FDA Calls for Health Systems to Lead AI Governance in Healthcare

WELLESLEY, Mass. -- The U.S. Food and Drug Administration (FDA) commissioner, Robert Califf, emphasized the need for health systems to take a proactive role in the governance of artificial intelligence (AI) in healthcare.

During a recent discussion, Califf warned that health systems could face significant liability if they do not engage in the oversight of AI algorithms, which can malfunction. He noted that unlike pharmaceuticals, AI models evolve over time and their performance can vary across different patient populations.

Califf stated, "I think there's a lot of good reason for health systems to be concerned that if they don't step up, they're going to end up holding the bag on liability when these algorithms go wrong." He stressed that if health systems view the issue solely as a manufacturer problem, the entire system could fail.

This call for action highlights the critical intersection of technology and healthcare, urging stakeholders to prioritize effective governance as AI becomes increasingly integrated into medical practices.

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