Penn Bioethics Seminar Series (PBS): Ravi Parikh, MD, MPP - "Optimizing FDA Regulatory Policy for Artificial Intelligence-Based Clinical Decision Support in Medicine"

Optimizing FDA Regulatory Policy for Artificial Intelligence-Based Clinical Decision Support in Medicine

Ravi Parikh, MD, MPP

Assistant Professor, Medical Ethics and Health Policy, and Medicine
Associate Director, Penn Center for Cancer Care Innovation
Director, Human-Algorithm Collaboration Lab
Perelman School of Medicine

     As artificial intelligence explodes onto the clinical scene, many questions have emerged regarding how the FDA should regulate tools that influence clinical decision support (CDS). The FDA has made a deliberate choice to classify most AI as “software as a medical device” – a decision with large implications regarding the level of validation necessary for such a tool.
     In this “Works in Progress”, Dr. Parikh will present an overview of the FDA’s regulatory approach to AI-based CDS, how this differs from AI regulation in Europe, and will present results from a preliminary analysis classifying current AI-based devices’ risk classification in the US and in Europe. We will conclude with preliminary aims for future work and discuss potential additional studies.

Lunch provided.
Streaming available via Zoom.