Global Regulatory Framework for AI in Healthcare: A Comparative Analysis

In this episode of AI Revolution in Healthcare: A Regulatory Perspective, Dr. Nirdosh Jagota examines the global regulatory landscape for AI in healthcare. As AI technologies transcend borders, understanding the similarities and differences between regulatory frameworks is critical for innovators seeking worldwide implementation.

Dr. Jagota explores key approaches taken by major regulatory bodies, including the FDA's total product lifecycle management, the EMA's emphasis on risk classification, and Asia's focus on real-world performance evaluation. Using real-world examples, he highlights how differing requirements for validation, data privacy, and post-market monitoring affect AI deployment across regions.

Listeners will gain insights into the ongoing international harmonization efforts, including the role of organizations like the International Medical Device Regulators Forum. Dr. Jagota also discusses forward-looking trends such as regulatory sandboxes and the development of global AI standards, which promise to streamline the approval process for AI-powered healthcare solutions.

Join Dr. Jagota as he provides a comparative analysis of regulatory frameworks and offers practical guidance for navigating the complexities of global AI regulation in healthcare.

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For more resources and insights, visit Nirdosh Jagota's Official Website.