Bennet-Hatch Bill Clarifies FDA Authority to Regulate Software & Mobile Apps - Bennet-Burr-Hatch Bill Advances Breakthrough Devices for Patients
Washington, D.C. - The Senate Health, Education, Labor, and Pensions (HELP) Committee today advanced two bipartisan bills introduced by Colorado U.S. Senator Michael Bennet to help clarify the FDA's authority to regulate health software and mobile apps, boost medical innovation, and protect patient safety.
The Medical Electronic Data Technology Enhancement for Consumers' Health (MEDTECH) Act that Bennet introduced with Senator Orrin Hatch (R-UT) would eliminate the current gray area and provide certainty for companies, consumers, and patients regarding what software will be regulated by the FDA.
Bennet introduced the Advancing Breakthrough Devices for Patients Act with Hatch and Senator Richard Burr (R-NC) to help bring breakthrough devices to patients in as timely a manner as possible with a focus on ensuring patient safety.
"Medical innovation is helping drive Colorado's economy, and it's improving the lives of patients across the country," Bennet said. "These bills will help ensure that these lifesaving and life changing medical technologies are safe for consumers and patients while spurring innovation in health IT. As we've done throughout the process, we'll continue to work with the FDA and consumer advocates to give Americans access to, and confidence in, medial mobile apps software in the 21st century."
Bennet also supported an amendment to provide funding for the National Institutes of Health (NIH) and to address medical device safety. During the hearing, Bennet called the funding an "economic competitiveness issue." He will continue to push for resources to ensure any final package addresses this important area of biomedical research.
Background on Bennet's bills:
The Medical Electronic Data Technology Enhancement for Consumers' Health (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, it would clarify 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.
The Advancing Breakthrough Devices for Patients Act builds on legislation, the Advancing Breakthrough Therapies for Patients Act, that the Senate passed in 2012 from Senators Bennet, Hatch, and Burr. Both the 2012 legislation and the newly introduced bill share similar principles, such as an "all hands-on-deck" approach to devices. It also complements and enhances the existing tools, such as priority review, currently in place for devices, with the goal of expediting the development and review of breakthrough products.