Lack of AI regulatory, clinical standards pose potential risks

While artificial intelligence promises to create actionable insights for clinicians to make better care decisions for patients, the regulations and standards for evaluating AI-based algorithms are lacking. Writing in the February 22 issue of the journal Science, they make the case that evaluations of AI-based algorithms are not held to traditional clinical trial standards--and, as a result, there has been little prospective evidence that predictive analytics improve patient care. "Several commercial algorithms have received regulatory approval for broad clinical use. But the barrier for entry of new advanced algorithms has been low," charge the authors. "To unlock the potential of advanced analytics while protecting patient safety, regulatory and professional bodies should ensure that advanced algorithms meet accepted standards of clinical benefit, just as they do for clinical therapeutics and predictive biomarkers."