Apple Watch: ECG In Australia

Yes, gosh darnit, this for darn sure, is a honey pot. And attracting more flies by the week.

By the way PawPaw, there are not quite 200 countries in the world, less than 50 have been approved by their governments to allow the ECG app on Watches to access the function. Just because Australia, a large land mass with a rather disproportionately small population, doesn't yet have access to the function doesn't mean Apple isn't living up to the COO's commitment.

Apple doesn't discuss its product or business decisions publicly. It usually announces a decision has been taken when appropriate and leaves it at that.

A previous thread was taken down that was similar to this. I'm surprised that this one hasn't since it is starting to move towards violating Section B, 1, ii of the TOS: Discussion of Apple policies or procedures.

I believe that is just not good enough. Apple should not advertise the feature in countries where it is not available. It does seem misleading to do so. And, if, as posts have suggested here Apple has not applied for permission in Australia because they know their current technology will not meet Australian standards there is even more reason not to advertise that feature in Australia?

If the staff gave you incorrect information and said the warnings and ECG would work on your Watch you had 14 days to take it back and get your money back. If you can prove they said that you could go back to the store manager now and I would bet that they would give you your money back. And the mistake you made is if ALL you wanted the watch for was those two functions your money would have been better spent buying buying an approved device. All of your other factors you have listed are pure BS, they do not charge any more for the ECG feature. Your Watch will do the same thing as all other ones in the world with the exception of those two features. It can do hundreds of other things and it is not sold as primarily an ECG device.

Did it really take you more than 14 days to determine that the heart functions didn't work in your country? Did the specialist actually tell you that those functions worked in Australia? Have you complained to the store manager? Are you going to? When it didn't work did you double-check what the specialist told you?

A very basic understanding of voltage measurement is required. From this article, "Electrodes built into the Digital Crown and the back crystal work together with the ECG app to read your heart’s electrical signals." Please take the time to read the contents of the link before sending back a flippant reply.

Both the basic Kardia and the Apple Watch operate on exactly the same principle to measure one ECG signal at the extremeties of the arms.

The Kardia is approved in Australia, the Watch is not yet both use the same measurement technique.

The crystal completes the current but does not serve as a second measurement axis. If you look at the measurement chart you will see that. I believe the Kardia not only closes a circuit but also takes a second measurement.

I did get a detailed explanation on ECG technology and such by a technician while I was connected to one in the ICU. I also discovered that the cardiologists there were not too enamored with any of the wearable ECGs.

You could call the TGA and ask to see their description of the Kardia and ask them why they approved it.

Well here’s my two bucks worth.

I did buy the Apple Watch for the ECG function - to help with my health issues. I also very much appreciate that it links to my iphone, ipad and Macbook. But, my trigger to buy was ECG.

I knew the function was not yet activated in Australia but as I trust Apple as a brand I also trusted what the COO said .

Please read my original post...

-o0o-

I am now 74 years old.

Jan 17, 2019 bought Watch for ECG function/AFIB.

ECG not active in Australia, but at 2018 Special Event the Apple COO had said Apple "working hard to bring to customers around the world."

20 months later, it is reported www.gizmodo.com.au/2020/06/apple-watch-hearting-monitoring-australia-ecg/ that Apple has not even applied for approval and has declined to comment on why it is yet to put the devices on the register and on whether it has ever started this process.

I contacted Apple about ECG and got nowhere so would appreciate any suggestions on how to take this further as I feel I have been misled and ignored.

-o0o-

It has proven impossible to get a straight answer out of Apple - and none of the posts here have addressed my question on how to get Apple to give an indication of when ECG will be activated in Australia.

This is my issue.

Posts making assumptions about why Apple does what (or does not) are just that, assumptions and irrelevant to my issue.

I would like suggestions on how to get Apple to respond with a statement about when ECG will be activated in Australia.

The buck stops with Apple.

deggie wrote:

Do a search for ECG Axis. Hospital machines use lots of them. It just means two points of contact for dual axis, on the Watch the digital crown provides a single axis point, the back of the watch does not serve as an axis.

Apple Watch provides a single lead; what’s known as lead 1 monitoring. Measuring the current flow from arm-to-arm, across the heart, looking for current flow from right to left and left to right, as the heart beats.

The axis of the three-dimensional electrical current flowing across the surface of the heart is derived from readings made in parallel across multiple leads; across 12 leads connected to the patient, most commonly.

Most low-end cardiac monitors tend to use three leads, lead 1, lead 2, and lead 3, the so-called limb leads, and will default to the display of lead 2, not lead 1. Three-lead cardiac monitoring tends to be used for and suitable for semi-automatic defibrillators, but seldom preferred for cardiology.

Various non-cardiac conditions can and routinely mess with ECG readings, too; metabolic problems that aren’t cardiac problems.

SamoAt18 wrote:

Thanks StanlyG.

What do you feel will get Apple to speed up making ECG available in Australia?

Product Feedback - Apple <<< here

AND contact your representative to change the TGA regulations. <<< Most Important.

OR somehow get widespread media attention.

Not really hearsay, it was supposed to be last month but they postponed it

"The Regulations 2019 would be amended to delay implementation of the reforms from August 25, 2020 to: November 25, 2021 for reclassification of certain devices."

Delays to the commencement of certain medical device ... - TGA

In fact, they reform it almost every single year from what I can tell from this link - https://www.tga.gov.au/archived-regulatory-decisions-notices

"Thank you for your enquiry to the TGA.

Unfortunately the TGA is not able to provide advice to third parties in relation to a company’s intent to apply for marketing Authorisation within Australia.

You may wish to contact Apple or their Australian representatives as they are best placed to advice when they will apply for approval of this function."

I see two shames happening here:

1) Apple not being able to enable the feature in Australia while even Brazil has it.

2) Apple charging customers full price on a caped devices.

I recently called Apple Support prior the Watch 6 series launch to know whether the device would have ECG. They said 'no' but they said the device has the ECG hardware onboard so it is a matter of time... then I said the feature is two years old now and Apple is unable to get it on!

I'm keeping my Watch Series 2.

I thought it might be productive to write to Tim Cook...

Dear Tim,

I am a long-standing Apple customer  with 8 iphones, 3 apple computers, 9 ipads in my family and a ‘bee in my bonnet’ about information on when ECG will be available in Australia for my Apple Watch.  So far, Apple has not lived up to my trust in your brand,

.

I am now 74 years old and on Jan 17, 2019 bought and Apple Watch for the ECG function so as to help me monitor my AFIB. I knew ECG was not active in Australia when I bought the watch but at 2018 Special Event the Apple COO had said Apple "working hard to bring to customers around the world."

20 months later, it is reported www.gizmodo.com.au/2020/06/apple-watch-hearting-monitoring-australia-ecg/ that Apple has not even applied for approval and has declined to comment on why it is yet to put the devices on the register and on whether it has ever started this process.

Further, another Apple customer has posted a letter from the Australian regulatory authority (image below)which I read as saying that Apple has not even put in a submission for approval.

I am writing to you now in the hope that you will be forthcoming about what is happening with ECG approval for the watch in Australia. Just two days ago it was raised in Australian media so without a clear statement from you it is quite possible that it will result in unfavourable publicity.

I am delighted with my Apple Watch but concerned about being unable to get any clear reply from Apple on ECG activation progress in Australia - particularly given the Apple COO‘s statement at your 2018 special event which does not seem to have been honoured.

Please let me know if you are able to release ECG progress information for Australia.

I have been unable to obtain an answer through any other Apple sources.

Thank you,

Bob

Hi Bob, I understand your concerns and how you feel (we’re in the same boat).

The issue is with the Australian Government really, not with Apple. The review of these devices keeps being pushed into the future: 2018, 2019, Aug 2020, and now Feb 2021.

Apple won’t apply until the regulation changes given that, as far as the current regulation goes, it would be certainly rejected.

I feel that our pressure should be directed towards TGA or whoever above them keeps pushing this review to the future. This time they are (maybe even correctly so) blaming COVID, but it would be good to have some clarity on this, and the contact of some specific body or representative that we could pester.

Thank you Luca.

My feeling is that Apple should let customers know that they have not yet applied - why not.- and when they expect to be able to.

Something like...

“We know that the ECG function on our Apple Watch does not meet Australian requirements so we have not applied for approval - however...”

Whatever...