CullmanTimes.com - Cullman, Alabama

March 13, 2013

Lawmakers Push FDA to Finish Rules on Health Apps

By Hayley Tsukayama
The Washington Post

WASHINGTON — House lawmakers urged the Food and Drug Administration on Tuesday to quickly finalize rules governing the growing field of health-care apps, including clarifying whether the industry will be subject to new taxes under the Affordable Care Act.

Consumers already use the apps to track blood sugar levels and weight loss, which they can share with their doctors. But regulators are struggling to determine when the apps turn smartphones and tablets into a medical device subject to additional regulations.

The FDA has been mulling over these issues for years, releasing a proposal in 2011 that gave it wider authority over apps that duplicate the functions of existing medical devices, such as apps that show MRI scans or measure heart rates.

But the agency has yet to issue final guidance on the matter and declined to comment on the latest push from Congress.

Now lawmakers are questioning whether defining the apps as medical devices subjects them to new taxes under the Affordable Care Act.

"Most Americans have no idea that their smartphone, tablet or the mobile apps that have become part of their daily lives could be subject to added red tape or a new tax under Obamacare," Energy and Commerce Committee Chairman Fred Upton, R-Mich., said in a statement.

The committee will hold three hearings next week to put further pressure on the FDA to take action. The hearings will examine how FDA regulations could affect patients, physicians and developers looking to capitalize on the growing field.

The FDA's progress on the issue has been watched closely by privacy advocates concerned about how the agency would balance the potential medical benefits of the apps against the privacy concerns of having such sensitive data in the hands of the private companies that develop the software.

The market for health-related apps has been growing for years. Mobile health apps and accessories are expected to reach $26 billion in sales by 2017, up from $718 million in 2011, according to Research2Guidance, a consulting firm.

Some smaller developers could be slowed down by new regulations, which can be costly to navigate, said Ben Chodor, chief executive of the medical-app curator Happtique.

But, Chodor added, that's not necessarily a bad thing. Medical apps deal in sensitive information, he said, and FDA input could help with the current "Wild West" app environment. Additional taxes, he said, could simply be the cost of doing business in the field.

"In a lot of ways, it needs an element of regulation," Chodor said. He said he hopes the FDA will take a narrow focus, regulating only those apps that truly turn phones into medical devices. "No one wants to stop innovation," he said. "But we have to know, will this app be safe?"

Other developers are finding other ways to work with medical data, such as striking partnerships with companies that are already regulated. That's the path being taken by Moxie Fit, a Rockville-based company, that has partnered with Aetna on its exercise app.

The partnership allows Moxie Fit to focus on the wellness app, while Aetna shoulders the administrative, logistical, security and financial burdens, said Thomas Wavering, Moxie Fit's senior director of strategic technologies and transitions. "It makes sense for a company like us to partner with Aetna. [They're] a big company, they can handle that. They can do what they do, and we do what we do," he said.

Emi Kolawole contributed to this report.