Apple may not receive the necessary approval from the U. K.’s MHRA regulatory agency to use the electrocardiogram feature on the Apple Watch Series 4 until a clinical trial is completed. This could take years to accomplish. Apple may not receive the necessary approval from the U. K.’s MHRA regulatory agency to use the electrocardiogram feature on the Apple Watch Series 4 until a clinical trial is completed.
A few days ago, we told you that it took a last second letter sent by the FDA to Apple to keep the Apple Watch Series 4 from being a no show at the September 12th “Gather round” event. In the letter, the FDA approved the ECG feature on the timepiece. The electrocardiogram can help detect irregular heart rhythms, making it an important personal health tool along with the heart rate monitor on the watch.
There have been some concerns about the ECG on the Apple Watch, because it uses only one lead compared to the 12 leads used on a standard ECG test performed in a Doctor’s office. Despite that, the ECG feature on the smartwatch did have a 98% accuracy rate in detecting AFib in one test (20 million patients worldwide have this serious condition). Still, the FDA gave its blessing with the warning that no clinical action be taken on the basis of the Apple Watch’s ECG “without consultation of a qualified healthcare professional.” In the U. S. the feature will be enabled following an OTA update later this year.
In the U. K., Apple Watch Series 4 owners might end up waiting years before the ECG feature shows up on their wearable device. Approval there requires approval from the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA would have to examine documents provided by Apple and feel assured that the electrocardiogram feature is not only effective, but is also reliable. Apple might also be asked to repeat a clinical study. While Apple has done this already, the MHRA likes to know in advance when such a test is being run. 60 days prior to the start of the clinical test, Apple would have to file its intentions with the agency. A brand new clinical trial could take years.
Since the U. K. is still in the EU for now, there is a workaround. Apple could file with a similar regulatory agency from another EU country, like Germany. The restrictions are not as onerous in that country, according to a German cardiologist. The German Doctor says that approval in that country could come quickly. If Apple were to get approval from the German healthcare agency, it would have approval from all EU countries, the U. K. included.
