This week’s 4th annual mHealth World Congress is set to wrap up today in Boston. For those with the topic of mHealth on their minds, the level of discussion went into great depth. [1]
During the opening of the three-day conference on Wednesday afternoon, the issues of mobile device security and medical application regulations were the first of two panel discussions. Due to the depth of the panel discussion and multiple questions from the audience, it is evident these topics will be on the table for some time.
The U.S. Food and Drug Administration will release a final draft of guidelines for mobile medical apps in the fall. The focal point of the panel discussion was on what should and should not be regulated. It was noted by panel members that in a market overflowing with a variety of medical apps, it is difficult to distinguish which ones are harmless and which ones are potentially dangerous and in need of regulation. [2]
The FDA is concerned with a small portion of mobile medical apps, according to Brad Merrill Thompson, JD, general counsel for the mHealth Regulatory Coalition and counsel for the Continua Health Alliance. Stakeholders want to clarify the issue of the intended use of the app, focusing on the difference between health and wellness apps.
“It all comes down to how you promote the product,” said Thompson.
Some apps muddy the waters between health and wellness, moving from language like “improve” and “monitor” to risky claims like “diagnose.”
While many in the mHealth field are wary of proposed FDA regulations, some see it as an advantage. Sridhar Iyengar, PhD, co-founder and chief technology officer for AgaMetrix, a developer of diabetes tools, said having the FDA seal of approval could be used for marketing purposes, and also believes it would be easier to seek FDA approval than try to maneuver around it.
According to Bakul Patel, MS, MBA, a policy advisor with the FDA’s Center for Devices and Radiological Devices, the FDA believes mHealth tools are promising and have the potential to promote public health. However, the regulatory agency’s primary concern is safety and to guarantee that patients have the same confidence in mHealth tools as in other FDA-regulated medical devices.
To achieve this effort of regulating mHealth tools, the FDA’s greatest challenge is to balance the goal of encouraging innovation, protecting the health of the public and promoting public health, Patel said during the panel.
Can this goal be reached? Will FDA regulations for mHealth apps promote health and protect the public, in addition to encouraging the innovation of developers? Tell us what you think.
