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TECHNOLOGY IS REVOLUTIONIZING the
health industry. “Digital health” is becoming an
everyday term that encompasses health services and
information via mobile technologies, health information technology, wearable devices and telemedi-cine. Although technology is allowing the same
kind of ease and efficiency in health care that it has
in other industries, there are challenges to address.
Questions about accuracy of information, privacy, security and regulation are at the center of the
discussions on digital health among experts and
federal regulatory agencies. Representatives at the
U.S. Food and Drug Administration (FDA) and Dr.
Eric Topol, director of the Scripps Translational
Science Institute and a Costco member, note some
of the issues you need to be aware of.
Privacy and security
When medical devices are connected to the
Internet, hospital networks and other medical
devices, they become vulnerable to security
breaches. Devices that possess the highest cyber
security vulnerabilities include CT scanners, infusion pumps and implantable cardiovascular defibrillators. Such threats cannot be completely
eliminated; manufacturers, distributors, hospitals
and facilities can only manage them and continue to
take steps to ensure appropriate safeguards.
Finding technical solutions to prevent hacking
is an ongoing challenge
Taking doctors out of the equation has raised
some concerns about the accuracy of do-it-yourself
health-care devices: apps that monitor vital signs,
analyze blood and urine, track medication adher-
Dilemmas in digital health
ence and more. Even if data is provided to a doctor
from your own testing device, your doctor should
repeat the test.
According to health experts, the tech industry
knows it has to focus on making health-care devices
more accurate and reliable. Make sure to consult
with a qualified physician if you are looking at your
The FDA and the Federal Communications
Commission (FCC) work together to provide regulatory oversight to preserve digital health users’ privacy and security and to ensure that digital health
devices work effectively. Failure to go through the
FDA regulatory approval process for a medical
device is a criminal offense.
In regard to mobile medical apps, the FDA has
so far cleared more than 100 of them, but does not
regulate most of them. The agency focuses its regulation on a small subset of mobile apps that are
medical devices and present a greater risk to patients
if they do not work as intended.
Most mobile medical apps do not meet the definition of medical device. Among the ones that do,
most carry minimal risks to patients and consumers, and the FDA has announced its intention to
exercise enforcement discretion with those.
The FDA’s main concern with digital health—as
with all medical products the agency regulates—
focuses on the safety and effectiveness of medical
devices as they pertain to public health. Learn about
mobile medical devices on the FDA’s website at
www.fda.gov/medicaldevices under “Digital Health.”
Most mobile medical apps are Class I or Class II. You
can search the FDA’s 510(k) database for any medical
device that has been cleared through that process.
The FCC is working to raise awareness of
broadband, advanced technology and health
through the Connect2HealthFCC Task Force. Learn
about the task force and its work on consumer
health issues at fcc.gov/health. C
THE IMPORTANCE OF
emergency contact infor-
mation on your mobile
device cannot be over-
stated. Listing a trustwor-
thy family member or
friend familiar with your
medical history under the
acronym “ICE” (In Case of
Emergency) in your mobile
device could save your life.
You can do this directly
in your list of contacts or
use an app that places ICE
information on your lock
screen. You can also do it
the old-fashioned way and
have an easy-to-find card
in your wallet.
In addition to emer-
gency contacts, be sure to
have information about
medicines, allergies and
doctors accessible as well.
An emergency is
something you may not
think will happen to you,
but it is better to be pre-
pared than sorry. C
In case of an
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