My hope was to make a simplified decision tree to aid IRB’s in determining when or if their clinical decision support tools are considered “medical devices” and therefore require adherence to the FDA regs.
Ms. Eto has over 17 years of experience in the field of human subjects research protections and manages IRB review and research compliance, including the facilitation of technology risk assessment and data sharing contracts, at a large healthcare institution's Division of Research. The research portfolio there comprises over 7 million members with a large profile of AI-related research projects including FDA-regulated Software as a Medical Device (SaMD). Concurrently, Ms. Eto also serves on the AI Ethics Advisory Board for the Institution of Experiential AI (EAI) at Northeastern University. Prior to her work at the Division of Research, Tamiko served as Acting Director at Stanford Research Institute’s (SRI) Office of Research Integrity and Chair of SRI IRB, where she performed scientific reviews, policy interpretations and the development of AI-related projects. She has now leveraged her experience to implement regulatory policies to health care research projects that delve into AI research. She works closely with AI researchers and institutional /regulatory bodies in addressing ethical and regulatory challenges related to AI. To facilitate researchers and IRB professionals across the US she has developed tools and checklists for IRBs to use in their review of AI research. Developing these tools, she also actively collaborates on research to be at the forefront of developing an ethical and regulatory framework for research involving human subjects. She is now currently pursuing her second Master’s Degree at Stanford University in Ethics and Policy.
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