NYSDA Publications

FDA Highlights AI-Enabled Health Care

Jul 25, 2024

Per the notice below, the United States Food and Drug Administration (FDA) is highlighting the use of artificial intelligence (AI) in health care.

U.S. Food and Drug Administration, Center for Devices and Radiological Health

Digital Health Blog: A Lifecycle Management Approach toward Delivering Safe, Effective AI-enabled Health Care

As global interest in artificial intelligence (AI) in health care soars, it’s crucial to ensure the safety and effectiveness of AI-enabled medical devices, as well as their trustworthiness, fairness, and performance.  A new blog post, written by Troy Tazbaz, Director, Digital Health Center of Excellence (DHCoE), and John Nicol, PhD, Digital Health Specialist, DHCoE, both of the Center for Devices and Radiological Health, U.S. Food and Drug Administration, explores these issues in the context of AI in health care settings.  Our new blog post focuses on the potential of Lifecycle Management (LCM) concepts to address the unique challenges of generative AI in health care, toward helping to ensure these systems meet real-world needs while managing their inherent risks across the software lifecycle.

Questions?

Our “virtual” doors at the FDA’s Digital Health Center of Excellence are always open.  We welcome your comments and feedback related to AI use in health care.  E-mail us at digitalhealth@fda.hhs.gov, noting “Attn: AI in health care” in the subject line.