Course Descriptions

All class time for all courses will be held remotely through Zoom, an on-line remote platform.  Course participants are required to have a device with a working microphone, camera, and internet connection to be able to fully engage and participate in all aspects of the virtual classroom lectures, discussions and exercises.  Attendance will be taken and attendance in all class hours is required to receive academic credit (or CLE, if applicable). Please reach out to Health Law and Policy Summer Institute Director Asha Scielzo with any questions.

COURSE OFFERINGS FOR SUMMER 2020
 

THE FALSE CLAIMS ACT IN THE HEALTH CARE INDUSTRY (LAW 719B1-001)

1 academic credit*
CLE: Total 60-minute hours: 10 (substantive law) | Total 50-minute hours: 12 (substantive law)**

Friday May 29 (1:30 pm - 5:30 pm ET) & Saturday, May 30 (10 am - 5 pm ET)
Three additional hours of class time will be held remotely later in the summer in the form of online class discussions, pre-recorded modules, or other virtual content.  The lecturer will work with enrolled students to set the schedule for these additional hours.
Lecturer: Ms. Erica Kraus

The False Claims Act is a very powerful fraud and enforcement tool for the government in its effort to combat fraud, waste, and abuse in the health care and pharmaceutical industries. This course will study the elements of the False Claims Act and consider enforcement, compliance, defense strategies, and qui tam provisions with an emphasis on health care and pharmaceutical applications. Students will also delve into recent announcements from the U.S. Department of Justice, noteworthy settlements and case law.  The teaching strategies for this course will include readings, lecture, group discussions and mock hypothetical exercises.

*This course credit may be applied towards earning the Health Care Compliance Certificate.

** This online course is approved for 10 CLE credit hours in Pennsylvania.

Attorneys licensed in Alaska, Connecticut, Colorado, Maine, Montana, New Jersey, New York, North Dakota, and Wisconsin may obtain CLE credit for courses approved by Pennsylvania. Attorneys licensed in California and Hawaii may obtain CLE credit hours through reciprocity only if they were physically outside of their state while attending the online course.   

Per request, the Continuing Legal Education Program at American University Washington College of Law will provide attorneys with all necessary documents and information to obtain CLE credits for all other MCLE jurisdictions that have not specifically approved this course. Please contact cle@wcl.american.edu if you have any questions.

PHARMACEUTICALS AND THE LAW (LAW-719JJ-001)

1 academic credit
CLE: Total 60-minute hours: 10 (substantive law) | Total 50-minute hours: 12 (substantive law)*

Sundays, May 31 & June 7 (10:00 am - 4:30 pm ET)
Two additional hours of class time will be held remotely later in the summer in the form of online class discussions, pre-recorded modules, or other virtual content.  The lecturer will work with enrolled students to set the schedule for these additional hours.
Lecturer: Ms. Sonali Gunawardhana

This course will introduce students to the broad range of legal and policy issues that impact the biopharmaceutical industry in the United States. Through reading materials, lectures and discussions, students will explore the complex regulatory framework governing pharmaceutical innovation and patient access to new therapies. Emphasis will be placed on students learning about drug pricing and regulation of drug plan financing (including pharmacy benefit management and rebate regulation) and the regulation of drug and biologic development, approval, and promotion.  Additional topics that will be covered include: (i) fraud and abuse laws and regulations and "transparency" policy trends, including disclosure of and restrictions on interactions with healthcare providers; (ii) healthcare reform policy trends; (iii) First Amendment issues arising in the regulation of various pharmaceutical industry activities; and (iv) the interplay between biopharmaceutical regulation and product liability.  The teaching strategies for this course will include readings, lecture, group discussions and mock hypothetical exercises..

*This online course is approved for 10 CLE credit hours in Pennsylvania.

Attorneys licensed in Alaska, Connecticut, Colorado, Maine, Montana, New Jersey, New York, North Dakota, and Wisconsin may obtain CLE credit for courses approved by Pennsylvania. Attorneys licensed in California and Hawaii may obtain CLE credit hours through reciprocity only if they were physically outside of their state while attending the online course.   

Per request, the Continuing Legal Education Program at American University Washington College of Law will provide attorneys with all necessary documents and information to obtain CLE credits for all other MCLE jurisdictions that have not specifically approved this course. Please contact cle@wcl.american.edu if you have any questions.

DIGITAL HEALTH & THE LAW: ARTIFICIAL INTELLIGENCE & TELEHEALTH APPLICATIONS (LAW 719HT-001)

1 academic credit
CLE: Total 60-minute hours: 10 (substantive law) | Total 50-minute hours: 12 (substantive law)*
Saturdays, June 6 & 13 (10 am - 4:30 pm ET)
Two additional hours of class time will be held remotely later in the summer in the form of online class discussions, pre-recorded modules, or other virtual content.  The lecturer will work with enrolled students to set the schedule for these additional hours.
Lecturer: Professor Asha Scielzo

This course will explore the latest legal developments pertaining to the use of digital technologies in the delivery of healthcare, focusing on the following key areas of innovation:  artificial intelligence and telehealth applications. 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. Lectures and class discussions will consider the various legal and regulatory challenges to implementation and adoption of these advancements, with particular emphasis on reimbursement, licensing, credentialing, liability, and privacy - and with consideration also given to the current pandemic situation. The teaching strategies for this course will include readings, lecture, group discussions and mock hypothetical exercises.

*This online course is approved for 10 CLE credit hours in Pennsylvania.

Attorneys licensed in Alaska, Connecticut, Colorado, Maine, Montana, New Jersey, New York, North Dakota, and Wisconsin may obtain CLE credit for courses approved by Pennsylvania. Attorneys licensed in California and Hawaii may obtain CLE credit hours through reciprocity only if they were physically outside of their state while attending the online course.   

Per request, the Continuing Legal Education Program at American University Washington College of Law will provide attorneys with all necessary documents and information to obtain CLE credits for all other MCLE jurisdictions that have not specifically approved this course. Please contact cle@wcl.american.edu if you have any questions.