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`The Washington Post,Democracy Dies in Darkness
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`The new Apple Watch says my lungs may besick. Or perfect.
`it ean’t decide.
`
`Boln ihe Angle Welch Series G and Filo Sense have new tioocd-oxygen aos. They're rnoslly useless,
`
`By GeoffreyA.Fowler
`CSolunvust
`
`September 23, 2020
`
`@ om
`
`
`
`Sometimes the new Apple Watch Series 6 reports my lungs and heart are
`the picture of health, pumping blood that’s 100 percent saturated with
`oxygen.
`
`At othertimes, it reports my blood oxygenis so low I might be suffering
`from emphysema. (I am not.)
`
`The watch can’t decide. This much is clear: Don’t buy one of these $400
`devices in the hopes of monitoring your lung health.
`
`An Apple oxygen check a daywill not keep the doctor away,at least not
`yet. The way consumer tech companies are marketing health capabilities
`is getting ahead of what their gadgets can actually, reliably do. That’s a
`
`dangerous trend, and it jeopardizes the potential positive effect that
`collecting body data could have on cur health.
`
`It’s particularly deceptive at a time when manypeople are looking to
`health monitors for anyclue that they may have covid-19, theillness
`caused by the novel coronavirus.
`
`For the past week, I’ve been wearing a smartwatch on each wrist, all day
`andall night long. On the right I have the Apple Watch Series 6, and on
`the left I wear the new $330 Fitbit Sense, which went on sale this week.
`
`There are many reasons people buy wearable gadgets. I wear an Apple
`Watchfor fitness motivation and to receive phonenotifications, and an
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`Oura Ring to track mysleep. Butthis fall’s smartwatch upgrades from
`Apple and Fitbit are all about health. Apple’s slogan reads: “The future of
`health is on yourwrist.”
`
`These watchesalso read heart rate and rhythm, but I’m focusing this
`reviewon the headline addition to the Apple watch and the Fitbit: an
`oximeter, which measures the oxygen in your blood. Doctors are
`increasingly treating oxygenation as a vital sign (alongside pulse and
`temperature) because it can help reveal aspects of conditions including
`sleep apnea, pulmonary embolism and covid-19. That certainly sounds
`helpful to have on yourwrist.
`
`That’s what Apple Vice President for Health Sumbul Ahmad Desai implied
`at Apple’s prerecorded launch event. “Adding blood oxygen brings another
`valuable health measurementto users. Blood oxygen and pulse oximetry
`are termsthat we've heard a lat about during the covid pandemic,” she
`said.
`
`But youstart to get a different picture when you read what both
`companies say in their disclaimers. Neither device is approved by the
`Food and Drug Administration.
`
`Thetinytype at the bottom of Apple’s website says its blood oxygen appis
`“not intended for medical use” andis “only designed for generalfitness
`and wellness purposes.” Fitbit’s small print says its blood-oxygen appis
`“not intended to diagnose or treat any medical condition”andis useful to
`“help you manage your well-being and keep track of your information.”
`
`There are important differences in the blood oxygen data that Apple and
`Fitbit repert. But in my experience, neither company’s measurement
`serves much purposeatall. You should knowwhat you’re buying, because
`it might do more harm than good.
`
`Measuringblood: Fingervs. wrist
`
`To understand myfrustrating Apple Watch readings, I called
`pulmonologists who haven’t had a chanceto test the watches but
`understandthe science. When doctors test blood oxygen, they often use
`sensors on fingers called pulse oximeters. These devices shine light
`throughthe skin and nail to detect the color of the blood as a measure of
`howmuch oxygen is there. They produce a measure called SpO2; most
`
`healthy people range between 95 percent and 100 percent.
`
`The finger oximeters used by doctors are approved by the Food and Drug
`Administration. To compare my smartwatchresults, I bought a finger
`oximeter for $60 from Medline Industries that is FDA approved and
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`reports an error rate of plus or minus two percentage points.
`
`Unlike finger pulse oximeters, these two smartwatchestry to read your
`blood oxygen from your wrist. And they’re conspicuouslysilent about
`accuracy.
`
`Apple’s new watch haslights on the bottom to generate signals that are
`reflected back from the blood in your wrist and read by sensors. An app
`lets you do spot checks anytime andalso runs onits own while you sleep.
`You have to hold really, really still for 15 seconds to get a reading.
`
`Thefirst time I tried this on the Apple Watch6, it said my oxygenlevel
`was 88 percent — shockingly low, given that I am in good health and
`wasn’t wheezing. Five minutes later, I tested again andit said my SpO2
`
`was 95 percent. I kept trying it and kept getting different readings — and,
`frequently, an “unsuccessful measurement” error message.
`
`I told Apple about my experience, and it sent me a new watch. Myfirst
`measurement on my second Apple Watch 6 reported my SpO2 as 100
`pereent. If these readings were accurate, mylungs were having a really
`wild Wednesday.
`
`Over several days of comparing my second Apple Watch’s measurements
`to my FDA-approved finger oximeter, Apple’s readings most often differ
`
`bytwo or three percentage points — though they’ve also sometimes
`exactly matched, and sometimes have been as much as seven percentage
`points lower.
`
`Is it just me? Skin, fat and blood vessels do vary. Apple would not
`commentontheerrorrate of its sensor, but spokeswoman AmyBessette
`said it “has been rigorously tested across a wide spectrumof users and
`across all skin tones.” (When I tested the Apple Watch on a colleague
`whose skin is darker than mine, the results were also off fromthe finger
`pulse oximeter, but less wildly so.)
`
`Bessette also said, “For a small percentage of users, various factors may
`makeit difficult to get a blood oxygen measurementincluding motion,
`watch placement on the wrist, skin temperature and skin perfusion, and
`the blood oxygen app provides dynamic feedback to help users get the best
`reading possible.”
`
`The companysent me additional Apple watch straps — eight in total — to
`wear while testing its second watch. This year, Apple is selling a new kind
`of stretchy bandthatis called the Solo Loop and comesin a variety of
`sizes. Going down onesize (to a modelthat leaves a slight imprint on my
`wrist) did eliminate some but notall of the “unsuccessful measurement”
`error messages.
`
`With the Fitbit, I’ve had less-erratic results, but the device also provides a
`lot less information. You can’t ask the Senseto run spot checks. Instead,it
`measures vour SpO2 while vou sleep and provides a nightly average.
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`CX-1616
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`Myoxygenlevel, Fitbit reports,is typically in the range of 95 percent to 97
`percent. That soundsbelievable, though I can’t compareit to results from
`my finger pulse oximeter because I’m not awaketo turn it on.
`
`In an interview, Fitbit’s director of research, Conor Heneghan,said the
`company decided the overnight view was a morereliable piece of
`information.“It’s a pretty hard technical problem to measure SpO2 on the
`wrist,” he said. Unlike fingers, which have manyblood vessels near the
`surface that offer a strong signal, the wrist is prone to obstructions and
`poorreadings.
`
`“You movea little bit, or even just youarealittle bit colder than normal,
`
`you can get a very weak signal,” Heneghan said. “We’ve goneafter long-
`term averaging, so that way, when we take overnight measurements, we
`can comfortably exclude the periods when wefeel that signal is too noisy
`or weakto be reliable.”
`
`Heneghan still wouldn’t diselose the Fitbit’s exact error rate. But he said it
`beats the range set by an international standards organization. That’s not
`muchto brag about: It would allow someone with a true SpO2 reading of
`95 percent to be told they're at 91 percent.
`
`He was forthcomingon the testing Fitbit did, such as working with a lab at
`the University of California at San Francisco to test the device on
`volunteers, including people with different skin tones. “Wetried to
`overrepresent darker-skin-toned people in our testing to make sure that
`it’s not skewed toward a particular tone,” he said.
`
`Marketing vs. medicine
`
`Let’s be clear: These companies are marketing a device with medical
`functions while winking andinsisting they're not medical functions. Okay,
`so then whatelse, exactly, are we supposed to use oxygen apps for?
`
`Fitness? You can’t use these sensors while you work out. Just the slightest
`bit of movement — even breathing too heavily — sends my Apple Watch
`into error mode. Neither Apple nor Fitbit makes anyeffort to explain how
`your SpO2 levels might be linked to your workouts. (SpO2is different
`from another oxygen indicator called VO2z Max, which measures how your
`body uses oxygen while you exercise.)
`
`That leaves us with the industry’s term “wellness.” So, are we supposed to
`get together with friends over drinks and talk about O2 stats? “Hey, bud,
`my hemoglobin works better than yours!”
`
`Whateverthe fine print might say, some people are going to treat these as
`medical devices — and that’s a eancern
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`“Pulse oximeters can tell you in a trending situation if your oxygen is in
`the normal range,” said Albert Rizzo, the chief medical officer for the
`American Lung Association. But it’s not necessarily a leading indicatorof
`problems, including covid-19. “Nobody shouldbe waiting for their pulse-
`ox to go down beforecalling their doctor,”he said.
`
`There could be consequences if consumersactually believe the hype about
`these devices. “T agree with youthatit is a dangeroustrend for technology
`
`companies to release medical devices that don’t meet FDA standards and
`claim that they are not medical devices,” said Brian Clark, a pulmonologist
`and professor at the Yale University School of Medicine.
`
`The most common negative consequenceis likely to be people calling their
`doctors too often becauseof false low readings. “But the more concerning
`and potentially dangerous scenario is when the devices provide false
`reassurance and people don’t seek health care when theyreallyneedit,”
`Clark said.
`
`Apple was more upfront in 2018 whenit added an electrocardiogram, or
`ECG,appto its watch. It did get FDA clearance (not quite the same as
`“approval’) for its app, and worked with researchers to publish studies on
`its aceuracy. Butstill, there’s fine print: the Apple Watch’s irregular-
`rhythm notification is not intended for use by “those who have been
`
`previously diagnosed with atrial fibrillation (AFib).”
`
`Fitbit said an ECG appit added to the Sense this year also received FDA
`clearance. Whynot do the samefor the oximeter? “If we were to make a
`claim,like we could detect sleep apnea, we would definitely go through the
`regulatory process and be veryclear on our messaging and very clear on
`
`the limitations,” said Fitbit’s Heneghan.
`
`A release-with-disclaimers approach could leave consumers without
`guardrails as more body sensors come to market. To the Sense, Fitbit also
`added a skin temperature sensor and an electrodermalactivity sensor —
`similar to what’s in a polygraph — thatit says “may indicate your body's
`responseto stress.” Neither of those sensors has been cleared by the FDA.
`
`Questions about accuracy also interfere with the work of academics
`combing through the body data from smartwatchesto see if it can be used
`to detect disease. This summer, I wrote about promising early results from
`academics using heart rate and temperature data from the Oura Ring and
`Fitbit to predict the onset of covid-i9 symptoms.
`
`Several of those researchers told me they were excited bythe addition of
`blood-oxvgen data — but there’s not enough information aboutits validitv.
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`CX-1616
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`“We have toys, and we have things that are used for clinical purposes. And
`it really needs to be a clear distinction,” said Duke University’s Jessilyn
`Dunn,an assistant professor of biomedical engineering whois helping to
`lead a studycalled Covidentify.
`
`It should not be acceptable for giant tech companies to market devices
`that take readings of our bodies without disclosing how those devices were
`tested and whattheir error ranges might be.
`
`I believe collecting accurate data about our bodies can help advance our
`health. But the key word hereis “accurate.”
`
`By Geotfrey Fowler
`
`
`
`
`
` Street Journal. He won the 2020 Gerair
`
`Loeb Award for commerntan
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`af Twitter
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