Apple Confirms ECG Functionality is Coming to Canada ‘as quickly as Possible’

Apple today told The Canadian Press that it is aiming to bring ECG functionality to Apple Watch Series 4 devices in Canada "as quickly as possible."

The news comes after Health Canada this month approved the ECG app and irregular heart rhythm notifications on the Apple Watch Series 4, clearing the way for the features to be released in the country.


Health Canada classified the Apple Watch Series 4 as a Class II medical device, which places it in the "low-to-medium risk" category alongside other products like contact lenses.

Apple launched the ECG app in the United States in December as part of watchOS 5.1.2. It expanded to 19 European countries and Hong Kong in March 2019, and five additional European countries last week.

The ECG app is designed to allow Apple Watch Series 4 readers to place a finger on the Digital Crown to get a single-lead ECG reading, which can detect atrial fibrillation, a condition that can be indicative of major health problems. Irregular heart rhythm notifications are a separate feature, meant to let users know if an unusual heart rhythm is detected so medical attention can be sought.


Apple did not provide specific timing on when we can expect ECG and irregular heart rate notifications to be available in Canada, but it could perhaps come in the watchOS 5.3 update, which is being beta tested right now, or it could be incorporated into watchOS 6, which will be announced at the Worldwide Developers Conference on June 3.

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This article, "Apple Confirms ECG Functionality is Coming to Canada 'as quickly as Possible'" first appeared on MacRumors.com

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Health Canada Gives Green Light to ECG App on Apple Watch

Health Canada has cleared the ECG app and irregular heart rhythm notifications on the Apple Watch Series 4, suggesting that both features will make their much-anticipated debut in Canada in the near future.


As spotted by the blog iPhone in Canada and confirmed by MacRumors, Health Canada issued active licenses for both features on May 16. The regulatory agency classifies the Apple Watch Series 4 as a Class II medical device, placing it in a "low-to-medium risk" category alongside the likes of contact lenses.

To view the licenses, navigate to the Health Canada search page and search for Apple based on company name.


The ECG app first launched in the United States last December as part of watchOS 5.1.2. The feature expanded to 19 European countries and Hong Kong in watchOS 5.2 in March and to five more European countries in watchOS 5.2.1 last week.

With clearance from Health Canada, Apple could expand the ECG app to Canada in either watchOS 5.3 or watchOS 6, the latter of which should be unveiled at Apple's annual Worldwide Developers Conference next month.

Apple Watch Series 4 users can generate an ECG waveform in just 30 seconds by placing their finger on the Digital Crown.
Electrodes built into the Digital Crown and the back crystal work together with the ECG app to read your heart's electrical signals. Simply touch the Digital Crown to generate an ECG waveform in just 30 seconds. The ECG app can indicate whether your heart rhythm shows signs of atrial fibrillation — a serious form of irregular heart rhythm — or sinus rhythm, which means your heart is beating in a normal pattern.
Apple has yet to mention the ECG functionality on the Apple Watch health and fitness page on its Canadian website.

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This article, "Health Canada Gives Green Light to ECG App on Apple Watch" first appeared on MacRumors.com

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iOS 12.2 Suggests ECG App May Be Coming to UK and Other European Countries With watchOS 5.2

After installing iOS 12.2, some Apple Watch Series 4 owners in the UK are seeing new ECG screens that suggest ECG functionality will expand to the Apple Watch in the country when watchOS 5.2 is released.

MacRumors readers Sam and Chris have seen ECG setup screens in the Apple Watch and Health apps on the iPhone after installing iOS 12.2. The app is not, however, available on the Apple Watch in the UK right now because Apple hasn't yet released watchOS 5.2, which is likely required for the feature to work.


There's new documentation in the Health app in iOS 12.2 under ECG's "Instructions for Use" that also hints at upcoming support for the UK and other European countries:

  • For US Regions: The ECG app is available on Apple Watch Series 4 with watchOS 5.1.2 or later, paired with iPhone 5s or later or iOS 12.1.1 or later.

  • For non-US regions: The ECG app is available on Apple Watch Series 4 with watchOS 5.2 paired with iPhone 5s or iOS 12.2 or later.


There's also a new CE mark for the ECG feature in iOS 12.2 in the same document, which, as 9to5Mac points out, indicates that Apple may be planning to expand ECG functionality to all European Economic Area countries that use the CE certification mark.




It's not yet clear when Apple will launch watchOS 5.2, but with iOS 12.2 already available, it could be coming in the near future. Apple has not updated the list of countries where ECG features are available, but it could be changed once watchOS 5.2 sees a release.

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This article, "iOS 12.2 Suggests ECG App May Be Coming to UK and Other European Countries With watchOS 5.2" first appeared on MacRumors.com

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Tim Cook Tweets Story of User’s Apple Watch Detecting Atrial Fibrillation

Apple CEO Tim Cook today shared a story on Twitter of an Apple Watch that alerted its user to atrial fibrillation, potentially saving their life in the process.


Elissa Lombardo tweeted Cook with her husband's experience with Apple Watch that occurred just two days after he started wearing the device.

The smartwatch's ECG feature detected the case of A-Fib during an elevated heart rate, which led her husband to seek medical attention.

Medical professionals apparently discovered a "major blockage" in his arteries but were able to correct the problem, and two days later he was feeling fine again.

According to Lombardo, her husband presented with similar symptoms in the past, but on those occasions he never visited the emergency room to get them checked out.


This isn't the first time an Apple Watch has potentially saved someone's life. When the ECG feature launched in December in the U.S., TIME published a story about a 46-year-old Texas resident who was having trouble breathing normally.

Fortunately, since he was wearing an Apple Watch and participating in the recent Apple Heart Study, he was alerted to signs of an irregular heartbeat and went to the emergency room.

At the hospital, doctors hooked him up to an ECG machine and found signs of atrial fibrillation, an irregular heartbeat that can lead to stroke and other potentially fatal complications. He spent the next few days in the hospital while doctors returned him to a normal sinus heart rhythm.

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

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.

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Apple Releases watchOS 5.1.2 With ECG, New Infograph Complications and Walkie-Talkie Control Center Toggle

Apple today released watchOS 5.1.2, the third update to the watchOS 5 operating system that runs on modern Apple Watch models. watchOS 5.1.2 comes one month after the release of watchOS 5.1.1, an update that introduced new emoji and color watch faces and addressed a bricking bug that had been introduced with watchOS 5.1.

watchOS 5.1.2 can be downloaded for free through the dedicated Apple Watch app on the iPhone by going to General --> Software Update. To install the new software, the Apple Watch needs to have at least 50 percent battery, it needs to be placed on a charger, and it needs to be in range of the iPhone.


watchOS 5.1.2 introduces the long-awaited ECG feature for Apple Watch Series 4 models in the United States. The ECG functionality works through electrodes built into the back of the Apple Watch Series 4 and the Digital Crown, allowing users to take a single-lead electrocardiogram with the wrist-worn device. An ECG measures the electrical activity of the heart and is often used to diagnose heart conditions.

Alongside ECG functionality, watchOS 5.1.2 introduces a new feature that will let you know if the Apple Watch is detecting an abnormal heart rhythm that's indicative of atrial fibrillation, which can be a sign of a serious health problem. The ECG feature is limited to the Series 4, but the irregular heart rhythm notifications will be available on all Apple Watch models able to run watchOS 5 - that's Series 1 or newer.

The watchOS 5.1.2 update also brings new complications for the Infograph watch faces on the Apple Watch Series 4. Complications that have been added include Mail, Messages, Home, Maps, Apple News, Find My Friends, Phone, and Remote, all of which can now be assigned to the available complication slots on the Infograph watch face.


With most of these complications, the icon is designed to provide quick access to opening up an app rather than relaying information like unread messages or emails.

watchOS 5.1.2 also includes a new toggle in Control Center for turning the Walkie-Talkie feature on and off, which makes it a lot easier to disable Walkie-Talkie when it's not in use and turn it back on when it's needed.

Apple's release notes:
This update includes new features, improvements and bug fixes:

- New ECG app on Apple Watch Series 4 (US and US territories only)
* Allows you to take an electrocardiogram similar to a single-lead electrocardiogram
* Can indicate whether your heart rhythm shows signs of atrial fibrillation—a serious form of irregular heart rhythm—or sinus rhythm, which means your heart is beating in a normal pattern
* Saves ECG waveform, classification and any noted symptoms in a PDF on the Health app on iPhone to share with your doctor

- Adds the ability to receive an alert if an irregular heart rhythm that appears to be atrial fibrillation is detected (US and US territories only)

- Enables direct access to supported movie tickets, coupons, and rewards cards in Wallet when tapped to a contactless reader

- Receive notifications and animated celebrations when you achieve daily maximum points in a day during an Activity competition

- New Infograph complications for Mail, Maps, Messages, Find My Friends, Home, News, Phone, Remote

- Manage your availability for Walkie-Talkie from Control Center
More details on the features introduced with the watchOS 5 update that came out in September can be found in our watchOS 5 roundup.

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Apple Watch Chief Jeff Williams Says ECG App is ‘Huge Opportunity’ to Empower People About Their Health

Apple today announced that its ECG app will be available on the Apple Watch Series 4 today as part of watchOS 5.1.2. Alongside that news, TIME has published a new interview with Apple's CEO Tim Cook and COO Jeff Williams.


The article begins with a story about 46-year-old Texas resident Kevin Foley, who was having trouble breathing normally during a movie. Fortunately, since he was wearing an Apple Watch and participating in the recent Apple Heart Study, he was alerted to signs of an irregular heartbeat and went to the emergency room.

At the hospital, doctors hooked Foley up to an ECG machine and found signs of atrial fibrillation, an irregular heartbeat that can lead to stroke and other potentially fatal complications. Foley spent the next few days in the hospital while doctors worked to return him to a normal sinus heart rhythm and is doing fine now.

"We have tens of millions of watches on people's wrists, and we have hundreds of millions of phones in people's pockets," said Williams. "There's a huge opportunity to empower people with more information about their health. So this is something we view as not only an opportunity, but a responsibility of ours."

"Apple's largest contribution to mankind will be in improving people's health and well-being," Cook boldly proclaimed.

The report says a traditional hospital ECG is often referred to as a "12-lead" machine, as its 10 different electrodes provide information on 12 different areas of the heart. The new Apple Watch is the equivalent of only a single-lead device, but research suggests the ECG app is still very accurate.

In a press release, Apple said the accuracy of its ECG app was validated in a clinical trial with around 600 participants. The study found the ECG app on Apple Watch demonstrated 98.3 percent sensitivity in classifying atrial fibrillation:
Rhythm classification from a gold standard 12-lead ECG by a cardiologist was compared to the rhythm classification of a simultaneously collected ECG from the ECG app. The study found the ECG app on Apple Watch demonstrated 98.3 percent sensitivity in classifying AFib and 99.6 percent specificity in classifying sinus rhythm in classifiable recordings. In the study, 87.8 percent of recordings could be classified by the ECG app.
"The FDA has been very rigorous, and they should be," said Williams, referring to the Apple Watch's heart health features.

The article goes on to claim that some cardiologists and other experts have raised concerns that the Apple Watch's ECG feature is "unnecessary for the general population" and "could cause problems," including false positives.

"If everybody with an Apple Watch and an alert from an Apple Watch went to a heart-rhythm doctor that was super comfortable with this, then I think it would be O.K.," said Dr. John Mandrola, a cardiac electrophysiologist. "But there are going to be millions of people going to the doctor that in many cases will be just fine."

Apple responded that no medical test is 100 percent accurate, so some false positives are inevitable, according to the report. Moreover, the Apple Watch will only alert users to a potential heart-related problem if it detects five instances of what it considers a cardiovascular episode, including arrhythmia.

Importantly, in an internal document obtained by MacRumors, Apple cautioned that the ECG app is "not intended to be a diagnostic device or to replace traditional methods of diagnosis," and "should not be used to monitor or track disease state or change medication without first talking to a doctor."

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.

Irregular heart rhythm notifications will also be available on Apple Watch Series 1 through Series 4 models in watchOS 5.1.2.

Apple says the setup process for these heart health features will include details about who can use the features, what the features can and cannot do, what results users may get and how to interpret them, and instructions for what to do if users are feeling symptoms that require immediate medical attention.

watchOS 5.1.2 should be available through the Apple Watch app on a paired iPhone around 10:00 a.m. Pacific Time as usual. At launch, the ECG app will be limited to the U.S., but Apple is likely working to get regulatory clearance elsewhere.

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Apple Says watchOS 5.1.2 Coming Today With ECG App Enabled on Apple Watch Series 4

Apple has announced that watchOS 5.1.2 will be publicly released today and will enable the long-awaited ECG app on Apple Watch Series 4 models in the United States. The update will also enable irregular heart rhythm notifications on Apple Watch Series 1, Series 2, Series 3, and Series 4 models.


watchOS 5.1.2 should be available through the Apple Watch app on a paired iPhone around 10:00 a.m. Pacific Time as usual.

Apple's COO and Apple Watch team head Jeff Williams:
Apple Watch has helped so many people around the world and we are humbled that it has become such an important part of our customers' lives. With the release of these heart features, Apple Watch takes the next step in empowering people with more information about their health.
Last week, MacRumors was first to report that watchOS 5.1.2 will enable the ECG app on Apple Watch Series 4 models, based on an internal Apple Store training document. ECG data will be available in the Health app and exportable via PDF on an iPhone 5s or newer, after updating to iOS 12.1.1 released yesterday.

watchOS 5.1.2 will feature an Apple-designed ECG app that can indicate whether your heart rhythm shows signs of atrial fibrillation, a serious form of irregular heart rhythm, or a normal sinus rhythm. This is possible thanks to new electrodes built into the back crystal and Digital Crown on Series 4 models.

Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram, according to the FDA. Both the ECG app and irregular heart rhythm notifications are regulated features that have received De Novo classification from the FDA, making them available over the counter.

The ECG app will check heart rhythm every few hours or so, and if there are five consecutive readings that appear to be abnormal, the Apple Watch will alert the user to see a doctor. As for notifications, users will be alerted if an irregular heart rhythm is detected on five checks over a minimum of 65 minutes.

Importantly, in an internal document obtained by MacRumors, Apple cautioned that the ECG app is "not intended to be a diagnostic device or to replace traditional methods of diagnosis," and "should not be used to monitor or track disease state or change medication without first talking to a doctor."

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.

Apple says the ECG app's accuracy was validated in a clinical trial of around 600 participants in the United States:
Rhythm classification from a gold standard 12-lead ECG by a cardiologist was compared to the rhythm classification of a simultaneously collected ECG from the ECG app. The study found the ECG app on Apple Watch demonstrated 98.3 percent sensitivity in classifying AFib and 99.6 percent specificity in classifying sinus rhythm in classifiable recordings. In the study, 87.8 percent of recordings could be classified by the ECG app.
Apple is making good on its promise of making the ECG app available by year's end. watchOS 5.1.2 has been in beta testing since November 7, but the ECG app was nowhere to be found during the pre-release period.

Apple says the setup process for these heart health features will include details about who can use the features, what the features can and cannot do, what results users may get and how to interpret them, and instructions for what to do if users are feeling symptoms that require immediate medical attention.

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Apple Watch Will Have Extended 45-Day Refund Period Tied to Heart Health Features

While the Apple Watch typically has a 14-day return policy, Apple will honor refund requests related to upcoming heart health features for up to 45 days after purchase, according to an internal document distributed to Apple Stores and Apple Authorized Service Providers in the United States.


The document, obtained by MacRumors, states that Apple Stores will refer these requests to Apple Support, so customers will need to contact Apple by phone, email, or online chat to initiate a refund beyond the usual two-week period.

Heart health features include the upcoming ECG app on Apple Watch Series 4 models and irregular heart rhythm notifications on Apple Watch Series 1 through Series 4 models. A separate Apple document obtained by MacRumors indicates that the ECG app, and likely the notifications, will be enabled in watchOS 5.1.2.

Apple Stores are not required to inspect the Apple Watch if a customer has a heart health-related refund request greater than 14 days after purchase, so it sounds like as long as a customer mentions the ECG app or irregular heart rhythm notifications as the reason for the return, Apple will honor it up to 45 days.

Apple's document does not provide any further details, so it's unclear why this policy exists. While the ECG app and irregular heart rhythm notifications are regulated features, the extended refund policy is not mandated by the FDA, according to a spokesperson for the agency. Apple did not respond to a request for comment.

Perhaps this is simply more time for customers to try out the heart-related features. Apple cautions that the ECG app is "not intended to be a diagnostic device or to replace traditional methods of diagnosis," and "should not be used to monitor or track disease state or change medication without first talking to a doctor."

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.

ECG and other heart data will be collected in the Health app on a paired iPhone 5s or newer running iOS 12.1.1 or later.

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watchOS 5.1.2 Will Enable ECG App on Apple Watch Series 4

ECG functionality will be enabled on the Apple Watch Series 4 in the publicly released version of watchOS 5.1.2, which is currently in beta testing, according to an internal Apple Store training document obtained by MacRumors.


watchOS 5.1.2 will feature an Apple-designed ECG app that can indicate whether your heart rhythm shows signs of atrial fibrillation, a serious form of irregular heart rhythm, or a normal sinus rhythm. Apple Watch Series 4 is capable of generating an ECG similar to a single-lead electrocardiogram, according to the FDA.

ECG and other heart data is collected in the Health app on a paired iPhone. Apple's document lists a minimum requirement of an iPhone 5s or later running iOS 12.1.1, currently in beta testing, or later.

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.

Apple's training document states that the ECG app is regulated and only available in regions cleared for use. The app will initially be limited to the United States, where Apple has received FDA clearance, but Apple Watch Series 4 models sold worldwide include the electrical heart sensor for future expansion.

Apple Store employees are instructed to advise customers that the ECG app is "not intended to be a diagnostic device or to replace traditional methods of diagnosis," and "should not be used to monitor or track disease state or change medication without first talking to a doctor," according to Apple's document.

Apple promised that the ECG app will be available later this year, but it's unclear when watchOS 5.1.2 and iOS 12.1.1 will be released. watchOS 5.1.2 has been in beta testing since November 7, while iOS 12.1.1 has been in beta testing since October 31, so both software updates should be released relatively soon.

A separate Apple training document obtained by MacRumors suggests that irregular heart rhythm notifications will also be enabled in watchOS 5.1.2 on Apple Watch Series 1 through Apple Watch Series 4 models.

The ECG app will not be available on previous-generation Apple Watch models, including the original through Series 3.

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