Health Law (HLTLW)

When should a vaccine be licensed, a drug approved, or an N95 mask authorized for sale? How do we assure the safety of produce grown in widely dispersed locations or of seafood harvested throughout the world? Should herbal supplements be regulated as food, drugs, or something in between? How aggressively, and in what manner, should the federal government regulate the cosmetics, tobacco, medical device, and human tissue industries? This course examines the work of the primary federal agency responsible for these issues, the U.S. Food and Drug Administration. In addition to covering this substantive material, the course will introduce you to the process of understanding a complex statute, its implementing regulations, and related enforcement policies.

This course surveys U.S. health law, focusing primarily on health insurance, and the organization and regulation of healthcare providers, organizations, and industry, which are the essential areas of health law practice. The first third of the course focuses on health insurance. Public health insurance programs, Medicare and Medicaid, are covered first before moving onto the Affordable Care Act and the regulation of private insurance. The remainder of the course covers topics such as regulation of healthcare entities and providers; tax exemption requirements for hospitals; healthcare fraud and abuse; and antitrust issues in the provision of healthcare.

This course surveys the law of bioethics. Most of the course will focus on the law of decision making in healthcare or medical settings. We will begin by examining the treatment relationship between patients and their healthcare providers, focusing on the fiduciary nature of the relationship and the doctrine of informed consent. Informed consent is also the foundation of human subjects research regulation, which is the next topic in the course. We will then explore the law of organ transplantation before moving into special types of healthcare decision making-reproductive and end-of-life decision making. We conclude the survey with the law of public health.

This course surveys public health law, which consists of local, state, federal, and international law used to protect the public from illness, death, and disability. The first part of the course will focus on the sources of state and federal legal authority to regulate for public health, as well as the tensions with public health regulation and civil liberties and individual rights. The second part of the course will focus on some common areas of public health regulation (e.g., drugs, tobacco, obesity, etc.). The third part of the course will focus on whether public health regulation is consistent with the U.S. constitution, specifically the first, second, and fourteenth amendments. The fourth part of the course will focus on public health tools such as testing, screening, and searching for health risks and corresponding issues with privacy, confidentiality and surveillance. If time permits, the course will also cover emergency preparedness and bioterrorism. The field of public health law is rapidly changing, and I encourage you to keep up on current events and legal changes.

Special Topics