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. 

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.

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.

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

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.

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

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With 19 million regular users in the United States, cannabis is one of the most popular drugs in the country. It is also one of the most highly regulated. Until recently, such regulation was virtually synonymous with prohibition. But over the past two decades, a growing number of states have experimented with new approaches to regulating the drug, treating it more like other legal medicines or alcohol than heroin or methamphetamines. These experiments have created a new body of law governing a host of cannabis-related behaviors, from simple possessing the drug to employing those who use it, along with a host of intriguing questions regarding who has authority to regulate the drug. This course takes an in-depth look at the competing approaches to regulating cannabis, the rationales behind these approaches, and where legal authority resides for choosing among them. What are the elements of a cannabis trafficking offense? May a state legalize a drug the federal government forbids? Who is allowed to use and traffic cannabis under state law? How do states prevent diversion of cannabis into forbidden markets? Are contracts with cannabis dealers enforceable? May employers fire employees who use cannabis for medicinal or recreational purposes? This course will examine these and other questions as well as examine New Jersey’s recently-enacted cannabis legalization statute and its implementing regulations.

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

This course will examine how national governments in different countries approach key health law issues (“comparative health law”), as well as how the international community works together to manage health-related issues of global concern (“international health law”). It will begin by exploring the concept of a “right to health” in international law, as well as different approaches countries have taken to structuring their national health care systems. It will then examine how different countries regulate core aspects of the provider-patient relationship, including the right to be free from medical negligence, the right to informed consent, and the right of control over patient information. Next, the course will consider diverse national approaches to a range of bioethical issues, including abortion, assisted reproduction, the termination of life-sustaining treatment, and physician aid in dying. Finally, the course will conclude with international issues in public health, with a focus on infectious diseases, tobacco regulation, and research with human subjects.

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

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

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

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: HealthCare Fraud & Corruption

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 MLS program.

This course will examine the legal and ethical foundations of pandemic and emergency preparedness, intervention, and evaluation in the context of the novel coronavirus (SARS-CoV-2), which causes the illness COVID-19. The spread of SARS-CoV-2 and resulting illness has created legal, ethical, and social challenges that are largely unprecedented in the United States—many of which are likely play out in the American courts for years to come. This course will examine the biomedical and epidemiological evidence regarding SARS-CoV-2 spread, clinical manifestations, disease progression, and outcomes and survey the myriad law and policy implicated by the pandemic. As such, the course will require students to evaluate the SARS-CoV-2 public health emergency from a multi-doctrinal (e.g., constitutional, criminal, administrative, health, employment, privacy, and civil rights) law and policy perspective. While the course will be designed to ensure topical flexibility in light of the evolving dynamics attendant to the pandemic, proposed SARS-Cov-2-related topics include:

1. Legality of quarantine and stay-at-home orders;
2. Legal viability of compulsory testing and/or vaccination;
3. Scope and limits of federal/state/local authority to mitigate potential pandemic harms (e.g., issuance of emergency declarations and orders, et.);
4. Function and scope of policing during a pandemic and the role of the Fourth Amendment;
5. Right to access affordable health care treatment and services;
6. Law and ethics of health care resource rationing;
7. Role and responsibility of the federal Food and Drug Administration under its national emergency authority;
8. Scope and application of employment and disability anti-discrimination laws;
9. Law and policy issues implicated by potential impacts on special populations (health care providers, individuals with underlying health conditions, essential employees, and socioeconomically disadvantaged groups); and
10. Privacy and civil liberties challenges that attend to the use of technology to track, trace, and otherwise surveil individuals.

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.

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

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.

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

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.

<p>Pre/co-requisite for JD only: Business Associations </p>

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.

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.

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

<p>Prerequisite/Co-requisite: Health Law

Recommended: Health Care Fraud and Abuse</p>

This course introduces students to the various statutes and regulations used to address corrupt behavior in the health care system and the various government actors who enforce them. The course comprises a study of the health and non-health related laws that address corruption, both domestically and abroad, including the Anti-Kickback Statute, Stark Law, False Claims Act, and the Foreign Corrupt Practices Act. Students will also learn about various Department of Justice and HHS-OIG policies (and those of other enforcers) which drive government efforts to prevent fraud and abuse and as a result impact the provision of care throughout the health care system.

Note: Course offered as a seminar up until the end of Spring 2020 and will transition to a lecture format after Spring 2020 semester has concluded.

This course examines legal issues in the hospitality industry, such a licensing, torts, corporate law, and property law. It will also develop skills to facilitate the transactional dimensions of hospitality, including agreements regarding franchising, the creation of hotel chains, and real estate development.

Introduction to bioethical analysis and application of different bioethical theories to current issues in health care. This course is not focused on legal doctrine per se - it is designed to provide analytical tools to aid in thinking through the ethical dimensions of current legal debates.

*available late 2023

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

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.

<p>NOTE: The course is available only to students in the MSJ program.

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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

This course will introduce you to the issue of lawyer and law student wellness.  Students will regularly participate in exercises and discussions to develop skills to reduce everyday stress. The class will also include lectures on the scientific research backing up these methods, as well as their philosophical and psychological underpinnings.  The class material is based on the Mindfulness Based Stress Reduction (MBSR) curriculum developed at the Univ. of Massachusetts by Dr. Jon Kabat-Zinn.  This curriculum is widely followed by professional programs in the

U.S. and around the world.

Every class will begin with a short centering practice, after which there will be a lecture/discussion period, followed by wellness practices, including guided and silent meditations, simple yoga (which can be done in a chair), breathing exercises, and the like.

 

This course examines legal and ethical issues in medical treatment and research. Topics covered include the formation and termination of the physician-patient relationship, medical malpractice, informed consent, health care confidentiality, medical decision-making at the end of life, organ transplantation, the determination of death, health care decisions for minors, and research involving human participants.

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.

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.

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.

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.

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

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.

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.

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.

<p>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.</p>

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

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 MLS program and is not available to students in other degree programs.