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

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 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 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 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

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.

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

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

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 describes practical frameworks for data privacy and security risk management and compliance. We examine the CIA (Confidentiality, Integrity, and Availability) Triad, the NIST Cybersecurity and Privacy Frameworks, and essential principles of Privacy by Design (PbD), along with qualitative and quantitative methods of cyber risk assessment. We apply these frameworks and methods to realistic cybersecurity and privacy scenarios. We further explore methods of transferring cyber risk, including third-party contract terms and cyber insurance. Finally, we discuss legal requirements relating to data breach response and other forms of legal process concerning digital information.

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.

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

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

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 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

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

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.

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

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

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.

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

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 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

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.

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?

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

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

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

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

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

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

This course explores the nature and policies of rulemaking and governance in collegiate and Olympic sports in the U.S. It focuses on the National Collegiate Athletic Association (NCAA), which imposes on its more than 1,000 members a significant set of compliance policies regarding nearly every aspect of athletic eligibility, programmatic participation, and oversight. In addition to the NCAA, the course examines conferences and leagues, which have significant compliance rules for their members, and the Olympic sports governance and oversight structures.

Coming 2024

This course is designed to provide skills development in deal formation and dispute resolution. It will discuss the legal, ethical, and economic concerns that guide the competitive and collaborative approaches to these practices. It will also allow students to engage in simulations and other experienced-based opportunities.

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

This course illuminates the way racial hierarchy has played a role in the development of American law. It examines the historical origins of racial hierarchy beginning in the colonial period and continues that examination through modern legal doctrine. Students will evaluate the continuing impact of the history of white supremacy in areas such as housing, law enforcement, and education. The course concludes with an analysis and critique of some current efforts to repair the harms that have been created by racial hierarchy.

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.

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.

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

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

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

This course examines the newly created right of college athletes to access entrepreneurial opportunities based on their common law rights of publicity, often called of Name, Image, and Likeness (NIL) rights. Topics covered include:

1. a detailed examination of the legal environment surrounding NIL;

2. the NCAA rules still applicable to NIL and the interplay of these rules with state laws;

3. the key contractual terms and provisions that shape NIL transactions;

4. opportunities allowed and limited under current NIL laws and regulation;

5. institutional responsibilities and liabilities created by NIL;

6. strategies for limiting risk in pursuing entrepreneurial opportunities available under NIL;

7. and the range of third-party participants that have sprung up in the NIL space.

Coming 2024

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

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 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.

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

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.