FDA proposes rules for m-health apps

As m-health apps proliferate on various consumer- and enterprise-centric devices and operating systems, the U.S. Food and Drug Administration wants to ensure that specific apps work as intended under a set a proposed guidelines.
“The FDA has a public health responsibility to oversee the safety and effectiveness of a small subset of mobile medical applications that present a potential risk to patients if they do not work as intended. In order to balance patient safety with innovation, it is important for the FDA to provide manufacturers and developers of mobile medical applications with a clear and predictable outlines of our expectations,” the agency wrote on its site.
The FDA is particularly focused on apps that enable health care professionals to view medical images and apps that can transform a mobile device into a regulated medical devices, such as an electrocardiography machine.
“There are advantages to using medical apps, but consumers and health care professionals should have a balanced awareness of the benefits and risks,” FDA policy advisor Bakul Patel said in a prepared statement.
The proposed rules are open for public comment through Oct. 19. “We want to hear from as many consumers, advocacy groups, health care professionals, and software creators and distributors as possible to help us finalize the proposed guidelines,” Patel added.