FDA to monitor medical apps

By Dr. Ananya Mandal, MDJul 20 2011

The Food and Drug Administration (FDA) has stepped in to regulate the rapidly expanding field of medical applications, or apps, for smart phones and other handheld devices. With the rise of the iPhone, Android and other mobile devices has come a flood of applications designed to help people stay healthy. Industry analysts estimate there are already more than 17,000 medical applications available, ranging from calorie counters to programs that let doctors view medical scans on their phones.

The FDA says it will begin regulating a handful of these programs that pose the greatest risk if they don't work appropriately. The agency drafted a proposal where it says it will regulate applications that combine with medical devices already regulated by the agency, such as heart monitors that transmit to a smartphone.

Bakul Patel, a FDA policy adviser who helped craft the guidelines, said the agency sought to balance the potential for innovation with patient safety in the rapidly changing mobile space. “What we have done is we have taken that approach and formulated policies that were narrowly focused on a very small subset while allowing apps that are out there to foster and continue developing that space,” he said.

According to the guidelines three types of applications should require the FDA’s sign off: a mobile application that acts as an accessory to a regulated medical device, turns a mobile gadget into such a device or makes suggestions regarding a patient’s diagnosis or treatment.

For example, an app that allows radiologists to view X-rays on an iPad or that turns an Android phone into a heart monitor would be regulated. But an app that stores medical records or provides training videos to physicians would not. Patel explained, “We wanted to make sure that we are consistent in regulating medical devices so nothing has changed. If somebody makes a stethoscope on an iPhone, it doesn’t change the level of oversight we have of a stethoscope.”

“If I’m using a traditional medical device and I’m expecting it to be safe and effective, just because it’s on a mobile platform those same expectations apply. And the same risks… also apply,” said Jeff Shuren, director for the FDA’s Center for Devices and Radiological Health.

The guidelines won’t be enforced until the agency collects feedback over the next 90 days from manufacturers and health care providers. The proposals come as some industry groups have pressed the agency to outline its intentions in hopes of eliminating the kind of regulatory uncertainty that can make investors and companies skittish about backing a product. “We have been asked by many different groups in the past [for guidance],” Patel said. “We are listening to them and responding to them.”

“We are seeing these kind of software programs develop and we’re seeing that happen in the future,” Shuren said. “We are trying to get out ahead of technology so we’re prepared and allow these technologies to be developed quickly and modified quickly.”

In 1989 the agency prepped a policy statement on how it planned to regulate computer-based products and software, which was known as the “Draft Software Policy.” Since the use of computer and software products accelerated so quickly, however, and the types of these devices grew “exponentially” the FDA decided it wasn’t practical to create guidelines that would address all medical devices containing software. So those draft guidelines were withdrawn. Both Patel and Shuren were confident that this set of draft guidelines would not meet the same fate as the Draft Software Policy.