Health IT Regulators Face Challenges As Medical Apps Proliferate

The regulation of health information technology was always bound to unspool slowly, given the involvement of multiple agencies with overlapping jurisdiction and a rapidly changing and important industry. The first piece of finalized health IT regulation, which laid out rules for mobile applications, was released Sept. 23 following two years of debate. The government is required to outline its plans for the rest of the sector by January 2014.

Three agencies are charged with regulating the sector: the Food and Drug Administration, which will approve some apps and software and oversee the use of IT in clinical practice; the Federal Communications Commission, which manages wireless spectrum; and the Office of the National Coordinator for Health Information Technology, which oversees electronic medical records. The agencies have indicated they will take a flexible approach to health IT regulation in the hopes of encouraging innovation.