At Connective DX we spend a lot of time thinking about healthcare. In particular, we might be regarded as slightly obsessed with improving the digital patient experience, which is why it is impossible to ignore when two of our favorite consumer technology companies announce moves in the healthcare space.
With their products moving beyond mere fitness or wellness apps, a handful of stars in Silicon Valley (and beyond) were recently selected by the US Food and Drug Administration to participate in the accelerated clearance process for software medical devices. And while many consumers see this as a good thing, as we’ll share, some of the excitement has been a little more cautious.
Smoke, mirrors, and the Apple Watch 4
Last week, Apple held a big event at the Steve Jobs Theater and announced new products in their iPhone and Apple Watch categories. On the wearable side, in addition to boasting a couple of extra millimeters screen size, the Apple Watch team revealed: "new features to help you stay even more active, healthy, and connected." Most specifically, this included integrated ECG and AFib monitoring devices.
Hardcore Apple fans immediately observed the death of Fitbit and returned to marveling over Tim Cook's all-white Nike Epic React sneakers. While I am excited about new Apple products and innovations, I tend to be a wet blanket when it comes to the hype-train. And as far as this event was concerned, I wouldn't count Fitbit out just yet.
If you read the fine print after Apple's big event, you know that the ECG and AFib features will not be included with initial shipments of the new Apple Watch 4 this month. It is unclear exactly when these net-new features will be available for purchase but they have received FDA clearance for sale, so we're pretty sure they're real. Apple claims the full-featured upgrade will be on the market "later this year."
If we're comparing functionality today, without the ECG and AFib features you might as well buy the Fitbit Versa or step up to the GPS-enabled Fitbit Ionic for feature parity and still pay $100 less than the base model of the Apple Watch 4. Or keep your older Apple device for a few more months.
That said, from the perspective of digital healthcare experience, the addition of ECG heart monitoring and AFib detection to the Apple Watch 4 is a development worth getting excited about. Once available, it will move the Apple Watch beyond a mere fitness wearable and into the category of products known as health monitoring devices.
Although Apple is careful to point out their watch can (and not will) detect life-threatening irregularities in a wearer's heartbeat, if it provides one, single user with early warning of Atrial fibrillation, a treatable heart condition which can cause stroke, heart failure, and other severe heart-related problems, it's worth every penny of the increased cost.
Interestingly, even without the newer features, there are already examples of these devices potentially saving lives.
Fitbit is still a significant player
Not one to take things lying down, this week Apple’s biggest competitor in the fitness wearable category pushed further into healthcare with the rollout of Fitbit Care, a connected platform play for health plans and employers. Much more than just another fitness app, Fitbit Care offers health coaching and personalized virtual care.
By combining a wearable device, digital interventions, and health coaching, Fitbit Care delivers a personalized healthcare experience with the ultimate goal of improving health outcomes among their customers.
“With Fitbit Care, we are delivering a solution that empowers people to take control of their health, by providing the accountability, support, guidance, and resources that remove some of the most difficult barriers to behavior change,” said Dr. John Moore, Medical Director, Fitbit Health Solutions. “Supporting patients beyond the walls of the doctor’s office is one of the most important things we can do to drive successful outcomes, and as a clinician, I see great potential for Fitbit Care to help tackle some of the biggest challenges in healthcare and improve health outcomes at scale.”
Fitbit also announced a new partnership with health insurance leader Humana Inc., who selected Fitbit Care as a preferred coaching solution for its employer group segment. More than 5 million Humana members will now be able to access Fitbit health coaching via a range of wellness programs and capabilities.
"The surest and best way to decrease healthcare spending is to increase health. That's the goal of population health, and initiatives like these by payers and providers to energize people to manage their health more actively." - Dave Wieneke, Director, Connective DX Healthcare Practice
My heart's a flutter for the future of digitally-enabled healthcare
All of this competition to improve health outcomes is undoubtedly good for consumers overall though some in the medical community are, rightfully, more cautious. Various corners of the healthcare industry have raised concerns about false-positives1, quality control, and cybersecurity2 but Apple and Fitbit are unlikely to be alone in this space for long. Their innovations are being brought to market under the FDA's new pre-certification pilot program for Software as a Medical Device or SaMD, explicitly designed for technology companies looking for an accelerated clearance process for software medical devices.
In total, nine companies were selected to participate in the SaMD pilot program. Here’s the full list of organizations to watch for more developments:
- Apple, Cupertino, California
- Fitbit, San Francisco, California
- Johnson & Johnson, New Brunswick, New Jersey
- Pear Therapeutics, Boston, Massachusetts
- Phosphorus, New York, New York
- Roche, Basel, Switzerland
- Samsung, Seoul, South Korea
- Tidepool, Palo Alto, California
- Verily, Mountain View, California
When it comes to public health, it's important to consider the aggregate outcome. Small innovations can create significant value in terms of lives saved, and otherwise unnecessary costs avoided. Any tech developments that can provide medical professionals with information about their patient’s condition more quickly than previously possible should be cleared for public use as soon as possible. To that end, the FDA SaMD pre-certification program is a very positive development.
If you've got questions about improving the digital experience for your patients or members, we've got answers. Please don't hesitate to contact us and download our Hospital Digital Experience report, the HDX-15.
1 Apple Watch's ECG could prompt unneeded medical visits, cardiologists say - Becker’s Hospital Review
2 HIMMS weighs in on the FDA software pre-certification process - Healthcare IT News