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
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.
Blugle wrote:
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.
1) This is not a blog. It's a user-to-user support forum.
2) No, Apple developers and engineers are not reading here for feedback. You can send your feedback to them here:
I just found your thread entry on Kardia. You have it completely wrong in confusing the way that the watch measures pulse vs ECG.
The ECG technology of reading the voltage between the two limbs is virtually identical between the watch and Kardia. Do you relly think that there is a difference in voltage between the wrist and a finger?
I don't understand your eagerness in shooting people down?
Please read about the technology and do your homework.
We aren't going to read the entire Australians law just over the regulation of the dang watch. We're volunteers for heavens sake. Your government has something called the Therapeutic Goods Act of 1989 that has been revised over and over and is now freaking 400 pages strong. Thats something only a lawyer would read. People that have read it explains that their definitions of an ECG isn't equal to what Apple's definitions has.
read this, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6651039/#sec1-sensors-19-02894title
Now you show me documentation that shows the Alivecor sensors reads an ecg the same way. You said there is no difference. Prove it. Since you think differently than your government maybe you can tell them they have to approve the Apple Watch since it the same as the Alivecor device.
With respect to everyone commenting on this string, we don't seem to be getting to a point where we can work together to make this happen.
I appreciate all of the work the volunteers do on sites like this to help us all and thank them for their time.
However this site is hosted by Apple, I assume in the US, so sending in feedback doesn't appear it will get any traction and I haven't been able to find out how or who we can talk to in Apple Australia to get things moving.
I think this is where we should start, can anyone give me contact details for Apple Australia, a real person located within our borders who we can talk to and help to get this across the line?
There really isn't anything Apple can do other than get your agency to change their rules allowing a single axis ECG to be certified as a medical device. Apple can't force your government to make this change. What you can do is contact your elected representative to make your voice heard.
Apple is not going to talk to you about their negotiations and conversations with your government agencies. You have it backwards, you go to your elected representative and ask them to check with your agency and get answers. This thread somewhere at the start had an article from a writer with an Australian publication that had done research and doubted that the ECG function would ever be approved in Australia. Do some internet sleuthing, see if you can find that article, then contact the writer in question and see what their advice is.
I'm sorry but you don't get to dictate who can post here and what they can say. Pointing out that the ECG has to be approved by your government is not political. Pointing out that according to authors who live in your country and wrote articles that were published in your country that show the current rules would not allow approval of a single axis ECG device is not political.
The TGA provides a log of all disclosures under the Freedom of Information Act at https://www.tga.gov.au/foi-disclosure-log neither this nor any search of the TGA website leads to anything from Apple.
I understand that the existing regulations would need to be modified to permit single-axis technology, but whatever form that change takes will be the result of negotiation, a discussion between TGA and interested parties, including Apple. Until a conversation starts, there is no impetus for change, and it can only be started from outside the TGA.
It’s not impossible to change government regulations, happens all the time, but not in a vacuum.
What is the Apple COO’s Word worth?
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 https://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.
Isn’t the question why will Apple not give a clear answer about why they said ECG approval would be sort in Australia?
Call the Apple Helpline and you basically get shrugged off. If they know that their technology as it exists will not be approved by the Aust. Govt. then why continue to feature this so prominently in advertising to Australians? Doesn’t seem right. I have posted about this as below...
What is the Apple COO’s Word worth?
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 https://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.
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 https://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.
Thank you. I will do that. A simple and thoughtful solution would simply be for Apple to give out straight answers when they are contacted by their customers. I asked Apple Care and went to Apple Help and Chat etc basically their answer was “they didn’t know what he situation was.”. To be fair to Gizmodo they asked Apple for enlightenment and it was denied. So?...
To get answers to this you can’t expect first line support employees to be able to answer you. You would need to be talking to senior level executives. And they aren’t going to answer you. The fact that Apple hasn’t applied publicly is meaningless. The same type of article was printed about Canada.
What reason can you state that Apple would intentionally try NOT to get it approved in Australia?
At the very least, our should be made clearer that these features aren’t available on the website and it should come from staff in store. Unfortunately myself and at least a couple of others who have contributed here have been sold a lie when staff told us this feature was available here.
Also simply omitting those features from the Apple sales website simply isn’t clear enough.
Apple Watch: ECG In Australia
