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Regulatory Impacts on Data and AI in Healthcare

Oracle via YouTube

Overview

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Explore the evolving regulatory landscape for AI and data management in healthcare through this 35-minute keynote from Oracle Health and Life Sciences Summit 2025. Learn from Stacy Amin, Chief Counsel for Global Health Regulatory and Policy at Oracle, alongside experts from the UK's Medicines and Healthcare Products Regulatory Agency (MHRA) as they share critical insights on navigating complex compliance requirements. Discover how Oracle collaborates with global regulators to build robust safety and surveillance systems while maintaining data security and ensuring trust in AI-driven healthcare solutions. Examine the role of AI in modern healthcare and understand three key ways artificial intelligence is transforming regulatory approaches. Gain insights into real-time data utilization for safety monitoring, accelerating clinical trials with real-world data, and the importance of international harmonization in regulatory frameworks. Address critical topics including clinical trial access and equity, lessons learned from Brexit and COVID-19, cybersecurity challenges in healthcare, and the transformative power of generative AI in medical applications. Master strategies for balancing innovation with compliance while learning practical steps for ensuring the safe use of AI tools in health and life sciences organizations to protect patient and population health.

Syllabus

00:00:00 Oracle and MHRA: Data and AI Regulations
00:05:05 Role of AI in Modern Healthcare
00:09:13 Regulating AI for Patient Safety
00:12:06 Three Ways AI Changes Regulation
00:15:37 Real-Time Data for Safety
00:17:42 Accelerating Clinical Trials with Real-World Data
00:18:46 Importance of International Harmonization
00:21:46 Clinical Trial Access and Equity
00:22:18 Lessons from Brexit and COVID
00:26:00 Addressing Cybersecurity in Healthcare
00:30:05 Generative AI’s Power in Healthcare
00:32:02 Ensuring Safe Use of AI Tools
00:34:34 Final Takeaways

Taught by

Oracle

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