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 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 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 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.

Prerequisite: INDL7550 Cybersecurity I

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include data protection and privacy in the European Court of Human Rights, the Data Protection Directive and the General Data Protection Regulation (GDPR), data protection supervisory authorities and international data transfers, the "right to be forgotten," and cybersecurity in Europe.

This course 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 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 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 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 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.

Prerequisite: INDL7550 Cybersecurity I

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include data protection and privacy in the European Court of Human Rights, the Data Protection Directive and the General Data Protection Regulation (GDPR), data protection supervisory authorities and international data transfers, the "right to be forgotten," and cybersecurity in Europe.

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

1. Entities and information to which HIPAA applies

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

3. Types of health information requiring heightened protection

4. Use of health information for research and marketing

5. Security measures required to protect digitized health information

6. Individuals’ right to access their health information

7. Business associate agreements

8. HIPAA compliance and enforcement

Introduction to bioethical analysis and application of different bioethical theories to current issues in health care. This course is not focused on legal doctrine per se - it is designed to provide analytical tools to aid in thinking through the ethical dimensions of current legal debates.

*available late 2023

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 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 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.

Prerequisite: INDL7550 Cybersecurity I

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include data protection and privacy in the European Court of Human Rights, the Data Protection Directive and the General Data Protection Regulation (GDPR), data protection supervisory authorities and international data transfers, the "right to be forgotten," and cybersecurity in Europe.

This course 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 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 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 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 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 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.

Prerequisite: INDL7550 Cybersecurity I

This course introduces students to the legal regime governing information privacy, data protection, and data security in the European Union. Topics covered include data protection and privacy in the European Court of Human Rights, the Data Protection Directive and the General Data Protection Regulation (GDPR), data protection supervisory authorities and international data transfers, the "right to be forgotten," and cybersecurity in Europe.

This course 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 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 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.