The FDA Is Stepping Back From Medical AI. California Is Stepping In.

Artificial intelligence is an increasingly common presence in America’s exam rooms and hospitals. This includes use cases like AI scribes which listen to a conversation and create draft doctor’s notes, and clinicians asking AI clinical questions about a patient.

Yet what is unsettled these days is who gets to write the rules about these tools are regulated. The federal government and the states are currently moving in opposite directions on this issue. The outcome of this regulatory tug of war will shape how much evidence stands behind the AI tools doctors utilize.

As an ER doc who spends a lot of my time thinking about, developing and deploying these AI tools, I see this as one of the most consequential health policy questions we face today.

Here is where things stand. And how it all could play out.

The FDA Has Been Loosening Regulations

The Food and Drug Administration (FDA) regulates AI as a medical device. In January, the agency loosened its guidance on clinical decision support software. AI tools that, for example, recommend a single diagnosis or treatment where the clinician can review the reasoning can now avoid FDA device requirements.

But even for the AI tools the FDA does review, this is a modest bar. Most devices are cleared through what’s called the 510(k) pathway. The requirement is to show similarity to a product already on the market, not proof that it works. A census of all 1,357 AI devices FDA had cleared or approved through early December 2025 found that only 34 (2.5%) had been tested in prospective trials, and only three had been studied with patient-centered outcomes such as death, complications or readmissions.

In August, the FDA released a discussion paper on how it might regulate generative AI devices in the future. Comments are due October 19 (the day of this article’s release). Importantly, the paper is not guidance, nor does it propose any policy. But it is a preview where the agency may go. I see four possible paths: