Yes, short answer that the Apple Watch is not approved as a medical device (that is, the ECG function component) by the authorities in either country.

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?

Davy: Well our approval process must be incredibly rigorous then, because it was approved by US authorities way back in December 2018. You would think that our bureaucrats could simply take a look at the US approval documents and sign it off, yes?

That's kind of what happens when your company has the biggest cash reserve in the world and is based in the same country as the people certifying the device.  

Davy: Well our approval process must be incredibly rigorous then, because it was approved by US authorities way back in December 2018. You would think that our bureaucrats could simply take a look at the US approval documents and sign it off, yes?

The NZ and Australian requirements are a lot stricter than the US, and the FDA decision ruffled a lot of feathers how it was handled. Just because something is FDA approved does not mean it is (or should) be approved automatically in other countries. Likewise the FDA refuse to approve many medical devices and drugs that the rest of the world has.

I recall reading not long before Xmas that Apple still had yet to make any official application yet in Australia to have the product approved under the therapeutic goods act.

sbiddle:

 

Davy: Well our approval process must be incredibly rigorous then, because it was approved by US authorities way back in December 2018. You would think that our bureaucrats could simply take a look at the US approval documents and sign it off, yes?

 

The NZ and Australian requirements are a lot stricter than the US, and the FDA decision ruffled a lot of feathers how it was handled. Just because something is FDA approved does not mean it is (or should) be approved automatically in other countries. Likewise the FDA refuse to approve many medical devices and drugs that the rest of the world has.

 

I recall reading not long before Xmas that Apple still had yet to make any official application yet in Australia to have the product approved under the therapeutic goods act.

 

I cannot agree, in this case. There is no point in NZ trying to duplicate US approval for apple ECG.  By all accounts, it is already saving lives.  And accuracy is very good. 

Why don' t they just say that it isn't necessary accurate and is just a guide and not a proper medical device, and not a replacement for a proper ECG, so it doesn't need approval? Is the heartrate sensor in devices approved?. Surely it could be saving lives if it was available here today

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

mattwnz:

 

Why don' t they just say that it isn't necessary accurate and is just a guide and not a proper medical device, and not a replacement for a proper ECG, so it doesn't need approval? Is the heartrate sensor in devices approved?. Surely it could be saving lives if it was available here today

 

They already do this in the states.

Reality is there are many technologies and ideas that have been built for other markets that implement poorly in NZ. Google's refusal to launch most of their products here and support them directly, Apple's frankly baffling avoidance with their home speaker already in use in australia are just two.

I find it frustrating there are many useful medical devices in other markets that just take way too long to get here if at all.

You can see the opportunity risk for Apple; to launch it saying 'we warned you' and people start dying, is the best way to tarnish your rep. What good is portable ECG machine if your doctor or the hospitals wont even acknowledge it and what it could be saying? MoH has come out with reports on the effects on human health, and there is still a huge part of this country who are convinced it will destroy the planet and all life therein.

In some ways NZ is an advanced market (FTTH for just $40US/month, seriously?), but in others (eSIM support, looking at you 2D) we lag. So the market gets passed over....

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?

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.  

 

Yes, if it was not accurate. But, it seems the apple watch is fairly accurate. 

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.  

 

True, but not sure if that is a problem in the US. And if it was, I would have thought they would expect apple would be getting complaints from medical institutions that they weren't happy. Both NZ and Oz have tiny populations compared to the US.

surfisup1000:

 

Yes, if it was not accurate. But, it seems the apple watch is fairly accurate. 

 

Clearly there are unanswered questions about that if it's taking so long to certify it outside US.  

gehenna:

 

Clearly there are unanswered questions about that if it's taking so long to certify it outside US.  

 

Exactly - it's only been certified in such a small number of the markets it is being sold in.

mattwnz:

 

True, but not sure if that is a problem in the US. 

 

It'd be hard to analyse US hospital stats effectively in this case given there is a large subculture of American's that won't go to the hospital at all because of insurance ramifications.