Business Law Section 2025 Spring Meeting

Please join us for our 2025 spring meeting!

Topics to be discussed:

• The fundamentals of responsible AI and their implementation: Responsible AI refers to the ethical development, deployment, and use of AI systems that are designed to benefit humanity while respecting rights and values and built around certain key principles and practices among which: Fairness and Non-discrimination; Transparency; Privacy and Security; Accountability; Safety and Reliability. From a practical perspective, such AI systems must be built with at the minimum the following features: Diverse and Representative Data; Regular Testing and Auditing; Human Oversight; Clear Use Guidelines; and Ongoing Monitoring. In addition, responsible AI systems must refer to a governance framework within which humans should remain capable of evaluating risks, document, and comply with applicable regulation and with the constant engagement of all stakeholders. Ethical design and responsible AI experts will go over and beyond these major topics
• AI regulation comparison between the U.S. and the E.U. applied to health care and medical devices: The regulatory landscape for AI-based medical devices is evolving rapidly. In the US the FDA framework includes risk-based classification, pre-certification program, SaMD (and IMDRF at the international level), adaptive algorithm and real-world performing monitoring. Key regulatory requirements are clinical validation, transparency of the algorithm, performance testing and risk management. In the EU the regulatory framework includes the Medical Device Regulation (MDR); In Vitro Diagnostic Regulation (IVDR) and the EU AI Act. This session will discuss and compare the US and EU regulatory landscape and the emerging regulatory challenges among which the AI continuous learning systems, performance drift, bias, privacy, and cybersecurity.