AI and Software in Research: When FDA Rules Apply - On Tech Ethics

Discusses the use of AI in the legal discovery process.  Our guest today is Mary Kathryn Curry who is an experienced labor and employment attorney at Honigman. Her practice focuses on labor and employment counseling and compliance, working directly with client human resources teams. She supports her clients in all matters relating to the workforce and has served as in-house legal counsel to clients in both technology and healthcare settings.  Additional resources:Mary Kathryn Curry: https://www.honigman.com/professionals-mary-kathryn-curry CITI Program’s Tech Ethics solution: https://about.citiprogram.org/solutions/tech-ethics/ 

Discusses ethical considerations for vibe coding, which is the practice of prompting AI tools to generate code.  Our guest today is Shreya Kumar, who is an Associate Teaching Professor in Computer Science and Engineering at the University of Notre Dame. Shreya works to ensure future software engineers understand their professional responsibilities, encouraging them to take ownership of their everyday decisions. Her mission is to prepare rigorously trained, technologically proficient students who also critically evaluate the impact of their technology on society.  Additional resources: Software Development Ethics: https://about.citiprogram.org/course/software-development-ethics/ CITI Program’s Tech Ethics solution: https://about.citiprogram.org/solutions/tech-ethics/ 

Discusses the EU Biotech Act, which is a legislative proposal focused on health biotechnology, streamlining clinical trials, and boosting biomanufacturing.  Our guest today is Eline D’Joos who is a life sciences associate in Crowell & Moring’s Brussels office. Her practice focuses on regulatory issues and commercial transactions in the life science sector, as well as interplays with general intellectual property and data protection questions.  Additional resources: EU Biotech Act: https://health.ec.europa.eu/publications/proposal-regulation-establish-measures-strengthen-unions-biotechnology-and-biomanufacturing-sectors_en  Crowell & Moring Insights on the EU Biotech Act: https://www.crowell.com/en/insights/client-alerts/european-commission-proposes-biotech-act-to-boost-health-biotechnology-in-the-eu CITI Program’s Tech Ethics solution: https://about.citiprogram.org/solutions/tech-ethics/ 

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/ 

Discusses ethical issues associated with the use of AI in teaching.  Our guest today is Tiffany Bourelle, who is a professor at The University of New Mexico, an instructional strategist, and an AI ethics scholar with more than a decade of experience designing high-impact educational programs.  Additional resources: The EU Artificial Intelligence Act: https://artificialintelligenceact.eu/ Multiliteracies for a Digital Age: https://www.siupress.com/9780809325511/multiliteracies-for-a-digital-age/ Empire of AI: https://www.penguinrandomhouse.com/books/743569/empire-of-ai-by-karen-hao/ Anatomy of an AI System: https://anatomyof.ai/ AI Ethics: https://mitpress.mit.edu/9780262538190/ai-ethics/ Stuart Selber on AI: https://sites.psu.edu/selber/chatgpt/ Teaching with AI: https://www.press.jhu.edu/books/title/54122/teaching-ai Tiffany Bourelle Publications: https://www.tiffanybourelle.com/about CITI Program’s Tech Ethics solution: https://about.citiprogram.org/solutions/tech-ethics/ 

Discusses the unique ethical challenges virtual reality raises for research, including participant risk, consent, privacy, and institutional oversight.  Our guest today is Myra Luna-Lucero, who is the Research Compliance Director at Teachers College. Her contributions to academia span a diverse array of topics, including studies on student motivation within STEM disciplines and advancing ethical research practices.  Additional resources: CITI Program’s Tech Ethics solution: https://about.citiprogram.org/solutions/tech-ethics/ CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

Discusses the ethical challenges that telehealth providers must consider, including informed consent, standards and quality of care, professionalism in virtual care, verification and trust, and equity and access.  Our guest today is Kathy Wibberly, who is the Director of the Mid-Atlantic Telehealth Resource Center, which is one of 14 federally funded telehealth resource centers working to expand access to quality care through telehealth solutions for communities facing the greatest barriers to optimal health outcomes. Kathy also serves as the Director of Research at the University of Virginia’s Center for Telehealth.  Additional resources: National Consortium of Telehealth Resource Centers: https://telehealthresourcecenter.org/ Mid-Atlantic Telehealth Resource Center: https://matrc.org/ American Telemedicine Association: https://www.americantelemed.org/ Alliance for Connected Care: https://connectwithcare.org/ TelehealthVillage @UVA: https://about.citiprogram.org/series/teleheatlhvillage-uva/ CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

Discusses the regulation of cell therapy products and the importance of training on this topic.  Our guests today are Kathy Loper and Jared Schuster.  Kathy serves as the Director of Regulatory Affairs for NMDP, a nonprofit providing life-saving cellular therapies to patients. Kathy has extensive experience in biological product manufacturing and works closely with regulatory agencies, professionals, and other organizations to move the industry forward. Jared also has extensive experience in biotech, specializing in cell therapy CMC, regulatory strategy, and analytical development. He has held scientific, quality, and regulatory roles throughout his career, and is clinically certified as a Histotechnologist and Advanced BioTherapies Professional. At NMDP, he oversees regulatory CMC and strategy functions for cell and gene therapy programs, focusing on procurement of cellular starting materials.  Additional resources: NMDP: https://www.nmdp.org/ Regulation of Cell Therapy course: https://about.citiprogram.org/course/regulation-of-cell-therapy-products/ CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

Discusses how the development and deployment of ethical technology products is a competitive advantage for companies. Our guests today are Jennie Baird and Robert Levitan from the Ethical Tech Project.  Jennie is the Co-Chair of the Ethical Tech Project and a digital media trailblazer. Throughout her 30+ year career, she's driven growth and innovation for some of media’s most successful digital brands and legacy-to-digital crossovers. Today, she dedicates her work to supporting and advising tech-for-good businesses and organizations. At ETP, she spearheads the nonprofit’s strategy to educate, convene, and equip technology and AI builders in making design, engineering, and go-to-market decisions that foster trust and enable human flourishing. She ardently believes that good technology should make the world better and that doing good is good for business. Robert is the Co-Chair of the Ethical Tech Project. He is an entrepreneur and internet pioneer who has started six companies across a variety of industries and raised more than $150 in venture capital funding. Robert co-founded iVillage, an early online community that went public in 1999. He also co-founded Flooz.com, one of the first online digital currency platforms in 1999. Robert was also the co-founder of Pando Networks, which was sold to Microsoft in 2013. Robert is a collaborative business leader passionate about helping mission-driven organizations grow through strong customer relationships and productive strategic partnerships.  Additional resources: The Ethical Tech Project: https://www.ethicaltechproject.org/ CITI Program’s Tech Ethics training solution: https://about.citiprogram.org/solutions/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