Attorneys are cautioning that this year will face significant changes in rules.
With 2012 behind us, the first year in which mhealth played an important role in patient education and care has come to a close, and this year will open up new opportunities for both the use of the technology and for its regulation.
There were already regulatory issues for mobile health in 2012 and these will carry over into this year.
Arent Fox law firm attorneys, based in Washington D.C. recently published an article on the mHIMSS website along with the close of last year. Within this digital publication, they went over some of the larger regulatory issues faced by the mhealth industry throughout 2012, and that they believe will carry over into 2013.
Leading the list were the FDA’s efforts to establish their guidance over mhealth apps.
The U.S. Food and Drug Administration (FDA) has been making a series of continuing efforts to solidify guidance over mobile medical applications (MMAs) used for mhealth purposes. This guidance is meant to create a process to be followed for the regulation of certain MMAs for use as actual medical devices.
In July 2011, the FDA issued their “Draft Guidance for Industry on MMAs”, which was then open to the industry for comment. In response, the agency did receive a large amount of feedback from the mhealth industry.
At the moment, the FDA feels that the mhealth category will continue to be a “small subset” of the much broader health application marketplace. That agency is therefore placing its concentration “only [on] those mobile medical apps that present the greatest risk to patients when they don’t work as intended.” This, according to the director of the Center for Devices and Radiological Health at the FDA, Jeffrey Shuren.
It is expected that the mhealth industry and the agency will continue to work together throughout this year in order to establish a balanced Final Guidance to Industry for regulating those apps. In their article, the lawyers also stated that they anticipate Meaningful Use to generate a greater impact on the mobile health industry as 2013 progresses.