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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.
Yes, the Democrats certainly victimized her. Looking at you Feinstein.
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.
SJW n. One who posts facts.
"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.
A company who does an EKG test on me, creates a health record. There are strict privacy rules for what they can do with that (or gov. revokes their licence to do business).
An apple watch is not covered by that - unless some medical co uses apple watches for EKG procedures.
If I use my apple watch to get myself an EKG - that too is a medical record. But it is MY OWN medical record. While corporations & doctors are under the strictest of rules, I can do what I want with MY RECORD. I don't have to "store it in a safe way to ensure privacy", because I am allowed to violate my own privacy. I can post my own EKG on facebook if I like. (One gotten by using an apple watch myself, or the one my doctor's lab provided me.)