Business Organizations
An introduction to the law of business organizations, including agency, partnership, and business corporations. Topics include formation and structure of the corporation, power and fiduciary responsibility of management, rights and liabilities of shareholders, shareholders' derivatives litigation, acquisitions and tender offers and insider trading.
Civil Litigation Fundamentals
The potential for lawsuits plays a critical role in business decisions, particularly in regulatory compliance, risk management, and contract procurement and vendor risk management. This is often especially true in highly regulated fields such as healthcare, finance, HR, cybersecurity, and supply chain management. Litigation – whether in front of administrative agencies or courts – is generally the endgame for regulatory, contractual, or other liability problems that institutions may face. This class provides students with a basic understanding of the process of civil litigation in the U.S. We will trace the pathway of a lawsuit from the initial pleading stage to the appeal. Students will gain a solid grasp of the concepts and vocabulary that underlie the U.S. litigation system. Topics include types of lawsuits, forums, pleadings, response, discovery, trial procedures, appeals, administrative adjudication, and arbitration.
Compliance Failures: Investigation, Reporting and Remediation
A study of the obligations of regulated companies when there has been a compliance failure. Topics covered include: audits and other internal governance approaches for discovering compliance problems in a timely fashion; investigations; reporting; mitigation; regulatory responses; and remediation.
Drug Regulation and Compliance
This course provides an analysis of major legal issues in the pharmaceutical and medical device industries. The course explores the FDA’s regulation of these industries, including the FDA approval process, advertising and promotional regulations, and enforcement by the FDA and other regulatory entities. Other topics include product liability and FDA preemption, research, patient care, and privacy, pricing and market access.
E-Health and Telemedicine
A study of legal issues affecting e-health and telemedicine. Topics covered include electronic health records, Health Insurance Portability and Accountability (HIPAA) and other privacy issues; live video and store-and-forward techniques; remote patient monitoring, mobile health, and healthcare robots; reimbursement issues under public and private insurance schemes; licensure, credentialing, and privileging; and fraud and abuse.
Governance, Risk Management and Compliance
An introduction to corporate governance, risk management, and compliance within business firms and financial institutions. Topics include: the role of the board of directors and executives in managing firms and overseeing risk management and compliance; Codes of Ethics; internal controls; the Sarbanes-Oxley Act; the Foreign Corrupt Practices Act; whistleblowers; crisis management; and disclosure requirements under Federal Securities Laws and under banking statutes and regulation.
Health Care Disability Law: Mental, Physical and Age-Related
Laws dealing with the provision, financing and regulation of health care in the U.S. are based largely on a model presuming the involvement of autonomous health care consumers. In reality, however, many health care consumers today have mildly to severely compromised autonomy because of mental, physical, and/or age-related deficits or disabilities. These compromised individuals are often particularly vulnerable in terms of their health care needs and may require special legal attention and protections within the health care system. This course will address vulnerable patient populations with mental, physical, and/or age-related disabilities, focusing especially on responses of the legal system to the relationship of those patients to the health care and broader service systems.
Health Care Fraud and Abuse
A study of federal and state laws regulating fraud and abuse within health care, including the Anti-Kickback Statute, the False Claims Act, the Stark I and Stark II (physician self-referral).
Health Care Payer-Provider Relationships
A study of the legal and contractual issues arising in health care payer-provider relationships, in the context of private payers. Topics covered include: key terms in payer contracts; collaboration; conflicts; arbitration; and privacy. Special focus will be given to best practices for compliance and contractual and legal risk management.
Health Care Privacy and Cybersecurity
A study of privacy and cybersecurity issues, including Health Insurance Portability and Accountability Act of 1996 (HIPAA); and security of health care information under state and federal law, including HIPAA, the Health Information Technology for Economic and Clinical Health (HITECH) Act, and breach notification requirements. The course will also introduce issues related to emerging uses of technology, including telemedicine.
Health Care Regulation Research
An introduction to legal sources relevant to health care regulation. Students will also learn advanced research techniques.
Health Care Transactions Between and Among Health Care Providers
This course covers transactions between and among health care providers, including hospital-physician relationships and governance issues within healthcare entities.
Insurance Contracts
A study of insurance contracts and insurance law. Topics covered include: the nature of insurance, insurable interests, persons and interests protected, contractual obligations of the insured and insurer, the claims process, bad faith, and subrogation. We will explore insurance contracts from the point of negotiation and execution through the claims process, settlement and dispute resolution.
Medical Malpractice
This course examines the broad array of legal and policy-related issues arising out of litigation seeking redress for harms in the context of the provision of medical services. The course also covers liability insurance for individuals and healthcare entities.
Medicare, Medicaid and Managed Care
An introduction to the legal issues associated with public and private health insurance and benefits plans. Students will learn about federal and state financing programs, including Medicare and Medicaid/SCHIP, employer provided insurance, and federal and state regulations of private health insurance markets and managed care, including population care management, provider payment, quality and accountability, and cost-containment.
Negotiations & Bargaining: Theory and Practice
In this course, you will learn the main principles, concepts, tools, and skills of negotiations and bargaining. These will not only help you develop a good understanding of the subject but will also equip you with what is needed to be a “successful” negotiator. We will give primary attention to negotiation and bargaining in legal contexts. These include: contract negotiations; bargaining during the performance of long-term contracts and during other long-term relationships; bargaining between a business firm and its employees, customers, suppliers, vendors, and investors; bargaining among business firms regarding joint ventures and supply chain management; and bargaining during legal conflicts, both before and during litigation. You will learn how to identify the parties’ relative bargaining power and how to increase bargaining power–e.g., by using pre-commitment devices and acquiring information. You will also learn about the factors that can lead to quick, efficient agreements and those that can lead to costly delays and bargaining breakdowns, including the role played by bargaining procedures, informational gaps between parties, “credible” and “non-credible” threats, and trust and fairness.
Patient Safety and Quality
An introduction to the regulatory compliance and risk management issues affecting patient safety and quality improvement. Specific topics will include laws and regulations governing: the documentation of patient safety and quality, including incident reporting and charting of medical care; principles of zero harm and high reliability; culture of safety and process improvement; reporting and publicizing results and unintended consequences; HIPAA and other patient privacy issues; technology and human error, wearable technology, AI, and cybersecurity; safety of the health care team; and communication among healthcare providers on risk management, patient safety and quality improvement.
Professional Licensing, Discipline, Accreditation and Regulation
A study of professional licensing, including the accreditation of healthcare entities.
Public Health Law
This course will offer an overview of basic concepts and principles in public health law, examined in the context of issues such as government planning for natural and manmade disasters, mandatory immunization programs, mandatory medical screening of particular population groups, mandatory disease reporting laws, infectious disease control methods like quarantine, public health research, and regulation and litigation concerning tobacco, alcohol, firearms, and drugs with abuse potential. The focus will be on identification and analysis of the duties, powers, and limits of government in its pursuit of protecting and promoting the public’s health.
Regulatory Compliance
An introduction to basic statutes, regulation and administrative practices relevant to regulatory compliance by business entities, financial institutions, and healthcare organizations and practitioners. The course will also introduce students to basic concepts of risk management. Students will learn how to: identify applicable laws, regulations and industry standards necessary to develop an effective compliance management program; construct and implement effective compliance policies and procedures; develop appropriate audit procedures in order to analyze the effectiveness of current policies and procedures, and organize and lead the organization’s response to a regulatory audit or investigation.
Risk Management and Patient Safety
An introduction to risk management practices in healthcare contexts, as they relate to medical errors and patient safety.
Vendors and Other Third-Party Risk Management
A study of the legal issues related to outsourcing contracts, including liability issues arising from these relationships. Students will also learn about best practices for assessing, monitoring, and managing vendor and outsourcing risks.
