Rep. Marsha Blackburn (R-Tenn.) joined a bipartisan group of representatives on Monday to introduce the Sensible Oversight for Technology with Advances Regulatory Efficiency Act.
The act would provide clear regulations to the Federal Drug Administration in regard to mobile medical applications, clinical decision support, electronic health records and other health care related software.
“Our legislation takes the necessary steps to protect technological innovation that is filtering into growth sectors like health care,” Blackburn said. “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 which protecting patient safety.”
Under current law, the FDA would use an overly broad definition of a medical device to assert regulations on a wide variety of software. The proposed bill would tailor the definition of a medical device and allow the FDA to focus attention on products that pose a potential risk, Blackburn said.
“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,” Blackburn said.