CRACKING DOWN ON APPS: With some doctors now making clinical decisions based in part on information and analysis from smartphone applications, the government is trying to decide how much to regulate the apps. Image: ISTOCKPHOTO/LUKELIGHT
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When John Allen Reilly visits his hospice patients, he always takes along his iPhone. One of the applications he uses is A2Z of Dermatology to help classify skin conditions and to show photographs to his patients for comparison.
Similar apps for health care professionals include Skyscape's Medical Bag, which contains a host of treatment guidelines such as how to handle various cardiac conditions, read diagnostic lab tests and calculate weight-based dosing as well as On Call Notes, a basic notepad. Along the same lines, medical illustration apps such as 3D Brain Human Body Anatomy work as teaching tools for students (and motivated patients). Other apps have been developed to give doctors access to hospitals' patient charts and other data.
Nearly 1,500 smart phone applications for health care professionals are already available for downloading (along with many more for patients), and by 2012, 81 percent of physicians will have a smart phone, according to a report from Manhattan Research. As apps enter the realm of routine medical care, the U.S. Food and Drug Administration (FDA) must consider whether and how to ensure patient safety around the hodgepodge medical apps market—the top 10 medical apps include Medical Calculator and Sex-Facts. The fact that some specialized medical apps are openly available to anyone with a smart phone may raise additional concerns. But excessive regulation of medical apps could also squelch what might be the part of the next great wave of innovations in health care.
Medical applications are technically medical devices and therefore subject to federal regulation. There currently are no clear federal measures in place, however, to guarantee their quality and accuracy. The FDA is considering various degrees of oversight of so-called health information technology, which includes apps and other digital systems (such as electronic health record software). Regulation could be mild, focusing on postmarket safety via an electronic registry, according to Jeff Shuren, director of the FDA's Center for Devices and Radiological Health. He made his remarks this past February as testimony to the center's committee on health technology.
Manufacturers would be responsible for reporting any problems to the FDA and correcting safety issues, with some higher risk technology subject to closer surveillance. A middle-ground approach would require manufacturers of apps to adhere to specific FDA guidelines on quality and consistency. The most intensive regulation under consideration would require premarket safety and efficacy review of medical apps, as is the case for other clinical devices, such as heart monitors and computed tomography scanners.
An FDA spokesperson declined to comment on whether there are concrete plans to regulate medical smart phone apps and when new policies might be instituted, saying the agency's role in these applications and other health information technology is evolving.
With the rapid integration of apps into routine health care, however, time seems be of the essence. And as many physicians already use apps to check and update patient status, concern about logging crucial data incorrectly is not unfounded. Adverse events resulting from medical apps and other health information technology errors have already been reported to the FDA. Because of a programming error, allergy information for a patient failed to display on a clinical decision support app, according to Shuren's testimony. In another instance, results of a nuclear medicine study were saved in the wrong patient's file when accessed using health care management software.
Although many doctors embrace medical apps, no one is talking about abandoning the use of good clinical judgment or the human touch. Reilly, whose private practice in Frederick, Md., focuses on geriatrics, internal medicine, bariatrics and hospice has 105 apps on his iPhone but emphasizes that they will never replace his own system of checks and balances. "I don't make huge medical judgments [based on apps]," Reilly says. "These are here to help me."
Most currently available apps are simply a way to make it so reference tomes can be accessible on handheld devices, so FDA approval should be unnecessary, says Adam Wilcox, professor of medical informatics at Columbia University. "If the FDA is going to regulate referential information, are they going to monitor the textbooks from which the information is coming from?" he asks.
As another example, Wilcox recently developed an app that allows physicians at New York–Presbyterian Hospital to access patients' online records. The computer-based interface was not subject to regulation, so neither should the app be, Wilcox explains. Kavapoint, which manufactures several top medical apps, distributes medical information from the FDA rather than creating it. "We are confident that the data are correct, because we are taking it directly from the source," says Kavapoint co-founder Joseph Mao, arguing against strong regulations.