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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 Foreword 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 FRAUD AND ABUSE: PRACTICAL PERSPECTIVES. Both are down-to-earth 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 CHAIR-ELECT MICHAEL E. CLARK CHAIR 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 Preface 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. xi 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 EDITOR-IN-CHIEF 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. xiii xiv E-Health Business & Transactional Law—2004 Supp. Paul R. DeMuro (Chapter 1: Introduction to E-Health Law Issues) 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 Intelligence. 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 Associations. 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 Regulatory) 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 Transactions) 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 Transactions) 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 Transactions) 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, http://www.freivogelonconﬂicts.com. 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 http://www.healthlawyer.com. 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- ecutive. 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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