On Day Two of Three-Day Hearing Series, Experts Warn FDA Regulation of Health Information Technology Could Stifle Innovation, Barring Patients’ Access to Apps

March 20, 2013

WASHINGTON, DC – The Subcommittee on Health, chaired by Rep. Joe Pitts (R-PA), today held the second hearing of a three-part series on “Health Information Technologies.” Members today focused on how innovative medical technologies can benefit American patients and discussed what steps need to be taken to foster innovation and growth. Providers and patient groups elaborated on how these technologies benefit patients and the impact FDA regulations would have on these medical advancements.

“There are now mobile medical apps for wireless thermometers, apps that calculate body mass index, apps that track the number of miles a runner has jogged and those that can wirelessly transmit data to wearable insulin pumps,” said Chairman Pitts. “These apps can range from the complex, like mobile cardiac outpatient telemetry that uses wireless sensors, to those that allow users to count calories. It has been estimated that 500 million people will be using medical apps by 2015. Therefore, it goes without saying that these technologies hold great potential for patients and providers. This hearing is an appropriate place to examine the extent to which the FDA – and other federal agencies – should be involved in regulation of health information technologies and what such a regulatory framework might look like.”

In July 2011, the Food and Drug Administration proposed regulating medical applications. This month, committee leaders wrote to FDA Commissioner Margaret Hamburg seeking more information on whether FDA intends to regulate smartphones, tablets, and mobile apps and whether it would trigger the 2.3 percent medical device tax included in the president’s health care law.

Jim Bialick, Executive Director at the Newborn Coalition, provided every day examples of how lives are being changed through the application of these new medical technologies. “Not everybody is born in a city center so access to some of these remote home monitoring devices is very functional. Not only that but the telemedicine capacity that we are seeing especially through some of these devices has really expanded. As someone said in the hearing yesterday, it’s the new house call.”

Dr. Jacqueline Mitus, Senior Vice President of Clinical Development and Strategy at McKesson Health Solutions, explained that regulations are already failing to keep up with health technology innovation and applying medical device regulations to health IT would further hamper innovation. Mitus stated, “We are using a 40 year old law to regulate rapidly changing and dynamic technology. We are regulating manufacturing instead of use, and we are marginalizing the role of clinicians. Simply put, we must not impede medical advances with medical device regulation that is ill-suited for health IT.”

Dr. Joseph Smith, Chief Medical and Chief Science Officer for West Health Institute, stated, “I think it’s quite challenging for the FDA, for many reasons, to stay as current as possible on those things which are simply just emerging.” 

Jim Bialick also echoed concern voiced at yesterday’s Communications and Technology Subcommittee hearing that the uncertainty surrounding FDA’s draft guidance could stifle innovation, stating, “The threshold for a blockbuster app is gigantic now, I mean it’s millions of dollars. And so even to get the investment now to let’s say you’re going to develop it beyond just in your garage and have a large scale launch. The concern that you’ll have the potential for, or if it’s known that, you’ll have additional regulation on top of that cuts out the bottom line. So there’s an investment side to it to.” Rep. Morgan Griffith (R-VA) concluded, “So they’re more likely to try and find the next angry bird than the next angry mole.” 

Scheduling Note
On Thursday, the Subcommittee on Oversight and Investigations will conclude the hearing series with a look at “Health Information Technologies: Administration Perspectives on Innovation and Regulation.” More here.

###