Committee Weighs Pros, Cons of a Regulated mHealth App Industry | Healthcare Informatics Magazine | Health IT | Information Technology Skip to content Skip to navigation

Committee Weighs Pros, Cons of Regulated mHealth App Industry

March 20, 2013
by Gabriel Perna
| Reprints

Members of the House Energy and Commerce Subcommittee on Communications and Technology openly weighed the pros and cons of having the Food and Drug Administration (FDA) regulate and tax mobile health (mHealth)-based applications. The committee, which is chaired by Rep. Greg Walden (R-OR), said it was necessary to regulate for patient safety purposes, but warned that over-regulation of wireless mHealth could thwart innovation.

Energy and Commerce Committee Chairman Fred Upton (R-MI) said the medical device tax, which is a component of the Affordable Care Act, when applied to the wireless world could “prove disastrous and grind this innovation cycle to a halt.”

“We all want to ensure patient safety, but why would we treat mobile applications the same as a dialysis machine? Wireless has and can continue to bring the mobile revolution to our nation’s health and wellness sector. But we must ensure that as we bring the innovation of the wireless economy to health and wellness that we not place unnecessary hurdles in the way of the developers and investors that are fueling mHealth,” Walden said during the meeting.

Representatives from the mobile app community expressed concern over the FDA not finalizing the rule that they say could apply to apps, smartphones, and tablets. They couldn’t rule out the tax could hamper innovation from their end and talked about how the “overbroad application of the arduous medical device approval process” would hurt the mHealth app marketplace. They also said over-regulation would be a deterrent to investment.

“These types of taxes, if they are applied to mobile medical applications and devices, will stifle innovation, will tempt entrepreneurs to pursue as you suggested other types of innovation, and apply their genius and their efforts to other parts of the mobile ecosystem rather than efforts to make our children, our families, our parents, healthier. So there is an impact, and we need to be very, very vigilant and cautious about going down this path,” said Jonathan Spalter, Chairman of Mobile Future, a non-profit mobile advocate group.

Video of part of the hearing. More can be seen here.



NewYork-Presbyterian, Walgreens Partner on Telemedicine Initiative

NewYork-Presbyterian and Walgreens are collaborating to bring expanded access to NewYork-Presbyterian’s healthcare through new telemedicine services, the two organizations announced this week.

ONC Releases Patient Demographic Data Quality Framework

The Office of the National Coordinator for Health IT (ONC) developed a framework to help health systems, large practices, health information exchanges and payers to improve their patient demographic data quality.

AMIA, Pew Urge Congress to Ensure ONC has Funding to Implement Cures Provisions

The Pew Charitable Trusts and the American Medical Informatics Association (AMIA) have sent a letter to congressional appropriators urging them to ensure that ONC has adequate funding to implement certain 21st Century Cures Act provisions.

Former Michigan Governor to Serve as Chair of DRIVE Health

Former Michigan Governor John Engler will serve as chair of the DRIVE Health Initiative, a campaign aimed at accelerating the U.S. health system's transition to value-based care.

NJ Medical Group Launches Statewide HIE, OneHealth New Jersey

The Medical Society of New Jersey (MSNJ) recently launched OneHealth New Jersey, a statewide health information exchange (HIE) that is now live.

Survey: 70% of Providers Using Off-Premises Computing for Some Applications

A survey conducted by KLAS Research found that 70 percent of healthcare organizations have moved at least some applications or IT infrastructure off-premises.