Apple Watch Irregular Heart Rhythm Notifications Approved in Australia as ECG Approval Edges Closer

[MacRumors]

The Apple Watch's irregular heart rhythm notifications have been approved in Australia, indicating that approval for the ECG feature may be soon to follow after years of waiting, according to EFTM.

Documents seen by EFTM from Australia's Therapeutic Goods Administration show that the Apple Watch's irregular rhythm notifications feature has now been approved and added to the Australian Register of Therapeutic Goods. While this does not mean that the ECG function has been medically certified for use in Australia, it concretely proves that Apple has begun submitting its devices and software to Australian regulatory authorities for approval.

The irregular rhythm notification feature intermittently checks heart rhythm in the background and sends a notification if an irregular heart rhythm is identified that could potentially be atrial fibrillation (AFib). Upon receiving a notification, users in territories where the feature is approved can immediately launch the ECG app and perform a more comprehensive test in just 30 seconds by placing their finger on the Digital Crown to generate an ECG waveform. The irregular rhythm notifications and ECG feature therefore work hand in hand, so it seems unlikely that one feature will be approved long before the other.

Atrial fibrillation is a health condition that often goes undiagnosed, so ECG app and heart rhythm alerts on Apple Watch are highly useful for detecting early signs of disease. ECG readings also normally require a full ECG machine and a visit to the doctor, which is far less convenient than a reading taken with the Apple Watch.

Apple routinely has to gain approval from government health agencies before making the ‌Apple Watch‌'s ECG feature available in different countries. Apple won U.S. FDA clearance to promote and launch the function when the ‌Apple Watch‌ Series 4 was released in 2018. Over two years later, the feature is still not available in Australia.

Last year, the Withings ScanWatch, which similarly features the ability to take an ECG, was approved in Australia, so it is not clear why it is taking Apple so long to apply or gain approval. Regardless, the irregular rhythm notifications approval is the strongest indication yet that the ECG feature is finally edging toward regulatory assent in Australia.

Article Link: Apple Watch Irregular Heart Rhythm Notifications Approved in Australia as ECG Approval Edges Closer

 

[-BigMac-]

HELL YEH! About time. Now for ECG

 

[Biglethal69]

I wouldn’t get too excited and I’m not holding my breath I still think it’ll be weeks or months away before this is past knowing the TGA and how long It’s taken apple To even get to this point I think I watch seven I’ll be out before we even get it hope I’m wrong. Apple I’d like a credit for my iPhone Apple Watch for five and six As you’ve taken so long to get this implemented I can really see your self drive car getting off the ground so quickly I predict 2050 before they ever get a car off the ground one that doesn’t crash anyway because it’s the software in the car is as good as the software on their phones and computers then I wouldn’t be buying one.

 

[bobob]

The hold up is on the Australian end, not Apple's.

 

[mw360]

The hold up is on the Australian end, not Apple's.

When did Apple submit it for approval?

 

[-BigMac-]

The hold up is on the Australian end, not Apple's.

"It concretely proves that Apple has begun submitting its devices and software to Australian regulatory authorities for approval." Only like 4 years late

 

[Killbill2]

Yay! So just maybe Apple wasn’t ignoring Australia, dropping the ball… now we’ll just the whinging about how Apple charges soooo much more for the watch... (under $40 more actually)
Buying my parents watches now...

 

[richard779]

Apple only submit their paperwork yesterday. So yes Apple is the hold up.

From Watch S4 to now.

This is a bloody joke.

I can’t believe that it took Apple so long before they pull that finger out finally to do it. It is a shame if you ask me. Why? Because with their resources they could have paid for study in australia to show it does what it ask for.

but no; they found it was too hard to apply via TGA, so instead of trying to work with TGA and get this approve they waited for the law to chang.

shame on you. Now let’s see how if we need to wait until another year before it get was available to us.

 

[bobmans]

When did Apple submit it for approval?

Why would they bother submitting if it would get denied? That’s like applying for a CEO position when you’re a 16-year old highschooler.

TGA delayed their changes that would allow ECG on a smartwatch to get approved from July 2020 to February 25 2021. So the Apple watch ECG feature literally can’t get approved before that date.

Link so you can read the changes: https://www.tga.gov.au/medical-devices-reforms-medical-device-software-regulation

Apple is probably one of the companies that was lobbying for these changes. No need to blame TGA’s problems and delays on Apple.

 

[actcyclist]

I wouldn’t be surprised if the Apple Watch is never approved as an ECG in Australia. The reports of false positives and concern it would cause a rise in unnecessary doctor visits and tests would be enough to stop it.

 

[JoshBoy]

Only yesterday was I looking online to see if there was any new work around. Hopefully next update will include this.

 

[Wanted797]

When did Apple submit it for approval?

Probably before the device was released. No company wants to tell some of their consumers in other countries “sorry you don’t get this feature”

 

[Cleartz]

Finally, a step closer.

 

[wbeasley]

I wouldn’t be surprised if the Apple Watch is never approved as an ECG in Australia. The reports of false positives and concern it would cause a rise in unnecessary doctor visits and tests would be enough to stop it.

better a false positive than say dying.

people go to the doctors and have tests done all the time to eliminate suspected problems.

never look at any of the exercise/health functions on your watch? no sleep pattern stats?

it's all data.
use it or dont.
but if the sensors are there and being used to save lives overseas then why can't we have the same functions here?

 

[whatgift]

Doesn’t the irregular rhythm notifications use the existing heart rate feature, and has nothing to do with the ECG functionality? I’ll admit I’m not an expert on this, but to my understanding the ECG functionality does not run constantly, it requires the user to put their finger on the Digital Crown. This means that the irregular heart rhythm notification is using the background heart rate functionality.

As bobmans has stated above, the regulations need to change before Apple watches implementation of ECG can be approved for use in Australia, and there was no point in Apple submitting for approval with the existing regulations.

Still amused by some thinking that Apple is (for whatever reason) holding the ECG feature back in one of its key markets 😂😂😂.

 

[Davidglenn]

Why would they bother submitting if it would get denied? That’s like applying for a CEO position when you’re a 16-year old highschooler.

Well Withings has their watch approved in November so it seems Apple could have applied earlier.

While other smartwatches can monitor and record your heart rate, only the Withings ScanWatch has been approved by the Australian Government's Therapeutic Goods Administration as a medical device. It's beaten Apple, Fitbit, Garmin and all the other players that offer similar wearables with ECG hardware available on board but unfortunately aren't approved for use Down Under.

Withings beats Apple Watch with first ECG smartwatch in Australia

Clinically-approved ECG functionality could literally be a life saver

www.techradar.com

Seems Apple waited till another company was approved.

 

[whatgift]

Well Withings has their watch approved in November so it seems Apple could have applied earlier.

My understanding is the Withings device measures ECG differently than the AW, and is within current TGA regulations.

it makes zero sense for Apple to hold off getting TGA approval.

 

[bobmans]

My understanding is the Withings device measures ECG differently than the AW, and is within current TGA regulations.

it makes zero sense for Apple to hold off getting TGA approval.

iirc it's related to being able to install 3rd party software (apps) on the "device", which makes it fall out of the current scope (that's getting changed on Feb 25) compared to the Withins watch where you're not able to modify the software.

 

[actcyclist]

better a false positive than say dying.

people go to the doctors and have tests done all the time to eliminate suspected problems.

never look at any of the exercise/health functions on your watch? no sleep pattern stats?

it's all data.
use it or dont.
but if the sensors are there and being used to save lives overseas then why can't we have the same functions here?

Actually, false positives use up resources in a system with limited resources. If you waste it somewhere, you reduce health elsewhere.

The cases of lives been saved due to ECG seems to be one off cases where people haven’t had standard tests that we in Australia can get for free.

also, what the government really wants is people to get a comprehensive test at 45, 50 etc and if people put that off because their watch says they’re healthy, thats a problem.

 

[Stephen.R]

I predict 2050 before they ever get a car off the ground

I dunno man, 30 years for a hover car seems pretty good to me.

 

[nightflight82]

OMG IS THIS FINALLY ON???

 

[alvindarkness]

For Aussies that have a jailbroken phone - just install "ECG Enabler". Working great here.

 

[EliasVaughn]

For Aussies that have a jailbroken phone - just install "ECG Enabler". Working great here.

Done the same here for years, works perfectly. The enabler modifies a single plist, then everything works as though you are in an approved country (the heart/ecg section of the health app, installing the ECG app on the watch etc). The beautiful thing is, once its done, you can even remove the enabler, and unjailbreak the phone and its persistent.

Of course it would be more ideal if ECG is just approved to work in Oz soon.

 

[Boeingfan]

Why would they bother submitting if it would get denied? That’s like applying for a CEO position when you’re a 16-year old highschooler.

TGA delayed their changes that would allow ECG on a smartwatch to get approved from July 2020 to February 25 2021. So the Apple watch ECG feature literally can’t get approved before that date.

Link so you can read the changes: https://www.tga.gov.au/medical-devices-reforms-medical-device-software-regulation

Apple is probably one of the companies that was lobbying for these changes. No need to blame TGA’s problems and delays on Apple.

Thank you for the link. I, like many others, have been looking forward to this feature, and by you providing the link I was able to read some factual information about what's happening from the TGA end. Cheers.

 

[bobob]

Why would they bother submitting if it would get denied? That’s like applying for a CEO position when you’re a 16-year old highschooler.

TGA delayed their changes that would allow ECG on a smartwatch to get approved from July 2020 to February 25 2021. So the Apple watch ECG feature literally can’t get approved before that date.

Link so you can read the changes: https://www.tga.gov.au/medical-devices-reforms-medical-device-software-regulation

Apple is probably one of the companies that was lobbying for these changes. No need to blame TGA’s problems and delays on Apple.

The people who think that Australian regulatory bodies are just waiting with open arms for Apple to finally get their act together and submit an application, must believe that Apple hates money.