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.

Building Better Policy

Over the past several years, studies such as those conducted by the CDC and the National Institute of Health have constantly shown great disparity in levels of healthcare access across America. Particularly for poorer and rural areas, a lack of proper access has historically been extremely costly both in terms of human life and a greater economic impact. Policy makers, government officials, and leaders of health care organizations have recognized this divide, and are focused on identifying and eliminating barriers to patient access to provide a better, more uniform standard of effective healthcare across the country.

Thanks largely to leaps in technology and growing infrastructure, telemedicine is emerging as a highly effective solution with the potential to shape the future landscape of healthcare in America. The innovative, modern solutions offered by the growing telemedicine field combat the logistical challenges of the current state of healthcare, while having been proven to be more cost effective. Now, legislators are finally beginning to see the light.

On a state level, governments that have passed new telehealth legislation have seen positive results across the board. Powerful new applications and techniques have helped simplify and streamline remote patient consultation and monitoring, delivering better care with less economic impact with patient satisfaction rates nearing 100%. A dozen states, including Georgia, are leading the way on acknowledging telemedicine as an effective and efficient solution. So far in 2012, Maryland and Vermont have become the latest states to require private insurance companies to pay for telemedicine services.

The adoption of telemedicine marks a revolution in healthcare that carries great possibility for lasting impact. Creating a legislative environment in which telemedicine can flourish must continue to become a priority in a nation interested in reducing costs and saving lives.