As AI becomes increasingly integrated into medical devices, the U.S. Food and Drug Administration (FDA) is working to address the unique regulatory challenges posed by this technology. In August 2024, the FDA proposed regulating predetermined change control plans, which detail how AI devices may evolve post-approval. These recommendations emphasize the need for manufacturers to monitor AI models, validate updates, and assess potential risks associated with retraining algorithms. While these measures aim to improve patient safety, they also highlight the difficulty of matching the fast-paced development of AI devices with regulatory scrutiny. Industry professionals have noted gaps in clinical validation data, with a study revealing that nearly half of FDA-authorized AI devices lack real-world patient data validation.
Beyond safety, cybersecurity remains a significant concern as AI-enabled devices generate vast amounts of sensitive data. The FDA has issued guidelines encouraging manufacturers to identify vulnerabilities and implement safeguards against cyber threats. The Biden-Harris administration's 2023 executive order further underscored the need for AI safety in healthcare, mandating a reporting program for unsafe practices. However, researchers have flagged limitations in current safety reporting systems, arguing for more robust frameworks to track AI-related risks. As AI reshapes healthcare, balancing innovation with patient safety will be critical for ensuring public trust and effective outcomes.
