Call for Enhanced FDA Oversight on Healthcare Artificial Intelligence Tools

A recent report emphasizes the need for a more transparent and adaptive regulatory system for artificial intelligence (AI) in healthcare, urging the U.S. Food and Drug Administration (FDA) to strengthen oversight mechanisms. The report, published in the open-access journal PLOS Digital Health by Leo Celi from the Massachusetts Institute of Technology and colleagues, highlights the rapid integration of AI into medical diagnosis, patient monitoring, and treatment recommendations. Unlike traditional devices, many AI tools continuously learn and evolve post-approval, posing challenges for existing regulatory frameworks.

The authors argue that current FDA oversight is insufficient to monitor these ongoing changes, especially considering the risk of bias and safety concerns, particularly for vulnerable populations. AI algorithms trained predominantly on datasets from specific groups may perform poorly when applied to a more diverse patient population. Therefore, they advocate for increased transparency, requiring developers to disclose training and testing data, and for greater involvement of patients and community advocates in decision-making processes.

Practical recommendations include establishing public repositories to track AI performance in real-world settings, incentivizing ethical development through tax benefits, and professional training for medical students to critically assess AI tools. These steps aim to ensure AI remains a safe and effective asset in clinical practice while addressing disparities.

The authors emphasize that such reforms could foster a patient-centered, risk-aware, and continuously adaptive regulatory environment, ultimately ensuring AI enhances healthcare without compromising safety or equity. This move aligns with the need for proactive oversight as healthcare AI technologies rapidly advance.

More detailed insights can be found in the original article: DOI: 10.1371/journal.pdig.0000866, published in PLOS Digital Health.

Source: https://medicalxpress.com/news/2025-06-scientists-fda-oversight-health-ai.html