When Apple Watch was first released in 2015, it came with a built-in basic heart rate monitor. That pushed Apple into the healthcare sector, as users started reaching out to the company with stories about how the device had saved their life. As the company’s COO Jeff Williams told CNBC in 2017, “We’ve been really surprised with the deluge of letters and emails we’ve gotten where just the simple heart rate monitor was able to have such an impact on people’s lives.”
Now, the company is expected to take these health ambitions a step further by introducing an electrocardiogram or “ECG” sensor that measures the heart’s rhythm—and not just the heart rate.
That’s according to Apple analyst Ming-Chi Kuo, who issued a research note seen by CNBC. The note said that the ECG “will attract more users.” Kuo is known for having a particularly strong track record for predicting updates for Apple products.
Assuming Kuo is correct, Apple releasing an ECG is a big deal for people with certain diseases. But it’s also complicated because the company would need to figure out how to communicate sensitive medical information to consumers without freaking them out.
The last thing Apple would want to do with its device is send tens of thousands of anxious users into the emergency room thinking they’re having a life-threatening medical problem when they’re not.
So after talking to a series of health experts, including cardiologists and technologists, here are some questions we’re asking on the eve of the event:
Will Apple need approval from federal regulators?
It depends.
If Apple shows the ECG reading to a consumer, then yes. That would make the Apple Watch a regulated medical device.
But Vic Gundotra, CEO of AliveCor, a start-up making big waves in the space, sees another path. He suggests that the company could use the ECG to get more accurate heart rate data, which wouldn’t necessarily require an approval process. That’s because Apple might not want to take on the risk of providing erroneous information back to a user.
If Apple decides to go down the regulatory route, the company faces another decision. It might need to the green light for its ECG sensor as well as the algorithms that sit on top of it that provide feedback to users (“abnormal” or “normal”, for instance). AliveCor did that, so we know it’s possible. As Gundotra recalls, the FDA approved both the algorithms and the hardware at the same time.
