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 voice as a biomarker of diseases, including ethical considerations and how this technology could change the way we diagnose and monitor diseases. 

 
Our guest today is Yael Bensoussan, who is an Assistant Professor of Otolaryngology at the University of South Florida Health Morsani College of Medicine and a fellowship-trained laryngologist. She is also the principal investigator of the Bridge2AI-Voice project, a multi-institutional endeavor funded by the National Institutes of Health to fuel voice as a biomarker of diseases. 
 

Additional resources: 

• Bridge2AI-Voice: https://b2ai-voice.org/ 
• Voice AI Symposium: https://b2ai-voice.org/voice-ai-symposium/ 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

Discusses Active Physical Intelligence, a model designed for real-time data collection and acquisition, which serves as an adaptive foundation. 
 
Our guests today are the co-founders of KavAI: Tara Javidi and Sam Bigdeli.  

Tara has been appointed as the inaugural holder of the Jerzy (George) Lewak Endowed Chair in the Jacobs School of Engineering at the University of California, San Diego (UCSD). Tara and UCSD have been selected to join the Eric and Wendy Schmidt AI in Science Postdoctoral Fellowship, a program of Schmidt Futures, to accelerate the next scientific revolution by applying AI to research in science, technology, engineering, and mathematics (STEM). 

Sam is the CEO at KavAI, which aims to revolutionize various industries, saving time, labor, and financial resources. He is also a founding advisor at XIRA Connect and a partner at Competitive Knowledge Inc., which invests in entrepreneurs with unique technologies and helps transform their visions into reality. Sam previously held the position of Chief Operating Financial Officer at Advanced MP Technology. 
 

Additional resources: 

• KavAI: https://www.kavai.com/ 
• What is Active Physical Intelligence?: https://www.kavai.com/dev/active-physical-intelligence 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog  

Discusses the Centers for Medicare & Medicaid Services’ proposed rule for the 2026 hospital outpatient prospective payment system and ambulatory surgical centers. 

Our guest today is Eric Tower, a partner at the law firm Blank Rome. Eric serves as a trusted advisor to healthcare clients on a wide range of corporate transactional and operational matters. He is well-versed in handling mergers and acquisitions, joint ventures, fraud and abuse compliance, physician practice acquisitions, financing, litigation, and corporate governance matters. 

Additional resources: 

• CMS fact sheet: https://www.cms.gov/newsroom/fact-sheets/calendar-year-2026-hospital-outpatient-prospective-payment-system-opps-and-ambulatory-surgical 
• Impact of Recent CMS Rule on Site Neutrality and 340B Programs—Implications for Oncology Services: https://www.blankrome.com/publications/impact-recent-cms-rule-site-neutrality-and-340b-programs-implications-oncology
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog  

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  

Discusses various ethical and practical challenges organizations face in managing cybersecurity risks and responding to breach incidents. 

Our guest today is Lynn Sessions, the lead of the Healthcare Privacy and Compliance team and co-lead of the national Healthcare Industry team at BakerHostetler. Lynn focuses her practice on healthcare privacy and data security, breach response, regulatory defense, and Health Insurance Portability and Accountability Act (HIPAA) compliance. 
 

Additional resources: 

• BakerHostetler Data Counsel: https://www.bakerdatacounsel.com/ 
• Health Care Compliance Association: https://www.hcca-info.org/ 
• American Health Law Association: https://www.americanhealthlaw.org/ 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog  

Discusses the need for bioethics departments in HBCU medical schools. 

Our guest today is Dr. Donald Carter III, a biomedical ethicist and Assistant Professor at Mercer University School of Medicine. He holds degrees from Fisk, Tennessee State, Vanderbilt, and Loyola Chicago. A 2023 Hastings Center Sadler Scholar, his research explores clinical ethics, AI in medicine, race, and social justice. 
 

Additional resources: 

• The Hastings Center for Bioethics – https://www.thehastingscenter.org/ 
• The American Journal of Bioethics – https://www.tandfonline.com/journals/uajb20 
• Bioethics Today – https://bioethicstoday.org/ 
• Bioethics in the Margins – https://bioethicsinthemargins.org/ 
• Bioethics for the People – https://www.bioethicsforthepeople.com/ 
• CITI Program’s Bioethics course – https://about.citiprogram.org/course/bioethics/ 
• CITI Program’s Healthcare Ethics Committee course – https://about.citiprogram.org/course/healthcare-ethics-committee/ 

Discusses the responsible integration of AI into healthcare delivery. 

Our guest today is Dr. Yauheni Solad who is a Managing Partner at Dalos Partners, leading healthcare AI strategy and validation. Dr. Solad is a research affiliate at Yale University and a board-certified physician in clinical informatics. He formerly led digital health innovation at UC Davis Health and Yale, advancing FHIR interoperability, telemedicine, and responsible AI standards. 
 

Additional resources: 

• ReAligned Healthcare podcast: https://realignedhealthcare.com/ 
• Journal of the American Medical Informatics Association: https://academic.oup.com/jamia 
• The Lancet Digital Health: https://www.thelancet.com/journals/landig/home 
• Deep Medicine: https://dl.acm.org/doi/10.5555/3350442 
• Request for Information on the Development of an AI Action Plan: https://www.federalregister.gov/documents/2025/02/06/2025-02305/request-for-information-on-the-development-of-an-artificial-intelligence-ai-action-plan 
• WHO Harnessing AI for Health: https://www.who.int/teams/digital-health-and-innovation/harnessing-artificial-intelligence-for-health 
• National Academy of Medicine AI and Emerging Technology: https://nam.edu/our-work/key-issues/artificial-intelligence-and-emerging-technology/ 
• CITI Program’s course catalog: https://about.citiprogram.org/course-catalog 

Discusses the updated International Council for Harmonisation (ICH) Guideline for Good Clinical Practice known as E6(R3) and what it means for researchers. 

Our guest today is Cindy Gates, JD, RN, an experienced leader in human subjects research protections and clinical research. Cindy has previously worked at WIRB, the University of California Davis, the University of Miami, the Houston Methodist Medical Center, and George Washington University. 

This episode is co-hosted by Eric D. Kupferberg, PhD, Associate Director of Clinical Research Education at CITI Program. 
 

Additional resources: 

• ICH E6(R3): https://www.ich.org/page/efficacy-guidelines#6-2 
• CITI Program’s ICH E6(R3): An Introduction course: https://about.citiprogram.org/course/ich-e6r3-an-introduction/