Healthcare Law

What does it take to comply with privacy laws? In this course, we’ll look at the practical aspects of navigating the complex landscape of privacy requirements. Better understanding privacy laws and data protection will enable you to protect your organization and the constituents that depend on your organization to safeguard their personal information. First, we will examine the historical context that drove the creation of laws, best practices, and other standards for protecting personal information. We will also consider where in the U.S. privacy laws exist and which sectors remain unregulated. Next, we will focus on the federal health privacy law, the Health Insurance Portability and Accountability Act of 1996 (HIPAA) – and what it takes to comply with it. How do you know the scope of the requirements? And once you know HIPAA applies, how do you actually put measures in place to ensure compliance? We’ll explore the notion that one cannot have privacy without strong security and examine various models that promote the security of personal information. We’ll look closely at breach notification laws – one of the most significant drivers of change in organizations – and discuss strategies for the improvement of data protection overall. Lastly, we will look at international law, state law, the unique and important role of the Federal Trade Commission in protecting privacy. Most importantly, we get practical – we will discuss real-world, practical approaches to how compliance professionals can navigate the complex landscape of privacy requirements to best protect their organizations.

This course begins with an overview of general intellectual property law in the United States, then examines how the policy choices behind those laws shapes the behavior of major players in the healthcare industry. We will examine how patents and trademarks shape the behavior of pharmaceutical companies, and how complex issues involving medical research in university settings, and ownership of genetic information and material, are resolved by intellectual property laws. The course concludes with in-depth case studies of an international pharmaceutical company, a major medical device company, and a start-up in the emerging DNA-testing industry.

This course uses comparative analysis of health care systems to gain a better understanding of health care systems in several high-income, middle-income and low-income countries. One focus of analysis in this course will therefore be to develop a better knowledge of these health care systems. A second focus will be to use to this analysis to gain a better understanding of the health care system in the United States. This analysis is relevant for those who are directly interested in the United States, but it is also relevant for those students who are seeking to enhance knowledge of the health care systems in their home countries by gaining a better understanding of the United States’ health care system. A comparative analysis of health systems will help managers and health care professionals who are responsible for optimizing organizational outcomes by improving the quality of health care and simultaneously reducing the costs of health care. The course will use of a combination of the World Health Organization building blocks framework along with theories of complex systems to establish a framework to compare health systems in a number of high-income, middle-income, and low-income countries. This analysis will develop the capacity of managers to critically evaluate relationships between their organizations and the broader set of interactions between the building blocks that make up particular health care systems.