Course Details

Health Care Law and Regulation

The delivery of health care items and services is a major commercial enterprise, with national health expenditures accounting for 17.5% of Gross Domestic Product in 2014. As a guardian of the public interest, the government is involved in regulating the delivery of health care, so as to protect patient rights, assure quality, and limit provider conflicts of interest. As the most significant source of payment for health care items and services, the government also has a compelling interest in cost transparency and containment. This course will provide an overview of some of the key state and federal laws that address these public policy goals, with reference to recent events, including, for example, news stories, enforcement actions, and shareholder suits. At the conclusion of the course, you should have sufficient familiarity with the legal landscape to enable you to be an effective contributor to efforts to bring compliant health care products and services to market. By way of example, this course will introduce you to state laws dealing with professional and facility licensing, CON, fee splitting and corporate practice, and to federal laws dealing with kickbacks, civil money penalties, open payments, and false claims. This course will explore the context, substance and purpose of these laws, with a view to identifying the imperatives, obstacles and opportunities that they create. At the conclusion of the course, you should have sufficient familiarity with the legal landscape to enable you to be an effective contributor to efforts to bring compliant health care products and services to market. This course will build on the principles learned in the Legal and Regulatory Process course, and is related to, but not duplicative of, the following courses: Global Business Regulation and Risk Assessment; Regulatory Compliance (distinction: this course is focused on U.S. regulation and compliance rather than on global compliance, and on the substance of the regulation rather than on compliance strategies); Corporate Criminal Law (distinction: this course will touch on corporate criminal law as just one of many theories of liability and regulation); Regulation: Medicine and Health (distinction: this course may touch on but is not focused on FDA matters); and, Integration of Science and Clinical Care (distinction: this course may touch on but is not focused on the intersection of these two areas). No pre-requisites. No final exam required. No required text. All required readings will be posted in Canvas.

Catalog Number: REGLAW 970-0


Course History

Spring 2017
Title: Health Care Law and Regulation
Faculty: Sanders, Sheva
Section: 1     Credits: 1.0
Capacity: 20     Actual: 14