AI Revolution in Healthcare: A Regulatory Perspective with Dr. Nirdosh Jagota

Machine Learning in Medical Imaging: A Regulatory Success Story

In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota explores the transformative role of machine learning in medical imaging and its regulatory journey. He highlights a Swedish study where AI-assisted breast cancer screening improved detection rates by 4% compared to traditional methods.
Dr. Jagota examines three key aspects of AI in imaging: regulatory frameworks, performance validation, and integration into clinical workflows. He discusses the FDA’s approach to AI imaging devices, including concepts like predetermined change control plans (PCCP) to accommodate AI's ability to learn over time.
Listeners will gain insights into the validation requirements for AI imaging systems, including analytical and clinical validity, and the importance of transparency in AI decision-making. The episode also covers the growing trend of real-world performance monitoring.
Join Dr. Jagota as he discusses how regulatory frameworks are enabling AI to safely innovate medical imaging, paving the way for advancements in other healthcare sectors.

Artificial Intelligence in Clinical Trials: Transforming Drug Development

In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota dives into the transformative role of artificial intelligence in clinical trials and drug development. Titled "Artificial Intelligence in Clinical Trials: Transforming Drug Development," Dr. Jagota discusses how AI is addressing critical challenges in clinical research, such as the high costs and lengthy timelines of traditional trials.
Dr. Jagota explores three key areas where AI is making an impact: patient selection and recruitment, real-time data monitoring, and adaptive trial designs. AI is revolutionizing patient matching, reducing trial costs, and improving data accuracy, while also enabling adaptive trials that can modify based on real-time results.
He also delves into the regulatory challenges of integrating AI, emphasizing the need for compliance with Good Clinical Practice (GCP) and maintaining data integrity. AI systems must be validated, and AI-driven changes must be documented carefully to meet regulatory standards.
Listeners will gain insights into emerging regulatory frameworks, including FDA guidelines and the concept of "regulatory-grade AI," ensuring AI's safe and ethical use in clinical trials.
Join Dr. Jagota as he examines how AI is reshaping clinical trials and the evolving regulatory landscape that supports this revolution.
 
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The Dawn of AI in Healthcare: Understanding the Regulatory Landscape

In the very first episode of "AI Revolution in Healthcare: A Regulatory Perspective," Dr. Nirdosh Jagota takes listeners on a journey to explore how artificial intelligence is transforming healthcare and what it means for regulatory processes. In this episode, titled "The Dawn of AI in Healthcare: Understanding the Regulatory Landscape," Dr. Jagota discusses the unprecedented transformation AI is bringing to the healthcare sector—from drug discovery to diagnostics—and the unique regulatory challenges that accompany this revolution.
Listeners will gain an in-depth understanding of how regulatory bodies like the FDA and EMA are adapting to these new advancements, focusing on critical areas such as adaptive algorithms, predetermined change control plans, and real-world performance monitoring. The episode also includes insights into the steps companies need to take to align with evolving regulatory standards, including establishing robust data management practices and post-market surveillance.
Join Dr. Nirdosh Jagota as he unravels how regulations are adapting to foster innovation while ensuring patient safety in this exciting era of AI in healthcare. Subscribe today to stay updated on future episodes where we dive deeper into specific applications of AI across the healthcare spectrum.
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