An introduction to the formation, performance and breach of contracts. The course will also introduce students to contract interpretation, damages, conditions, rights of third parties and assignments.
Obligations imposed by the government on businesses are numerous, substantial and increasing. These obligations emanate mainly from statutes enacted by legislatures and regulations promulgated by administrative agencies. This course explores how statutes and regulations come into existence, when they may be invalid, how courts interpret them, and what steps businesses take in responding to statutory and regulatory initiatives. Business and law have become so intertwined and inseparable that statutes and regulations are not just for lawyers anymore. To perform their responsibilities competently, effectively, and ethically, numerous non-lawyers – including middle-level and top-level executives – must acquire the knowledge and skills needed to navigate regulatory-intensive environments. This course is the foundation for acquiring these competencies.
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.
The course covers the law of torts or civil wrongs outside contract law. For example, lawsuits for fraud, car accidents, product injuries and negligent management of employees are all tort suits. The course covers the foundations of the “negligence” cause of action, including topics such as duty, breach, causation and damages. It also covers principles of vicarious liability (that is when an organization or employer is responsible for the actions of its employees), economic harms and statutory negligence. The principles and techniques you will learn in this course underlie many other legal subjects that you will later encounter.
Health Care Regulation Electives
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.
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.
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.
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.
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).
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.
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.
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.
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.
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.
Health Care Privacy, Cybersecurity, and Data Analytics Electives
This course focuses on the legal and risk management issues that arise after a cybersecurity breach. Students will learn about different aspects on incident response, including initial internal communications and related corporate governance issues, the role played by in-house and outside counsel, forensics experts, IT staff and others in investigating the source and scope of the breach, and in mitigation and remediation of cyber breaches. The course will cover myriad issues related to cyber-insurance (before and after a breach), the preservation of digital data and physical documents, attorney-client privilege and a number of legal issues that can arise when coordinating with federal, state, and foreign regulators and criminal investigation agencies. Students will also learn about various mitigation best practices, including disclosure to regulators, customers, cyber-insurance carriers, investors, and vendors and other affected third parties.
This course focuses on the design and implementation of cybersecurity compliance programs, including developing policies and procedures, auditing processes, and strategies for ensuring the resiliency and adaptability of the program in an evolving cyberspace and regulatory environment.
A study of legal and risk management issues surrounding the use of big data analytics, machine learning and other AI technologies by regulators, business firms and other organizations. Special focus is given to issues arising in health care regulation, financial and securities regulation, and employment law—for example, health care fraud and abuse, Bank Secrecy Act and Anti-Money Laundering, economic sanctions, Federal securities Laws, and employment discrimination. Topics include privacy, cybersecurity, algorithmic fairness, smart contracts, robot and computer system accountability, social media censorship, regulatory reporting, monitoring of employees and transactional monitoring.
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.
This course introduces students to key concepts in law of patents, trademarks, trade secrets and copyright. Special focus is given to risk management techniques to protect a company’s intellectual property, including monitoring for potential infringements, addressing suspected infringements, IP licensing, non-compete agreements and non-disclosure agreements.
An introduction to fundamental technology concepts for compliance officers, risk-manager, and others working in technology-intensive, regulated areas, including cybersecurity, privacy, AI, and intellectual property.
Contracting, Governance, and Risk Management Electives
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.
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.
This course examines concerns, protections and regulations particular to consumer transactions in formation, substance, and remedies. Regulatory, statutory, and common law doctrines will be addressed, with an emphasis on federal and Florida consumer protection statutes. Major topics will include fraud, deceptive practices, fair and accurate credit reporting, Truth-in-Lending law, fair debt collection, and enforcement of consumer rights. We will examine the evolution of consumer protection law as well as the economic and social policies behind it, and also focus on the practical application of the law.
This class covers contract risk management best practices, as applied to both individual and portfolio of contracts. Topics include contract negotiations, term sheets, pre-contractual liability, contract performance, breach, waivers, post-breach actions, and the relationship between liability and business risks. Students will also learn about key contract terms including representations and warranties, conditions, default, indemnification, arbitration, liquidated damages, and choice of law and venue.
This course will cover the principles, frameworks, and best practices for analyzing and managing risks within business firms. Students will learn how to construct frameworks for managing strategic, operational, financial, and legal/regulatory risks. They will also learn how to assess and measure these risks.
This course covers basic accounting principles necessary to understand, interpret and analyze financial statements, formulate effective inquires, and communicate intelligently with business and financial professionals (as well as with their future clients). Students will read and use the information from real companies to analyze and interpret their financial statements. Specifically, this class will use real-world examples to illustrate the interrelationships between financial statements and the documents underlying certain deals/transactions. The students will learn about financial reports, cash flow versus income, tax versus accounting books, the quality of earnings and analytical ratios, all of which may be necessary to conduct due diligence on a particular matter and to draft operative agreements. The class will also spend time analyzing past financial scandals and the financial issues that led to them (and the role various professionals could/may have played in preventing them).
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.
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.
Introduction to Legal Studies and Research introduces students to the American legal system, the study of law and effective legal research techniques. This course provides students with practical, hands-on experience with legal resources and research tools. This course emphasizes building the practical research skills required to succeed in an increasingly complex legal and regulatory environment.
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.
In this course, students will learn about program management and project management from the perspectives of governance, contracting, and regulatory compliance. Topics: Project management lifecycle, from project conception, negotiation, and initiation through project delivery and closure. Predominant project management types—e.g., Waterfall, Agile, and Lean/Scrum. Selecting and managing the project team, assessing and managing risk, engaging and managing stakeholders, and determining and managing outsourcing and procurement strategy. The course gives special attention to legal risk management issues. These include project governance, contract risk management, project finance, human resources and employment law, intellectual property, and vendor 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.