Michelle: Welcome. Thank you for being here today.

Atty: Thank you so much. And before we start, just to disclaimer, all the opinions are mine and they do not reflect my company or any organization I'm part of. But yeah, thanks for having me. And I'm very honored to be nominated as the Rookie Award Winner this year.

Michelle: Congratulations, you're well -deserved. I know you've done a lot of different work in the medical space regarding AI. Could you tell us a little bit about your medical AI experience?

Atty: What I basically work on is on the regulatory and the quality side of things when it comes to AI -enabled medical devices. And most of this work is basically kind of research-based. It's with groups which are like focus groups and associations which are kind of like industry groups. So that's where I actually met many of my collaborators. and I ended up publishing some research with them on like in 2024 about the general AI regulations for medical device was at that point there was a lot of discussion about regulations in general but it didn't really talk about specifically about the medical device part so it kind of started with that like just doing a kind of understanding of you know how different countries are regulating it what aspects are they focusing on what are their points of convergence and divergence and so on but then as the new year rolled in we started noticing that well regulation is I mean it has come a long way when it comes to AI but the next question is how do we implement it or how do we actually like incorporate it in a product development lifecycle so that's like what I've been focusing more on this year and we are scheduled to publish a paper on that also very soon. Me and my collaborator Mandarkar Hade. And yeah, I think that's the gist of my involvement with AI outside like in my own in my own time.

Michelle: I know you've presented on this topic at a few different events. Could you tell us what kind of the takeaways were from those sessions?

Atty: When it comes to like the general regulatory landscape a lot of things actually came up we noticed that most of the focus was actually around the US and the EU but there was less focus on emerging economies and how they are doing it so we were actually pretty surprised ourselves to find that many emerging economies like even in Saudi Arabia where they actually specifically talk about positive predictive values and other kind of metrics like that which we thought was a big thing. The main concepts were similar around WHO's main principles like documentation, transparency, explainability, and all of that. But one major kind of gap we found was the intended use in the clinical aspect of AI, which I think still remains a very hot topic in how do we clinically validate AI systems and things like that.