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  #2413704 6-Feb-2020 16:11
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JarrodM:
eracode:

 

Quite likely a stupid question but does the ECG function work via an app? Just wondering if it’s possible to access it by changing your Apple ID region/country setting on the Watch and using a VPN - i.e. similar to the approach used to download and run, say, BBC iPlayer on Apple TV and iPad?

 


Based on location of purpose I believe, which can then be unlocked by future software updates (like a few European countries I believe)
I have a series 4 purchased in America and the ecg app has worked since it first came in, even though I’m signed into my NZ Apple account.

 

I have just googled all this and it appears that there is a small amount of rigmarole involved but the key point is first registering a capable Watch in a country that is ECG App eligible.





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  #2413710 6-Feb-2020 16:41
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Here is a good video, made by a ... cardiologist ... which explains in some medical detail how the Apple Watch deals with ECG, it is a very good presentation.

 

https://www.youtube.com/watch?v=s0sv3Kuurhw

 

the key takeaway is, for most people, the ECG function is pretty ‘meh’, as the kids say, when it comes to beneficial medical outcomes.

 

so I would suggest it’s neither here nor there if it’s approved or not.





BlinkyBill


 
 
 
 


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  #2413712 6-Feb-2020 16:52
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I don't get it, you can get blood pressure monitors and ecg meters here in nz that are not "signed off" by nz health departments.

 

Why would you need to get the watch or app signed off, would it not be at users risk ??





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  #2413714 6-Feb-2020 17:08
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JaseNZ:

 

I don't get it, you can get blood pressure monitors and ecg meters here in nz that are not "signed off" by nz health departments.

 

Why would you need to get the watch or app signed off, would it not be at users risk ??

 

 

because those don’t suggest to you that you might have a medical condition that needs attention.





BlinkyBill


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  #2413718 6-Feb-2020 17:17
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JaseNZ:

 

I don't get it, you can get blood pressure monitors and ecg meters here in nz that are not "signed off" by nz health departments.

 

Why would you need to get the watch or app signed off, would it not be at users risk ??

 

 

ECG machines aren't the sort of thing you just buy off the street - they cost thousands. They do also require testing and compliance to be sold in NZ. EKG's are the same.

 

Anybody can buy a blood pressure monitor because they're very different.

 

 


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  #2413786 6-Feb-2020 18:43
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  #2413797 6-Feb-2020 18:57
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My Garmin Fenix6 watch tells me my Oxygen Levels and my Heart rate (And how stressed I am, and my "Body Battery" which is a measure of how much energy they think I have left) and also will tell me what my VO2Max level is.

 

The suggested use for the Oxygen Level is for those mountain climbing who might not be aware of how low their levels are getting, and to take a break to recover if they're getting low.

 

I bought my watch at Harvey Norman.  Or Noel Leeming. I can't never tell the two apart.

 

It also gives alarms if your heart rate spikes when you're sitting still (like when you find out the phone call you're about to have is actually a job interview, that set it off once for me) which is purely a "medical event" type alarm.

 

 

 

Why isn't/wasn't this subject to the same sort of strict certification that the Apple Watch is being subject to?


 
 
 
 


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Ultimate Geek


  #2413814 6-Feb-2020 19:25
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JaseNZ and Muppet you are missing an important point. The Apple Watch notifies of possible Atrial Fibrillation, in those terms. AFib is a medical diagnosis. The Fenix doesn’t do that, and of course a $75 Chinese junker almost certainly doesn’t either, and if it did no-one would reasonably rely on it.

 

It is worthwhile having a look at the video I linked above, you may find it helpful.





BlinkyBill


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  #2413817 6-Feb-2020 19:27
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BlinkyBill:

 

JaseNZ and Muppet you are missing an important point. The Apple Watch notifies of possible Atrial Fibrillation, in those terms. AFib is a medical diagnosis. The Fenix doesn’t do that, and of course a $75 Chinese junker almost certainly doesn’t either, and if it did no-one would reasonably rely on it.

 

It is worthwhile having a look at the video I linked above, you may find it helpful.

 

 

Ok, thank you, makes sense why it's different.

 

I will go watch video and shut up :)


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  #2413830 6-Feb-2020 19:56
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Withings is selling an ECG watch in NZ (JB HiFi). I don't particularly see what the hold up is, except that maybe Apple has not applied for certification here yet. It took them quite some time to even get to Canada.

 

gehenna:

 

It could also add demand to already busy emergency departments with false positive people who then use resources to go through the triage process.  

 

 

This argument comes up every time but you literally have it been used in one of the worlds largest economies / countries (USA) and the majority of the EU and yet nothing bad has happened. Where is your evidence?


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  #2413865 6-Feb-2020 20:48
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There are no specific requirements if a medical device manufacturer wants to sell a medical device in New Zealand (the Director General and Minister of Health have some reserved powers but they are limited and blunt). Most manufacturers register their product voluntarily in the WAND database maintained by Medsafe.

There are plans to introduce a bill for regulating medical devices - was out for consultation last year.

https://www.health.govt.nz/our-work/regulation-health-and-disability-system/therapeutic-products-regulatory-regime

I have raised this issue (availability of ECG) with Apple directly last year, they understand the situation, the ball is in their court.

Jon

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  #2414025 7-Feb-2020 09:42
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There is already legislation covering medical devices- the Medicines Act 1984 and the Medical Devices Regulations 2013 (not the exact name). The therapeutic regulations consultation only includes devices *not* covered by the legislation I mentioned, which is a pretty specific sub-set of medical devices - it will not replace the Medicines Act or subsequent regulations.

 

Those wishing to sell a non-exempt medical device *must* register it in WAND, it is not optional.

 

This Medsafe webpage describes the situation https://medsafe.govt.nz/regulatory/DevicesNew/2Legislation.asp 

 

I can only assume the Withings device is approved.





BlinkyBill


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  #2414374 7-Feb-2020 20:07
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To be clear, these regulations from 2003 (not 2013) aren't very useful because they don't provide useful descriptions of what a medical device is, particularly in the context of software and more interestingly 3D bio-printing and genomics (like Car-T Cell therapy), this is a fundamental issue and a large part of the reason for developing new legislation. You can read more here about some of these issues here (there are more issues than are listed here):

https://www.pharmac.govt.nz/hospital-devices/fairer-access-to-hospital-medical-devices/

This is also useful to read in this context (the definition of what a medical device is according to the regulations):

http://www.legislation.govt.nz/regulation/public/2003/0325/latest/DLM224296.html#DLM224296

Secondly and maybe more importantly, which it appears Apple and @BlinkyBill have failed to realise is this is a registration only, not an approval.

Jon

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  #2414382 7-Feb-2020 20:25
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BlinkyBill:

 

There is already legislation covering medical devices- the Medicines Act 1984 and the Medical Devices Regulations 2013 (not the exact name)...

 

 

Just for context, Jon runs the Emerging Health Technology team at Ministry of Health.  He'd know.  


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Master Geek

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  #2414635 8-Feb-2020 14:06

An interesting discussion re ECG devices. Thought it might be relevant to describe my wife's experiences. She had repeated episodes of palpitations a year ago and a medical relative suggested she get an ECG device from AliveCor. The device (had to be bought), was called a Kardia Mobile and it attached to the back of her iPhone SE5. When she got the palpitations she connected to the device with two forefingers, while holding the iPhone, and was able to record an ECG on a downloaded Kardia app. The downloaded ECG recording can be sent as a .pdf file to a doctor or a specialist for review and diagnosis. After a number of recordings she was eventually diagnosed as having an arrhythmia called Recurrent Atrial Fibrillation. She has been on appropriate medication ever since.  Of more relevance is the fact that an e-watch she got for Christmas also shows an ECG, which displayed on the iPhone under health. It is not as expensive as the Apple watch!

 

 

 

 

 

 


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