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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.
Slashdot, fix the reply notifications... You won't get away with it...
'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"?
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He loves Hillary Clinton in 2008. You are a retard lol. Putin bought him cheap, and turned him into Putin's bitch, then his traitor sons and whore daughter. All of them will die traitors in Federal prison. That's what makes MY day, lol.
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That is vaguely similar to Lead 1 ECG, but does it even register electric polarisation in heart? I strongly doubt that. Thus you can not just call it ECG. Call it something else and I will be happy to watch how these devices evolve. And get a medic employed to help developers and documentation creators.
The Galaxy probably did because Samsung actually had a real medical division and makes real medical grade tech. apple is just hawking snake oil and gimmicks.
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.
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.
I can't see many doctors accepting the results from a watch, even if it is approved. Doctors tend to be conservative about these sorts of things.
Oh I wouldn't be so sure of that. Doctor I know (and I'm married to one) would probably regard it as another piece of data - useful for what it tells you and probably very useful for some patients who need monitoring in some circumstances. Some problems are hard to diagnose especially if they only occur occasionally. That said, they probably have to double check anyway for liability reasons if nothing else. After all how do they know your watch is functioning properly, is appropriately calibrated and being used correctly, etc? Any lab or test equipment is supposed to be periodically calibrated (at minimum at time of manufacture) and you can be pretty certain your watch never has been calibrated or tested against international standards. In the event of a lawsuit one of the first things any lawyer worth his diploma would ask is for the calibration and training records for any device used for measurement. Imagine the hilarity that would follow if the answer came back "patient supplied uncalibrated and unverified data from their smartwatch".
'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.
Just like how a lot of things may take long for the FDA in America to approve things. To be classified as a medical device considered good enough to share the data with medical professionals, who will be making decisions that will effect your life from that data then it should be rigorously verified that it works accurately enough.
If you have this device and when measuring your vitals, it reporting an irregular heartbeat not because your body is off, but because the CPU is being over used, because of the animation on the weather app. The doctor may prescribe drugs (they probably should follow thru with additional tests), or more possibly change the dosage of a drug because of a reoccurring condition and the data fault, will make it seem there isn't the correct response to the drug.
If something is so important that you feel the need to post it on the internet... It probably isn't that important.
This can't actually be a real APK post, it doesn't include any bullshit about host files. Try again, troll.
"You're right," Fisheye says. "I should have set it on 'whip' or 'chop.'"
I hope it never gets approved because Apple is not in the business of selling medical devices. There is no way an Apple watch is going to be more accurate or reliable than a true ECG machine.
It is an actual Lead I ECG, but a fairly crummy version that was filtered into oblivion in order to reduce noise.
Full disclosure: I work in big pharma.
The problem is that the decision making process of a medical person in routine conditions (i.e. not field emergencies etc) is only supposed to depend on things that were approved for medical use. Not only drugs go through very strict procedures. Things like heart monitors etc do to IF they are used for medical purposes.
If you wear a cheap fitbit knockoff to help you with cardio training, you can do that for personal use, but your doctor is not going to consider that anything but indicative. That fitbit is not medically certified. It has an unknown accuracy. It may not work correctly in some conditions, etc. He is not going to hinge his diagnosis on what your fitbit tells him unless it is corroborated by alternate and certified sources. The reason is that unless it is certified, he is not supposed to rely on its information.
So yes, your fitbit might provide him with an original clue, and then he needs to follow up with real medical devices. He is not allowed to rely on that data. And if he does, he opens himself up to severe penalties. Otoh, if he uses a medically certified devices that says 'A', then he can rely on it being 'A' without being required to put that data in doubt if it aligns with his medical opinion.
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.
While the national process may be broken, it could still be fixed without completely removing it from the people's control. On the contrary, it is almost impossible to fix a broken EU process. In other words, you managed to use a bad UK policy to remind the brits they were right to brexit.