Seton Hall Law School offers an in-person or online Masters of Laws (LLM) degree in Health Law. The LLM degree provides attorneys with the opportunity to explore health law and policy or to focus more narrowly on courses designed for the lawyer planning to represent the health provider, payor, regulator, patient, and pharmaceutical companies. The LLM degree program, whether taken in-person, online or a combination of both, enhances the knowledge and skills possessed by practicing health care attorneys, as well as those seeking to expand their practice to health care clients.
ADMISSION
A candidate seeking admission to the LLM program must have a J.D. degree from a law school that is approved by the Section of Legal Education of the American Bar Association or the foreign equivalent from a school of law. As Seton Hall Law School admits highly qualified candidates, the program is very competitive. The Admissions Committee considers practice experience, graduate degrees in the health field, quality of law school academic record, demonstrated interest in health, drug or biotechnology law, and evidenced ability to excel in academic pursuits. The application process is a rolling application process and applications for admission are accepted at any time.
APPLICATION REQUIREMENTS
COURSE OF STUDY
LLM candidates must complete 24 credit hours of course work at the Law School or in eligible online courses. LLM students are expected to complete all course work within six years. The Health Law LLM candidate will pursue courses in two sub-specialties, traditional health law and drug law. Some students also integrate intellectual property courses as part of their health law studies. The health faculty and administration work closely with each student in selecting electives appropriate to the student’s sub-specialty.
Required Courses | 4 credits
In-Person Option
Number | Name | Credit | Offering |
---|---|---|---|
HLTH7503 |
Health LawThis 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. |
3 |
in-class |
or Online Option (both courses required)
Number | Name | Credit | Offering |
---|---|---|---|
HLTH7670 |
Compliance Issues for Healthcare ProvidersThis course introduces students to the primary areas of law that impose compliance obligations on healthcare providers. Topics covered include:
|
2 |
online |
HLTH7660 |
The Law of Patient CareThis course provides an overview of key legal, ethical, and regulatory issues related to the provision of medical care. Topics covered include:
|
2 |
online |
Core | 4-6 Credits
- Must choose two (2)
In-Person Option
Number | Name | Credit | Offering |
---|---|---|---|
HLTH8500 |
Food and Drug LawThis 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. |
3 |
in-class |
HLTH8504 |
Healthcare Access and PaymentThis 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. |
2 |
in-class |
HLTH9524 |
HealthCare Fraud and CorruptionThis 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. |
3 |
in-class |
or Online Option
Number | Name | Credit | Offering |
---|---|---|---|
HLTH7590 |
Compliance Issues in the Life Sciences - Advertising, Promotion and TransparencyThis 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:
|
2 |
online |
HLTH7580 |
Compliance Issues in the Life Sciences - Fraud and CorruptionThis course examines life science companies’ obligations under laws designed to detect and respond to bribery, fraud, waste, and abuse. Topics covered include:
|
2 |
online |
HLTH7560 |
FDA Regulation and LiabilityThis 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:
|
2 |
online |
Advanced Writing Requirement | 2 or 3 Credits
The in-person LLM student shall write his or her advanced writing requirement in an 3-credit AWR seminar taught by a full-time faculty member. The full-time faculty member teaching the AWR seminar shall serve as the LLM student's supervisor. The final paper should be of Law Review publishable quality, and at least 25 pages in length.
The online LLM student shall write his or her advanced writing requirement in a 2-credit graded writing mentorship, under the supervision of one or more faculty members. During the mentorship, students will conduct advanced research on one or two topics relevant to the student's degree program and produce one or two written papers of Law Review publishable quality, totaling 25 pages in length.
Electives | 11-14 Credits
* Students may take up to 2 elective courses from another concentration area.
Number | Name | Credit | Offering |
---|---|---|---|
HLTH7509 |
Accountable Care OrganizationsThe 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. |
2 |
in-class |
PUBG7801 |
Administrative LawThis course studies the theory of administrative actions; administrative process; agency organization; determination and promulgation of the administrative regulations; right to notice and hearing; enforcement; judicial review; standing; and the Administrative Procedure Act. |
3 |
in-class |
HLTH9529 |
Biotechnology and the LawThis course examines a variety of legal, policy, scientific, social, and ethical issues in the realm of biotechnology. Topics covered include:
|
2 |
online |
HLTH9513 |
Birth, Death and the LawNew 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. |
3 |
in-class |
HLTH7524 |
Children's Health and the LawThis 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:
|
2 |
online |
HLTH7685 |
Clinical Research and the Law: Compliance Issues for Research SponsorsThis 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. |
2 |
online |
HLTH7680 |
Clinical Research and the Law: Ethical and Regulatory Issues in Designing Clinical TrialsThis course immerses students in the laws, regulations, and ethical guidelines applicable to designing clinical research in the United States, the European Union, and elsewhere in the world. Topics covered include an overview of the regulatory framework in the US, the EU, and other regions; the role of international ethical guidelines; ethical and regulatory considerations in choosing a study methodology; informed consent; confidentiality and data protection; the inclusion of women and minorities in clinical research; pediatric research; and post-trial obligations. |
2 |
online |
HLTH9655 |
Compliance SkillsThis 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. |
2 |
in-class |
INDL7550 |
Cybersecurity and Privacy I: Law & PolicyThis course provides a broad overview of key issues at the intersection of cybersecurity and privacy. Topics covered include:
|
2 |
online |
HLTH7514 |
Disability LawThis 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. |
3 |
in-class |
PROP7710 |
Elder LawRepresenting clients as they age with a focus on: health care and long term care needs, Medicare and Medicaid eligibility and services; representing clients with diminished capacity and surrogate decision-making options including guardianship; end-of-life, hospice and palliative care planning; estate planning, including financial needs, long term care insurance, strategies to protect assets, protection against spouse impoverishment and support rights, and use of Medicaid qualifying trusts, family law issue in the context of elder law representation, and consumer protection law for older clients. |
3 |
in-class |
CORP7180 |
EU Data Protection and Privacy Law: The GDPRThis course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include data protection and privacy in the European Court of Human Rights, the Data Protection Directive and the General Data Protection Regulation (GDPR), data protection supervisory authorities and international data transfers, the "right to be forgotten," and cybersecurity in Europe. |
2 |
online |
HLTH8500 |
Food and Drug LawThis 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. |
3 |
in-class |
INDL7312 |
Genetics: Law, Policy and BioethicsRapid advances in genetics are having extensive effects on our life both within and outside the medical arena. This course will examine the legal transformations taking place in a broad range of legal fields to accommodate these technological innovations. Among the topics to be examined in this course are: (1) genetic testing in the clinical scenario, such as duty to warn issues; (2) Privacy and discrimination related to collection of information by insurers and employers and by the government; (3) Commercialization of genetic research, focusing on gene patents; and (4) Use of genetic information in the courtroom. |
2 |
in-class |
CORP7160 |
Global Corruption: Regulation, Compliance, and EnforcementThis course introduces students to the theory and practice of global anti-corruption compliance. Topics covered include the definition, identification and measurement of corruption; the OECD Convention on Combatting Bribery of Foreign Public Officials; the U.S. Foreign Corrupt Practices Act; the UK Bribery Act; anti-corruption laws in other countries; investigation, enforcement and resolution of corruption activities; jurisdiction, corporate liability and individual responsibility; and anti-corruption compliance programs and international organizational responses. |
2 |
online |
HLTH7518 |
Health PrivacyAs 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. |
2/3 |
in-class |
HLTH9524 |
HealthCare Fraud and CorruptionThis 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. |
3 |
in-class |
HLTH7504 |
HIPAA Privacy and SecurityThis course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:
|
2 |
online |
HLTH7519 |
Introduction to BioethicsIntroduction 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. |
2 |
online |
HLTH9509 |
Law of Death and Dying, TheThis course explores legal, ethical and public policy issues related to end-of-life medical care. Topics covered include:
|
||
HLTH8508 |
Medical MalpracticeThis 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. |
2 |
in-class |
HLTH7511 |
Mental Health LawMost 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. |
2 |
in-class |
HLTH9515 |
Public Health LawThis 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. |
3 |
in-class |
HLTH7520 |
Regulating Research with Human SubjectsThis 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. |
3 |
in-class |
HLTH9650 |
Skills for Health Law PracticeThis 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. |
2 |
in-class |
HLTH7690 |
Stark Law and ComplianceThis course provides an opportunity to explore, in-depth, the federal physician self-referral prohibition, known as the Stark Law. Topics covered include:
|
2 |
online |
ACADEMIC STANDING
LLM students must remain in good academic standing throughout the program. View the full academic policy.
EXAM PROCEDURES
In-person students should indicate on their exams that they are LLM candidates. This will allow professors to exclude graduate students from the mandatory grading curve. No other reference to identity should be indicated on the exam. Every effort to maintain a student's anonymity will be made; however, anonymity may sometimes be compromised due to the small number of graduate students enrolled in a given class.
How to Apply or Request Additional Information About the Seton Hall Law LLM Program
LLM Application
For additional information, please contact Enrollment Services at [email protected] or request information online.