On February 21-22, 1991, the Centers for Disease Control convened an Open Meeting on the Risk for Transmission of Bloodborne Pathogens to Patients During Invasive procedures in Atlanta, Georgia. Over 80 organizations testified at that meeting.

Almost without fail, every organization testified against the use of mandatory HIV testing to screen out HIV-infected surgeons and dentists from practice. Various groups and individuals, however, advocated that HIV-infected professionals should voluntarily restrict themselves from selected procedures and/or should voluntarily disclose their HIV status to their patients.

Larry Gostin, the Executive Director of the American Society of Law and Medicine, argued that HIV-infected health care workers should voluntarily self-defer from selected invasive procedures. I believe that the approach of voluntary self-deferral has legal and practical flaws and is not the appropriate public policy for the CDC to adopt.

The death of William Schroeder in Louisville, Kentucky, on August 6, 1986, brought to a close a remarkable chapter in public human experimentation. Artificial heart implants represent the most public experiments in the history of the world. The manner in which they are conducted is a matter of utmost public and professional concern, since it graphically portrays the seriousness with which we take our laws and ethical rules regarding the protection of the rights and welfare of human subjects. Unfortunately, the brief history of artificial heart implants is neither a happy nor a proud one. Begun with high hopes and therapeutic intentions with the Barney Clark implant, the permanent procedures rapidly became little more than publicity stunts used to advertise Humana, Inc., a for-profit hospital chain. Indeed, on the night Mr. Schroeder died, Humana Hospital Audubon sent its public relations director to justify the experiment to a national television audience on Nightline, apparently because no physician at the hospital was willing or able to publicly defend the experiment.

I propose in this essay to briefly describe some of the main current stakeholders who issue guidance on the ethics of human subjects research. This will be preceded by a very brief historical introduction.

Prior to World War II, as far as I have been able to ascertain, there were no international efforts to regulate human experimentation. National activities were few and far between. One exception was a Directive on Human Experimentation issued in December 1900 by the then Prussian Minister of Religious, Educational and Medical Mairs. This was followed by a Circular on innovative therapy and scientific experimentation promulgated by the then Reich Minister of the Interior in February 1931. Just over five years later, in April 1936, the Bureau of the Medico-Scientific Council of the People’s Commissariat for Health of the Russian Socialist Federated Soviet Republic (RSFSR), the main constituent Republic of the then Union of Soviet Socialist Republics, issued an Advisory Resolution on the procedures for testing new medicinal substances and methods which may present a hazard for the health and life of patients.

A regulatory moment for prenatal health care is here. An increasing amount of legislative attention has concentrated on the decisions pregnant women make after prenatal testing. The impetus for this legislation is a new non-invasive prenatal genetic test (NIPT). From the beginning of pregnancy, cell-free fetal DNA travels across the placental lining into the mother’s bloodstream, increasing in quantity as the pregnancy progresses. Laboratories can now analyze that DNA for chromosomal abnormalities and for fetal sex at 10 weeks of gestation. NIPT, which relies on a sample of the pregnant woman’s blood, is painless, occurs early in pregnancy, and is available for clinical and commercial use. In 2013, major health insurance plans began to cover NIPT for certain populations of women, such as women over 35 years old. And private companies have started marketing prenatal testing kits directly to consumers, who return a blood sample from the prospective mother to a company laboratory.

The least infringement principle has been widely endorsed by public health scholars. According to this principle, public health policies may infringe upon “general moral considerations” in order to achieve a public health goal, but if two policies provide the same public health benefit, then policymakers should choose the one that infringes least upon “general moral considerations.” General moral considerations can encompass a wide variety of goals, including fair distribution of burdens and benefits, protection of privacy and confidentiality, and respect for autonomy.

In this article, we argue that the Center for Disease Control and Prevention's (CDC) 2006 HIV screening recommendations (“Recommendations”) may violate the least infringement principle. This is a concern because, although not legally binding, the Recommendations appear to have already influenced state laws and will likely continue to do so as legislative proposals continue to be passed. At a minimum, therefore, the Recommendations have important implications for HIV screening within the United States.

The above bit string encodes personal information about one of the authors of this essay. Of course, without rules to decode the bit string, it is impossible to say whether it is genetic information, weight, age, fingerprint, religion, etc. Layered on top of that technical decoding process is a social decoding process – how sensitive is this information? How useful is it to the government for various purposes? The objective of this paper is to offer some key lessons for the regulation of genetic information collected by the state for law enforcement purposes. In the first part of the paper, we discuss two fundamental principles of informational privacy theory. Utilizing these, we then examine the statutory regimes that have emerged for the regulation of the information that the government collects in three different domains – fingerprints, department of motor vehicle (DMV) records, and tax records. In the third and final part we use the results of our analysis as analogies for similar regulatory challenges in the regulation of genetic information collected for law enforcement purposes, and make some tentative recommendations.

The United States is in its fifth year of what is now widely referred to as “the new medical malpractice crisis.” Although some professional liability insurers have begun to report improvements in their overall financial margins, there are few signs that the trend toward higher costs is reversing itself - particularly for doctors and hospitals. In 2003-2004, the presidential election and tort reform proposals in Congress brought heightened public attention to the need for some type of policy intervention to ease the effects of the crisis.

The darling of tort reformers at both the federal and state levels has been legislation to limit, or “cap,” damages awarded to plaintiffs in malpractice cases. Health care provider groups, liability insurers, and the Bush Administration have all seized on the example of California's MICRA law, which since 1975 has capped noneconomic damages in malpractice cases at a flat $250,000, as the path to financial recovery.

Finland has aimed to make itself an international leader in genomic research and related business and, in working towards that goal, has enacted biobank legislation. The Biobank Act requires biobanks to gain approval, be supervised, and register at the national level. Numerous other laws may also apply in any given research setting, such as the Personal Data Act, the Medical Research Act, and the Act on Medical Use of Human Organs and Tissues. In terms of privacy protection, anonymization is generally not permitted under Finnish law and therefore most biobanks pseudonomize data and samples. However, the broad understanding of what is identifiable data in Finland has created difficulties in sharing with non-EU countries. Furthermore, consent to biobank research is only applicable to the sample and related data, not to data stored in other health-related registries, and consent is only to the field of research for that particular biobank. These restrictions impede the sharing of samples and data for research.

In 1967 Osamu Takeuchi of Honda Research and Development Co., Ltd. took some spare motorcycle parts to an outdoor area in Japan. American Honda Motor Corporation, the United States distributor for Honda Motor Company, Limited of Japan had requested the development of a vehicle to compete with snowmobiles. The result of Mr. Takeuchi's work was the All Terrain Vehicle (ATV), first distributed in the United States in 1970.

By the end of 1987, an estimated 2.5 million ATVs had been sold by the major Japanese manufacturers and distributors: Honda, Yamaha, Kawasaki and Suzuki, and by Polaris, the sole American-owned manufacturer and distributor. According to U.S. Consumer Product Safety Commission (CPSC) estimates, over 340,000 hospital-emergency-room treated injuries have been associated with the use of ATVs. Almost 1000 deaths have been recorded by CPSC through their system for tracking state medical examiner's and coroner's offices. Almost half the deaths were children under 16 years of age and approximately 20 percent were children 12 and under. CPSC estimates that approximately 5 percent, or one of every 20 three-wheeled ATVs, is involved in a hospital emergency room treated injury each year.

Concussion is a form of mild traumatic brain injury (mTBI) that can occur as a result of contact to the head or other parts of the body that causes a rapid acceleration-deceleration force to the brain that may cause a functional disturbance in an individual’s ability to concentrate or learn new information. Contrary to popular belief, it is not a bruise to the brain, and there is usually nothing detectable on standard imaging such as a computed tomography or magnetic resonance imaging. Symptoms and signs are therefore important to detect and include decreased levels of consciousness, headache, nausea, difficulty concentrating, memory loss, and poor coordination. These signs and symptoms usually occur within minutes after the injury but may also appear several hours or even days later.

The relationship between dementia and criminal behavior perplexes legal and health care systems. Dementia is a progressive clinical syndrome defined by impairment in at least two cognitive domains that interferes with one's activities of daily. Dementia symptoms have been associated with behaviors that violate social norms and constitute criminal actions. A failure to address a gap in policies that support appropriate management of individuals with dementia reflects a failure in our social obligation to care for those who are most vulnerable amongst us. Categorical protections, informed by precedent models applied to juveniles and individuals with psychiatric illness, could help meet a social obligation to provide protections to individuals with dementia. We propose an approach that integrates affirmative defenses to mitigate criminal liability and sentencing restrictions to prevent cruel and unusual punishment.

As this nation embarks on new efforts to reform the U.S. health system, we face a critical unfinished agenda from the mid- 1960s: persistent racial, ethnic, and socioeconomic disparities in health and health care. Medicaid, Medicare, and Community Health Centers — public programs with very different legislative histories and financing mechanisms — were the first federally funded, nationwide efforts to improve health care access for low-income and elderly Americans. Members of racial and ethnic minority groups also greatly benefited from these efforts because recipients of federal funds, such as Medicare, were required to comply with the newly passed Civil Rights Act of 1964, which barred racial discrimination. Unquestionably, government played a major role in the gains in health care access that have occurred in the last half century. Yet today all Americans do not have the same opportunities for health, access to care, or quality of care when they receive it.

In response to increasing use of practice guidelines in medicine, physicians have focused their attention on how these guidelines can restrict their medical practices. However, guidelines not only restrict physician discretion, but they also limit the treatment options available to patients. As a result, treatments which patients consider beneficial may not be recommended; for example, some hysterectomies for abnormal uterine bleeding, and cataract surgery in patients with dementia. When guidelines are used to determine which medical treatments a health care organization or insurer will cover, these recommendations become restrictions. Thus far, guidelines have been developed without adequate attention to the impact that their restrictive use has on diverse patient values.

Two significant tensions in current medical ethics relate to the inclusion of patient values in practice guidelines. First, a tension exists between the traditional paternalistic model of care, in which the physician judges unilaterally which treatments will benefit the patient, and the more recent autonomy model, in which the physician elicits the individual patient's health values to determine which treatments will be beneficial.

Despite some improvements in access to evidence-based medications for opioid use disorder, treatment rates remain low at under a quarter of those with need. High costs for brand name products in these medication markets have limited the volume of drugs purchased, particularly through public health insurance and grant programs. Brand firm anti-competitive practices around the leading buprenorphine product Suboxone — including product hops, citizen petitions and Risk Evaluation and Mitigation Strategy abuses — helped to maintain high prices by extending brand exclusivity periods and hindering generic drug entry. Remedies to address costly anti-competitive activities include adoption of the proposed CREATES Act and modernization of the Hatch-Waxman Act by the Congress, and implementation of substantive modifications to the Food and Drug Administration citizen petition filing procedures. Given the persistence of these abuses, prescriptive changes are favorable to the procedural and clarifying steps thus far favored by the federal government. Extrapolating from the 37% price declines attributable to generic entry for buprenorphine tablets in 2011, our calculations suggest that implementing these remedies to facilitate generic competition with Suboxone film would have resulted in savings of approximately $703 million overall and $203 million to Medicaid in 2017.

The United States Court of Appeals for the Third Circuit held that when quitam relators file a multi-claim complaint under the Fraudulent Claims Act (FCA), their share of the proceeds must be based on an individual analysis of each claim. More importantly, the court held that relators are not entitled to any portion of the settlement of a specific claim if that claim was subject to dismissal under section 3730(e)(4) Relator Merena filed a quitam suit against his employer, SmithKline Beecham (SKB), claiming, among other things, that SKB defrauded the government by billing for laboratory tests that were not performed, paying illegal kickbacks to health care providers, and participating in an “automated chemistry” scheme. Soon thereafter, additional relators filed suit.

The foregoing, both appearing in early 2012, represent very different understandings about the significance of being substantially overweight and possible responses. The first focuses on being fat as the problem. 3 The solution is weight loss or, better still, prevention of weight gain. Of particular note is the plight of obese children and their physical ailments and psychological stress because of bullying by other children and embarrassment in wider society. The second underscores the enormous difficulty of losing weight and, even more so, of maintaining any such reduction. Being fat may give rise to problems. But the greatest difficulty may be in not accepting that most people who become fat will remain fat. That denial stymies efforts to foster the healthiest state possible for the obese and to create effective prevention programs, especially for children.

A number of indications suggest that we may be on the verge of another massive shift in the orientation of our system for the civil commitment of the mentally ill. After nearly one and one-half centuries during which commitment criteria were based on the mentally ill person's need for care and treatment, the late 1960s and 1970s saw a rejection of this standard in favor of criteria based solely on the individual's dangerousness to self or others. Now, in the 1980s, we are witnessing an outcry against dangerousness-oriented standards and the beginnings of a return to a need-for-treatment model.

Proposals to make neocortical death, sometimes called cerebral death, a medical and legal indication of human death are becoming more common. Increased sensitivity to the futility and costs of providing life support for patients long after they could be considered dead guarantees that interest in the proposals will continue for some time. Neocortical death would be an acceptable indication of human death if 1) it is consistent with our concepts of human death, 2) it can be diagnosed with certainty and 3) it is sufficiently understood by the general public to be accepted as public policy.

In this paper the phrase “neocortical death” will refer to permanent loss of consciousness due to the irreversible cessation of whatever chemical and biological functions of the brain are needed to support consciousness. By consciousness is meant “the state of awareness of the self and the environment.”

Patents and free trade make strange bedfellows. For most of their history, patents have been instruments deployed to resist trade with other countries, not to enhance it. Whether one looks at Venetian laws that punished citizens who practiced local crafts outside the city, the Mercantilist uses to which patents were put in Elizabethan England, or the cartels of the 19th and 20th centuries created on a foundation of interlocking patent rights, patents have had a distinctly protectionist function. It is thus ironic that it is intellectual property rights in general, and patents in particular, that have been held up in recent years as the poster child of much that is wrong with globalization and free trade. Nowhere is this more so than in debates concerning international human rights law and patents, in particular the position that patents violate an international right to health.