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Health Law Institute

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2010 SUMMER INSTITUTE COURSES

 

Health Care Compliance Institute 3 credits

Tuesday, June 1, 2010 – Friday, June 4, 2010 

9:00 a.m. – 12:00 p.m. / 12:30 p.m. – 2:30 p.m. 

 

Monday, June 7, 2010 – Thursday, June 10, 2010 

9:00 a.m. – 12:00 p.m. / 12:30 p.m. – 2:30 p.m. 

 

This is an intensive two week, three credit course designed to deliver the tools necessary for working professionals and traditional students to enhance job performance and become more competitive in the compliance job market.  During the course students will gain a more sophisticated understanding of the laws and regulations encountered by compliance professionals in daily practice, develop the skills to conduct audits and investigations, learn billing and coding basics, including how to create and enforce a code of conduct, identify and better manage employee and vendor issues, including enforcement and reporting requirements.  The course is highly interactive.  Students will test legal and operational concepts through a variety of simulation-based projects and small group exercises.


Barbara Colombo, Senior Fellow, Director, Health Care Compliance Certificate Program, Hamline University School of Law 

 

Food, Drugs & Devices:  The Regulatory Framework 1 credit

Tuesday, June 8, 2010 – Friday, June 11, 2010 

9:00 a.m. – 10:30 a.m. / 10:45 a.m. – 12:15 p.m. 

 

 

The course will start by examining core elements of the regulation of drugs, including the basic prohibition on misleading statements and the development of the requirements for pre-market approval of drug safety and efficacy.  Other topics include the prescription status for drugs, direct-to-consumer advertising, post-market safety risks and user fees for drug approvals.  The relevance of constitutional protections for commercial speech will also be considered.  This course will also provide an overview of key features of device regulation, including the scope of the device definition and the significance of the classification of a device and substantial equivalence determinations.  The discussion will consider piggybacking and equivalence creep.  The course also takes account of the FDA's regulatory role as an administrative agency.  This will include the extent to which courts defer to the agency's statutory interpretations, the difference between rules and Guidance Documents, and the scope of the agency's enforcement powers.


Margaret Gilhooley, Professor Emeritus, Seton Hall University School of Law, Newark, NJ 

 

Patients’ Rights 2 credits

Monday, June 14, 2010 – Thursday, June 17, 2010 

9:00 a.m.  – 12:00 p.m. / 12:30 p.m.    4:00 p.m. 

 

This course examines the legal and ethical sources of patients' rights as well as the duties of patient advocates, ombudspersons, ethics committees, and risk management departments as they relate to patients' rights. Examples of issues that will be examined during class include whether patients have the right to refuse to be examined and treated by medical and nursing students and residents; whether patients have a right to know their prognosis; whether patients have the right to know the HIV-status of their physicians; whether hospitals can prevent patients from leaving; whether health care facilities can videotape their residents' activities; whether patients in all health care facilities have the right to receive visitors; whether pregnant women have the right to be informed of the option of genetic counseling and screening; whether pregnant women can elect to give birth at home; and whether patients can refuse to consent to autopsy prior to death.


Stacey Tovino, PhD, Associate Professor, Director of the Health Law and Policy Center, Drake University Law School; Senior Fellow, Hamline University School of Law 

 

Industry Spotlight: Drugs, Devices, and the False Claims Act 1 credit  

Thursday, June 17, 2010 –  Friday, June 18, 2010 

9:00 a.m. – 1:00 p.m.  

Saturday, June 19, 2010 

9:30 a.m. – 1:30 p.m.  

 

The course will explore and examine the legal, policy and practical uses of the federal and state false claims acts (FCA) in the pharmaceutical and medical device industry.  After learning FCA parameters, the class will examine cases involving allegations of Medicaid and Medicare pricing, Medicare billing, and off-label promotion fraud.  It will also address proactive client counseling and compliance initiatives which may help prevent or contain FCA claims and liability.

 

Marc S. Raspanti, Partner, Pietragallo Gordon Alfano Bosick & Raspanti, Philadelphia, PA 

 

 

 

Mental Health Law 2 credits

Monday, June 21, 2010 – Thursday, June 24, 2010 

9:00 a.m.  – 12:00 p.m. / 12:30 p.m.    4:00 p.m. 

 

This course examines the legal and ethical duties that apply to mental health care providers, as well as the rights of individuals with mental illness, intellectual disabilities, neurodegenerative diseases, alcohol and drug dependency, and brain injuries.  Special attention is given to the licensing, certification, and accreditation of mental health care providers; informed consent to mental health treatment and behavioral research; the confidentiality of mental health records under Minnesota and federal law; the requirements for using physical and chemical restraints, seclusion, and electroconvulsive therapy; the question of whether patients have a right to mental health care; the prerequisites for involuntary mental health commitment; mental health parity legislation; and the burgeoning field of neuroethics.

 

Stacey Tovino, PhD, Associate Professor, Director of the Health Law and Policy Center, Drake University Law School; Senior Fellow, Hamline University School of Law 

 

Registration opens Monday, March 8, 2010 

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Tuition

Tuition for degree-seeking students is $1100 per credit. This includes students seeking credit for a graduate degree or those seeking credits to complete the Hamline Certificate Program in Dispute Resolution.

Tuition for non-degree students is $550 per credit.

A $150 per course, non-refundable tuition deposit must accompany all applications. The tuition deposit will be deducted from the total tuition amount. This deposit will only be returned if the applicant is not accepted into the course. The balance of the tuition is due one week prior to the beginning class session for each course after which no refund will be made.

Applications are accepted on a first-come/first-registered basis. Students will be notified by mail of their acceptance in the program. Hamline University School of Law reserves the right to cancel any course that does not meet minimum enrollment requirements.

Course Materials

All courses require completion of a reading assignment prior to the first class meeting. There is a separate charge for books and course materials, for which you will be billed along with the balance of your course tuition which is due one week prior to the start of each course. The cost of books and materials varies. A course syllabus, advance reading assignment, and course materials will be mailed to you approximately two weeks prior to the start of the course.

For more information contact:

 

 

Stephanie Harkema 

Programs Administrator, Health Law Institute

Phone: 651-523-2738  

Email: sharkema01@hamline.edu