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The FDA is adjusting for the new world. This is promising.


today in health, it, the FDA is proposing new rules to try to stay ahead of AI development. And today we're going to take a look at that with our friend John Hopkins, actually, he's not here, but we're going to read an article that he wrote. My name is bill Russell. I'm a former CIO for a 16 hospital system and creator of this week health. Instead of channels, dedicated to keeping health it staff current and engaged.

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We want to thank you for your generosity and the generosity of our community. All right. Our friend, John Halamka has written a article, actually sat him alone. It is a Paul wrote it with him. Did he? Let's see. Yes. Paul Sorento. , senior research analyst and communication specialist for Mayo clinic platforms, along with John Hopkins.

M D president Mayo clinic platform. Wrote an article, and this is about the FDA proposed rules around AI. So, , He starts it off with the Bob Dylan quote times they are changing, although he didn't have a food and drug administration in mind, when he wrote the protest song, the agency realizes it needs to revise its AI related software guidelines and regulations to keep pace with the ever evolving AI landscape.

I was commenting to somebody over the weekend. It was mother's day weekend. I was with family, a bunch of other people, and we were talking about AI and it's really interesting to me. AI has gotten to the point where it is common. , conversation. It could be because of the chatty PT craze and all those things, but it is common conversation. And, and my nephews, my younger nephews wanting to talk about, are we seeing the beginning of a, they didn't use the term Terminator, but are we seeing that.

You know, the machines are going to take over kind of thing. And we had that conversation. It was kind of fun to have that conversation. , I had a conversation with one of my nephews around, is AI going to fundamentally change the business that he's in? And the answer was absolutely. It is going to fundamentally change.

The business that he's in, but we have to define the business. He's incorrectly. Before, you know, it, his business is not, you know, what he thought it was, his business was something else. And once we defined it, I said, you know, AI can't do that, but it can do pieces of what you did in order to deliver that. And so I, and then, you know, we were also talking about just the pace.

The pace of the AI landscape. And, , it is really kind of fascinating. And we do not want to slow this down. Except from a, you know, a quality and safety standpoint. Obviously we want to slow it down as much as possible. , in order to, to ensure quality and safety. But outside of that, we want to lean into this. This has the potential I have, and I've seen some different quotes. And we talked about this last week.

Where essentially we could, we could eliminate a significant amount of costs out of healthcare. Bye. Really intelligently looking at our workflows and looking at our work and seeing if AI couldn't lend a hand. And we're seeing that at Stanford today. With their, , with their notes program and the beta of that program for, , really for all of healthcare. And to be honest with you, I've mentioned that specific program and I know they're doing it. They're I think they're going to do it at U C S D as well. San Diego, , California system.

But I've talked to others and there's like 10 other health systems that are heading down this path. So AI is moving fast. This is specifically. , About what the FDA is looking at in terms of medical devices. So. It goes on from there. Unfortunately, the acronym that describes the new regulations can get confusing, including S a M D, which is software as a medical device, P CCP predetermined change control plan. I mean, these.

If you're in a development world, if you're in the software world, this sort of makes sense to you. When you hear these terms software as a medical device, predetermined change control plan. You've you under you just by the words that are used here, you get an idea of what that is. And then QMS quality management system.

All those things make sense. If you live in the development world, if you don't, those things can look like a bunch of, , squirrelly language. So he's gonna, he's gonna break these down. , in their, in their blogs. So here we go, FDA recently posted the marketing submission recommendations for a predetermined change control plan for artificial intelligence machine learning, AI ML enabled device software functioning.

If you're not familiar with AI ML ecosystem and the traditional way in which the agency usually approves medical devices, a few basics need to be clarified. In the past, the agency was accustomed to approving hardwired devices that remained locked. And my gosh, that was the bane of my existence. I had windows.

I mean, this was in 2012. And I, and we. I saw a windows 95 windows, 98 windows and T devices on our network. And I was like, we've. Why aren't we upgrading these devices and the answer was. You can't. The FDA has, has locked those systems. They are approved by the FDA and once they are approved, they can't be touched. If you touch them, they now have to be reapproved. Therefore, the manufacturer was not allowing us to update them. Now, I don't know if that's changed per se since then, but this is a.

That's what they're referring to by locked. Okay. If a manufacturer wanted to make significant changes to its product, it had to submit new documentation and evidence to justify the changes to the agency. Along expensive process. The new draft recommendations will likely require significant documentation as well. Still, according to one legal analyst, essential, essentially.

They, the developers will have to periodically, right. What amounts to submissions, but they just don't have to file them with FDA. All that documentation must be in their files. Should the FDA come to inspect? Other suggests that the agency is now willing to give manufacturers the autonomy for specific authorized modifications to AI, M L devices. To understand the draft recommendations. We need to look closely at the pre-determined change control plan, PCP.

After I explained that the PCP is the documentation describing what modifications will be made to the ML. DSF machine learning. Disease software function. And how the modification will be assessed. The modifications described in the PCP include device changes that would otherwise require a PMA pre-market approval supplement.

Denovo submission or new 5 0 1 Notification the PCP includes a description of modifications, modification, protocol, and impact assessment. The new FDA guidelines and important are important because the agency now appreciates the iterative process involved in software development and deployment. And I would say that that's true. I mean, there's a little bit that you're a little leery that the manufacturers will use this for license, but on the flip side, the locking of devices was such a.

A bad problem. It really did slow down so much of what needed to happen on the medical device side. That you have to address that in order to do that, you have to, , create the policy and the framework and allow the vendors to work within that. Knowing that there is going to be oversight and that's essentially the direction they're going with changes in modeling technology, updated patient data that can be incorporated into the algorithms and the availability of data sets that are more representative of marginalized populations.

It would be unethical to insist that S a M D do you remember what S AMD is software as medical device? Products remain locked. Considering these concerns, the new guidelines. Allow developers to make certain post-market updates when change, protocol and impact assessment can reasonably assure, continued safety and efficacy.

Of course vendors will have to be cautious about such changes, limiting them to well-defined ones that can be verified and validated with established methodology. And they give you some for instances here, stakeholders can make comments and suggestions to the FDA regarding the draft recommendation until July 3rd, after which time it will begin working on the final version, you can provide feedback to the

, over a decade over the decades, many in the digital health community have found the FDA slow to act, but the new guidelines suggest it is. In fact, recognizing the times they are a changing, I like this. , you know, my, so what on this is, this is a long time coming. Really looking forward to seeing where this goes. I do want to see oversight. I am concerned a little bit.

About what, , what the manufacturers will do. But with that being said, I think this kind of. You know, policy framework and then guidelines in allowing people to, , to make those modifications with oversight is, is the right path to go. Otherwise you just move way too slow. In an era where things are moving way too fast. And so this is one of the ways.

That, , we are going to see, , you know, the progress in healthcare really accelerated. And to be honest with you, , I've never seen it move this fast. And I think it's going to continue to pick up pace so exciting times to be in healthcare. All right. That's all for today. If you know someone that might benefit from our channel, please forward them a note. They can subscribe on our website this week

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