ECG of the Apple Watch Series 4 years in the United Kingdom: and in Italy?
During the last Apple keynote held on the 12th of September in Cupertino, the company apple presented the latest version of its smartwatch, the Apple Watch series 4. One of the most interesting and the most useful that the Apple executives presented on the stage of the Steve Jobs Theatre is the opportunity, through the clock, to make an electrocardiogram of the person who wears it. All this is possible by means of the sensors for the heart rate under the clock and a new sensor placed on the digital crown of the Watch. A study conducted by Apple has confirmed that the rate of accuracy of the ECG on the watch is 98%.
In the US, Apple has achieved, after 24 hours from the presentation of the new Apple Watch, the permission from the FDA to use the functions in the ECG of the wearable device. In the United Kingdom, however, the situation seems quite different. In fact, here the devices of this type must be certified by the MHRA, the agency that regulates medical products and health care. It should examine the documentation provided by Apple and make sure that the parameters of effectiveness and reliability are met.
Unfortunately for Apple, however, the tests carried out previously in the USA, are not valid in the United Kingdom and should conduct a new clinical trial to test the effectiveness of the measurements of the Apple Watch Series 4. Apple should inform the MHRA 60 days prior to the beginning of the test, and then start it, only after having received a positive response from the agency, which has an additional 60 days to review the requests. This procedure, therefore, could be very long.
In Italy, as in the rest of the European Union, instead, the situation seems not to be so difficult, since enough only Country that certifies the new Apple Watch as “CE” in the ECG feature to allow Apple to launch throughout the European Union.