HIA’s comments to the Trump administration were included in an Inside Health Policy article on efforts by healthcare groups to help shape the administration’s efforts to regulate healthcare artificial intelligence tools.
This “risk-based” approach to health AI regulations was also endorsed by the Health Innovation Alliance, Consumer Technology Association, Connected Health Initiative, Healthcare Leadership Council, the Center for Telehealth and e-Health Law and regulatory compliance support company ALIGNMT AI, an Inside Health Policy review of comments found.
But the Health Innovation Alliance disagrees with ASTP’s approach of requiring transparency beyond AI-enabled medical devices.
The coalition argued FDA takes the appropriate “risk-based” approach to AI regulation, while ASTP’s regulations take an inappropriate “function-based” approach “where any technology that possesses machine learning or AI functionality is subject to increased regulatory requirements.”