Expertise in law, medicine, and health care

As the practice of science-based medical evidence has challenged the medical profession to consider the scientific bases for its methods and procedures, on a seemingly parallel path, the United States Supreme Court's 1993 decision in Daubert v. Merrell Dow Pharmaceuticals has challenged the legal system to consider the science underlying claims of medical expertise. This article examines how the legal system has responded to that challenge and why the response has been more limited than many had expected; the implications of the legal system's approach to scrutiny of claims of medical expertise for the practice of science-based medical evidence; and, the central elements of any meaningful change in legal assessments of expertise in medicine and health care.     

Gaining confidence in the law of confidence

Legal context. The recent case of EPI v Symphony has left theUK law of confidentiality in an uncertain state: the extentto which recipients of confidential information may be permittedto ‘use’ mixtures of such information with publiclyavailable material remains unclear. The Court of Appeal in EPIfelt that it was hard to reconcile the principle that any claimin confidence must fail if the material in question is in thepublic domain with the ‘springboard’ doctrine; butis the distinction illusory? Key points. Issues raised in this case include considerationof what precisely is ‘use’ of confidential information,when mixed with public information, and whether a confider shoulddo more than rely on confidentiality obligations to protectthe fruits of his/her disclosures. This article asks how confidentialityobligations may be aligned with the control of statutory intellectualproperty rights. It considers whether the Court of Appeal inMarkem v Zipher has confused the issue and speculates as tohow far the general law of contract can assist the confider. Practical significance. Finally, this article discusses whichlegal tools will best assist the confider seeking to protectits intellectual property.     

The iceperson cometh: cryonics, law and medicine

The "New Biology" has already made profound impact on the law. Cryonics and genetic engineering represent technological triumphs. The natural, organic process of dying is being replaced by a humanly engineered technological process for living. The dying phase of life is prolonged until biological knowledge is available to reverse the dying phase and restore the living phase. Both cryonics and genetic engineering in their attempts to replace the organic process with the technological process disturb the delicate balance of the triad of life which each individual experiences--faith, health, and justice. Since law is a basic tool to achieve justice among human beings, how should it respond to the health argument of the cryonics' physician who views death as a disease which is curable? How should the law respond to the faith questions surrounding the cryonics patient? What am I? A block of ice. Who am I? A living, comatose patient or a dormant, static body with the possibility of a reverter. Why am I? A new human being now endowed with immortality through the triumph of life over death founded on man's current faith in the God called Technology. Cryonics through its unbalancing of the traditional triad of life poses formidable challenges to the major institutions of faith, health and justice. The practitioners in these institutions: clergy, physicians and lawyers must now reassess the rules of the game of life be they religious, medical or legal. This article offers insights to begin this reassessment.     

Substantive equality in South African health care: the limits of law

The article considers the scope and limits of law as an instrument for facilitating equitable access to health care in South Africa. The focus is on exploring the extent to which the notion of substantive equality in access to health care services that is implicitly guaranteed by the Constitution and supported by current health care reforms, is realisable for patients seeking treatment. The article highlights the gap between the idea of substantive equality in the Constitution and the resources at the disposal of the health care sector and the country as a whole. It is submitted that though formal equality in access to health care services has been realised, substantive equality is currently unattainable, if it is attainable at all, on account of entrenched structural inequality, general poverty and a high burden of disease.     

Regulating through information: disclosure laws and American health care

Efforts to reform the American health care system through direct government action have failed repeatedly. Nonetheless, an alternative strategy has emerged from these experiences: requiring insurance organizations and health care providers to disclose information to the public. In this Article, Professor Sage assesses the justifications for this type of regulation and its prospects. In particular, he identifies and analyzes four distinct rationales for disclosure. He finds that the most commonly articulated goal of mandatory disclosure laws--improving the efficiency of private purchasing decisions by giving purchasers complete information about price and quality--is the most complicated operationally. The other justifications--which he respectively terms the agency, performance, and democratic rationales--hold greater promise, but make different, sometimes conflicting assumptions about the sources and uses of information. These insights have implications not only for health care, but also for other regulated practices and industries.     

Using law to fight a silent epidemic: the role of health literacy in health care access, quality, & cost

The dominant rhetoric in the health care policy debate about cost has assumed an inherent tension between access and quality on the one hand, and cost effectiveness on the other; but an emerging discourse has challenged this narrative by presenting a more nuanced relationship between access, quality, and cost. This is reflected in the discourse surrounding health literacy, which is viewed as an important tool for achieving all three goals. Health literacy refers to one's ability to obtain, understand and use health information to make appropriate health decisions. Research shows that improving patients' health literacy can help overcome access barriers and empower patients to be better health care partners, which should lead to better health outcomes. Promoting health literacy can also reduce expenditures for unnecessary or inappropriate treatment. This explains why, as a policy matter, improving health literacy is an objective that has been embraced by almost every sector of the health care system. As a legal matter, however, the role of health literacy in ensuring quality and access is not as prominent. Although the health literacy movement is relatively young, it has roots in longstanding bioethical principles of patient autonomy, beneficence, and justice as well as the corresponding legal principles of informed consent, the right to quality care, and antidiscrimination. Assumptions and concerns about health literacy seem to do important, yet subtle work in these legal doctrines--influencing conclusions about patient understanding in informed consent cases, animating decisions about patient responsibility in malpractice cases, and underlying regulatory guidance concerning the quality of language assistance services that are necessary for meaningful access to care. Nonetheless, health literacy is not explicitly treated as a legally relevant factor in these doctrines. Moreover, there is no coherent legal framework for incorporating health literacy research that challenges traditional assumptions about patient comprehension and decision-making, and that emphasizes the need for providers to improve communication and take affirmative steps to assess patient understanding. The absence of a clear and robust consideration of health literacy in these doctrines undermines core access and quality aims, and it means that such laws are of limited efficacy in promoting health literacy. Returning to the theme that the health literacy problem reflects a complementary view of access, quality and cost, it is likely that the cost implications of this problem (and not concerns about quality and access) will motivate the kind of health literacy reform that may ultimately strengthen existing quality and access standards. One recent example of this can be seen in reforms linked to government, insurer and provider attempts to reduce costly medication errors.     

Immigrant workers: health, law, and public policy

Immigrant workers are a large segment of the lower echelon of the U.S. labor force, and as many as 3.6 to 6 million of these workers and their families are living in the U.S. illegally. This paper examines who the recent immigrants are: explains why their current situation in the U.S. is an important public health matter; discusses the ethical and policy issues stemming from their health needs and from illegal status; and concludes with a brief look at some implications of the Simpson-Mazzoli Immigration and Reform Act, currently before Congress. The paper suggests that the illegal status of undocumented workers intensifies their health risks; that the immigrants' responsibility for budget short-falls in public services is not as clearcut as frequently assumed; and that legislation aimed at regulating the status of immigrant workers in the U.S. is unlikely to solve many of the central problems.     

The trust in Spanish and Italian private international law: Part I

Civil Law jurisdictions' recognition of trusts depends on theindividual conflict of law rules of each jurisdiction. The HagueConvention on the Recognition and Enforcement of Trusts intendsto bring a degree of certainty into how a foreign trust is received.However, the matter is complicated, in particular, as to thestatus granted in each jurisdiction to the convention. Thisarticle, based on a paper presented at the convention on CatalanCivil Law, ‘Los patrimonios fiduciarios y el trust’,held in Tarragona on 20 and 21 October 2005, examines the positionof trusts under the conflict of law rules in Italy and in Spainand the impact made on the recognition of trusts by the HagueConvention. This article appears in two parts; in this firstpart the position in Italy is examined and the second part concludeswith the position in Spain.