Study

This course analyzes the legal and policy regimes that shape the introduction of new products, processes, and services in the life science industries. Innovation in biopharmaceuticals, medical devices, health services, and health care delivery is central to the heavily regulated life sciences sector, and thus the sector offers a window into multiple intersections of scientific innovation, regulatory policy, and law.  Innovation in this sector is also shaped by multiple bodies of law (e.g. intellectual property law, FDA law, federal and state-based insurance and professional regulation, antitrust, tax), each with its own private and public constituencies, and therefore offers an opportunity to assess how different bodies of law approach the common issue of innovation.  Although this course focuses on innovation in the life science industries, this focus will produce lessons for innovation policy in other regulated and less-regulated industries. 

Artificial intelligence is on a tremendous growth trajectory and is being developed, adopted and used for many purposes throughout society.  From a legal and policy perspective, AI presents many interesting and complex issues because the technological developments have greatly outpaced the legal, ethical, and policy developments.  One of the important questions centers on what legal and policy frameworks and practices are appropriate to build an ecosystem of trust that will help ensure citizens and other stakeholders that artificial intelligence will benefit them and is being developed and deployed in an ethical, safe, reliable and responsible manner (the “Legal and Policy Framework Question”).  Policymakers and other stakeholders around the globe are grappling with this Legal and Policy Framework Question.  As the discussions unfold, organizations also are designing their own practices for operationalizing trustworthy or ethical artificial intelligence.

The goal of the seminar is to give students a foundation in the emerging AI laws and policies and insight on the broader process of how laws and policies need to adapt for significant technological changes.  This seminar will explore in detail several approaches currently being considered to answer the Legal and Policy Framework Question, including regulatory approaches, standards, soft law, and self-regulation. As the students study various approaches, they will be asked to consider several sub-questions, such as (a) how the AI legal and policy framework should be calibrated to address risk, (b) the extent to which the framework should be sector specific or apply across industries, (c) which frameworks enable society to capitalize on AI’s benefits and mitigate potential risks, and (d) what is the optimal level of cross-border harmonization and how best to achieve it.   The course also will explore certain other legal issues arising in connection with AI, such antitrust and competition law and intellectual property and proprietary rights matters.

Faced with myriad health, safety, environmental, security and financial risks, how should societies respond?  This course studies the regulation of a wide array of risks, such as disease, food, drugs, medical care, biotechnology, chemicals, automobiles, air travel, drinking water, air pollution, energy, climate change, finance, violence, terrorism, emerging technologies, and extreme catastrophic risks. (Students may propose to research other risks as well.)

Across these diverse contexts, the course focuses on how regulatory institutions deal with the challenges of risk assessment (technical expertise), risk perceptions (public concerns and values), priority-setting (which risks should be regulated most), risk management (including the debates over "precaution" versus benefit-cost analysis, and risk-risk tradeoffs such as countervailing harms and co-benefits), and ongoing evaluation and updating.  It examines the rules and institutions for risk regulation, including the roles of legislative, executive/administrative, and judicial functions; the challenge of fragmentation and integration; the roles of oversight bodies (such as judicial review by courts, and executive review by US OMB/OIRA and the EU RSB); and the potential for international regulatory cooperation.

The course examines these issues through a comparative approach to risk regulation in the United States, Europe, and beyond (especially those countries of interest to the students in the course each year).  It examines the divergence, convergence, and exchange of ideas across regulatory systems; the causes of these patterns; the consequences of regulatory choices; and how regulatory systems can learn to do better.

This is a research seminar, in which students discuss and debate in class, while developing their own research.  We may also have some guest speakers.  Students' responsibilities in this course include active participation in class discussions, and writing a substantial research paper.  Students’ papers may take several approaches, such as analyzing a specific risk regulation; comparing regulation across countries; analyzing proposals to improve the regulatory system; or other related topics.

This course is Law 590, cross-listed as Environ 733.01 and PubPol 891.01.  Graduate and professional students from outside the Law School should enroll via those Environ and PubPol course numbers, and may contact the Nicholas School registrar, Erika Lovelace, e.love@duke.edu, or the Sanford School registrar, Anita Lyon, anita.lyon@duke.edu, with any questions about enrollment.  (The Law School does not use “permission numbers.”)

Robots, with us for several generations already, were long confined to narrow uses and trained users, assembling our vehicles and moving our products behind the scenes. In recent years, robotic tools have begun to step out of the back room and take center stage. Even more, these tools are fueled by constantly advancing artificial intelligence and machine learning tools that allow them to participate in the world of the mind as much as the world of muscle. Are we ready? Probably not. In order to capture the full opportunities and benefits of AI & robotics, surely our legal systems and ethical frameworks must evolve. We must find ways to ensure that human-robot interactions occur in ways that are safe and are consistent with our cultural values. We must take care that our policies and laws provide artificial intelligence tools with the direction we need without quashing or hindering the innovations that could improve our lives.

The course will bring together three core areas: (1) law, (2) ethics, and (3) applied technology. Because frontier technologies challenge existing legal regimes and ethical frameworks, this course and its assigned project encourage law, ethics, and policy students to interact with networks of experts who are actively thinking about ethical technology development and with technology policy networks that explore the social implications of a world increasingly inclusive of AI.

Beyond time spent for class preparation and in-class time, each student in Frontier AI & Robotics: Law & Ethics will be required to complete a substantial research-based Report that demonstrates a deep, research-based understanding of a topic about which the student shall become knowledgeable such that he/she could take part meaningfully in and contribute to present-day discussions of law, policy, and ethics in the topic area. This Report may qualify for the JD SRWP degree requirement or the International LLM writing requirement upon permission of the instructor.

NO PRIOR EXPERIENCE WITH ARTIFICIAL INTELLIGENCE OR TECHNOLOGY IS NEEDED FOR THIS COURSE.