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An introduction to the regulatory compliance and risk management issues affecting patient safety and quality improvement.

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. 

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 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

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. 

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.

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. 

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.

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. 

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).