Hey Kids, last week Apple announced a new "HealthKit" for capturing health and fitness data, and one of their targets is supposedly diabetes care, which is very exciting -- because who doesn't want Apple to get involved in this stuff?!
The only caveat being that like the recent announcement about Google developing glucose-sensing contact lenses, this appears to be more of a vision and a call for development partners than a real, concrete solution at the moment. In other words, it's still just a superstructure, but with the very real advantage of having a Consumer Technology Giant publicly committing to the need for improved health monitoring and data solutions.
What is Apple HealthKit?
According to a terrifically frank article by Forbes: "HealthKit isn't an app itself — but a software framework that's now included in Apple's latest release of their mobile operating system — iOS 8. The framework is built into iOS 8 as a way to collect, store and then present health information from apps that are designed to communicate with it. Those apps (often associated with wearable sensors for capturing health or fitness data) can be ones built by Apple or independently by 3rd party developers."
HealthKit comes with an app simply called "Health," and the whole thing appears to act as an "aggregator" to allow people to use a variety of health apps all in one place. It's just very unclear how valuable this will be for people living with diabetes or other chronic conditions where the most important tools and sensors are actually medical devices that require FDA regulation.
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And even though Apple Senior VP of Software Engineering Craig Federighi specifically mentioned diabetes monitoring in his remarks at the HealthKit launch during Apple's annual World Wide Developer Conference (WWDC) -- and the company touted glucose sensing with their earlier "iWatch" announcement -- there's no evidence that they've made any inroads integrating with existing diabetes technology.
In fact, Apple showed off their naivetÃ© of diabetes with an on-stage glucose goof-up at the launch: how is blood sugar measured again?
The Forbes article goes on to say: "It's hard not to be a tad cynical with these big announcements because they always arrive with such great fanfare — and scant details. The vision may be there, but it's challenging to articulate when it's incomplete. It's also reflective of the muddy waters of consumer fitness, health, wellness and then actual clinical healthcare. The more that line is intentionally blurred (and breached), the easier it is to attract the single most important human organ in all of Silicon Valley — the eyeball."
Note that competitor Samsung also announced its own "framework for a new consumer-centered biohealth ecosystem" last week, featuring a new sensor-filled watch called "Simband" (to compete with Apple's iWatch) and a cloud platform for storing health data collected by the device. All the same concerns apply.
One diabetes industry insider, who asked not to be named, confirmed those suspicions: "That's the problem when companies like Google and Apple get involved in the healthcare and medical world. They don't really know what they're doing. They just know that health data tracking and health data management services are going to be huge... and they know that diabetes, with at least 24 million Americans affected, is the area to focus on when it comes to the potential of these services... It's a huge industry, and they want a part of that. But I don't know that they've thought through any further than that in terms of the regulatory side."
Obviously, there are lots of non-FDA-regulated diabetes logging and educational apps that Apple could pull into this new platform -- more than 1,100 in the iTunes store, researchers say. But the same researchers note that only about 1.2% of people with diabetes are using any of those on a regular basis, because they just don't add any real value to patients' lives (too much manual data entry required, too little actual impact on our daily disease outcomes!)
Health Toys vs. Medical Solutions
If you want to add value for people with chronic illnesses, you've got to move beyond connecting with "health toys" like Fitbit, Wahoo Fitness, iHealth and Withings to real-time integration with the FDA-regulated sensors and devices that keep us alive -- in our case glucose meters, CGMs (continuous glucose monitors), and any and all apps or tracking software worth their weight in actually assisting people to make real decisions about their disease management.
But real-time integration is exactly the stumbling block that FDA continues to struggle with regarding how to regulate mobile health apps. This is where FDA has to consider all the safety and efficacy risks associated with relying on a smartphone to serve an active medical function: what if the battery dies, the phone freezes up, wifi connection is disturbed, other apps interfere with medical functions, or somebody "butt dials" a medical command by accident?
What about these risks with iBGStar, the first glucose meter to physically plug into the Apple iOS platform, or with the new OneTouch Verio Sync meter that beams results right to your phone, you may ask? The workarounds there are clear: iBGStar is a fully functioning stand-alone glucose meter that just happens to plug into the iPhone4 port to share data for logging purposes. Same with Verio Sync. Although in both cases, the apps were required to be part of the 510K clearance process of the medical providers.
Dexcom on Your iPhone
Meanwhile, we all know that Dexcom's new Share platform and the accompanying Share Follower app are coming soon, currently in the latter stages of FDA review. That platform will transmit your real-time CGM results via Bluetooth to the cloud, and from there to as many as five smartphones — even in places as far away as overseas! So how is that integration possible?
"The FDA is getting comfortable with real-time medical information on a phone, as long as it's not dependent on the risks of the phone," Dexcom's VP of Strategy and Corporate Development Steve Pacelli tells us.
"Share will be the first app to display 'live' medical data on the phone versus just 'retrospective' data (for record-keeping purposes). It's considered safe as long as there's a 'normal' medical system plus a separate app. Even our next-generation Dexcom G5 (that will send data directly to the phone) would still have a Transmitter, Receiver and Sensor. The data on the phone will simply be paired with the data on the Receiver for viewing purposes."
While the phone will be officially considered just a "secondary display device," Pacelli acknowledges that lots of patients will probably leave their Receivers at home. Still, the protection is in place; patients eventually using the Dexcom G5 will not be solely dependent on the phone to access their glucose readings.
See also: Dexcom CEO Terry Gregg in this CNBC interview talking about Apple's HealthKit as a "boon" to the convergence of wearable technology and open connectivity. "It's where we want to see this market move, and we'll be right at the leading edge of that," he says.
Actually, Courtney Lias, Director of FDA's Division of Chemistry and Toxicology Devices, told us the agency's unable to comment specifically on HealthKit, or on any particular technologies under current evaluation.
"I can say that, as we discussed during the session at last year's DiabetesMine Summit, we believe that the continued integration of diabetes devices with mobile devices/applications has great potential, and we believe that it will benefit patients as well," she said. "We are working closely with industry to facilitate the process to try to promote the development of smaller and more integrated tools. Any CGMs or meters are subject to FDA regulation, and we already have many meters that interact with mobile apps. Mobile apps are also now common in Artificial Pancreas device studies. We expect that trend to continue and innovations in this area to improve public health."
Hope Not Hype
So as it stands, you can have an FDA-regulated device that displays medical data on the phone via an app. That's a step in the right direction. But will Apple's HealthKit be the panacea to bring together useful health/fitness monitoring with chronic illness tools? That remains to be seen.
We say: Don't get too excited just yet about HealthKit for diabetes care.
But DO get excited about the fact that Apple is making a huge international statement with this announcement, per Federighi: "Up until now the information gathered by (health and medical) applications lives in silos. You can't get a single comprehensive picture of your health situation."
That needs to be fixed, he says -- and given Apple's track record, let's all give a cheer that they're on the job!