Bill Exempts Low-Risk Medical Software, Mobile Apps from Over-Regulation
Washington, DC –U.S. Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) today reintroduced a bill to cut red tape at the Food and Drug Administration (FDA) and help boost innovation in health IT.
The Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act would exempt low-risk medical software and mobile apps from FDA regulation and provide greater certainty regarding what software will be regulated by the agency to protect consumers.
“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.”
“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.”
Background
The MEDTECH Act takes a risk-based approach and builds upon a Food and Drug Administration Safety Innovation Act Workgroup report released earlier this year. The report was commissioned by Bennet and Hatch through an amendment to the 2012 FDA reform law.
Specifically, the bill limits and clarifies the FDA’s role regarding regulation of administrative and financial software, wellness and lifestyle products, certain aspects of electronic health records, and software that aids health care providers in developing treatment recommendations for their patients. As the rate of innovation rapidly increases in the medical technology field, this bill provides greater clarity to ensure that businesses understand the rules of the road and safe and effective products reach consumers as soon as possible.
