Colorado U.S. Senator Michael Bennet today encouraged health IT experts in Colorado to review and provide feedback to the U.S. Food and Drug Administration (FDA) on a Bennet-requested report on how to best and most appropriately regulate the industry. The FDA will use the report and the feedback it receives to propose a health IT regulatory framework with a goal of protecting patients, promoting innovation, and avoiding duplicative rules.
“New innovations and technologies, such as health care apps, are helping doctors and hospitals care for patients and lower health care costs in ways we’ve never imagined. And many of these advances are being developed right in Colorado,” Bennet said. “It’s important for Colorado’s health IT community to provide feedback so our regulatory system doesn’t impede this type of innovation, and patients can feel confident their health and safety are top priorities.”
The draft report entitled “Food and Drug Administration Safety and Innovation Act (FDASIA) Health IT Report: Proposed Risk Based Regulatory Framework” can be viewed by clicking here. Electronic comments can be submitted here.
The FDA Safety and Innovation Act, which was signed into law in 2012, included a compromise Bennet helped craft regarding health IT and mobile medical apps. The bill requires HHS to develop a strategy and a set of recommendations for regulating health IT, including medical mobile apps, that promotes innovation, protects patient safety, and avoids regulatory duplication.
Following the release of the draft report, Bennet recently joined a bipartisan group of senators to urge the FDA to provide more clarity and transparency in how it will regulate medical mobile apps.