The Trump administration has welcomed artificial intelligence (AI) as a transformative tool in healthcare, particularly by enhancing the efficiency of the Food and Drug Administration (FDA) in drug approvals. Health and Human Services Secretary Robert F. Kennedy Jr. has touted AI’s potential, especially with the introduction of Elsa, an AI system designed to expedite drug and medical device evaluations. However, internal reactions from FDA officials reveal concerns about Elsa’s reliability, with reports of it fabricating studies and generating inaccurate data. This leads to increased scrutiny and the need for double-checking, which counters efficiency claims. As regulatory frameworks for AI in healthcare remain undeveloped in the U.S., the situation underscores the urgency for proper oversight amidst a rapidly evolving technological landscape. Experts advocate for caution in deploying AI without robust safeguards, as the integration of such systems into critical health decisions poses potential risks.
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