Apple Watch ECG feature not arriving in Canada anytime soon
Are you in Canada and looking for the ECG feature of the Apple Watch? You may be in for a long wait.
Apple Watch Series 4's ECG app
In response to a query on Twitter asking if the approval process has commenced to allow the ECG function to work, government agency Health Canada advised it "has not received an application for the Apple Watch Series 4" at all.
The regulator's response also appears to lay the blame at the lack of progress at Apple's door, noting "The decision to submit a medical device license application rests with the manufacturer."
ECG monitoring is typically only performed by hardware provided to medical professionals and healthcare providers, and are typically prevented from being provided to the general public. For it to be available to use by consumers, the Apple Watch has to receive regulatory approval for the Apple Watch Series 4 on a country-by-country basis.
The feature is available in the United States after the U.S. Food and Drug Administration cleared it for sale, making the smartwatch the first consumer device to do so without requiring medical review. While not available at launch, the ECG app was enabled for users in the U.S. as part of the watchOS 5.1.2 update on Thursday.
Apple has already advised it intends to bring the function to other Apple Watch Series 4 users, but doing so involves passing regulatory muster in each market, a process that can take a considerable amount of time.
Shortly after its availability, the ECG function has already proved itself to be a life-saver, with cardiologists noticing an uptick in patients directly as a result of its availability.
Apple Watch Series 4's ECG app
In response to a query on Twitter asking if the approval process has commenced to allow the ECG function to work, government agency Health Canada advised it "has not received an application for the Apple Watch Series 4" at all.
The regulator's response also appears to lay the blame at the lack of progress at Apple's door, noting "The decision to submit a medical device license application rests with the manufacturer."
Hi Gary. To date, Health Canada has not received an application for the Apple Watch Series 4 with the EKG feature. The decision to submit a medical device licence application rests with the manufacturer.
-- GovCanHealth (@GovCanHealth)
ECG monitoring is typically only performed by hardware provided to medical professionals and healthcare providers, and are typically prevented from being provided to the general public. For it to be available to use by consumers, the Apple Watch has to receive regulatory approval for the Apple Watch Series 4 on a country-by-country basis.
The feature is available in the United States after the U.S. Food and Drug Administration cleared it for sale, making the smartwatch the first consumer device to do so without requiring medical review. While not available at launch, the ECG app was enabled for users in the U.S. as part of the watchOS 5.1.2 update on Thursday.
Apple has already advised it intends to bring the function to other Apple Watch Series 4 users, but doing so involves passing regulatory muster in each market, a process that can take a considerable amount of time.
Shortly after its availability, the ECG function has already proved itself to be a life-saver, with cardiologists noticing an uptick in patients directly as a result of its availability.
Comments
It’s frustrating as we often pay more for the same product to boot, but as long as we continue to buy their products anyway they have no real incentive to care.
Alivecore has the Kardia ECG that works very well and was approved by medical review. I imagine if one was truly concerned about their heart they would go with this device that is far more accurate, vastly less expensive, integrated with real-time medical review by doctors, or transmitted to you own. Even comes with a clip to fit to your smartphone. https://www.alivecor.com
They also support the iwatch.
The watch probably isn’t accurate enough to pass medical review - thus the legal tie-up in other countries, not so much for the feature, but the ‘marketing’ aspect of it being a medical device. Neither are as good as an 8 point lead at a hospital - but can indicate something isn’t right with rhythm.
Class I and II get FDA clearance. Class III gets approval. Both clearance and approval are synonyms in English, but in reference to the FDA and their device classes they have very specific meanings. They are all reviewed for their medical claims. There is no perfunctory rubber-stamp because Apple paid someone off.
AliveCor's KardiaBand looks to be a Class II device, too.
Apple also has to actually submit the devices for regulatory approval to each of the countries' appropriate boards. So, if Apple were concentrating on the FDA, they might not have applied to the Therepeutic Goods Administration (for example) until later. Getting FDA approval helps with getting it approved in other markets, but it isn't automatic, and nor should it be, just as getting something approved here wouldn't be an automatic pass to the FDA. Otherwise everyone would be submitting their products to the one place where it was seen as easier to get things approved for whatever reason.
Haven't heard if it's approved here, should probably check. Hopefully it will be by the time I upgrade my AppleWatch.
Yes, regulatory approval etc does take time and laws vary country to country. But there are frequent examples where Apple has been pushing right up to the last minutes to get a new feature ready for approval at launch in the USA and then taking years to make it to other countries.
Lets take Apple Pay Cash as an example, apart from the USA where is it? Apple Pay is heavily supported by UK banks, I don’t think a single major bank does not support it.
But despite the UK being a key market with almost 50% iOS market share there is still no Apple Pay Cash support.
Sure, Apple is certainly working on it. But not with any urgency etc.
Apple is a company that requires a fair bit of emotional investment to be fully immersed in the ecosystem. And it is hard more and more often to justify. If services are so important for the future, then services require a full commitment, regular updates, and rapid roll out.
Maybe the executives are too busy showing how full of good they are to to be bothered? They get paid the mega bucks anyway,
Glacial roll outs for hardware are nothing new either : *cough* Mac mini; MBA; and there isn’t a current tech iMac either, at Christmas. Apple’s flagship computer is out of date but priced like it is new.
I think Apple Pay Cash uses the Discover Network. So that may not be something Apple is allowed to do/use in the UK. Apple may need Visa or Mastercard to get that feature, and they may want to charge a fee to use it where it's FREE to use here and so that is one of the hold ups. Things are not as simple as many people would think they are.
The UK or the EU could always create some new Phone OS and make phones for it and release everything for those phones FIRST for the EU and UK. That would be how it was. You would be focused on your own market first as everyone would expect. I'm all for Apple getting all these features out there as fast as possible, but they have to follow the laws of every country. It really is a global mess that is not going to change any time soon. We still have a growing list of Banks just getting Apple Pay support here.
There are other options besides Apple Pay Cash that also work with Android.
It's amazing that some people actually believe Apple is obstinately refusing to add Apple Pay Cash in the UK when there are only positive reasons with zero hurdles or drawbacks. Not knowing a reason doesn't mean a reason doesn't exist.
- I don't see why the Alivecore portable finger-based ECG would be any more accurate. What is your evidence?
- its $100, not "vastly less expensive"
- it also costs $10/mo for unlimited cloud storage of results
- but it's also a single-purpose device, and requires carrying around, making it less useful than an ECG already in your daily watch
- yes, the Apple Watch ECG is accurate enough to "pass medical review"
- you can transmit your Apple Watch ECG to your doctor
- there is no such thing as an iwatch.
...you could at least try, you know.