Steve Ruark for The New York Times
Anand K. Iyer, president of WellDoc, which is marketing the DiabetesManager app.
By JOSHUA BRUSTEIN
Published: August 19, 2012
Before long, your doctor may be telling you to download two apps and call her in the morning.
Ozier Muhammad/The New York Times
Lee Perlman, left, and Benjamin Chodor of Happtique,
developer of a medical app that can facilitate the writing of
prescriptions.
Smartphone apps already fill the roles of television remotes, bike
speedometers and flashlights. Soon they may also act as medical devices,
helping patients monitor their heart rate or manage their diabetes, and
be paid for by insurance.
The idea of medically prescribed apps excites some people in the health
care industry, who see them as a starting point for even more
sophisticated applications that might otherwise never be built. But
first, a range of issues — around vetting, paying for and monitoring the
proper use of such apps — needs to be worked out.
“It is intuitive to people, the idea of a prescription,” said Lee H. Perlman, managing director of Happtique,
a subsidiary of the business arm of the Greater New York Hospital
Association. Happtique is creating a system to allow doctors to
prescribe apps, and Mr. Perlman suggested that a change in the way
people think about medicine might be required: “We’re basically saying
that pills can also be information, that pills can also be
connectivity.”
Simple apps that track users’ personal fitness goals have already gained
wide traction. Now medical professionals and entrepreneurs want to use
similar approaches to dealing with chronic ailments like diabetes or
heart disease.
If smartphone-based systems can reduce the amount of other medical care
that patients need, the potential benefit to the health care system
would be enormous; the total cost of treating diabetes alone in 2007 was $174 billion, according to the most recent statistics from the Centers for Disease Control and Prevention.
But unlike a 99-cent game, apps dealing directly with medical care
cannot be introduced to the public with bugs that will be fixed later.
The industry is still grappling with how to ensure quality and safety.
One of the pioneers in the prescription-app field is a company called WellDoc.
Its DiabetesManager system, which patients can use through a smartphone
app, standard cellphone or desktop computer, collects information about
a patient’s diet, blood sugar levels and medication regimen. Patients
can enter this data manually or link their devices wirelessly with
glucose monitors.
DiabetesManager then gives advice to a patient, perhaps suggesting the
best food after recording a low midday blood-sugar reading. It also uses
an algorithm to analyze the medical data and send clinical
recommendations to the doctor.
WellDoc says that in a clinical trial, DiabetesManager was shown to
reduce significantly the blood sugar levels in diabetes patients.
Those results persuaded the Food and Drug Administration to give the
system clearance to operate as a medical device. At over $100 a month,
the cost is more akin to diabetes drugs than to most smartphone apps.
But two insurance companies have already agreed to pay the bill for
patients whose doctors ask them to use the system when it is available
early next year, said Anand K. Iyer, the company’s president. He
declined to name the companies.
When Mr. Iyer began planning an app for WellDoc, he had something simple
in mind. But as the company pursued it he realized that it would have
to build something much more ambitious, in a process that ended up
taking years and millions of dollars in investment.
“As I learned more and more about the health care system, I realized
that the way to monetize this wasn’t as a 5-cent app in the app store,
but as a high-value system,” he said. “It wasn’t going to be a quick
ride.”
The app is one of fewer than 10 to date that has gained clearance from the F.D.A.
Sailesh Chutani, the co-founder of MobiSante,
which created a smartphone-based ultrasound system, said that his
company initially considered marketing it as a veterinary tool, or
selling it only overseas, to avoid an expensive vetting process. But the
company chose to ask to be regulated, in part because it made it easier
to attract investment. Last year the F.D.A. approved the system, which
includes an app and an ultrasound device that connects to the phone.
“Suddenly you’re sending a market signal that you have been vetted and
cleared by the toughest regulatory agency in the world,” Mr. Chutani
said.
It is still not completely clear how far regulation over medical apps
will extend. The F.D.A. plans to release guidelines later this year
outlining its approach to apps, while other agencies will be in charge
of privacy and data security.
Continua Health Alliance, an industry group, is also working on
standards so that medical apps collect data in compatible formats,
allowing patients to move their data from one app to another. There are
also questions of what happens when a prescribable app is available only
on certain types of phones.
At the same time, many apps being marketed as medical tools are being
designed to skirt federal regulation, in part by piling on the
disclaimers. Still, there is wide acknowledgment that many apps violate
current regulations by making dubious or untested medical claims. The
F.D.A. has shied away from going after such apps until its guidelines
are in place. The agency, which does not want to choke innovation, will
regulate only applications that act as medical devices by making
clinical or diagnostic decisions, said Bakul Patel, an F.D.A. policy
adviser.
Mr. Perlman of Happtique says he believes that doctors will soon
prescribe both clinically tested apps and more modest apps, like those
that track physical activity or remind patients to take their pills. The
company has established its own set of guidelines to determine the
quality of health care-related apps, and helps doctors integrate them
into their medical practice.
The company evaluates apps in several areas — diabetes, cardiology,
rheumatoid arthritis and physical therapy — and allows doctors to
prescribe apps to their patients from selected lists. It monitors
whether the patient has downloaded the app, and can send automated
reminders to those who have not done so. The company is opening its
system to doctors this week.
Skeptics, including John Moore, a physician at the M.I.T. Media Lab’s
new media medicine project, say that Happtique is ahead of its time,
since there are relatively few apps that are worth prescribing.
“Making a clearinghouse for apps today is a tough job because you’re
just filtering through a lot of stuff that doesn’t do much,” said Dr.
Moore. “But as a long-term vision, it’s an interesting idea.”
But the company says that it is setting up a framework so that it can
persuade insurance companies to pay for apps that doctors recommend. It
is also lobbying federal regulators to allow patients to use flexible
spending accounts to buy prescribed apps through its system.
“This is the transition from something that is superficial to serious
health care delivery,” Mr. Perlman said. “The health care system is
going to need somebody to help organize this.”
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