Ferdous Al-Faruque

The explosion of medical devices and apps that integrate with smartphones has the potential to transform the healthcare system by allowing doctors to collect information about patients in real-time.

The marketing research firm Research2Guidance projects the global business in “mHealth” technology will grow 61 percent from 2013 to rake in $26 billion in revenues by 2017.

While healthcare providers and doctors are enthusiastic about the technology, federal officials are grappling with how the apps fit in with the broader regulatory system that is intended to protect patients. The Food and Drug Administration (FDA) is charged with overseeing of all medical devices in the United States, including apps that integrate with smartphones.

Lawmakers including Reps Michael Burgess (R-TX) and Marsha Blackburn (R-TN) had criticized the FDA’s approach to mHealth technology, warning a heavy regulatory hand could slow innovation and prevent useful tools from reaching the marketplace. In response, the FDA said it would use its discretion to avoid regulating the overwhelming majority of mHealth technology, because it poses only minimal risk to consumers.

Top Republicans are questioning whether an office within the Health and Human Services Department has the authority to regulate software applications used in the health industry and impose user fees.

In a letter to Karen DeSalvo, national coordinator for health information technology (IT) at HHS, GOP leaders questioned whether the Office of National Coordinator (ONC) has the statutory authority to regulate health IT products based on a new report and whether it has the authority to receive user fees under its budget request.

“It is not clear to us under what statutory authority ONC is now pursuing these enhanced regulatory activities, including the levying of new user fees, on Health IT,” said the lawmakers on the House Commerce Committee. They included Chairman Fred Upton (R-MI), Vice Chairman Marsha Blackburn (R-TN), Health Subcommittee Chairman Joe Pitts (R-PA) and Communications and Technology Subcommittee Chairman Greg Walden (R-OR).