Online LL.M. Degree in Health Law

LL.M. Programs at Seton Hall Law

LLM Program Formats

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

can be viewed here.

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 may pursue one of two sub-specialties: traditional health law or drug/biotechnology 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 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.

4

in-class


or Online Option (both courses required)

Number Name Credit Offering

HLTH7670

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

2

online

HLTH7660

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

2

online

 

Core | 4-6 Credits

  1. Must choose two (2)

In-Person Option

Number Name Credit Offering

HLTH7509

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. 

2

in-class

HLTH8500

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.

3

in-class

HLTH9524

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. 

3

in-class

 

or Online Option

Number Name Credit Offering

HLTH7590

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

2

online

HLTH7580

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

2

online

HLTH7560

FDA Regulation & 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

2

online


Advanced Writing Requirement | 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 covered in a prior course and produce one or two written papers of Law Review publishable quality, totaling 25 pages in length.

Electives | 11-14 Credits

Number Name Credit Offering

HLTH7509

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. 

2

in-class

PUBG7801

Administrative Law

This 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 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

2

online

HLTH9513

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.

3

in-class

HLTH7524

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

2

online

HLTH7680

Clinical Research and the Law

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

2

online

HLTH9655

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.

2

in-class

INDL7550

Cybersecurity & Privacy: Law, Policy, Compliance

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

2

online

HLTH7514

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.

2

in-class

PROP7710

Elder Law

Representing 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

European Data Protection and Privacy Law

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include the privacy jurisprudence of the European Court of Human Rights, the EU Data Protection Directive and the General Data Protection Regulation, data protection authorities, international data transfers, and cybersecurity in Europe.

2

online

HLTH8500

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.

3

in-class

INDL7312

Genetics: Law, Policy and Bioethics

Rapid 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 Enforcement

This course introduces students to the theory and practice of global anti-corruption compliance.  Topics covered include the definition 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; enforcement and resolution of corruption activities; jurisdiction, corporate liability, accomplice and inchoate offenses; and anti-corruption compliance programs.

2

online

HLTH7518

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.

2/3

in-class

HLTH9524

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. 

3

in-class

HLTH7504

HIPAA Privacy & 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

2

online

HLTH9509

Law of End-of-Life Decision-Making, 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

2

online

HLTH8508

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.

2

in-class

HLTH7511

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.

2

in-class

HLTH9515

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.

3

in-class

HLTH7520

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.

3

in-class

HLTH9650

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.

2

in-class

HLTH7690

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

2

online

ACADEMIC STANDING

In order to graduate, LLM students must achieve an overall GPA of 3.0. Students will be dismissed if their grades render it impossible to attain this GPA at the completion of the required program of study.

LLM students must remain in good academic standing throughout the program. If a student's GPA falls below 2.50 at any time, the student must meet with and receive permission in order to continue the program. The Law School has complete discretion as to whether such a student may continue and may impose conditions, restrictions, or limitations.

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 lawgrad@shu.edu or request information online.




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