The Apple Watch Series 5 was announced at Apple’s big iPhone launch in mid-September with new features including always on display, international emergency calling and a new compass ” and it was confirmed the heart-monitoring app, ECG, from the Apple Watch Series 4 would appear again in the upcoming model.
But the reality is a little different in Australia: if you buy an Apple Watch Series 5 here, the heart-monitoring app is not available ” and won’t be in the near future.
It’s a story we have heard before. Australians would have noticed last year’s Apple Watch Series 4 also didn’t come with the ECG feature, first announced during the 2018 special event. During the event, Apple COO Jeff Williams said Apple was “working hard to bring [the ECG feature] to customers around the world.”
But it never arrived.
The reason?
To sell medical devices in Australia, companies need to get prior approval from the Therapeutic Goods Administration (TGA) for inclusion on the Australian Register of Therapeutic Goods (ARTG) in order to be legally supplied in the country. Specifically, devices that intend to provide therapeutic benefits or modify or monitor anatomy or physiological functions of the body need to be on the ARTG in order to be imported and supplied in Australia, per the Therapeutic Goods Act 1989.
And despite the promise of the EGC heart-monitoring app coming to Australia, the TGA confirmed to Gizmodo Australia that Apple has not applied for any of its products to be on the ARTG in Australia. Yes, any.
“If Apple claims the ECG function in its Apple Watch has therapeutic benefit for wearers, the watch would need to be included in the ARTG in order to be legally supplied in Australia,” a TGA spokesperson said to Gizmodo Australia in a statement.
“TGA has not received any applications for products manufactured and/or supplied by Apple, nor is there any Apple device included on the ARTG.”
Apple declined to comment on why it hadn’t applied for the TGA’s approval in Australia prior to the Series 5’s release but TGA did admit it had been in discussions with Apple “regarding the regulation of the software as a medical device.”
While it’s unclear why Apple didn’t file an application in time, it could have something to do with Australia having more stringent regulation.
“As the minimum requirement, sponsors [like Apple] must have evidence that the manufacturer has applied appropriate conformity assessment procedures to its product. The sponsor also must have evidence that their medical device complies with the requirements for essential principles of safety and performance,” a TGA spokesperson said.
“Risks can be associated when people self-diagnose and avoid seeing their doctor when they may have a serious underlying problem ” this could be due to the problem not being something which can be detected by the ECG.”
Apple’s in-built app allows wearers to take a heart-monitoring test called an electrocardiogram (ECG), which according to Apple, can monitor “rapid or skipped heart beat and help provide clinically important data to physicians.”
ECG tests in Australian hospitals require a patient to lie still while 10 electrode leads placed around the body capture the patient’s heart rhythm looking for any irregularities. The Apple version instead detects blood flowing through your wrist by using green LED lights.
“When your heart beats, the blood flow in your wrist ” and the green light absorption ” is greater. Between beats, it’s less. By flashing its LED lights hundreds of times per second, Apple Watch can calculate the number of times the heart beats each minute ” your heart rate,” Apple said on its blog.
[referenced url=”https://gizmodo.com.au/2018/09/aussie-apple-watch-series-4-wont-be-getting-that-impressive-ecg-electrocardiogram-function/” thumb=”https://gizmodo.com.au/wp-content/uploads/2018/09/heart-2-410×231.jpg” title=”Aussie Apple Watches Won’t Get That Cool Heart Monitoring Function” excerpt=”The new iPhones may have been the main event of today’s Apple product launch, but the Apple Watch Series 4 also made quite the impression. One of the standout features is the new heart-monitoring hardware that allows the device to take an electrocardiogram (ECG) to monitor electrical activity in the heart. There’s just one problem. We won’t be getting it in Australia.”]
In 2018, the US Food and Drug Administration (FDA), approved the device allowing Apple to call the app, containing the feature, an ECG. Medical device regulators in Europe, Hong Kong and Singapore have also since approved the software.
Aside from the ECG functionality, the watches also monitor pulse, offer low and high heartbeat monitoring and fall detection, which detects hard falls and gives wearers the option to call emergency services immediately.
As these features don’t claim to monitor heart problems, the TGA told us they don’t need to be included in the ARTG. In Australia, it is the fact Apple claims its ECG can monitor heart problems that would make it more difficult to be regulated.
“If the manufacturer claims that the product monitors heart problems then the product will become a medical device,” a TGA spokesperson said. “Monitoring of heart rate on its own is not considered to be monitoring of [heart] disease.”
Although the Apple Watch Series 4 and 5’s hardware is the same globally, Gizmodo Australia understands Australians are prevented from downloading and using the app as it hasn’t been TGA-approved. If the ECG functionality was to be approved in the future by TGA, the devices could receive a software update, which would include the native Apple app onto the device.
There is a workaround, however. Apple Watch Series 4 or 5 bought in the US could theoretically use the ECG functionality in Australia as it’s preloaded onto the device. It’s understood there may be some limited functionality with cellular devices due to it being tied to US mobile carriers but using WiFi, the ECG app would be functional inside Australia’s borders. However, we haven’t tested this.
We asked Apple Australia if it had any immediate plans to get the ECG functionality approved by TGA, or whether it would do so for future additions, but it declined to comment. That approval process, however, isn’t a walk in the park.
“Medical devices are classified according to their level of risk. The classification will depend on the specifics of the device,” a TGA spokesperson told us, pointing to the regulation.
“The timeframe for approval in Australia is dependent on a number of factors including, but not limited to, the classification of the device and the need for auditing or review of the information provided.”
The lack of an ECG feature might not be a huge dealbreaker for those interested in purchasing the device but it does make us wonder why Australians are paying higher premiums for imported technology and still getting locked out of flagship features.
[referenced url=”https://gizmodo.com.au/2019/09/apple-watch-series-5-australian-price-specs-and-release-date/” thumb=”https://gizmodo.com.au/wp-content/uploads/2019/09/apple-watch-5-410×231.jpg” title=”Apple Watch Series 5: Australian Price, Specs And Release Date” excerpt=”The Apple Watch Series 5 is now official, and comes with a few new upgrades and features. Here’s how much it’s going to cost you and when you can get it in Australia.”]