Episode 017: Harsh Thakkar (@harshvthakkar) interviews Vivek Thakkar (@vivekbthakkar), the Senior Digital Health Consultant at Biologics Consulting

Vivek 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.

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Links:

* MedPaLM
* FDA draft guidance on predetermined change control plan
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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