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Contributing Authors


									                Contributing Authors

    Paul R. DeMuro                 Cheryl V. Reicin
 Latham & Watkins LLP                 Torys LLP
San Francisco, California          Toronto, Canada

   Joel L. Rubinstein              Lisa L. Dahm
McDermott, Will & Emery           DDF & Associates
  New York, New York               Houston, Texas

    Richard D. Marks             George W. Bodenger
  Patient Command, Inc.           Duane Morris LLP
    McLean, Virginia          Philadelphia, Pennsylvania

 R. Christopher Raphaely          Andrew J. Ferren
    Duane Morris LLP            Goulston & Storrs, PC
Philadelphia, Pennsylvania      Boston, Massachusetts

 J.A. (Tony) Patterson, Jr.        Paul D. Gilbert
   Fulbright & Jaworski       Waller Lansden Dortch &
           L.L.P.                   Davis, PLLC
       Dallas, Texas            Nashville, Tennessee

     Andy Norwood                  Stephen Page
Waller Lansden Dortch &       Waller Lansden Dortch &
      Davis, PLLC                   Davis, PLLC
  Nashville, Tennessee          Nashville, Tennessee

      Mark Plotkin            Eileen Burkhalter Smith
Waller Lansden Dortch &       Waller Lansden Dortch &
      Davis, PLLC                   Davis, PLLC
  Nashville, Tennessee          Nashville, Tennessee
Shannon B. Hartsfield      Jacqueline Myles Crain
Holland & Knight LLP      Holland & Knight LLP
 Tallahassee, Florida     St. Petersburg, Florida

   Michael F. Sexton           John D. Blum
     Ropes & Gray        Loyola University Chicago
 Boston, Massachusetts         School of Law
                             Chicago, Illinois

 William H. Roach, Jr.     L. Robert Guenthner
McDermott Will & Emery   Gardner Carton & Douglas
   Chicago, Illinois         Chicago, Illinois

   Arthur G. House            William Freivogel
  Gardner, Carton &          Aon Risk Services,
       Douglas           Professional Services Group
  Washington, D.C.            Chicago, Illinois

   Alan S. Goldberg        Daniel H. Orenstein
   Goulston & Storrs          Orenstein LLC
   Washington, D.C.      Marblehead, Massachusetts

  Amy Jurevic Sokol            David Voran
  Carondelet Health          Leawood, Kansas
 Kansas City, Missouri

                Bradley G. Allen
        Whiteman Osterman & Hanna, LLP
               Albany, New York
     The American Bar Association (ABA) Health Law Section
proudly presents its 2004 Supplement to E-HEALTH BUSINESS AND
TRANSACTIONAL LAW—a book that has helped lawyers and their clients
better understand and find solutions to the legal issues arising from
the integration of the Internet and other technology into the health
care delivery system. This book is the second full-length book pub-
lished by the Section with our friends at BNA Books, a Division of The
Bureau of National Affairs, Inc., the first having been HEALTH CARE
references that were written by practitioners for practitioners.
     The Health Law Section expresses its continuing appreciation to
Editor-in-Chief Barbara Bennett, who has spent many hours of ser-
vice in writing, editing, and chasing after the other authors in order
to keep this book current and meaningful. We also want to recognize
again the contributions of past Section Chairs Howard Wall and Pa-
tricia Meador, who helped initiate this effort and saw it become a re-
ality. Thanks also to James Fattibene and Ann Gerster at BNA Books
and, particularly, to the Supplement authors for their hard work and
service to the profession.
     On behalf of the ABA and its Health Law Section, we are pleased
to have this continuing opportunity to share our members’ collective
experience in the dynamic area of e-health. We believe you will find
this Supplement to be a continuing valuable resource. We would wel-
come your thoughts about how the Section can further use its BNA
book series to address your practice needs.

                                          J.A. (TONY) PATTERSON, JR.
                                                      SECTION CHAIR

                                              GREGORY L. PEMBERTON

                                                  MICHAEL E. CLARK
                                            PUBLICATIONS COMMITTEE

                                               HEALTH LAW SECTION
                                          AMERICAN BAR ASSOCIATION

October 2004
     The American Bar Association
          Health Law Section
     2004–2005 Officers & Council
           Chair                           Secretary
  J.A. (Tony) Patterson, Jr.           Andrew J. Demetriou
          Dallas, TX                     Los Angeles, CA

        Chair-Elect                      Budget Officer
    Gregory L. Pemberton                 Paul R. DeMuro
      Indianapolis, IN                  San Francisco, CA

         Vice Chair                  Immediate Past Chair
          [Vacant]                      Bonnie S. Brier
                                       Philadelphia, PA

                Council Members At Large
     David W. Hilgers              Alan S. Goldberg
        Austin, TX                 Washington, D.C.

      Larry I. Palmer                 Bernadette Broccolo
       Louisville, KY                     Chicago, IL

    Linda A. Baumann                    Vicki L. Robinson
     Washington, D.C.                    Washington, D.C.

           Section Delegates to the House of Delegates
    E. Paul Herrington III                Howard T. Wall
         Louisville, KY                    Brentwood, TN

Young Lawyers Division Liaison     Law Student Division Liaison
     J. Ronald Ward, Jr.                 Irving Freeman
         Covington, LA                    Pittsburgh, PA

                  Board of Governors Liaison
                       H. William Allen
                        Little Rock, AR

                      Publications Chair
                       Michael E. Clark
                         Houston, TX

  Chair, Editorial Board                 Section Director
     Charles M. Key                         Jill C. Peña
      Memphis, TN                           Chicago, IL
     The term “E-health” has taken on a new meaning since this trea-
tise was first published in June 2002. The idea for the book originally
grew out of the need of businesses and their counsel for legal guidance
in the “dot com” days of the Internet bubble. When the downturn ar-
rived, the attraction of the “e” moniker seemed to dissipate, and those
of us involved in this project wished we had used “health technology”
rather than “E-health” to describe an area of health care that was
larger and much more pervasive and solid than the Internet bubble.
     Very soon, however, the financial markets reflected an increased
interest in biotechnology and life science businesses, each of which
also faces the regulatory issues that make the health care industry
both an opportunity and a challenge for those willing to thread that
needle. A new convergence of interests in the development of elec-
tronic medical records; the Medicare Prescription Drug, Improve-
ment, and Modernization Act of 2002 with its e-prescribing grants; the
appointment of a federal government E-health czar; the popularity of
and controversy surrounding Internet sites enabling drug reimporta-
tion; and the seemingly endless HIPAA regulations all reinvigorated
the cache associated with the E-health label.
     Thus E-health remains an extraordinarily fertile field for growth
and development and, as before, it is impossible to publish a hard copy
text that remains altogether current. The pace of development is
breathtaking, and those who authored chapter updates for this Sup-
plement have simply tried to stay within sight of the emerging issues.
Nonetheless, the new developments and issues covered in this Sup-
plement are remarkable and many.
     Without repeating my acknowledgments of the numerous au-
thors and champions that are found in my original Preface, I would
like to recognize each of them again without reservation. All that was
said before shall stand, and then some.
     I would like to take this opportunity to acknowledge new authors
who have contributed to this Supplement. Cheryl Reicin and Joel
Rubinstein very ably assumed responsibility for updating Chapter 2
on business and finance issues. Paul Gilbert and his coauthors have
expanded and improved Chapter 7 on contracting principles for E-
health transactions. Alan Goldberg and Daniel Orenstein stepped up
to the plate and contributed an entirely new and remarkable Chap-
ter 14 on HIPAA enforcement issues. Andrew Ferren provided the im-
pressive supplement for Chapter 5 on property rights in technology
and information.

xii         E-Health Business & Transactional Law—2004 Supp.

     As before, I invite and welcome comments and suggestions, criti-
cal and otherwise, from readers so that each future supplement is an
improvement as well as an update of recent developments.

                                                    BARBARA BENNETT
                                                Hogan & Hartson, LLP
October 2004
About the Contributors

Barbara Bennett (Editor-in-Chief)
     Barbara Bennett is a partner at Hogan & Hartson LLP and a
member of both the firm’s Business and Finance Group and its
Health Group. Ms. Bennett’s practice focuses on health care trans-
actions, technology, and strategic advice, with a concentration in
e-health and bioscience clients and issues. Ms. Bennett has repre-
sented a leading health care Internet company, other clients that pro-
vide telemedicine or health care information technology services, and
biotech businesses, as well as more traditional health care busi-
nesses. Ms. Bennett’s health care experience includes working with
investment bankers, publicly held corporations, and emerging busi-
nesses, as well as in-house experience at both nonprofit and for-profit
companies. Ms. Bennett formerly served as General Counsel and Cor-
porate Secretary of TriPoint Health Group, a for-profit venture that
by contract created and managed TennCare, Medicare, and commer-
cial HMOs for a major academic medical center and also created and
owned its own commercial HMO and physician management com-
pany. Before joining TriPoint, Ms. Bennett was Associate General
Counsel of Vanderbilt University, where she represented Vanderbilt
University Medical Center for managed care issues and transactions,
and where her areas of substantial practice included intellectual
property and technology transfer; cost accounting (audit and negoti-
ation); and insurance and risk management. Ms. Bennett also is
trained in dispute resolution and served on the approved panel for
court-appointed mediators in Tennessee state courts. She was ap-
pointed to and served on both the Tennessee Supreme Court Com-
mission on Alternative Dispute Resolution and the Civil Justice
Reform Act Advisory Committee for the U.S. District Court for the
Middle District of Tennessee. She has held various positions with the
Business and Transactional Law Interest Group of the ABA Health
Law Section. Ms. Bennett received both her B.S. in mathematics and
her J.D. from Vanderbilt University, where she was Phi Beta Kappa,
Order of the Coif, and served as Articles Editor of the Vanderbilt Law
Review. Upon graduation from law school, she completed a federal
court judicial clerkship and practiced in the commercial litigation
section of a large law firm in New Orleans. Ms. Bennett is admitted
to the Tennessee and District of Columbia Bars.

xiv          E-Health Business & Transactional Law—2004 Supp.

Paul R. DeMuro (Chapter 1: Introduction to E-Health Law
    Paul DeMuro is a CPA with an M.B.A. in finance and practices
law in the corporate department of the international law firm of
Latham & Watkins. He is a member of the firm’s Life Sciences and
Healthcare, Venture & Technology, and Merger & Acquisitions
Groups. Mr. DeMuro holds a B.A. in Economics, summa cum laude,
from the University of Maryland at College Park; an M.B.A. in finance
from the University of California at Berkeley; and a J.D. from the
Washington University in St. Louis, where he was a member of the
Board of Editors of the Law Review. He is the Budget Officer for the
Health Law Section of the American Bar Association (ABA) and has
served on the National Board of the Healthcare Financial Manage-
ment Association and its Executive Committee. He is a former presi-
dent of the Northern California Chapter of the Healthcare Financial
Management Association. Mr. DeMuro is a Fellow in the Healthcare
Financial Management Association, a Fellow in the American College
of Medical Practice Executives of the MGMA, and is certified in
Healthcare Compliance by HCCA. Mr. DeMuro has authored over 50
publications and has delivered almost 300 presentations throughout
the world.
Cheryl V. Reicin (Chapter 2: The E-Health Industry: General
Business and Financing Issues)
     Cheryl Reicin is a partner in the law firm of Torys LLP (New
York/Toronto) and Practice Leader of the firm’s Technology and Life
Sciences Groups. Her practice focuses on health information, biotech-
nology, medical devices, and other technology-based companies, and
representation of private equity/venture capital funds and investment
banks that fund such companies. She also represents hospitals, acad-
emic medical centers, and universities. Ms. Reicin assists companies
in formulating domestic and international growth strategies and in
sourcing capital. She advises on venture and later-stage financings,
IPOs, mergers and acquisitions, licensing transactions, and joint ven-
tures or alliances with strategic partners. Ms. Reicin received her
Bachelor of Arts degree, summa cum laude, from Barnard College, Co-
lumbia University, and her Juris Doctor degree from Harvard Law
School. She is an author of An Insider’s Guide to Going Public and nu-
merous other publications relating to the health technology sector.
Ms. Reicin is a director of several boards in the health technology field,
including, among others, The Institute for Study of Aging, and Hasa-
dit, the technology arm of Hadassah Medical Center.
Joel L. Rubinstein (Chapter 2: The E-Health Industry:
General Business and Financing Issues)
    Joel Rubinstein is a partner in the corporate department of the
law firm of McDermott Will & Emery LLP, based in the firm’s New
                          About the Contributors                     xv

York office. Mr. Rubinstein represents software and other high tech-
nology companies, both private and public, in obtaining financing
through venture capital funds and other private sources, as well as
through the public markets. He also represents companies in mergers
and acquisitions, intellectual property licensing, stock option pro-
grams, and other general corporate matters. On the investor side, he
represents venture capital and private equity funds in their formation
and investment activities. In addition, Mr. Rubinstein represents
public companies in securities matters, including public offerings and
compliance with reporting and other requirements under securities
laws and stock exchange rules. Mr. Rubinstein received a J.D. from
the University of Michigan Law School and a B.A. in Economics,
magna cum laude, from Wayne State University, where he was made
a member of Phi Beta Kappa.
Lisa L. Dahm (Chapter 3: Privacy)
     Lisa Dahm currently practices health care law in Houston, and
provides consulting services as a partner at DDF & Associates, a
HIPAA and health care compliance consulting firm. Ms. Dahm has ex-
tensive and comprehensive knowledge and understanding of health
care laws and regulations with particular emphasis on privacy and
confidentiality (including HIPAA), fraud and abuse, physician trans-
actions, and Stark statutes and regulations. Prior to graduation from
law school, Ms. Dahm worked for health care information systems
vendors, health care providers, and her own and another Big Five con-
sulting firm. Following law school, Ms. Dahm spent three years as in-
house counsel for a major integrated delivery system located in
Houston, Texas, where she helped draft the system’s corporate com-
pliance program, served on the corporate compliance committee, re-
sponded to requests and subpoenas for business and health
information, served on the system’s Institutional Review Board, and
advised the system on and drafted required policies, procedures, cre-
dentialing activities, and all types of contracts. She joined Deloitte &
Touche as a Senior Manager, serving as member of the National
HIPAA Advisory Services Task Force and assisting in creating the
firm’s approach to providing HIPAA services to its health care clients;
she conducted numerous executive briefings for health care clients to
raise awareness of HIPAA, and managed and participated in HIPAA
Privacy and other health care risk assessments. Ms. Dahm received
her J.D. (magna cum laude) from South Texas College of Law in 1995,
and was admitted to the Bar in Texas the same year. Ms. Dahm has
authored a monograph on patient confidentiality laws (American
Health Lawyers Ass’n June 1999) and has written numerous articles
and papers on HIPAA and other legal topics. She is a recognized ex-
pert on privacy and confidentiality, and a frequent speaker at health
care, HIPAA, and legal regional and national conferences. Her expe-
rience in the health care industry spans more than 25 years.
xvi         E-Health Business & Transactional Law—2004 Supp.

Richard D. Marks (Chapter 3: Privacy)
     Richard Marks is a founder and president of Patient Command,
Inc., McLean, Virginia, a company that is developing a personal, cer-
tified, primary, secure, digital medical record system for the Internet.
He practiced law in Washington, D.C., from 1971 to 2003. His practice
included advising and litigating on behalf of telecommunications com-
panies; negotiating and enforcing contracts for outsourcing or acqui-
sition of large computer systems; litigating on intellectual property,
privacy, freedom of expression, encryption, and security issues; and
advising on implementation of HIPAA. Mr. Marks successfully tried
the first case in history declaring part of the Communications Act un-
constitutional and, in 1998, in the U.S. Supreme Court, he argued and
won a landmark First Amendment–free press case dealing with tele-
vised political debates. He is Chair (2003–2005) of the Program Com-
mittee of the ABA’s Section of Science and Technology Law and is a
member of the American Law Institute. He is past Chair of the HIPAA
Task Force and past Chair of the Computer Law Division of the ABA’s
Section of Science and Technology Law, and a past member of the Na-
tional Conference of Lawyers and Scientists. He is also a past Direc-
tor of the Computer Law Association. He was Co-Chair of the Security
Policy Advisory Group of the Workgroup for Electronic Data Inter-
change (WEDI), and Chair of the committee on HIPAA security certi-
fication. The author of many articles and chapters in a variety of legal
publications, he is also a frequent speaker on corporate governance,
HIPAA, computer acquisition, intellectual property, information and
computer security, privacy, and related topics at industry and legal
education seminars around the country. Mr. Marks holds a B.A. from
the University of Virginia and a J.D. from Yale Law School. In 1971
he served in the U.S. Army in Vietnam as a Captain in Military
George W. Bodenger (Chapter 4: Fraud and Abuse: Overview
of Business and Legal Issues)
     George Bodenger is a partner with Duane Morris LLP, in
Philadelphia, Pennsylvania. Mr. Bodenger practices in the area of
health law, with particular emphasis in the structuring and develop-
ment of commercial arrangements between health care providers and
related fraud and abuse compliance matters. He provides corporate
and regulatory counseling in hospital affiliations, various types of
physician-hospital initiatives, and large private medical practice con-
solidations. Mr. Bodenger’s areas of practice also include health care
antitrust and Medicare/Medicaid payment, managed care contract-
ing, and fraud and abuse counseling. A published author and frequent
speaker, he is a member of the American Health Lawyers Association
(AHLA), the American Hospital Association, the ABA, and the Health
Law subcommittees of the Pennsylvania and New Jersey State Bar
Associations. Admitted to practice in Pennsylvania and New Jersey,
Mr. Bodenger is a 1994 graduate of Temple University School of Law,
                         About the Contributors                    xvii

a graduate of Drexel University, where he earned an MBA degree, and
a graduate of The Pennsylvania State University.
R. Christopher Raphaely (Chapter 4: Fraud and Abuse:
Overview of Business and Legal Issues)
     Christopher Raphaely is a partner with the firm of Duane Morris
LLP, Philadelphia, Pennsylvania. Mr. Raphaely represents health
care providers and organizations in various regulatory and transac-
tional matters, with emphasis on managed care contracting, payor ap-
peals and reimbursement matters, business combinations, medical
staff relations, and e-health. Admitted to practice in Pennsylvania
and New Jersey, he is a member of the ABA and the Philadelphia Bar
Association, as well as the AHLA. Mr. Raphaely is a frequent speaker
on HIPAA, as well as other health care topics. He is a 1990 graduate
of Temple University School of Law and a 1986 graduate of the Uni-
versity of Pennsylvania.
Andrew J. Ferren (Chapter 5: Proprietary Rights in
Technology and Information)
    Andrew Ferren is a partner in the Boston office of Goulston &
Storrs, P.C. Mr. Ferren handles a wide range of business matters for
established and emerging companies, nonprofit organizations, closely
held businesses, and individual entrepreneurs, many of which are in
the health care industry. His practice focuses on intellectual property
counseling, protection, and transactions; technology transfer and li-
censing matters; and complex business agreements. Mr. Ferren re-
ceived his undergraduate degree from Harvard University and his law
degree from The University of Chicago Law School.
J. A. (Tony) Patterson, Jr. (Chapter 6: Professional
Licensure and Liability Issues)
     Tony Patterson is a partner at the Dallas, Texas, office of Ful-
bright & Jaworski L.L.P., where he practices exclusively in the health
law area, representing health care facilities, providers, and payors in
a wide variety of health law matters. Mr. Patterson received a B.A.
from Coe College, Cedar Rapids, Iowa, and a J.D., with honors, in
1970, from Southern Methodist University. He was admitted to prac-
tice law in Texas in 1973. Mr. Patterson is currently the Chair of the
ABA Health Law Section. Mr. Patterson speaks frequently before in-
dustry trade groups and attorneys. Mr. Patterson spoke at the ABA
Health Law Section mid-year meeting and conference Emerging Is-
sues in Health Care 2001, in February 2001, on “Emerging Issues in
Electronic Health Law.”
Paul D. Gilbert (Chapter 7: Contracting Principles for
E-Health Transactions)
    Paul Gilbert is a member in the Nashville office of Waller Lans-
den Dortch and Davis PLLC and serves on the firm’s Board of Direc-
xviii       E-Health Business & Transactional Law—2004 Supp.

tors. Mr. Gilbert practices in the areas of mergers and acquisitions
and securities law, virtually always on behalf of health care clients.
In the past few years, he has acted as outside counsel to investor-
owned and not-for-profit hospitals and health care systems in the ac-
quisition, affiliation, sale, or merger of more than 70 acute-care and
psychiatric hospitals throughout the United States and the Caribbean.
He has also served as outside counsel in a significant number of health
care joint ventures, syndications, public hospital privatizations, and
not-for-profit conversions. During this same period, Mr. Gilbert has
acted as lead outside counsel in a number of public and private equity
and debt securities offerings for various health care clients. Mr.
Gilbert received his Bachelor of Arts degree, magna cum laude, from
Wake Forest University in 1988. At Wake Forest, he was the recipi-
ent of the Claude H. Richards Award in Politics (awarded by univer-
sity faculty to one senior) and graduated with Honors in Politics. In
1991, he received his Juris Doctor degree from Vanderbilt University,
where he graduated Order of the Coif. Chambers USA included Mr.
Gilbert in its “America’s Leading Business Lawyers” and the
Nashville Business Journal named him a member of its “Healthcare
100” and the “Best of the Bar” in the mergers and acquisitions cate-
gory. As member of the ABA, Mr. Gilbert serves as Vice Chair of the
Publications Committee of the Health Law Section and is active in the
Committees on Negotiated Acquisitions and Federal Regulation of Se-
curities. Mr. Gilbert is also an active member of the AHLA.
Andy Norwood (Chapter 7: Contracting Principles for
E-Health Transactions)
     Andy Norwood is a member of Waller Lansden Dortch and Davis
PLLC, in Nashville, Tennessee, and has extensive experience in the
practice of law as it pertains to intellectual property, including copy-
right, trademark, First Amendment issues, and trade secrets. Mr. Nor-
wood received his Bachelor of Arts degree, cum laude, from the
University of Alabama in 1984. In 1987, he received his Juris Doctor de-
gree from the University of Alabama School of Law. Mr. Norwood was
the recipient of the M. Leigh Harrison Award for legal writing in 1987.
He served as Co-Editor-in-Chief of The Journal of the Legal Profession
and wrote “The Prosecutor and Pre-Trial Publicity” for that publication.
Stephen Page (Chapter 7: Contracting Principles for
                          About the Contributors                       xix

E-Health Transactions)
    Stephen Page is a member of Waller Lansden and Davis PLLC,
in Nashville, Tennessee, and concentrates his practice in health care
and intellectual property law. He advises clients on matters including
e-health issues, HIPAA, and the confidentiality of health information,
fraud and abuse laws, physician self-referral laws, Medicare reim-
bursement issues, managed care law, and facility licensure. In 1987,
Mr. Page received his Bachelor of Science degree from the University
of Tennessee, where he was on the Dean’s List, and in 1994 he re-
ceived his Juris Doctor degree, cum laude, from the University of Ten-
nessee. He is a frequent contributor to health law publications and
speaks regularly at health law seminars. Mr. Page is active in the
Health Law Sections of the Nashville and Tennessee Bar Associations
and is a member of the AHLA’s Health Information and Technology
and Hospital/Health Systems Sections, the ABA Health Law Section,
and the American Health Information Management Association.
Mark Plotkin (Chapter 7: Contracting Principles for
E-Health Transactions)
     Mark Plotkin is an associate at Waller Lansden Dortch and Davis
PLLC, in Nashville, Tennessee. Mr. Plotkin practices in the area of in-
tellectual property law and focuses on advising clients on trademark,
copyright, trade secret, Internet law, and licensing issues. Mr. Plotkin
received his Bachelor of Arts degree, summa cum laude, from Emory
University, and his J.D. from Vanderbilt University School of Law,
where he served as the Senior Editor of the Vanderbilt Journal of En-
tertainment Law and Practice. Mr. Plotkin has authored a number of
articles related to intellectual property and privacy law and is active
in the International Trademark Law Association and the Intellectual
Property Law Sections of the Nashville, Tennessee, and American Bar
Eileen Burkhalter Smith (Chapter 7: Contracting Principles
for E-Health Transactions)
    Eileen Smith is an associate with Waller Lansden Dortch and Davis
PLLC, in Nashville, Tennessee, and practices in the area of general dis-
pute resolution. Her practice includes the resolution of federal and state
court lawsuits, administrative actions, and licensure actions concerning
health care providers and their employees. Ms. Smith received her
Bachelor of Arts degree from the University of Notre Dame and her
Juris Doctor degree, with honors, from the University of Tennessee.
Shannon B. Hartsfield (Chapter 8: Other Liability—Tort and
    Shannon Hartsfield is a partner with the firm of Holland &
Knight LLP, in Tallahassee, Florida. She practices in the area of
xx           E-Health Business & Transactional Law—2004 Supp.

health law, advising clients on state and federal health care regula-
tory matters including e-health, patient privacy, compliance, licen-
sure, telemedicine, and reimbursement. Ms. Hartsfield graduated Phi
Beta Kappa and magna cum laude with a B.A. in English and Com-
munications from Florida State University in 1992. As a recipient of
a University Fellowship, she earned her J.D., with high honors, from
Florida State University in 1995, where she was a member of the Law
Review, the Journal of Land Use and Environmental Law, and Order
of the Coif. The clients she serves include assisted living facilities,
medical equipment companies, tissue banks, nursing homes, phar-
macies, clinical laboratories, e-health companies, disease manage-
ment companies, and other members of the health care industry.
Currently, Ms. Hartsfield serves as Chair of the ABA’s eHealth, Pri-
vacy & Security Interest Group. She is also past chair of the Health
Care Law Committee for the Young Lawyers Division of the ABA.
Jacqueline Myles Crain (Chapter 8: Other Liability—Tort
and Regulatory)
     Jacqueline Myles Crain practices in the area of health care law,
advising clients on issues related to state and federal health care reg-
ulatory matters including compliance, patient privacy, and reim-
bursement. She is experienced in a variety of issues affecting health
care providers, including institutional review board and clinical re-
search issues, Medicare and Medicaid regulatory work, registration
and licensure for health care entities, Stark law, and HIPAA compli-
ance. Ms. Crain is admitted to practice in the State of Florida and be-
fore the U.S. District Court for the Middle District of Florida. She is a
member of the ABA, AHLA, the Florida Bar, and the St. Petersburg
Bar Association. She is currently a vice chair of the Health Law Com-
mittee for the Young Lawyers Division of the ABA. In her community,
Ms. Crain volunteers her time for the County Legal Assistance Pro-
gram and Northwest Elementary School. Ms. Crain graduated cum
laude from Florida State University in 1997. In 2001, she earned her
M.B.A. and her J.D. cum laude from Stetson University College of
Law, where she was the research editor of the Stetson Law Review and
a teaching fellow. A frequent speaker on HIPAA, Ms. Crain’s recent
speaking engagements include: “Applying the HIPAA Security Rules
to Employer Sponsored Health Plans: Complex Issues and Compli-
ance Strategies” (presentation at Florida Bar CLE seminar titled The
HIPAA Security Rules: One Year to Go—Are You Ready?, April 20,
2004); “HIPAA and Employee Benefit Plans” (presentation at seminar
on HIPAA for Employers in Florida organized by Lorman Education
Services, March 26, 2004); “HIPAA After 2003: Focusing on Enforce-
ment and the Security Rules” (presentation to employers, third-party
administrators, health plan and benefits personnel, and human re-
sources groups at the 12th Annual Employee Health Benefits Confer-
ence, January 22, 2004); “HIPAA Compliance for Employers—
Complex Issues and Superhero Strategies” (presentation to human re-
sources and benefits personnel at 11th Annual Treasure Coast HR
                          About the Contributors                     xxi

Conference at PGA Educational Center, October 3, 2003); and
“HIPAA The Real Issues” (presentation at 2003 Annual Meeting of
Florida Society of Ophthalmology, September 13, 2003).
Michael F. Sexton (Chapter 9: Internet Pharmacies and
Other FDA Regulation of E-Health)
    Michael Sexton is a partner in Ropes & Gray’s Health Care Group
and Life Sciences Group in Boston, Massachusetts. Mr. Sexton repre-
sents pharmaceutical companies, pharmacy benefit managers, acad-
emic medical centers, venture capital firms, and other types of health
care and life sciences companies. Prior to joining Ropes & Gray in
1993, he was a law clerk for the Honorable Levin Campbell of the
United States Court of Appeals for the First Circuit. Mr. Sexton grad-
uated magna cum laude from Amherst College in 1987, and he earned
a J.D. cum laude in 1992 from Harvard Law School, where he was an
editor of the Harvard Law Review.
John D. Blum (Chapter 11: International and Comparative
Law Considerations in E-Health)
     Professor John D. Blum is the John J. Waldron Research Profes-
sor of Health Law at Loyola University Chicago School of Law. Pro-
fessor Blum was the founding director of the Loyola Institute for
Health Law, and was the Institute director for 14 years. He teaches in
the areas of health law and policy, and has been a two-time Fulbright
scholar in comparative health law in Canada and Malaysia. In recent
years, Professor Blum has been active in researching and publishing
in the areas of domestic and international e-health, and he is a fre-
quent lecturer in these areas. He is a graduate of Canisius College,
Buffalo, N.Y. (B.A.), Notre Dame Law School (J.D.), and the Harvard
University School of Public Health (M.H.S.).
William H. Roach, Jr. (Chapter 12: Due Diligence in E-Health
    William Roach is a partner in the Health Law Department of Mc-
Dermott Will & Emery LLP, and he is located in Chicago, Illinois. Mr.
Roach received an A.B. from Columbia University, a J.D. from Van-
derbilt University (where he was a Patrick Wilson Scholar), and an
M.S. from the Health Law Program of the University of Pittsburgh.
His practice includes corporate transactions involving hospital sys-
tems and providers, regulatory compliance matters, tax-exempt orga-
nizations, and medical staff organization, credentialing, and
contracts. He has served as a key advisor to the boards of directors of,
as well as the principal outside counsel for, numerous health care or-
ganizations. Mr. Roach is a well-known expert in the law governing
use of health care information. He has spoken and written widely and
has co-authored a book entitled Medical Records and the Law, the
fourth edition of which is in production. Mr. Roach is a member of the
editorial advisory boards of numerous professional journals, includ-
xxii        E-Health Business & Transactional Law—2004 Supp.

ing Managed Care Law Manual, Medical Staff Briefing, and Briefings
on HIPAA and Health Information Security. He is a Contributing Ed-
itor of the Hospital Law Manual and a Special Features Editor for
Topics in Health Information Management.
L. Robert Guenthner (Chapter 12: Due Diligence in E-Health
     Robert Guenthner is an associate with Gardner, Carton & Douglas
in Chicago, Illinois. Mr. Guenthner is a member of the firm’s Health
Law and Corporate Departments and serves as chair of the Associates
Committee. His practice includes the representation of diversified
health systems, managed care organizations, medical equipment man-
ufacturers, and various other health care and general corporate enti-
ties. He concentrates his practice in the areas of mergers and
acquisitions, divestitures, joint ventures, corporate reorganizations,
and other commercial transactions. He has substantial experience in
the acquisition and divestiture of various types of regulated and non-
regulated entities, both publicly traded and privately held. Mr. Guen-
thner received his law degree from Washington University School of
Law in Saint Louis, where he was inducted into the Order of the Coif,
a national honor society for law school graduates. He also received his
Masters in Business Administration with a joint concentration in fi-
nance and organizational behavior from Washington University’s John
M. Olin School of Business, and his B.S. from the University of Dayton.
Arthur G. House (Chapter 12: Due Diligence in E-Health
     Arthur House is a partner in the Washington, D.C., office of Gard-
ner, Carton & Douglas and is co-vice chairman of the firm’s TechVen-
tures Group. Mr. House’s practice is focused on licensing and venture
formation in biotech and other technology areas, including license,
distribution, storage and assignment transactions, strategic alliance
agreements, and litigation. He has overseen the growth and develop-
ment of a number of technology and science-based clients from start-
up through venture capital, merger, acquisition, and IPO stages. He
received his B.A., cum laude, from Tufts University in Medford, Mass-
achusetts, and his J.D. from the University of Virginia School of Law
in Charlottesville, Virginia.
William Freivogel (Chapter 13: Legal Ethics and E-Health)
    Bill Freivogel is Senior Vice President–Loss Prevention at Aon
Risk Services and is a member of its Professional Services Group
where he provides legal ethics and loss prevention services to Aon’s
law firm clients. Mr. Freivogel provided similar services as ALAS’
Loss Prevention Counsel from 1988 until 2000. He was a private con-
sultant to law firms from 2000 until July 2002, and a trial lawyer from
1965 until 1988, handling matters in the following substantive areas:
                          About the Contributors                      xxiii

antitrust, securities, civil rights, and products liability. Mr. Freivogel
is a member of the American Law Institute, where he was a member
of the Members’ Consultative Group for the Restatement of the Law
Governing Lawyers project. He was a member of the Advisory Coun-
cil to the American Bar Association “Ethics 2000” Commission, and he
is a member of the ABA Business Law Section Legal Opinions Com-
mittee. Mr. Freivogel has written and spoken extensively in the areas
of legal ethics and loss prevention. He is the author of Freivogel
on Conflicts, a comprehensive online guide to conflicts of interest, A partial list of his other writ-
ings includes: Conflicts of Interest: A Storm Warning from the U.S.?,
EUR. LAW. 20 (Nov. 2001); Selected Ethics Issues in Litigation Practice,
72 TULANE L. REV. 637 (1997) (co-author); Conflicts of Interest and the
Business Lawyer: A Professional Liability Epidemic, 11 DEL. LAW. 32
(Winter 1993); Emerging Conflict of Interest Issues, 79 ILL. B.J. 628
(Dec. 1991). Mr. Freivogel received his LL.B. from the University of
Illinois College of Law in 1965 and his B.S. from the University of
Illinois in 1962.
Alan S. Goldberg (Chapter 14: Enforcement of the Health
Insurance Portability and Accountability Act; and
Appendix F-4)
     Alan Goldberg, of Goulston & Storrs (Boston, New York, Wash-
ington, D.C., and London, U.K.), concentrates in the practice of busi-
ness law, including the business of health care and information
technology. Mr. Goldberg’s current interests include challenges and op-
portunities in the application of technology to the practice of law and
medicine and the delivery of health care, such as issues involving busi-
ness transactions, the Internet, ePrescribing, security and encryption,
privacy and confidentiality, software licensing and devices, corporate
compliance programs, and telemedicine. Mr. Goldberg joined Goulston
& Storrs in 1967 on graduating from Boston College Law School, where
he was a member of Law Review, and served on active duty in the
United States Navy Judge Advocate General’s Corps. In 1978, Mr.
Goldberg received an LL.M. in Taxation from Boston University School
of Law. He is an Adjunct Professor of Law at Boston’s Suffolk Univer-
sity Law School and the University of Maryland School of Law in Bal-
timore. He is active in the ABA and is a past President of the AHLA
and the first Moderator of the AHLA’s Health & Information Technol-
ogy listserv. Mr. Goldberg has served as Vice Chair of the AHLA Health
Information and Technology Practice Group, and Chair of the ABA
Health Law Section’s e-Health, Privacy & Security Interest Group; he
co-chairs the National HIPAA Summit series of events and is a Coun-
cil Member of the ABA Health Law Section and its first Substantive
Webmaster, and a member of the Steering Committee of the District of
Columbia Bar Association Health Law Section, and the Webmaster of Among other activities, Mr. Goldberg
has published extensively on a wide range of health law and other legal
xxiv         E-Health Business & Transactional Law—2004 Supp.

issues and is a frequent lecturer for health lawyer, bar association, in-
formation technology, and health care groups. He is a member of the
District of Columbia, Massachusetts, New York, and Florida bars.
Daniel H. Orenstein (Chapter 14: Enforcement of the Health
Insurance Portability and Accountability Act)
     Daniel Orenstein is a corporate and health care attorney who ad-
vises and represents businesses and individuals on a wide range of
matters, including business formations, transactions, and structuring
business arrangements to comply with federal and state laws and
regulations affecting the health care industry, including the federal
anti-kickback statute, the Stark law, reimbursement rules, and the
HIPAA privacy and security standards. Mr. Orenstein also has sub-
stantial experience assisting businesses in managing and licensing in-
tellectual property, and in preparing and negotiating employment
agreements, consulting agreements, and vendor contracts. He has
worked with a wide range of companies and health care organizations
throughout the country, including both of the major health care sys-
tems in the Boston area. Prior to forming the law firm Orenstein LLC,
Mr. Orenstein practiced law with firms in Washington, D.C., and
Boston. Mr. Orenstein received his bachelor’s degree from Columbia
University and his law degree from the Georgetown University Law
Center. He is fluent in Russian and has spent time volunteering with
Russian immigrants to the United States.
Amy Jurevic Sokol (Appendices A, B, and D)
     Amy Jurevic Sokol is the Vice President and General Counsel for
Carondelet Health in Kansas City, Missouri. She is also the Corporate
Responsibility and Privacy Officer. Ms. Sokol received her J.D. degree,
cum laude, from St. Louis University School of Law, where she was
the executive managing editor of the St. Louis-Warsaw Transatlantic
Law Journal. She received her Masters degree in Health Adminis-
tration with Great Distinction from St. Louis University School of
Public Health. Ms. Sokol is an adjunct faculty member at Rockhurst
University in the Healthcare Leadership Program. Ms. Sokol is a
member of the American College of Healthcare Executives, where she
is a member of the Regent’s Advisory Council for the Missouri Show-
Me-Area and a member of the Editorial Board for the Healthcare Ex-
David Voran (Appendix A)
     Dr. David Voran is a client physician executive for the Cerner
Corporation and chief medical information officer for Health Midwest,
a 14-hospital network in the Kansas City–area and his primary
Cerner client. Dr. Voran was formerly the Executive Director of In-
formation Technology at Kansas University, where he was responsi-
ble for computing, telecommunications, printing, mail room, medical
                         About the Contributors                    xxv

informatics, and telemedicine. He is a board-certified family practi-
tioner and a faculty member of the Family Practice Residency pro-
gram at Goppert Family Care, a Health Midwest Facility. He is also
a volunteer preceptor and Family Practice faculty at the University of
Kansas Medical Center. Dr. Voran earned his undergraduate degree
from Wichita State University in 1974, with a B.A. in anthropology
(1974) and an A.A. in respiratory therapy (1978). In 1988, he was
awarded an M.D. degree from the University of Kansas–School of
Medicine; in 1991, he was awarded a post-graduate degree from the
University of Kansas–Family Practice. Dr. Voran lectures at many
conferences, has written several publications, and has an in-depth
knowledge of medical practice and the Internet.
Bradley G. Allen (Appendix F-4)
     Bradley Allen is with Whiteman Osterman & Hanna LLP, in Al-
bany, New York. Mr. Allen was formerly an associate with the law
firm of Goulston & Storrs. He is a member of the Corporate and Tech-
nology Groups, and focuses his practice on general corporate matters,
mergers and acquisitions, and for established and emerging compa-
nies and non-profit organizations. He received a J.D., cum laude, from
the University of Pennsylvania Law School, an M.A. from Syracuse
University, and a B.A. magna cum laude from the State University of
New York at Albany. Mr. Allen is admitted to the Massachusetts and
New York bars. He is also the coauthor of HIPAA Terms: An Anno-
tated Glossary (American Health Lawyers Ass’n 2003).

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