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.
This course introduces students to government contracting. The course cover statutes and regulations governing the government procurement process, as well as the core contract law issues relevant to government contracting. The course will also look at the specific contracting issues related to defense contracting, including the Department of Defense’s Cybersecurity Maturity Model Certification (CMMC).
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.
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.
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 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 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.
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.
