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This is not a textual record. This is used as an
administrative marker by the George Bush Presidential
Library Staff.
Record Group/Collection:
Donated Historical Materials
Collection/Office of Origin: Frieden, Lex, Collection
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Related Materials
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Bush Medal
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Bush Medal [1999]
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GEORGE BUSH
March 15, 1999
Dear Lex,
I have your letter of March 9. I am pleased that you are
in close touch with Mike Deland and Alan Reich and that,
in some ways, your event is being blended in with their
event at my library.
Kathy Super is handling the details of all of this for me.
I am very willing to participate in the torch lighting, and
Kathy is empowered to commit me to whatever participation
you and she can agree to.
I hope you enjoyed your trip to Kuwait. Also, thanks for all
your help with the bike I wanted to send to Saudi Arabia. I'm
sorry that didn't work out, but I appreciate your efforts.
Warm regards, always,
Mr. Lex Frieden
Senior Vice President
TIRR
1333 Moursund
Houston, TX 77030-3405
P.O. BOX 79798
HOUSTON, TEXAS 77279-9798
PHONE (713) 686-1188
FAX (713) 683-0801
Bush Library Photocopy George Bush Handwriting
GEORGE Bush
ABUSTON
by Bunt
MAR16'99
PO3TAGE AND FEES
PAID
TX
Mr. Lex Frieden
Senior Vice President
TIRR
1333 Moursand
Houston, TX 77030-3405
77030+3408
HEALTH LAW
&
POLICY
INSTITUTE
UNIVERSITY OF HOUSTON LAW CENTER
4800 CALHOUN ROAD
HOUSTON, TEXAS 77204-6381
713-743-2101
713- 743-2117 FAX
Mark A. Rothstein
Cullen Distinguished Professor of Law
Director
Laura F. Rothstein
Law Foundation Professor of Law
To:
Associate Director for Development
Advisory Board Members
Mary Anne Bobinski
Professor of Law
From:
Associate Dean for Academic Affairs
Mark A. Rothstein MAR
William J. Winslade
Distinguished Visiting
Date:
Professor of Law
March 16, 1999
Associate Director for
Graduate Programs
Seth Chandler
Re:
Meeting on March 10, 1999
Associate Professor of Law
Ronald Turner
Associate Professor of Law
Mary R. Anderlik
I am sorry you were unable to attend last week's meeting, but I certainly
Research Professor
understand that this is a particularly busy season. I just wanted to report that we
Elaine A. Lisko
Research Professor
had an excellent meeting, and the members in attendance provided some valuable
Melanie R. Margolis
advice about possible collaborative programs and publications.
Research Professor
S. Van McCrary
Research Professor
I announced at the meeting that the Gardere & Wynne Lecture for 2000
Ronald L. Scott
Research Professor
will celebrate the 10th Anniversary of the ADA. Former Attorney General
Kathleen Sheridan
Richard Thornburgh has agreed to speak, and former President Bush has
Professor of Psychology
Research Professor
indicated that he will also speak at our luncheon. Board Member Lex Frieden
Cathy F. Rupf
and TIRR are working with us on this lecture, in the same way that M.D.
Assistant Director
Anderson did with the 1999 lecture by Dr. David Kessler. Please save the date:
STAFF
Bobbie L. Hurman
February 24, 2000.
ADVISORY BOARD
Jerry Bell
Teel Bivins
Board Member Elizabeth Rockwell received the 5th Annual Distinguished
Calvin'Botley
Phyllis Brasher
Service Award in recognition of her support of the Institute and its programs in
Chet Brooks
Samuel Ward Casscells
1998.
J. Richard Cheney
Paul Colbert
Garnet F. Coleman
Samuel S. Crocker
I look forward to seeing you at the fall meeting, if not sooner.
Debra Danburg
Dianne W. Delisi
Mary desVignes-Kendrick
J.D. Epstein
Sheila Kay Johnstone-Ferendelli
Lex Frieden
Mario Gallegos, Jr.
Bob Gammage
Jack Harris
R. King Hillier
Bruce Levy
M. David Low
Melinda H. Perrin
Charles R. Parker
Glen J. Provost
John Robertson
Elizabeth D. Rockwell
Shelby R. Rogers
Michele Sabino
Daniel W. Shuman
J. Michael Solar
Kathryn S. Stream
HEALTH LAW AND POLICY INSTITUTE
ANNUAL REPORT
1998-1999
MARCH 1999
HEALTH LAW
&
POLI
INSTITUTE
UNIVERSITY OF HOUSTON LAW CENTER
4800 CALHOUN ROAD
HOUSTON, TEXAS 77204-6381
713- 743-2101
713-743-2117 FAX
Mark A. Rothstein
Cullen Distinguished Professor of Law
Director
Dear Friend of the Institute:
Laura F. Rothstein
Law Foundation Professor of Law
Associate Director for Development
During the last year, the Health Law and Policy Institute celebrated its 20th
Anniversary. It was not only a year of anniversary publications and parties, but one in which
Mary Anne Bobinski
Professor of Law
we continued to reach new heights in pursuit of our mission of education, research, and
Associate Dean for Academic Affairs
service.
William J. Winslade
Distinguished Visiting
Professor of Law
The community support for the Institute continues to grow, as evidenced by the new
Associate Director for
Graduate Programs
members of the Advisory Board, who represent a variety of backgrounds and interests. Our
Seth Chandler
relationship with the Texas Legislature improves every year, as more members become aware
Associate Professor of Law
of our role and request research and policy analysis. We continue to attract students with a
Ronald Turner
strong interest in health law and excellent credentials.
Associate Professor of Law
Mary R. Anderlik
Research Professor
Among the highlights of 1998-99 are the following:
Elaine A. Lisko
Research Professor
o
The Institute added two new research faculty members, Mary Anderlik and
Melanie R. Margolis
Kathleen Sheridan.
Research Professor
S. Van McCrary
The Institute launched a new web site, which already has received recognition for
Research Professor
"Health Law Perspectives," our continually-updated analyses of health law and policy.
Ronald L. Scott
Research Professor
The Health Law News has expanded in length, scope, circulation, and recognition.
Kathleen Sheridan
Professor of Psychology
Research Professor
The highly successful, 1999 Gardere & Wynne Lecture, featuring Dr. David
Cathy F. Rupf
Assistant Director
Kessler, marked the first time the lecture was cosponsored by a Texas Medical Center
Institution (M.D. Anderson Cancer Center).
STAFF
Bobbie L. Hurman
ADVISORY BOARD
o Four of our May 1998 Law Center graduates began one-year fellowships working
Jerry Bell
on health issues for the Texas Legislature before and during the 76th Legislative Session.
Teel Bivins
Calvin Botley
Phyllis Brasher
Chet Brooks
o The Robert Wood Johnson Foundation awarded the Institute (along with UTMB) a
Samuel Ward Casscells
J. Richard Cheney
$75,000 planning grant to coordinate the Texas End-of-Life Partnership. We hope to receive
Paul Colbert
an additional implementation grant of $375,000, and are seeking matching funds of $150,000 over
Garnet F. Coleman
Samuel S. Crocker
three years.
Debra Danburg
Dianne W. Delisi
Mary desVignes-Kendrick
J.D. Epstein
In summary, although the Institute continues to experience some growing pains, our future
Sheila Kay Johnstone-Ferendelli
has never looked brighter.
Lex Frieden
Mario Gallegos, Jr.
Sincerely,
Bob Gammage
Jack Harris
R. King Hillier
Main A. Rothste
Bruce Levy
M. David Low
Mark A. Rothstein
Melinda H. Perrin
Charles R. Parker
Cullen Distinguished Professor of Law
Glen J. Provost
John Robertson
Director
Elizabeth D. Rockwell
Shelby R. Rogers
Michele Sabino
Daniel W. Shuman
J. Michael Solar
Kathryn S. Stream
I.
ACADEMIC PROGRAMS
Courses
HEALTH LAW COURSE ENROLLMENT BY YEAR
700
# of Students
600
536
500
477
430
447
of Students
400
364
346
322
317
327
338
300
271
200
100
0
1988-89
1989-90
1990-91
1991-92
1992-93
1993-94
1994-95
1995-96
1996-97
1997-98
1998-99
Academic Year
A total of 447 students completed eighteen health law courses from the summer of 1998 through
the spring of 1999. The enrollment by course is indicated in Appendix A. The January 1999
intersession course, "Health Care Rationing," was taught by Professor Mark Hall, Professor of Law and
Public Health at Wake Forest School of Law.
New Faculty
Mary R. Anderlik has joined the Institute Research Faculty and will be working with the TIRR grant to
study access to health care for persons with disabilities. She will also be working on various
Legislative research projects.
Dr. Kathleen Sheridan, Professor of Psychology at UH has been appointed as a Research Professor
with the Institute. She will teach Law and Psychology and work on various health research projects.
NEW COURSES
Two new courses were added to the schedule this year. Dr. Bill Winslade taught Regulation of
Biomedical Research and Dr. Kathy Sheridan taught Law & Psychology.
- 1 -
JD/MPH
Eighty students have participated in the concurrent J.D./M.P.H. program, and twelve students
have graduated since the beginning of the program in 1988. Health law students are choosing to be non-
degree seeking students and taking a few courses for credit at The University of Texas School of Public
Health. We currently have eight students enrolled in the concurrent degree program.
JD/PhD
The JD/PhD program currently has three students enrolled: third year law student Cheryl Erwin, and
second year law students Karla Tomyos and Amy McGuire.
L.L.M. Program
Since its inception in 1992, the LL.M. program in Health Law has enrolled 67 students, and 30
have received an LL.M. Approximately 10 new students are enrolled each year.
Student Activities
The student Health Law Organization (HLO) has approximately 60 active members. The HLO
participated as volunteers at The People's Law School and New Student Orientation. They gave the
second annual Alumni Recognition award honoring the accomplishments of UH Alumnus J. Richard
Cheney. Presentations were made throughout the year including Becky Nesmith, Program
Coordinator for CASA- a child advocacy organization. That meeting was kicked off with a
successful holiday toy drive benefiting CASA children.
II. PUBLICATIONS, CONFERENCES/LECTURES, AND RESEARCH
Publications
(See listing of Health Law faculty publications in Appendix B)
Due to the lack of a Health Law Section of the State Bar of Texas Health Law Writing Competition
- UH students did not sweep the competition this year.
The Health Law News is published quarterly circulation continues to increase, with
approximately 6,500 individuals, academic institutions, hospitals, law firms, businesses, and
government agencies across the U.S. Special sections in the Health Law News during 1998-99
included: Supreme Court Review (Sept. 1998), The 76th Texas Legislative Preview (Dec. 1998),
Medical Privacy (March 1999), and Medically Underserved Populations (June 1999).
- 2
The Houston Law Review's annual health law symposium issue has published eight issues (1988,
1989, 1990, 1991, 1992, 1994, 1995, 1996, 1997, and 1998) based on health law conferences. The
1999 symposium issue will feature Dr. David Kessler.
Update on Health is a monthly briefing for the Texas Legislature and other key state officials. It
summarizes health law developments in federal and state agencies, federal and Texas courts, and
other sources of importance to Texas lawmakers.
Current Issues in Managed Care is a publication specific to the Texas Cancer Council and
March 99 marks the eighteenth issue published.
The Health Law and Policy Institute web site, which was extensively redesigned in December 1998 to
be more user friendly (i.e., reduced load time and made getting around easier), includes:
Health Law Perspectives, which contains articles by Institute faculty and scholars analyzing
recent developments in health law;
Health Law News, published quarterly by the Institute;
Health Law Faculty information;
Academic Program information;
Information on Research, Publications, and Conferences; and an
Advisory Board listing.
The web site was recognized by the Cornell Law Library's In-Site awareness service on
February 22, 1999. (The law librarian at Cornell evaluates potentially useful law-related
web sites, select the most valuable ones, and provide commentary and subject access
to them). A consumer health links feature is in the works and will be added to the web
site soon.
Conferences/Lectures
The 19th Annual ASLME Health Law Teachers Conference, was held on June 4-6, 1998, at the
Wyndham Warwick Hotel. The Institute was host to150 health law professors from across the U.S.
and abroad. As a pre-conference activity, the Institute set up a tour of the Texas Medical Center
which included ethics rounds at five locations, including Texas Children's Hospital, The Methodist
Hospital, M.D. Anderson Cancer Center, Baylor College of Medicine, and Hermann Hospital.
Approximately 40 conference attendees participated.
The 1998 Gardere & Wynne Lecture was held February 16, 1998. Dr. David Kessler, Dean, Yale
University School of Medicine and former Commissioner, Food and Drug Administration, spoke to a
crowd of approximately 260 people who attended the lecture at the M.D. Anderson Cancer Center,
which included, attorneys, physicians, and community and industry leaders.
- 3 -
Research Projects
Texas Cancer Council
Two consumer oriented brochures were printed: "Cancer and the Law: 1998" and "Choosing a
Health Care Plan." Distribution on both publications has been started through mail, on the Institute
web site, the TCC site, and The American Cancer Society site.
Additionally, a third publication has been drafted, The "Employers Guide to Health Insurance,"
and is currently under review by TCC.
A briefing paper on "Cancer Care Under the Indigent Health Care Act" was prepared and
distributed to key members of the Texas Legislature.
The monthly publication "Current Issues in Managed Care" is currently being mailed to Texas
Cancer Council, Managed Care Steering Committee.
Legislative reports were prepared on identifying and discussing recently filed bills related to
cancer and managed care.
Texas Legislature
Prepared several briefing papers for members of the Legislature. These included: a report on
epilepsy, inadvertent hospital billing, a survey on health care coverage programs for low-income
populations, mandatory premarital HIV testing legislation, and ephedrine products and TDH
regulation.
Forthcoming legislative briefings on consent for emergency medical treatment, exemption from
mandatory immunization, and hepatitis.
The Institute for Rehabilitation and Research (TIRR)
The Health Law and Policy Institute has received a $50,000 grant from the National Institute on
Disability and Rehabilitation Research of the U.S. Department of Education. The Health Law and
Policy Institute is working with The Institute for Rehabilitation and Research (TIRR), conducting legal
research as part of a TIRR study to identify the barriers to accessing appropriate health care services
faced by persons with disabilities enrolled in managed care. The Health Law and Policy Institute
began work on this three-year study in June 1998.
Robert Wood Johnson Foundation End-of-Life Grant
The Health Law and Policy Institute recently received a $75,000 grant from the Robert Wood
Johnson Foundation, the nation's largest philanthropy devoted exclusively to health and health care,
to support the Texas Partnership to Improve End-of-Life Care. The partnership consists of over 30
organizations of health care professionals, policymakers, educators, social service workers, and the
public, that will work together to reshape public policy to improve care for persons nearing the end of
life, and their families.
- 4 -
III. FINANCE
Budget
For the past four years, the UH Law Foundation Institute budget has remained flat or has
declined, depending on accounting methods. The $48,000 budgeted covers .3 of the salary of the
assistant director, maintenance and operations (telephone, postage, copying, supplies), a portion of
the Health Law Library (acquisitions, binding), including the Health Law News, poster, brochure, and
intersession course.
HEALTH LAW AND POLICY INSTITUTE
1998-1999 FINANCES
State Line Item
$ 337,153
UH Law Foundation Budget
48,000
Texas Cancer Council
104,700
Gardere & Wynne
15,000
TOTAL
$ 504,853
HEALTH LAW AND POLICY INSTITUTE GIFTS
Houston Endowment - $100,000
Health Law Library Endowment - Mimi & Bill Walker $50,000
John B. Neibel Scholarship Fund
$10,000
Created in the Spring of 1998, the John B. Neibel Scholarship was set up, from contributions, to honor
Professor John Neibel for his leadership in initiating the Law Center's health law program. The scholarship
is awarded annually to a health law student.
- 5-
APPENDIX A
Health Law Enrollment, 1998-99
Fall 1998
Fraud and Abuse
20
Clark
Health Care Law and Policy
20
Epstein
Health Law
46
Chandler
Law and Disabilities
47
Rothstein, L.
Law and Bioethics
18
Winslade
Health Law Master's Class
11
Winslade
Health Law & the Constitution Seminar
13
Bobinski
Health Legislation Seminar
12
Rothstein, M.
Total
187
Spring 1999
Regulation of Biomedical Research
14
Winslade
Medical Malpractice Litigation
31
Baker
Current Issues in Health Law (HIV)
25
Turner
*Health Care Rationing
31
Hall
Genetics and the Law
24
Rothstein, M.
Health Law Master's Seminar
8
Winslade
Law and Psychology
13
Sheridan
Regulation of Health Care Professionals
11
Pate
Health Law
66
Bobinski
Health Care Organizations
21
James/Dacso
Total
244
Health Law Clinic
(Includes Sum. 98, Fall 98, Sp. 99)
16
TOTAL:
447
Intersession course held January 2-12. Course was limited to students with at least one health law course or a health
law background.
- 6-
APPENDIX B
HEALTH LAW FACULTY
RECENT PUBLICATIONS
Mark A. Rothstein
"Protecting Genetic Privacy by Permitting Employer Access Only to Job-Related Employee Medical
Information: Analysis of a Unique Minnesota Law," 24 American Journal of Law and Medicine 399 (1998)
(with Betsy D. Gelb and Steven G. Craig).
"Genetic Privacy and Confidentiality: Why They Are So Hard to Protect," 26 Journal of Law, Medicine &
Ethics 181 (1998)
Laura F. Rothstein
Disabilities and the Law (West Group April Supp. 1998)
"Guidelines Emerge for Accommodating Students Who Have Learning Disabilities," Chronicle of Higher
Education, p. B6 (April 24, 1998)
Disability Law: Cases and Materials (2d edition)(The Michie Company 1998) and 1998 Teacher's Manual
"The Americans with Disabilities Act, Section 504, and Adults with Learning Disabilities in Adult Education
and Transition to Employment," Chapter in Bridging the Gap: Learning Disabilities, Adult Education, and
Literacy (Paul H. Brookes 1998)
"Teaching Disability Law," 48 Journal of Legal Education 297 (Fall 1998)
"The Affirmative Action Debate in Legal Education and the Legal Profession: Lessons from Disability and
Discrimination Law," 2 University of Iowa Journal of Race, Gender, and Justice 1 (1998)
- 7 -
Mary Anne Bobinski
"The Expanding Domain of the ADA: The Supreme Court's Decision in Abbott V. Bragdon," 60 Texas Bar
Journal 918 (1998)
"Is a Medicare Fiscal Intermediary's Refusal to Reopen a Provider's Cost Report Subject to Administrative or
Judicial Review?" Preview of Supreme Court Cases (December, 1998)
S. Van McCrary
"Legal and Ethical Aspects of End-of Life Medical Treatment: A Brief Overview of Major Trends in the United
States,"7 Studies in Ethics and Law 107 (1998)
- 8 -
HealthLaw News
March 1999
LEX
Vol. XII, No. 3
A Quarterly Publication of the University of Houston Health Law and Policy Institute. Established in 1978.
http://www.law.
uh.edu/healthlaw
Institute Awarded Robert Wood Johnson
Foundation End-of-Life Grant
he Health Law and Policy Institute recently
Institute and the Institute for the Medical Humanities at the
received a $75,000 grant from the Robert
II
University of Texas Medical Branch at Galveston, has identified
Wood Johnson Foundation, the nation's
numerous goals, including the following: (1) educating and
largest philanthropy devoted exclusively to
collaborating with policymakers in an effort to improve laws
health and health care, to support the Texas
and other public policies on end-of-life care; (2) fostering
Partnership to Improve End-of-Life Care.
public awareness of end-of-life issues; (3) serving as a resource
The partnership consists of over 30 organi-
and clearinghouse to educate the public and refer persons to
zations of health care professionals,
appropriate health and social service professionals; and (4)
policymakers, educators, social service workers, and the public,
supplementing the professional development of physicians,
that will work together to reshape public policy to improve care
nurses, social workers, hospice personnel, and other health-
for persons nearing the end of life, and their families. According
related professionals.
to S. Van McCrary of the Health Law and Policy Institute, "this
The one-year grant will fund the planning phase of the
Partnership will provide a unique opportunity for a
Partnership. Later this year, the Health Law and Policy
multidisciplinary group of professionals in Texas to work
Institute and the Institute for the Medical Humanities will apply
together toward the common goal of developing a statewide
to the Robert Wood Johnson Foundation for the implementation
network of quality, comprehensive end-of-life care."
phase of the Partnership which, if awarded, will provide two
The Partnership, founded by the Health Law and Policy
years of additional funding.
Mark Rothstein
Kessler Delivers Gardere &
Receives Public
Wynne Lecture
Health Hero
Award
On February 16,
1999, David A. Kessler,
M.D., J.D., dean of the
Mark A. Rothstein, director
Yale University School
of the Health Law and Policy
of Medicine and former
Institute, has been selected as a
Commissioner of the
Public Health Hero for 1998-1999
Food and Drug Adminis-
by the University of California-
tration (FDA), delivered
the second annual
Berkeley School of Public Health.
Gardere & Wynne
He was chosen for this honor for
lecture. The lecture, held
his outstanding contributions in
at the M.D. Anderson
THE UNIVERSITYOF TEXAS
leading the nation's discussions on
Cancer Center, attracted
MDANDERSON
CANCERCENTER
the ethical, legal, and social
nearly 300 physicians,
implications of genetic research.
lawyers, public health
officials, civic leaders,
The award, established in 1996,
and students. The topic
recognizes individuals and
was "Regulation of
EALTH LAW
organizations that have made
Tobacco: Health Promo-
&
POLICY
significant contributions to the
tion and Cancer Preven-
tion."
INSTITUTE
public's health. Rothstein will be
Dr. Kessler, a
Mark A. Rothstein and David A. Kessler
presented the award at an awards
graduate of Amherst
dinner in San Francisco on March
College, the University of Chicago Law
from 1990 to 1996. He has been dean of
19, 1999.
School, and Harvard Medical School,
the Yale University School of Medicine
served as Commissioner of the FDA
since July 1, 1997.
SPECIAL SECTION
Health Law and Policy Institute
UNIVERSITY OF HOUSTON
LAW CENTER
Health Law News is published
quarterly by the University of Houston
Health Law and Policy Institute,
Houston, TX 77204-6381.
Phone: (713) 743-2101.
MEDICAL
PRIVACY
Inquiries and comments are encouraged.
Mark A. Rothstein
CONFIDENTIAL
Cullen Distinguished Professor of Law
Director
Laura F. Rothstein
Law Foundation Professor of Law
Associate Director for Development
Mary Anne Bobinski
Professor of Law
Associate Dean for Academic Affairs
William J. Winslade
Distinguished Visiting Professor of Law
Protection of Medical
Associate Director for Graduate
Programs
S. Van McCrary
Records is a
Research Professor
Ronald L. Scott
Research Professor
Growing Concern
Elaine A. Lisko
Research Professor
ith the growth in managed care and the increase in
Melanie R. Margolis
Research Professor
W
electronic data maintenance, individuals are becoming
increasingly concerned about protection of their medical
Mary S. Anderlik
records. As genetic testing becomes more common,
Research Professor
privacy concerns surrounding individuals' genetic predispositions will
Cathy F. Rupf
continue to grow.
Assistant Director
Numerous parties may have access to one's medical records at any
STAFF
given time. In addition to physicians, medical records are likely to be
Bobbie Hurman
accessible by physicians' office personnel, hospital personnel, and
health plan personnel, just to name a few. A survey conducted by
Melanie R. Margolis
Princeton Survey Research Associates and released January 28, 1999
Editor
revealed that Americans trust their doctors and hospitals with confi-
Design & Production
dential medical information, but fear disclosure when it is handled and
Janie Alderman Design
stored by private health insurance plans or others. Individuals worry,
HLPI Advisory Board: Jerry A. Bell, Jr.,
for example, that a potential employer may gain access to medical
Teel Bivins, Calvin Botley, Phyllis Brasher,
Chet E. Brooks, Samuel Ward Casscells,
information which might be used in making hiring determinations.
J. Richard Cheney, Paul Colbert, Garnet F.
Privacy legislation is pending in Congress because the Health
Coleman, Samuel S. Crocker, Debra
Insurance Portability and Accountability Act of 1996 (HIPAA) man-
Danburg, Dianne White Delisi, Mary
desVignes-Kendrick, J.D. Epstein, Lex
dates that Congress pass health record privacy legislation by August
Frieden, Mario Gallegos, Jr., Bob
Gammage, Jack Harris, R. King Hillier,
21, 1999. If Congress fails to pass such legislation, the U.S. Depart-
Sheila Kay Johnstone-Ferrendelli, Bruce
ment of Health and Human Services must promulgate privacy regula-
Levy, M. David Low, Charles R. Parker,
Melinda H. Perrin, Glen Provost, John
tions by February 21, 2000. Privacy legislation is pending in virtually
Robertson, Elizabeth Rockwell, Shelby R.
every state as well.
Rogers, Michele Sabino, Marc Samuels,
Daniel W. Shuman, J. Michael Solar,
Clearly, medical privacy has become a topic worthy of closer
Kathryn S. Stream
examination. The articles in this Special Section offer some insights
into this important issue.
2
MEDICAL
PRIVACY
CONFIDENTIAL
Patient Privacy
A Time To Act
By Denise Nagel, M.D.
others the opportunity to tap into your records without your
Executive Director, National Coalition for Patient Rights
knowledge or consent. With this type of system you may as
well advertise in your local paper so your doctor could read
A woman who dedicated her life to working in a hospital
your records over morning coffee. It would make the office
with troubled teenagers lost her job after her employers used
visit a whole lot shorter.
their personal access to computerized hospital records to
The public is wary. A recent Harris poll shows 85% of
discover she was undergoing treatment for depression. An
the general public placed protecting the confidentiality of
elderly woman was in her home cooking dinner when she
people's medical records ahead of providing data on diseases
received a telephone call from a medical researcher asking
and treatments. In terms of importance to the public, privacy
questions about the woman's treatment for colon cancer.
protection ranks ahead of providing insurance for those who
After offering protestations that she never had colon cancer,
do not have it. Privacy must be maintained, so Americans
the researcher proceeded to read to the woman from her
can make this choice.
medical records. It seems the woman's family had decided
The National Coalition for Patient Rights (NCPR)
against telling her about the cancer after it was successfully
believes that federal privacy protection legislation must be
removed. Her medical records were turned over to this
enacted that (a) requires a patient's voluntary, informed and
researcher without her knowledge or consent.
specific consent before information about him or her is
These stories reflect a larger truth: the once sacrosanct
disclosed to anyone; (b) prohibits the use of national health ID
principle of doctor-patient confidentiality has been nearly
numbers and (c) limits the amount of information health
obliterated. Its demise started with managed care demands
insurers can demand. These principles protect privacy while
for increased information. It has been hastened by
also assuring the integrity of any information being collected.
policymakers and pressured by those wanting to make money
That integrity is critical and is why much of the proposed
by mining our medical records. In 1996 Congress passed
legislation, more accurately dubbed "anti-privacy" legislation,
and the President signed a law calling for the creation of a
actually jeopardizes quality care and research. The reason is
"unique identifier system" or a national health care database
simple - coerced data are not reliable data. Patients who
designed to track your health care issues from cradle to
know their health care records will be viewed by legions of
grave. Fortunately, lawmakers have time to pass privacy
strangers and non-strangers will not be truthful. They will
protections to head-off feared abuses. Unfortunately,
have an incentive to omit details or fail to see a doctor at all if
Congress is showing an appalling lack of interest in passing
they feel a breach of confidentiality will have serious conse-
genuine privacy protections.
quences. As a physician, I know that by guaranteeing privacy
A national database would put all of your medical
and restoring patients' faith in confidentiality, we are guaran-
records into a centralized computer filing system. Many
teeing ourselves more accurate research data and better access
individuals with a passing interest in the state of your health
to quality care.
and a computer would have easy access to those records.
According to former Director of the National Institutes of
The database is a shocking attack on privacy; it
Health Dr. Bernadine Healy the unique
is also quite unnecessary.
identifier runs the risk of turning us into a
Privacy takes on different meanings for
nation of guinea pigs. "Patients used in
different people. For some it is a choice - a
research must be informed, must understand
choice to have one's medical records used in
any potential risks and benefits, and must
research. For others, it is simply an issue of
voluntarily agree to participate. But with the
confidentiality, being able to trust that what is
Federal database, patients do not have the
said to one's doctor remains within the office
choice of participating in research; all medical
walls. Finally, it is a defense against those
treatment becomes research data."
who would use a patient's vulnerabilities
The balance between the potential of
against him or her. That is why the prospect
modern technology and the promise of the age-
of a database is so frightening.
old Hippocratic Oath can only be achieved by
The "unique identifier" or its alter ego,
assuring privacy so that trust in the patient
the "master-patient index," allows easy linkage
doctor relationship can be safeguarded. It is
of computerized data systems. The proposed
Congress' responsibility to legislate that
regulations afford employers, law enforcement
protection. It is all of our responsibilities to
officials, insurance companies, and many
Denise Nagel
insist on nothing less.
3
MEDICAL
PRIVACY
CONFIDENTIAL
What Price for Medical Privacy?
By Mark A. Rothstein, J.D.
used for purposes unrelated to treatment.
Hugh Roy and Lillie Cranz Cullen Distinguished
Computer networks can coordinate patient medical records
Professor of Law
stored in several different sources. "Smart cards" - credit
Director of the Health Law and Policy Institute
card-sized memory cards - can store an individual's entire
medical record on a single, portable card. Software to read
To Americans, medical privacy is like motherhood and
the cards is inexpensive. Already used in Europe, the cards
apple pie. We all are in favor of it. Yet, most people don't
would be invaluable for the treatment of individuals in acci-
realize how little medical privacy we have or that new efforts
dents or medical emergencies, for people who don't speak
to protect medical privacy would not be free - either in
English well, or those who have mental disabilities. In the
financial or social costs.
absence of strict privacy protection, however, third parties
In some other countries, the public is willing to pay a high
might require viewing the cards as a condition of employment,
price for medical privacy. For example, in 1991, French
insurance, a mortgage, or some other transaction. If one's
researchers studying mental illness were surprised to discover a
card is lost, the finder might be able to learn the most intimate
pattern of blindness caused by hereditary juvenile glaucoma.
details of the individual's treatment for mental illness or
Over half of all cases of juvenile glaucoma in France were traced
substance abuse, their HIV or reproductive status, the results
to descendants of a single couple living in the 15th century.
of genetic tests, or other sensitive information.
Even though the disease, open-angle glaucoma, can be cured if
Large managed care organizations can use computerized
treated promptly, and even though the researchers knew the
medical records to assess whether individuals have received all
names of all the people at risk of becoming blind, strict French
necessary preventive health services, as well as the periodic
privacy laws prevented the researchers from contacting them.
checkups necessary to monitor their specific medical condi-
In the U.S., we have yet to determine the level of medical
tions. By analyzing data from medical records, researchers
privacy we want and the costs we are willing to pay to achieve
could determine what procedures and medications were most
it. Today's two greatest challenges to medical privacy are
effective in treating certain conditions. Computers also could
computerization and managed care. At many hospitals, all
help auditors from the government and other payers to uncover
patient medical records can be accessed by anyone with entry
fraud or abuse in billing. The unresolved question, however,
into the hospital computer system, including billing clerks,
is when is it appropriate to use individual medical records for
food service workers, and office employees. A variety of
purposes other than treatment?
abuses have been reported, such as hospital personnel snooping
Patients frequently overestimate the extent to which their
in the files of celebrities or other hospital employees.
medical records are private. In fact, in most jurisdictions
Hospitals could increase privacy by permitting access to
video rental records and consumer credit reports have more
medical records only by health care providers seeing the
legal protection than medical records. Despite abstract support
records of their own patients, encrypting sensitive information,
for medical privacy, we tolerate a system with little privacy
requiring passwords for access to the system, and using audit
and are seemingly indifferent to the specific measures needed
trails that record each entry into the records.
to protect medical privacy. It also remains
These measures would protect privacy, but
unclear whether we consider medical privacy
they would increase the cost of health care and
worth the additional costs to public health,
might make access more time-consuming and
medical research, and law enforcement, as
burdensome for those with a legitimate need to
well as time and money.
see the records.
In my view, medical privacy is essential
Most patients don't realize that when they
to human dignity. It is worth protecting, and
have a blood test or tissue biopsy, their
it may be possible to minimize the costs of
biological specimens are often retained for
doing so. Our national debate needs to focus
quality control or research purposes. If the
more clearly on the costs and benefits of
hospital or researchers were required to
medical privacy. We also need to move
recontact each former patient to get new
expeditiously to implement policies and laws
consent to experiment on the sample, it would
that reflect our shared values before new
be an impediment to medical research. On the
technology eliminates what little medical
other hand, many of these samples still contain
privacy we have.
the names of the patients, and the patient
This article is reprinted from Newsday.
probably never consented to having the sample
Mark A. Rothstein
4
MEDICAL
PRIVACY
CONFIDENTIAL
What Will Congress Do About
Health Privacy?
By Robert Gellman, J.D.
Regulations are likely to draw major industry objections and
Privacy and Information Policy Consultant
that could stop the regulatory process in its tracks.
Third, if both the Secretary and the Congress miss their
Congress has considered health privacy legislation since
deadlines, what happens? Nothing. No one goes to prison.
1993. The 105th Congress saw at least seven general health
Funds will not stop
privacy bills, not counting a proposal from the Secretary of
flowing. Programs will
Current proposals range
Health and Human Services on behalf of the Clinton Adminis-
not terminate. We
tration. The last Congress also had many bills on genetic
simply continue in the
from giving health plans
information issues including genetic privacy.
current sorry state of
and employers complete
What will happen in 1999? Predicting what Congress will
affairs. This is the
dominion over patient
do is a dangerous business, especially when writing for a
most likely result.
records on one extreme to
publication with a long lead time. Predictions are not any
The reason that
easier when the House of Representatives is operating with a
nothing will happen is
giving patients the right to
new Speaker and the smallest majority in decades.
that there is no consen-
decide if their records can
The 106th Congress has to face something unprecedented:
sus today. Current
a deadline. The 1996 Health Insurance Portability and
proposals range from
be computerized on the
Accountability Act provides that if Congress has not passed
giving health plans and
other.
health privacy legislation by August 21, 1999, then the
employers complete
Secretary of Health and Human Services is required to issue
dominion over patient records on one extreme to giving
regulations.
patients the right to decide if their records can be computer-
If you think that the deadline means that something will
ized on the other. Every user of health records wants to be
happen, you have not spent enough time watching Congress.
exempt from any new privacy rules. Solutions will only be
First, the deadline is statutory. Congress can change it at
found in the middle, but no one seems willing to compromise
whim. Indeed, moving the deadline to October 2000, the
and we don't have enough congressional leadership to force
ending date for the Congress, would make sense. Major
interest groups out of their entrenched positions.
legislation rarely passes by August of a first session.
My best advice, however, is not to take any predictions
Second, the Secretary's authority can be changed or
seriously. Eighteen months ago, genetics legislation seemed
repealed. Further, the Secretary's authority to write regula-
likely to pass. Six months later, the genetics bills were dead
tions is limited. The statute directs the Secretary to write
and the general privacy bills came back to life briefly.
rules about the privacy of electronic health care transactions.
A good rule of thumb for the Congress is to assume that
Thus, the likely scope of HHS privacy
nothing will ever pass. You will be right
regulations is an administrative subset of
most of the time. The first federal health
health information. New rules would be
privacy bill was considered in 1980, and we
overlaid on top of the existing patchwork
have had nearly twenty years of failure since.
quilt of state and federal laws that cover some
Something will pass eventually, but you
health record keepers and parts of health
cannot look at history and be confident that
records, such as genetic, AIDS, mental
1999 will finally be the year. Congress can
health, and substance abuse information.
act quickly when it wants, but remember that
Electronic health privacy regulations could
legislation to regulate wiretaps took nearly
actually make things worse rather than better.
forty years to pass.
Robert Gellman
5
MEDICAL
PRIVACY
CONFIDENTIAL
Safeguarding Genetic Privacy
By Jean E. McEwen, J.D., Ph.D.
society as a whole. Nevertheless, the notion of genetic
Associate Professor
privacy as including at least a limited proprietary component
Boston College Law School
remains very much alive.
Genetic privacy also encompasses a notion of deci-
As genetic information proliferates in our society, so do
sional autonomy. This
efforts to regulate its creation, maintenance, dissemination,
aspect of genetic pri-
and use. Although a number of bills are under consideration
Because each
vacy-the underpinnings
at both the federal and state levels under the broad rubric of
of which also underlies
person's genetic
"genetic privacy," most are focused on protecting the
the constitutional right of
confidentiality of genetic information (preventing genetic data
procreative autonomy-
makeup is unique,
from falling into the hands of third parties without the
begins with the decision
some have suggested
authorization of the person from whom the data were
of an individual whether
derived).
to undergo genetic
the existence of an
But the term "genetic privacy" encompasses something
testing in the first place.
"ownership" interest
broader than this notion of confidentiality. Although one
The concern here is not
aspect of genetic privacy is indeed informational (the right to
so much with the physi-
in one's own DNA.
control the extent to which genetic test results, once gener-
cal intrusion as with the
ated, can be accessed by others), the term has other impor-
potentially much more
tant dimensions.
serious (though less tangible) psychological, social, and
One such dimension-the principle that informed consent
economic harms that may follow from the testing (or
must be obtained for the physical intrusion entailed in genetic
from knowing the test results). These harms include the
testing-raises few novel issues-at least in clinical and
potential for reduction in self-esteem, stigmatization in
research settings. While physical privacy issues are raised
the eyes of others, disruption in familial relationships,
by proposals for mass population screening (which provide
and overt discrimination in insurance, employment,
no opportunity for informed consent), these issues are not
education, and other areas of communal life.
unique to the genetic screening context.
But what of the individual who wishes to know his or
However, genetic privacy encompasses several other
her own genetic status, but is afraid to undergo genetic
dimensions that arguably are quite unique. One such dimen-
testing for fear that he or she will be pressured or compelled
sion, concerning the proprietary nature of genetic data,
to release the results to others? Genetic privacy includes not
usually arises in the context of research using stored tissue
only the right not to be tested, but also the right to be tested
samples taken from members of families with rare genetic
(if such testing is medically indicated)-without running the
disorders. Because each person's genetic makeup is unique,
risk of unfair discrimination based on genetic status. While
some have suggested the existence of an "ownership"
the ability of the law to ameliorate the individual and
interest in one's own DNA. Under this
intrafamilial psychosocial risks associated
approach, a person should be entitled to
with genetic testing may be limited (at least
control how his or her genetic material is
in the clinical setting), the law may well have
used (even if the sample has been
a role to play in minimizing the risks of
"anonymized") and should be able to prevent
misuse by societal institutions. Still, there
the exploitation of that material for commer-
are no easy answers here. For the immediate
cial gain by genetic researchers and their
future, absent fundamental changes in the
affiliated institutions. An alternative ap-
way we determine access to health care,
proach conceptualizes the human genome as
insurance coverage, and other societal
our common heritage and the products of
benefits, our quest for meaningful genetic
genetic research as goods properly held by
privacy laws may remain an elusive goal.
Jean E. McEwen
6
MEDICAL
PRIVACY
CONFIDENTIAL
Trends in International Privacy Law-
The European Union's
Data Protection Directive
By Paul M. Schwartz, J.D.
Professor of Law
elaborated a broad set of principles for fair information
Brooklyn Law School
practices that address the acquisition, use, storage, transmis-
sion, and dissemination of personal information. In an effort
Health care data are now transmitted electronically among
to increase the level of data protection within Europe, the
the computers of hospitals, insurers, government regulators,
European Union formally approved its Directive on Data
and physicians. Each of these entities may use these personal
Protection on October 24, 1995. The European Directive's
data for different purposes. Such data sharing functions as
Goal is to harmonize the domestic law of its Member States at
part of statewide computer networks and on a nationwide and
a shared high level of protection for "the fundamental rights
even international basis.
and freedoms of natural persons, and in particular their right
Despite these significant exchanges of personal health care
to privacy."
information, the legal response in the United States has been
The Directive's strategy is three-fold. First, it sets out
to create only a patchwork of laws that regulates data differ-
the mandatory, essential principles for personal data
ently depending on where the information is found at a given
processing within Member Nations of the European Union.
time. The resulting level of protection - and the nature of
Second, it requires Member Nations to bring their domes-
any loopholes available - will be widely different for the
tic law into full compliance with these standards by
same personal health care information depending on whether it
October 1998. Third, it requires each Member State to
is in the control of a federal agency, or a clinic for substance
restrict data flows from Europe to non-Member States that
abuse that receives federal funding, or an insurance company,
fail to assure an "adequate" level of protection. From this
or a private company that funds health care for its workers
general requirement of adequate protection, the European
through self-insurance.
Directive also provides a number of exceptions. Should
Global trends are now altering this existing legal picture
none of these exceptions apply, the European Directive
concerning the regulation of health care information in the
calls for an evaluation of adequacy "in light of all the
United States. Because global data flows are no longer an
circumstances surrounding a data transfer operation or set
exceptional event, international legal developments are testing
of data transfer operations." The Directive requires a
the existing single-nation approach. With the continuing
contextual analysis of a third country's protection for a
development of global communication technologies, effective
specific transfer, including the type of protection offered
protection of privacy can no longer stop at
by both the legal order and the relevant
any nation's borders. As a result of this need
business practices in the receiving nation.
to extend privacy protection to a global scale,
At present, no one can foresee the full
foreign data protection laws, international
impact of the European Directive. The U.S.
legal instruments, and transnational private
government, led by Commerce Department
agreements will have an increasing influence
representatives, is engaged in negotiations
on fair information practices within the United
with the European Union regarding the
States.
possibility of establishing "safe harbor"
Outside of the United States, the national
principles for American companies. Thus
standards for the treatment of personal
far, these American proposals have been
information tend to be comprehensive. These
viewed with some skepticism in Europe.
standards are also increasingly shaped by
The only safe prediction is that Europe will
international agreements. Both the Organiza-
continue to pressure for improvement in
tion for Economic Co-operation and Develop-
U.S. privacy law due to the internationaliza-
ment (OECD) and the Council of Europe have
tion of data flows.
Paul M. Schwartz
7
Book Review
debate is a debate about power: who
medical decisions, but that they cannot be
should have it, and how it should be
the basis for unilateral decisions by
exercised." This openness to talk
physicians. Rubin's central claim is that
Explaining the Futility of
plainly about the problem serves Rubin,
patients and their surrogates are entitled to
"Futility"
and the reader, well throughout the
know about, and have the occasion to
By S. Van McCrary
entire book.
challenge, the underlying context of the
The core of Rubin's argument
data presented to them as medical "facts;"
When Doctors Say No: The
refuting the fact/value distinction,
thus, unilateral physician decision making
Battleground of Medical Futility
requires some explication. She points
is wrong because it denies patients this
by Susan B. Rubin
out that regardless of the substantive
opportunity. The result should instead,
Indiana University Press, 1998, 208
position they support, virtually all
she maintains, allow a conversation about
pp., $24.95
participants in the futility debate accept
the appropriate relationship between raw
the legitimacy of a fact/value
scientific data and determinations of its
Few issues in bioethics have
distinction as a way of comparing
significance for sick persons, between
aroused more controversy during the
different meanings of futility. Thus,
scientists, physicians, and the public at
past decade than those surrounding the
when futility is operating as a factual
large. The failure to engage in this
concept of "medical futility." Suc-
judgment, it means that a particular
conversation has, in Rubin's view, been
cinctly stated, the principal question in
medical treatment is ineffective because
primarily responsible for the ongoing
this debate is should physicians have
it simply would not work; in contrast,
futility debacle.
unilateral authority to refuse to provide
when futility is operating as an evalua-
The primary disappointment of the
life-sustaining treatments desired by
tive judgment, treatment is inappropri-
book is that Rubin does not provide a
patients or surrogate decision makers,
ate because it would not be worth it.
more detailed plan for constructing the
on grounds that such treatment is
The factual function of futility, some-
way beyond futility. The plan she outlines
medically futile? In When Doctors Say
times known as physiologic futility, has
would combine genuine dialogue between
No Susan B. Rubin, a philosopher and
been argued by proponents of futility
all parties, moral suasion, and full
clinical bioethicist, offers an effective
theory as beneficial because of its
disclosure of the reasoning behind each
critique first, of the ongoing futility
purported objectivity and independence
participant's position in an effort to
debate and second, of "medical futility"
achieve social consensus. The results of
itself as a useful concept for engaging
this discourse would then serve as grounds
public discourse regarding the issue of
for "collectively and prospectively" (and,
allocating limited health care resources.
Laudably, Rubin confronts
presumably, universally) authorizing
Rubin's central arguments are that no
early and directly the "dirty
physicians to refuse certain treatments.
existing conception of futility is
Hard decisions would still remain, she
adequate to justify unilateral physician
little secret" that often goes
notes, about first, how to accommodate
decision making, that the controversy
unspoken in conversations
any minorities whose views were not
about futility has distracted us from the
about futility-that the
reflected in the social consensus, and
issues most in need of public debate,
second, how to resolve conflicts deter-
and that futility as a concept should be
controversy is fundamentally
mined to be intractable after collective
abandoned altogether. The way to
about power.
dialogue. All these points are a good
resolve futility issues at the bedside,
start, but I would like to have seen these
she claims, is first to resolve the
ideas developed in a much richer and
problem of just allocation of health care
more nuanced way. In sum, my criticism
resources at the societal level.
from context. It is this notion that
is not so much a complaint as a lament
Rubin proceeds logically through
draws Rubin's most vigorous objections.
that the book is not longer.
her task, first by presenting in chapter
Applying social constructionist theory,
This is a worthy book by an accom-
one a sketch of the debate itself and
she sequentially attacks the problems of
plished writer. It is important reading
then in chapter two a detailed concep-
objectivity, value-neutrality, method,
for clinical ethicists, hospital lawyers,
tual analysis of futility terminology.
interpretation, and uncertainty, and
and hospital ethics committee members.
The heart of the book, chapters three
concludes that the fact/value distinction
The book is deserving of our attention,
and four, then turns attention to what
is indefensible. Under this analysis,
but as a preamble rather than an end. In
she sees as the central problem-the
science is understood fundamentally as a
my view, Rubin's arguments effectively
inadequacy of the fact/value distinction
social practice, having a complex
dismantle the concept of futility as a
to enable actual decisions about proper
texture of assumptions, rules, biases,
useful tool for health care allocation at
allocation of life-sustaining treatments.
and unique relationships to the sur-
the bedside. Instead, she would have us
In chapter five, she then points the way
rounding world. Rubin notes that,
turn to a broad-based social discourse to
beyond futility to what she believes will
"Hence scientific knowledge has its
determine our collective goals of health
be a "more fruitful line of inquiry."
source not in direct unmediated contact
care. The hard work of this public
Laudably, Rubin confronts early and
with some objective reality, but in the
discourse has only just begun. So too,
directly the "dirty little secret" that
variety of influences-personal, profes-
determining the role of managed care
often goes unspoken in conversations
sional, and social-that converge to create
organizations, hospital ethics committees,
about futility-that the controversy is
our understanding of the 'truth' (p. 97).
the legal system and other social institu-
fundamentally about power. On page
Her point is not that facts derived from
tions, in disputes about limiting medical
three she states "At its heart the futility
scientific or clinical data do not belong in
treatment is only beginning.
8
From The Web
Health Law Perspectives, a publication available on the Health Law and Policy Institute's web site,
features articles by Health Law and Policy Institute faculty and scholars analyzing recent developments in
health law. All of these articles can be accessed on the Institute's web site at http://www.law.uh.edu/
healthlaw.
Recent Articles Added to the Institute's Web Site
The following is a list of articles that
Informed Consent on Behalf of
Managed Care Will Receive an
were published in Health Law Perspec-
Children
Overhaul with the 106th Congress
tives on the Institute's web site from
Does Funding Atypical Antipsychotic
Beneficiaries Caught in the Crossfire:
November 15th to February 15th, 1999:
Drugs Save Money For State Govern-
The Battle Between Medicare and the
ments?
Home Health Industry
Texas Hospital Seeks Preemptive
Year 2000 Issues Facing the Health
Can I Sue My Health Care Provider
Court Order for Continued Treatment
Care Industry
for False or Deceptive Statements?
of a Premature Infant: An Ethics
Efforts to Regulate Physician Finan-
Shifting Responsibility for Health
Committee Usurped?
cial Incentives
Care Billing Mistakes in Texas
Why Is Consumer Demand For
The Impact of Physician Financial
State Licensure Issues Hamper
Medical Savings Accounts Lower Than
Incentives
Telemedicine
Anticipated?
Ethical Issues Regarding Cosmetic
Ethical and Public Health Implica-
New Initiative Addresses Long-term
Surgery for Minors
tions of Under-counting Crime
Care
Physician-Assisted Suicide
Genetic Malpractice Claims Raise
Genetics and Life Insurance
Ethical and Practical Benefits of the
Legal and Ethical Issues
New EMTALA Position Announced
New Atypical Antipsychotic Medications
Informed Consent on Behalf of Children
This article was published on the
patient has the right to refuse treatment
made by the parents. This is the
Institute's web site on January 25,1999.
even against medical advice, and the
parents' right and responsibility, and
patient has a right to be informed of
their role as decisionmaker will be
By Ronald L. Scott
unusual and/or undesirable outcomes
respected and supported unless they
and side effects. In certain circum-
proceed in a manner inconsistent with
When the Food and Drug Adminis-
stances, doctors can be liable for failing
applicable law. The courts have
tration (FDA) recently announced new
to obtain consent altogether or exceed-
overridden parental rights in cases
rules requiring pharmaceutical compa-
ing consent that has been given.
involving parental refusals of life-saving
nies to test drugs on children see (see
However, implicit in the above
interventions or "medical neglect"
http://www.fda.gov/ohrms/dockets/
concept is the idea that the patient
(cases involving parental indifference to
98fr/120298c.txt), some drug compa-
legally has the capacity to consent.
the well-being of a child). In such
nies expressed concern that the tests
What if the person being tested is a
cases, courts consider whether a
could be unethical, because they might
child? When a person lacks capacity to
proposed consent to medical treatment
put children at risk. Companies also
consent to (or refuse) medical treatment,
or refusal of treatment is in the child's
expressed concern that children injured
two broad questions arise. First, who
best interests. The difficulty is that
in drug tests might file lawsuits years
should decide? In the case of a minor,
most courts have tried to find a "one
later, even though parents gave consent.
the usual possibilities are the child's
size fits all" test.
Although testing drugs in children
parents or legal guardian, the physician,
Courts often use a narrow, medical
is too recent for the law of informed
or the state, i.e., the courts. On what
view of what the best interests of the
consent for children participating is
basis should such a decision be made?
person are. This is the sort of approach
tests of new drugs to be fully devel-
The two most common tests are asking
that seems desirable in deciding whether
oped, an instructive body of law does
whether the proposed treatment or
a child should be used as an organ
exist with respect to informed consent
refusal is in the "best interests" of the
donor or enrolled in a research study
on behalf of children in other settings.
incompetent person, or alternatively
posing greater than minimal risk and
The concept of informed consent arose
what the incompetent person would have
that has no potential to benefit the child.
from the idea of bodily autonomy. A
decided if he were competent, i.e., a
The substituted judgment test is an effort
physician has a duty to advise a patient
"substituted judgment."
to make the decision the person would
of the benefits and burdens of any
The starting point is clearly that the
have made if competent, even if such
proposed treatment, and secure a
decision to consent to or withhold
decision is not what others would think
patient's consent to treatment. The
consent for medical treatment is to be
Continued on page 10
9
Informed Consent
majority of pediatric cancer patients are
review to ensure scientific validity and
Continued from page 9
likely to be enrolled in a clinical trial
subject protection, refrain from any
of as being in the patient's best inter-
during some stage of their treatment.
form of coercion, fully inform legal
ests. This standard requires weighing
To obtain legally-enforceable informed
surrogate decisionmakers, and carefully
the patient's previously stated prefer-
consent to participate in such clinical
document the informed consent process
ences, religious beliefs, and lifestyle.
trials, researchers have an obligation to
should not fear a barrage of lawsuits.
For patients that have previously been
advise the child's decisionmaker about
FDA will convene a panel of pediatric
competent, the substituted judgment
the probability of adverse side effects
experts and seek its advice on a range
standard is quite appropriate. However,
from the treatment component of the
of issues, including ethical issues raised
for infants, young children, or those
trial and the prognosis with and without
by clinical trials of pediatric patients.
that have never been competent, the test
treatment. Where children are mature
The benefits of obtaining detailed and
is illogical.
enough to understand, i.e., "mature
accurate information about drugs used
Although widespread drug testing
minors" their consent (or "assent")
by children are substantial. See Why
on children may have been uncommon
should also be obtained.
FDA Is Encouraging Drug Testing in
in the past, children have been involved
Ethical pharmaceutical companies
Children at http://www.fda.gov/bbs/
in some clinical trials. For example, a
that submit drug trials to external
topics/CONSUMER/CON00098.html.
LL.M. Graduates Enter
Focus on Our
Academia
Graduates
John J. Fraser, Jr., M.D. (J.D. '96)
A number of graduates of the Univer-
Program on Legal and Ethical Issues in
is serving his second term on the
sity of Houston Law Center Health Law
Correctional Health at the Institute for
American Academy of Pediatrics
Masters Program are teaching at
the Medical Humanities at the Univer-
Committee on Medical Liability.
graduate schools around the world.
sity of Texas Medical Branch -
Sharona Hoffman (LL.M. Candidate
Galveston. He teaches Correctional
Kayhan Parsi (J.D. '93) is a Medical
'99) will be teaching at Case Western
Health as an Adjunct Professor at the
Ethics Education Specialist at the
Reserve University in the fall. She
University of Houston Law Center.
Institute for Ethics at the American
graduated from Wellesley College with
Another graduate, Ronald L. Scott
Medical Association.
a B.A. in English Literature in 1985
(LL.M. '96), Research Professor at the
and received a J.D. from Harvard
Health Law and Policy Institute, teaches
Steven M. Petak, M.D. (J.D. '96), is
Introduction to American Law to
an Associate at the Texas Institute for
foreign LL.M. students at the Univer-
Reproductive Medicine and Endocrinol-
sity of Houston Law Center. On an
ogy, where he also serves as Director
international note, Varda Samuels
of its Bone Densitometry Unit and
(LL.M. '98) is teaching health law at
Osteoporosis Center. In addition, he is
the University of Haifa in Israel, and
a Clinical Assistant Professor at the
Richman Wee (LL.M. '96) taught
University of Texas Medical School,
health law in New Zealand at the
Chair of the Osteoporosis Advisory
Waikato School of Law in 1997 and
Committee of the Texas Department of
1998.
Health, a member of the Board of
Directors and Chair of the Women's
Sharona Hoffman
Health Committee of the American
THANK YOU
Association of Clinical Endocrinolo-
University in 1988. Prior to entering
gists, and a member of the Scientific
the Health Law Masters Program, she
The Health Law and Policy
Advisory Committee of the Interna-
was a Senior Trial Attorney with the
Institute would like to thank the
tional Society of Clinical Densitometry.
Equal Employment Opportunity Com-
following alumni for contributions
mission in Houston. Another graduate
they have made to the Institute
Jessica L. Quinn (J.D. '96) is an
in academia is Frederick R. Parker, Jr.
and/or the John Neibel Scholarship
Associate in the Health Industry Group
(LL.M. '98). He teaches corporate tax,
Endowment.
at Vinson & Elkins, in Austin,
business aspects of health law, and
Texas.
bioethics in the undergraduate and
John J. Fraser, Jr.
graduate schools at Louisiana State
Susan Feigin Harris
Stacey Tovino (J.D. '97) is an Associ-
University in Shreveport, Louisiana.
Elizabeth Sulzberger Hollas
ate in the Health Industry Group at
He also teaches bioethics at LSU
Steven M. Petak
Vinson & Elkins, L.L.P. in Houston,
Medical School. Also, T. Howard
Kayhan Parsi
Texas.
Stone (LL.M. '95) is Assistant Profes-
T. Howard Stone
sor and Research Director of the
10
Faculty Notes
Presentations
Legal Issues in Occupational Medi-
cine, University of Cincinnati College
Mary Anne Bobinski was invited to
MARK A. ROTHSTEIN
of Medicine, Cincinnati, Ohio, March
participate in the "ABA AIDS Coordi-
25, 1999
nating Committee Conference on HIV in
Hepatitis Screening in the Work-
the Next Millennium," on January 22-
place, American Liver Foundation, San
LAURA ROTHSTEIN
23, 1999 in Washington, D.C. Iso, On
Diego, California, January 22, 1999
february 8, 1999, she was interviewed
"Employment and Disability Dis-
on "Weeknight Edition" on PBS
Nonfinancial Barriers to Health
crimination," AALS Annual Meeting
concerning "Legal and Ethical Aspects
Care, University of Texas School of
Workshop on Work, Workers, and Law
of Infertility Treatment."
Public Health, Houston, Texas, Febru-
in the 21st Century, January 7, 1999,
ary 3, 1999
New Orleans, Louisiana
Laura F. Rothstein attended a work-
shop on "Bragdon V. Abbott: Implica-
Behavioral Genetics and Reproduc-
"Affirmative Action: Strategies,"
tions for Asymptomatic Genetic Condi-
tive Freedom, University of Texas
Conference sponsored by the American
tions," sponsored by the National Action
School of Law, Austin, Texas, Febru-
Jewish Committee, January 27, 1999,
Plan on Breast Cancer and the National
ary 5, 1999
Houston, Texas
Human Genome Research Institute on
February 19, 1999 in Washington D.C.
Behavioral Genetics and the Law,
"Affirmative Action: The Impact of
She prepared a paper for the conference
Dallas Bar Association, Dallas, TX,
Hopwood," American Council on
on "Genetic Discrimination: Why
February 17, 1999
Education Workshop, January 29, 1999,
Bragdon Does Not Ensure Protection."
Atlanta, Georgia
Behavioral Genetics and Society,
Mark A. Rothstein was a moderator for
University of California-Berkeley
"Affirmative Action: The Impact of
the workshop on "Bragdon V. Abbott:
School of Public Health, Berkeley,
Hopwood," American Council on
Implications for Asymptomatic Genetic
California, March 18, 1999
Education Workshop, March 26, 1999,
Conditions," sponsored by the National
Denver, Colorado
Action Plan on Breast Cancer and the
National Human Genome Research
Institute held on February 19, 1999 in
Washington D.C.
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Mark A. Rothstein
Cullen Distinguished Professor of Law
Director
Laura F. Rothstein
March 11, 1999
Law Foundation Professor of Law
Associate Director for Development
Mary Anne Bobinski
Governor Richard Thornburgh
Professor of Law
Associate Dean for Academic Affairs
Kirkpatrick & Lockhart
William J. Winslade
1800 Massachusetts Avenue, N.W.
Distinguished Visiting
Professor of Law
Washington, D.C. 20036
Associate Director for
Graduate Programs
Seth Chandler
Dear Governor Thornburgh:
Associate Professor of Law
Ronald Turner
Associate Professor of Law
We were delighted to learn that you have agreed to deliver the Gardere & Wynne
Mary R. Anderlik
Lecture on Thursday, February 24, 2000. This letter will confirm the details that
Research Professor
we have to date.
Elaine A. Lisko
Research Professor
Melanie R. Margolis
Research Professor
Your lecture would be approximately 45 minutes, with 15 minutes for questions.
We will begin about 9:00 am. The topic we would like you to address is access
S. Van McCrary
Research Professor
to health care for individuals with disabilities, reflecting on where we are on the
Ronald L. Scott
Research Professor
10th Anniversary of the Americans with Disabilities Act. The lecture will be part
of a half day program co-sponsored by TIRR (The Institute for Rehabilitation and
Kathleen Sheridan
Professor of Psychology
Research Professor
Research) and its Senior Vice President - Lex Frieden. We are still working on
the location, but it may be in the Texas Medical Center.
Cathy F. Rupf
Assistant Director
STAFF
Bobbie L. Hurman
We will provide you with an honorarium of $2,500 for your presentation and
ADVISORY BOARD
written paper for publication in a special ADA symposium issue of the Houston
Jerry Bell
Teel Bivins
Law Review. We would also pay for your travel and hotel, including first class
Calvin Botley
Phyllis Brasher
air fare for you and your wife, and other expenses. Because the lecture is in the
Chet Brooks
Samuel Ward Casscells
morning, you will need to come in the evening before.
J. Richard Cheney
Paul Colbert
Garnet F. Coleman
Samuel S. Crocker
We have been in contact with Alan Reich of the National Organization on
Debra Danburg
Dianne W. Delisi
Disability in an effort to coordinate our program with a national conference that
Mary desVignes-Kendrick
J.D. Epstein
they plan to hold in College Station, Texas, at the Bush Library on the day
Sheila Kay Johnstone-Ferendelli
Lex Frieden
following our program. President Bush will be participating in the College
Mario Gallegos, Jr.
Bob Gammage
Station event, and he has expressed interest in being involved in our program as
Jack Harris
R. King Hillier
well. We are hoping to have your lecture followed by a panel of individuals who
Bruce Levy
M. David Low
played a role in the passage of the ADA. This will be followed by a luncheon
Melinda H. Perrin
Charles R. Parker
at noon, at which time we have asked President Bush to make some remarks.
Glen J. Provost
John Robertson
The program would end by about 2:00 pm that day, so that attendees who also
Elizabeth D. Rockwell
Shelby R. Rogers
Michele Sabino
Daniel W. Shuman
J. Michael Solar
Kathryn S. Stream
want to attend the program in College Station can do so. It was because of
President Bush's request that we try to coordinate the events that we changed the
date of our program from February 18 to February 24. We believe that this
change will enhance both programs and will increase the probability that President
Bush will participate in our events as well.
We will be contacting you later regarding travel arrangements and other details,
and we will keep you informed as our program becomes finalized. In the
meantime, we would appreciate your sending a CV and one or two photos that
we can use for publicity. Please let me know if you have any questions.
Again, we are honored and pleased that you will be presenting this lecture.
Sincerely,
Laura F. Rothstein
Law Foundation Professor of Law
cc:
Lex Frieden
bcc:
Nancy Hudgins, Cathy Rupf, Sandra Gates, Leah Gross, Wendy Adair,
Mark Rothstein