I will have some tough decisions to make.

 

[indent]

honestly I knew it was not ready yet did not know it was not coming to anyone outside of US to a mate told me and came to find this thread.
Was going to buy one next week held out buying a watch as poor battery life compared to other wearable I have now.. Although I am getting older now thought ECG feature would be good. Now sorry your lost a sale Apple.
The skyrocketing prices is why I keeping old ipads, iphones and still rocking a modded 2011 Mac Mini The price rose $200 in OZ for features never to come.. Although now you do a whole keynote about how the watch can do everything and now its US only.

If you look on the Apple Australia page nice picture of the ECG shown under the below
Track all your health data in one convenient place.

https://www.apple.com/au/apple-watch-series-4/health/
[doublepost=1544270027][/doublepost]Interesting Canada, UK, Germany Apple have a diff pic under the same section which does not show ECG function
https://www.apple.com/ca/apple-watch-series-4/health/
https://www.apple.com/uk/apple-watch-series-4/health/
https://www.apple.com/de/apple-watch-series-4/health/
Where Australia and New Zealand shows ECG pic so you would expect the device to do it.
https://www.apple.com/au/apple-watch-series-4/health/
https://www.apple.com/nz/apple-watch-series-4/health/

I will also add under feature nothing mentioned ECG in OZ , where other countries show its US only.
So wonder if a Australian website update will come so they clear up the mess

 

[TwoBytes]

For people who don't have ECG take your heart rate on the watch and rest your finger on the crown. Then go into the health app on the phone and look under heart rate. It will show it's read an ECG. It's not the full ECG the way we want. I wonder if developers will get access to the API to create 3rd party apps.

 

[ralphyman]

I live in Switzerland, needless to say that ECG doesn’t work..
Now when I look at the Apple.ch page, there is a big screenshot of the ECG app..
Wouldn’t that qualify as false advertising?!?

 

[tromboneaholic]

Historically, when Apple says a new feature will be available "in the US first" or "in the US only" they don't mean literally on US soil.

The law governs the soil on which they can sell over the counter medical devices, not the nationality or Apple ID of who can buy it.
[doublepost=1544273107][/doublepost]

Now when I look at the Apple.ch page, there is a big screenshot of the ECG app..

That's not a screenshot of the ECG app. That's the Health app.

The text says your information will be collected in one place on your iPhone's Health app, which is what the photo shows.

 

[sero]

You guys in the EU can thank your heavy handed regulators for not having the ECG feature yet, and for it likely taking YEARS before it will even be approved.

What? You have no idea what you're talking about. EU device approval is way easier than FDA approval. They obviously just didn't bother. When they do, it should go pretty quickly.

 

[ralphyman]

The law governs the soil on which they can sell over the counter medical devices, not the nationality or Apple ID of who can buy it.
[doublepost=1544273107][/doublepost]
That's not a screenshot of the ECG app. That's the Health app.

The text says your information will be collected in one place on your iPhone's Health app, which is what the photo shows.

Ok, I see what you mean.. still, this is directly from within the Apple Watch 4 page so misleading
[doublepost=1544275086][/doublepost]

What? You have no idea what you're talking about. EU device approval is way easier than FDA approval. They obviously just didn't bother. When they do, it should go pretty quickly.

Like they didn’t even bother to file an application in Canada, according to health Canada... sloppy

https://www.iphoneincanada.ca/watch/health-canada-apple-watch-ekg/

 

[tromboneaholic]

Ok, I see what you mean.. still, this is directly from within the Apple Watch 4 page so misleading

A post above shows that it is a different screenshot of the health app in some countries, so it appears it could be an oversight.

If you have seen the US apple.com page, you'll see there is a lot of marketing of the ECG app and even animations of it.

Just curious, if you open the Health app on iOS 12.1.1, do you have ECG as an option where you can select another source?

 

[ralphyman]

Nope, I can add ECG to favorites, but cannot select a source..
I guess the source would get added if I buy another ECG montor and add it’s app, then set it up as a source..

 

[KPOM]

What? You have no idea what you're talking about. EU device approval is way easier than FDA approval. They obviously just didn't bother. When they do, it should go pretty quickly.

It isn’t that they “didn’t bother.” They haven’t completed it yet. They aren’t familiar with medical device regulation in all the countries where they sell the Apple Watch.
[doublepost=1544281498][/doublepost]

honestly I knew it was not ready yet did not know it was not coming to anyone outside of US to a mate told me and came to find this thread.
Was going to buy one next week held out buying a watch as poor battery life compared to other wearable I have now.. Although I am getting older now thought ECG feature would be good. Now sorry your lost a sale Apple.
The skyrocketing prices is why I keeping old ipads, iphones and still rocking a modded 2011 Mac Mini The price rose $200 in OZ for features never to come.. Although now you do a whole keynote about how the watch can do everything and now its US only.

If you look on the Apple Australia page nice picture of the ECG shown under the below
Track all your health data in one convenient place.

https://www.apple.com/au/apple-watch-series-4/health/
[doublepost=1544270027][/doublepost]Interesting Canada, UK, Germany Apple have a diff pic under the same section which does not show ECG function
https://www.apple.com/ca/apple-watch-series-4/health/
https://www.apple.com/uk/apple-watch-series-4/health/
https://www.apple.com/de/apple-watch-series-4/health/
Where Australia and New Zealand shows ECG pic so you would expect the device to do it.
https://www.apple.com/au/apple-watch-series-4/health/
https://www.apple.com/nz/apple-watch-series-4/health/

View attachment 809373
View attachment 809374

I will also add under feature nothing mentioned ECG in OZ , where other countries show its US only.
So wonder if a Australian website update will come so they clear up the mess

It is coming to more countries next year. Apple was upfront in its presentation in September that the US would get it first, just like many other features have started here and spread around the world gradually.