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About Apple Watch, the ECG app, and health features


What you need to know about Apple Watch, the ECG app, and health features



 Apple Watch Series 5 and its health features can help inspire customers to lead a healthier life. Because the ECG app and irregular rhythm notifications* are government-regulated, it’s important to use the correct terminology when you talk with customers about these features.

Here are key points to share with customers. The words in bold are the most important things to say, and the Remember sections provide you with more context.
What you can say about Apple Watch Series 5, the ECG app, irregular rhythm notifications, and the FDA
  • “The ECG app has been granted a De Novo classification by the FDA. What this means is it’s the first-ever ECG app offered directly to consumers. The ECG app is available on Apple Watch Series 4 or later.”
  • “The irregular rhythm notification has been granted a De Novo classification by the FDA and is available on Apple Watch Series 1 or later.”
Remember: It’s the ECG app and the irregular rhythm notifications that are government-regulated, not Apple Watch. It’s not correct to say that the ECG app or irregular rhythm notifications are “approved” by FDA.
How the ECG app on Apple Watch Series 5 works
  • “Apple Watch Series 5 and the ECG app work together to analyze your heart rhythm in order to provide a classification of sinus rhythm or atrial fibrillation.”
Remember: The ECG app and Apple Watch Series 5 enable this feature, not just Apple Watch Series 5.
  • “The ECG app on Apple Watch Series 5 generates an electrocardiogram, similar to a Lead I ECG.”
Remember: The electrocardiogram generated by the ECG app is similar to a Lead I ECG, but it’s not the same.
  • “The ECG app can indicate whether your heart rhythm shows signs of sinus rhythm, which means your heart is beating in a normal pattern, or atrial fibrillation—a serious form of irregular heart rhythm. The resulting ECG waveform, its classification, and notes that you enter on related symptoms are automatically stored in the Health app on your iPhone. Your health and fitness information, including information from the ECG app, is always under your control, and it’s encrypted on your devices and in iCloud.”
  • “You can share the information with your doctor and have a more informed conversation about your health.”
Remember: The ECG app can indicate whether a customer’s heart rhythm shows signs of atrial fibrillation, but it’s not meant to detect or diagnose AFib or be used for disease management.
Learn more about Apple Watch at
Find out more about the ECG app at

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