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 and saved her baby. Later, Apple
announced it would expand its health initiatives byembarking on three new
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 have the potential to be some of the
largest-ever studies involving worn sensors. Don?t 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. Still, while
there remain questions about methods, 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 that theoretically could
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

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, theDaysy fertility tracking
[] 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 alegal []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 newIgnite 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 sentenceson the product?s website
[]. (The support page
a little more info
[].) Is
exercise recovery real? Yes. Polar has ablog
[]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
hasa gigantic page
[http://ASSOCIATION%20BETWEEN%20HEART%20RATE%20VARIABILITY%20THRESHOLD%20AND%20POST-EXERCISE%20VAGAL%20REACTIVATION%20Duarte%20TS,%20Ferreira-J%C3%BAnior,%20AJ,%20Rezende%20EC,%20Pertence%20LC,%20Marins%20JCB,%20Lima%20JRP%20JEPonline%2017(5):%2058-64,%202014/] 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 releasedpreliminary 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, theApple 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. 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 averagetwo 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 inthis 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 hasguidelines
[] 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 beyondbrief news
[] 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

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 theyabsolutelyshould. Clinical research can beprohibitively 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
beenmired in regulation hell
[] , and the ECG functionality on theActive2
[] 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 withnew ECG
[] , 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 trulyneedtheir smartwatch to take ECGs? That?sstill
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.?

Original Article: