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Congressman Gene Green

Representing the 29th District of Texas

Reps. Green, Blackburn, Gingrey, DeGette, Walden and Butterfield Introduce SOFTWARE Act

October 23, 2013
Press Release

Washington, DC – Congressman Gene Green (D-TX) joined Representatives Marsha Blackburn (R-TN), Dr. Phil Gingrey (R-GA), Diana DeGette (D-CO), Greg Walden (R-OR), and G. K. Butterfield (D-NC) in introducing the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act to provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records, and other health care related software. By building on the guidance recently released by the FDA and codifying their risk based regulatory approach this important legislation provides the regulatory certainty that technology companies need in order to continue to drive innovation and ensure patient safety.  

Estimates indicate that the number of consumers using medical apps on their smart phones will grow to 500 million by 2015. But today the Food and Drug Administration (FDA) lacks the necessary tools to appropriately oversee these innovative products without overstepping their 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 SOFTWARE Act tailors their authority to the realities of the 21st century by focusing their authority onto the products that pose a potential risk to human health.
Rep. Gene Green: “As new technologies emerge, it’s important that federal regulatory agencies like the FDA are properly equipped to provide a common sense level of oversight of medical software. This bill builds on the steps forward made by the FDA in their recently released guidance and focuses federal resources on the medical software that pose a risk to patients and should be trusted to be safe and effective by patients and providers alike. This bill aims to encourage innovation in medical related software while providing the regulatory framework to keep us safe.”

Rep. Marsha Blackburn: “Our legislation takes the necessary steps to protect technological innovation that is filtering into growth sectors like health care. This bill would provide the FDA with the tools it needs to effectively protect consumers who use high risk technologies, while allowing the innovation of low risk technologies to continue without being caught up in the expensive and time consuming FDA approval process all while protecting patient safety. Technology and connectivity is sweeping into nearly every industry, revolutionizing the products and services we rely on and it is imperative that we work to encourage the continued development of new technologies to improve healthcare and create new jobs.”

Dr. Phil Gingrey: “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. 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.”

Rep. Diana DeGette: “As technological advances change the face of medicine in the 21st century, the FDA is hamstrung with outdated tools that limit oversight and could ultimately stifle innovation. This bill will help create a regulatory framework that ensures emerging technologies are effective and secure, while protecting patient safety. The SOFTWARE Act is also a great example of bipartisan cooperation paving the way for a stronger, healthier future for our country.”

Rep. Greg Walden: “Every day, innovative pioneers in the mobile health sector are working on solutions that help patients while reducing health care costs. The app economy is characterized by low barriers to entry, quick time to market, and the ability to adapt to quickly changing user needs. Medical devices, on the other hand, face a long and costly pre-market approval process at the FDA. We all want to ensure patient safety, but why would we treat mobile applications the same as a dialysis machine?  Our common-sense legislation gives regulatory clarity to this innovative industry while focusing efforts on potential risks to human health.”  

Rep. G. K. Butterfield: “In rural areas like many I represent, access to care can be a challenge. Smartphone apps can help individuals better monitor their health and improve health outcomes when used in conjunction with the tools available to healthcare providers. With more than 40 million people gaining access to affordable health care thanks to the Affordable Care Act, the use of mobile healthcare applications will only continue to rise.  That’s why it’s important that the FDA be given clear direction from Congress moving forward.”  

According to a recent report, there are currently 97,000 mobile health apps in the Apple app store that generate 3 million free and 300,000 paid downloads. 15 percent of these apps are designed specifically for health care providers and over 60 percent of doctors are using tablets – compared to half of that just over a year ago.

Click here to read the full bill text of the SOFTWARE Act.