Online Master of Laws in
Health Law and Policy — Curriculum

This course is an overview of the two most important government-funded health care programs. The course begins with a review of the history, purposes, expectations and evolution of Medicare/ Medicaid legislation and then emphasizes recent changes including the new prescription drug benefit under Medicare. The student will become familiar with issues important in the legal representation of patients, hospitals, doctors and other providers under these laws. Special attention is given to the lawyer’s role regarding fraud and abuse statutes. The legal mechanisms of cost containment and utilization control within these programs are examined. The class explores policy issues and compares these programs to other federally funded health care programs. The requirements of the course can be met either by taking the final exam or by writing an erudite paper.

This course explores contemporary problems involving law, medicine and ethics. The rights of patients, the responsibilities of physicians and the interests of society are examined in the contexts of medical treatment, death and dying, abortion, the new reproductive technologies, genetics, research on human subjects and organ transplants.

This course will explore the influence of law and regulation in the United States and other jurisdictions on the pharmaceutical and biotechnology industry. The central focus will be the pathway of the discovery, development and commercialization of new medicines and the effect of various stakeholders, legal disciplines, governmental structures and globalization on that pathway. Students will learn the lawyer’s role in negotiating agreements, resolving disputes, making policy and otherwise building consensus in this complex setting. Topics include the history of food and drug and related law, the evaluation of drug safety and efficacy, market exclusivity and market protection, and the roles of the FDA and other U.S. and non-U.S. government agencies. Students will have the option of taking the final examination or writing a paper.

Passage of the Affordable Care Act has, in many ways, encouraged health care payers and providers to partner, merge or acquire their way to establishing economies of scale. This course will explore several of the most prevalent commercial business transactions in the health care industry today. After studying the structure, purpose and best-practice approaches to identifying the right business transaction for an organization, students will explore the case law, statutes and regulations applicable to health care transactions. With an emphasis on building a sustainable business combination, students will walk through the fundamental elements of a negotiated acquisition process: due diligence; preliminary negotiations and agreements; transaction structure; final negotiations; definitive agreements; and post-closing relationships. By the end of the course, students will be familiar with all phases of the health care partnership/merger/acquisition process and be able to apply core partnership principles to every transaction

Public Health Law, Policy, and Ethics will focus on the application of law to public health and on the ethical and policy parameters of that application. During most of its history, the United States has struggled to improve population health without compromising the health of individuals. This course addresses legal and policy responses to issues such as mandatory vaccination, addiction, obesity, hunger, genetic testing, environmental pollution, epidemics, bioterrorism, natural disasters and limitations on access to health care, among other issues. Students will consider how best to shape public health policy, the role of law in implementing policy and the ethical implications of efforts by lawmakers to improve population health.

This course covers the fundamentals of statutory interpretation through the lens of a particular statute, the Americans with Disabilities Act of 1990, as amended. The course introduces students to the basics of statutory interpretation, then asks students to apply what they have learned in doctrinal context. Students will be exposed to the various mechanisms by and forums in which statutes are analyzed and interpreted, and the evidence used in the process, including but not limited to legislative history, agency interpretation, judicial decisions, and administrative regulations. Although the course is not designed as a doctrinal course in disability law, students should come away from the offering with a solid grasp of its fundamentals, as well as an understanding of the subject matter at hand.

Lawyers representing health care providers, whether the provider is an individual health care practitioner, a group, a single institution or a large health care system, must deal with different areas of law to address the diverse issues that apply. This course is intended to acquaint students with the wide variety of federal and state legal and regulatory issues which health care attorneys encounter in their day-to-day practice. Specific examples of federal and state laws and regulations will serve as a framework to demonstrate the impact on health care providers. A paper is required.

Health care compliance covers a vast legal landscape, and this course is intended as a general exploration of the major sources of law applicable to health lawyers, government agencies, health care providers, research institutions, researchers, inventors and developers. This course is a practical application of the intersection of the areas students have already studied at this point in the program, from administrative agency law to ethics and policy, and the business of health care; it is not intended to focus on any one topic, such as Medicare and Medicaid. However, since health data privacy and security issues are pervasive across all areas of health law, particular attention will be paid to HIPAA and HITECH, and how they intersect with: human subjects research regulations under the Common Rule; electronic medical records and personal health records; and regulation of mobile medical devices, mobile medical apps and mobile health apps. Other areas that will briefly be explored include the European Data Privacy Directive and its various amendments; the death of Safe Harbor; PIPEDA and PHIPA; and certain state regulations, using New York State and California as models. We will also explore how to create and foster a culture of compliance within any health-related organization. Statutes, rules and regulations will be analyzed through lecture and practical exercises, which will include drafting sample internal policies, memos and proposing gap-filling legislation or regulations.