MLS - Health & Hospital Law

BE THE BEST in your own field.

Woman working on online course.

The Master of Legal Studies (MLS) with a concentration in Health & Hospital Law is a superior online degree for working professionals. Throughout each 8-week course, law professors challenge students intellectually while exposing them to various legal and ethical issues in healthcare. Students in this health law masters program develop industry-specific legal knowledge and learn to write and communicate more effectively.

This online master’s degree in health law is one of the programs in healthcare offered through the Seton Hall Law School Center for Health & Pharmaceutical Law, a leading center for research and scholarship. The Center educates lawyers and professionals in the healthcare and life sciences industries regarding the intricate and multifaceted set of laws that govern patients, healthcare providers, manufacturers, and suppliers. The Center at Seton Hall Law School has more than 20 years of experience delivering exceptional healthcare compliance education to working professionals.

Browse our online health law courses below. All online courses are designed by Seton Hall Law’s nationally ranked Health Law faculty. Our nationally respected faculty members are committed to helping you achieve your professional goals and move forward in your career. You can count on having the support you need to get the most out of your education. Please contact us using the form at the right if you have additional questions or view our admissions requirements here.

Required Courses

  1. Must take all in sequence
  2. All courses are offered ONLINE only
Number Name Credit Offering

HLTH7390

Introduction to Law and Legal Writing

This course introduces students to the American legal system and the basic components of legal analysis. Topics covered include:

  1. The structure of the American legal system

  2. The role of statutes, regulations, and judicial decisions

  3. Spotting legal issues, identifying governing rules and principles, and applying the law to different factual situations

  4. Using free Internet resources to locate legal documents and research legal issues

  5. Writing clear and accurate legal summaries and analyses

4

online

HLTH7409

Torts: Liability for Civil Wrongs

This course examines the law governing private recovery for injuries to person or property, with a particular focus on the law of negligence. Topics include:

  1. The negligence principle

  2. Affirmative duties to act

  3. Duties based on statutory violations

  4. Causation

  5. Defenses to tort liability

  6. Damages

  7. Defamation

This online course examines the law governing private recovery for injuries covered by "civil wrongs."  Focusing on the law of negligence, topics will include determining the standard of care; the roles of judge, jury, custom, and statute; exceptions to the duty to exercise reasonable care; actual and proximate causation; defenses to negligence liability; and damages.  The course will include regular writing assignments designed to strengthen students' analytical and writing skills.  The course is required for students in the MLS program and is not available to students in other degree programs.

3

online

HLTH7400

Fundamentals of Business Law

This course introduces students to the law of contracts and to basic principles governing different forms of business associations. Topics include:

  1. The nature and limits of contractual agreements

  2. Contract formation

  3. Defenses to contact enforcement

  4. Remedies for breach of contract

  5. Agency and sole proprietorships

  6. Partnerships

  7. Corporations

  8. Business torts

3

online

HLTH7402

Constitutional Law Survey

This course provides an overview of the key concepts and legal doctrines underlying the American constitutional structure. Topics covered include:

  1. The Supreme Court’s authority and role

  2. Justiciability and standing

  3. The commerce clause

  4. Separation of powers

  5. Due process and fundamental rights

  6. Equal protection

NOTE: This course is available only to students in the MLS program.

3

online

Core Courses

  1. Must take four courses (at least two have to be Compliance Issues for Healthcare Providers, HIPAA Privacy & Security or The Law of Patient Care)
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. 

3

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.

4

in-class

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.

<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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4

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

3

online

HLTH7685

Clinical Research and the Law: Compliance Issues for Research Sponsors

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

3

online

HLTH7680

Clinical Research and the Law: Ethical and Regulatory Issues in Designing Clinical Trials

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.

3

online

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

3

online

INDL7550

Cybersecurity and Privacy I: Law & Policy

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

3

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.

4

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.

4

in-class

CORP7180

EU Data Protection and Privacy Law: The GDPR

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.

3

online

HLTH8515

Genetics: Law, Policy, and Bioethics

The course will examine a variety of legal, policy, scientific, social, and ethical issues relating to genetics and genomics. It will take an interdisciplinary approach to examination of these issues, drawing upon a diverse set of reading materials within the casebook. Topics to be covered include the intersection of law and science generally; genetics research and bioethical issues in human subject research; commercialization, ownership, and gene patenting; genetic testing and reproduction; access and liability issues; clinical applications of genetics research; and genetic privacy.

3

in-class

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.

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

4

in-class

HLTH7504

HIPAA Privacy and Security

This course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:

  1. Entities and information to which HIPAA applies

  2. When consent is required for the use and disclosure of health information

  3. Types of health information requiring heightened protection

  4. Use of health information for research and marketing

  5. Security measures required to protect digitized health information

  6. Individuals’ right to access their health information

  7. Business associate agreements

  8. HIPAA compliance and enforcement

3

online

HLTH7519

Introduction to Bioethics

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

3

online

HLTH9509

Law of Death and Dying, The

This course explores legal, ethical and public policy issues related to end-of-life medical care. Topics covered include:

  1. Cost of end-of-life care
  2. Supreme Court end-of-life jurisprudence
  3. Advance directives and POLST
  4. Minimally conscious state
  5. Challenges at the beginning of life
  6. Physician-assisted suicide

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.

3

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.

3

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.

Prerequisite: Constitutional Law, or Constitutional Law I and Constitutional Law II

4

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

3

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

3

online

Elective Courses

  1. Must take two
  2. Can be from any of the concentration areas (including health law courses above)
  3. ONLINE and ON-CAMPUS options
  4. Health Law (HLTH7503) course requires prior written approval from Academic Director
  5. INTRODUCTION TO CORPORATE LAW is a prerequisite for all Financial Service Electives. SECURITIES REGULATION AND COMPLIANCE is an additional prerequisite for the REGULATING BROKER DEALERS and REGULATING FUNDS AND INVESTMENT ADVISERS courses.
  6. SECURITIES AND CORPORATE LAW: THEORY & PRACTICE and BANKRUPTCY & CREDITORS RIGHTS courses require prior written approval from Academic Director


Intellectual Property Law Concentration

Number Name Credit Offering

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.

4

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

3

online

INDL8301

Copyright Law

This course introduces students to the basic concepts and doctrines of copyright law. Topics covered include:

  1. Foundational principles of copyright law

  2. Copyright in special issues, such as software, architecture, and databases

  3. Derivative works, work for hire, and joint authorship

  4. The doctrine of fair use

  5. Copyright issues raised by new technologies that facilitate copying

  6. Digital works and information technologies

3

online

INDL9331

Current Topics in Internet Law

This research seminar will focus on specific areas based upon individual student research topics, which may include any aspect of Internet Law, including but not limited to NSA Surveillance, Data Mining, Computer Fraud & Abuse Act, Consumer Contracts, BitCoin and other Virtual Currencies, Filtering & Site Blocking, ISP Liability for User Generated Content, Broadcast/Cable/Satellite/Internet Content Systems, and Search & Seizure of Internet Content. Classes will include overview of specific topics followed by problems and role play. 

4

in-class

INDL7550

Cybersecurity and Privacy I: Law & Policy

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

3

online

INDL7316

Entertainment Law: Legal Regulation of Industry Practices

Entertainment Law 2 examines industry-specific approaches with an eye toward transactional practices, insulation from liability, as well as typical workplace and consumer issues. The course covers contracting practices with respect to the following, among others:

  1. Music royalties
  2. Film actor agreements
  3. Liability waivers for reality television and game shows
  4. Contracts regarding credit, pay or play, and profit participation

It also examines recurrent workplace and social issues in the industry, such as the following:

  1. Race and gender discrimination
  2. Sexual harassment
  3. Censorship

3

online

INDL7313

Entertainment Law: Torts

Entertainment Law 1 provides an introduction to the torts that are frequently encountered in the entertainment business. The course covers topics such as the following:

  1. Law of ideas
  2. Copyright law
  3. Trademark law
  4. Privacy torts
  5. Defamation law
  6. Breach of contract

3

online

CORP7180

EU Data Protection and Privacy Law: The GDPR

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.

3

online

HLTH8515

Genetics: Law, Policy, and Bioethics

The course will examine a variety of legal, policy, scientific, social, and ethical issues relating to genetics and genomics. It will take an interdisciplinary approach to examination of these issues, drawing upon a diverse set of reading materials within the casebook. Topics to be covered include the intersection of law and science generally; genetics research and bioethical issues in human subject research; commercialization, ownership, and gene patenting; genetic testing and reproduction; access and liability issues; clinical applications of genetics research; and genetic privacy.

3

in-class

HLTH7403

Hospitality Law

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.

3

online

INDL8317

Intellectual Property Licensing

The seminar will provide a comprehensive study of all aspects of Intellectual Property licensing and related issues. Students will analyze and draft various trademark, copyright, character, right of publicity/privacy, merchandizing, music, software, confidentiality, patent/technology, and new media licenses, and develop related negotiation skills and litigation strategies. The focus will be practical and will show how value can be unleashed in Intellectual Property Assets through licensing.

3

in-class

INDL7500

Patent and Trade Secret Law

This course provides an overview of the basic doctrines of patent law, as well as related rights such as trade secret law and drug law exclusivity under the Hatch-Waxman Act. Topics covered include:

  1. Standards and procedures for obtaining patent protection

  2. Patent infringement litigation

  3. The relationship between patent protection and trade secret law

  4. The role of patent law and litigation in the pharmaceutical industry

3

online

INDL9310

Patent Application, Preparation and Prosecution

This seminar develops the writing and analytical skills required to draft applications for United States patents. Patent claim drafting skills are not undertaken in this course. Patent prosecution techniques, however, including evaluation of Patent and Trademark Office Official Actions and preparation of responses to these Official Actions are studied. There also is practice in drafting appellate briefs for submission to the Board of Patent Appeals and Interferences.

<p>Prerequisite: Patent Law and Practice.</p>

<p>NOTE: Students are required to have a degree in engineering or a physical science.</p>

3

in-class

INDL9305

Patent Claim Drafting

This drafting seminar will focus on the "claim" or "claims" appended to a patent specification. The claim defines the scope of the grant, or the technical extent of the exclusive privilege the patent accords to its owner. Claim drafting assignments will be distributed to the students before each class. Each student's work will be reviewed on an individual basis, with rewriting and revision as needed.

<p>Prerequisite: Patent Law and Practice.</p>

<p>NOTE: Students are required to have a degree in engineering or a physical science.</p>

3

in-class

INDL7308

Sports Law

An exploration of the impact of the legal system on the sports industry in America, particularly the sources of legal authority, development and recognition of property rights in sports and the substantive principles of contract law. The course examines the legal relationships among athletes, teams, leagues, governing bodies, sports facilities, licensees, agents and fans, as threaded together through contract, property, labor, intellectual property, constitutional, and tort law. We will also study the legal implications of the financial and business platforms relating to the sports industry.

INDL7308

Sports Law (Online)

This course explores the impact of the legal system on the sports industry in America, particularly the sources of legal authority, development and recognition of property rights in sports and the substantive principles of contract law. The focus is on the legal relationships among athletes, teams, leagues, governing bodies, sports facilities, licensees, agents and fans, as threaded together through contract, property, labor, intellectual property, constitutional, and tort law. We will also study the legal implications of the financial and business platforms relating to the sports industry.

Coming 2024

3

online

INDL8302

Trademark and Unfair Competition

This course explores common law and statutory protection of ideas, trade secrets, and trademarks. Topics covered include:

  1. Acquisition and loss of trademark rights

  2. Registration and licensing

  3. Problems of infringement, dilution, and misappropriation of trademarks

  4. Fair use and Internet use of trademarks and related remedies

3

online

INDL9322

Trademark Registration

Federal registration provides important benefits to trademark owners, including corporations. Trademarks are among a company’s most valuable assets. Registration work is a staple of many law firm and in-house intellectual property practices. This class will cover the basics of domestic and international trademark registration practice, from selection of a mark and legal screening/clearance through opposition proceedings, registration, and beyond. Hands on, practical use of the USPTO website for filings and research will be explored. Assignments will include hands on drafting of opinion letters, registration papers, and pleadings drawn from real-world examples.

3

in-class


Financial Services Compliance Concentration

Number Name Credit Offering

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.

4

in-class

COML8130

Bankruptcy and Creditors' Rights

This course provides a survey of remedies available to consumer and business debtors and their creditors under state law and the United States Bankruptcy Code. The course covers topics such as: enforcement of money judgments, commencement of bankruptcy cases, the automatic stay, property of the bankruptcy estate, exemptions, secured and unsecured claims, avoidance of transfers, executory contracts, distribution of property, dismissal and conversion of bankruptcy cases, and discharge of debts in bankruptcy.

4

in-class

INDL7550

Cybersecurity and Privacy I: Law & Policy

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

3

online

CORP7180

EU Data Protection and Privacy Law: The GDPR

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.

3

online

CORP8160

Financial Crimes Compliance

This course introduces students to the theory and practice related to financial crimes compliance in the United States, and at the global level. Particular laws examined include: the Money Laundering Control Act, the Bank Secrecy Act, and associated regulations.

At the international level, the course also outlines the work of the Financial Action Task Force and its recommendations on combatting money laundering and terrorism financing.

3

online

CORP8138

Financial Institutions

This course provides an overview of the regulation of the banking and financial services industry.  The class will situate bank regulation in the broader context of other financial institutions, including investment funds, broker-dealers, and insurance firms, and in the context of other national, regional and international approaches to regulation finance. In addtion to covering U.S. banking law basics - safety and soundness, activities and affiliation restrictions, geographic limit, deposit insurance and supervision - the class will consider issues in central banking, resolving complex financial conglomerates, cross-border regulatory cooperation, institutional design for regulating finance, and financial crisis response.

<p>Prerequisite: Business Associations</p>

4

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, 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.

3

online

CORP8165

Introduction to Corporate Finance

This corporate finance course explores the key financial instruments used by corporations, and the legal rules that govern those instruments. Topics covered include:

  1. Capital structure

  2. Financial instruments

  3. Mergers & Acquisitions

  4. Financial Distress

3

online

CORP8170

Regulating Broker-Dealers

This course explores the roles and duties of brokers and dealers, the legal rules that govern these investment professionals, and the regulatory authorities that create and enforce these rules.  Topics covered include a general overview of the financial markets regulatory framework; the economic realities that create legal obligations under federal securities regulations and self-regulatory organizations' rules; supervision of broker-dealer financial distress, including protection of customer funds and liability for customer losses.

3

online

CORP7150

Regulating Depository Banks

This course introduces students to the primary laws and regulations governing banks whose primary function is to accept cash deposits.  Topics covered include the regulation of bank formation, bank deposit regulation, capital regulation, the Consumer Financial Protection Bureau, holding companies and SIFIs, bank governance and supervision, and special areas of regulatory concern.

3

online

CORP8180

Regulating Funds and Investment Advisors

This course examines mutual funds (investment companies) and other related entities like hedge funds and private equity funds. Topics covered include:

  1. Investment Company Act of 1940

  2. Investment Advisers Act Of 1940

  3. Dodd-Frank Act

  4. Sarbanes-Oxley Act

  5. Role of the CFTC in regulating this market

  6. Fiduciary Duties

  7. Relationship between funds and their broker-dealers

  8. Compliance and ethics programs

Prerequisite: Securities Regulation

3

online

CORP9133

Securities and Corporate Law: Theory and Practice

This course is designed to bridge the gap between the legal theory and practical realities of the practice of law by focusing on the various problems that arise in the daily practice of corporate and securities law. The course will include guest speakers who are prominent practicing lawyers. This course will also include field trips to the

American Stock Exchange, to a leading NASDAQ brokerage firm, and to a leading financial publication where students will have the unique experience of seeing how markets are made and reported with respect to major corporations. This course will explore problems engendered by investigations and disciplinary proceedings initiated by the Securities and Exchange Commission, the National Association of Securities Dealers, Inc., the stock exchanges and state regulatory authorities. Students will engage in "moot court" arbitrations as council for various parties. The preparation of prospectuses, proxy statements and annual reports will be addressed and students will prepare portions of these documents. Substantive areas of corporate and securities law such as the securities exchange act of 1934 section 10(b) and rule 10b-5 will be discussed. There will be writing assignments during the course of the semester.

<p>Prerequisite: Business Associations

Recommended: Securities Regulation</p>

3

in-class

CORP7170

Securities Regulation and Compliance

This course focuses on mandatory affirmative disclosure requirements under the Securities Act of 1933 and the Securities Exchange Act of 1934, triggered by the public offering of securities and by their trading in public markets. Topics covered include:

  1. Federal regulation of the offer and sale of securities under the Securities Act of 1933

  2. Exemptions from federal registration

  3. Reporting obligations of public companies under the Securities Exchange Act of 1934

  4. Sanctions and civil damage liability for violating these requirements

3

online


Pharmaceutical & Medical Device Law & Compliance

Number Name Credit Offering

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.

4

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

3

online

HLTH7685

Clinical Research and the Law: Compliance Issues for Research Sponsors

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

3

online

HLTH7680

Clinical Research and the Law: Ethical and Regulatory Issues in Designing Clinical Trials

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.

3

online

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

3

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

3

online

INDL7550

Cybersecurity and Privacy I: Law & Policy

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

3

online

CORP7180

EU Data Protection and Privacy Law: The GDPR

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.

3

online

HLTH7560

FDA Regulation and Liability

This course explores the FDA's extensive regulation of the pharmaceutical and medical device industries, as well the relationship between FDA regulation and state-law tort liability. Topics covered include:

  1. The drug and biologic approval processes

  2. The medical device approval and clearance process

  3. Postmarket obligations and pharmacovigilance

  4. Products liability and federal preemption

  5. FDA enforcement

3

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.

4

in-class

HLTH8515

Genetics: Law, Policy, and Bioethics

The course will examine a variety of legal, policy, scientific, social, and ethical issues relating to genetics and genomics. It will take an interdisciplinary approach to examination of these issues, drawing upon a diverse set of reading materials within the casebook. Topics to be covered include the intersection of law and science generally; genetics research and bioethical issues in human subject research; commercialization, ownership, and gene patenting; genetic testing and reproduction; access and liability issues; clinical applications of genetics research; and genetic privacy.

3

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, 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.

3

online

HLTH7504

HIPAA Privacy and Security

This course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:

  1. Entities and information to which HIPAA applies

  2. When consent is required for the use and disclosure of health information

  3. Types of health information requiring heightened protection

  4. Use of health information for research and marketing

  5. Security measures required to protect digitized health information

  6. Individuals’ right to access their health information

  7. Business associate agreements

  8. HIPAA compliance and enforcement

3

online


Privacy Law Concentration

Number Name Credit Offering

INDL7306

Consumer Data Privacy Law

This course examines the complicated and porous scheme of legal privacy protections governing online and offline individual consumer information in the United States. The course will examine topics including:

  1. The role of privacy policies
  2. The Federal Trade Commission’s (FTC) enforcement of privacy violations
  3. Electronic Communications Privacy Act (ECPA) and the Computer Fraud and Abuse Act (CFAA)
  4. Protections for children’s information under the Children ‘s Online Privacy Protection Act (COPAA)
  5. Statutes providing protections against marketing calls and spam
  6. The role of tort lawsuits for individual consumer privacy violations

3

online

INDL7550

Cybersecurity and Privacy I: Law & Policy

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

3

online

CORP7180

EU Data Protection and Privacy Law: The GDPR

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.

3

online

CORP7185

Financial Privacy Law

This course explores the federal, state and judicial scheme designed to protect the privacy and security of financial information. Topics covered include:

  1. Regulation of sharing consumer information by financial institutes under the Gramm-Leach Bliley Act.
  2. Regulation of credit reporting agencies under the Fair Credit Reporting Act (FCRA).
  3. Identity theft and businesses’ responsibilities under the Federal Trade Commission’s (FTC) Red Flag Rules.
  4. Protections of individual financial information against the government under the Fourth Amendment and the Right to Financial Privacy Act (RFPA).
  5. State financial privacy law
  6. Breach Notification and Financial Privacy

3

online

HLTH7504

HIPAA Privacy and Security

This course explores the federal regulatory scheme designed to protect the privacy and security of health information. Topics covered include:

  1. Entities and information to which HIPAA applies

  2. When consent is required for the use and disclosure of health information

  3. Types of health information requiring heightened protection

  4. Use of health information for research and marketing

  5. Security measures required to protect digitized health information

  6. Individuals’ right to access their health information

  7. Business associate agreements

  8. HIPAA compliance and enforcement

3

online

LABR7600

Workplace Privacy Law

This course examines the modern realities of privacy in the workplace, covering the kinds of personal information an employer may want to learn about an employee, or prospective employee, as well as the kinds of monitoring an employer may conduct in relation to employees: email monitoring, social media monitoring, drug testing, and even DNA testing. Attention is paid to the use of new technologies, including digital technologies and biotechnological advances, that enable new forms of incursion into employee privacy. The course surveys the current patchwork of American laws that apply to workplace privacy, including principles of constitutional law, tort law, contract law and federal statutes that protect employee privacy. Some comparison is made with laws in other countries, specifically countries of the European Union, as these laws are increasingly relevant to organizations that operate across national borders.

3

online


Electives not specific to a concentration
ONLINE and ON-Campus options available

Number Name Credit Offering

LABR7030

Conducting Internal Investigations

This course gives you the tools you need to participate in all aspects of internal workplace investigations. Topics covered include:

  1. When companies should (or must) conduct internal investigations

  2. Who should conduct investigations

  3. The role of the investigator

  4. Obtaining cooperation from witnesses

  5. "Adnarim" warnings when attorneys are involved

  6. HR training and development

  7. Privilege and work product issues and their waiver

3

online

HLTH7405

HealthCare Compliance Certificate Program

This live course, offered over the course of four days, immerses students in the statutes, regulations and other guidance that comprise the body of law known as “fraud and abuse law.” Topics covered include:

  1. Data Privacy - HIPAA, HITECH, and others

  2. FDA approval and regulation of new drugs and devices

  3. Federal Anti-Kickback Statute

  4. Federal and State False Claims Acts

  5. Federal and State Sunshine Laws

  6. Foreign Corrupt Practices Act (FCPA) - including worldwide anti-corruption and enforcement

  7. Government Investigations

  8. Healthcare fraud sentencing, penalties, damages, and other considerations

  9. OIG Compliance

  10. Prescription drug and device marketing and advertising

<p>Prerequisite/Co-requisite: Health Law

Recommended: Health Care Fraud and Abuse</p>

3

in-class

LABR7000

Managing Legal Issues in the Workplace

This course explores the core doctrines that govern the employment relationship. Topics covered include:

  1. Definitions of “employee” and “employer”

  2. The employment-at-will doctrine and its principal exceptions

  3. Employee harassment

  4. Antidiscrimination protections

  5. Health and familial leave protections

  6. Diversity in the workplace

  7. Wage and hour laws

  8. Employee privacy

  9. Liability and litigation risk management

3

online

LABR7570

Managing Whistleblower Risks

This course explores the vast array of federal and state laws that protect employees who report misconduct by their employers.  Topics covered include:

  1. Common-law whistleblower protections

  2. State and federal whistleblower statutes

  3. Strategies for managing whistleblowers and whistleblowing

  4. The role of human resources and compliance professionals in the whistleblower management process

3

online


Courses denoted with * require prior written approval from Academic Director.


Division of Online Learning

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