On Tech Ethics with CITI Program – Détails, épisodes et analyse

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 

Discusses digital health solutions that support health promotion and disease prevention. 

 
Our guest today is Danielle Louder, who serves as the Co-Director of MCD Global Health’s U.S. Programs and the Director of the Northeast Telehealth Resource Center. In these roles, she is responsible for advancing the use of digital health strategies to improve health access and outcomes. 
 

Additional resources: 

• National Consortium of Telehealth Resource Centers: https://telehealthresourcecenter.org/ 
• National Telehealth Technology Assessment Resource Center: https://telehealthtechnology.org/ 
• Northeast Telehealth Resource Center: https://www.netrc.org/ 
• U.S. Department of Health and Human Services: https://telehealth.hhs.gov/ 
• Center for Connected Health Policy: https://www.cchpca.org/ 
• National Digital Inclusion Alliance: https://www.digitalinclusion.org/ 
• National Digital Equity Center: https://digitalequitycenter.org/ 
• DiMe Digital Health Series: https://about.citiprogram.org/series/dime-digital-health-series/ 
• TelehealthVillage @UVA: https://about.citiprogram.org/series/teleheatlhvillage-uva/ 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

Discusses the importance of fostering AI literacy in research and higher education. 

Our guest today is Sarah Florini who is an Associate Director and Associate Professor in the Lincoln Center for Applied Ethics at Arizona State University. Sarah’s work focuses on technology, social media, technology ethics, digital ethnography, and Black digital culture. Among other things, Sarah is dedicated to fostering critical AI literacy and ethical engagement with AI/ML technologies. She founded the AI and Ethics Workgroup to serve as a catalyst for critical conversations about the role of AI models in higher education. 

This episode is co-hosted by Alexa McClellan, MA, Associate Director of Research Foundations at CITI Program. 
 

Additional resources: 

• Distributed AI Research Institute: https://www.dair-institute.org/ 
• Mystery AI Hype Theater 3000: https://www.dair-institute.org/maiht3k/ 
• Tech Won’t Save Us: https://techwontsave.us/ 
• CITI Program’s Essentials of Responsible AI course: https://about.citiprogram.org/course/essentials-of-responsible-ai/ 

Discusses data privacy compliance and environmental, social, and governance (ESG) reporting. 

Our guest today is Katrina Destrée who is a globally experienced privacy and sustainability professional. Katrina’s work in privacy and sustainability focuses on privacy programs, ESG reporting, awareness and training, and strategic communications. 
 

Additional resources: 

• International Association of Privacy Professionals (IAPP): https://iapp.org/ 
• ISACA: https://www.isaca.org/ 
• Global Enabling Sustainability Initiative (GeSI): https://www.gesi.org/ 
• Agréa Privacy & ESG: https://agreaprivacyesg.com/ 
• CITI Program’s “GDPR for Research and Higher Ed” course: https://about.citiprogram.org/course/gdpr-for-research-and-higher-ed/  
• CITI Program’s “Big Data and Data Science Research Ethics” course: https://about.citiprogram.org/course/big-data-and-data-science-research-ethics/ 
• CITI Program’s “Essentials of Responsible AI” course: https://about.citiprogram.org/course/essentials-of-responsible-ai/ 

Discusses citizen or participatory science, including its benefits and key ethical issues. 

Our guest today is Lisa Rasmussen who is a Professor in the Department of Philosophy at the University of North Carolina Charlotte and Editor-in-Chief of the journal Accountability in Research. Lisa has been a principal investigator or co-principal investigator on over $1 million in National Science Foundation awards and serves as a Co-Editor of the book series Philosophy and Medicine and an Associate Editor of the publication Citizen Science: Theory and Practice.  

Additional resources: 

• Association for the Advancement of Participatory Sciences: https://participatorysciences.org/ 
• Citizen Science: Theory and Practice: https://theoryandpractice.citizenscienceassociation.org/ 
• Citizen Science: How Ordinary People are Changing the Face of Discovery: https://scistarter.com/cooper 
• SciStarter: https://scistarter.org/ 

Discusses the 3Rs of animal research, teaching, and testing (replacement, reduction, and refinement), including the methods and technologies that support their application. 

Our guest today is Megan LaFollette, who is the Executive Director at The 3Rs Collaborative, where she advances better science for both people and animals. She received her PhD and Master of Science in Animal Behavior & Welfare from Purdue University. She is an expert in advancing the implementation of practical, impactful, and evidence-based 3Rs techniques. 

Additional resources: 

• The 3Rs Collaborative: https://3rc.org/ 
• The 3Rs Collaborative Initiatives: https://3rc.org/workstreams/ 
• CITI Program ACU Core Courses: https://about.citiprogram.org/series/animal-care-and-use-acu/ 
• CITI Program ACU Advanced Courses: https://about.citiprogram.org/series/animal-care-and-use-acu-advanced/ 

Discusses data privacy considerations in the context of digital technologies. 

Our guest today is Emilee Rader, an associate professor at the Information School at the University of Wisconsin-Madison. Emilee’s research focuses on the human-centered aspects of data privacy. She studies how people reason and make choices about data collection and inferences enabled by digital technologies to better understand why people struggle to manage their privacy and to discover new ways to help people gain more appropriate control over information about them. 

Additional resources: 

• Consumer Reports: https://www.consumerreports.org/issue/data-privacy
• Electronic Frontier Foundation: https://www.eff.org/
• Family Educational Rights and Privacy Act (FERPA): https://about.citiprogram.org/course/family-educational-rights-and-privacy-act-ferpa/ 
• Health Insurance Portability and Accountability Act (HIPAA): https://about.citiprogram.org/series/health-insurance-portability-and-accountability-act-hipaa/ 
• Human Subjects Research (HSR): https://about.citiprogram.org/series/human-subjects-research-hsr/ 

Discusses the use of synthetic data in research and healthcare. 

Our guest today is Dennis L. Shung, MD, MHS, PhD, an Assistant Professor of Medicine at Yale School of Medicine and Director of Digital Health in Digestive Diseases. He leads the Human+Artificial Intelligence in Medicine lab, which focuses on enhancing human presence with AI. Dennis is also involved in multiple gastroenterology AI initiatives and research.  

Additional resources: 

• NSF Program Solicitation on Mathematical Foundations of Digital Twins: https://new.nsf.gov/funding/opportunities/math-dt-mathematical-foundations-digital-twins/nsf24-559/solicitation 
• AI models collapse when trained on recursively generated data: https://www.nature.com/articles/s41586-024-07566-y 
• Synthetic data in machine learning for medicine and healthcare: https://www.nature.com/articles/s41551-021-00751-8 
• Synthetic data in medical research: https://bmjmedicine.bmj.com/content/1/1/e000167 
• Harnessing the power of synthetic data in healthcare: innovation, application, and privacy: https://www.nature.com/articles/s41746-023-00927-3 
• Essentials of Responsible AI: https://about.citiprogram.org/course/essentials-of-responsible-ai 
• Big Data and Data Science Research Ethics: https://about.citiprogram.org/course/big-data-and-data-science-research-ethics/ 

Discusses ethical issues and governance considerations associated with the collection, analysis, and sharing of genetic material and information. 

Our guest today is Shelly Simana, an assistant professor at Boston College Law School. Before joining BC, she was a fellow at Stanford Law School’s Center for Law and the Biosciences and a doctoral candidate at Harvard Law School. Her scholarship lies at the intersection of law and bioethics. 

Additional resources: 

• Shelly Simana: https://www.bc.edu/bc-web/schools/law/academics-faculty/faculty-directory/shelly-simana.html 
• National Human Genome Research Institute: https://www.genome.gov/
• Technology, Ethics, and Regulations: https://about.citiprogram.org/course/technology-ethics-and-regulations/
• Bioethics: https://about.citiprogram.org/course/bioethics/ 

Discusses cellular agriculture, including current applications, benefits, technological progress and challenges, and ethical issues. 

Our guest today is Natalie Rubio, the executive director of the Cellular Agriculture Commercialization Laboratory at Tufts University, who is working to convert early-stage innovations to impactful technologies to reduce costs, increase scale, and improve the quality of cellular agriculture products. Previously, Natalie worked at New Harvest, Perfect Day Foods, and Ark Biotech. 
 

Additional resources: 

• Tufts University Center for Cellular Agriculture: https://cellularagriculture.tufts.edu/ 
• New Harvest: https://new-harvest.org/ 
• Good Food Institute: https://gfi.org/ 
• CITI Program’s “Technology, Ethics, and Regulations” course: https://about.citiprogram.org/course/technology-ethics-and-regulations/