Senators Michael Bennet (D-CO) and Orrin Hatch (R-UT) recently introduced a bipartisan bill to cut the red tape at FDA to help boost innovation in health IT. The “Medical Electronic Data Technology Enhancement for Consumers’ Health” (MEDTECH) Act (S.2977) would exempt low-risk medical software and mobile apps from FDA regulation and provide greater certainty regarding the software that should be regulated by the agency to protect consumers.
The MEDTECH Act takes a risk-based approach and builds upon a FDA 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.
Also, another report published by the Bipartisan Policy Center titled “An Oversight Framework for Patient Safety in Health Information Technology” contains recommendations that align with the MEDTECH Act. Janet Marchibroda Bipartisan Policy Center’s www.bipartisanpolicy.org Innovation Director applauds the introduction of the legislation by Senators Bennet and Hatch.
The MEDTECH legislation limits and clarifies FDA’s role regarding regulation of administrative and financial software, wellness and lifestyle products, certain aspects of EHRs and software that would help healthcare providers develop treatment recommendations for their patients.
As the rate of innovation rapidly increases in the medical technology field, this bill would ensure that businesses understand not only the rules of the road but also would provide safe and effective products for consumers as soon as possible.
“New and innovative technology is helping our healthcare providers take better care of their patients, and helps to put tools into the hands of families to help them manage their own health”, Bennet said.
He continued to say, “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 helps innovators in the life sciences and the FDA know which devices and software need to be monitored to keep consumers safe.”
“Advances in technology have allowed us to continuously improve the efficiency and quality of healthcare, Hatch assed. “This bill will give innovators the certainty they need about health IT regulation to continue pioneering medical software for consumers and healthcare professionals.”