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Listen "The Promise and Perils of Large Language Models in Healthcare and AI-based Software as a Medical Device with Vivek Thakkar"
Episode Synopsis
Episode 017: Harsh Thakkar (@harshvthakkar) interviews Vivek Thakkar (@vivekbthakkar), the Senior Digital Health Consultant at Biologics ConsultingVivek emphasizes the importance of validating AI-based software in clinical settings to ensure safety and efficacy. He also discusses the challenges of continuous improvement in algorithms and the need for a predetermined change control plan.Harsh and Vivek also discuss the role of AI in healthcare, the challenges of regulating AI in medical devices, and how companies can go about validating AI-based software as medical devices. They also touch on the potential for AI to generate outlines for regulatory submissions.-----Links:* MedPaLM* FDA draft guidance on predetermined change control plan* Do you love LS 360 and want to see Harsh's smiling face? Subscribe to our YouTube channel.-----Show Notes:(3:05) What are the regulations around AI?(8:59) Clinical research and clinical trials.(14:15) Regulatory Intelligence and regulatory submissions.(17:42) Can AI be used to write regulatory submissions?(22:55) The importance of humans in the loop in healthcare.(32:21) Will AI take your job? For transcripts, check out the podcast website - www.lifesciencespod.com
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