Bob Wachter

So what do you see as the proper role of government in regulating AI in healthcare generally?

Well, I think that's one.

One is to create a level playing field and to be sure that innovators have a fair chance to succeed in an environment where there is a tendency toward monopoly, in part because of this idea that one company owns all your data.

The issue of regulating AI tools, I have a chapter on it, and I came up with the very unsatisfying answer of this is really hard.

And our existing structures, meaning the FDA or the Joint Commission, which currently accredits American hospitals, are not fit for purpose for this tool.

The FDA can regulate a new radiology tool because they've regulated devices forever.

They've regulated pacemakers and defibrillators, and they've regulated drugs.

They can regulate a tool that gives a static answer, the same answer three years from now that it gives today.

And whose implementation, the way we put it in at UCSF versus the way it's put in in a rural hospital 100 miles from here, probably isn't going to change all that much about the way a torvastatin works on your blood pressure or a CT scan reader works in giving you an accurate reading.

But most of AI is not like that.

Most of AI can shapeshift tomorrow compared to what it did today.

Most of what it's doing is giving answers or insights based on the literature.

How is that different than regulating a textbook or a medical journal?

So I don't think we have even begun to think about what the regulatory infrastructure looks like to get this right.

I think the Trump administration is going too far in an anti-regulatory way, but I do think the risk of over-regulating this in the short term is higher than the risk of under-regulating it.

There are sufficient guardrails in the healthcare system, maybe with the exception of direct-to-consumer use of these tools.

But in terms of my institution, a place like UCSF, is a $15 billion business that has a terrific reputation.

It's surrounded by a whole lot of malpractice attorneys.

We're going to be really careful about bringing an AI into our system until we're pretty darn sure that it's going to work and be effective and not hurt anybody.

There are a lot of existing guardrails, along with just professional conservatism, that I think if you try to have government regulate every single decision support tool, that's impossible.