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Mark Sullivan

Blood Pressure, Diabetes and Sleep Science : Three new areas of focus for Apple Health?

In Tim Cook’s comments on CNBC last week, he seemed to hint strongly that Apple will introduce new healthcare services or device features in the near to midterm. Here’s Cook’s quote: “On the healthcare, in particular, and sort of your well-being, this is an area that I believe, if you zoom out into the future, and you look back, and you ask the question, ‘What was Apple’s greatest contribution to mankind,’ it will be about health… And as we’ve gotten into healthcare more and more through the Watch and through other things that we’ve created with ResearchKit and CareKit and putting your medical records on the iPhone, this is a huge deal…We are democratizing it. We are taking what has been with the institution and empowering the individual to manage their health. And we’re just at the front end of this.”

If Cook is teasing future news, the question is “what and when?” Naturally, he isn’t saying. But Apple has telegraphed some of its likely moves to play a more meaningful role in the healthcare system. The company is likely to pursue three areas: blood pressure management, diabetes management, and sleep science.

BLOOD PRESSURE

Apple built an impressively accurate heart rate sensor into the very first version of the Apple Watch in 2015, and has continued to add to the device’s heart monitoring capabilities. Its last major improvement was adding the electrical sensors needed to form an electrocardiogram (ECG), which measures the characteristics of the electrical signals that govern the pumping of the heart muscle. While the Watch’s ECG has already positively affected the lives of some users, it’s not exactly a mainstream feature that applies to all or even most Watch wearers. A blood pressure monitor, however, might come closer to that mark. The CDC says about 75 million American adults have high blood pressure, or one of every three adults. (I’m one of them.) That’s mainstream.

Apple has left clues that it’s thinking about this type of technology. The Patent Office published an Apple patent in June 2018 describing a “low-profile blood pressure measurement system.” In one application of the technology, an inflatable blood pressure cuff could be built into the band of the Watch. The wearer would feel a squeeze around the wrist, and new sensors on the Watch itself would measure systolic and diastolic pressure.

Medical device maker Omron displayed a new product at CES recently that seems to prove that such a product can be approved by the Food and Drug Administration and brought to market. Like the technology described in the Apple patent, Omron’s product–called HeartGuide–uses an inflatable cuff built into the band of a wrist-wearable device to measure blood pressure. Other wearable blood pressure monitors exist, but they rely only on sensors and can provide only estimated blood pressure readings, Omron says. The device also contains the electrical sensors needed to create an ECG. Apple may be looking for ways to add blood pressure readings to the Watch’s existing heart monitoring functions.

DIABETES MANAGEMENT

“Apple has shown great interest in diabetes, and the continuous glucose monitoring concept,” says Creative Strategies president and long-time Apple analyst Tim Bajarin. Bajarin, who is diabetic, uses a system from Dexcom, which monitors blood sugar via a couple of small prongs that penetrate just beneath the wearer’s skin at the abdomen, and derives a measurement by sampling the glucose present in the interstitial fluid there. The blood sugar levels are available continuously and are transmitted wirelessly to the Apple Watch display.

Apple has also worked with a company called One Drop, which makes a blood glucose monitoring kit that can send the results of a user’s blood test directly to the Apple Watch.

While Dexcom and One Drop currently rely on directly sampling fluid or blood from the user’s body, Apple is said to be chasing the holy grail of a contactless means of sampling blood sugar levels. The company would like to measure blood sugar levels using a light emitting sensor that could, perhaps, shine light down into the bloodstream in a user’s wrist and identify blood sugar molecules.

“It’s very difficult to do but I know they have great interest in it,” Bajarin told me. If Apple were to find a way to use such an approach to gather reliable results, it could change the lives of a great many people. The American Diabetes Association says roughly 23 million people in the U.S. have diabetes, and another 7 million have it but are undiagnosed. Worldwide, the number of people living with diabetes is well past 400 million.

SLEEP SCIENCE

People on Apple’s health and smartwatch teams have taken a keen interest in sleep science, a source tells me. But so far Apple has not built native sleep-monitoring apps into iOS or watchOS, nor has it built special sleep-detecting sensors into the Apple Watch or AirPods.

Last year Apple bought the Finnish sleep science company Beddit, which makes a thin sensor pad that slips underneath the user’s mattress and can detect things like sleep time, heart rate, breathing, snoring, and bedroom temperature and humidity. It also make companion apps to display and manage data gathered from the device. In December Apple began selling the first updated version of the Beddit product since acquiring the company. It would make sense for Apple to eventually build some of the Beddit functionality into iOS or watchOS.

Apple has experimented with a number of ways to help people measure and understand their sleep. The company even created a prototype of a sensor-laden “sleep mask,” the source told me.

Rival wearable maker Fitbit’s work in sleep science might also provide clues as to where Apple may go. The company has added a relative SpO2 (peripheral capillary oxygen saturation) sensor to its wearables, which measures the amount of oxygen in the bloodstream. With that data Fitbit can determine interruptions in breathing during sleep, such as those caused by sleep apnea. Other Fitbit sensors detect things like sleep duration and quality of sleep. Fitbit is testing a method of rolling up a group of sleep measurements into a simple “sleep score” that the user can see after each night of sleep.

At the moment, the Apple Watch could not be used in this way because its battery won’t last through a whole day’s use and then through the night. But Beddit already can create a “sleep score” from data collected by its under-mattress pad. So Apple already owns the software and the expertise it needs to monitor sleep It now needs to land on an approach to supporting that feature in its hardware.

APPLE’S HEALTH HISTORY

We often associate Apple’s health endeavors with the Apple Watch, but they actually started well before that, Bajarin points out. The company began with health and wellness features for the iPhone, including things like a step counter and exercise routines. It then built in a unified platform for the collection of all kinds of personal health data in iOS’s Health app. Apps for researchers (ResearchKit) and caregivers (CareKit) followed. More recently, Apple has added a function that lets people keep a limited version of their electronic medical records on their device.

Things got more serious when the Apple Watch came along in 2015. “The Watch brought health features into wearables and added precision to the measurements,” says Bajarin. The Watch was first positioned as a fitness device, but the goal has always been to build in features that more directly monitor health. Aside from the ECG reader, the Watch also now has a fall detection feature, which can alert caregivers or loved ones if the sensors in the device detect the wearer has taken a sudden fall.

For a long time, Silicon Valley companies such as Apple and Google sought to avoid dealing with the Food and Drug Administration, seeking instead to offer health features that didn’t require government approval. That has changed, as tech companies realized that doing anything very meaningful for a user’s health required going through the FDA. Apple, for instance, got its first experience working with the FDA when it submitted the Watch’s new ECG function for approval. The ECG system got its de novo clearance from the FDA one day before its public announcement.

Working with the FDA involves bringing the agency and its guidelines into the development process early on. And it requires a different way of thinking about product creation, as AliveCor’s Vic Gundotra explained to me. AliveCor made Kardia Band, the first FDA-approved ECG band for the Apple Watch. Seeking approval for a digital health product is an expensive and time-consuming process that often seems foreign and off-putting to Silicon Valley companies. Gundotra, an ex-Google executive who oversaw the development of Google Photos and Google+, says it took some time for he and his team to adapt to the agency’s methodical, evidence-based way of doing things.

Apple is now well into that process. And it has the advantage of being able to allocate lots of engineers and clinicians to work closely with the FDA to move the approval procedure along, Bajarin points out. Apple has the funds to hire whatever healthcare professionals it needs, and it has hired many already. Many of them work in its health lab in Santa Clara, where Apple employees are often brought in to help test new health features for the iPhone and Apple Watch. We’ve probably only just begun to see the fruits of their labors.

POSITIONED FOR PRIVACY

Aside from the health features and functions, Apple has already done a lot to position itself to make a difference in health. Data privacy is a huge consideration for any tech company working in the health sphere, and Apple has been on a long, high-profile crusade to protect personal data, even from law enforcement. It’s also been critical of companies like Facebook that profit from the harvesting and leveraging of user data. On the technical side, Apple stores sensitive personal data (such as Apple Pay transaction data) in a secure enclave inside the device that even Apple can’t see. All this builds trust, and prepares consumers for a time when Apple devices store even more sensitive health data than they already do.

THE MD ON YOUR WRIST

The more the Apple Watch emphasizes healthcare, the more relevant it can become, says Ari Roisman, the CEO of CMRA, which makes a camera band for the Watch. “For many people, the Watch is a trustworthy companion, and what will make it essential is that it’s almost like a doctor on your wrist. It knows you,” Roisman said. “Eventually, it will have a sense of what kind of nutrients are running through your bloodstream.” Blood-pressure and blood-sugar data would also be complements to this.

The Watch already touches a lot of people. It hasn’t changed the world–or Apple–as much as the iPod or iPhone did, but it still could. Analysts say Apple has sold as many as 60 million Apple Watches to date, and adoption may grow to more than 100 million by the end of next year. “When you have powerful compute coupled with sensors on-skin, there’s a lot you can do and a lot you can intuit,” says Roisman.

The variety and amount of biometric and diagnostic data gathered by the Watch will likely grow quickly in the coming years. The challenge may be to limit the flow of data to caregivers to only the most meaningful and immediately actionable facts.

Before the death of Steve Jobs, Tim Cook and others at Apple made a commitment to the dying CEO to start looking at ways Apple could be involved in health. “Steve was so disillusioned with what he saw during his own illness, and that began a discussion about how Apple could play a significant role in improving the healthcare system and healthcare monitoring,” says Bajarin. By the sound of Cook’s comments last week, that commitment is still fresh in Cook’s mind.

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