Health Policy

Mobile app guidelines by FDA

The U.S. Food and Drug Administration hopes to release guidelines by the end of the year on how it would govern certain mobile medical apps.


President Barack Obama signed the bipartisan Food and Drug Administration Safety and Innovation Act (S. 3187).. The law allows the FDA to move ahead with plans to regulate mobile medical apps while the Department of Health and Human Services develops a report on an “appropriate, risk-based regulatory framework pertaining to health information technology, including mobile medical applications that promotes innovation, protects patient safety and avoids regular duplication.”

The law also amends FDA policy to speed up the approval of potentially life-saving products and improves the agency’s oversight of safety regulations. The law has support in the San Diego-based independent non-profit West Wireless Health Institute, which issued a joint press release on July 9 with BIOCOM and CONNECT, two other southern California-based life sciences advocacy groups.

The entire mobile health ecosystem is developing inherently low-risk technologies to extend care beyond offices and hospitals, and these novels, low-risk devices and integrated solutions can be expedited via these changes to the FDAs de novo pathway. The FDA reforms help create a more predictable, safe and effective regulatory process that encourages the immense investment to get a concept from discovery to commercialization, giving patients access to high quality products in a timely fashion.


As for mobile medical apps, Congress should have a role in helping develop a framework that makes sense for mobile health technologies as they exist today, but is flexible enough to evolve with the market. NPR’s Rob Stein, Jeffrey Shuren, who leads the FDA’s Center for Devices and Radiological Health, cautioned that the FDA doesn’t want to regulate all apps “ just those that act as medical devices or contribute to the clinical decision-making process. Health and wellness apps or apps that help users manage medical conditions won’t fall under the FDA’s purview, he said.


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