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Health Affairs This Week places listeners at the center of health policy’s proverbial water cooler. Join editors from Health Affairs, the leading journal of health policy research, and special guests as they discuss this week’s most pressing health policy news. All in 15 minutes or less.
Hello and welcome to Health Affairs This Week. I'm your host Jeff Beyers. We're recording on 05/28/2025. Join our insider program and gain access to our upcoming summer slam of health policy. On June 17, we have a risk adjustments primer event with J.
Jeff Byers:Michael McWilliams. And on July 9, Sarah Rosenbaum will moderate a panel wrapping up the current supreme court session. This is the fourth time we've hosted this popular event, so join Insider to join us. And today on the pod, we have health affairs own Michael Gerber. Last week, Insider released its first trend report on AI and health care.
Jeff Byers:This is hot on the heels of the FDA releasing a timeline this month to scale AI across its centers. While we won't dive into the actual report, you'll have to join Insider for that, we wanted to talk about FDA's AI efforts, what it says, what it doesn't say, etcetera, etcetera. Michael, welcome back to the program.
Michael Gerber:Hey, Jeff. Thanks a lot for having me.
Jeff Byers:Michael, so how would you define your relationship with technology?
Michael Gerber:That is a great question. I mean, I was able to, you know, log in to record this podcast, so I feel like that was a success. But I am certainly not an early adopter when it comes to AI and would probably say sometimes sometimes a skeptic, although I'm trying to be open minded about it and certainly see the benefits it can have.
Jeff Byers:Yeah. So when I say the words or phrase single sign on, do you get filled with dread or excitement?
Michael Gerber:I I mostly I think I can handle single sign on, Jeff. But beyond that, it starts to get a little tricky.
Jeff Byers:Yeah. When looking to AI, we are men of a certain age. I'm probably in the same boat as you are where I'm optimistically skeptical about the phrase and technology itself. Because as we talked about off mic, it can be used to be a very broad descriptor or a very specific pinpoint descriptor. And with that framing, as we talk about the FDA press release, I think it kinda lends itself to the to the vague descriptors.
Jeff Byers:That's just my interpretation of it. So looking at the FDA release, they released a timeline to try and scale AI across their centers. By the June, which checking on my calendar is within thirty days or so, so not a long time. This follows the completion of a generative AI pilot. So what can you tell us about the timeline and the general purpose of this Gen AI use at the FDA?
Michael Gerber:Yeah. I mean, based on what the FDA said and and the minimal other reporting out there, there's not a lot more to really say about it. They they did release this announcement where, you know, the new FDA commissioner said he was, quote, blown away by the success of their first AI assisted scientific review pilot, but there was no more detail really as to what that means, what what that pilot was, how extensive it was. Was it used just for one piece of the review of one, you know, product or drug? Was it used more widely than that?
Michael Gerber:And at the same time, you know, he he also said that they have an aggressive timeline to scale use of AI internally across all FDA centers, so, you know, all the centers offices within the FDA by June 30, which as you said is just a month away. But it's also unclear on what that means. I mean, if every center is using it, but how much are they using it? Because they say full integration by the June, which sounds pretty extensive, but also that they will continue to refine it after. I mean, they say, quote, to expand use cases, improve functionality, and adapt to the evolving needs.
Michael Gerber:So they're not really saying every use case will be determined by the next month. But certainly excited about using AI to review, you know, different drugs, different medical devices, food, whatever else the FDA is doing to to do those reviews faster and more efficiently.
Jeff Byers:Yeah. Thanks thanks for that quick overview. Yeah. It it's a little vague, also there has been some news reports on it, not a large amount. Stat News published a under paywall article called, like, three or five burning questions about FDA's AI review.
Jeff Byers:So there are some people looking into this. What were some of the details not included?
Michael Gerber:Right. Well well, as as we sort of alluded to, some of the details are exactly how they're using this. So and and also how how much this announcement actually means anything new is happening. It's not as if the FDA wasn't looking at AI and using some form of AI already. I mean, even defining what AI is, right, as we talked about is tough, you know, to some of us have sort of been using AI since Google was created in some ways, and it's it's a sliding scale.
Michael Gerber:But some of the things weren't talked about is, you know, there's some obvious sort of simple, I think, use cases that maybe even to you and I don't sound that scary. When a company or manufacturer is is submitting for approval at the FDA, you know, it's it's hundreds, if not thousands of pages of paperwork often of scientific data and other information they have to submit. And maybe AI is already or can be used to just sort of look at that application and see if anything's missing. And without a human having to do that first step, which can be very tedious and time consuming just to go back to someone and say, hey, you forgot this page or this isn't filled out right. So that's sort of the first step in how AI might be used.
Michael Gerber:But then, you know, all the way up to actually evaluating the data and comparing it to previous applications and other, you know, drugs, for example, to see the safety and effectiveness of the drug and and help the scientists, you know, go through all that and determine exactly what they're looking at.
Jeff Byers:You know, this press release kinda reminds me of my time as a business reporter when I was working at Health Care Dive where you'd get so many, so many press releases. And some of them had some really interesting information, and some of them you could kinda tell were just created to, like, people that a company actually existed. So I you know, FDA is a lot different in that that they are not trying to, like, get venture funds for the most part, but it was a little vague, and maybe they're trying to get some shine that comes from AI or talking about AI. And, you know, we at Health Affairs are trying to promote our AI and health care insider report, which you can get for signing up for insider for a hundred and $80 a year. And so based on that, now we're talking about it, the FDA release.
Jeff Byers:So interesting with that. Going back to the press release, again, kinda going on what we see in it, does this signify a shift in governmental thinking regarding AI deployment?
Michael Gerber:Yeah. I think I think yes and no. I think the FDA announcement may or may not. I mean, they're in the the little reporting that has happened since the announcement, you know, Robert Califf, the former commissioner under president Biden and and previous to that as well, you know, said we were already using AI. This was already underway, but he did express a little bit, you know, a little concern over this timeline.
Michael Gerber:Again, not knowing exactly what it means, but that they don't wanna rush into it because we do know the dangers of using AI in different ways, and I think that's, you know, where you and I have certainly seen that some of the skepticism we have, and within healthcare and algorithms and things like that. So I think it might be a shift in in just doing it faster at the FDA, but then we don't know again exactly what it means. I think that the Biden administration certainly, you know, one of did put out an executive order that proposed some sort of, you know, guardrails or potential regulations, and and they were not not necessarily anti AI, but certainly trying to be careful and think about it. And, you know, beyond the FDA or even beyond health care, the Trump administration has rolled back that executive order and just in general seem to be a little more aggressive with saying they're gonna use AI. I think the other aspect of that, you know, commissioner McCary was pretty careful in the press release to say, you know, this is to help people do their jobs better, not to replace people.
Michael Gerber:At the same time, as we know, a lot of people have been let go from the FDA and other organizations throughout the administration. They certainly there certainly is a fear, I think, among people in organizations that are regulated by the FDA or have products up that things would take longer because they had fewer people. So perhaps it's a a reaction to that as well to say, hey. Look. You know, we we might have cut some of these people, but we're making progress with AI, which will make things more efficient and faster.
Michael Gerber:Sort of a you know, they they don't mention Doge directly, and I don't think this is necessarily straight out of that. But it's along those same lines of, you know, maybe fewer people, but faster computers, they can do their job just as well, if not better.
Jeff Byers:Yeah. So it sounds like they're pointing into a direction of where they're going, but without the concrete details, you you and I and other people can probably put our thoughts and feelings about AI onto this press release about whether it's and how it mean what it means to them.
Michael Gerber:Right. Now the the the one thing the one reporting sort of separate from this, but recently, Wired magazine did report that the FDA and their new chief AI officer, who they recently appointed from industry, has a lot of experience in consulting and technology and government, but has been meeting with OpenAI about, you know, developing a specific chat GPT model, I guess, or OpenAI model for the FDA to use. At the same time, you know, some of the big concerns with AI and the FDA that people are raising are, you know, what does it mean when you work with those outside companies, and will the AI software or the AI model itself be completely closed off to prevent, you know, proprietary information from being leaked or being used to teach a model and then being out there in the world. So
Jeff Byers:So what can we expect moving forward? Like, what are the immediate next steps?
Michael Gerber:Right. Well, I think the the first thing is that the FDA did say that in June, so that's, you know, just a few days away, that additional details and updates on the initiative will be shared publicly. So we'll wait and see if this really was just a teaser for a lot more details or if sort of another example of saying we're gonna tell you a lot more and then, we only get a little taste or not much more in June. So, beyond that, I think waiting to see really what some of the the people who work with the FDA, what they say. Are they seeing reviews come back with, you know, evidence?
Michael Gerber:Are they being told AI was used as part of this review? Are reviews happening faster? And those things will take time. Right? Reviews can take up to a year, so it'll take time to see if they're faster, if they're more efficient, and then even longer to see if they're even more safe and effective than what happens now or not.
Jeff Byers:So potentially lots more details to come. Many questions to weigh and to ask in the future. So Michael Gerber, thanks for joining us today on Health Affairs this week. And if you, the listener, have more questions about AI, you can join Health Affairs Insider for a hundred and $80 a year and get our new trend report on AI in health care, which breaks down, some current uses of AI, what are some state laws happening in AI, and where they intersect in the health care landscape. And with that, share this episode with the, generative robot in your life, and we'll see you next week.
Jeff Byers:Thanks all.