The House Small Business Subcommittee on Health and Technology, under the chairmanship of Congressman Chris Collins, held a hearing to highlight the contributions of mobile applications entrepreneurs to economic growth and improved health care. Witnesses included Sabrina Casucci, a Ph.D. candidate in industrial and systems engineering at the University at Buffalo.
"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."
Casucci, representing a team of UB graduate engineering students, discussed the team's app, which will make the hospital discharge planning process more effective and efficient.
"Solutions like ours can make a significant impact on health care in the U.S.," Casucci said. "Mobile solutions can connect fragmented care processes and improve continuity of care, both contributors to improved patient outcomes and reduced care costs."
The Federal Drug Administration, the Health and Human Services 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 percent 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 On July 21, 2011, the FDA released draft guidance on the regulation of mobile medical apps; however, some believe its vagueness has created uncertainty for the industry.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. Collins' camp said these regulatory developments will have a major impact on the innovation of small medical app manufacturers.