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Online Courses

 

Division of Online Learning

lawonline@shu.edu | 973-642-8747 or 973-761-9000 ext. 8747

Number Name

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

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

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.

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.

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

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

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

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

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 MSJ program.

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

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

INDL7550

Cybersecurity and 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

INDL7600

Cybersecurity Compliance and Investigations

This course introduces risk management tools and best practices for cybersecurity compliance, including qualitative and quantitative risk management measures, the "CIA" triad, the principle of least privilege, and critical controls frameworks. The course also discusses basic investigative tools and techniques, including traffic logging, stateful inspection, network mapping, IP address lookups, and preservation of evidence for forensic recovery. Finally, the course covers legal authorities under which law enforcement or other government actors can request access to user information, including search warrants, wiretap orders, the Electronic Communications Privacy Act, FISA orders, and National Security Letters, with an emphasis on policies and procedures for responding to such requests.

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.

INDL7311

Education Privacy Law

This course examines laws governing student records, school searches and surveillance and drug testing. Topics will include the Family Education Rights and Privacy Act (FERPA); the Interaction between FERPA and the federal law governing health information (HIPAA); the role of the Fourth Amendment in governing searches, drug testing and surveillance in schools and institute of higher education; and big data and the privacy of student information.

CORP7180

EU 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.

INDL8342

Evidence, Cyber-Compliance and Cyber-Investigations

This is a skills-based module centered on the role of the lawyer or compliance officer in mitigating an organization's cyber-risks, conducting forensic investigations in the event of data breaches or other cyber incidents, and presenting evidence in court or in other legal proceedings regarding the nature and causes of a cyber incident. Students will engage in a variety of hands-on skills exercises, such as a simulated "table top" cyber-risk assessment. 

Internet Law and Governance Foundations

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

CORP8160

Financial Crimes Compliance

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

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

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.

CORP7144

Governance, Compliance, Enforcement and Risk Management

This course explores corporate governance metrics for complying with federal and state regulatory frameworks, including internal corporate compliance protocols used to fulfill the company’s mission and to minimize risk in the management of the corporation. Topics covered include:

  1. Corporate governance internal protocols

  2. Relationship dynamics between corporate fiduciaries and stakeholders

  3. Development of compliance and risk management policies and procedures

  4. Governmental regulatory compliance frameworks

  5. Attorney’s role in compliance programs

HLTH8504

Healthcare Access and Payment

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.

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. 

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

INDL7330

Internet Law and Governance Foundations

Internet Law and Governance Foundations. This is the required foundational course module. It asks the questions "what is cyberspace" and "what does it mean to govern in cyberspace?" We will examine questions relating to jurisdiction, enforcement, democratic control, speech, and commerce from the early days of the Internet to the present. This study raises the basic questions addressed throughout all four modules: what is the relationship between "liberty" and "security" in cyberspace?

HLTH7404

Introduction to Contracts and Torts

This course introduces students to fundamental common-law concepts and doctrines applicable to a broad range of professional and business relationship transactions. 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. The concept of reasonable care

  6. Causation

  7. Defenses to tort liability

  8. Business torts

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

CORP7140

Introduction to Corporate Law

This corporate law course examines the organization and operation of business enterprises, with particular emphasis on the corporate form. Topics covered include:

  1. Sole proprietorships

  2. The law of agency

  3. Partnerships

  4. Limited liability companies

  5. The nature of the corporation

  6. Corporate privileges and powers

  7. Rights of shareholders

  8. Powers and fiduciary duties of directors, officers, and controlling shareholders

  9. Derivative lawsuits

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

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

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

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

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.

CORP7150

Regulating Depository Banks

This course introduces students to the primarily 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.

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. Regulation of swaps and other derivatives under Dodd-Frank

  4. Role of the CFTC in regulating this market

  5. Relationship between funds and their broker-dealers

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

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

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

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

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

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.


 


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