Health Care and Pharmaceutical Compliance

Major: Health Care and Pharmaceutical Compliance
Degree Awarded: Master of Laws (LLM)
Calendar Type: Semester
Total Credit Hours: 24.0
Classification of Instructional Programs (CIP) code: 44.0503
Standard Occupational Classification (SOC) code:
11-9111

About the Program

The LL.M degree is designed for experienced domestic and international attorneys who are looking for advanced skills in legal regulatory analysis and policy pertinent to their practices. As the health care and pharmaceutical industries become increasingly regulated, legal employers, including law firms, hospitals, health systems, government agencies, and multi-national pharmaceutical and medical device manufacturers, seek lawyers with deeper understanding of the complex interaction between these regulations and the industry to better serve their clients or business interests. LL.M students must hold a J.D. or its international equivalent. This degree is not designed to prepare students for any Bar Exam.

Admission Requirements

Domestic students must have earned a JD from an ABA accredited law school.

International students must have an earned Bachelor of Laws (LL.B.) or its equivalent. Admissions will be based on applicant grades from their prior institutions. No entry exam is required, except that students who have completed their first law degree program in a language other than English will be required to have a minimum score on the TOEFL or a comparable exam.

Degree Requirements

Required Courses
LSTU 501SCompliance Skills: Auditing, Investigation & Reporting3.0
LSTU 507SRisk Assessment and Management3.0
Foreign-trained students may also be required to complete one or more of the following:
Introduction to United States Legal Systems
Introduction to the Legal System
Legal Research and Analysis
Electives18.0
Students will take 18 additional credits of course offerings (or 12 credits of course offerings plus Thesis I & II).
Health Care Fraud and Abuse
European Union Data Privacy and Protection
Health Care Quality Regulation
Health Care Cost and Access Regulation
Health Care Finance
Legal Regulation of Pharmaceutical and Medical Device Research and Development
Legal Regulation of Pharmaceutical and Medical Device Sales and Marketing Practices
Regulating Patient Safety
Food and Drug Law
Health Law Legal Research
Thesis I –Scholarly Legal Writing: Planning and Preparation
Thesis II – Scholarly Legal Writing: Writing, Refining, and Presentation
Ethics and Professional Standards
Health Care Rules and Regulations
Health Care Quality, Patient Safety and Risk Management
Patients and Privacy: HIPAA and Related Regulations
Information Privacy Law
Total Credits24.0

Sample Plan of Study

First Year (Part-Time)
FallCredits
LAW 780SHealth Care Quality Regulation3.0
LSTU 501SCompliance Skills: Auditing, Investigation & Reporting3.0
 Term Credits6.0
Spring
LAW 781SHealth Care Cost and Access Regulation3.0
LSTU 507SRisk Assessment and Management3.0
 Term Credits6.0
Second Year (Part-Time)
Fall
LAW 785SLegal Regulation of Pharmaceutical and Medical Device Research and Development3.0
LAW 998SThesis I –Scholarly Legal Writing: Planning and Preparation3.0
 Term Credits6.0
Spring
LAW 787SLegal Regulation of Pharmaceutical and Medical Device Sales and Marketing Practices3.0
LAW 999SThesis II – Scholarly Legal Writing: Writing, Refining, and Presentation3.0
 Term Credits6.0
Total Credit: 24.0
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