Apple Watch Series 4's ECG Feature Will Work Internationally When Set to U.S. Region

[MacRumors]

Apple revealed the Apple Watch Series 4 during an event in September, highlighting a new electrocardiogram (ECG) app that will be coming to users in the United States through a watchOS software update later in the year. Regulatory clearance is required for the ECG feature, and because of this it will be limited to the U.S. at launch, although the company is working on approval for other countries.

In a new post by 9to5Mac today, code found within iOS related to the ECG feature suggests that the ECG limitation is based on software, not hardware. This means that gaining access to the ECG app in a non-U.S. territory will be as simple as changing the region of the Apple Watch Series 4 and connected iPhone to the United States.

iPhone region can be changed by going to the Settings app > General > Language and Region, and then selecting the Region of your choice. Those who switch regions should note that the time, date, currency formats, and more will be affected by the change.

The ECG app on Apple Watch Series 4 works by placing a finger on the Digital Crown while wearing the watch. The electrodes in the Apple Watch detect the electrical impulses from your heartbeat and route the data to the S4, where it is converted into a signal for Apple's algorithms. This results in a heart rhythm classification that can vary between a normal rhythm to an atrial fibrillation. All of your ECG results are stored in the Health app in PDF format and can be easily shared with your doctor.

While the FDA has granted de novo clearance for the ECG feature, that's not the same as FDA approval and the agency 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. The Series 4 is the first ECG product being offered over the counter directly to consumers.

Article Link: Apple Watch Series 4's ECG Feature Will Work Internationally When Set to U.S. Region

 

[kdagher]

FaceTime application is also software based and not hardware, yet it doesn't work for phones bought in countries where FaceTime is banned (even if US store or Location was selected).

The FaceTime App searches for the Model number from the approved list in Apple Servers or within the iOS itself and if it is not there it will simply not install nor show up in the APP store.

Therefore, i assume it will be the same thing for the ECG App, unless Apple makes an exception..

 

[tom.humphrey]

Should I be impressed with this? Either have it set to my country and have time/date/currency correct, or try to use the ECG (touted as one of the major features) and have basic functionality incorrect everywhere....

 

[tehStickMan]

Sweet can't wait for it to tell me my heart PSI while Siri shows me that I'm 12 feet away from my next left-turn.

 

[Putzytart]

Apparently ECG device approval normally takes years in the UK. As in like 4-5 years. I’m sure Apple will be fast tracking the process but good to know there is a stop gap measure for people who want a portable ECG

 

[Jetfire]

Apparently ECG device approval normally takes years in the UK. As in like 4-5 years. I’m sure Apple will be fast tracking the process but good to know there is a stop gap measure for people who want a portable ECG

I don’t know about that. Qardio has their’s (Qardiocore) approved for Europe but it’s still not approved by the FDA in the USA. I can buy it on Amazon UK

 

[H2SO4]

Sweet can't wait for it to tell me my heart PSI while Siri shows me that I'm 12 feet away from my next left-turn.

One thing I love in life is sarcasm, (no really). That I'm sure, has a beneficial effect on the heart.

 

[ejfontenot]

I am sure that Apple will not recommend this as functionality. This could be seen as promoting a device that is not cleared for use in that geography.

I know it is semantic, but Class II devices are typically "cleared" for use by the FDA. Approvals are related to devices that require a Pre Market Approval (PMA) and have a different process for review by FDA.

 

[CmdrLaForge]

I assumed they connect it to the Apple Store ID. So lets see. If true I might even get one. I don't think this is a feature I would use all the time.

 

[Rogifan]

Should I be impressed with this? Either have it set to my country and have time/date/currency correct, or try to use the ECG (touted as one of the major features) and have basic functionality incorrect everywhere....

Isn’t the reason it’s not available everywhere at launch due to regulatory requirements? Which I would imagine are different across countries. It’s only natural that Apple would start with the US.

 

[strategicthinke]

FaceTime application is also software based and not hardware, yet it doesn't work for phones for bought in countries where FaceTime is banned (even if US store was selected).

The FaceTime App searches for the Model number from the approved list in Apple Servers or within the iOS itself and if it is not there it will simply not install nor show up in the APP store.

Therefore, i assume it will be the same thing for the ECG App, unless Apple makes an exception..

Apple News can be turned on by selecting a different region. And Apple has no reason to take away the ECG app from the watch, especially as they hope it will be approved in other places as well. So, I wouldn’t worry about it.

 

[tromboneaholic]

Apple News can be turned on by selecting a different region. And Apple has no reason to take away the ECG app from the watch, especially as they hope it will be approved in other places as well. So, I wouldn’t worry about it.

Agreed. There is difference between being "banned" and "awaiting approval."

 

[Defender2010]

Who in their right mind would ever think it was hardware based? Clearly Apple have not made two different watches - one type for US consumers and another for the rest of the world.

 

[zorinlynx]

I don't get why they can't just enable it world-wide, and just say "This is not a medical device. This feature is for entertainment only." in the areas where it doesn't have approval.

 

[srshaw]

Who in their right mind would ever think it was hardware based? Clearly Apple have not made two different watches - one type for US consumers and another for the rest of the world.

Actually that's what I thought they did given that the cellular bands are different across different regions. The model numbers are certainly different between us/uk.

 

[Mike MA]

It's hard to be hypochondriac these days.

 

[centauratlas]

Should I be impressed with this? Either have it set to my country and have time/date/currency correct, or try to use the ECG (touted as one of the major features) and have basic functionality incorrect everywhere....

You should be talking to the control-freaks who are running your government then about why are not allowing you the freedom to use a device they way you want to. So, no, you shouldn't be impressed with it, as long as you are looking at the correct people to blame for the lack of functionality in your country.

It definitely sucks for people who buy the watch and then have their government block them from using all the features.

 

[zuiram]

Has anyone actually tested switching region, doing an ECG and switching back to their original region? If that works, it would probably be a worthwhile update.

 

[tromboneaholic]

Has anyone actually tested switching region, doing an ECG and switching back to their original region? If that works, it would probably be a worthwhile update.

No one outside of Apple has been able to test it at all.

 

[simply258]

Who in their right mind would ever think it was hardware based? Clearly Apple have not made two different watches - one type for US consumers and another for the rest of the world.

Well they did that for the dual sim Chinese phones, so why not? Maybe someone should try to use a Dual sim tray in another regions iPhone and see if it works.

 

[Jarman74]

I don't get why they can't just enable it world-wide, and just say "This is not a medical device. This feature is for entertainment only." in the areas where it doesn't have approval.

Not sure it would be a smart move when you have already spent millions in R&D to create a medical device. I mean, the last thing Apple may want is temporarily selling it as a toy and then awkwardly backtrack after it finally gets approval.

It would be much safer to enable the feature with a warning every time you use it - e.g. it is an approved medical device in the US awaiting for approval wherever it is sold. But I guess this would not be a great user experience according to Apple, so they just decided to delay the feature altogether.

 

[KPOM]

Should I be impressed with this? Either have it set to my country and have time/date/currency correct, or try to use the ECG (touted as one of the major features) and have basic functionality incorrect everywhere....

Time and date will be correct (it will still detect you are in another time zone), though activating cellular may not work. And you can simply switch modes when you want to run the ECG app.
[doublepost=1540830397][/doublepost]

Actually that's what I thought they did given that the cellular bands are different across different regions. The model numbers are certainly different between us/uk.

Since modern chipsets support over 25 LTE bands the new iPhones work just about everywhere. China was different only because they ban eSIM.

 

[tromboneaholic]

Since modern chipsets support over 25 LTE bands the new iPhones work just about everywhere. China was different only because they ban eSIM.

However, there are different Apple Watch models supporting different bands for different regions. That said, it was fairly clear this was a software restriction.

 

[CmdrLaForge]

Maybe we hear some news about it tomorrow, even so I doubt that.

 

[Nmeyrick]

Should I be impressed with this? Either have it set to my country and have time/date/currency correct, or try to use the ECG (touted as one of the major features) and have basic functionality incorrect everywhere....

Actually changing the region seems to do much less than you would imagine; as far as I can recall it basically determines defaults for things like units, date display format etc - but crucially you csn still override these defaults to your preferred values.

When apple pay launched I tried setting my AW 0 region to usa and found I was able to use apple pay on it in London a couple of months before it launched in the uk. I was only able to link one of my wife's us credit cards since uk banks weren't supported, but other than that it worked great. As best I recall I was able to change pretty much all other settings to uk values so that the USA region didn't really bother me