Administrative Health Law (HLTH7500)
3 credits. Lecture.
This course explores the powers and processes of administrative agencies in our governmental system, paying particular attention to why and how administrative agencies came to secure such a prominent place in our political, legal and constitutional landscape. It further explores the relationship administrative agencies have with the executive, legislative and judicial branches of government, and how these three branches of government, both formally and informally, limit and affect administrative agency policy and activity. In exploring these issues, particular emphasis will be placed on agencies and processes that affect the health care industry.
NOTE: Students cannot apply both Administrative Health Law (HLTH7500) and Administrative Law (PUBG7801) towards degree requirements.
back to topAnatomy of a Medical Malpractice Case (HLTH9521)
2 credits. Lecture.
This seminar provides students with the tools to prepare and try a medical malpractice case. Students are provided with three redacted (but otherwise complete) medical charts to analyze. They then conduct medical research, and learn how to locate expert witnesses. Following this each participant prepares pleadings and serves and responds to discovery requests. Students take simulated depositions of parties and experts. They prepare pretrial motions, and attend portions of an on-going medical malpractice trial, a trial call, and motion days. The grade is based on demonstrated competence in preparation of pleadings, discovery documents, motions, and taking depositions.
back to topAntitrust and The Life Sciences (HLTH8509)
2 credits. Lecture.
The course in health care antitrust law is structured to expose the students to the fundamentals of antitrust law through a review of antitrust policy, the basic antitrust statutes and foundational case law. The concepts of standards of legality, relevant antitrust markets, market power, monopoly power and enforcement/penalties will be explored. The course will apply these legal principles, using health care industry cases when available, to explore Sherman Act §1: horizontal agreements among competitors (i.e. price fixing, market allocation, concerted refusal to deal or boycott); Sherman Act §1 vertical agreements (i.e. tying arrangements, and exclusive dealing agreements); Sherman Act §2: monopolization, attempted monopolization and conspiracy to monopolize; and Clayton Act §7: Horizontal mergers and joint ventures. Finally, the course will review traditional antitrust exemptions and defenses and the regulatory agencies' Statements of Enforcement relating to the health care industry.
back to top3 credits. Seminar
This seminar will introduce students to the principles and methods of bioethics analysis, and the focus on the way that the law deals with human reproduction and birth, human genetics, the definition of death, the process of health care decision-making at the end of life, physician assisted death, the regulation of research involving human subjects, the regulation of public health, and the just distribution of health care resources.
back to topBusiness Law Survey (HLTH7400)
3 credits. Lecture.
This course introduces M.S.J students to principles of contract and corporate law necessary to provide an appropriate background to health law courses. The course includes a writing component that focuses on drafting skills.
NOTE: This course is available only to students in the MSJ program.
back to topComparative Health Law (HLTH7408)
2 credits. Lecture.
The Constitution of the World Health Organization states that “[t]he enjoyment of the highest attainable standard of health is one of the fundamental rights of every human being. . ..” This aspiration must be filtered through the reality of each nation’s legal system. The constitution and laws of each nation must answer questions such as: Who has the obligation to provide necessary care? Who decides what care is “necessary?” Does access to health care depend on ability to pay? When can an individual refuse care, choose to engage in unhealthful activity, or engage in conduct that creates health risks for others? This course will provide an overview of the answers that the law of several nations provides to these and other questions. The goal of the course is not to make students experts in every nation’s health law, but rather to provide them with a context in which to understand health systems in other nations – and thereby perhaps better understand our own.
back to topCompliance Planning: Planning and Implementing an Effective Corporate Compliance Program (HLTH7528)
2 credits. Lecture.
The course will focus on the managerial and legal aspects of corporate compliance programs including the need for, and development of, an effective corporate compliance program. The course will examine government regulations, guidance documents and enforcement initiatives which have created a framework for modern compliance programs in the health care industry. In addition, the course will examine other laws and standards such as Sarbanes-Oxley and NYSE and NASDAQ listing rules which mandate certain elements of a corporate compliance program. The course will provide a practical overview of how to design, implement and manage a corporate compliance program, focusing on the essential "seven elements" of an effective program. Emphasis will also be placed on the incorporation of ethics into a compliance program with the goal of creating a culture of compliance within an organization.
back to topConstitutional Law Survey (HLTH7402)
3 credits. Lecture.
This M.S.J. course provides a general overview of the constitutional law doctrines that are most relevant to health professionals. Particular attention is paid to separation of powers, privacy and reproductive rights, and the First Amendment as they relate to government regulation of health care. The course also considers constitutional and other issues raised by the role of administrative agencies and the implementation of legislation in the health care system.
NOTE: This course is available only to students in the MSJ program.
back to topDrug and Medical Device Liability and Policy (HLTH7513)
2 credits. Lecture.
The course will examine liability within the drug and device industries. It will cover liability based on inadequate warnings, state statutes that provide presumptions about medical product warnings, proximate cause in warning cases and how “over-promotion” permits imposition of liability despite the presence of an adequate warning. It will also examine whether design defect liability is applicable to FDA-approved drugs and discuss application of design and manufacturing defect theories to devices. The course will explore preemption of state law tort claims and provide an overview of FDA regulation of drugs and devices, including issues pertinent to litigation of the preemption issue. It will consider the absence of a private right of action under the Food Drug & Cosmetic Act, the implied preemption doctrine in pharmaceutical cases, and cover the case pending before the Supreme Court (to be argued fall, 2010) in which the Court will rule on preemption of state law design defect claims under National Childhood Vaccine Injury Act of 1986. The course will address the issue of causation and different methods of proving causation, including use of epidemiological evidence and will address damages and remedies in medical products cases including the remedy of “medical monitoring” and the divergent ways in which the courts have analyzed and resolved claims for medical monitoring. The course will analyze mass torts where much of pharmaceutical and medical device litigation takes place including public events like a product recall or publication of a significant clinical study and will examine the difficulty of using the class action vehicle in the drug and device liability area for personal injury claims. The course will evaluate evolving approaches to settling mass-tort cases and their implications, including the settlements in the Dalkon Shield litigation, diet drug litigation and, more recently, Vioxx litigation. The course will look at how to allocate compensation among injured claimants, the question of limiting the size of the ultimate settlement, and ethical issues for defendants’ and plaintiffs’ counsel in devising settlements.
The course will also analyze how well the current system works including whether the traditional litigation process works adequately in compensating injured claimants and deterring industry misconduct and will explore some of the arguments against the current system: that it negatively impacts innovation and investment in medical products and technology, increases the cost and decreases the availability of certain products and that it unequally compensates injured patients.
Finally, the course will consider the alternatives to the current system and opportunities for tort reform in the drug and device arena.
back to topDrug Innovation, Regulation and Costs (HLTH9508)
3 credits. Seminar.
This seminar will examine the process and rationale for the regulation of drugs and medical devices and current issues about the impact of the regulatory scheme. Topics to be covered include whether speeding up drug approval increases safety risks, what lessons are provided by Vioxx, and when comparative efficacy testing of drugs is warranted. Attention will be given to matters that can affect the cost of drugs including the standards for approval of generic drugs, non-patent regulatory protections, and OTC switches. FDA’s role with respect to innovative drugs such as those for human enhancement will be examined.
While there is no prerequisite for the seminar, a course in Food and Drug law is recommended.
back to topDrugs and Devices: Law and Current Issues in the Practice (HLTH7512)
2 credits. Lecture.
This course will cover the basic legal requirements for both prescription drugs and over the counter drugs as well as devices for marketability in US commerce. There will be discussion on the government bodies which have jurisdiction over these products and the enforcement tools they have to assure safe and efficacious drugs and devices in the US. We will cover some of the major current issues and cases which affect constitutional limits on the FDA regulations as it relates to 1st amendment rights and other compliance issues regarding advertising, constraints on distribution of new clinical trial results and methods which allow new data to reach the medical population.
back to top3 credits. Lecture.
This course provides an overview of the laws and regulations of the Food and Drug Administration that restrict the sale of unsafe, deceptive or unproven foods and drugs. The pre-market approval system governing drugs will be examined along with the debate about the length of testing. Other topics include the prescription status of drugs, consumer advertisements, and the impact of commercial speech protections. Major issues concerning food regulation are considered such as the appropriateness of a no-risk policy for carcinogens and the use of biotechnology in foods. The justification for the deregulation of dietary supplements will also be explored. The course aims to provide students with an understanding of the principal regulatory means used by the agency, such as rulemaking, and court enforcement. In addition students will be able to consider the appropriateness of schemes based on disclosure and those that impose additional restrictions.
back to topHealth Care Bankruptcy (HLTH9512)
2 credits. Seminar.
As the health-care industry continues to have financial difficulties, more hospitals, physician practice groups, clinics, nursing homes and home health agencies are filing for bankruptcy or restructuring their debt. This seminar will focus the following topics: how some health-care providers became financially distressed; legal issues surrounding a health-care debtor in bankruptcy under the Bankruptcy Code and the recently enacted Bankruptcy Abuse Prevention and Consumer Act of 2005; and public policy issues that may provide a solution to what some call a "health-care financial crisis". Students will also gain practical experience by working in groups to present what legal advice they would provide to a health-care debtor, physicians, patients, and general creditors in a pre and post bankruptcy scenario.
back to topHealth Care Finance (HLTH8504)
2 credits. Lecture.
The financing of health care is a fundamental aspect of the U.S. health care system. Health care finance has grown and changed over the years and has become an increasingly complex and confusing mix of fragmented private and public mechanisms. The extent and rapidity of the changes that have taken place have created a number of problems which relate to such basic issues as: who provides care, where it is provided, what incentive exists, and who receives services. This course examines and explores the current issues and problems in health care finance policy and offers an in-depth study of the finance dimensions of specific topics (e.g., politics and players in health care financing: government, providers, payers and consumers; reimbursement methodologies; regulating and rate setting; ect.).
back to topHealth Care Fraud and Abuse (HLTH8505)
2 credits. Lecture.
The complex business of health care finance and delivery is increasingly structured by reference to an array of federal regulatory and statutory requirements. Attorneys reviewing relationships among the providers and between providers and payors must be familiar with the anti- kickback laws, the False Claims Act, Stark I & II, and RICO. This course examines the application of those laws in the context of commercial relationships, regulatory reviews, and criminal investigation and prosecutions. It also examines the burgeoning area of corporate compliance programs.
Prerequisite: Health Law I
back to topHealth Information Privacy and Innovation (HLTH9530)
3 credits. Seminar.
This course will focus on the uses (and misuses) of health information compiled about patients, insureds, research subjects, and populations. Medical privacy law has focused on assuring the privacy, security, and accuracy of medical data. The post-ARRA and post-ACA landscape will include more concern about balancing privacy, innovation, access, and cost-control.
The course will also examine the legal aspects of data portability, integrity, and accuracy. When two health records conflict, which takes priority? What is “meaningful use” of an electronic health record under ARRA, and how will regulators and vendors assure interoperability between medical records systems? The course will also cover innovators’ efforts to protect their health data systems using contracts, technology, trade secrecy, patents, and copyright, and "improvers'" efforts to circumvent those legal and technological barriers to openness. We will also examine pharmaceutical companies’ past and present strategies regarding the disclosure of their research, including non-publication of adverse results and ghostwriting of positive outcomes. Will a “reproducible research” movement, popular in the hard sciences, reach pharmaceutical firms? After covering provider data, we will turn to insurer data, including trade-secret protection of prices paid to hospitals, conflicts over the interpretation of disclosure requirements in the ACA, and state regulation of insurer-run doctor-rating sites. Post-HCQIA quality improvement programs will also be examined.
All students will be required to write a comment on a current rulemaking on health records, data, or privacy (at agencies like FDA, HHS, or state health departments). They may incorporate the comment (with proper editing) into an AWR paper at their discretion. The course will emphasize creative, critical thinking about using state and federal law and regulation to advance clients’ interests and the public interest.
4 credits. Lecture.
This survey course introduces students to the major legal and policy issues surrounding the provision of health care. Topics include the organization and governance of nonprofit hospitals and other health care organizations, financing of care through public and private insurance programs, health care fraud and abuse, quality control in health care, confidentiality of medical information, informed consent, reproductive health care, medical decisions at the end of life, and medical research with human subjects.
back to topHealth Law and Governance (HLTH9525)
3 credits. Seminar.
This seminar will explore the rise of new forms of governance and regulation and their implications for legal interventions in health care. Governments and international organizations around the world have begun to use new tools and processes to achieve public policies. These may involve the use of broad standards instead of fixed rules; rely on networks of policy makers, experts, stakeholders, non- government organizations, and patients for decision-making; and employ measurement and monitoring in place of mandates and sanctions. The goal is to consider different types of governance that are problem solving rather than controlling, coordinating rather than mandatory and bottom-up rather than top-down. The seminar provides an opportunity to learn about health law and governance in the context of analyzing case studies in using alternative regulatory approaches to contemporary health issues. The seminar will open with three classes that discuss theoretical and legal perspectives on health law and governance. Each student is expected to submit a two-page response paper to one of the three introductory classes. The remaining classes will use “case problems.” Each student will be expected to choose a case problem and present an analysis of alternative regulatory and governance approaches in class. Each case problem is based on the materials assigned for the course and solutions proposed will vary with the type of issue and the attitudes and interests of the student. All students are expected to actively participate in class discussions.
back to topHealth Law for MSJs I: Health Care Organizations (HLTH7515)
3 credits. Lecture.
This course will examine the means by which patients gain access to health care and through which sponsors of health coverage organize and compensate health care providers. It will include a study of private and public means of health insurance and different types of third party payors, including Medicare, Medicaid, and managed care organizations. The class will also survey the organization of hospitals and other health care entities and introduce students to the issues, laws, regulations and accreditation standards essential to understanding the structure and permitted functions of health care entities. The course will introduce students to the physician-patient relationship, which includes studying the confidentiality of medical information, informed consent, and the standard of care used for malpractice actions.
NOTE: This course is available only to students in the MSJ program.
Health Law for MSJs II: Patient Rights and Public Health (HLTH7517)
2 credits. Lecture.
This course will examine the major legal and ethical issues surrounding patients' rights and varied approaches to medical practice and research. Topics will include medical decisions at the end of life, procreative rights and parenting issues, and the use of human subjects in medical research and drug development. The course will also examine alternative medicine and the means by which medicine is regulated. The class will also introduce students to a variety of public health issues.
NOTE: This course is available only to students in the MSJ program.
back to topHealth Policy and Professional Development (HLTH7525)
2 credits. Lecture.
This seminar focuses on understanding the formation of health policy and how it relates to one's personal development and professional advancement within an organization. Students will explore the dynamics of policy process and formation as they relate to specific health care issues facing our society today, while gaining an understanding of the interplay between those issues and the missions of various health care industries. Emphasis will be placed on ways to become involved in the policy process within various health care industries, the governmental institutions that regulate those industries, and related professional associations. The organizational structures, cultures, behaviors and politics of these entities, and potential opportunities for career advancements within or through them will be considered. The importance of developing one's management and leadership skills to achieve professional goals in an ethical manner will be discussed.
Note: For MSJ students only.
back to topHealthCare Compliance Certification Program (HLTH7405)
1 credit. Lecture.
This innovative Health Care Compliance program is a four day, full-tme program for compliance amd other pharmaceutical professionals, as well as attorneys and provides grounding in health care fraud and abuse and an overview of laws governing the pharmaceutical and medical device industries. Faculty for this program include high-level government and private lawyers who are expert in pharmaceutical and device fraud and abuse issues. A Health Law and Policy Program professor participates in each semi-annual session.
NOTE: Available only to students in the MSJ program.
back to top3 credits, Seminar
This seminar will explore the history, rationale for, and effect of health reform legislation. The class will focus on any legislation that has been adopted by Congress by the beginning of the semester; if none has passed, the class will examine the several proposals that cleared House and Senate Committees at the end of 2009. Students will critically analyze many of the significant legal and regulatory changes wrought by the legislation, including insurance market reforms, the public option, Medicare reform, Medicaid expansion, and delivery system reform. A central theme will be the interplay of the new law with established legal doctine in areas such as fraud and abuse, nonprofit corporate law, exempt organization law, antitrust, and insurance regulation. In addition, the class will evaluate the distributive and fiscal effects of taxes and other methods of paying for expanding coverage.
Prerequisite: Health Law (co-requisite for students with background in health care)
back to topHIPAA and Health Privacy (HLTH7504)
2 credits. Lecture
This seminar provides a comprehensive analysis of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) health privacy provisions, which pose substantial technology and privacy requirements for health plans, health care clearinghouses, and many health care providers. Topics include HIPAA's administrative simplification provisions, the Privacy Rule, the Transaction Rule, and an overview of electronic data interchange concepts as applied to health information. Students will also explore the developing body of case law in this area. Practical experience will be offered in drafting and negotiating HIPAA business associate contracts as well as in developing privacy policies and procedures.
back to topHuman Reproduction and the Law (HLTH7529)
2 credits, Lecture
This course will analyze the way that the law protects, limits and regulates the process of reproduction. It will review the possible definitions of personhood, the legal and ethical issues surrounding the recognition of human life, legal regulation of contraception, sterilization and abortion, "conscience" clauses in law, the law regulating assisted reproduction (including in vitro fertilization and related techniques, gestational surrogacy and cloning), fetal maternal decision-making, legal determination of parenthood and the distribution of the rights of parenthood, legal issues in human genetics, and the legal issues surrounding population control.
back to topLaw of Death and Dying, The (HLTH9509)
3 credits. Seminar.
This seminar engages the student in an extensive study and analysis of empirical data, current statutes and cases as well as proposed changes to the law dealing with issues related to death and dying. Class topics include alternative definitions of death, organ donation, withholding and withdrawal of death-prolonging and life-sustaining treatment, advance directives, patient demands for futile treatment, the cost of end-of-life care, wrongful living, and physician-assisted death.
back to topLegal System, Research and Writing I, The (HLTH7390)
4 credits. Seminar.
This course provides M.S.J. students with an introduction to the legal system as well as basic legal research and writing skills, with a focus on topics relevant to the health and pharmaceutical industries. Students will receive LEXIS, WESTLAW and Internet research training.
back to topLegal System, Research and Writing II, The (HLTH7391)
3 credits. Seminar.
This course continues to hone the skills that students learned in The Legal System, Research & Writing I, with a particular focus on statutory and regulatory analysis.
NOTE: The course is available only to students in the MSJ program.
LLM Thesis I - II (HLTH9500, 9502)
First semester; 2 credits. Second semester; 3 credits
The LLM student shall write his or her thesis independently of any course or seminar, with a full-time faculty member acting as a supervisor. In semester one, the student will select a topic, and a thesis supervisor. Before the conclusion of semester one, the student shall make an oral presentation of his or her work-in-progress to the health law faculty and other LLM students; submit a paper abstract of approximately ten pages; and submit an annotated bibliography. The student shall receive a Pass/D or Fail designation and an award of two credits for the completion of this work. The student shall complete the thesis in semester two, for which the student shall upon completion, be awarded three credits and a letter grade. The final thesis product must be of professional law review publishable quality, at least 50 pages in length unless otherwise waived. LLM students are expected to attend the oral presentations of their colleagues.
back to top2 credits. Lecture.
This course focuses on the use of governmental authority to restrict or deprive individuals with mental disorder of liberty or property in a variety of civil contexts. These interventions are intended to either prevent future harm to self/others or "incompetent" choices. The civil commitment, both inpatient and outpatient, of individuals with major mental illnesses is the main context studied. The commitment of sex offenders, the right to refuse psychiatric medication, the duty to warn and competency determinations will also be examined. To provide a foundation for the legal analysis, the nature and treatment of mental disorders will be summarily explored. A variety of mental health professionals and advocates participate in the seminar to enhance understanding of the issues and provide diverse perspectives.
back to top3 credits.
The MSJ student will write the thesis independently from any seminar or course, with a full time faculty member acting as a supervisor. The student will select a topic, and a supervisor, and will receive three credits upon successful completion. The topic should be health-related and approved by the supervisor.
back to topNon-Profit Organizations (HLTH9519)
2 or 3 credits. Seminar.
This seminar examines state corporate law and the state and federal laws governing the taxation of non-profit health care organizations. It addresses issues of public charity, unrelated business income and private foundation status as they relate to corporate restructuring, financing and joint ventures.
back to topPharmaceutical and Medical Device Marketing and Compliance (HLTH7522)
2 credits. Lecture.
This class will address the regulatory issues that pharmaceutical and medical device companies confront after drugs and devices have been approved by the FDA for market. The class will examine the pricing, marketing, reimbursement, anti-trust, and fraud and abuse issues that pharmaceutical and medical device companies must face. It will also touch on some intellectual property questions and privacy issues.
back to top3 credits. Seminar.
This seminar examines the structure of public health law, with emphasis on government responsibility and power, individual rights, and the relationship between the law concerning population and individual health. Topics will include responses to threats of terrorism, infectious disease, environmental threats such as tobacco and lead, and privacy concerns.
Prerequisite: Constitutional Law, or Constitutional Law I and Constitutional Law II
back to topRegulating Research with Human Subjects (HLTH9517)
3 credits. Seminar.
This seminar examines the legal, ethical and public policy issues surrounding the use of human subjects in biomedical research, focusing on current controversies and efforts to reform the existing regulatory structure. The seminar begins with a historical examination of human subject research, but the bulk of the semester is devoted to critical analysis of the current system for overseeing human subject research. Throughout the seminar we consider how the regulatory system should take into account the changing relationship between academia, industry and government.
back to topTransactional Health Law (HLTH8507)
3 credits. Seminar.
This course provides LL.M. students with practical legal experience relevant to the health care industry. Students participate in various simulations and exercises that integrate theory and practice and provide an opportunity to work with practicing health attorneys. In special circumstances, J.D. students may enroll in this class.
NOTE: This course is available only to students in the LLM program.
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