bluuebunny/crossref_metadata_2025 huggingface dataset:
The Legal, Ethical, and Practical Implications of Noncompetition Clauses: What Physicians Should Know before They Sign
Authors: Loeser Derek W.
Published: January 2007

Employers of all types, including group practices, health maintenance organizations (HMOs), and university and other hospital practices, commonly include noncompetition clauses in physician employment contracts. The clauses only apply in the event physicians leave their employers, and typically only limit activities in relatively narrow geographic areas. Consequently, physicians often agree to the clauses without much thought or analysis. This is a mistake, as the clauses may have broad adverse ramifications for both physicians and patients.

This article identifies the standard components of noncompetition clauses, addresses the ethical and practical concerns they raise, and reviews recent court decisions on point. The article concludes that despite public policy concerns, courts can and often do enforce the clauses. The purpose of the article, therefore, is to increase physicians’ awareness of the potential impact of these clauses, and to encourage physicians to carefully consider whether to accept contracts that contain them, or at the very least to negotiate for the least restrictive terms possible.
In Whose Interest? Current Issues in Communicating Personal Health Information: A Canadian Perspective
Authors: Weitz Mark , Drummond Neil , Pringle Dorothy , Ferris Lorraine E. , Globerman Judith , Hébert Philip , Tracy C. Shawn , Cohen Carole
Published: January 2007

The continuing spread and development of electronic data interchange in health care settings is fuelling a significant global debate about the practicality, ethics, and legality of such a practice. The uncertainties implicit in this debate are particularly acute in the context of disease or population groups for whom multidisciplinary, multipleagency teamworking has become acknowledged as the “best practice” for providing effective and timely care or support. The greying of the population is a demographic phenomenon that will have a profound impact on the health care system, social care agencies, and caregivers, and will require a greater degree of service coordination in order to meet the complex care needs of both care-receiver and caregiver.
Child Fatality Review: Recommendations for State Coordination and Cooperation
Authors: Elster Nanette R. , Alcalde M. Gabriela
Published: January 2007

Preventable childhood injuries and deaths are a major public health problem in the United States. In 2000, the most recent year for which mortality data are available, over 10,000 children from birth to age 18 died from unintentional injuries in the United States and nearly 3,000 from the same age group died from homicide or suicide. According to theChildhood Injury Fact Sheetproduced by the Centers for Disease Control and Prevention (CDC), “unintentional injuries are the leading cause of death for children one to 21 years of age.”

Preventing child fatalities requires further understanding of the causes and circumstances surrounding child deaths. One mechanism for doing this is multidisciplinary child fatality review teams. These teams exist at the state and local level and perform the functions of identifying, reviewing, and recommending preventive measures to reduce the number of preventable child deaths and life-threatening injuries.
Punitive Damages: Court Orders Two-Thirds to Go to State University Cancer Research Program
Authors: Geertsma Meleah A.
Published: January 2007

On December 20, 2002, the Ohio Supreme Court issued an opinion in Dardinger v. Anthem Blue Cross & Blue Shield granting a landmark punitive damages award against the defendant-insurer for breach of contract and bad faith in its coverage of a cancer patient. The court directed that the punitive damages award of $30 million, should it be accepted by the plaintiff, be apportioned between the plaintiff and a cancer research fund to be established in the name of the plaintiff's deceased wife, Esther Dardinger. In so doing, the court broke new ground in the scope and social purpose of punitive damages in health care litigation, as well as the courts’ role in distributing those damages.

After being diagnosed with metastatic brain tumors in October 1996, Esther began intra-arterial chemotherapy (IAC) treatments at the recommendation of her physician, Dr. Newton. IAC is a targeted form of chemotherapy in which an arterial catheter is threaded through a cranial artery near the tumor and into the brain.
Public Health: Bush's Smallpox Vaccination Plan
Authors: Gray Jennifer
Published: January 2007

At the end of last year, President George Bush implemented a smallpox vaccination plan covering military operatives, health care workers, and “first-responders” (such as firefighters and police). The program is administered by the federal Department of Health and Human Services in conjunction with the states and follows the smallpox vaccination guidelines established by the Centers for Disease Control and Prevention (CDC) in September 2002. While inoculation is mandatory for military personnel, health care workers and first-responders are vaccinated on a voluntary basis. The Administration had hoped that 450,000 health care workers would be inoculated within the first month of the program. Toward the end of February, however, only about 1 percent of the anticipated recipients had been inoculated. In Connecticut, which was the first state to begin the nonmilitary component of the program, only three people received vaccinations on the first day.
Child Welfare: Court May Determine Whether Life-Sustaining Treatment Should Be Withdrawn
Authors: Schneider Brooke A.
Published: January 2007

In In re Christopher I., the California Court of Appeal upheld a juvenile court's decision to withdraw life-sustaining medical treatment for a then-1-year-old dependent of the court. Christopher I. had come under juvenile court custody after his biological father, Moises I., physically abused him and rendered him comatose. Christopher's biological mother, Tamara S., was either unwilling or unable to protect him. After the disposition hearing, Tamara petitioned for a “Do Not Resuscitate” (DNR) order for Christopher and/or removal of his life-sustaining medical treatment. Moises opposed, asserting that the juvenile court did not have authority to make medical decisions for a dependent child, for whom counsel had been assigned, without appointing a guardian. The juvenile court rejected Moises's argument and proceeded with an evidentiary hearing. All six physicians who testified supported the withdrawal of treatment or at least a DNR order.
Using Preimplantation Genetic Diagnosis to Create a Stem Cell Donor: Issues, Guidelines & Limits
Authors: Wolf Susan M. , Kahn Jeffrey P. , Wagner John E.
Published: January 2007

Successful preimplantation genetic diagnosis (PGD) to avoid creating a child affected by a genetically-based disorder was reported in 1989. Since then PGD has been used to biopsy and analyze embryos created through in viuo fertilization (IVF) to avoid transferring to the mother’s uterus an embryo affected by a mutation or chromosomal abnormality associated with serious illness. PGD to avoid serious and early-onset illness in the child-to-be is widely accepted. PGD prevents gestation of an affected embryo and reduces the chance that the parents will be faced with a difficult decision of whether to terminate the pregnancy. More controversial have been PGD to select the sex of the child-to-be for “family balancing” (rather than to avoid a sex-linked disorder), PGD for mere susceptibility to disease and for late-onset disorders such as Alzheimer diseas, and most controversially, PGD to create a donor child who is Human Leukocyte Antigen (HLA-matched with a preexisting sibling in need of stem cell transplant.
Substance Abuse during Pregnancy: Clinical and Public Health Approaches
Authors: Jos Philip H. , Perlmutter Martin , Marshall Mary Faith
Published: January 2007

The treatment of pregnant women addicted to drugs provides an especially important and illustrative example of how political and popular demands can successfully challenge professional ethical norms associated with clinical medicine — norms such as confidentiality, patient autonomy, and the right to consent to and to refuse treatment. One increasingly popular policy approach is to limit patient autonomy by coercing women in an attempt to change their behavior, either by involuntary civil commitment or by imprisoning them for drug abuse or child neglect. Thirty-five states have criminally prosecuted women for substance abuse or alcohol use during pregnancy. Other states aggressively use involuntary civil commitment as a means to protect the yet-to-be-born from harm during pregnancy. Medical professionals have been forced to participate in these programs by mandatory reporting requirements.
Providing Subsidies and Incentives for Norplant, Sterilization and other Contraception: Allowing Economic Theory to Inform Ethical Analysis
Authors: Mauldon Jane Gilbert
Published: January 2007

Policymakers use financial incentives to achieve a wide variety of public objectives, from pollution reduction to the employment of welfare recipients. Combining insights from economic theory with lessons learned from actual implementation, this article analyzes the implications of two such policies: first, subsidizing contraception, and second, offering financial incentives to individuals for sterilization or for using a long-term, semipermanent method of contraception such as the Intra-Uterine Device (IUD), Depo-Provera or Norplant. These subsidy and incentive policies achieve their goals through a myriad of individuals who make their reproductive choices in response to particular costs and benefits. Such programs are ethically and politically controversial. In this paper, I address the question of whether they can be justified either economically or ethically.

The first section of this article presents an economic theory to assess whether a subsidy, tax, or incentive is economically efficient, both generally and in the context of contraception.
Human Rights and Genetic Discrimination: Protecting Genomics’ Promise for Public Health
Authors: Silvers Anita , Stein Michael Ashley
Published: January 2007

The potential power of predictive genetic testing as a risk regulator is impressive. By identifying asymptomatic individuals who are at risk of becoming ill, predictive genetic testing may enable those individuals to take prophylactic measures. As new therapies become available, the usefulness of genetic testing undoubtedly will increase. Further, when a person's family medical history indicates a propensity towards a particular genetic disease, a negative test result may open up otherwise denied opportunities by showing that this person has not inherited suspect genes. In the latter type of case, a negative test result may reassure the individual that pursuing a particular course of action (such as planning a family or training for a job) is worthwhile, or may convince prospective employers that the individual will be a serviceable employee.
Discourse Ethics as an Ethics of Responsibilty: Comparison and Evaluation of Citizen Involvement in Population Genomics
Authors: Racine Éric
Published: January 2007

Population genomics seeks to better understand genomic diversity and variation at the level of populations. Numerous ethical questions are raised by large studies of human genomic diversity. First, at the level of ethical means, the confidentiality of the genetic data obtained and its handing (data banks, access, involvement of private sector, etc.) are challenging. Second, at the more fundamental level of ethical goals or ends, we find questions concerning the meaning and the interpretation of genetic knowledge. What shall we do with this knowledge? Who will decide research orientation and priorities? Ethical questions raised by population genomics imply those of “classical genomics,” but they have the additional ethical complexity of research done on populations. How should we take this particular aspect into account?
The Human Subjects Trade: Ethical and Legal Issues Surrounding Recruitment Incentives
Authors: Lemmens Trudo , Miller Paul B.
Published: January 2007

Over the past 5 years, a series of articles in leading American newspapers has revealed the extent to which the conduct of clinical trials may be affected by inducements offered by corporate research sponsors and accepted by some unscrupulous physicians. The cases described were disturbing. They involved physicians engaged in excessive “enrollment activities” in exchange for money. Some of these physicians perpetrated fraud, falsifying their recruitment records in order to increase their profits. Others ignored exclusion criteria designed to ensure the safety of subjects and the validity of research results, referring their patients to research investigating treatments for conditions from which they did not suffer. One of the articles reports that physicians focusing exclusively on commercial research regularly divulge annual incomes upwards of $1,000,000 with profits in excess of $300,000. Two physicians accumulated well over $10,000,000 through clinical trials activities in less than a decade.
Research-Related Injury: Problems and Solutions
Authors: Scott Larry D.
Published: January 2007

The highly publicized deaths of research participants Ellen Roche and Jesse Gelsinger are stark reminders that risk is inherent in medical research and while untoward outcomes are infrequent when compared to individual and societal benefits, injury and even death will happen. Who is responsible for the welfare of research subjects and what are they owed? Why were they put at risk to begin with? Are obligations, if any, to research subjects dependent on the type of study in which they participate, in recognition that there may be personal benefit from participation in some studies?

The issue of injury resulting from participation in research and answers to questions such as those just posed were last considered in depth nearly 20 years ago by the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research.
The French Law on “Protection of Persons Undergoing Biomedical Research”: Implications for the U.S.
Authors: Berlin Ivan , Gorelick David A.
Published: January 2007

Because research involving human subjects exposes people to risk not always for their own potential benefit, the question arises as to how best ensure that: (1) research participants are protected and benefited according to the highest ethical standards, while, on the other hand, (2) researchers are protected and free to do research that will produce clinical advances for both research participants and society as a whole.

The balancing of the risk to research participants versus the benefits derived from the research is performed in many counrries by a system for the protection of human research participants that is laid out in national laws and regulations. In the United States, this system is based on principles emanating from the Nuremberg Code, the World Medical Association Declaration of Helsinki,and the report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (the Belmont Rept).
A Pilot Survey on the Licensing of DNA Inventions
Authors: Henry Michelle R. , Cho Mildred K. , Weaver Meredith A. , Merz Jon F.
Published: January 2007

Intellectual property in biotechnology invention provides important incentives for research and development leading to advances in genetic tests and treatments. However, there have been numerous concerns raised regarding the negative effect patents on gene sequences and their practical applications may have on clinical research and the availability of new medical tests and procedures. One concern is that licensing policies attempting to capture for the benefit of the licensor valuable rights to downstream research results and products may increase the financial risks and cliniinish potential payoffs of — and therefore motivation for — performing downstream research and development. In addition, very broad patent claims allowed by the U.S. Patent and Trademark Office, the sheer growth in patents claiming genetic sequences, and threats of overlapping patents create a veritable minefield for researchers in both academia and industry. The concern is that research may be stifled because of the high cost and hassle of negotiating access.
Currents in Contemporary Ethics
Authors: Anderlik Mary R. , Rothstein Mark A.
Published: January 2007

In financial disputes involving research, the parties are traditionally individual researchers and their institutions, biotech and pharmaceutical companies, and other entities engaged in the commercial development of biomedical research. Occasionally, research subjects claim that researchers have misled them or misappropriated their biological materials to derive financial gain. The best known example is the case of Moore v. Regents of the University of California, decided in 1990.

With new developments in genomics, large-scale repositories of tissue and other biological specimens are increasingly important. Biobanks have been established by various researchers, commercial entities, health-care institutions, and even entire countries. Individuals who contribute specimens almost always retain no commercial interest in any resulting research and language to that effect is now customarily included in informed consent documents signed at the time the specimen is given. Suppose, however, that the research subjects actually collect the specimens themselves, recruit the researcher, and provide financial support for the research.
Child Safety: Homicide by Child Abuse: South Carolina Upholds Conviction under “Crack Mom” Law
Authors: Smith Marcella
Published: January 2007

In State v. McKnight, the Supreme Court of South Carolina decided 3-2 to affirm McKnight’s conviction for homicide by child abuse based on the finding that her cocaine use during pregnancy caused her daughter to be stillborn. Under South Carolina law, a person is guilty of homicide by child abuse if he or she “causes the death of a child under the age of eleven while committing child abuse or neglect, and the death occurs under circumstances manifesting extreme indifference to human life.” During the trial, the pathologist who conducted the autopsy testified that (1) the only way for the infant to have cocaine byproducts present in her system was ifthe mother had ingested cocaine, and (2) the cause of death was intrauterine fetal demise. Another pathologist testified that there was a reasonable degree of medical certainty that the cause of death was intrauterine cocaine exposure.
SARS: Political Pathology of the First Post-Westphalian Pathogen
Authors: Fidler David P.
Published: January 2007

In March 2003, the world discovered, again, that I humanity's battle with infectious diseases continues. The twenty-first century began with infectious diseases, especially HIV/AIDS, being discussed as threats to human rights, economic development, and national security. Bioterrorism in the United States in October 2001 increased concerns about pathogenic microbes. The global outbreak of severe acute respiratory syndrome (SARS) in the spring of 2003 kept the global infectious disease challenge at the forefront of world news for weeks. At its May 2003 annual meeting, the World Health organization (WHO) asserted that SARS is “the first severe infectious disease to emerge in the twenty-first century” and “poses a serious threat to global health security, the livelihood of populations, the functioning of health systems, and the stability and growth of economies.”
Partners: Discernment and Humanitarian Efforts in Settings of Violence
Authors: Campos Nicole Gastineau , Farmer Paul
Published: January 2007

One hundred years ago, most wars occurred between nations; today, large-scale violent conflict consists almost exclusively of civil wars in which civilians constitute 30 percent of casualties.’ According to a recent World Bank study of conflict, the poorest one-sixth of the worlds population suffers four-fifths of the consequences of civil wars. While poverty is the greatest risk factor determining a nation’s likelihood of entering into conflict, it is also one of instability’s most predictable consequencet—thus, war is a vicious cycle, and poor nations may remain at risk for intense violence for years or even decades.
War, Terrorism, and Public Health
Authors: Sidel Victor W. , Levy Barry S.
Published: January 2007

Kill one person, and it is considered murder.

Kill ten thousand person, and it is considered foreign policy.

-Anonymous
When Terrorism Threatens Health: How Far are Limitations on Human Rights Justified
Authors: Gostin Lawrence O.
Published: January 2007

A single defining question perennially intrigues scholars and practitioners interested in public heath: To what extent should human rights be limited to protect the community’s health and safety? The question achieved prominence in the aftermath of the attacks on the World Trade Center and Pentagon on September 11, 2001 and with the intentional dispersal of anthrax spores through the U.S. Postal Systein. The conflict between security and public health intensified with the development of the Model State Emergency Health Powers Act (“Model Act”), drafted by the Center for Law and the Public’s Health at the request of the Centers for Disease Control and Prevention. The Model Act grants states consiclernble powers to control persons and property in response to a public health emergency, defined to inclucle bioterrorism or the appearance of novel or previously controlled or eradicated infectious agents or biological toxins.
International Trade, Law, and Public Health Advocacy
Authors: Sapsin Jason W. , Thompson Theresa M. , Stone Lesley , DeLand Katherine E.
Published: January 2007

Public Health Science and practice expanded during the course of the 20th century. Initially focused on controlling infectious disease through basic public health programs regulating water, sanitation and food, by 1988 the Institute of Medicine broadly declared that “public health is what we, as a society, do collectively to. assure the conditions for people to be healthy.” Commensurate with this definition, public health practitioners and policymakers today work on ;in enormous range of issues. The 2002 policy agenda of the American Public Health Association reflects positions on genomics’ role in public health; national health and safety standards for child care programs; sodium in Americans’ diets; the health and safety of emergency rescue workers; and war in Central Asia and the Persian Gulf.
Public Health and the Built Environment: Historical, Empirical, and Theoretical Foundations for an Expanded Role
Authors: Perdue Wendy C. , Gostin Lawrence O. , Stone Lesley A.
Published: January 2007

In 2000, the Center for Disease Control and Prevention’s National Center for Environmental Health issued a report that explored some of the ways in which “sprawl” impacts public health. The report has generated great interest, and state health officials are beginning to discuss the relationship between land use and public health. The CDC report has also produced a backlash. For example, the Southern California Building Industry Association labeled the report “a ludicrous sham” and argued that the CDC should stick to “fighting physical diseases, not defending political ones.”

In retrospect, it is probably unfortunate that this report was funded by an organization called “Sprawl Watch.” “Spraw” is a word that has no clear meaning but is applied to a huge range of issues involving suburban development.
Technologies to Detect Concealed Weapons: Fourth Amendment Limits on a New Public Health and Law Enforcement Tool
Authors: Vernick Jon S. , Pierce Matthew W. , Webster Daniel W. , Johnson Sara B. , Frattaroli Shannon
Published: January 2007

Firearm violence is a major public health problem in the United States. In 2000, firearms were used in 10,801 homicides – two-thirds of all homicides in the U.S. – and 533,470 non-fatal criminal victimizations including rapes, robberies, and assaults. The social costs of gun violence in the United States are also staggering, and have been estimated to be on the order of $100 billion per year.

Illegal gun carrying, usually concealed, in public places is an important risk factor for firearm-related crime. In the 1980s and 1990s, police departments across the country began to develop and implement strategies to address illegal weapons carrying. Often these strategies have involved aggressive efforts to identify and physically search individuals suspected of illegally carrying a firearm.
“The King of Terrors” Revisited: The Smallpox Vaccination Campaign and its Lessons for Future Biopreparedness
Authors: Schneider Cynthia P. , McDonald Michael D.
Published: January 2007

“Smallpox was always present, filling the churchyard with corpses, tormenting with constant fear all whom it had not yet stricken, leaving on those whose lives it spared the hideous traces of its power, turning the babe into a changeling at which the mother shuddered, and making the eyes and cheeks of the betrothed maiden objects of horror to the lover.” In 1848, British historian T.B. Macaulay first captured the picture of the devastation smallpox wreaked on its victims, but the “King of Terrors,” as it was dubbed by future president John Adams, had already decimated populations in the ancient world from Greece to Egypt to China. Smallpox had no respect for authority: the earliest identified victim, Pharaoh Ramses V (d.1157 B.C.) was but the first in a long line of monarchs and rulers who succumbed,. including the Hittite king Suppiluliumas I, Aztec Emperor Cuitlahuac, and Queen Mary II of England.
Finding a Way through the Hospital Door: The Role of EMTALA in Public Health Emergencies
Authors: Rosenbaum Sara , Kamoie Brian
Published: January 2007

This article examines the Emergency Medical Treatment and Labor Act (EMTALA) in a public health emergency context. Congress enacted EMTALA in 1986 to prohibit the practice of “patient clumping,” which involved hospitals’ refusal to undertake emergency screening and stabilization services for individual patients who sought emergency room care, typically because of insurance status, inability to pay, or other grounds unrelated to the patient’s need for the services or the hospital’s ability to provide them. But in fact EMTALA, whose conceptual roots can be found in the Hospital Survey and Construction Act of 1946 (Hill Burton) as well as an evolution in both the common law and state statutes related to hospital licensure, can be viewed as having a far broader purpose than protection of individuals, and indeed, one that is related to the protection of communities and the public health.
New Hope for Victims of Prison Sexual Assault
Authors: Mair Julie Samia , Frattaroli Shannon , Teret Stephen P.
Published: January 2007

Senate Bill 1435, the “Prison Rape Elimination Act of 2003,” was introduced into the Senate on July 21, 2003, and in less than a week passed both the Senate and House by unanimous consent. The Bill was presented to President Bush on September 2, 2003, and he signed it two days later on September 4, 2003. The stated purposes of the Act are far-reaching and ambitious:

(1)

establish a zero-tolerance standard for the incidence of prison rape in prisons in the United States;

(2)

make the prevention of prison rape a top priority in each prison system;

(3)

develop and implement national standards For the detection, prevention, reduction, and punishment of prison rape;

(4)

increase the available data and information on the incidence of prison rape, consequently improving the management and administration of correctional facilities;

(5)

standardize the definitions used for collecting data on the incidence of prison rape;
Dealing with Humpty Dumpty: Research, Practice, and the Ethics of Public Health Surveillance
Authors: Fairchild Amy L.
Published: January 2007

Alice considered [the idea of un-birthday presents] a little. “I llke birthday presents best,” she said at last.

“You don’t know what you’re talking about!” cried Humpty Dumpty. … “[There are three hundred and sixty-four days when you might get un-birthday presents… And onlyonefor birthday presents, you know. There’s a ‘glory’ for you!”

“I don’t know what you mean by ‘glory,’” Alice said.

Humpty Dumpty smiled contemptuously. “Of course you don’t—till I tell you. I meant ‘there’s a nice knock-down argument for you!’”

“But ‘glory’ doesn’t mean ‘a nice knock-down argument,’” Alice objected.

“WhenIuse a word,” Humpty Dumpty said in a rather scornful tone, “it means just what I choose it to mean—neither more nor less.”
The Myth of Exceptionalism: The History of Venereal Disease Reporting in the Twentieth Century
Authors: Fairchild Amy L. , Colgrove James , Bayer Ronald
Published: January 2007

As therapeutic advances in the treatment of AIDS began to emerge in the late 1980s and public health began to have more to offer than just the threat, or the perceived threat, of quarantine or partner notification, fissures began to appear in the alliance against named HIV reporting that had emerged a few years earlier. In 1989, New York City’s Health Commissioner stated that the prospects of early clinical intervention warranted “a shift toward a disease-control approach to HIV infection along the lines of classic tuberculosis practices,” including the “reporting of seropositives.”

Although his proposal met with fierce and effective resistance, it is now clear that his call represented part of a national trend. The CDC continued to press for cases of HIV to he reported by name to health departments, an effort that assumed the dimensions of a campaign. It was supported by a growing number of public health officials.
Applying the Common Rule to Public Health Agencies: Questions and Tentative Answers about a Separate Regulatory Regime
Authors: Burris Scott , Buehler James , Lazzarini Zita
Published: January 2007

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically from the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention (CDC) has adopted guidelines that require Common Rule review for “research” but not “practice” activities.
The Role of State Law in Protecting Human Subjects of Public Health Research and Practice
Authors: Burris Scott , Gable Lance , Stone Lesley , Lazzarini Zita
Published: January 2007

“Public health practice” consists of activities and Programs managed by public health agencies to promote health and prevent disease, injury, and disability. Some of these activities might be deemed to fit within the broad definition of “research” under federal regulations, known as the Common Rule, designed to protect human research subjects. The Common Rule defines research as “a systeniatic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” Public health activities that might under some circumstances be considered research include disease reporting, review of medical records, surveys, interviews, focus groups, specimen collection (blood, urine, etc.), and laboratory testing (both identifiable and anonymous).

There are questions about the extent to which the Common Rule applies or was intended to apply to public health practice: and it has been suggested in any case that Common Rule regulation of public health practice may not be socially optimal for both practical and principled reasons.
Health Information Privacy and Public Health
Authors: Hodge James G.
Published: January 2007

Protecting the privacy of individually-identifiable health data and promoting the public’s health often seem at odds. Privacy advocates consistently seek to limit the acquisition, use, and disclosure of identifiable health information in governmental and private sector settings. Their concerns relate to misuses or wrongful disclosures of sensitive health data that can lead to discrimination and stigmatization against individuals. Public health practitioners, on the other hand, seek regular, ongoing access to and use of identifiable health information to accomplish important public health objectives. The collection and use of identifiable health data by federal, tribal, state, and local health authorities support nearly all public health functions and goals.

Identifiable health data are the lifeblood of public health practice. When aggregated, these data help authorities monitor the incidence, patterns, and trends of injury and disease in populations. Health data are acquired by public health authorities through testing, screening, and treatment programs.
What is Public Health Legal Preparedness?
Authors: Moulton Anthony D. , Gottfried Richard N. , Goodman Richard A. , Murphy Anne M. , Rawson Raymond D.
Published: January 2007

“Public health legal preparedness” is a term born in the ferment, beginning in the late 1990s, that has led to unprecedented recognition of the essential role law plays in public health and, even more recently, in protecting the public from terrorism and other potentially catastrophic health threats.

The initial articulation of public health has not kept pace with rapid evolution in the concept and in practical development of public health preparedness itself. This poses the risk that legal preparedness may fall behind construction of general readiness in the public health system—and may, in fact, undercut achievement of comprehensive public health preparedness for massive threats to health in both the United States and world-wide. Inadvertent results might include both negative health impacts and infringement on individual rights.
Public Health Literacy for Lawyers
Authors: Parmet Wendy E. , Robbins Anthony
Published: January 2007

Public health professionals recognize the critical role the law plays in determining the success of public health measures. Even before September 11, 2001, public health experience with tobacco use, HIV, industrial pollution and other potent threats to the health of the public demonstrated that laws can assist or thwart public health efforts. The new focus on infectious threats and bioterrorism, starting with the anthrax attacks through the mail and continuing with SARS, has highlighted the important role of law.

For lawyers to serve as effective partners in public health, they should have a basic familiarity with public health: how public health professionals see the world and the key issues they tackle. A practical grasp of public health can be acquired, and often is acquired, “on the job.”
Currents in Contemporary Ethics
Authors: Hoffman Sharona , Morriss Andrew P.
Published: January 2007

Contemporary developments in reproductive technology hold great promise for those who have difficulty conceiving naturally. However, they have generated extensive debate among lawyers, ethicists, legislators, the media, and the public. Concern has intensified recently in light of claimed attempts to clone human beings. One implication of the new reproductive technologies upon which few commentators have focused is their effect on inheritance rights and on the notorious Rule Against Perpetuities. For example, what impact should the possible existence of frozen sperm or frozen embryos have upon the execution of wills and implementation of the Rule? If one leaves property to one’s children but has frozen sperm or embryos that might produce children the Rule? If one leaves property to one’s children but has frozen sperm or embryos that might produce children decades after one’s death, what should be done about the distribution of the estate? These difficult questions can no longer be ignored.
Fast Food Fighters Fall Flat: Plaintiffs Fail to Establish that McDonalds should be Liable for Obesity-related Illnesses
Authors: Falit Ben
Published: January 2007

This nation’s obesity epidemic is hardly a laughing matter. Approximately 300,000 Americans die from obesity-related causes each year, and without corrective measures, obesity may soon be responsible for as many deaths as cigarette smoking. Sixty-one percent of adults are overweight or obese, and the cost of obesity for the year 2000 was estimated to be 117 billion dollars.

In Pelman v. McDmalds, a case decided in September 2003, a federal judge dismissed an amended complaint that attempted to hold McDonalds liable for its customers’ obesity-related illnesses. While many argue that such litigation is frivolous and that the plaintiffs did not deserve direct compensation for their injuries, the debate has largely overlooked the important question raised by these cases - who should pay for the enormous financial strain that obesity places on America’s health care system? Although the courtroom may not be the appropriate forum to deal with this issue, the litigation has undoubtedly brought a great deal of much-needed attention to a vexatious social problem.
Kentucky Association of Health Plans, Inc. v. Miller
Authors: Gutmann Valerie
Published: January 2007

In Kentucky Association of Health Plans, Inc. v. Miller,, the Supreme Court unanimously held that states’ “any willing provider” laws are not preempted by the Employee Retirement Income Security Act of 1974 (ERISA). The Court ruled that states can regulate their health maintenance organizations (HMOs), and thus upheld a Kentucky law that requires insurers to reimburse services of any health care provider who is willing and able to meet established criteria. The Supreme Court has heard several cases related to ERISA in the last few years, and other such cases are working their way through the court system. Coupled with this most recent decision in Miller, the Supreme Court may significantly alter the shape of the insurance industry.
Healthcare Reimbursement: HMO Arbitration Clause Enforced
Authors: Kelly Carly
Published: January 2007

In Pacificare Health Systems, Inc. v. Jefrey Book, the US. Supreme Court ruled that the mandatory arbitration clause in an HMO contract should be enforced to compel a physician to arbitrate his RICO charges against the health plan, even though the clause could be construed to limit the arbitrator’s authority to award full damages under the RICO statute. The ruling could prevent physicians with health plan arbitration agreements from taking future reimbursement claims against insurance companies directly to court, even when the allegations involve a potential statutory breach outside of the explicit scope of the provider contract.

Dr. Book’s arbitration claim was part of a larger class action lawsuit filed in August of 2000 by a group of physicians and patients seeking reimbursement from eight managed care companies for unpaid health insurance claims.
Second Circuit Permits State Malpractice Suit against HMO
Authors: Lumelsky Anna
Published: January 2007

On February 11, 2003, the Second Circuit ruled inCicio v. Vytra Healthcarethat patients may in some cases sue health maintenance organizations (HMOs) for medical malpractice under state law. The decision is particularly notable for opening the door to state tort claims in an area that had heen considered preempted by the Employee Retirement Income Security Act of 1974 (ERISA).

ERISA is a federal statute that regulates employee benefit plans, establishing a complex set of rules and minimum standards for most health and pension plans in private industry. ERISA requires that participants receive certain information about their benefits plans, and imposes fiduciary responsibilities on individuals with discretionary control over plan assets. These individuals have certain specific duties, and are required to work “solely in the interest of the participants and beneficiaries and for the exclusive purpose of: (i) providing benefits to participants and their beneficiaries; and (ii) defraying reasonable expenses of administering the plan.”
Supreme Court Limits Permissible Scope of Government’s Ability to Force Medication of Mentally Ill Defendants
Authors: Prieto-Gonzalez Mayelin
Published: January 2007

On June 16, 2003, the Supreme Court ruled that forced administration of antipsychotic drugs to a defendant facing serious criminal charges is appropriate in order to render that defendant competent to stand trial, but only in limited circumstances. The treatment must be medically appropriate, substantially unlikely to have side effects that may undermine the fairness of the trial, and necessary to significantly further important government interests, after taking account of less-intrusive alternatives.

Charles Sell, a former dentist, had a long history of mental illness. He had been hospitalized twice, in 1982 and 1984, after expressing paranoid ideas to law enforcement officials. In May 1997, Sell was charged with fifty-six counts of mail fraud, six counts of Medicaid fraud, and one count of money laundering. He was released on bail after a magistrate determined that he was currently competent to stand trial.
Holes in the Health Insurance System-Who Lacks Coverage and Why
Authors: Hoffman Catherine , Rowland Diane , Carbaugh Alicia L.
Published: January 2007

Lack of health insurance coverage is a large and growing problem for millions of American families. Rising health care costs and economic insecurity continue to threaten the bedrock of the health insurance system - employer-sponsored coverage - while states’ fiscal situations and the escalating federal deficit complicate any efforts at reform. Providing health insurance coverage to the millions of uninsured remains a major health care challenge for the nation and understanding the current health insurance environment, who the uninsured are, and why they are uninsured is critical when considering health care reform. This paper aims to define the problem of the uninsured, providing an overview of the uninsured in America and the roles and limits of private and public insurance. Following this discussion, the paper describes the current health insurance environment and examines the prospects for improving coverage.
The Consequences of Uninsurance for Individuals, Families, Communities, and the Nation
Authors: Wolman Dianne Miller , Miller Wilhelmine
Published: January 2007

Until very recently, the lack of health insurance has been viewed primarily as a problem of financial risk for uninsured individuals. This article documents far broader adverse effects, drawn from the work of the Institute of Medicine (IOM) Committee on the Consequences of Uninsurance. It also synthesizes the Committee’s key findings, conclusions, and recommendations.

In early 2004, following 3½ years of study, the IOM Committee on the Consequences of Uninsurance recommended that “...the President and Congress develop a strategy to achieve universal insurance coverage and establish a firm and explicit schedule to reach this goal by 2010.” The Committee presented 5 principles to be used to assess various proposals for extending coverage or to guide the design of a new strategy, specifying that health care coverage should be universal, continuous, affordable to individuals and families, and affordable and sustainable for society.
The Current State of Employment-Based Health Coverage
Authors: Glied Sherry A. , Borzi Phyllis C.
Published: January 2007

American policymakers and health policy analysts have a love-hate relationship with job-based health insurance. The policy press routinely runs articles about the demise of the current system of voluntary employer-sponsored health insurance coverage. Conservatives argue that it ought to be replaced with individually-purchased insurance, such as tax-favored spending accounts (see Mark Pauly’s article this issue). Liberals assert that government insurance ought to supplant it.

Meanwhile, as the debate rages on about the future of employer coverage, states and the federal government pass legislation buttressing and building on the existing employment-based system. Most recently, California has passed an employer mandate requiring employers to cover their workers (and many other states have contemplated similar legislation) and Maine has adopted a universal coverage initiative that includes a voluntary small employer insurance program offered through a state agency (Dirigo Health Care).
The Struggle for the Soul of Medicare
Authors: Vladeck Bruce C.
Published: January 2007

Not so very long ago - in historical terms - the politics of Medicare were thought to be stable and well-established. Medicare’s 1965 enactment culminated an epochal political battle that spanned fifteen years and involved mass mobilization, millions of dollars in lobbying expenditures (including the development of such techniques as “grass-roots lobbying” and targeted direct mail), and bitter partisan controversy. By the late 1980s those seemed to be distant birthing pains long since overshadowed by the program’s robust health and popularity. Medicare politics had devolved into a model of pluralist “normalcy” in which a relatively specialized and autonomous group of subject-matter experts in the federal bureaucracy, the Congress, and affected interest groups largely made policy by negotiating among themselves, primarily on issues of provider reimbursement. Even the extraordinary events involving the 1988 enactment of the “Medicare Catastrophic Coverage Act” legislation (which, among other things, established good coverage for prescription drugs), and the ensuing public firestorm that led to its partial repeal in 1989, could be seen as an aberrational deviation from a more placid pattern.
Attending to Medicaid
Authors: Mann Cindy , Westmoreland Tim
Published: January 2007

[P]layers line up in a long line and hold hands. The player at the front of the line is the ‘head’ and the player at the end of the line is the ‘tail’.… The game begins when the head begins to run wildly in any direction, making sharp turns and quick double-backs.… The force created by the twists and turns will often send the tail of the whip flying.… It may be best for the tail to hold on with both hands to keep from flying off the end. Sometimes, however, the tail will go flying no matter how hard they hold on ... Be prepared to get dirty if you play this game!

--"Crack the Whip: Party Game Central

If the evolution of American health policy (in both its purposeful and its accidental forms) is compared to the children’s game of Crack the Whip, then there is no question that the Medicaid program is the tail of the line. When those at the head of the line (e.g., employer-based insurance, Medicare, managed care plans, and pharmaceutical companies) start to move. Medicaid receives whatever shocks and unintended consequences result, and when the line “begins to run wildly in any direction,” it receives them faster and harder than the players at the center.

Shocks also come from other sources. When the economy slumps, an epidemic arises, or a path in another part of the system becomes a cul-de-sac, new twists and turns occur, with Medicaid absorbing much of the change.