Bill offers guidance for FDA's medical app regs

A bipartisan group of House members—three Democrats and three Republicans—has introduced a bill to provide the FDA with guidance about mobile medical app regulations. 

Following FDA's September release of its own final guidance on mobile medical apps, the legislators said the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act seeks to "provide regulatory clarity regarding mobile medical applications, clinical decision support, electronic health records and other healthcare related software," according to an announcement.

"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," according to the announcement.

Estimates indicate that the number of consumers using medical apps on their smartphones will grow to 500 million by 2015. But today the FDA lacks the necessary tools to appropriately oversee these innovative products without overstepping their authority and stifling innovation, argue the members of Congress in their statement. "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."

The SOFTWARE Act defines three classification levels of software—clinical software, health software and medical software.

The bipartisan group includes Congressman Marsha Blackburn (R-Tenn.) and Representatives Gene Green (D-Tex.), Phil Gingrey (R-Ga.), Diana DeGette (D-Col.), Greg Walden (R-Ore.) and G. K. Butterfield (D-N.C.). “Our legislation takes the necessary steps to protect technological innovation that is filtering into growth sectors like healthcare," said Blackburn. "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.”

Green said the bill "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.”

Walden called the bill "commonsense legislation" that gives "regulatory clarity to this innovative industry while focusing efforts on potential risks to human health.”

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