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.

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 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 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 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 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 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 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

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 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.

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.

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 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.

This 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.

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.

This course provides a broad overview of key issues at the intersection of cybersecurity and privacy. Topics covered include:

1. Security practices, standards, and insurance

2. Data breaches, incident response, and corporate governance considerations

3. Consumer protection law and enforcement actions

4. The Computer Fraud and Abuse Act (aka the “anti-hacking” statute)

5. Law enforcement surveillance

6. Emerging technological paradigms and legislative responses

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.

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.

This 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.

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.

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.

This 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.

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 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 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 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.

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 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 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.

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 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.

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