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Apple Watch ECG Feature Could Take Years To Be Approved In UK (macrumors.com)
One of the most appealing new features of the Apple Watch Series 4 is its electrocardiogram (ECG) sensor that measures the electrical activity of your heartbeat, providing you with a heart rhythm classification that can be shared with your doctor. While the feature will be available later this year in the United States, 9to5Mac reports that it could take years for it to be approved in the United Kingdom. From a report: 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.
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.
I'm assuming that they can still enable the feature, but they just can't advertise it as being an ECG. I think it's kind of cool that they're doing more health stuff as that's what would make me want a smartwatch more than any of the phone integration stuff, but I don't think the features are quite there, or at least not for what Apple wants to charge.
Not sure. In a few months, Brexit. Tough financial crisis follows. UK becomes the 51st US state. ECG feature approved by the US. q.E.D.
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It becomes illegal when you try to spruik it as a medical device. Same stupid reason they won't let me sell my cancer repelling rocks.
Nobody ever measures lives saved by stringent certification against lives lost because everything is delayed years getting certification.
It's essentially a chronic lag of technology behind where it otherwise would be.
A rolling rollout of new things in the proces of being studied would probably be statistically the best.
(-1: Post disagrees with my already-settled worldview) is not a valid mod option.
When the nurse checks your heart rate, she finds out what it is at the moment. Obviously heart rate changes from moment to moment, not to mention day to day. If the device logs heart rate over time, storing hundreds of values, that's one piece of information a doctor can add to whatever other information is available. The exact fact being "the patient's Apple watch reports ...". The doc can then decide to do stress tests or not do them, or whatever else bases on the totality of all of the information available.
If the watch logged a few instances per day of your heart rate suddenly spiking dangerously high, I would hope the doctor wouldn't completely ignore that fact.
That is vaguely similar to Lead 1 ECG
Apple said the same damn thing in their presentation, except without the snarky language.
does it even register electric polarisation in heart? I strongly doubt that. Thus you can not just call it ECG.
Well, they did call it an ECG, and the President of the American Heart Association seemed OK with that when he stood up on stage, so I think I'll take comfort from that.
And get a medic employed to help developers and documentation creators.
Oh please. Apple employs hundreds of medics, physiologists, biomedical engineers etc. Obviously.
If you actually read the article itâ(TM)s clear that they have no actual information to base it on. It basically boils down to âif apple have done zero research and preparation about how to certify this and so are starting from scratch right now, today, it could take a long timeâ(TM), which may be true but itâ(TM)s a rather implausible scenario.
"MHRA requires companies to notify the regulator in advance of a study."
That's the way you should have to do it everywhere - too many companies get away with doing 8 studies and then only publishing the one that showed a benefit.
So the UK is expecting Apple to prove the effectiveness of a product before marketing it as a medical device, what is wrong with that? People relying on things like this for their health need guarantees that it has been properly tested.
'Cmon when I was a teen (1965) I built an ecg and it didn't even take that many transistors. Had to borrow an oscilloscope to see the waveform but I first tested it with a VOM. At what point is it illegal? Sale, Manufacture, or Use? Why not sell it "as is" and "not medically calibrated"?
You don't sell it "as is" because people's lives could literally depend on it. Same as with drugs the point is to avoid people selling medical "treatments" that in reality are just fakes made to make a buck. How do I as a patient know that you are trustworthy and that your device actually functions how you describe unless it is subjected to rigorous and independent testing? Would you trust your life to a medical device made by some random dude in his garage which might or might not actually work? I sure as hell wouldn't and if you would then you are an idiot.
In the US whenever you hear the ads using the phrase "this product is not intended to diagnose, treat, cure, or prevent any disease", that is a fancy legalese way of saying that this product does nothing except separate you from your money and at best is a placebo.
Apple is incorporating some cool technology into their watches but if they want to sell it as device that provides information used for medical treatments then they no longer are just selling a simple gadget. That is a very clear line that should not be crossed lightly. They have to prove that their device works, under what circumstances, used by whom, and with what reliability. Because if they say their watch is an ECG then there are going to be people who take them at their word and think that they shouldn't rely on the advice of a doctor because they (mistakenly) think their watch is a suitable replacement for years of medical training. Don't believe for a moment that wouldn't happen either.