The Smartphone App Regulations Are Here

Smartphone use for health care is a rapidly growing market and may reach over one billion downloads and a market worth of $400 million by 2016 (see Smartphone Wellness Application Market Value To Triple by 2016). Until now, these apps have gone largely unregulated – but no longer. Last month the U.S. Food and Drug Administration issued its final regulations for application developers, promising "enforcement discretion" and limited regulation of most apps (see Mobile Medical Applications Guidance for Industry and Food and Drug Administration Staff).

What medical apps will the FDA focus on?

Medical apps that are intended to be . . .