Steve Ruark for The New York Times
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
Ozier Muhammad/The New York Times
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.”