Apple Watch: ECG In Australia

Ok, it’s now 04 July 2020.

So, when will ECG be released in Australia.

I upgraded my Apple Watch specifically to get ECG, promised by Apple at that time.

Who is responsible in the Medical profession here for this absurd level of procrastination, please tell me...

Apple Watch

Posted on Jul 3, 2020 5:16 PM

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Posted on Feb 3, 2021 11:43 AM

Given the registration hasn't occurred the issue is hardly solved!

Interesting that Apple doesn't seem to be able to negotiate the relatively easy TGA registration process, especially since there exists what is known as a Global Medical Device Nomenclature code (recognised by the TGA) that covers the hardware and another that covers the software! Would hate to think it is just laziness on Apple's part or that they won't provide any details to TGA, which to be frank is usually less than the US and the same as the UK and EU.


For information, the relevant codes are below. Registration takes less than a day to complete the form and usually an answer is received within a couple of days.

Hardware

Name

Wearable multiple physiological parameter recorder

Definition

An electrically-powered, wearable device (e.g., wristband, watch, finger probe, head-worn sensor) designed to continuously or intermittently measure and record multiple physiological parameters [e.g., heart rate, respiration rate, electrocardiograph, haemoglobin oxygen saturation (Sp02), routine body movement] using one or more technologies [e.g., photoplethysmography (PPG), reflectance pulse oximetry, electrocardiography, accelerometry). The data is typically transferred to a local application (e.g., smartphone) or central database for analysis, which might include evaluation of lifestyle factors (e.g., energy expenditure, activity level, sleep patterns).


Software


Name

Smartphone camera home cardiovascular monitoring application software


Definition


A software program designed for use in a smartphone/watch with a built-in camera to periodically measure, via transcutaneous optical reading, and display cardiovascular parameters (e.g., pulse wave, heart rate variability, SpO2, blood pressure, LVEDP) for assessment of cardiovascular function to assist diagnosis of disease (e.g., arrythmia, cardiac autonomic neuropathy); it may also be used to provide general lifestyle/fitness advice or during a controlled Valsalva manoeuvre to facilitate cardioversion of supraventricular tachycardia (SVT). This is a home-use device which may allow for remote communication of data with a clinician; it may in addition be used in a clinical setting.

425 replies

Jul 20, 2020 4:34 AM in response to Dimov4

Generally users like us, only have a 10,000 foot (3,000 meter) view. And a year and 3/4’s after ECG was first made available, Apple will have approached every government (unless prohibited by U.S. law). So we mostly assume if ECG has not been approved, it is the country government that needs to approve at this point.


In the case of Australia, some users have found government reports indicating Australia is the one dragging its feet. See above links. So in this case us users maybe have a 1,000 foot view, but still not close enough to know exactly who’s turn it is to do something.

Sep 11, 2020 2:10 AM in response to deggie

And don’t buy the “they haven’t applied” argument, that isn’t the way it works.

In Australia, that is how it works. But you have to have all of your ducks in a row before applying or it's a waste of time. The deck is stacked against Apple in AU because the manner in which the Apple Watch measures an ECG, doesn't fit the method defined for medical devices approved by the AU regulatory agency. So first Apple would need to get that method of taking an ECG approved before even thinking of getting the Apple Watch approved as a medical device that takes an ECG by the newly approved method. These Aussies mitching & boaning here don't appear to realized the level of nanny state they live under!

Sep 15, 2020 3:38 PM in response to Harbs1921

watchOS 7 will be released tomorrow and if there are any new countries included you will hear about it then. Even if ECG is approved tomorrow for Australia you would need a Series 6 to use the blood ox feature and yes your government would have to approve it. You could always move to New Zealand or one of the other 37 countries where it is approved. Or talk to your elected representative.

Sep 15, 2020 4:17 PM in response to saiprasadkulkarni

No one here can confirm that and if Apple has received an indication from the government that it would not be approved then Apple would not have applied. If they are anything like our Food and Drug Administration (FDA) it is quite complex, full of politics, and the agency speaks in bureaucratese. For example, to apply for formal approval of a new drug with the FDA you have to submit research and testing then the FDA invites you to apply. But if you ask the FDA about getting approval they will tell you the company has not applied. They won't tell you about the full process.


Everything I've read from Australian pundits who follow these things they don't think the government will ever approve the single-axis ECG function on the Apple Watch.

Sep 16, 2020 12:07 AM in response to Robert J McInnes

TGA appears not to be the problem... Apple have not applied... We don’t matter....


June 25, 2020


“the Therapeutic Goods Administration (TGA), has confirmed to Gizmodo Australia that Apple Watches still aren’t allowed to have ECG functionality in Australia....


“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, repeating the same statement it provided us in September 2019.

“TGA has not received any applications for products manufactured and/or supplied by Apple, nor is there any Apple device included on the ARTG.”


”Gizmodo Australia asked Apple to confirm why it is yet to put the devices on the register but it declined to comment. It also declined to comment on whether it has ever started this process.”


https://www.gizmodo.com.au/2020/06/apple-watch-hearting-monitoring-australia-ecg/





Sep 17, 2020 12:14 PM in response to Shichimi

Your response doesn’t answer the question. This has nothing to do with Canberra. According to all reports, the TGA themselves, and the response above from Tahveed, Apple haven’t bothered to compile the evidence required to lodge an application with the TGA. They haven’t even made an attempt to apply. So it is not on our government, it’s on Apple to make the first move and apply first! If they had applied and it wasn’t approved, then it would be on the TGA AND Apple.


The problem is, staff in stores in Australia are telling customers the watch has this functionality. While the Australian website has removed reference to an ECG function, it is still misleading because it mentions another feature Australia doesn’t have - the heart irregularities function by stating it detects irregularities. It also doesn’t explicitly state that these features aren’t accessible to people who have purchased the watch in Australia.


I don’t know about others but I’ve had lengthy discussions with staff in more than one store about the watch as I was considering upgrading and I specifically mentioned my desire to upgrade for these features and I was never told they aren’t available. In one case the sales rep mentioned the new watch would be great for me given my family history of heart issues and went on to tell me stories she had heard from Apple (presumably in keynotes and from Apple in the states) about people whose lives have been saved by these features. Those discussions and the recent media event compelled me to trade my older model watch in and purchase an S6 watch. I went back to check the Apple Store app and it doesn’t explicitly state those features aren’t available here.


I, like many others, feel absolutely cheated. I could have kept my old watch and be better off financially for it. I made the decision to spend the money at the time as I felt the life saving features justified the purchase.I feel like they could at least do more to explicitly tell customers we can’t access the ECG function or Heart Irregularity function in Australia. They should also be charging us less based on the reduced functionality.



[Edited by Moderator]

Sep 18, 2020 6:43 AM in response to Dah•veed

Ok, I have now updated my iPhone and updated my Apple Watch then reinstalled my Apple Watch as it was quite messed up.

As a person who found themselves in the sad position of having a heart condition a couple of years ago, I found a bit of comfort in being able to monitor my Heart Rate myself with the use of the Apple Watch, I had hoped to also be able to use the ECG function as promised by the Apple Shop staff in my home town of Melbourne.

Now the new update has removed some of the functionality to check on my Heart Rate which has really upset me.

My only hope is the App developers actually read these blogs and stop listening to the Marketing wankers, stop listening to the legal wankers, stop listening to the accounting wankers and start listening to the users who need this technology.

Stop messing with something just to make it look nice and continue to make it a useful device to help those that need it.

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Apple Watch: ECG In Australia

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