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THREAD: Sometime in the next few weeks I'm expecting Apple to switch on its ECG function on its watch in the UK.
Apple is not ready to discuss how this device will be approved. Nor whether it has provided any data on its watch to the health services such as @NHSEngland that will have to handle patients.
Watch approval will *probably* be a CE mark as a class 2a medical device, granted by private firms known as notified bodies. These assess if a product sold meets certain standards. You have no right to information from this process.
If the ECG is approved prior to Brexit then the approval will apply to the UK and all EU countries.
In America, the Apple Watch ECG has been credited with saving lives. Many, though, worry about false positives (and to a lesser extent false negatives)
There is another issue. Because the watch is expensive, it is potentially a new health screening programme just for the rich. Yet another, bigger, issue is that...
...in the context of public health systems, having corporation decide that the UK, or any other country, is setting up an afib screening programme creates a health priority outside of the normal (and democratic) way in which such priorities are decided.
Three public health academics @felly500 have written to the @NHSEngland and its boss asking it to consider its position with regards to the Apple Watch (as well as other new diagnostic technologies). blogs.bmj.com/bmjebmspotligh…
In many ways, the issue is emblematic of what will be a growing conflict between new health technologies that individuals may want or need, and how societies decide to spend money in order to maximise health.
On the watch, public health systems have to decide how to allocate resources to follow-up screening and the protocol that GPs should follow when worried patients turn up. Will they have enough information to do this? It is hard to see they will.
New results on the Apple Watch are expected next week. statnews.com/2019/03/14/car… h/t @matthewherper Will this tell us more? Not enough suggests...
@cardiobrief. Observational studies like this can't say what happened to people who didn't use the watch. That means we can't weigh the risks of using the watch as a screening device. statnews.com/2019/03/15/app…
If many irregular rhythm in younger and middle aged users are false alarms, how do we decide who to follow up? Who needs blood thinning drugs? Who needs yearly appointments with the cardiologist? How worried should patients be?
In short, we don't know whether Apple's ECG is going to be a good or a bad thing yet in public health. Even if it is marginally better than not doing it, there is still a question of who decides where the next healthcare pound or euro is spent.
New health technologies have great potential for good. @erictopol But also can increase the cost of healthcare, lower productivity, worsen inequality and cause harm. That is why the job of deciding how, and if, they are used rests in the hands of doctors rather than tech nerds.
Tim Cook has said Apple's biggest legacy will be in health care. That legacy is just starting to be written.
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