Programs & Centers

Health Law Regulatory & Compliance Competition


Competition Supporters

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AHLA

 

The 4th Annual Health Law Regulatory & Compliance Competition will be held on Saturday, February 21, 2015, at the University of Maryland Francis King Carey School of Law.

The 4th Annual Competition will focus on several interactions between various health care stakeholders, including hospitals, physicians, drug and device manufacturers, and related third parties. Specifically, this year's problem will challenge students to address several areas, including but not limited to:

  • FDA life-cycle management, including but not limited to pre-clinical research, clinical trials, FDA marketing applications
  • Bioethical research issues, Common Rule, and human research protection issues for drugs, medical devices, and/or biologics
  • FDA post-marketing requirements, including but not limited to labeling, advertising, promotion, manufacturing, and supply chain
  • Health care fraud & abuse issues, including the Anti-Kickback Statute and applicable safe harbors and exceptions, Stark Law, exclusion, and the False Claims Act and applicable whistleblower or qui tam provisions

The Competition Steering Committee will craft a fact pattern based on these different areas of health law and regulatory compliance.  Each subsequent year, the Committee will choose new and different topics and will post on the Competition website general areas and topics the fact pattern will cover so that students can prepare accordingly.

Detailed Description

The Health Law Regulatory & Compliance Competition requires teams of two or three students to analyze a particular fact pattern using federal health regulations, rules, and agency documents, and to present a legal and policy solution and/or recommendations to a panel of regulatory and compliance attorneys.  Participating students will be evaluated on an oral presentation of issues identified in the fact pattern and proposed actions and solutions to such issues. Judges may also consider written notes submitted to the judges in the "competition template," which will be provided at the competition. See the Competition Rules for more information about how teams will be scored.

The fact pattern will be given out the day of the competition. Teams will have approximately 1.5 hours to review the fact pattern. The competition is open universe, therefore, teams will have access to the internet and may bring any additional materials with them. The actions of teams and students will be governed by the Competition Rules. After their allotted times, teams will have approximately 15-20 minutes to present their recommendations and findings. Teams will present twice, to two separate judge panels. The competition will award the top three finalists. The winner will be announced at the competition during our commencement luncheon. For this year’s competition, the First Place team will receive complimentary registration to the AHLA’s Fundamentals of Health Law program, along with complimentary copies of the new edition of AHLA’s Fundamentals of Health Law publication. Additionally, the Top Three teams will receive complimentary AHLA membership for one year.

The competition is open to teams from all ABA-accredited law schools and is appropriate for 2nd and 3rd year law students who have taken at least one health law course – preferably a survey course that touched on fraud and abuse issues and Food and Drug Law. Note: post-graduate law students, such as LLM, MJ, or Ph.D., students are not eligible to participate.

Instructions for Registering

Click here to download the Intent to Compete Form, which is due by 5 p.m. on Friday, December 12, 2014. Please email forms to Apurva Dharia at MarylandCareyHealthCompetition@gmail.com

Sample Competition Problems from Prior Years

2012 Problem »

General Considerations About Competing

Over the last few years of the competition, we have permitted and recommended that teams seek out assistance from health law faculty or alumni of their respective law schools or communities.  Teams that have prepared generally meet several times before the competition to review fact patterns from past years (posted above) and to do mock presentations to panels of judges to become acclimated with organizing and prioritizing issues, presenting recommendations, and fielding questions.  In addition, several law schools have been able to offer competing students academic credit for their time spent competing and preparing for the competition as an extra incentive.  We highly recommend that teams pursue coaches or health law faculty or alumni that have experience in the issues listed above to help student teams prepare for this year’s competition.  Other resources include the ABA Health Law Section, the AHLA, and FDLI, many of which have mentoring programs that may be able to assist students.

Finally, we have received significant interest from law schools and students throughout the country over the last several years, however some of these teams have not been able to participate due to limited funds.  As noted above, the competition is completely free for students, and meals are provided in the morning and afternoon along with snacks; transportation and lodging is the only expense.  We recommend that students interested in competing reach out to their respective student bar associations, student health law groups, or deans of students to request funding, scholarships, or other requests. Alternatively, students may want to attempt fundraising events or donations to attend the competition.

Competition Rules

Below is the link to the 2014 rules.  We anticipate that they will remain substantially the same for the 2015 competition but they may be adjusted slightly.  We will send the registered teams the final 2015 rules by December 15, 2014.

2014 Competition Rules »

Judges

The link below sets forth the judges who will participate in the 2015 competition.

2015 Panel of Judges »

Competition Logistics for 2015 Competition

The competition will begin at 8 am and take place at the University of Maryland Francis King Carey School of Law located at 500 W. Baltimore Street, Baltimore, Maryland.  Participants will gather at 8 am in the Krongard Room on the first floor of the law school.  See the “Travel Information” link below for driving, parking, and hotel information.  Breakfast will be provided starting at 8 am and snacks will be available throughout the competition.  The competition will end at 3 pm.

Travel Information »

More details about the 4th Annual Health Law Regulatory and Compliance Competition will be posted here throughout the year, including a logistics information for the day of the competition, travel and lodging information, competition rules, and other resources.

If you would like more information about the Competition or have any questions please email Apurva Dharia at MarylandCareyHealthCompetition@gmail.com or Virginia Rowthorn, Managing Director, Law & Health Care Program at vrowthorn@law.umaryland.edu.


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500 W. Baltimore Street, Baltimore, MD 21201-1786 PHONE: (410) 706-7214 FAX: (410) 706-4045 / TDD: (410) 706-7714

Copyright © 2014, University of Maryland Francis King Carey School of Law. All Rights Reserved