Sens. Orrin Hatch (R-Utah) and Michael Bennet (D-Colo.) have reintroduced the Medical Electronic Data Technology Enhancement for Consumers' Health Act that would exempt certain health-related software and technology from federal regulation.
The MEDTECH Act seeks to exclude certain low-risk devices and software from oversight by the U.S. Food and Drug Administration. The bill proposes that devices exempt from regulation include software intended for administrative and operational support of a healthcare organization, software intended for maintaining or encouraging healthy lifestyles, electronic patient records that don't include software intended for clinical diagnoses or analysis and lab reports that don't include information intended for clinical diagnoses or analysis.
The senators suggest this bill will help provide greater certainty around the regulatory environment and in turn help boost innovation in health IT.
"As the possibilities for medical technology continue to defy expectations, we must provide innovators with clarity about the regulatory rules of the road," Sen. Hatch said in a statement. "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 healthcare professionals and consumers alike."
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