The rapid rise of mobile health technology has triggered warnings that scientific rigor is critical when developing and using medical apps. The cautions are coming from both the federal government and the private sector.
"Mobile health and mobile health research have tremendous potential," says Robert Kaplan, director of the Office of Behavioral and Social Sciences Research in the National Institutes of Health. "The concern is that mobile health is moving ahead of the evidence." Kaplan participated in a recent NIH mHealth Evidence Workshop that sought to outline an approach for developing scientific evidence in mobile health.
The Food and Drug Administration recently issued nonbinding draft guidance on how it intends to regulate mHealth apps. In general, the guidance says the FDA will regulate mobile apps that perform the functions of a traditionally regulated device or affect the performance of a regulated device.
The FDA will use its discretion in deciding whether to regulate a mobile app that technically qualifies as a medical device under the Federal Food, Drug and Cosmetic Act, but performs such functions as automating medical information or help with self-treatment of chronic disease, according to the guidance.
"If you're uploading information to your cardiologist, that is a different thing than checking your heart rate," says Wendy Nilsen, health scientist administrator in the office that Kaplan directs.
An organization that performs mHealth research and is one of its most fervent backers — Scripps Health — also is calling for a measured approach to using mHealth apps. Steven Steinhubl, M.D., newly named director of the digital medicine program at Scripps, says there's a lot of excitement and enthusiasm for using mobile health technology but not a lot of evidence as to what works.
For example, Steinhubl says, it's known that apps and devices to help people track their eating and exercise can work from a functional standpoint, but what isn't known is whether people could be induced to use them for the long term. "People may try and fail with one of these applications, and sort of give up," he says.