Why is ECG App Not Available on Apple Watch Series 4 outside the US? – Demystifying the mystery

With the release of watchOS 5.1.2, ECG app is now only available to Apple Watch Series 4 users in the US. Before the launch, it was assumed that just like other geo-restricted apps, even ECG app would be accessible by changing the country location in Settings. However, that’s not the case; using ECG app outside the United States, Puerto Rico, Guam, and US Virgin is literally impossible.

Most of the watchOS users besides the above-listed countries were highly disappointed, and they took it on the internet to pour out their frustration. Some users even tried to find a loophole to get their hands on the ECG app, but they failed miserably. If you have landed on this article, you are likely to be one of the frustrated users trying to find the answer to why ECG app is not available outside the US. That’s precisely what we will discuss here.

Why is ECG App Not Available on Apple Watch outside the US?

Heart Health is a big deal

When a company designs a product or a feature that deals with lives of people, they make sure that it is 100% accurate and perfect for the location. ECG is one such app that deals with a critical health-related subject – heart.

Take an ECG directly from the wrist
GIF Credit: Apple.com

Well, I am neither a health expert nor a certified doctor, but I do understand that geolocation has a significant role to play on anyone’s health, especially heart. Apart from that, lifestyle, food habits, work environment, etc. also play a vital role in determining heart health.

It does not make sense to generalize ECG app for all geolocation even though symptoms of heart diseases are almost similar around the world.

Lack of research study in other countries

In its press statement, Apple states, “The irregular rhythm notification feature was recently studied in the Apple Heart Study. With over 400,000 participants, the Apple Heart Study was the largest screening study on atrial fibrillation ever conducted, also making it one of the largest cardiovascular trials to date”.

For launching the ECG app, Apple had enough data for the US and some of its territories, but that’s not the case with other parts of the world. Apple will need to conduct studies with participants of the countries where they plan to launch the app. As said earlier, when health is involved, it is better to delay than to regret.

Regulatory limitations

Irregular Rhythm Notification on Apple Watch Series 4
Image Credit: Apple.com

The above research data was submitted to FDA to prove the accuracy of ECG app and the same was granted De Novo classification by the FDA. Also, certain risk disclosures were asked to be made to the user. But in the end, approval allows Apple to launch the app successfully. But again, that’s not the case with other countries.

Every country has a centralized body for health and drugs. Apple will need a positive clearance from every country they plan to launch the ECG app. Launching it without approval is not a sensible idea.

That’s all from my side!

Signing off…

I do understand that restriction to such a useful app is a big disappointment. At the same time, a health app that may not deliver accurate data in your country is also not recommended. With that said, I’ll rest my thoughts here and ask you what are yours?

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