Digital health lobbyists are looking to use the reauthorization of the Medical Device User Fee Amendments (MDUFA) to advance policies governing artificial intelligence and digital health technologies. HIA was interviewed for the article, which highlights industry priorities, including establishing a federal clinical AI testing environment and clarifying regulatory requirements for software associated with prescription drugs and medical devices.
“HIA sees limited opportunity for major AI or digital health reforms in reconciliation. There may be narrow openings in a continuing resolution or end-of-year package, but those vehicles are more likely to carry ready-to-move policies than transformational health tech reforms,” HIA Executive Director Roslyn Docktor told IHP.