Bridge2AI: a FAIR AI BRIDGE Center (FABRIC) Ethics Core Summary The use of artificial intelligence (AI), and particularly machine learning (ML), in healthcare opens up many opportunities to improve healthcare and biomedical research. However, AI/ML also raise important issues that implicate ethics and trust, including defining parameters for consent and re-use of personal data, protecting privacy, ensuring transparency and engagement with stakeholders about this research, and developing and deploying tools that are useful and valid for all people. Without an ethically robust set of principles and practices that are generalizable and reusable in a wide range of biomedical environments, AI/ML could violate personal rights, widen the gap between fairness and equality, and fan the flames of mistrust, as exemplified by recent work showing how racial bias can influence clinical decision algorithms. Our vision for the FAIR AI Bridge Center - Ethics Core (FABRIC-Ethics) is to ensure that AI/ML is developed and applied in an ethical and trustworthy manner. FABRIC-Ethics will support the Bridge2AI program to become sustainable by making it more ethical and trustworthy by the end of the four-year project period. To realize this vision, we will use an iterative and reflective four-step cycle: 1) Scaffold, 2) Assess, 3) Facilitate and 4) Evaluate and educate, or SAFE, to provide a platform for convening, analyzing and curating, public relations and original research in a multidisciplinary manner. We will work with the Bridge2AI program to formulate ethical and trustworthy principles for AI/ML (ETAI) to address existing and future practices in biomedical AI research and applications. These include the collection and management of data, the development and deployment of AI/ML technologies and AI/ML applications. In close collaboration with the Bridge2AI program and its Data Generation Projects (DGPs), we will conduct a closed- and open-ended survey, discuss priorities and experiences with Bridge2AI DGPs, and develop an open, curated catalog of relevant literature. These efforts will run in parallel with multiple mechanisms for building a learning ETAI community, convening Bridge2AI data generation projects to distill best practices, and organizing studio sessions to support contact with the other core areas of the Bridge2AI Center and the broader community. Our core will further develop a digital health checklist and framework that prepares Bridge2AI DGPs to evaluate: 1) access and usability, 2) risks and benefits, 3) privacy and 4) data management. We will work with the Bridge2AI DGPs to share knowledge about ETAI, inform the development of principles and best practices, and to set up conferences for sustainable development of ETAI culture beyond Bridge2AI. The team assembled for the core has expertise in a wide range of areas, including bioethics, digital health research ethics, law, public policy, AI/ML, data protection, informatics, medicine, human- centered design, implementation science, and community engagement. To ensure success, FABRIC-Ethics will be led by four PIs with a proven track record in multidisciplinary approaches to the study of ethical issues in technology, center management, and core support.