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Apple Watch ECG Feature Could Take Years To Be Approved In UK (macrumors.com) 87

Posted by BeauHD from the feeling-left-out dept.
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.
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Apple Watch ECG Feature Could Take Years To Be Approved In UK More

Apple Watch ECG Feature Could Take Years To Be Approved In UK

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  • Does it even need to be? (Score:4, Interesting)

    by alvinrod ( 889928 ) on Thursday September 27, 2018 @08:23PM (#57387954)
    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.

    • Re: (Score:1)

      by Anonymous Coward

      If it's a "medical" device it has to be all kinds of certified to do "anything" really. Even store EKG info, because medical privacy laws. Of course they can roll out some compliant lesser-version for the UK with different kit.

      But the idea was to have people show this data to their doctors and have doctors make decisions based on that, so obviously that's going to require certifying.

    • I know it's a long way from an ECG, but my smart watch can take my heart rate, and seems to be accurate.
      When I go to give blood, the nurse insists on checking my heart rate herself though.
      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.

      • 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 availa

      • 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 be

    • Re: (Score:1)

      by Anonymous Coward

      Yes, it's only an issue if they want it to be used by doctors, rather than simply by end users.

      If they want the medical profession to treat it as a medical device, then it needs to go through all the hurdles a medical device does. If they're happy with it being just another gadget then they don't need to do anything.

      So it's really down to how they want to market it, if they want to market it formally as a medical device that can provide data to doctors, then they need to go through the clinical trials that

    • We can have the feature, but because it isn't approved, the Doctors will not be able to perform actions based on its data, or use the data as part of an official study. Much like sleep cycle alarm clock, or the pulse reader from combining the flash LED with the phones camera. Kinda fun toy which you may be able to get a ball park. But other then that you can't use it for any meaningful use.

      • We can have the feature, but because it isn't approved, the Doctors will not be able to perform actions based on its data

        Wow...so, there are laws over there the limit your doctors to ONLY using information from government blessed tools? No independent observations?

        Frankly, that's a bit scary, I'd want my Dr. to be able to use ANY information they could gather by whatever means.....I'm trusting my Dr. to balance all information avenues as to how much weight to put on any of them, based on their medical tr

        • 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 any

  • Years to be approved (Score:4, Funny)

    by hcs_$reboot ( 1536101 ) on Thursday September 27, 2018 @08:37PM (#57387994)
    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.

    • Re: (Score:2, Interesting)

      by Anonymous Coward

      The Queen welcomes the colony that got away back to the loving arms of the British Commonwealth, Trump voluntarily pledges allegiance to the Queen and the nation gets its first prime minister, wearing an Apple watch. Apple watches become a success throughout the Commonwealth. And not a single armored suit was powered up for it, for the private East-Indian Trading Company army, double the size of any nation state army in Commonwealth, is no more.

      • Re:Years to be approved (Score:4, Funny)

        by drinkypoo ( 153816 ) <drink@hyperlogos.org> on Thursday September 27, 2018 @08:56PM (#57388072) Homepage Journal

        The Queen welcomes the colony that got away back to the loving arms of the British Commonwealth, Trump voluntarily pledges allegiance to the Queen

        Not a chance. If Trump were to pledge allegiance to anyone else, it would be his boss Putin.

        • I wonder why Trump's boss is not making him remove the current sanctions on Russia and why he's allowing him to impose fresh ones.

          • I wonder why Trump's boss is not making him remove the current sanctions on Russia and why he's allowing him to impose fresh ones.

            It looks good. Also, the new sanctions will have little effect because Obama already placed sanctions on equipment with military benefit.

            • It looks good to who?

              • It looks good to who?

                To Trump's base, without whom he is nothing. In the court of public opinion, when Trump is accused of being a Russian asset. For the record, I don't think he knows he's an asset. I think he's a useful idiot, being manipulated by Putin. Trump thinks he's a player, but he had no experience playing the game at this level. Putin, on the other hand...

                • A lot of Trump's base like Putin and think he's a great leader but aside from that Putin allowing policies that hurt his closest allies financially when he allegedly has the power to have sanctions loosened sounds unlikely.

                  There are multiple reasons why Trump is in the White House. Putin may have been a factor but he's not the only one and I think you're giving him more credit than he deserves

      • Re: (Score:1)

        by Anonymous Coward

        And then the French come raping and hon hon hon'ing into the picture, swearing unintelligibly and knocking out grandma Queen with a crusty baguette before making off with poor Boris Johnson, mistaken for a Christmas ham.
        In the final scene Boris desperately calls for help from patriotic Britons, who at this point by definition ignore his wolf cries entirely, and horror overtakes him as he realizes the Apple watch is not actually a phone! The oven door closes.

        Fin

  • '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"?

    • 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.

      • Re: (Score:1)

        by Anonymous Coward

        REEEEEEEEEEEEEE too much govt regulation!!!!!! why can't i buy the cancer rocks you're infringing my freedom

    • '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

  • 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.

    • Re: (Score:3)

      by shilly ( 142940 )

      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.

    • That is vaguely similar to Lead 1 ECG, but does it even register electric polarisation in heart?

      It is an actual Lead I ECG, but a fairly crummy version that was filtered into oblivion in order to reduce noise.

  • But why bother (Score:3)

    by Impy the Impiuos Imp ( 442658 ) on Thursday September 27, 2018 @11:05PM (#57388446) Journal

    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.

    • And that's how you end up with devices like Fitbit, which report "calories burned" with very little correlation with reality.

      • My Garmin watch tells me how many calories I've burned too. I don't necessarily believe the actual number (that's not too important), what is very useful is seeing the relative difference between activities. If I see a drop it means that I either haven't worked as hard as I could have, or that I need to increase the load (ie distance cycled or walked).

        There are of course people who will take those numbers as gospel and those people are likely to do the same with Apple's "ECG", which is no doubt what the con

    • Re:But why bother (Score:4, Insightful)

      by serviscope_minor ( 664417 ) on Friday September 28, 2018 @01:27AM (#57388678) Journal

      Nobody ever measures lives saved by stringent certification against lives lost because everything is delayed years getting certification.

      Indeed not but certification requirements didn't come out of nowhere. It used to be a free-for-all and that caused real problems too.

      An on the flip side of what you've said people have recently started to look at the lives lost by excessive medical diagnostics. There now exist poplation scale screening for certain conditions (generally types of cancer). It's very hard to tune the false positive rate; you don't want to miss real cancer, but if the FPR is too high, it can send a lot of people for further treatment some of which will go wrong.

      • Re: (Score:2)

        by JD-1027 ( 726234 )

        FPR is too high, it can send a lot of people for further treatment some of which will go wrong

        This can't be correct. No one would be sent to treatment with something that has anything but a very low FPR. You would send to them to get further diagnosis with something that has a extremely low FPR.

    • Re: (Score:2)

      by Bert64 ( 520050 )

      For devices such as these there is no health risk of using them, and thus you are free to use them for personal use despite them not being certified. What they won't do is use the resulting data as part of a medical diagnosis.

  • 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.

    • I see you've never dealt with the UK government. Just because you have the right to something, the entitlement to something, and even the necessary paperwork completed doesn't mean you're not in for a world class bureaucratic experience.

  • Quite Encouraging (Score:2, Insightful)

    by Anonymous Coward

    "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.

  • Evidence backed claims (Score:3)

    by Going_Digital ( 1485615 ) on Friday September 28, 2018 @05:01AM (#57388980)
    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 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.

  • Yeah, tell me again why national healthcare is a good idea. No matter what you say, you're wrong.

  • 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.

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