Let's cut to the chase here. it's a toy on your wrist that can't tell any sentient human being what they don't already know.
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ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom
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The UK wasn't the country that gave the world a coffee cup emblazoned with the wise words : "caution may contain hot liquid"
What's the trouble with Apple Pay in the UK? Works fine for me.
The problem with all this is that the commies in mainland China are actively trying to stop the innovation Apple is trying to bring to the people.
Privacy and all associated with it. A secure OS, encrypted storage, esims, accurate mapping and open search.
Apple is doing the Chinese people a favour by making a dual SIM card phone. This is a special version because of the ridiculous restrictions the communists have mandated.
I live in HK too and the utter backwardness of the government and institutions is what will block the health related features here. I’m sure Apple will be able to bring the new technology in after the Chinese manufactures are given a head start. FWIW, Tesla has been hit with the same idiocy.
So why not do what I do and keep a US iTunes account? Problem solved.
Not surprising EGG having issues in UK. no When Apple pay is also not everywhere else either. And it's been out longer.
So our country is damned and you have an issue with chasing tax dodgers? Well I quite like the idea that we have robust testing and approval processes....and if that means approving a gimmick on an expensive trinket takes a little time, so be it. Maybe Apple shouldn’t be so disingenuous to promote features that were clearly unavailable without overtly sharing that information.
We've had Apple Pay in the UK for years. The state of Apple pay in other countries has absolutely no bearing on the ECG in the new Apple Watch gaining approval from the UK health authorities.
Apple Pay not being everywhere is due to retailers not updating their terminals to accept contactless payments. Anywhere contactless is available Apple Pay is Available.
I find it more amazing that the USA still uses magnetic strip and signatures for card verification, the staff didn't even bother checking the card when I last used one (a few weeks ago).
I also fail to see how the two compare since it's up to the retailers to support Apple Pay and not some government body, where I work we don't support it because of our bespoke till software while I use Apple Pay all the time in places which does accept it.
If you mean the comments section, too late.
Apple is now touting the watch as a medical device. Heart monitoring and fall detection are two of the most prominent features.
Apple has committed to this and has informed Regulatory agencies around the world that their intentions are to be a player in the world of consumer and at least in medical monitoring.
Apple can and has stated what the capabilities of the watch are. They were very specific in saying they have obtained FDA approval and working with regulatory agencies around the world to make the feature available.
Apple has had to been working on this for at least 3 to 5 years. Even fast tracking takes this long.
Be sour all you want at apple. Many technology based devices have features built in that are not turned on.
Apple has promised nothing but has said they have the technology to provide these features.
And yes Hawaii is a state and falls under US FDA jurisdiction.
Attorneys are usually very expensive, but you're playing Apple's defens ecounsel for free. Amazing
Regarding some comments that it might be enough to use a USA apple account to get the ECG function I do not believe that this would be enough.
In the series 3 watch the heart rate variability (HRV) is not enabled for watches sold in South Africa, China, Malaysia and Turkey.
t has no effect to change the Apple ID. The serial numbers of the watches are coded to these locations and the firmware seems to lock out the HRV of these devices regardless of apple id.
The same will most likely apply to the S4
In the series 3 watch the heart rate variability (HRV) is not enabled for watches sold in South Africa, China, Malaysia and Turkey.
t has no effect to change the Apple ID. The serial numbers of the watches are coded to these locations and the firmware seems to lock out the HRV of these devices regardless of apple id.
The same will most likely apply to the S4
BREAKING: Capitalist corporation doing what they can to max their profits and focus on their main market. News at 6
Been in the industry for a while. Written thousands of pages regarding the regulatory subject matter.
There are always a lot of questions, doubt and then the other evil side of those that see a new idea as a threat and feel they have to squash it.
This technology is empowering to the individual.
Me, I applaud the FDA for giving the green light.
Other agencies, hopefully, are taking the watch and see approach. For the short term
You can argue the hypochondriacs will be bouncing into their doctors offices at a single data point.
I would argue, make it feature available. The life it saves may be yours or mine.
How do you get your gadgets listed you have? I see most people have them in the comments but I don’t you can list them in a comment
Health Canada approval does not mean that the safety and efficacy of a device have been fully worked out. Caveat emptor.
[doublepost=1538210382][/doublepost]I was wondering if anyone knows I go to the USA and purchase the watch, will I be able to use the ECG feature back in Australia? Sine the serial number is for a US watch?
Earlier this month, Apple unveiled the Apple Watch Series 4 with a new electrocardiogram (ECG) feature that measures the electrical activity of your heartbeat, providing you with a heart rhythm classification that can be shared with your doctor. The feature isn't out yet, but it will be limited to Series 4 models in the United States later in 2018.
Today, 9to5Mac shared a potential time window for the launch of the ECG feature in the United Kingdom. The Medicines and Healthcare products Regulatory Agency (MHRA) explains that the process starts by examining Apple's documentation surrounding the ECG feature and performing an audit of the quality assurance system.
While this step doesn't appear to be lengthy, the proceeding steps could make the process longer. MHRA says it would require Apple to perform a new clinical investigation to judge the effectiveness of the ECG on Apple Watch, but Apple would likely not be able to use any of the data from the studies it's already completed because MHRA requires companies to notify the regulator in advance of a study.
Once the study is submitted, MHRA has 60 days to approve it (which may become longer if the regulators have further inquiries for Apple), and then Apple can begin the study. These last few steps are what the MHRA say "could potentially add years" onto the debut of the ECG in the UK. Despite the potential for years-long approval, Apple may find ways to expedite this process. While the United Kingdom remains part of the European Union, it's possible that Apple could receive approval from a broader regulatory body and sidestep the MHRA's processes.
In the United States, Apple has obtained de novo FDA clearance for the ECG feature in the Apple Watch Series 4 and the feature that can send a notification if an abnormal heart rate has been detected. However, FDA clearance is not the same as FDA approval and the FDA does not recommend that the ECG feature be used by those under 22 or those who have already been diagnosed with atrial fibrillation.
The FDA warns that Apple's ECG app is not designed to replace traditional methods of diagnosis or treatment and is intended for informational use only.
Elsewhere, Apple has said it is working with Health Canada to bring the ECG functionality to the Canadian market, although no timeline has been specified.
Article Link: ECG Feature on Apple Watch Could Take Years to Be Approved in the United Kingdom
i am in healthcare, and no, devices do not need to be FDA approved, but it gives validation to any device and allows doctors to bill for the interpretations that their patients send them. I believe last time i looked the average reimbursement was abut $7 per interpretation that the doctor do from devices like this. Doesnt sound like much but imagine you are a cardiologist and you have an app that notifies you every time one of your patients does an ecg reading and you look at it for a few seconds and verbally dictate a 1 sentence interpretation into the phone which generates an official report with your digital signature and uploads it to the patients electronic medical record and bills the insurance automatically each time. It will also allow you to immediately send an alert to the patient telling them to go to an er if required.
I think apple assumes FDA approval is imminent and wants to come out of the gate as an FDA approved device/feature (the first of its kind on a watch) so there is no confusion.
I have used this device > and its a great feature https://www.alivecor.com/
the ECG will never be fda-approved. See my other posts in this thread as to why. Also, I’m not sure if there are any additional clearances required or not. They already have 2 from the fda.
I had about 4 ECG's carried out on me about 2 weeks ago when it was thought I was having a heart attack. The machine they used was quite big and was on wheels, many wires were attached to my body with stickers and read outs were printed in real time. [Sarcasm] I am glad that Apple have managed to get all the above with a device that has multiple uses and attaches to the wrist [/Sarcasm]
Apple isn't claiming or even suggesting that they can compete with professional lab equipment, so your sarcasm is unwarranted.