ABA Health eSource May 2011 Volume 7 Number 9
ABA Health eSource - Your link to the ABA's Health Law Section
May 2011 Volume 7 Number 9
Health Law Section NewsMay 10, 2011
ACO Special Edition eSource Available Now
With the recent publication of the proposed regulations and commentary on Accountable Care Organizations (ACOs), the ABA eSource Editiorial Board in conjunction with the Section's ACO Task Force has decided to publish a series of Special Editions focused on ACOs. The first edition is available by clicking here.

May 16, 2011
HIPAA Privacy Post HITECH Act: Managing Risks & Responsibilities
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Chair's Column
By Priscilla D. Keith, Indiana University School of Law, Indianapolis, IN*

One of the best ways to become involved with the ABA Health Law Section is to join one or more of the twelve Interest Groups (IGs). When I joined the Health Law Section several years ago, I also joined the Public Health and Policy IG. This turned out to be one of the best decisions I have ever made professionally and personally! I was able to network immensely inside and outside the Interest Group and develop my skills in the specific area of public health. I made life-long friends, as well. I reached out to members of the Section and they took me by the hand and mentored me every step of the way.

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*This month's Chair's Column is written by guest columnist, Priscilla Keith. Priscilla is a member the Section's Governing Council, and the Chair of the Interest Group Leadership Team.


This edition of eSource is brought to you by the eHealth, Privacy & Security Interest Group .

Premarket Notification and the 21st Century Regulatory System: Safety, Efficacy – Economy?
By Sean W. Develin, DevRose Systems Ltd, West Chester, PA

With the specter of the United States economy still looming over his administration, President Obama began 2011 by signing an executive order requiring that “federal agencies ensure that regulations protect our safety, health and environment while promoting economic growth.” An early example of this particularly difficult balancing act, cited by the President in his January 18th Wall Street Journal Op-Ed article, is the revised 510(k) Premarket Notification process for new medical devices.

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DOJ's Kyphoplasty Initiative: AHA Urges Greater Oversight in the Wake of Continuing Settlement Announcements
By Steven W. Postal, Associate and Post-Graduate Fellow, Office of the Maryland Attorney General, Baltimore, MD and
Robyn Whipple Diaz, Associate General Counsel, St. Jude Children’s Research Hospital, Memphis, TN

On April 4, 2011, a North Carolina hospital agreed to pay the federal government $1.9 million in a settlement to resolve claims that it overcharged Medicare in billing for kyphoplasty, a procedure used to stabilize and reduce pain associated with spinal fractures often related to osteoporosis. This settlement is the sixth publicly known kyphoplasty settlement in three years.

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Health Information Exchanges: What Your Client Needs You To Know
By Karen Chrisman, GOEHI, Cabinet for Health and Family Services, Frankfurt, KY

The HITECH Act, part of the American Recovery and Reinvestment Act of 2009 (ARRA), signed into law by President Barack Obama on February 17, 2009, authorizes funding for the development of health information exchanges in the United States. The Office of the National Coordinator for Health Information Technology (ONC) is the principal federal office coordinating nationwide efforts to implement and advance health information technology and the electronic exchange of health information.

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Compliance on the Road: Government and Industry Efforts to Monitor Field Force Compliance
By Heather McCollum, Senior Consultant, Polaris Management Partners, New York, NY; Chuck Bell, Director, Polaris Management Partners, New York, NY and Elise Roth, JD, Counsel, Bayer HealthCare LLC, Wayne, NJ

The use of field representatives is a crucial component of pharmaceutical sales models. Yet interactions between field representatives and healthcare practitioners (HCPs) often pose compliance risks for pharmaceutical manufacturers, such as the risk of off-label promotion and the provision of perceived kickbacks. Monitoring, both retrospectively and in real-time, identifies the risks inherent in these interactions and serves as part of a risk mitigation strategy. This article will examine monitoring techniques imposed by the federal government and by industry to address compliance risks during field interactions with HCPs, and provides a framework for addressing observed non-compliant behavior by the field force.

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Did you know membership in an interest group is FREE with your Health Law Section membership?

Did you know your membership in the ABA Health Law Section qualifies you for free membership in up to three interest groups of your choice? Interest groups, which are comprised of twelve practices areas within health law, make significant contributions to the Section's programming, publications and legislative initiatives. The interest groups also provide an excellent opportunity for you to interact with and have access to some of the most outstanding lawyers in the legal community. You can enroll on our webpage by clicking here. If you have any questions or need more information, please contact Simeon Carson at simeon.carson@americanbar.org


eHealth, Privacy and Security Interest Group

The eHealth, Privacy & Security Interest Group focuses on three substantive areas - Health Information Privacy, Healthcare Electronic Communication & Information Technology Transactions, and Healthcare Technology Dispute Resolution.

The IG is led by Chair W. Andrew Gantt III, Latham & Watkins LLP, Washington, DC and Vice-Chairs John Christiansen, Christiansen IT Law, Seattle, WA; Deborah C. Hiser, Brown McCarroll LLP, Austin, TX; Linda Malek, Moses & Singer LLP, New York, NY and R. Hal McCard, Jr., Community Health Systems, Franklin, TN.

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, Duane Morris LLP, Houston, TX; Adrienne Dresevic, The Health Law Partners, PC, Southfield, MI; Marla Durben Hirsch, Potomac, MD; Conrad Meyer, Chaffe McCall, LLP, New Orleans, LA and Jennifer Tsao, Hernandez Schaedel & Associates LLP, Pasadena, CA.


Do you want to communicate your ideas to thousands of other members? To contribute a newsletter article on a health law topic, send us your ideas to simeon.carson@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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