Will You Be Getting Your Folks an Apple Watch for Christmas?

In all the flurry of phone-related frenzy, Apple showcased the latest version of the Apple Watch, Apple Watch Series 4, the fifth version of the smartwatch since 2015. It's one of the few over-the-counter devices to offer ECG (electrocardiogram) readings and includes a feature that detects cardiac arrhythmias, such as atrial fibrillation, as well as a Siri-connected fall detection monitor.  

To receive an ECG, users touch the Digital Crown (the bit on the side that you wind), and after 30 seconds, they will receive information on whether their heart is beating normally. Users can then see their heart’s reading and information in the Health app, which can be shared with physicians.

It's far from Apple's first foray into the health space, creating life-changing health tech. You may recall the story when a man's Apple watch was able to alert him to the early stages of a heart attack while wearing the device for sleep tracking. The Apple Watch woke him up around 1 am with an alert from a third-party app called HeartWatch, saying his resting heart rate was elevated while sleeping (Apple introduced a built-in capability of this functionality from Apple Watch Series 1 forward.)   

Apple’s latest smartwatch even analyses heart rhythms intermittently and will send users a notification if an irregular rhythm is detected. Users will also be alerted if their heart rate is too high or too low, acting as a personal warning device.

Not Apple's First Rodeo

Apple has also enjoyed success with HealthKit, a central repository for health and fitness data on the iPhone and Apple Watch. With the user’s permission, apps communicate with the HealthKit store to access and share this data. Then, there's also Research kit, an open source framework introduced by Apple that allows researchers and developers to create powerful apps for medical research, and CareKit, which enables developers to build apps that let users regularly track care plans, monitor their progress, and share their insights with care teams. Earlier this year, Apple released Health Records, a feature that brings together hospitals, clinics, and the existing Health app to make it easy for consumers to see their available medical data from multiple providers, whenever they choose.

How Helpful Can the Watch Be? 

Keen to get more insights, I spoke to Dr. Steven LeBoeuf, President and Co-Founder of Valencell who develop the world's most accurate wearable biometric sensor systems in the world, making them the leaders in biometric technologies and design with use in devices from HUAWEI, Sony, LG, Bose, Jabra, and Suunto to name a few. Steven commented: 

"It's interesting to see that Apple is clearly really serious about getting into the medical space. My best guess is there’s more to come."

We discussed whether the new features were a push for an older consumer market and he noted:

 "It is well known in the space that the type of monitoring they're doing is really only useful for those who are managing chronic disease conditions. Actually, it's worse in some cases to get this kind of information if you are not at risk as it creates hypochondria, costing the system more than it helps. Any medical solution in this modern day has to do one core thing: it saves cost. The only folks this potentially saves costs for it those battling chronic conditions. so it will be interesting to see how they market it."

A document to Apple from the FDA details some fairly large caveats regarding who the device is not intended for and the limited notification:

"The Irregular Rhythm Notification Feature is a software-only mobile medical application that is intended to be used with the Apple Watch. The feature analyzes pulse rate data to identify episodes of irregular heart rhythms suggestive of atrial fibrillation (AFib) and provides a notification to the user. The feature is intended for over-the-counter (OTC) use. It is not intended to provide a notification on every episode of irregular rhythm suggestive of AFib and the absence of a notification is not intended to indicate no disease process is present; rather the feature is intended to opportunistically surface a notification of possible AFib when sufficient data are available for analysis. These data are only captured when the user is still. Along with the user’s risk factors, the feature can be used to supplement the decision for AFib screening. The feature is not intended to replace traditional methods of diagnosis or treatment.

The feature has not been tested for and is not intended for use in people under 22 years of age. It is also not intended for use in individuals previously diagnosed with AFib."

This suggests that the watch isn't the diagnostic or monitoring tool that some were hoping for given the significant caveats details. 

Nepotism by the FDA?

Steven had a less than optimistic view of Apple's dealings with the FDA:

"It's extremely clear that the benefits that Apple have received from the FDA are not those that others have been able to get. Their approvals have occurred incredibly quick, much quicker than another competing against Apple has ever seen. And, it's really discouraging to see a company that owns such a huge percentage of the U.S. Treasury able to have this kind of favoritism in the FDA. There is another company that was a trailblazer AliveCor. [The KardiaBand from AliveCor offered the same feature as Apple, via a small attachment to the Apple Watch]. It really was the first company to make a big name for itself and combining ECG into a wrist-worn device in a consumer product.  

And, when you look at the process they went through, it seemed a much harder process than Apple had. I hope this ease is now available to the rest of the marketplace. If there is interest from other consumer brands to do things on the medical front, we will hope that the FDA will treat them with the same level of urgency as they did for Apple."

It's yet to be seen whether, as an over the counter medical device, Apple will be required to comply with the HIPPA law, restricting the use of medical data by insurers and health professionals. Steven notes that Google has taken a very strong stance of not making money off peoples data. Will they be able to maintain that stance?

Can Siri Catch you When you Fall?

The fall detection monitoring on the watch works through an improved accelerometer and gyroscope that can detect if someone has fallen over, a feature that could be useful for older people. According to Apple COO Jeff Williams: “After detecting a fall, Series 4 delivers an alert, and from that alert, you can initiate an emergency call. However, if the watch senses you are immobile for one minute, it will start the call automatically, and it also sends a message with your locations to your emergency contacts using the SOS feature that is already built into Apple Watch. If a fall is detected and the person remains immobile for more than a minute, the device automatically calls their emergency contact using Siri — I'm not entirely sure how good Siri would be in the scenario, presumably it's been thoroughly tested."

Ultimately, one of the challenges of the watch will be making the intended consumer actually wear it. Most hand-based wearables enjoy a life of three months' use before being consigned to a drawer, and with the watch's battery life of one day, it's questionable whether a user — particularly one who is aging — would remember to recharge their watch. But, it's an interesting advancement for health tech, and let's hope that Apple is paving the way for future inventors in the space.