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 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