Senators Michael Bennet (D-CO) www.bennet.senate.gov and Orrin Hatch (R-UT) www.hatch.senate.gov have reintroduced a bill to cut red tape at FDA to help boost innovation in health IT. The legislation called the “Medical Electronic Data Technology Enhancement for Consumers Health” (MEDTECH) Act (S 1101) would exempt low-risk medical software and mobile apps from FDA regulation and provide greater certainty on what software will be regulated by the agency to protect consumers.
The MEDTECH Act takes a risk-based approach and builds upon a FDA Safety Innovation Act (FDASIA) Workgroup report released earlier this year. The report was commissioned by Senators 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 EHRs, and software that helps healthcare providers develop treatment recommendations for their patients.
As the rate of innovation rapidly increases in the medical technology field, this bill would provide greater clarity to ensure that businesses understand the rules of the road so that safe and effective products reach consumers as soon as possible.