Your smartphone can bring a car to your door, connect you
with loved ones around the globe and help you order pizza without
talking to a single human being in the process. But then, you hear
reports of a company hack or major credit card breach at a store you
frequent, and you're quickly reminded of the risks you take with
technology.
As technology has progressed, it has altered more than our
takeout habits and communication preferences, it's also redefining our
health. With fitness trackers and medical devices that can plug into
your smartphone, more people are able to track their health in a way
they never could in the past. But there are dangers lurking in the
seemingly innocuous wrist bands and health apps you find in the Apple
App Store and Google Play store.
The concern isn't really centered around apps that let you
track your calorie intake and weight, but ones that claim to have
legitimate health benefits, but no FDA approval to back it up. In an
editorial, Nathan Cortez, associate dean of research
at Southern Methodist University Law School points out in a study in
the New England Journal of Medicine that in 2013, mobile health -- or
mhealth -- apps made $2.4 billion, but by 2017 that number is expected
to jump to $26 billion. Cortez points out that it's an unregulated
market, and although some of these apps are pretty low risk, there are
other apps that promise certain health benefits that aren't evaluated by
professionals in the healthcare industry.
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There are certainly legitimate apps that can help you track
serious medical conditions, but these apps are often designed in
collaboration with lawyers and professionals in the healthcare industry.
For example, in February 2011, the FDA gave approval to a healthcare app for the first time. The medical app is designed to let doctors view X-Rays on a smartphone or tablet.
However, for every mHealth app approved by the FDA, there
are a large number of apps that aren't. And that's what is prompting
more awareness around the need for regulation in the realm of mHealth.
"The FTC, for example, can look at the various medical claims made by
these wearables to determine if there is substantial evidence behind the
claims. Unsubstantiated claims can mislead device users and potentially
cause harm," says Anura Fernando, principal engineer of mHealth at UL; a
company focused on helping develop safe and secure wearable products.
Which medical apps can you trust?
While there are certainly dangers lurking in app stores when
it comes to mHealth, not all of these apps should be avoided. "Medical
wearables can be used to gather data under prescription and provide it
to remote clinicians. That data is trusted, as it is generated under
controlled conditions and seen as highly beneficial," says Fernando.
But that doesn't mean you should print out your FitBit data
to bring into your next doctor's appointment, says Fernando. "While the
data can be very useful, it can also be less reliable, perhaps more
prone to error and not as trusted. The trust aspect of data and how
clinicians can actually use this data is still under a lot of scrutiny
and there is a lot of discussion happening around how it should be
regulated to generate greater trust."
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The biggest pushback against FDA regulation of mhealth comes
from, not surprisingly, tech companies. Combined, Microsoft, McKesson,
Siemens, Dell and Intel spent over $20 million in lobbying efforts in 2012.
These tech companies are concerned about delaying progress on wearables
and medical mobile apps, since involving the FDA could hamper release
dates in the future. As Politico points out, this means that Apple can
allow an mHealth app into the App Store that connects with a diabetic
user's glucose meter to monitor their blood sugar. And it didn't stop in
2012, in 2014 Apple spent $1.2 million lobbying against FDA
regulations, while Intel spent another $1.5 million on lobbying efforts.
What to look for in mhealth apps?
This means that consumers need to become aware of what they
are downloading onto their mobile devices, or what they are strapping to
their wrists. Without FDA intervention, it might mean you are getting
faulty data or inaccurate medical advice. There are some things you can
look for, however, to help make an informed decision when downloading an
mhealth app or buying a connected device that promises certain medical
benefits.
"You want make sure they comply with current regulations and
regulatory guidance. And you want to make sure that the developers of
these technologies have gone through the process of making sure they
have correctly identified what regulations and standards apply to their
product and if they have received third-party testing on their product,"
says Fernando.
For Charles Settles, who has written numerous articles on
the topic of health IT, it's more than simply reviewing an app maker's
guidelines and practices. He personally wouldn't even use an app that
didn't connect him directly with his doctor in his home state. "I also
would be wary of any app without 510(k) approval, but that sort of
information is hard to find and even more difficult to understand for
the average consumer."
While our technology has certainly brought major
advancements in the realm of healthcare, including affordable 3D printed
prosthetics, electronic healthcare records and even telemedicine, it
certainly doesn't mean you should trust every mHealth app or device.
Without FDA regulation, it's important to ensure that the apps you
download aren't making false medical claims, and to consult your
physician before relying on the data from an mHealth app or wearable.
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