Current Students

Health Law   

Accountable Care Organizations (HLTH7509)

2 credits

The course uses an emerging health delivery and finance model to connect basic health law principles to a very practical setting.  Through health courses and otherwise, health students are exposed to the doctrine that many practicing lawyers have to apply on an everyday basis as they set up, contract with, and regulate ACOs.  These areas include antitrust, fraud and abuse regulation (civil and criminal), corporate, nonprofit tax, privacy, and malpractice/tort. Students will also work with health finance and insurance principles, and public policy principles driving the redirection of health delivery and finance.  The course will address several models of ACO, including Medicare ACOs, Medicaid ACOs, and private market ACOs. 

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Advanced Topics in Risk Management (CORP8190)

3 credits

This course explores the theory of risk management and federal and state regulatory efforts to impose risk management obligations on corporations through corporate governance. Topics covered include:

  1. Corporate governance

  2. Relationships and conflicts of interest among the board of directors, senior management, rank-in-file employees and regulators

  3. Effectiveness and execution of risk management roles and responsibilities

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Anatomy of a Medical Malpractice Case (HLTH9521)

2 credits

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.

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Antitrust 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.

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Bioethics (HLTH9526)

3 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.

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Birth, Death and the Law (HLTH9513)

3 credits

New technologies expand our options surrounding both the beginning and end of life.  New reproductive technologies give those who want to procreate more options than ever before, while advances in medical technologies can sustain and prolong life for the sick and dying. This seminar will examine the law and ethical problems that involve use of these technologies. Topics covered will include: egg and sperm donation, trait selection through use of reproductive technology, postmortem reproduction, patient demands for futile treatment, physician assisted suicide and organ transplants.

Note: Students cannot apply both Birth, Death and the Law (HLTH9513) and The Law of Death and Dying (HLTH9509) towards degree requirements.

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Children's Health and the Law (HLTH7524)

3 credits

This course examines the law governing medical treatment of minors, with an emphasis on the tension between parental authority, the child’s needs and wishes, the duty of medical professionals to provide adequate care, and the state’s interest in protecting the child from harm. Topics covered include:

  1. Religious objections to treatment

  2. Mental health and substance abuse treatment

  3. Reproductive healthcare

  4. The withholding or withdrawal of life-sustaining treatment

  5. Medical neglect and medical child abuse

  6. Public health and bioethical issues affecting children

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Clinical Research and the Law (HLTH7680)

3 credits

This course examines the legal, regulatory, ethical, and compliance issues that arise for individuals and entities involved in all aspects of clinical trials, including sponsors, researchers, research institutions, contract research organizations, and institutional review boards. Topics covered include:

  1. IRB review

  2. Risk-benefit assessment

  3. Informed consent

  4. Confidentiality and HIPAA compliance

  5. Conflicts of interest

  6. Inclusion of women and minorities in clinical research

  7. Pediatric research

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Comparative 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.

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Compliance Issues for Healthcare Providers (HLTH7670)

3 credits

This course introduces students to the primary areas of law that impose compliance obligations on healthcare providers. Topics covered include:

  1. Nonprofit corporation law

  2. Laws governing state and federal tax exemptions

  3. Federal fraud and abuse laws (including the Anti-Kickback Statute, the False Claims Act and the Stark Laws)

  4. Patient safety and quality

  5. Peer review and credentialing processes

  6. Medical error and safety programs

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Compliance Issues in the Life Sciences - Advertising, Promotion and Transparency (HLTH7590)

3 credits

This course provides an overview of the laws, regulations, guidances and enforcement actions related to the advertising and promotion of prescription drugs and medical devices. Topics covered include:

  1. Direct-to-consumer advertising

  2. Off-label promotion

  3. Scientific and educational exchange

  4. Social Media

  5. Constitutional limitations on government regulation of commercial speech

  6. Transparency and disclosure requirements

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Compliance Issues in the Life Sciences - Fraud and Corruption (HLTH7580)

3 credits

This course examines life science companies’ obligations under laws designed to detect and respond to bribery, fraud, waste, and abuse. Topics covered include:

  1. The Anti-Kickback Statute

  2. The False Claims Act

  3. The Foreign Corrupt Practices Act and other international anti-bribery legislation

  4. The Racketeer Influenced and Corrupt Organizations Act (RICO)

  5. Enforcement mechanisms

  6. Corporate compliance programs

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Compliance Skills (HLTH9655)

2 credits. Skills.

Course is graded High Pass, Pass, Low Pass or Fail.

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Conducting Internal Investigations (LABR7030)

3 credits

This course gives you the tools you need to participate in all aspects of internal workplace investigations. Topics covered include:

  1. When companies should (or must) conduct internal investigations

  2. Who should conduct investigations

  3. The role of the investigator

  4. Obtaining cooperation from witnesses

  5. "Adnarim" warnings when attorneys are involved

  6. HR training and development

  7. Privilege and work product issues and their waiver

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Constitutional Law for MSJs (HLTH7402)

3 credits

This course provides an overview of the key concepts and legal doctrines underlying the American constitutional structure. Topics covered include:

  1. The Supreme Court’s authority and role

  2. Justiciability and standing

  3. The commerce clause

  4. Separation of powers

  5. Due process and fundamental rights

  6. Equal protection

NOTE: This course is available only to students in the MSJ program.

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Cybersecurity & Privacy: Law, Policy, Compliance (INDL7550)

3 credits

This course examines the legal, policy, and compliance challenges raised by efforts to protect the Internet and other forms of networked computer systems from attack by hackers, organized criminal groups, terrorists, and others. Topics include:

  1. Threats to cybersecurity

  2. Domestic and international Internet governance

  3. The Computer Fraud and Abuse Act

  4. U.S. and European Union privacy law and personal data protection

  5. War, international terrorism, and U.S. surveillance law

  6. Private information infrastructure and the law of emergencies

  7. Emerging compliance frameworks for cybersecurity

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Drug 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.

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FDA Regulation & Liability (HLTH7560)

3 credits

This course explores the FDA's extensive regulation of the pharmaceutical and medical device industries, as well the relationship between FDA regulation and state-law tort liability. Topics covered include:

  1. The drug and biologic approval processes

  2. The medical device approval and clearance process

  3. Postmarket obligations and pharmacovigilance

  4. Products liability and federal preemption

  5. FDA enforcement

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Financial Crimes Compliance (CORP8160)

3 credits

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Food and Drug Law (HLTH8500)

3 credits

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.

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Fundamentals of Business Law (HLTH7400)

3 credits

This course introduces students to the law of contracts and to basic principles governing different forms of business associations. Topics include:

  1. The nature and limits of contractual agreements

  2. Contract formation

  3. Defenses to contact enforcement

  4. Remedies for breach of contract

  5. Agency and sole proprietorships

  6. Partnerships

  7. Corporations

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Governance, Compliance, Enforcement and Risk Management (CORP7160)

3 credits

This course explores corporate governance metrics for complying with federal and state regulatory frameworks, including internal corporate compliance protocols used to fulfill the company’s mission and to minimize risk in the management of the corporation. Topics covered include:

  1. Corporate governance internal protocols

  2. Relationship dynamics between corporate fiduciaries and stakeholders

  3. Development of compliance and risk management policies and procedures

  4. Governmental regulatory compliance frameworks

  5. Attorney’s role in compliance programs

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Health 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.).

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Health Data Analysis & Advocacy (HLTH9511)

3 credits. Seminar

This seminar will train law students in quantitative and analytic skills related to law enforcement and advocacy. Though many of our examples will relate to cutting edge health law enforcement and compliance, we expect that students in nearly any regulatory or litigation context will find the skills taught both transferable and useful. Substantively, the seminar will focus on fraud and abuse detection tools and methods used by public and private health insurers. Procedurally, the seminar will train students in skills of data analysis, basic statistical and quantitative methods, and data visualization. Skills such as text summarization, chart drafting, and spreadsheet management will be explained and practiced. The course will feature examinations of the intersection of health care law with e-discovery and computational legal analysis. The seminar will aim to enable students to: (1) excel as uniquely technically qualified attorneys at traditional firms; (2) leverage unique skill sets to compete for positions in compliance departments, revenue cycle management departments, and quality control divisions; and (3) understand cutting edge law enforcement tactics that will prove increasingly important in a world of predictive policing and algorithmic assessments of threats.

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Health Law (HLTH7503)

4 credits

This survey course introduces students to the major legal and policy issues surrounding the provision of health care. Topics include healthcare access and payment, the organization and governance of nonprofit hospitals and other health care organizations, health care fraud and abuse, antitrust issues for healthcare providers, hospital and managed care liability, confidentiality of medical information, informed consent, and medical decisions at the end of life.

Pre/co-requisite: Business Associations 

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Health 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.

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Health 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. 

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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.

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Health 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.

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HealthCare Compliance Certification Program (HLTH7405)

2 credits

This live course, offered over the course of four days, immerses students in the statutes, regulations and other guidance that comprise the body of law known as “fraud and abuse law.” Topics covered include:

  1. Data Privacy - HIPAA, HITECH, and others

  2. FDA approval and regulation of new drugs and devices

  3. Federal Anti-Kickback Statute

  4. Federal and State False Claims Acts

  5. Federal and State Sunshine Laws

  6. Foreign Corrupt Practices Act (FCPA) - including worldwide anti-corruption and enforcement

  7. Government Investigations

  8. Healthcare fraud sentencing, penalties, damages, and other considerations

  9. OIG Compliance

  10. Prescription drug and device marketing and advertising

Prerequisite/Co-requisite: Health Law Recommended: Health Care Fraud and Abuse

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HealthCare Fraud and Corruption (HLTH9524)

3 credits. Seminar. (2 credit exam option)

This seminar introduces students first to the market triggers that cause corruption in its various forms, the harms to various economies cause by corruption, and mechanisms that address corrupt behavior.  The remainder of the course comprises a study of the health and non-health related laws that address corruption, both domestically and abroad, including the Foreign Corrupt Practices Act and UK Bribery Act 2010; Stark, Anti-kickback and the False Claims Act; Sarbanes Oxley, Dodd-Frank and other relevant non-health laws.  Students may receive 3 credits for writing an AWR paper in the course, or 2 credits if they take an exam. 

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HealthCare Reform (HLTH9523)

3 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)

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HIPAA Privacy & Security (HLTH7504)

3 credits

This course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:

  1. Entities and information to which HIPAA applies

  2. When consent is required for the use and disclosure of health information

  3. Types of health information requiring heightened protection

  4. Use of health information for research and marketing

  5. Security measures required to protect digitized health information

  6. Individuals’ right to access their health information

  7. Business associate agreements

  8. HIPAA compliance and enforcement

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Human 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.

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Introduction to Contracts and Torts (HLTH7404)

3 credits

This course introduces students to fundamental common-law concepts and doctrines applicable to a broad range of professional and business relationship transactions. Topics include:

  1. The nature and limits of contractual agreements

  2. Contract formation

  3. Defenses to contact enforcement

  4. Remedies for breach of contract

  5. The concept of reasonable care

  6. Causation

  7. Defenses to tort liability

  8. Business torts

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Introduction to Corporate Finance (CORP8165)

3 credits

This corporate finance course explores the key financial instruments used by corporations, and the legal rules that govern those instruments. Topics covered include:

  1. Capital structure

  2. Financial instruments

  3. Mergers & Acquisitions

  4. Financial Distress

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Introduction to Corporate Law (CORP7150)

3 credits

This corporate law course examines the organization and operation of business enterprises, with particular emphasis on the corporate form. Topics covered include:

  1. Sole proprietorships

  2. The law of agency

  3. Partnerships

  4. Limited liability companies

  5. The nature of the corporation

  6. Corporate privileges and powers

  7. Rights of shareholders

  8. Powers and fiduciary duties of directors, officers, and controlling shareholders

  9. Derivative lawsuits

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Introduction to Law and Legal Writing (HLTH7390)

4 credits

This course introduces students to the American legal system and the basic components of legal analysis. Topics covered include:

  1. The structure of the American legal system

  2. The role of statutes, regulations, and judicial decisions

  3. Spotting legal issues, identifying governing rules and principles, and applying the law to different factual situations

  4. Using free Internet resources to locate legal documents and research legal issues

  5. Writing clear and accurate legal summaries and analyses

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Introduction to Law and Legal Writing (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.

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Law of End-of-Life Decision-Making, The (HLTH9509)

3 credits

This course explores legal, ethical and public policy issues related to end-of-life medical care. Topics covered include:

  1. Cost of end-of-life care
  2. Supreme Court end-of-life jurisprudence
  3. Advance directives and POLST
  4. Minimally conscious state
  5. Challenges at the beginning of life
  6. Physician-assisted suicide

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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.

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Managing Legal Issues in the Workplace (LABR7000)

3 credits

This course explores the core doctrines that govern the employment relationship. Topics covered include:

  1. Definitions of “employee” and “employer”

  2. The employment-at-will doctrine and its principal exceptions

  3. Employee harassment

  4. Antidiscrimination protections

  5. Health and familial leave protections

  6. Diversity in the workplace

  7. Wage and hour laws

  8. Employee privacy

  9. Liability and litigation risk management

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Managing Whistleblower Risks (LABR7570)

3 credits

This course explores the vast array of federal and state laws that protect employees who report misconduct by their employers.  Topics covered include:

  1. Common-law whistleblower protections

  2. State and federal whistleblower statutes

  3. Strategies for managing whistleblowers and whistleblowing

  4. The role of human resources and compliance professionals in the whistleblower management process

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Mental Health Law (HLTH7511)

2 credits

Most basically, this course focuses on the way law treats those who are deemed mentally disordered. This "special treatment" will be explored in both the criminal and civil contexts. In the criminal context, core topics such as the insanity defense, mens rea, and criminal sentencing will be deeply explored. In the civil context, the course focuses on the use of governmental authority to restrict or deprive individuals with a mental disorder of liberty or property by seeking to prevent future harm to self or others. The rules governing expert testimony, the right to refuse psychiatric medication, 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.

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MSJ Thesis (HLTH9600)

3 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.

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Non-Profit Organizations (HLTH9519)

2 credits. Lecture.

This course 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.

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Patent & Trade Secret Law (INDL7500)

3 credits

This course provides an overview of the basic doctrines of patent law, as well as related rights such as trade secret law and drug law exclusivity under the Hatch-Waxman Act. Topics covered include:

  1. Standards and procedures for obtaining patent protection

  2. Patent infringement litigation

  3. The relationship between patent protection and trade secret law

  4. The role of patent law and litigation in the pharmaceutical industry

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Pharmaceutical and Medical Device Marketing and Compliance (HLTH7522)

3 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.

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Public Health Law (HLTH9515)

3 credits

This seminar examines the use of governmental authority to identify, prevent, and respond to health risks at the population level. Topics include policies related to vaccines and antibiotics, legal responses to infectious disease outbreaks, public health surveillance and screening, and the role of law in controlling unhealthy behaviors such as smoking or eating unhealthy food.

Prerequisite: Constitutional Law, or Constitutional Law I and Constitutional Law II

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Regulating Broker-Dealers (CORP8170)

3 credits

This course examines government regulation of broker-dealer operations at all levels, but especially under the Securities Exchange Act of 1934. Topics covered include:

  1. Capital requirements

  2. Treatment of customer property

  3. Broker-customer relationship

  4. Securities Investor Protection Act

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Regulating Depository Banks (CORP8175)

3 credits

This course examines the regulation of depository banks and their holding companies. Topics covered include:

  1. State and federal charting and regulation of banks

  2. International efforts at regulatory coordination

  3. Laws related to depository insurance

  4. Permitted activities of banks

  5. General issues of supervision and enforcement

  6. Gramm-Leach-Bliley Act (GLBA) and its role after the enactment of Dodd-Frank

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Regulating Funds and Investment Advisors (CORP8180)

3 credits

This course examines mutual funds (investment companies) and other related entities like hedge funds and private equity funds. Topics covered include:

  1. Investment Company Act of 1940

  2. Investment Advisers Act Of 1940

  3. Regulation of swaps and other derivatives under Dodd-Frank

  4. Role of the CFTC in regulating this market

  5. Relationship between funds and their broker-dealers

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Regulating Insurance Companies (CORP8185)

3 credits

This course examines federal and state regulation of insurance companies. Topics covered include:

  1. Federal and State Relationship

  2. State Insurance Boards, Commissioners, and Similar Authorities

  3. Regulation of form and content of policies; kinds of insurance

  4. Intermediaries-brokers, broker dealers, producers, compensation, licensing

  5. Rate regulation

  6. Solvency regulation

  7. ERISA and group insurance regulation

  8. Regulation of reinsurance

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Regulating Research with Human Subjects (HLTH7520)

3 credits. Seminar.

This seminar explores regulatory, ethical, and compliance issues that arise for individuals and entities involved in all aspects of research involving human participants, including sponsors, researchers, research institutions, contract research organizations and institutional review boards (IRBs). Topics covered include risk-benefit assessment, informed consent, confidentiality, conflicts of interest, research with vulnerable populations, and international research.

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Securities Regulation and Compliance (CORP7170)

3 credits

This course focuses on mandatory affirmative disclosure requirements under the Securities Act of 1933 and the Securities Exchange Act of 1934, triggered by the public offering of securities and by their trading in public markets. Topics covered include:

  1. Federal regulation of the offer and sale of securities under the Securities Act of 1933

  2. Exemptions from federal registration

  3. Reporting obligations of public companies under the Securities Exchange Act of 1934

  4. Sanctions and civil damage liability for violating these requirements

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Skills for Health Law Practice (HLTH9650)

2 credits. Skills.

This Legal Practice course connects the substantive health law that students are learning in their health law classes with the legal skills and problems that commonly arise in the practice of health law. The course uses a mixture of lecture, guest speakers, class discussion, group work, simulations, and writing exercises to explore substantive law and skills specific to three common health law practice settings: government (enforcement, legislative, or regulatory); in-house counsel at a non-profit hospital or health insurer; and patient representation (policy, advocacy, or direct services). For example, students may negotiate and draft agreements between providers and hospitals, conduct investigative inquiries using redacted medical records and other investigative materials in a professional licensing investigation, and research, draft, and promote model health legislation from an advocate's perspective.

The course is graded High Pass, Pass, D, or Fail based on attendance, class participation, preparation for simulations, and writing assignments; there will not be a final examination. To maximize synergy between classroom and real world practice experiences, students are required to secure (or to have completed) a health law externship or other similar health law placement approved by the Health Law Program by the first week of classes. Pre- or Co-requisite: Health Law.

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Stark Law and Compliance (HLTH7690)

3 credits

This course provides an opportunity to explore, in-depth, the federal physician self-referral prohibition, known as the Stark Law. Topics covered include:

  1. Key elements of the Stark Law
  2. Regulatory exceptions to the Stark Law
  3. Identification of non-compliance
  4. Implications of Stark Law violations
  5. Mitigating risk of legal exposure under Stark
  6. Structuring compliant physician relationships

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The Law of Patient Care (HLTH7660)

3 credits

This course provides an overview of key legal, ethical, and regulatory issues related to the provision of medical care. Topics covered include:

  1. The formation and termination of the provider-patient relationship

  2. The Emergency Medical Treatment and Active Labor Act (EMTALA)

  3. Medical malpractice

  4. Informed consent

  5. Medical confidentiality (including HIPAA compliance)

  6. Treatment decisions for patients who lack decision-making capacity

  7. Treatment decisions for children and adolescents

  8. Mental health treatment

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Torts: Liability for Civil Wrongs (HLTH7409)

3 credits

This course examines the law governing private recovery for injuries to person or property, with a particular focus on the law of negligence. Topics include:

  1. The concept of reasonable care

  2. The roles of judge, jury, custom, and statute

  3. Exception to the duty to exercise reasonable care

  4. Causation

  5. Defenses to tort liability

  6. Damages

  7. Defamation

This online course examines the law governing private recovery for injuries covered by "civil wrongs."  Focusing on the law of negligence, topics will include determining the standard of care; the roles of judge, jury, custom, and statute; exceptions to the duty to exercise reasonable care; actual and proximate causation; defenses to negligence liability; and damages.  The course will include regular writing assignments designed to strengthen students' analytical and writing skills.  The course is required for students in the MSJ program and is not available to students in other degree programs.

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Transactional 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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