While the U.S. Food and Drug Administration unveiled its long-awaited final guidance on the regulation of mobile medical applications on Monday, some in the healthcare industry weren't sure it went far enough. For instance, Bradley Merrill Thompson, who serves as general counsel for the mHealth Regulatory Coalition, said the final guidance was porous in some areas, such as the definition of what are regulated; disease intended uses compared to unregulated, wellness intended uses; and the exact meaning of an accessory to a medical device.
To that end, we asked our FierceHealthIT Editorial Advisory Board to share with us their thoughts on the new guidance. Ed Bennett, (right) director of web and communications technology University of Maryland Medical System, called the guidance a "net positive" for the mobile medical market because of its focus on mobile medical apps with the highest potential risk.
However, David Harlow, a Boston-based healthcare attorney, said that because discretion is left to the FDA to define which mHealth apps and devices are "accessories to devices that transform an mHealth platform into a device," definitions are "a little squishy."
"That said, the guidance does make clear that the parade of horribles that some people imagined have not come to pass," Harlow (left) said. "The FDA will not attempt to regulate all smartphones as medical devices, etc."
Harlow added that a remaining area of concern is the cycle time for review of mHealth devices and accessories.
"If the review period is longer than the life cycle of the device, then this will be a significant problem for the mHealth market," he said. "Another interesting point is that the guidance regulates both consumer and healthcare professional devices--it will be interesting to see how these two parts of the market are further differentiated or further blended over time."
David Holland, (right) vice president and CIO at Carbondale, Ill.-based Southern Illinois Health System, said he was happy that the guidance finally was published.
"Almost any published set of guidance is better than unpublished guidance," he said. "The mobile app market moves very, very fast, something the government rarely does.
"It will be important that they strike a balance so they do not slow the market down," Holland added. "At the same time, I do agree that apps involved in direct patient care need oversight to protect patients."