This is not Apple's core expertise. They can make great products, but medical products educational or otherwise demand a rigorous process in order to gain clearance. ECG is a major addition and evaluator of health condition. As someone else here stated, these regulatory bodies do not want patients using this information for self diagnosis to then go and waste very very tight resources in their specific regions, especially the UK, which there are waiting lists months and months long to just see a doctor.
to make it even more difficult, the EU is releasing more stringent requirements, even tougher than the FDA come May 2020. This will require that basically any medical device be monitored and tracked with documentation from a clinical coordinator to report the safety and efficacy of the product on an ongoing basis. If you cannot prove it in a clinical environment, they will deny further access to the market. As you get into regions like Japan and China, these regulations become tougher and tougher.
The best way is to conduct a global clinical study in order to prove the validity of the claims. If you want China in the mix, this study needs to include a specific amount of asian population otherwise a separate study is required in China itself, with the only advantage is that it is manufactured in China and gives them a little head start in the process ...
This is what I do for a living, and I have simpler things that I have released that give us headaches and take years to release, not to mention a DeNovo clearance in the US with FDA is actually quite rare and they are actually lucky to have even gotten that! I wouldn't be surprised if they have to have a pop up every time you activate the ECG to say that it is not a diagnosis and they should see their doctor if they have any concerns regarding their condition. etc ...
Maybe I need to get a job with Apple
