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Health Law (HLTH)   





Number Name Credit Type Offering


Accountable Care Organizations

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. 





Anatomy of a Medical Malpractice Case

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.





Bioethics and the Law

This course examines legal and ethical issues in medical treatment and research, with an emphasis on the relationship between bioethical analysis and legal decision-making. Topics covered include medical decision-making at the end of life, organ transplantation, the determination of death, research involving human participants, sterilization of mentally incompetent persons, maternal-fetal decision-making, and assisted reproduction. The course will emphasize bioethical issues relevant to all stages of the life cycle, with a particular focus on issues concerning children and adolescents.

*Students may write a seminar paper in this course to fulfill the AWR requirement, or they may elect to complete a take-home exam rather than an AWR paper.





Biotechnology and the Law

This course examines a variety of legal, policy, scientific, social, and ethical issues in the realm of biotechnology. Topics covered include:

  1. Foundational technologies, such as recombinant DNA technology

  2. Current applications, including nanobiotechnology and synthetic biology

  3. Human subjects research and institutional review of clinical trials

  4. Regulatory oversight by federal agencies

  5. Academic-industry relationships

  6. Data privacy and security issues

  7. Protection of intellectual property




Birth, Death and the Law

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.





Children's Health and the Law

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



Clinical Research and the Law: Compliance Issues for Research Sponsors

This course examines the responsibilities of life science companies and other entities responsible for the initiation, management, and/or financing of clinical trials in the United States, the European Union, and elsewhere in the world. Topics covered include good clinical practice (GCP) compliance, clinical trial agreements, clinical trial registration and results reporting, access to clinical trial data, managing conflicts of interest, reimbursement issues, and the implications of anti-bribery laws and U.S. fraud and abuse laws for clinical research.



Compliance Issues for Healthcare Providers

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


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

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



Compliance Issues in the Life Sciences - Fraud and Corruption

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



Compliance Skills

This course is designed to expose students to key legal and operational concepts in the health care corporate compliance field. Students will use knowledge gained in prior mandatory coursework and participate in simulated-based projects that will require them to perform audits, investigations and reporting activities to ensure compliance with applicable federal and state laws. Through reading derived from various sources: industry articles, regulations, specific chapters of text books, government reports and materials created by content experts who will be brought in to guest lecture, students will have the opportunity to explore not only the legal facet of the compliance field but the operational reality of working as a compliance professional in the health care industry.

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

Prerequisite: Health Law





Constitutional Law Survey

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.



Disability Law

This course will examine the laws protecting persons with disabilities, including the Americans with Disabilities Act, Section 504 of the Rehabilitation Act, the Individuals with Disabilities Education Act, the Fair Housing Act, and the Fourteenth Amendment, as well as the cases interpreting these laws. We will explore the definition of “disability,” potential claims, covered entities and their defenses, and the range of remedies. Substantive areas to be covered include education, employment, housing, public accommodations, government services, and the rights of persons in institutions.





FDA Regulation and Liability

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



Food and Drug Law

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.





Fundamentals of Business Law

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

  8. Business torts



Health Law

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 for JD only: Business Associations 





Health Privacy

As our health information is being digitized and stored in electronic records, this transformation poses novel challenges for the laws designed to protect the privacy and security of our personal health information. This class will provide students with a substantive overview and analysis of the laws that directly govern or have an impact on health information privacy and security in the United States. The main focus of this course will be the privacy and security provisions of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), the foundation for federal protections of health information. Additionally, the course will examine the interplay between HIPAA and other federal and state health privacy laws and the application and enforcement of those laws in a variety of health care settings.





Healthcare Access and Payment

This course examines the public and private insurance programs connecting people to needed health care. The basic structures of the relevant law – Medicare, Medicaid, and the regulation of private insurance – are undergoing rapid change. We will examine sometimes-competing economic, political, and policy principles undergirding the structure of the system by which access and payment are governed, as well as less contested innovations in payment, such as social accountable care organizations and performance based reimbursement, that promise to improve care and moderate costs.





HealthCare Compliance Certificate Program

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





HealthCare Fraud and Corruption

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. 





HIPAA Privacy and Security

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



Introduction to Contracts and Torts

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



Introduction to Law and Legal Writing

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



Introduction to Law and Legal Writing

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.




Law of Death and Dying, The

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





Medical Malpractice

This course focuses on traditional principles underlying New Jersey medical malpractice law, using a practical and substantive approach to the subjection, focusing on the standard of care, expert-related issues, causation and damages relating or pertaining to medical malpractice actions. The school attendance will be in effect for this course, and class participation is expected.





Mental Health Law

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.





Neuroscience and the Law

This seminar examines cutting edge and controversial linkages between law and neuroscience. The seminar aims to highlight neuroscientific basis for behavior patterns with legal implications, including how neuroscience intersects with civil law, criminal law, evidentiary rules, memory bias and enhancement, lie and deception detection, adolescent brains and juvenile law. We will look critically at efforts to use neuroimaging in court in connection with predictions of dangerousness and predispositions towards mental illness and substance use and misuse, as well as efforts to identify neurobiological influences on the brain. Does it make sense to speak of the neurobiology of violence or the psychopathology of crime, or future dangerousness? This course will explore the relationship between law and science, more generally, and neuroscience in particular.





Non-Profit Organizations

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.




Public Health Law

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





Regulating Research with Human Subjects

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.





Risk Management Issues in Representing the Pharmaceutical Industry

This seminar introduces students to the various examples of enterprise risk confronting the pharmaceutical manufacturer and the independent and overlapping obligations imposed by government regulations, health care compliance statutes, and tort liability.

The course will include a study of a broad range of laws, regulations and policies that impact these forms of risk, including the Food, Drug and Cosmetic Act, federal and state False Claims Acts, Anti-kickback statutes, and various product liability and Lanham Act cases. Students will learn to identify potential risk areas and consider mitigation strategies in representation of pharmaceutical companies in the evolving environment of regulatory, compliance and liability oversight.





Skills for Health Law Practice

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.





Stark Law and Compliance

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



The Law of Patient Care

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


Torts: Liability for Civil Wrongs

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 negligence principle

  2. Affirmative duties to act

  3. Duties based on statutory violations

  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.