AI is an exciting new technology, especially for aesthetics. However, AI tools should undergo the same, or more, critical analysis that other medical devices and treatments are subjected to. Yet, a recent study in Nature Medicine found that not all AI health tools with regulatory authorization are clinically validated.
Almost half of the AI tools authorized by the US Food and Drug Administration (FDA) lack clinical validation data. The study analyzed over 500 FDA-approved AI medical devices. The findings state that 226 (about 43 percent) of these devices do not have publicly available clinical validation data.
While the absence of reported data doesn’t equate to these tools being unsafe, it certainly raises concerns. FDA-approved devices that lack adequate clinical validation can put patients at risk. Therefore, the study’s authors are proposing a new validation standard be put in place.
“Although AI device manufacturers often highlight FDA authorization as a mark of credibility, clearance doesn’t necessarily mean that these devices have been thoroughly evaluated for clinical effectiveness using real patient data,” said Sammy Chouffani El Fassi, MD candidate at the UNC School of Medicine and research scholar at Duke Heart Center, in a statement to the Dermatology Times. “Our findings underscore the need for the FDA and the industry to enhance the credibility of AI devices by conducting and publicly sharing clinical validation studies.”
Chouffani El Fassi says the team has shared their findings with the FDA, hoping it will help inform their regulatory decisions. “We also aim to inspire researchers and institutions worldwide to conduct more rigorous clinical validation studies to ensure the safety and effectiveness of AI in healthcare.”
