Six congressmen introduced legislation that will amend a section of the Federal Food, Drug, and Cosmetic Act for regulating medical software. Their aim is to provide clarity in terms of regulation of mobile medical applications, clinical decision support, electronic health records, and other healthcare related software.
Congressman Marsha Blackburn (R-TN) joined Representatives Gene Green (D-TX), Phil Gingrey, M.D. (R-GA), Diana DeGette (D-CO), Greg Walden (R-OR), and G. K. Butterfield (D-NC) have introduced the Sensible Oversight for Technology which Advances Regulatory Efficiency (SOFTWARE) Act. The SOFTWARE Act alters guidance released by the U.S. Food and Drug Administration (FDA) for developers of mobile health (mHealth) applications.
According to the congressmen, the number of consumers using medical apps on their smart phones will grow to 500 million by 2015, and the FDA lacks the tools to “appropriately oversee these innovative products without overstepping their authority and stifling innovation.” The SOFTWARE Act looks to tailor this regulatory authority, having the FDA focus oversight on products that pose a potential risk to human health.
“Our legislation takes the necessary steps to protect technological innovation that is filtering into growth sectors like healthcare. 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,” stated Rep. Blackburn.
The legislation looks to add to the definitions of medical software and clinical software. It also encourages that clinical software and health software not be subject to regulation under the original legislation. In addition, the President and Congress should develop and enact legislation that establishes a risk-based regulatory framework for such clinical software and health software, says authors of the SOFTWARE Act.