On Tech Ethics with CITI Program

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.

  1. Unpacking the FDA's Revised CDS and General Wellness Product Guidances - On Tech Ethics

    5 THG 2

    Unpacking the FDA's Revised CDS and General Wellness Product Guidances - On Tech Ethics

    Discusses key takeaways from the U.S. Food and Drug Administration’s revised Clinical Decision Support Software and General Wellness Product guidance documents.    Our guests today are Christina Kuhn and Olivia Dworkin from the law firm Covington. Christina advises medical device, pharmaceutical, and biotech companies on a broad range of FDA regulatory strategy and compliance matters. She has experience with cutting-edge and complex medical technologies, including software and digital health products, oncology products, next-generation sequencing, diagnostics, and combination products. Olivia minimizes regulatory and litigation risks for clients in the medical device, pharmaceutical, biotechnology, eCommerce, and digital health industries through strategic advice on complex FDA issues, helping to bring innovative products to market while ensuring regulatory compliance.    Additional resources:  FDA’s Clinical Decision Support Software guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software FDA’s General Wellness: Policy for Low Risk Devices guidance: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices 5 Key Takeaways from FDA’s Revised Clinical Decision Support (CDS) Software Guidance: https://www.cov.com/news-and-insights/insights/2026/01/5-key-takeaways-from-fdas-revised-clinical-decision-support-cds-software-guidance FDA Issues Revised Guidance on General Wellness Products: https://www.cov.com/en/news-and-insights/insights/2026/01/fda-issues-revised-guidance-on-general-wellness-products Covington Digital Health Blog and Resources: https://www.cov.com/en/practices-and-industries/industries/digital-health CITI Program’s Essentials of Software as a Medical Device and Clinical Decision Support Systems: https://about.citiprogram.org/course/essentials-of-software-as-a-medical-device-clinical-decision-support-systems/  CITI Program’s course catalog: https://about.citiprogram.org/course-catalog

    45 phút
  2. Vibe Research and the Future of Science - On Tech Ethics

    09/09/2025

    Vibe Research and the Future of Science - On Tech Ethics

    Discusses vibe research or science, which is an emerging approach to scientific research using AI.  Our guests today are from MIT Critical Data, which develops local AI capacity in healthcare by building open data and software, fostering community engagement through datathons, and advocating for AI equity in research.  Sebastian Cajas Senior is an AI scientist at CeADAR with expertise in generative AI, quantum machine learning, and responsible AI. Sebastian is a former fellow in computer science at Harvard University, leading projects in multimodal AI, AI safety, and federated learning. Sebastian is passionate about applying AI to healthcare, education, and high-impact societal challenges. Leo Anthony Celi is the principal investigator behind the Medical Information Mart for Intensive Care (MIMIC) and its family of databases. With close to 100k users worldwide, an open codebase, and close to 10k publications in Google Scholar, the datasets have shaped the course of machine learning in healthcare. Meskerem Kebede is a research officer at the London School of Economics and Political Science. Meskerem has previously worked as a clinician and lecturer at the ENT surgery department at Addis Ababa University, Ethiopia. She is passionate about strengthening surgical systems in low- and middle-income countries and has a special interest in health workforce development in East Africa. Hyunjung Gloria Kwak is an assistant professor at Emory University’s School of Nursing, with a PhD in Computer Science. She researches bias-aware modeling, social determinants of health, and simulation-based studies, integrating large-scale EHRs and multimodal data to improve decision-making, and leads interdisciplinary projects on predictive analytics, representation, and real-world AI evaluation in healthcare.   Additional resources:  MIT Critical Data: https://criticaldata.mit.edu/ CITI Program’s course catalog: https://about.citiprogram.org/course-catalog

    43 phút

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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.