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On Tech Ethics with CITI Program
Discusses a broad range of technology ethics topics. Hosted by Daniel Smith, Associate Director of Content and Education at CITI Program. New episodes every month. Learn more at about.citiprogram.org.
On Tech Ethics with CITI Program
AI and Software in Research: When FDA Rules Apply - On Tech Ethics
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CITI Program
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Season 1
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Episode 47
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Discusses regulatory considerations for research involving medical devices, particularly given the rise of AI and software as a medical device.
Our guest today is Lauren Hartsmith, who is a consultant at The HRP Consulting Group and a human subjects protection professional with over 15 years of experience in research compliance, Institutional Review Board oversight, and regulatory affairs.
Additional resources:
- FDA Software as a Medical Device: https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd
- FDA Clinical Decision Support Software Guidance: https://www.fda.gov/media/109618/download
- HRP Consulting Resources: https://thehrpconsultinggroup.com/resources/
- CITI Program’s Tech Ethics solution: https://about.citiprogram.org/solutions/tech-ethics/
