Health Care Business Transactions (LAW 719-008) (1 credit)
This course is designed to introduce students to the complex legal and business that arise in health care transactions and the regulatory environment surrounding such transactions. This course will cover health care mergers & acquisitions, joint ventures, and contracting with other providers/suppliers and vendors (especially business associates)—through the lens of applicable laws (including antitrust, tax, HIPAA, fraud and abuse, among others). The goal of this course is to provide students with practical knowledge and an opportunity to participate in contract drafting, issue spotting, and negotiation exercises.
This course will meet June 15-16, 2018 from 9:00 am - 5:00 pm each day.
Pharmaceuticals and the Law (719JJ-001) (1 credit)
Course Description: As the government determines or influences virtually every aspect of how drugs are developed and delivered to patients, it is important to understand the complex framework governing pharmaceutical innovation and patient access to new therapies. This course will provide an introduction to the range of legal and policy issues relevant to the biopharmaceutical industry, including: (1) the regulation of drug and biologic development, approval, and promotion; (2) laws and regulations governing access to biopharmaceuticals and other types of care under large government healthcare programs; (3) fraud and abuse laws and regulations and "transparency" policy trends, including disclosure of and restrictions on interactions with healthcare providers; (4) "healthcare reform" policy trends, including cost containment, expanding coverage for the uninsured, and improving the quality of healthcare; (5) statutory intellectual property protections for biopharmaceuticals, including patent-related processes and various exclusivities; (6) the interplay between biopharmaceutical regulation and product liability; and (7) First Amendment issues arising in the regulation of various pharmaceutical industry activities.
This course will meet June 20-21, 2018 from 9:00 am - 5:00 pm each day.
Digital Health and the Law (LAW 719HT-001) (1 credit)
This course will explore the latest legal developments pertaining to the use of digital technologies in the delivery of healthcare, focusing on three key areas of innovation: telehealth, mobile health, and the use of big data. We will address the various legal and regulatory challenges to implementation and adoption of these advancements, with particular emphasis on licensing, cybersecurity, and data privacy laws, nationally and internationally. Because these technologies are developing at a faster pace than the laws and regulations meant to address them, this area of law is dynamic and constantly evolving. The course will discuss how businesses can navigate this complex legal framework and ways to structure the business model to mitigate legal risks.
This course will meet June 22-23, 2018 from 9:00 am - 5:00 pm each day.