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 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

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