Before launching into its battery of Apple Watch announcements on Tuesday, Apple set the tone, as it often does, with a moving promotional video. Among the many characters featured was a mother who described how the Apple Watch helped catch a pregnancy-endangering heart condition. She rushed to the hospital, and her baby was saved. Later, Apple announced it would expand its health initiatives by embarking on three new health research studies that will use data gathered by its smartwatch. The Apple Watch, like most wearables, is billed as a product that can help you live a healthier life. These studies are Apple’s latest effort to prove that’s more than marketing bluster.
Though the announcement was light on details, we know the company is partnering with a half-dozen top medical institutions to investigate a range of topics including women’s health, the effect of mobility on cardiovascular health, and the impacts of everyday sound exposure on hearing. The studies will be conducted through Apple’s upcoming Research app, and they have the potential to be some of the largest-ever studies involving worn sensors. Don’t be surprised if these studies ultimately breed new features. In fact, all this altruistic-sounding research is probably a shrewd business decision since the company can’t legally market medical capabilities without research and FDA clearance. Even if they don’t turn into features, the studies lend Apple credibility and goodwill.
Questions remain about its methods, but Apple seems to be taking science seriously where most of its competitors have not. Since the Fitbit climbed onto our bodies a decade ago, improving your health has always been an intrinsic part of what made wearables appealing. But while initially fitness and activity tracking were the main draws, in recent years, there’s been a shift toward health-monitoring devices some of which could theoretically save your life. Juniper Research estimates that healthcare wearables will be a $60 billion market by 2023. The problem is this push has blurred the line between innocuous wellness tech and medical devices approved for the treatment and diagnosis of disease. It’s increasingly hard to tell what’s pseudoscience and what’s backed by legitimate research.
This is particularly true in the women’s health tech space, where some period tracking apps use dubious science to market themselves as contraceptive devices that can help you avoid pregnancy. In May, the Daysy fertility tracking thermometer that claimed it was 99.4 percent accurate at preventing pregnancy came under fire after it was revealed the study backing its claims was little more than cleverly worded marketing. The study was retracted, and Daysy is now the subject of a legal investigation that could lead to lawsuits.
Big wearables makers aren’t off the hook either. Fitbit, Garmin, and Polar all offer sleep advice based on proprietary algorithms. Garmin and Polar also purport to measure your blood oxygen saturation levels to deliver guidance on your ability to train. None of these companies have funded publicly reviewable studies to develop and validate their features, even if some of the features are based on scientific knowledge. Take Polar’s new Ignite smartwatch, which purports to measure your “Nightly Recharge.” This metric assesses a combination of how your autonomic nervous system calms down and how well you slept to advise you on how hard you should exercise. It sounds legit, but the science is only described in three sentences on the product’s website. (The support page has a little more info.) Is exercise recovery real? Yes. Polar has a blog post about that too, even though it doesn’t cite other medical sources and opts for paraphrasing basic concepts. Maybe there’s something to Nightly Recharge, but without validated science that shows it’s for real, it’s hard to know for sure.
To be clear, it’s not that other companies don’t participate in research. Polar has a gigantic page dedicated to research in which it participated and even research that it claims validates its technologies. Its products are often used in clinical studies as a means to non-invasively measure heart rate in relation to other conditions. Each company has its own in-house teams staffed with legitimate scientists and consultants who help develop products. Many of their sensors have been scrutinized and even scientifically tested. But when it comes to developing many of their promoted products important details are unknown, including what research was done, how it was done, who was involved, and how the research lead to the development of particular products. There’s no way to check for yourself that manufacturer claims are based on legit testing.
Apple’s approach to research appears notably divergent from the norm. It’s partnering with reputable institutions, including the Harvard T.H. Chan School of Public Health, NIH, the American Heart Association, Brigham and Women’s Hospital, and the University of Michigan. Previously, it conducted the Apple Heart Study with Stanford Medicine to see if data collected from the watch could identify atrial fibrillation. It’s released preliminary results, and the study itself contributed to the development of the Series 4's ECG and atrial fibrillation screening features. While we don’t know the specifics of how the three new studies will be conducted, the Apple Heart Study FAQ offers encouraging signs that Apple takes clinical methodology and privacy seriously.
“This is a space that’s been rapidly proliferating in the consumer world, but the well-designed peer-review research has lagged behind,” Dr. Nathaniel DeNicola, chair of telehealth medicine at the American College of Obstetricians and Gynecologists told Gizmodo. If rigorously tested, remote monitoring by consumer products could be a boon to the field of telemedicine.
“It’s a positive step that we’re getting more scientific rigor to look at where the true opportunities for benefit are,” said Dr. DeNicola. “The real promise of telemedicine is that it can enhance our standard of care. It’s been like the wild west long enough. It’s time for hard evidence.”
The studies might produce hard evidence medical professionals are looking for, but there are a few questions Apple has yet to answer. Heart-related studies make a lot of sense for the Apple Watch because it has a built-in heart rate sensor that you wear for most of the day. The path to data isn’t as direct when it comes to hearing and women’s health. WatchOS 6 does introduce noise-level monitoring, but that data alone isn’t useful if Apple and its partners don’t know your hearing health over time. Likewise, Apple has great ambitions regarding women’s health, aiming to “inform screening and risk assessment of conditions like polycystic ovary syndrome (PCOS), infertility, osteoporosis, pregnancy and menopausal transition.” It’s not exactly clear how you might track bone health with the Apple Watch without at least a doctor’s visit and relevant medical tests. Same goes for tricky-to-diagnose conditions like PCOS, which can take on average two years and multiple doctors to properly identify.
Asked for more information about the studies, an Apple spokesperson said, “We’ll have further details to share closer to the launch of the studies and the app later this year.”
With regard to the women’s health study, I’ve spoken with many doctors about period tracking apps, and the general consensus is these apps are deeply flawed.
“I am not certain if part of these plans involve conducting research on Apple’s Cycle Tracking app, and if so, what the focus will be,” Dr. Chelsea Polis, a senior researcher at the Guttmacher Institute, told Gizmodo over email. “As I noted in this article, there is limited information to understand how accurate Apple’s Cycle Tracking app is in predicting the timing of ovulation, so I am hopeful that this effort can provide more transparency around that feature.” Dr. Polis also noted that without further details on how the studies are crafted, it’s hard to determine the feasibility of screening for the aforementioned women’s health conditions just by wearing an Apple Watch and using the Cycle Tracking app.
Dr. DeNicola echoed some of these concerns, but added, “While the accuracy of apps predicting fertile windows is low, that isn’t necessarily a dealbreaker for conditions like PCOS or menopause.” In the case of women with irregular cycles, identifying a pattern is required for diagnosis. Dr. DeNicola notes that done correctly, digital logging removes doubt when a patient has trouble recalling their past period. That could help shorten the time it takes for women to identify conditions.
The Apple Heart Study offers some hints for how these new studies might proceed. That study lasted 15 months and required participants to download a companion app onto their iPhones and Apple Watches. If an abnormal heart rhythm was detected, some participants were connected with a telehealth provider and possibly asked to wear an ePatch for a week to further monitor heart rhythms. Participants had to wear the watch for the duration of the study, as well as participate in three short surveys.
It’s possible these new studies may also require a similar or greater degree of involvement, for potentially no compensation. The Apple Heart Study was sponsored by Apple but did not pay participants, though, it did cover some expenses. (Many studies do compensate participants, and the FDA has guidelines on the subject.) Of course, that’s up to the individual whether they choose to participate. It’s also not clear at this moment how such a large, mostly self-reported data set might impact or skew results, or how Apple and its partners will account for that. Ideally, results would be eventually published in peer-reviewed clinical journals or made publicly available beyond brief news snippets to educate consumers.
“Self-reported data does present a bias,” said Dr. DeNicola. “But if you get enough data, you can see what persists, and that’s one way to sort through the noise.”
Questions aside, let’s assume Apple does a stand-up job, takes all necessary precautions, and the studies result in groundbreaking revelations. This sets a high standard that will be hard for many health tech companies to follow, even if they absolutely should. Clinical research can be prohibitively expensive, and these companies all need their products to turn a profit. Apple has deep pockets and connections, but it’s not likely rivals like Fitbit, Garmin, Samsung, and Polar can match Apple at the same scale. Smaller brands and startups definitely don’t have the resources. That’s possibly the biggest hurdle facing health tech when it comes to developing products that could save your life.
Take the ECG feature Apple introduced with the Series 4. It was backed by research from the Apple Heart Study and received speedy FDA clearance. In the year since, ECG features have cropped up on multiple watches, including the Withings Move ECG and even Samsung’s Galaxy Watch Active2. Withings’ device has been mired in regulation hell, and the ECG functionality on the Active2 won’t be live until further research is done. At IFA in Berlin last week, there was no shortage of health tech that tried to lure showgoers in with new ECG features, some of which were not yet approved by regulatory agencies.
But while these companies weren’t nearly as fast as Apple, it’s heartening to see they are going through the FDA approvals process or attempting research. Does anyone truly need their smartwatch to take ECGs? That’s still not clear. Neither is what sort of effect widespread ECG wearables will have on the healthcare industry. But at least savvy consumers can do research and see if the FDA looked at the products and if appropriate testing was done.
Dr. Polis said the impact on flawed women’s health technology could be significant. “Apple has an opportunity to lead by not only undertaking high-quality scientific studies, but also [in] ensuring that communication and public education about how the Cycle Tracking app should and should not be used is very explicitly communicated to consumers, which may help influence other companies to be more conscientious about these issues, too.”