We explore how principles predicting the success of a medical information commons (MIC) advantaged or disadvantaged three MIC initiatives in three Canadian provinces. Our MIC case examples demonstrate that practices and policies to promote access to and use of health information can help improve individual healthcare and inform a learning health system. MICs were constrained by heterogenous health information protection laws across jurisdictions and risk-averse institutional cultures. A networked approach to MICs would unlock even more potential for national and international data collaborations to improve health and healthcare.

Debate over the relationship of law and bioethics is growing - what the relationship has been and what it should be in the future. While George Annas has praised law and rights-talk for creating modern bioethics, Carl Schneider has instead blamed law for hijacking bioethics and stunting moral reflection. Indeed, as modern bioethics approaches the 40-year mark, historians of bioethics are presenting divergent accounts. In one account, typified by Albert Jonsen, bioethics largely grew out of philosophy and theology, not law. In another account, law has deeply shaped bioethics from the start, forging its central commitment to the rights of patients and research subjects and the fields imposition of broad fiduciary responsibilities on health care professionals and researchers.

In addition to debating how to properly describe laws historical relationship to bioethics, commentators have argued over whether laws influence in bioethics is now good or bad.

The revised Common Rule adopts the reasonable person standard to guide research disclosure. Some members of the research community contend that the standard is confusing and ill-suited to the research oversight system. Yet the revised rule is not as radical as it might seem. During the 1970s, judges started using the standard to evaluate negligence claims brought by injured patients who said doctors had failed to obtain informed consent to the harmful procedures. In its influential Belmont Report, the National Commission recommended application of a “reasonable volunteer standard” to guide IRBs evaluating research disclosures. Evidence also suggests that IRBs often invoke the reasonable person standard in deliberations about consent forms. But past application of the standard has been informal and uneven. Robust application of the reasonable person standard will require researchers and IRBs to learn more about what ordinary people want and need to know about the studies they are invited to join. Input from people with personal experience as study participants could be particularly useful to this effort.

The practice of covertly administering medications to patients without their consent is often discussed in the framework of legal questions around the right of patients to consent and refuse medical treatment. However, this practice also raises significant questions surrounding the professional duties and obligations of health care professionals as it relates to the decision-making process of whether to engage in the covert administration of medications. In this paper, I present an overview of the origin of those duties and obligations, and discuss how those duties and obligations when seen from different perspectives may either justify or prohibit the practice. Further, I discuss whether the duties and obligations of health care professionals as they are currently framed are suited to address the complexities of this issue both from the health care professional and patient perspectives. This analysis is conducted in the context of duties and obligations that arise from not only legal framework but also from the ethical requirements from professional codes of ethics.

The federal regulations that govern biomedical research, most notably those enshrined in the Common Rule, are a product of their time. Born in the aftermath of wartime atrocities committed by Nazi doctors, and influenced by domestic research scandals like the Willowbrook and Tuskegee studies, the regulations express a protectionist ethos aimed at safeguarding subjects of human experimentation from the potential harms of research participation. Requirements for informed consent, risk minimization, equitable subject selection, and peer review of proposed research rest on the presumption that the research enterprise owes subjects a duty of protection.

Immigration poses numerous challenges for health professionals and public health lawyers. This article reviews these challenges. We begin by offering some background on immigration and health and then explain some of the reasons why immigrants are less likely than natives to have health insurance. Next we turn to a discussion of some of the particular challenges relating to the health care of refugees. We conclude by analyzing and rejecting some of the arguments that are made for discriminating against immigrants with respect to the provision of public health benefits and services.

The forced marriage of minors is child abuse, consequently duties exist to stop them. Yet over 14 million forced marriages of minors occur annually in developing countries. The American Bar Association (ABA) concludes that the problem in the US is significant, widespread but largely ignored, and that few US laws protect minors from forced marriages. Although their best chance of rescue often involves visits to health care providers, US providers show little awareness of this growing problem. Strategies discussed to stop forced marriages include recommendations from the UN, the ABA, and the UK. The author anticipates and responds to criticisms that first, no duty to intervene exists without better laws and practice guidelines; and second, that such marriages are not child abuse in traditions where parental rights or familism allegedly justify them.

Some pharmacists who believe that abortion is immoral are troubled by the thought that they might be required to fill prescriptions for abortifacient drugs like mifepristone. Do pharmacists have the right to refuse to fill such prescriptions?

Questions about the rights of professionals have both moral and legal dimensions. I will assume—although this assumption is by no means axiomatic or uncontested—that the rights and responsibilities of persons in general and professionals in particular ought to be grounded in morality and not the law. For example, a person who breaks the speed limit to bring a critically ill friend to a hospital's emergency room violates the law, but may be morally justified in doing so. There is no legal duty to rescue a person in danger, but many moral communities hold that our moral duty of beneficence requires us to prevent harm to others, at least if in so doing we are not placing ourselves and others at great risk of harm.

The acquired immunodeficiency syndrome (AIDS) and the entire spectrum of disease associated with infection by the human immunodeficiency virus (HIV) are the subject of intense international interest and concern. From the viewpoint of the World Health Organization (WHO), HIV is not simply one of a series of newly recognized diseases emerging during the past decade but is a problem with several biological and epidemiological features that justify a unique sense of urgency among public health officials, political leaders, and the general public.

This article describes the evolution of a global perspective and response to HIV, reviews the current international epidemiological situation, explores the principal elements, both conceptual and operational, of WHO's global strategy for HIV control, and discusses the major approaches to HIV prevention in the current global context.

Information technology is considered a potentially transformative element in the field of health care by payers, providers, vendors, and consumers alike. Because of this transformative potential, health information technology (HIT) adoption is viewed by many as a key component of health system reform. HIT is in its earliest stages, with diffusion of the technology still relatively limited; at the same time, there is growing awareness of its potential to affect the operation of the entire health care system as a result of the vast amount of information that will become available to both health professionals and patients.

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration (FDA) and, second, the scheduling decisions made by the Drug Enforcement Administration (DEA). If a “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.

The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin (acetylsalicylic acid) and began marketing it as an analgesic.

Race is becoming an increasingly common lens through which biomedical researchers are studying the relevance of genes to group predispositions that may affect disease susceptibility and drug response. These investigations contravene decades of research in the natural and social sciences demonstrating that social categories of race have little genetic significance. Nevertheless, a resounding debate has ensued over the utility of race in biomedical research — particularly as new drugs claiming to serve particular racial populations enter the marketplace. Now that the Food and Drug Administration (FDA) has approved BiDil as the first race-specific treatment despite conflicting evidence and unsettled debates, is there a way for federal regulators to promote research that may address minority health concerns without giving undue credence to the dangerous idea that social understandings of race are genetically relevant? It may be useful for the FDA to turn to an area with experience negotiating such dilemmas — constitutional law — and its approach — strict scrutiny — to help guide when and under which circumstances government should give effect to racial categories in biomedicine.

This project focuses on the extent to which disability insurers should be allowed to use genetic information in underwriting and rate-setting, but this subject cannot be completely isolated from the related questions of whether life and health insurers should also have this discretion. Federal and state laws place significant restrictions on insurers’ use of genetic information in health insurance, but regulation of such use in life and disability insurance is considerably more modest. This essay examines the reasons for this disparity and discusses the implications for future proposals to regulate disability insurers’ use of genetic information in underwriting and rate-setting. The thesis is relatively simple: Communitarian values are stronger in health insurance than in life and disability insurance. Accordingly, the public is likely to acquiesce to insurers’ insistence that they be allowed to make distinctions among insureds in disability insurance (and life insurance) that would not be tolerated in health insurance.

The United States Supreme Court has long recognized the value of scientific evidence - especially when compared to other types of evidence such as eyewitness identifications, confessions, and informant testimony. For example, in Escobedo v. Illinois, the Court observed: “We have learned the lesson of history, ancient and modern, that a system of criminal law enforcement which comes to depend on the ‘confession’ will, in the long run, be less reliable and more subject to abuses than a system which depends on extrinsic evidence independently secured through skillful investigation.” Similarly, in Davis v. Mississippi, the Court commented:

Each of us has written about the importance of reframing the debate over public health paternalism. Our individual explorations of the many and varied paths forward from libertarian “nanny state” objections to the “new public health” have been intimately informed by collaboration. This article represents a summary of our current thinking — reflecting the ground gained through many fruitful exchanges and charting future collaborative efforts.

Our starting point is that law is a vitally important determinant of population health, and the interplay among law, social norms, cultural beliefs, health behaviors, and healthy living conditions is complex. Anti-paternalists’ efforts to limit the scope of public health law to controlling only the proximal determinants of infectious diseases are utterly unjustifiable in the face of so much preventable death, disability, and disparity. Equally important, the anti-paternalism push is deeply counter-majoritarian and undemocratic, threatening to disable communities from undertaking measures to improve their own well-being.

The individual right of access to one’s own data is a crucial privacy protection long recognized in U.S. federal privacy laws. Mobile health devices and research software used in citizen science often fall outside the HIPAA Privacy Rule, leaving participants without HIPAA’s right of access to one’s own data. Absent state laws requiring access, the law of contract, as reflected in end-user agreements and terms of service, governs individuals’ ability to find out how much data is being stored and how it might be shared with third parties. Efforts to address this problem by establishing norms of individual access to data from mobile health research unfortunately can run afoul of the FDA’s investigational device exemption requirements.

This paper presents the available epidemiological data on human immunodeficiency virus (HIV) infection and AIDS among intravenous (IV) drug abusers, reviews HIV disease among intravenous drug abusers, and focuses on initial research findings that indicate intravenous drug abusers not only are educable but may indeed be altering their lifestyles as a direct consequence of their fear of HIV infection.

Although the initial clinical cases of AIDS were described in 1981, among gay men living in Los Angels, only a short time elapsed before IV drug abusers who shared their drug paraphernalia were identified as another risk group. A reasonable hypothesis, based on reports from the New York metropolitan area, is that there has been a relative increase in the percent of AIDS cases among IV drug abusers as compared to homosexuals. This may be explained by the transition group of sexually active homosexual men who also used intravenous drugs and thereby spread HIV from the gay community to IV drug abusers. In support of this hypothesis, the Centers for Disease Control (CDC) estimates that 8 percent of all reported AIDS cases from New York City have both risk factors.

Increasingly, genomic analysis is being utilized to diagnose children with developmental delay or dysmorphic facial features suggestive of a congenital disorder. Genetic testing has rapidly evolved, and the genome-wide tests that we use today are significantly different from the more targeted single-gene tests of the last decade. Chromosomal microarray analysis (CMA) is now a first line test for children with multiple birth defects, children with intellectual impairment (including autism), and children with an unusual constellation of symptoms that do not fit with a known disease. There are three types of CMA that are currently clinically available. CMA by oligonucleotide array-based comparative genomic hybridization (aCGH) compares the hybridization signal from the patient's DNA to that of a reference DNA sample for each oligonucleotide on the array. Depending on the specific array, this can range from tens of thousands to hundreds of thousands of oligonucleotides.

The standard of care with regard to any new medical technology develops slowly. Attitudes must change, and equipment must be purchased, installed and utilized. Technical problems must be resolved and protocols established. Advances are better understood and more aggressively pursued by some physicians than others, with a consequent disparity in implementation. Electronic fetal monitoring (EFM) is an example of such a technology. Little known to obstetricians 15 years ago, EFM has been accepted by practitioners widely and rapidly. Today, armed with guidelines from the American College of Obstetricians and Gynecologists (ACOG) and the recommendations of the National Institutes of Health (NIH), we monitor with EFM most obstetrical patients during labor and almost all high-risk patients before labor. While the practice or custom of a majority of obstetricians does not necessarily define the standard of care, the use of EFM for fetal surveillance during labor represents the prevailing medical and legal standard of care.