Mhealth apps generate concerns among lawmakers in the US

mhealth industry

MHealth Care IndustryThese worries have been voiced to the FDA, regarding the taxing of the mobile applications.

Republican House Energy and Commerce Committee members have voiced concerns to the U.S. Food and Drug Administration (FDA) regarding whether or not it plans to regulate mhealth apps for smartphones and tablets which could deem them medical devices under the rules of the Affordable Care Act.

The new healthcare law has imposed a excise tax on medical devices but it is unclear if apps are among them.

Six members of the committee wrote a letter to Margaret Hamburg, the FDA Commissioner, which expressed their worries that if the agency does decide that certain mhealth apps turn smartphones and tablets into medical devices, “it raises the possibility that they would also be subject to new taxes under the PPACA.”

The letter warned that by taxing the apps, the mhealth industry could potentially be held back.

They stated that taxation on these apps “could affect the growth and innovation” of the mhealth environment as a whole. The July 2011 draft produced by the FDA concentrated on an app’s “intended use” in order to decide whether or not it should be considered to be a medical device. The Republican committee members, however, are worried about the chance that “actual use” of the apps could turn into “a factor in the future”.

The letter sought to obtain written answers from the FDA so that they would have the following information:

• The time the FDA expects to provide updated or final guidance in terms of the approach that will be taken to its oversight of mhealth apps.
• Whether or not the FDA has looked into the potential impact of taxing smartphones and other mobile gadgets as medical devices and what it would do to the creators and distributors of those applications.
• If actually using a tablet or smartphone mhealth app will help to determine whether or not the FDA will decide to regulate it as a medical device.

At the time of the writing of this article, the FDA had yet to issue either a reply to these mhealth concerns or a new set or rules that would regulate medical apps on smartphones and tablets.

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