The intersection of AI, the FDA oversight, and the political landscape

Artificial intelligence is making critical health care decisions. The sheriff is MIA. (Politico by RUTH READER) Doctors are already using unregulated artificial intelligence tools such as note-taking virtual assistants and predictive software that helps them diagnose and treat diseases. Health care regulators say they need more people and more power to monitor the new tech.

A doctor views an X-ray with help from artificial intelligence. | Damien Meyer/AFP via Getty Images Government has slow-walked regulation of the fast-moving technology because the funding and staffing challenges facing agencies like the Food and Drug Administration in writing and enforcing rules are so vast. It’s unlikely they will catch up any time soon. That means the AI rollout in health care is becoming a high-stakes experiment in whether the private sector can help transform medicine safely without government watching. “The cart is so far ahead of the horse, it’s like, how do we rein it back in without careening over the ravine?” said John Ayers, associate professor at the University of California San Diego. Unlike medical devices or drugs, AI software changes. Rather than issuing a one-time approval, FDA ...


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