AcuteCare Telemedicine Blog


FDA, mHealth Regulations are on the Horizon

A battle is beginning to build between various stakeholders and investors in new medical mobile applications over the timing of the release of long-anticipated Federal Drug Administration (FDA) regulation of the medical app industry. A group of 100 organizations including medical trade associations and electronic health record product companies wrote to federal regulators recently, urging the need for slowing the course on mHealth regulation, particularly until a mandated federal workgroup finishes working on a report to guide Congress on the issue.

Brad Thompson, attorney for the mHealth Regulatory Coalition, the group working to prepare the report for Congress, submitted a letter to regulators the same week urging the release of mobile app regulations as soon as possible. Thompson, a member of the workgroup says he’s “pretty familiar with what that group is doing, and I don’t see publishing the FDA guidance as frustrating at all.”

Mobile app developers need regulations now in order to know if their product needs FDA approval. Without it, they could be breaking a federal statute

if they go to market before the regulation is released and may find that they will be undersold by competitors who do not seek FDA approval.

The dollar amount of investments awaiting federal guidance is significant and the risk is even greater.  The uncertainty over the guidelines which will ultimately determine whether some medical application need FDA approval before going to market is palpable for stakeholders who are reserving large amounts of capital pending the news.  As is often the case with governmental regulations, knowing is far better than not knowing in the eyes of many investors.

Medical applications for use with mobile devices are a very promising niche for those who are marketing medical services through telemedicine.  Mobile applications promises to expand and ease accessibility to chronic disease patients who currently are underserved, particularly when it comes to highly specialized medical care.

FDA officials have indicated that they are moving toward an October 2013 release of regulations.


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