Special
Section on Medical Privacy
Institute Awarded Robert Wood Johnson Foundation End-of-Life Grant
The Health Law & 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. According to S. Van McCrary of the Health Law & Policy Institute, "this Partnership will provide a unique opportunity for a multidisciplinary group of professionals in Texas to work together toward the common goal of developing a statewide network of quality, comprehensive end-of-life care."
The Partnership, founded by the Health Law & Policy Institute and the Institute for the Medical Humanities at the University of Texas Medical Branch at Galveston, has identified numerous goals, including the following: (1) educating and collaborating with policymakers in an effort to improve laws and other public policies on end-of-life care; (2) fostering public awareness of end-of-life issues; (3) serving as a resource and clearinghouse to educate the public and refer persons to appropriate health and social service professionals; and (4) supplementing the professional development of physicians, nurses, social workers, hospice personnel, and other health-related professionals.
The one-year grant will fund the planning phase of the Partnership. Later this year, the Health Law & Policy Institute and the Institute for the Medical Humanities will apply to the Robert Wood Johnson Foundation for the implementation phase of the Partnership which, if awarded, will provide two years of additional funding.
Kessler Delivers Gardere & Wynne Lecture
On
February 16, 1999, David A. Kessler, M.D., J.D., dean of the Yale University
School of Medicine and former Commissioner of the Food and Drug Administration
(FDA), delivered the second annual Gardere & Wynne lecture. The lecture,
held at the M.D. Anderson Cancer Center, attracted nearly 300 physicians,
lawyers, public health officials, civic leaders, and students. The topic
was "Regulation of Tobacco: Health Promotion and Cancer Prevention."
Dr. Kessler, a graduate of Amherst College, the University of Chicago Law School, and Harvard Medical School, served as Commissioner of the FDA from 1990 to 1996. He has been dean of the Yale University School of Medicine since July 1, 1997.
Mark Rothstein Receives Public Health Hero Award
Mark A. Rothstein, director of the Health Law & Policy Institute, has been selected as a Public Health Hero for 1998-1999 by the University of California--Berkeley School of Public Health. He was chosen for this honor for his outstanding contributions in leading the nation's discussions on the ethical, legal, and social implications of genetic research. The award, established in 1996, recognizes individuals and organizations that have made significant contributions to the public's health. Rothstein will be presented the award at an awards dinner in San Francisco on March 19, 1999.
BOOK REVIEW
Few issues in bioethics have aroused more controversy during the past decade than those surrounding the concept of "medical futility." Succinctly stated, the principal question in this debate is should physicians have unilateral authority to refuse to provide life-sustaining treatments desired by patients or surrogate decision makers, on grounds that such treatment is medically futile? In When Doctors Say No Susan B. Rubin, a philosopher and clinical bioethicist, offers an effective critique first, of the ongoing futility debate and second, of "medical futility" itself as a useful concept for engaging public discourse regarding the issue of allocating limited health care resources. Rubin’s central arguments are that no existing conception of futility is adequate to justify unilateral physician decision making, that the controversy about futility has distracted us from the issues most in need of public debate, and that futility as a concept should be abandoned altogether. The way to resolve futility issues at the bedside, she claims, is first to resolve the problem of just allocation of health care resources at the societal level.
Rubin proceeds logically through her task, first by presenting in chapter one a sketch of the debate itself and then in chapter two a detailed conceptual analysis of futility terminology. The heart of the book, chapters three and four, then turns attention to what she sees as the central problem--the inadequacy of the fact/value distinction to enable actual decisions about proper allocation of life-sustaining treatments. In chapter five, she then points the way beyond futility to what she believes will be a "more fruitful line of inquiry." Laudably, Rubin confronts early and directly the "dirty little secret" that often goes unspoken in conversations about futility--that the controversy is fundamentally about power. On page three she states "At its heart the futility debate is a debate about power: who should have it, and how it should be exercised." This openness to talk plainly about the problem serves Rubin, and the reader, well throughout the entire book.
The core of Rubin’s argument
refuting the fact/value distinction, requires some explication. She points
out that regardless of the substantive position they support, virtually
all participants in the futility debate accept the legitimacy of a fact/value
distinction as a way of
comparing different meanings of futility. Thus, when futility is operating
as a factual judgment, it means that a particular medical treatment is
ineffective because it simply would not work; in contrast, when futility
is operating as an evaluative judgment, treatment is inappropriate because
it would not be worth it. The factual function of futility, sometimes known
as physiologic futility, has been argued by proponents of futility theory
as beneficial because of its purported objectivity and independence from
context. It is this notion that draws Rubin’s most vigorous objections.
Applying social constructionist theory, she sequentially attacks the problems
of objectivity, value-neutrality, method, interpretation, and uncertainty,
and concludes that the fact/value distinction is indefensible.
Under this analysis, science is understood fundamentally as a social practice, having a complex texture of assumptions, rules, biases, and unique relationships to the surrounding world. Rubin notes that, "Hence scientific knowledge has its source not in direct unmediated contact with some objective reality, but in the variety of influences--personal, professional, and social--that converge to create our understanding of the ‘truth’ " (p. 97). Her point is not that facts derived from scientific or clinical data do not belong in medical decisions, but that they cannot be the basis for unilateral decisions by physicians. Rubin’s central claim is that patients and their surrogates are entitled to know about, and have the occasion to challenge, the underlying context of the data presented to them as medical "facts;" thus, unilateral physician decision making is wrong because it denies patients this opportunity. The result should instead, she maintains, allow a conversation about the appropriate relationship between raw scientific data and determinations of its significance for sick persons, between scientists, physicians, and the public at large. The failure to engage in this conversation has, in Rubin’s view, been primarily responsible for the ongoing futility debacle.
The primary disappointment of the book is that Rubin does not provide a more detailed plan for constructing the way beyond futility. The plan she outlines would combine genuine dialogue between all parties, moral suasion, and full disclosure of the reasoning behind each participant’s position in an effort to achieve social consensus. The results of this discourse would then serve as grounds for "collectively and prospectively" (and, presumably, universally) authorizing physicians to refuse certain treatments. Hard decisions would still remain, she notes, about first, how to accommodate any minorities whose views were not reflected in the social consensus, and second, how to resolve conflicts determined to be intractable after collective dialogue. All these points are a good start, but I would like to have seen these ideas developed in a much richer and more nuanced way. In sum, my criticism is not so much a complaint as a lament that the book is not longer.
This is a worthy book by an accomplished writer. It is important reading for clinical ethicists, hospital lawyers, and hospital ethics committee members. The book is deserving of our attention, but as a preamble rather than an end. In my view, Rubin’s arguments effectively dismantle the concept of futility as a useful tool for health care allocation at the bedside. Instead, she would have us turn to a broad-based social discourse to determine our collective goals of health care. The hard work of this public discourse has only just begun. So too, determining the role of managed care organizations, hospital ethics committees, the legal system and other social institutions, in disputes about limiting medical treatment is only beginning.
FROM THE WEB
Health Law Perspectives, a publication available on the Health Law & Policy Institute's web site, features articles by Health Law & 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/healthlawperspectives.
Recent Articles Added to the Institute's Web Site
The following is a list of articles that were published in Health Law Perspectives on the Institute's web site from November 15th to February 15th, 1999:
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In the past decade or so, most of the Academy Award winning actors have played roles of individuals with disabilities -- Dustin Hoffman in Rain Man (autism), Al Pacino in Scent of a Woman (blindness), Tom Hanks in Forrest Gump (retardation) and in Philadelphia (AIDS), Daniel Day-Lewis in My Left Foot (cerebral palsy), and most recently Jack Nicholson in As Good As It Gets (obsessive-compulsive disorder).
Reviewing movies such as these is one of the unique assignments for students enrolled in Disabilities and the Law, offered each fall semester and taught by Professor Laura Rothstein. The course, which she has taught since 1980 and for which she published a casebook, Disability Law: Cases, Materials, Problems (2d ed. 1998 LEXIS), introduces students to issues of disability discrimination law in a wide variety of areas -- employment, education, public accommodations, governmental services, transportation, housing, and health care.
In addition to an understanding of the statutes, regulations, and judicial interpretations relating to these issues, Professor Rothstein wants her students to become sensitized to how disability affects lives of individuals. To accomplish this, she assigns two outside class projects each year. One is the "Disabilities at the Movies" project. Students are required to watch one of a number of suggested movies (or other preapproved movies) and to write a short report on the movie. The report is to evaluate the accessibility of the theater where the movie was viewed or video rental location where it was obtained. Students also are required to discuss what major federal laws applied at the time the story occurred and whether they made a difference. If federal law did not apply at the time of the movie timeframe, would it have made a difference if it did? Finally, the students are to discuss whether the portrayal of the individual with a disability was positive or negative. Did it make the person pathetic or overly heroic? Was it realistic? Will the movie help to overcome stereotypes and myths, or will the portrayal make matters worse?
In addition to the movie project, students or student groups are assigned a field research project to evaluate a site such as a restaurant, college campus, shopping mall, or sports arena, from the perspective of individuals with disabilities (including mobility, sensory, and health impairments). Students are given general design standards as a guide and asked to evaluate parking, moving about the facility, and other access issues. The students or student groups provide a written report and an oral presentation at the end of the semester. Some oral presentations are elaborate, with power point or slide shows.
Students have the full semester to do both projects, and the goal is virtually always accomplished. Students report that they notice parking, ramps, location of telephones, and other architectural features wherever they go after the project. Students not only become more aware of the physical environment, but also of attitudes and stereotypes. In addition to the movie and field assignments, students have a final exam.
Movies with Disability
Issues
| Awakenings
The Bad Seed Benny and Joon Born on the Fourth of July Charly Children of a Lesser God Clean and Sober Coming Home Dominick and Eugene |
Elephant Man
Gattaca Longtime Companion The Miracle Worker Mr. Jones Of Mice and Men One Flew Over the Cuckoo's Nest Passion Fish |
Places in the Heart
Rear Window Shine Simon Birch The Theory of Flight Three Faces of Eve Waterdance What's Eating Gilbert Grape? |
Law Students to Vie in Interdisciplinary Health Care Competition
On the evening of March 25, 1999, three students from the University of Houston Law Center will participate in the seventh annual Health Care Team Competition sponsored by the University of Texas Health Science Center at Houston. The objective of the Competition is to enhance students’ knowledge about other health sciences disciplines and the biomedical sciences, and to encourage an interdisciplinary team approach to solving health care problems. There will be three teams composed of students from the six schools at the UT Health Science Center--Houston, and three schools from the University of Houston. Each of the three teams will interact in solving a complex clinical case study prepared and judged by UT--Houston and UH faculty. Health Law & Policy Institute faculty member Dr. S. Van McCrary is the health law and bioethics representative on the planning committee for the Competition, and Dr. Mary Anderlik of HLPI will also participate in judging this year’s event. Competing on behalf of the UH Law Center will be students Jennifer D. Jasper, Cynthia A. Bilbrough, and Christine N. Colleen. Cheryl Erwin, a participant in last year’s Competition, is the law student team advisor.
Mark
Hall Teaches Intersession Course
The Health Law & Policy Institute offered a course on Health Care Rationing during the Intersession in January 1999. The course, taught by Visiting Professor Mark A. Hall, a Professor of Law at Wake Forest University, considered legal and policy aspects of health care rationing in different settings, including legislative rationing, regulatory rationing, managed care rationing, and "bedside" rationing.
Children's Defense Fund 1999 Annual National Conference
Children's Defense Fund (CDF) 1999 Annual National Conference will be held April 29-May 2 at the Hyatt Regency Hotel in Houston, Texas. This year's CDF conference will focus on "Healthy Start, Achieving Children, Successful Futures," and will feature skill building workshops and intensive training sessions as well as speakers on vital issues facing our nation's children. The program coverage will include the State Children's Health Insurance Program and other topics affecting children and health. Mark Rothstein, Laura Rothstein, and Cathy Rupf have been involved in the planning for this conference.
Institute Alumni Enter Academia
A
number of graduates of the University of Houston Law Center Health Law
Masters Program are teaching at graduate schools around the world. Sharona
Hoffman (LL.M. Candidate '99) will be teaching at Case Western Reserve
University in the fall. She graduated from Wellesley College with a B.A.
in English Literature in 1985 and received a J.D. from Harvard University
in 1988. Prior to entering the Health Law Masters Program, she was a Senior
Trial Attorney with the Equal Employment Opportunity Commission in Houston.
Frederick R. Parker, Jr. (LL.M. '98) teaches corporate tax, business aspects of health law, and bioethics in the undergraduate and graduate schools at Louisiana State University in Shreveport, Louisiana. He also teaches bioethics at LSU Medical School. Also, T. Howard Stone ( LL.M. '95 ) is Assistant Professor and Research Director, of the Program on Legal and Ethical Issues in Correctional Health at the Institute for the Medical Humanities at the University of Texas Medical Branch -- Galveston. He teaches Correctional Health as an Adjunct Professor at the University of Houston Law Center. Another graduate, Ronald L. Scott (LL.M. '96), Research Professor at the Health Law & Policy Institute, teaches Introduction to American Law to foreign LL.M. students at the University of Houston Law Center.
On an international note, Varda Samuels (LL.M. '98) is teaching health law at the University of Haifa in Israel, and Richmond Wee ('96) has been teaching health law in New Zealand at the Waikato School of Law in 1997 and 1998.
Laura Rothstein Named Associate Dean for Graduate Studies and Special Programs
Law Foundation Professor Laura F. Rothstein, who is the Institute's Associate Director for Development, has another title to add to her business card—Associate Dean for Graduate Studies and Special Programs. For the second time in less than six years, Rothstein will serve the Law Center as an associate dean—albeit in a different capacity.
Rothstein served as Associate Dean for Student Affairs from 1988 to 1993 when she returned to the faculty to resume her civilian duties of teaching Disability Law and Property Law. While she looks forward to serving as Associate Dean for Graduate Studies and Special Programs, the post brings to her special challenges. "My goals are to build on the successes of our LL.M. programs by making the programs known to even more potential applicants in order to recruit the best, the brightest, and the most interesting for our student body. I also want to make the programs better known to the broader legal education and legal profession communities."
Focus on Adjunct Professor: Ann James
Ann N. James, Ph.D., J.D., teaches Business Aspects of Health Law at the University of Houston Law Center. She is Of Counsel to the firm of Jenkens & Gilchrist, P.C., where she heads a group focused on physicians and their business organizations. During the past two years, Dr. James has served as a senior executive in the physician practice management business, where she worked with physicians, corporate executives and payors throughout the country, bringing such experience back to her entrepreneurial practice of law.
She graduated from Radford College in 1965 with a B.A. cum laude in biology, received her Ph.D. in Medical Microbiology and Immunology in 1975 from Baylor College of Medicine, and her J.D. in 1980 from the University of Houston Law Center. She also is a founder of Women at Risk, Inc., a breast imaging/diagnostic company.
A substantial portion of Dr. James' practice is in the area of provider integration, from development of independent practice associations, physician group practices, to physician-hospital arrangements, to networks among and between a range of providers in local communities, all to address managed care and other joint opportunities.
Thank You
The Health Law & Policy Institute would like to thank the following alumni for contributions they have made to the Institute and/or the John Neibel Scholarship Endowment.
John J. Fraser, Jr.
Susan Feigin Harris
Elizabeth Sulzberger
Hollas
Steven M. Petak
Kayhan Parsi
T. Howard Stone
Focus on Our Graduates
John J. Fraser, Jr., M.D. (J.D. '96) is serving his second term on the American Academy of Pediatrics Committee on Medical Liability.
Kayhan Parsi (J.D. '93) is a Medical Ethics Education Specialist at the Institute for Ethics at the American Medical Association.
Steven M. Petak, M.D. (J.D. '96), is an Associate at the Texas Institute for Reproductive Medicine and Endocrinology, where he also serves as Director of its Bone Densitometry Unit and Osteoporosis Center. In addition, he is a Clinical Assistant Professor at the University of Texas Medical School, Chair of the Osteoporosis Advisory Committee of the Texas Department of Health, a member of the Board of Directors and Chair of the Women's Health Committee of the American Association of Clinical Endocrinologists, and a member of the Scientific Advisory Committee of the International Society of Clinical Densitometry.
Jessica L. Quinn (J.D. '96) is an Associate in the Health Industry Group at Vinson & Elkins, L.L.P. in Austin, Texas.
Stacey Tovino (J.D. '97) is an Associate in the Health Industry Group at Vinson & Elkins, L.L.P. in Houston, Texas.
PRESENTATIONS
Mark A. Rothstein
Mary Anne Bobinski was invited to participate in the "ABA AIDS Coordinating Committee Conference on HIV in the Next Millennium," on January 22-23, 1999 in Washington, D.C. lso, On february 8, 1999, she was interviewed on "Weeknight Edition" on PBS concerning "Legal and Ethical Aspects of Infertility Treatment."
Laura F. Rothstein attended a workshop on "Bragdon v. Abbott: Implications for Asymptomatic Genetic Conditions," sponsored by the National Action Plan on Breast Cancer and the National Human Genome Research Institute on February 19, 1999 in Washington D.C. She prepared a paper for the conference on "Genetic Discrimination: Why Bragdon Does Not Ensure Protection."
Mark A. Rothstein
was a moderator for the workshop on "Bragdon v. Abbott: Implications
for Asymptomatic Genetic Conditions," sponsored by the National 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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Special
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With the growth in managed care and the increase in electronic data maintenance, individuals are becoming increasingly concerned about protection of their medical records. As genetic testing becomes more common, privacy concerns surrounding individuals' genetic predispositions will continue to grow.
Numerous parties may have access to one's medical records at any given time. In addition to physicians, medical records are likely to be accessible by physicians' office personnel, hospital personnel, and health plan personnel, just to name a few. A survey conducted by Princeton Survey Research Associates and released January 28, 1999 revealed that Americans trust their doctors and hospitals with confidential medical information, but fear disclosure when it is handled and stored by private health insurance plans or others. Individuals worry, for example, that a potential employer may gain access to medical information which might be used in making hiring determinations.
Privacy legislation is pending in Congress because the Health Insurance Portability and Accountability Act of 1996 (HIPAA) mandates that Congress pass health record privacy legislation by August 21, 1999. If Congress fails to pass such legislation, the U.S. Department of Health and Human Services must promulgate privacy regulations by February 21, 2000. Privacy legislation is pending in virtually every state as well.
Clearly, medical privacy
has become a topic worthy of closer examination. The articles in this Special
Section offer some insights into this important issue.
By Denise Nagel, M.D.
Executive Director, National
Coalition for Patient Rights
A
woman who dedicated her life to working in a hospital with troubled teenagers
lost her job after her employers used their personal access to computerized
hospital records to discover she was undergoing treatment for depression.
An elderly woman was in her home cooking dinner when she received a telephone
call from a medical researcher asking questions about the woman's treatment
for colon cancer. After offering protestations that she never had colon
cancer, the researcher proceeded to read to the woman from her medical
records. It seems the woman's family had decided against telling her about
the cancer after it was successfully removed. Her medical records were
turned over to this researcher without her knowledge or consent.
These stories reflect a larger truth: the once sacrosanct principle of doctor-patient confidentiality has been nearly obliterated. Its demise started with managed care demands for increased information. It has been hastened by policymakers and pressured by those wanting to make money by mining our medical records. In 1996 Congress passed and the President signed a law calling for the creation of a "unique identifier system" or a national health care database designed to track your health care issues from cradle to grave. Fortunately, lawmakers have time to pass privacy protections to head-off feared abuses. Unfortunately, Congress is showing an appalling lack of interest in passing genuine privacy protections.
A national database would put all of your medical records into a centralized computer filing system. Many individuals with a passing interest in the state of your health and a computer would have easy access to those records. The database is a shocking attack on privacy; it is also quite unnecessary.
Privacy takes on different meanings for different people. For some it is a choice -- a choice to have one's medical records used in research. For others, it is simply an issue of confidentiality, being able to trust that what is said to one's doctor remains within the office walls. Finally, it is a defense against those who would use a patient's vulnerabilities against him or her. That is why the prospect of a database is so frightening.
The "unique identifier" or its alter ego, the "master-patient index," allows easy linkage of computerized data systems. The proposed regulations affords employers, law enforcement officials, insurance companies, and many others the opportunity to tap into your records without your knowledge or consent. With this type of system you may as well advertise in your local paper so your doctor could read your records over morning coffee. It would make the office visit a whole lot shorter.
The public is wary. A recent Harris poll shows 85% of the general public placed protecting the confidentiality of people's medical records ahead of providing data on diseases and treatments. In terms of importance to the public, privacy protection ranks ahead of providing insurance for those who do not have it. Privacy must be maintained, so Americans can make this choice.
The National Coalition for Patient Rights (NCPR) believes that federal privacy protection legislation must be enacted that (a) requires a patient's voluntary, informed and specific consent before information about him or her is disclosed to anyone; (b) prohibits the use of national health ID numbers and (c) limits the amount of information health insurers can demand. These principles protect privacy while also assuring the integrity of any information being collected.
That integrity is critical and is why much of the proposed legislation, more accurately dubbed "anti-privacy" legislation, actually jeopardizes quality care and research. The reason is simple -- coerced data are not reliable data. Patients who know their health care records will be viewed by legions of strangers and non-strangers will not be truthful. They will have an incentive to omit details or fail to see a doctor at all if they feel a breach of confidentiality will have serious consequences. As a physician, I know that by guaranteeing privacy and restoring patients' faith in confidentiality, we are guaranteeing ourselves more accurate research data and better access to quality care.
According to former Director of the National Institutes of Health Dr. Bernadine Healy the unique identifier runs the risk of turning us into a nation of guinea pigs. "Patients used in research must be informed, must understand any potential risks and benefits, and must voluntarily agree to participate. But with the Federal database, patients do not have the choice of participating in research; all medical treatment becomes research data."
The balance between the potential
of modern technology and the promise of the age-old Hippocratic Oath can
only be achieved by assuring privacy so that trust in the patient doctor
relationship can be safeguarded. It is Congress' responsibility to legislate
that protection. It is all of our responsibilities to insist on nothing
less.
By Mark
A. Rothstein, J.D.
Hugh Roy and Lillie Cranz
Cullen Distinguished Professor of Law
Director of the Health Law & Policy Institute
To Americans, medical privacy is like motherhood and apple pie. We all are in favor of it. Yet, most people don't realize how little medical privacy we have or that new efforts to protect medical privacy would not be free -- either in financial or social costs.
In some other countries, the public is willing to pay a high price for medical privacy. For example, in 1991, French researchers studying mental illness were surprised to discover a pattern of blindness caused by hereditary juvenile glaucoma. Over half of all cases of juvenile glaucoma in France were traced to descendants of a single couple living in the 15th century. Even though the disease, open-angle glaucoma, can be cured if treated promptly, and even though the researchers knew the names of all the people at risk of becoming blind, strict French privacy laws prevented the researchers from contacting them.
In the U.S., we have yet to determine the level of medical privacy we want and the costs we are willing to pay to achieve it. Today's two greatest challenges to medical privacy are computerization and managed care. At many hospitals, all patient medical records can be accessed by anyone with entry into the hospital computer system, including billing clerks, food service workers, and office employees. A variety of abuses have been reported, such as hospital personnel snooping in the files of celebrities or other hospital employees.
Hospitals could increase privacy by permitting access to medical records only by health care providers seeing the records of their own patients, encrypting sensitive information, requiring passwords for access to the system, and using audit trails that record each entry into the records. These measures would protect privacy, but they would increase the cost of health care and might make access more time-consuming and burdensome for those with a legitimate need to see the records.
Most patients don't realize that when they have a blood test or tissue biopsy, their biological specimens are often retained for quality control or research purposes. If the hospital or researchers were required to recontact each former patient to get new consent to experiment on the sample, it would be an impediment to medical research. On the other hand, many of these samples still contain the names of the patients, and the patient probably never consented to having the sample used for purposes unrelated to treatment.
Computer networks can coordinate patient medical records stored in several different sources. "Smart cards" -- credit card-sized memory cards -- can store an individual's entire medical record on a single, portable card. Software to read the cards is inexpensive. Already used in Europe, the cards would be invaluable for the treatment of individuals in accidents or medical emergencies, for people who don't speak English well, or those who have mental disabilities. In the absence of strict privacy protection, however, third parties might require to view the cards as a condition of employment, insurance, a mortgage, or some other transaction. If one's card is lost, the finder might be able to learn the most intimate details of the individual's treatment for mental illness or substance abuse, their HIV or reproductive status, the results of genetic tests, or other sensitive information.
Large managed care organizations can use computerized medical records to assess whether individuals have received all necessary preventive health services, as well as the periodic checkups necessary to monitor their specific medical conditions. By analyzing data from medical records, researchers could determine what procedures and medications were most effective in treating certain conditions. Computers also could help auditors from the government and other payers to uncover fraud or abuse in billing. The unresolved question, however, is when is it appropriate to use individual medical records for purposes other than treatment?
Patients frequently overestimate the extent to which their medical records are private. In fact, in most jurisdictions video rental records and consumer credit reports have more legal protection than medical records. Despite abstract support for medical privacy, we tolerate a system with little privacy and are seemingly indifferent to the specific measures needed to protect medical privacy. It also remains unclear whether we consider medical privacy worth the additional costs to public health, medical research, and law enforcement, as well as time and money.
In my view, medical privacy is essential to human dignity. It is worth protecting, and it may be possible to minimize the costs of doing so. Our national debate needs to focus more clearly on the costs and benefits of medical privacy. We also need to move expeditiously to implement policies and laws that reflect our shared values before new technology eliminates what little medical privacy we have.
The above article is reprinted
from Newsday.
By Robert Gellman, J.D.
Privacy and Information
Policy Consultant
Congress
has considered health privacy legislation since 1993. The 105th Congress
saw at least seven general health privacy bills, not counting a proposal
from the Secretary of Health and Human Services on behalf of the Clinton
Administration. The last Congress also had many bills on genetic information
issues including genetic privacy.
What will happen in 1999? Predicting what Congress will do is a dangerous business, especially when writing for a publication with a long lead time. Predictions are not any easier when the House of Representatives is operating with a new Speaker and the smallest majority in decades.
The 106th Congress has to face something unprecedented: a deadline. The 1996 Health Insurance Portability and Accountability Act provides that if Congress has not passed health privacy legislation by August 21, 1999, then the Secretary of Health and Human Services is required to issue regulations.
If you think that the deadline means that something will happen, you have not spent enough time watching Congress. First, the deadline is statutory. Congress can change it at whim. Indeed, moving the deadline to October 2000, the ending date for the Congress, would make sense. Major legislation rarely passes by August of a first session.
Second, the Secretary's authority can be changed or repealed. Further, the Secretary's authority to write regulations is limited. The statute directs the Secretary to write rules about the privacy of electronic health care transactions. Thus, the likely scope of HHS privacy regulations is an administrative subset of health information. New rules would be overlaid on top of the existing patchwork quilt of state and federal laws that cover some health record keepers and parts of health records, such as genetic, AIDS, mental health, and substance abuse information. Electronic health privacy regulations could actually make things worse rather than better. Regulations are likely to draw major industry objections and that could stop the regulatory process in its tracks.
Third, if both the Secretary and the Congress miss their deadlines, what happens? Nothing. No one goes to prison. Funds will not stop flowing. Programs will not terminate. We simply continue in the current sorry state of affairs. This is the most likely result.
The reason that nothing will happen is that there is no consensus today. Current proposals range from giving health plans and employers complete dominion over patient records on one extreme to giving patients the right to decide if their records can be computerized on the other. Every user of health records wants to be exempt from any new privacy rules. Solutions will only be found in the middle, but no one seems willing to compromise and we don't have enough congressional leadership to force interest groups out of their entrenched positions.
My best advice, however, is not to take any predictions seriously. Eighteen months ago, genetics legislation seemed likely to pass. Six months later, the genetics bills were dead and the general privacy bills came back to life briefly.
A good rule of thumb for
the Congress is to assume that nothing will ever pass. You will be right
most of the time. The first federal health privacy bill was considered
in 1980, and we have had nearly twenty years of failure since. Something
will pass eventually, but you cannot look at history and be confident that
1999 will finally be the year. Congress can act quickly when it wants,
but remember that legislation to regulate wiretaps took nearly forty years
to pass.
By Jean E. McEwen, J.D.,
Ph.D.
Associate Professor
Boston College Law School
As
genetic information proliferates in our society, so do efforts to regulate
its creation, maintenance, dissemination, and use. Although a number of
bills are under consideration at both the federal and state levels under
the broad rubric of "genetic privacy," most are focused on protecting the
confidentiality of genetic information (preventing genetic data
from falling into the hands of third parties without the authorization
of the person from whom the data were derived).
But the term "genetic privacy" encompasses something broader than this notion of confidentiality. Although one aspect of genetic privacy is indeed informational (the right to control the extent to which genetic test results, once generated, can be accessed by others), the term has other important dimensions.
One such dimension--the principle that informed consent must be obtained for the physical intrusion entailed in genetic testing--raises few novel issues--at least in clinical and research settings. While physical privacy issues are raised by proposals for mass population screening (which provide no opportunity for informed consent), these issues are not unique to the genetic screening context.
However, genetic privacy encompasses several other dimensions that arguably are quite unique. One such dimension, concerning the proprietary nature of genetic data, usually arises in the context of research using stored tissue samples taken from members of families with rare genetic disorders. Because each person’s genetic makeup is unique, some have suggested the existence of an "ownership" interest in one’s own DNA. Under this approach, a person should be entitled to control how his or her genetic material is used (even if the sample has been "anonymized") and should be able to prevent the exploitation of that material for commercial gain by genetic researchers and their affiliated institutions. An alternative approach conceptualizes the human genome as our common heritage and the products of genetic research as goods properly held by society as a whole. Nevertheless, the notion of genetic privacy as including at least a limited proprietary component remains very much alive.
Genetic privacy also encompasses a notion of decisional autonomy. This aspect of genetic privacy--the underpinnings of which also underlies the constitutional right of procreative autonomy--begins with the decision of an individual whether to undergo genetic testing in the first place. The concern here is not so much with the physical intrusion as with the potentially much more serious (though less tangible) psychological, social, and economic harms that may follow from the testing (or from knowing the test results). These harms include the potential for reduction in self-esteem, stigmatization in the eyes of others, disruption in familial relationships, and overt discrimination in insurance, employment, education, and other areas of communal life.
But what of the individual
who wishes to know his or her own genetic status, but is afraid
to undergo genetic testing for fear that he or she will be pressured or
compelled to release the results to others? Genetic privacy includes not
only the right not to be tested, but also the right to be
tested (if such testing is medically indicated)--without running the risk
of unfair discrimination based on genetic status. While the ability of
the law to ameliorate the individual and intrafamilial psychosocial
risks associated with genetic testing may be limited (at least in the
clinical setting), the law may well have a role to play in minimizing the
risks of misuse by societal institutions. Still, there are no easy answers
here. For the immediate future, absent fundamental changes in the way we
determine access to health care, insurance coverage, and other societal
benefits, our quest for meaningful genetic privacy laws may remain an elusive
goal.
By Paul M. Schwartz, J.D.
Professor of Law
Brooklyn Law School
Health care data are now transmitted electronically among the computers of hospitals, insurers, government regulators, and physicians. Each of these entities may use these personal data for different purposes. Such data sharing functions as part of statewide computer networks and on a nationwide and even international basis.
Despite these significant exchanges of personal health care information, the legal response in the United States has been to create only a patchwork of laws that regulates data differently depending on where the information is found at a given time. The resulting level of protection -- and the nature of any loopholes available -- will be widely different for the same personal health care information depending on whether it is in the control of a federal agency, or a clinic for substance abuse that receives federal funding, or an insurance company, or a private company that funds health care for its workers through self-insurance.
Global trends are now altering this existing legal picture concerning the regulation of health care information in the United States. Because global data flows are no longer an exceptional event, international legal developments are testing the existing single-nation approach. With the continuing development of global communication technologies, effective protection of privacy can no longer stop at any nation's borders. As a result of this need to extend privacy protection to a global scale, foreign data protection laws, international legal instruments, and transnational private agreements will have an increasing influence on fair information practices within the United States.
Outside of the United States, the national standards for the treatment of personal information tend to be comprehensive. These standards are also increasingly shaped by international agreements. Both the Organization for Economic Co-operation and Development (OECD) and the Council of Europe have elaborated a broad set of principles for fair information practices that address the acquisition, use, storage, transmission, and dissemination of personal information. In an effort to increase the level of data protection within Europe, the European Union formally approved its Directive on Data Protection on October 24, 1995. The European Directive's Goal is to harmonize the domestic law of its Member States at a shared high level of protection for ?the fundamental rights and freedoms of natural persons, and in particular their right to privacy."
The Directive's strategy is three-fold. First, it sets out the mandatory, essential principles for personal data processing within Member Nations of the European Union. Second, it requires Member Nations to bring their domestic law into full compliance with these standards by October 1998. Third, it requires each Member State to restrict data flows from Europe to non-Member States that fail to assure an "adequate" level of protection. From this general requirement of adequate protection, the European Directive also provides a number of exceptions. Should none of these exceptions apply, the European Directive calls for an evaluation of adequacy "in light of all the circumstances surrounding a data transfer operation or set of data transfer operations." The Directive requires a contextual analysis of a third country's protection for a specific transfer, including the type of protection offered by both the legal order and the relevant business practices in the receiving nation.
At present, no one can foresee
the full impact of the European Directive. The U.S. government, led by
Commerce Department representatives, is engaged in negotiations with the
European Union regarding the possibility of establishing "safe harbor"
principles for American companies. Thus far, these American proposals have
been viewed with some skepticism in Europe. The only safe prediction is
that Europe will continue to pressure for improvement in U.S. privacy law
due to the internationalization of data flows.
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