SOFTWARE Act to Address Mobile Health App Regulations

The act redefines the FDA's regulatory authority over medical software and provides companies with a better understanding of which apps require review.

A bipartisan bill was introduced in Congress last week called the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act, which would provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records and other health care-related software.

Currently, the Food and Drug Administration (FDA) lacks the necessary tools to appropriately oversee these innovative products without overstepping its authority and stifling innovation. Under current law, the FDA could use its definition of a medical device to assert broad regulatory authority over a wide array of software.

The act redefines the FDA's regulatory authority over medical software and provides companies with a better understanding of what applications require review and approval. The hope is that this will speed up innovation while also freeing regulators to increase their oversight of the medical applications, devices and drugs with the highest potential risk.

The act tailors the FDA's authority to the realities of the 21st century by focusing the administration's authority on the products that pose a potential risk to human health. Estimates indicate that the number of consumers using medical apps on their smartphones will grow to 500 million by 2015.

According to a recent report from Research2Guidance, there are currently 97,000 mobile health apps in Apple's App Store that have generated 3 million free and 300,000 paid downloads. Fifteen percent of these apps are designed specifically for health care providers, and more than 60 percent of doctors are using tablets—compared with half of that just over a year ago.

"Health care delivery will continue to be impacted by the advent of new technology, specifically with health care software. This bill provides innovators clear regulatory guidelines that allows for breakthrough medical advancements and innovation," Dr. Phil Gingrey, R-Ga., said in a statement. "As a physician, I’ve seen firsthand the benefits of life-changing medical software and applications that better support doctors, manage disease, and ultimately, save patients' lives."

Despite the growing sophistication level of mobile health (mHealth) applications, only 9 percent of the total market revenue in the next five years will come from application download revenue. The Research2Guidance report found 84 percent of total mHealth application market revenue will come from related services and products such as sensors.

Last week, the Information Technology and Innovation Foundation (ITIF) praised the introduction of the act, arguing that it will create a more effective regulatory framework for medical software, improve patient safety and spur more innovation.

"As long as there is regulatory uncertainty about medical software, many companies will avoid developing new technology for this market," Daniel Castro, senior analyst with ITIF, said in a statement. "The Act would have the FDA focus its regulatory oversight on those technologies that pose the greatest risk to human health, while allowing lower risk products into the marketplace more rapidly."

The ITIF is a non-partisan think tank whose mission is to formulate and promote public policies to advance technological innovation and productivity internationally, in Washington and in the states.