Here is the first ECG I took, using my Apple Watch. Apple just released the software which enables this new hardware feature of the Watch 4, which it announced back on September 12th.

My first ECG taken on the Apple Watch 4

This is a huge step forward for humankind and for medicine.

Twelve years ago I patented a method for detecting AF (Atrial Fibrillation, or Afib), which was used in an implantable heart monitor. To now have capabilities of that highly advanced medical device available in a consumer product is like a dream come true.

On December 6, 2018, Apple released a new version of iPhone and Watch software to enable the new heart rhythm capabilities. There are two different capabilities available in this new release:

1. An AF detection algorithm running in the background all the time you wear your watch

2. The ability to take a 30-second (single channel) ECG when you want.

We create disruptive digital health solutions that leverage data to improve patient outcomes.

The combination of these two features is very powerful. If someone is only occasionally in AF it can be very hard to catch. If they visit a physician and an ECG is taken, that is only a short snapshot of the heart rhythm, and most likely won't indicate the patient's AF. But with this new software update, from the constant monitoring of heart rhythms, the patient can be alerted that they might be in AF. They can then take an actual ECG by putting one finger on the crown of their watch. From their phone, they can send the recording to their physician for review. So this combination not only enables early detection of AF, but then provides a simple mechanism for sharing the data with their doctor.

I discussed the implications of this in an earlier blog: Apple's Watch Series 4 - a demonstration of their new relationship with the FDA? The lines between what is a medical device and what is a consumer device are becoming more flexible, as I described in my recent white paper: The new FDA: navigating the moving line between consumer & medical.

There are tremendous potential benefits to the consumer from streamlining the regulatory process, that can lead to new advancements like this new ECG capability. And similarly, increasing interconnectedness enables new technology leaps, which, in turn, allows companies to expand their reach to new consumers. Take the example of the Propeller Health connected inhaler, which we helped develop, for improving the management of asthma. ResMed saw this as a way to expand their ability to impact respiratory health through their connected ecosystems: ResMed acquired connected inhaler developer Propeller Health.

All these new developments hold great potential for improving our health. But there are potential downsides.

There are commentaries which question the value and validity of the new Apple Watch capabilities. There have been two main areas of critique:

1. This is a single-lead ECG, not the 12-lead ECG used by physicians.

Correct. The new ECG is providing the same information provided by a single-lead Holter monitor, which is one of the standard screening tools prescribed by physicians. The patient wears electrodes on their chest connected to a box that collects their data. In comparison, the 12-lead ECG used in a hospital or physician's office gives spatial information about the nature of any potential arrhythmia - it gives a bit of a 360 degree view of the electrical activity of the heart. However, all the information of the rhythm itself is captured by just one lead. 

2. It will give too many false alarms ('False Positives') - this is when the system informs a user that they may have AF, and therefore should contact a physician, but they don't actually have AF. If this rate is too high, it will overload the medical system, and users will lose faith in this system. Apple submitted data from 588 patients to the FDA to get clearance. There is a good analysis of this in: What did journalists overlook about the Apple Watch ‘heart monitor’ feature?

There will be false alarms. I think the questions to be answered through experience will be:

  • How big a burden will it actually place on the medical system? And what will the returns be, in terms of reduced deaths and hospitalizations, long-term outcomes, and total costs to society?
  • How will users react? Will this provoke anxiety, or peace-of-mind? What will users actually end up doing with this new information?

Long-term, I think this will be a win for our health and for our society. Even if short-term, it puts additional burdens on our systems, over the long term, methods will improve, advances in machine learning will help reduce the burdens, and we'll achieve a sustainable framework for managing self-reported medical data.

Everyone wants more data. A lot of that is being used to convince us to give up more of our disposable income. I'm excited to see more data being deployed to decrease the loss of our disposable health.

Come discuss this and other advances at CES 2019.

Author
David Ritscher
Connected System Architect
With a focus on connected devices, consumer products, wearables, and implantable medical  devices; design of sensor systems, algorithms, DSP, machine learning; experienced in bringing new concepts from ideation to research and development through successful product launch