How does the FDA’s latest AI guidance on medical devices impact manufacturers and cybersecurity challenges in healthcare?
In this episode, Christian discuss the latest FDA AI guidance and how it will impact real-world AI applications in healthcare.
Key points:
The FDA’s new guidance on AI in medical devices, released in January 2025.
Differences between artificial intelligence (AI) and machine learning (ML).
Historical context of AI, including early examples like Microsoft’s Clippy.
Potential risks of AI in healthcare, including data poisoning, model inversion, and evasion.
Challenges of ensuring AI integrity, confidentiality, and availability.
The concept of model bias and how it impacts diagnostic accuracy.
Practical cybersecurity strategies for AI-enabled medical devices.
Importance of ongoing post-market monitoring to address performance drift.
Value of consulting cybersecurity experts early in the development lifecycle.
Hi, welcome back to The Med Device Cyber Podcast. Today we're going to be talking about an important topic: AI, specifically AI medical devices and some of the risks that AI introduces. We'll also be talking a little bit about the history of AI. We'll go back to 1997 when AI first came out; a lot of people don't realize it. And we'll talk about what manufacturers can do to help secure their devices that have AI in them. We also talk a little bit about some of the attacks on AI and some of the guidance on AI. So, I'm your host, Christian Espinosa, I'm here with Trevor Slattery. How's it going today, Trevor? It's going pretty well. How are you doing today? You know, I did bookkeeping last night. I watched a little bit of our last episode, and I had nightmares about bookkeeping. But I did it last night and did not have nightmares, but I took um, some magnesium before I went to bed, and I think it helps me sleep better. Yep. Do you have that uh, what's that powder called? It's Calm or something like that? You know, I used to take Calm, the gummies. But they stopped selling the gummies; I used to get them at Whole Foods. I don't like the powder, but I like, like the Whole Foods, the gummies. Yeah. Okay, I should check again. I thought they stopped making it with the gummies. Yeah, I guess I've been trying to balance my energy, so like, in the morning, I have like coffee with uh brain octane oil, it's like MCT oil. And then if I have the right kind of nitro cold brew around 1:00 p.m., I have energy the whole day. But then I'm like a little bit wired, so I have to take magnesium to go to sleep. But if I had the wrong kind of cold brew, like there are only certain brands I can drink. If I had the wrong one, I get super irritable the rest of the day. So it's like this, this balancing act, you know. Huh, what's the right brand? It's a Modern Times, San Diego. They only have it at Whole Foods. I tried to order on Amazon, but they don't have it on Amazon. And then every time I go to Whole Foods, they're like out of it, so if I, they have it, I buy like every one of them they have. There you go. Yeah, I've been getting these Yerba Mates at Whole Foods. It's I think it's Peruvian or Brazilian or something like that, but super strong tea, and I can't have any after like 9:00 a.m. or I won't sleep at night. But hey, it works great in the day. Awesome. Well, I guess we're caffeinated and wired, so we can start the podcast talking about AI. So let's, let's kind of start at the beginning and define what AI is. I think there's a lot of ambiguity and confusion about AI, like what it is and how it relates to ML or machine learning. Do you want to explain AI to our listeners, Trevor? Yeah, I think that AI and machine learning are used interchangeably, incorrectly. They are similar and connected, but they're not the same. So AI, Artificial Intelligence, is exactly that. It's something that is trying to replicate human intelligence and human behavior, human process. Machine learning is essentially trying to get a computer to train itself to perform a specific task. So machine learning is effectively a type of AI, but not all AI is machine learning if that makes sense. Yeah, that makes sense. And I know we did a little prep for the podcast, and you mentioned Clippy as one of the first AIs, and we we confirmed that. And I I looked it up, and Clippy was manufactured, or I guess created by Microsoft in 1996 and came out with Office 97, so it's been almost 30 years. Do, do you remember Clippy or do you ever use Clippy? You seem to know a lot about Clippy, but I don't know if you used it before. I caught the tail end of Clippy back in I guess that was Windows Vista, Windows, kind of right when they sunset Clippy. Yeah, so Clippy was that, that paperclip that if you were trying to do something, it would like pop up on your screen, right? And tell you like,
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