U.S. Senators Orrin Hatch (R-UT) and Michael Bennet (D-CO) have reintroduced a bill that aims to boost innovation in health IT by exempting low-risk medical software and mobile apps from regulatory oversight.
Hatch and Bennet first introduced the bill, the Medical Electronic Data Technology Enhancement for Consumers’ Health (MEDTECH) Act, in December of last year. It was referred to the Senate Committee for Health Education Labor and Pensions (HELP). It aims to build on the Food and Drug Administration Safety Innovation Act (FDASIA) Workgroup report from last year. FDASIA is a wide-scale attempt to clarify the FDA's role in regulating 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,” 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 health-care professionals and consumers alike.”
Hatch and Bennet are among the most active Senators in the health IT landscape. The former was among a group of Republican Senators that asked the Centers for Medicare and Medicaid Services (CMS) and the Office for the National Coordinator of Health IT (ONC) to push pause on meaningful use.