An introduction to the legal issues associated with public and private health insurance and benefits plans. Students will learn about federal and state financing programs, including Medicare and Medicaid/SCHIP, employer provided insurance, and federal and state regulations of private health insurance markets and managed care, including population care management, provider payment, quality and accountability, and cost-containment.
This course examines the broad array of legal and policy-related issues arising out of litigation seeking redress for harms in the context of the provision of medical services. The course also covers liability insurance for individuals and healthcare entities.
This course covers transactions between and among health care providers, including hospital-physician relationships and governance issues within healthcare entities.
A study of privacy and cybersecurity issues, including Health Insurance Portability and Accountability Act of 1996 (HIPAA); and security of health care information under state and federal law, including HIPAA, the Health Information Technology for Economic and Clinical Health (HITECH) Act, and breach notification requirements. The course will also introduce issues related to emerging uses of technology, including telemedicine.
This course provides an analysis of major legal issues in the pharmaceutical and medical device industries. The course explores the FDA’s regulation of these industries, including the FDA approval process, advertising and promotional regulations, and enforcement by the FDA and other regulatory entities. Other topics include product liability and FDA preemption, research, patient care, and privacy, pricing and market access.
Laws dealing with the provision, financing and regulation of health care in the U.S. are based largely on a model presuming the involvement of autonomous health care consumers. In reality, however, many health care consumers today have mildly to severely compromised autonomy because of mental, physical, and/or age-related deficits or disabilities. These compromised individuals are often particularly vulnerable in terms of their health care needs and may require special legal attention and protections within the health care system.
An introduction to legal sources relevant to health care regulation. Students will also learn advanced research techniques.
A study of the legal issues related to outsourcing contracts, including liability issues arising from these relationships. Students will also learn about best practices for assessing, monitoring, and managing vendor and outsourcing risks.
A study of the obligations of regulated companies when there has been a compliance failure. Topics covered include: audits and other internal governance approaches for discovering compliance problems in a timely fashion; investigations; reporting; mitigation; regulatory responses; and remediation.
An introduction to the law of business organizations, including agency, partnership, and business corporations. Topics include formation and structure of the corporation, power and fiduciary responsibility of management, rights and liabilities of shareholders, shareholders' derivatives litigation, acquisitions and tender offers and insider trading.
