Earlier this year, the FDA published its final guidelines on choosing wireless networks for medical devices, focusing on issues such as co-existence, quality of service and security. "We do not regulate smartphones and tablets, but if you transform a smartphone into a device to monitor cardiac status, for example, we will" regulate it, he said.
The agency this year also published its recommendations for security issues medical device designers need to consider. "We are aware of devices affected by malware, including implanted devices, and we know of uncontrolled distribution of passwords including to tech support personnel, he said.
In August, the FDA published a list of 14 interoperability standards it will recognize, and it hopes to release guidelines on interoperability in 2014. "It will not be proscriptive about what you must do but will provide considerations to take into account," he said.
As many as 500 million smartphone users will employ health apps by 2015, according to one 2010 study he cited. Another report estimates the mobile health market will grow to revenues of $26 billion by the end of 2017.
Overall, "… health care delivery is vastly different even from a decade ago," Maisel said. "Much more often patients are going home more quickly, and consumers are making their own diagnosis on their smartphones over the Internet," he added.
— Rick Merritt, Silicon Valley Bureau Chief, EE Times