House Small Business Subcommittee on Health and Technology, under the chairmanship of Rep. Chris Collins (R-NY), held a hearing to highlight the contributions of mobile applications (apps) entrepreneurs to economic growth and improved health care. Witnesses also discussed how Washington regulations are helping or stifling innovation.
“The medical app industry is growing by leaps and bounds, providing economic opportunities and improving patient-focused health care in a digital age,” said Chairman Collins. “One study estimates that over 500 million smartphones will be using mobile medical apps by 2015. The medical app industry has created an estimated 500,000 jobs and nearly $25 billion in revenue. 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. 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.”
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 have roles in the regulation of mobile medical apps. In addition, the Internal Revenue Service is implementing the health care law’s 2.3% medical device tax, and has said that certain mobile medical apps fall under the description of a medical device.
The Food and Drug Administration Safety and Innovation Act, enacted in 2012, requires the Secretary of HHS to prepare a report by January 2014 that outlines a strategy for a risk-based regulatory framework that governs health information technology, including mobile apps. On July 21, 2011, the FDA released draft guidance on the regulation of mobile medical apps; however, some believe its vagueness has created uncertainty for the industry. In March, the FDA said it hopes to issue final guidance by the end of this fiscal year. These regulatory developments will have a major impact on the innovation of small medical app manufacturers.
Keith Brophy, Chief Executive Officer of Ideomed in Grand Rapids, MI said, “It is important to remember the impact laws and regulations have on small businesses. I thank the Committee for placing the spotlight on developers like Ideomed who are working hard in a very competitive industry. With the possibility of unintended consequences disproportionately affecting small businesses, it's important for Congress to move carefully when making changes that affect health care mobile technologies.”
Alan Portela, Chief Executive Officer of AirStrip in San Antonio, TX said, “Over the last 20 years, information management and information technology have played a transformative role in shaping the future of healthcare. Current and future innovations in healthcare information technology (HIT) 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.”
Sabrina Casucci, Ph.D Candidate of Industrial and Systems Engineering at the University at Buffalo in New York said, “Solutions like ours can make a significant impact on healthcare in the US. mobile solutions can connect fragmented care processes and improve continuity of care, both contributors to improved patient outcomes and reduced care costs.”