ABA Health eSource - Your link to the ABA's Health Law Section
October 2008 Volume 5 Number 2
Health Law Section News  October 1, 2008
Washington Healthcare Summit

October 2, 2008
HIPAA Enforcement: Privacy & Security Update -- Investigations, Resolutions, Penalties & Dispositions

(Teleconference & Live Audio Webcast)

October 7, 2008
Updated EPCRS and Plan Interim Amendments: New Rules and Coordination Issues

(Teleconference & Live Audio Webcast)

New BNA Products

October 8, 2008
The Revised PRRB Regulations and Instructions

(Teleconference & Live Audio Webcast)

October 27-28, 2008
19th Annual National Institute on Health and Welfare Benefit Plans: Responding to Change

(Arlington, VA)

November 10-11, 2008
23rd Annual National Institute on Compensation for Executives and Directors

(New York, NY)

November 10-11, 2008
23rd Annual National Institute on Compensation for Executives and Directors

(New York, NY)

November 17-18, 2008
Washington Healthcare Summit 2008

(Arlington, VA)

Interest Group Communication Highlights

Resources & News

Resources

A Practical Guide to Medicare Appeals

CDC Public Health Law News

CDC Newsletter is a free electronic newsletter published weekly by the Centers for Disease Control and Prevention, Public Health Law Program

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Chair's Column
by Vickie Yates Brown, Frost Brown Todd LLC, Louisville, KY

The new ABA Bar year is well under way. The "Big ABA" held the Section Officers Conference ("SOC") in Chicago in mid-September and in conjunction, the Health Law Section held its Interest Group ("IG") training and first Council meeting of this bar year. For this Chair's column, I will share aspects of each meeting which I think the Health Law Section ("HLS") members will find of interest.

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FDA Requires Foreign Clinical Studies be in Accordance with Good Clinical Practice to Better Protect Human Subjects
by W. Thomas Smith, University of Florida, Gainesville, FL

News reports in recent years have raised concerns of unethical use of human subjects in clinical drug trials sponsored by US companies but conducted in undeveloped countries. According to an article in the Boston Globe, as the number of foreign drug trials increases, ethical concerns, such as the exploitation of research participants, are raised. An article in the New York Times reported that pharmaceutical companies conducting research overseas often recruit the poor and illiterate for drug testing, fail to report adverse test results, and even conduct unauthorized clinical trials.

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FTC's Identity Theft Red Flag Regulations: Implications for Healthcare Providers
by Debra L. Hutchings, Paul Bond and Carol C. Loepere, ReedSmith LLP, Chicago, IL, Princeton, NJ and Washington, DC

In November 2007, the Federal Trade Commission ("FTC") issued sweeping regulations aimed at deterring, detecting and preventing identity theft. Under these rules, known as the Red Flag Regulations, 16 C.F.R. § 681.1 et seq. and Final Rule ("Red Flag Regulations"), financial institutions and creditors of covered accounts must establish a program to detect, prevent and mitigate identity theft. While somewhat unclear and perhaps counterintuitive, the breadth of the Red Flag Regulations and the FTC's current interpretation indicates that these rules apply to many participants in the healthcare industry. The rules become effective November 1, 2008.

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Pediatric Heart Donations after Cardiac Death Spur Debate
Kay M. Perry, JD, Regulatory Analyst for Research Operations, University of Texas Health Science Center San Antonio, San Antonio, TX

Organ transplants have become fairly commonplace; but a controversial study recently reported in the New England Journal of Medicine shows there may be a different approach to pediatric heart transplants. Between May 2004 and May 2007, physicians at Denver Children's Hospital performed the first heart transplants in pediatric patients where the donors died from cardiocirculatory causes. This naturally begs the question whether the donor was truly legally dead if his or her heart could function in another human body, a question that has spurred debate among bioethicists, physicians, and attorneys.

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Post Mortem Gamete Retrieval after Christy
by Bethany Spielman, Southern Illinois University School of Medicine, Southern Illinois University School of Medicine, Springfield, IL

The Revised Uniform Anatomical Gift Act (UAGA 2006) has rapidly become the majority version of UAGA in the U.S. It was targeted for adoption by all states by 2009 by the National Conference of Commissioners on Uniform State Laws and has been adopted by most states. With the support of the Act's principal drafter, a judicial interpretation of the act in Christy merged two previously disparate areas of healthcare services: cadaveric organ and tissue retrieval, and postmortem gamete retrieval. This article recommends that hospital legal counsel become familiar with three key areas of conflict between UAGA 2006 and ethical guidelines for reproductive medicine specialists .: Is consent to postmortem gamete retrieval required? May gametes be retrieved from minors? May gametes be donated to close family members?

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Medical Research, Biotechnology & Clinical Ethical Issues Interest Group

The Medical Research, Biotechnology & Clinical Ethics Interest Group provides a forum in which members of the Health Law Section can consider and seek guidance about the legal and ethical implications of the difficult conundrums that arise in the clinical arena.

The IG is led by Chair Bruce F. Howell, Powell Goldstein LLP, Dallas, TX and Vice-Chairs Kirk Lee Dobbins, King & Spalding LLP, Washington, DC; LaDale K. George, Foley & Lardner, Chicago, IL; Betty Pang, Latham & Watkins LLP, San Francisco, CA and W. Thomas Smith, University of Florida, Gainesville, FL.

If you would like to join the Interest Group, continue by clicking the following link: Health Law Section IG Sign-up Form.


ABA eSource Editorial Board

The ABA Health eSource Editorial Board is led by Chair Lisa Genecov, Locke Lord Bissell and Liddell LLP, Dallas, TX and editorial board members Michael E. Clark, Hamel Bowers & Clark LLP, Houston, TX; Adrienne Dresevic, Wachler & Associates, P.C., Royal Oak, MI; Marla Durben Hirsch, Potomac, MD and Conrad Meyer, Chaffe McCall, LLP, New Orleans, LA.


Do you want to communicate your ideas to thousands of other members through the wonders of cyberspace? To contribute a newsletter article on a health law topic, send us your ideas to Adam.Bielawski@americanbar.org

The opinions expressed are those of the authors and shall not be construed to represent the policies or positions of the ABA or the ABA Health Law Section.
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