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 introduced 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.
"New and innovative technology is helping our health care providers better take care of their patients, and it's putting tools into the hands of families that help them manage their own health," Bennet said. "Some of these tools, whether a new app to track your calorie intake or an activity tracker to help you while you exercise, are low risk and don't require in-depth oversight by the government. This bill provides certainty for innovators in the life sciences and the FDA as to which devices and software should be monitored to keep consumers safe."
"Advances in technology have allowed us to continuously improve the efficiency and quality of healthcare," Hatch added. "This bill will give innovators the certainty they need about health IT regulation to continue pioneering medical software for consumers and health care professionals. I'm proud to offer this important piece of legislation alongside Senator Bennet."
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.
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