U.S. Sens. Michael Bennet (D-CO) and Orrin Hatch (R-UT) reintroduced a bill on Monday that they hope will both cut red tape at the Food and Drug Administration (FDA) and give a boost to innovation in health-related information technology.
The senators have put their support behind the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, which would make low-risk medical software and mobile apps exempt from FDA regulations. It also would make clearer what software would be FDA-regulated.
“As the possibilities for medical technology continue to defy expectations, we must provide innovators with clarity about the regulatory rules of the road,” Hatch said. “The MEDTECH Act is a commonsense approach to give medical software pioneers the certainty they need to continue developing new technology that will benefit both health-care professionals and consumers alike.”
In short, the MEDTECH Act limits and clarifies the role of the FDA in the regulation of administrative and financial software, certain aspects of electronic health records, wellness and lifestyle products, and software that aids health care providers in developing treatment options for patients.
“Medical innovation is helping our health care providers better take care of patients, and it’s putting tools into the hands of families to help them manage their own health,” Bennet said. “Some tools, whether a calorie counter or an activity tracker to monitor your exercise routines, are low risk and don’t require in-depth oversight by the government. Our bill provides certainty for innovators in the life sciences and the FDA by clarifying which devices and software should be monitored to keep consumers safe.”