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I think we’re being naive thinking that Apple aren’t already well into this process already.

Agreed and with the previous device that Apple themselves sold in stores already gaining UK approval, before the US even, it would be hard to think this is going to take years
 
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Wait, so you can't even activate it in the UK for your own purposes? What about if you buy one in the US and then bring it over?

I'm wondering the same about the Chinese dual sim versions. I'd prefer the option they have there, but wondering if one slot will be region locked.
 
It is amazing that the UK government has to treat its citizens like babies who can't be trusted to make decisions for themselves. How about giving people the freedom to decide they want to use it or not? Sure, if they need to have a ton of disclaimers, go ahead.

Talk about heavy-handed, paternalistic interference in people's lives.

You're talking about a country whose people think nothing of ringing the emergency services when their dial-a-pizza is late or missing the jalapeños.

Well, I'm not surprised that governments that control healthcare would not like the Apple Watch ECG.
Just another benefit of government controlled universal healthcare. The best preventive care... last.

It's cute that you consider the Apple Watch to be the best preventative care.
 
And for those who have an avoidable heart attack because their gadget said they were OK and so they didn't visit a doctor?
Does the Apple Watch ever say that the wearer is ok or does it provide heart data that needs to be interpreted and only warns of user preset events?
 
When it comes to medical devices - the regulations are there for a reason - to stop ineffective or quite frankly BS devices being sold. I.e. if you're going to sell a medical device, you need to be able to back up your claims with a clinical study.

I honestly don't believe Apple didn't realise this/know the timelines involved. I'm assuming that either:

a) They're already going for an EU-wide license, so aren't bothered about the UK specifically (which will, of course, still be valid post-brexit); or

b) They're basically using this as a US trial - in order to gauge how well it works and get reactions, before rolling it out to other nations which have stricter checks.

Other reports seem to suggest option A - http://www.idownloadblog.com/2018/09/24/apple-watch-series-4-ecg-app-europe/
 
I am aware of the fact, that this is a very particular functionality, that deserves a profound introduction strategy.
Nevertheless: Please Apple. Getting my money is not BASIC programming à la IF - THEN - ELSE.

I buy the roasted chicken WITH ketchup. If you need further investigation on the ketchup - just sell the chicken with optional ketchup. I am not buying the "chicken with ketchup" at the price "with ketchup", if I finally may not get the ketchup at all. Please just add "mustard" if "ketchup" finally fails or takes ages to get delivered.
 
Can you imagine the lines at NHS A&Es of hypochondriacs? No thank you!
A watch wouldn’t stop that. It’s already happening
[doublepost=1538068226][/doublepost]The U.K. is notorious for red tape bureaucracy. Of course regulations are needed and safety test studies done but the U.K. runs on a capitalist money making machine. Any excuse to stretch out processes further than needs in order to maximise money made.
 
No surprise there NHS do not want someone running in for free checkups due to false alarms etc

Maybe, but it's not "free" is it, and this is the future. just the first steps.

The NHS should appreciate the fact that rather than explaining symptoms that may come and go but aren't present during your 10 mins with your GP you can now show them some data. Currently if you have intermittent symptoms you can be given a device from the NHS to do this work anyway.

The FDA are an incredibly hard regulatory body to please, I work with medical systems for a living. Some of this work should be valid for use here.

It's this backwards & slow, archaic thinking that holds us back these days, even when the tech is there. Same with autonomous cars. We need to embrace the future not be scared of it. The NHS needs all the modernisation it possibly can in my opinion, it's like stepping back into the 1990's in places.
 
Medicines and Healthcare products Regulatory Agency just want their palms greased. Europe is famous for waisting time via regulations. Nothing like log jamming a digital watch feature.

No, what we Europeans are famous for is a world-class healthcare system, which works in large part due to regulation. It sucks having to wait, but the reward is worth it.
 
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I think the USA FDA Clearance is harder than Europe, Canada and Australia. Qardio has been trying to get the ECG/EKG monitor approved for years in the USA. Their QardioCore is available in Canada, Europe and Australia. It's even available on Amazon in the UK. For some reason it's been held up in the USA.
I've been thinking about ordering on Ebay.
 
I am aware of the fact, that this is a very particular functionality, that deserves a profound introduction strategy.
Nevertheless: Please Apple. Getting my money is not BASIC programming à la IF - THEN - ELSE.

I buy the roasted chicken WITH ketchup. If you need further investigation on the ketchup - just sell the chicken with optional ketchup. I am not buying the "chicken with ketchup" at the price "with ketchup", if I finally may not get the ketchup at all. Please just add "mustard" if "ketchup" finally fails or takes ages to get delivered.
This may be the most confusing thing I've ever seen.
 
Its not the fact that people need this feature, or maybe they will only use it once a year. It's the fact that Apple promise and show off all these new features on a new device, some of them quite substantial, but fail to mention that the feature won't even be available to use when you purchase the device.
When will I be able to use that said feature? A year down the line when the 5th gen is released? Why make such a song and dance about this 'huge' new feature that you know a majority of your customers cannot even use?

Thats like me purchasing a convertible vehicle, to then be told I can't put the top down just yet. A rather attractive selling point, but I cant even use it until an undisclosed date!

Sorry, but I'm not going to purchase something with a particular feature when I don't even know when I will be able to use it. Or if I will be able to use it!!
 
What happens if you buy an Apple watch in the US. Will this feature work in another country?
 
Surly a company with billions and billions of dollars, the life-saving stories that will appear when the feature is available elsewhere, and a large outcry from the UK citizens will speed up the approval process.
I hope not. They need to approve things properly, not just because of pressure from the non-medically trained public.
 
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As a clinician, I think that the new apple watch and specifically the ECG capability is a huge technological step forward. With that being said the QUALITY and usefulness of this 1-channel recording probably will be limited at first (I'm thinking of the amount of filtering needed in even modern devices and under hospital conditions). What this little devices will be capable of in a few years however is amazing to think about.
 
Getting a medical device cleared is not trivial but this article is flat out wrong and uninformed. Clinical data from the US can and is regularly used for clearance in Europe. Technical files are produced directly from US design history files with a few basic changes and CE is actually a lower bar for various reasons not topical here. Apple will certainly already have a notified body in the UK and are in process. Whoever wrote the article isn't in the medical device business, but did perhaps stay at a Holiday Inn Express last night.

Yeah but it gave ill-informed Murcans a chance to vent about socialism in Europe.
 
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