Congress Members Weigh Uncertainties Around Health Mobile App Regulations

A House subcommittee last week took a close look into the rapid growth of mobile health applications and the impact of potential regulations under way, in an effort to address some uncertainty and the level of government intervention that is needed.

The House Small Business Subcommittee on Health and Technology cited estimates that there will be more than 500 million smartphones by 2015, many of which will be used for health care purposes. 

“This technology is still relatively new territory for Washington, but it is important that Congress realizes its economic potential and recognizes how federal regulation affects the industry’s innovation,” said committee Chairman Chris Collins (R-NY). “Today’s testimony by mobile medical app entrepreneurs provides a case for why the federal government should enact policies that responsibly balances patient safety, while fostering cutting-edge innovation and economic growth.”

At least three federal agencies including The Federal Drug Administration (FDA), the Health and Human Services (HHS) Office of the National Coordinator for Health Information Technology, and the Federal Communications Commission take part in the regulation of apps that offer mobile medical services. Under law, the Secretary of HHS must prepare a report by January 2014 that outlines a strategy for a risk-based regulatory framework that governs health information technology, including mobile apps.

There is uncertainty remaining for example, as to whether mobile medical apps are subject to the Patient Protection and Affordable Care Act’s (ACA) new 2.3% medical device tax. The Internal Revenue Services (IRS) has issued a final rule stating certain mobile medical apps can be defined as “medical devices.” 

“Over the last 20 years, information management and information technology have played a transformative role in shaping the future of healthcare.,” said Alan Portela, Chief Executive Officer of mobile health technology company AirStrip in San Antonio, Texas. “Current and future innovations in healthcare information technology will be no different and they will affect every facet of healthcare including how it is delivered, how it is consumed, how hospitals compete with one another to provide best value and how the healthcare labor force is realigned to meet ever-changing requirements.”

Written by Elizabeth Ecker

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