Regulation of the health care system to achieve appropriate containment of overall costs is characterized by Professor Havighurst as requiring public officials to engage, directly or indirectly, in the rationing of medical services. This rationing function is seen by the author as peculiarly difficult for political institutions to perform, given the public's expectations and the symbolic importance of health care. An effort on the part of regulators to shift the rationing burden to providers is detected, as is a trend toward increasingly arbitrary regulation, designed to minimize regulators’ confrontations with sensitive issues. Irrationality and ignorance are found to plague regulatory decision making on health-related issues, even though it is the consumer who is usually thought to suffer most from these disabilities. The author argues that consumer choice under some cost constraints is a preferable mechanism for allocating resources because it better reflects individuals’ subjective preferences, has a greater capacity for facing trade-offs realistically, and can better contend with professional dominance of the resource allocation process.

In view of the unlikelihood of regulation that is both sensitive and effective in containing costs, the author proposes that we rely primarily on consumer incentives to reform the system. A simple change in the tax treatment of health insurance or other health plan premiums, to strengthen consumers’ interest in cost containment while also subsidizing needy consumers, is advocated. Steps to improve opportunities for innovation in cost containment by health insurers, HMOs, and other actors are outlined briefly.

In civilian life, an individual has the right to refuse medical treatment in almost any circumstance. While a patient who refuses treatment may face adverse consequences such as prolonged illness, our society recognizes the importance of individual choice in health matters. Members of the military, however, enjoy no such right. Service members are required to submit to certain medical treatments as a part of their employment contract. Refusing such treatments is disobeying an order, and the service member then faces the prospect of a dishonorable or “other than honorable” discharge, and even imprisonment. Disobeying an order to receive treatment can thus result in the equivalent of a felony conviction on the individual's employment history forever.

This Article discusses potential legal liability for adverse effects resulting from reuse of disposable hemodialysis equipment. After explaining the dialysis process and the health risks involved with the reuse of dialyzers, the Article outlines possible theories of recovery for injured dialysis patients. The Article describes the possibility of recovery under a negligence theory against either the treating physician or the institutional provider, and includes a discussion of applicable statutory law. The remainder of the Article discusses possible recovery under the theory of strict liability.

The peer review privilege prevents patient-plaintiffs from obtaining the hospital records prepared in connection with quality review proceedings. The privilege, created by statute in most states, is rationalized by the need for confidentiality in promoting complete and candid peer review. In this Article, the Author argues that the privilege cannot effectively promote confidentiality since a common exception allows physicians to obtain the records when seeking judicial review of proceedings leading to their exclusion or dismissal from hospital medical staffs. More significantly, the Author notes that while the privilege began as a device to protect physicians from testifying against their will in malpractice suits—a condonation of the “conspiracy of silence”—it has evolved into a vehicle which enables hospitals to conceal the evidence of their own neglect.

As of April 2015, twenty-three states and the District of Columbia permit the therapeutic use of marijuana1 to treat various illnesses or conditions, with legalization statutes currently pending in eight other states. Despite the growing number of states that allow for the prescription and use of medicinal marijuana, the federal government still classifies the drug as a Schedule I controlled substance, the strictest classification of controlled substances and the only type healthcare providers may not legally prescribe. As states continue to deliberate the merits of allowing access to marijuana for therapeutic use, it is useful to examine the structural and political forces that have prevented a similar movement at the federal level. This Note does so, and argues that proactive changes—either legislative or administrative—are necessary to remove the handicap that the current regulatory system places on attempts to change federal marijuana policy.

In the decades since the United States Supreme Court’s consideration of informational privacy in Whalen v. Roe, a couple of worthy candidates to fulfill Justice Brennan's premonition of “future developments” have emerged. One is the nature of information technology itself. Today, sensitive health care data are generated, stored, transferred, and deployed toward countless uses with astonishing facility. An inexorable shift toward computerized medical records and fully automated storage and transfer of patient information is well underway.

Many individuals develop a temporary state of cognitive and emotional impairment after being diagnosed with catastrophic illness. Thus, when crucial decisions about medical treatment are required, they are unable to assimilate information; or worse, the legal need to be informed can rival a psychological desire to not be informed. The Canadian informed consent doctrine is unresponsive to crisis and clinically impracticable, and so paradoxically compromises the integrity and autonomy it was designed to protect. Many aspects of the physician-patient relationship and clinical setting also undermine the philosophical values enshrined in this doctrine. This further jeopardizes the individual's integrity. The Article explores proposals for change such as delaying the informing and consenting, improving the concept of consent, and improving the role of the physician.

Justice Stewart’s 1966 dictum about the inevitability of government success in challenging mergers under Section 7 of the Clayton Act held true for another fifteen years or so. In the early 1980s, however, federal enforcement agencies, the Department of Justice (DOJ) and the Federal Trade Commission (FTC), began to find the federal courts less hospitable to antitrust merger cases as more sophisticated economic inquiries and changing proof burdens complicated the task of identifying anticompetitive mergers. Indeed, since the early 1980s, the government has lost more litigated merger cases than it has won and has come under criticism from some quarters for becoming gun shy and not adequately policing the wave of consolidations that have occurred over the past decade.

Hospital mergers, however, are a different story. Until two years ago, the government rode a streak of important victories in federal courts and FTC administrative proceedings, and had obtained consent decrees from scores of hospitals that had announced plans to merge.

The American health care system has undergone tremendous transformation over the past few decades. The fee-for-service (FFS) health care system in which physicians enjoyed a great deal of autonomy has become a managed care system in which cost and utilization considerations play a larger role in physician decision making. Although physicians and other health care professionals are still patient advocates, this role often results in a conflict between their own economic interests and their duties to their patients.

Rather than depending on self-sacrificing health care professionals to advocate for them, patients need to assert their own power in the managed care arena. One way to gain such power is to use the class action device in litigation aimed at improving medical care quality, cost and access. Class actions, in fact, are likely to proliferate as managed care organizations (MCOs) grow and affect more patients’ lives. There are well-recognized dangers to using the class action device, but if used properly, it could prove a valuable remedy for patients.

Drug development prior to 1800 was based almost completely on observational trial and error. The earliest known exception was a controlled drug trial conducted by James Lind in 1747 on an English ship to show the effectiveness of citrus fruit in the treatment of scurvy. Clinical tests, but not concurrent comparative trials, were conducted by Charles Maitland in 1722 in London to show the effectiveness of variolation in preventing smallpox, and a controlled drug trial was conducted by Edward Jenner in London in 1796 to show the effectiveness of material taken from cowpox sores of young milkmaids (later called smallpox vaccine) in preventing smallpox. In 1775, William Withering learned from an elderly woman herbalist in Shropshire, England about her use of the Foxglove plant (whose active ingredient Withering later determined to be digitalis) in treating heart disease, and in 1785 published the results of his treatment of 158 patients with the drug, but he did not conduct a controlled study.

If any trend can be confidently predicted for the next millennium (or, more modestly, for our lifetimes) it is the globalization of health law. We live in an age of global markets and global communications. While care of the individual patient has remained largely local, national borders are quite porous to health care professionals. The cross-border flow of patients is a significant factor in some regions, and the development of telemedicine and internet pharmacies is radically expanding the possibility of cross-border medical practice.

Artificial intelligence (AI) machines hold the world's curiosity captive. Futuristic television shows like West World are set in desert lands against pink sunsets where sleek, autonomous AI fulfill every human need, desire, and kink. But I, Robot, a movie where robots turn against the humans they serve, reminds us that AI is precarious. Academicians who study how AI interacts with tort law, such as Jessica Allain, David Vladeck, and Sjur Dyrkoltbotn, claim that the current legal regime is incapable of addressing the liability issues AI present. Both Allain and Vladeck focus their research on whether tort law can accommodate claims against fully autonomous AI machines, while Dyrkoltbotn explores how AI can be leveraged to help plaintiffs identify the genesis of their injuries. The solution this article presents is not exclusively tailored to fully autonomous AI and does not identify how technology can be used in tort claims. It instead demonstrates that the current tort law regime can provide relief to plaintiffs who are injured by AI machines. In particular, this article argues that the manner in which Watson for Oncology is designed presents a new context in which courts should adopt a per se rule of liability that favors plaintiffs who bring damage claims against AI machines by expanding the definition of what it means for a device to be unreasonably dangerous.

Primary care is crucial to the United States health care system. It is essential to the provision of high quality care; including the ability to reach health outcomes, ensure patient satisfaction, and facilitate efficient resource use. Primary care also places strong “emphasis on health promotion, disease prevention, and care of the chronically ill.”

Physicians have introduced two business models in their attempts to improve the delivery of primary care: Concierge Medicine (“CM”) and the Patient Centered Medical Home (“PCMH”). Both models provide personalized, comprehensive preventive care services.

CM is a private medical practice in which the physician charges patients an annual fee to be a patient in the practice. In exchange, the physician limits the number of patients in order to offer more personalized services and amenities such as: direct access through email or cell phone, same day or next day appointments, longer, more personalized appointments, house calls, and physician accompaniment to a specialist.

Dr. Julia Green is a primary care physician (PCP) licensed to practice medicine in the Commonwealth of Massachusetts. On October 1, 1994, Dr. Green signed a one-year, renewable contract with Allcare Health Plan (AHP). Pursuant to the terms of the contract, on January 1, 1995, AHP placed her on its select list of PCPs available to its 100,000 covered lives (“enrollees”). Dr. Green provided for all primary care and specialist referrals for those enrollees who chose her as their physician. AHP paid her on a fee-for-service (FFS) basis for all preapproved procedures and treatments.

Dr. Green felt that this contract might decrease her autonomy slightly; however, she also felt that it would increase her patient pool significantly and lessen the burden of collecting fees directly from patients. Dr. Green knew that choosing not to sign the contract would preclude AHP enrollees from making her their PCP because AHP only covered treatment provided by its own physicians. She further feared that as enrollment in managed care organizations (MCOs) increases, and more of her colleagues sign managed care contracts, her pool of potential patients would decrease drastically.

The current medical malpractice system is broken. Many patients injured by malpractice are not compensated, whereas some patients who recover in tort have not suffered medical negligence; furthermore, the system's failures demoralize patients and physicians. But most importantly, the system perpetuates medical error because the adversarial nature of litigation induces a so-called “Culture of Silence” in physicians eager to shield themselves from liability. This silence leads to the pointless repetition of error, as the open discussion and analysis of the root causes of medical mistakes does not take place as fully as it should. In 1993, President Clinton's Task Force on National Health Care Reform considered a solution characterized by Enterprise Medical Liability (EML), Alternative Dispute Resolution (ADR), some limits on recovery for non-pecuniary damages (Caps), and offsets for collateral source recovery. Yet this list of ingredients did not include a strategy to surmount the difficulties associated with each element. Specifically, EML might be efficient, but none of the enterprises contemplated to assume responsibility, i.e., hospitals and payers, control physician behavior enough so that it would be fair to foist liability on them. Likewise, although ADR might be efficient, it will be resisted by individual litigants who perceive themselves as harmed by it. Finally, while limitations on collateral source recovery and damages might effectively reduce costs, patients and trial lawyers likely would not accept them without recompense. The task force also did not place error reduction at the center of malpractice tort reform—a logical and strategic error, in our view.

In response, we propose a new system that employs the ingredients suggested by the task force but also addresses the problems with each. We also explicitly consider steps to rebuff the Culture of Silence and promote error reduction. We assert that patients would be better off with a system where physicians cede their implicit “right to remain silent,” even if some injured patients will receive less than they do today. Likewise, physicians will be happier with a system that avoids blame—even if this system placed strict requirements for high quality care and disclosure of error. We therefore conceive of de facto trade between patients and physicians, a Pareto improvement, taking form via the establishment of “Societies of Quality Medicine.” Physicians working within these societies would consent to onerous processes for disclosing, rectifying and preventing medical error. Patients would in turn contractually agree to assert their claims in arbitration and with limits on recovery. The role of plaintiffs' lawyers would be unchanged, but due to increased disclosure, discovery costs would diminish and the likelihood of prevailing will more than triple.

This article examines the legal and policy issues surrounding the establishment of Societies of Quality Medicine, particularly the issues of contracting over liability, and outlines a means of overcoming the theoretical and practical difficulties with enterprise liability, alternative dispute resolution and the imposition of limits on recovery for non-pecuniary damages. We aim to build a welfare enhancing system that rebuffs the culture of silence and promotes error reduction, a system that is at the same time legally sound, fiscally prudent and politically possible.

This study of the occupational health law of the European Union looks first at the jurisdiction of the Union and the history and scope of its legislation in this area.

The main body of the Article examines the level of protection that is afforded to the workforce under European Union law. The Article first considers the way in which assessment of risk is handled and then passes on to measures that are provided for both preventing and protecting against health risks. It notes the greater role given to protection. The Article also mentions the ancillary measures that are destined to make both prevention and protection effective. Finally, it looks at the Union's detailed provisions for worker involvement in occupational health matters and the more meager ones on employment rights and compensation.

The Article ends with a discussion of the problems faced by the Union in enforcing its rules and an assessment of the strengths and weaknesses of the European Union's occupational health law. It is suggested that, overall, it deserves a positive judgment.

In response to the increasing attention to the link between health and nutrition, a wealth of information—and misinformation—is becoming available, especially via the Internet. Consumers are advised to carefully assess the reliability of information they use to determine whether a product is safe. Meanwhile, regulators are sorting out the facts themselves, but despite the ever-increasing availability of scientific research, our evolving understanding of nutrition is still supplemented by our perceptions about risk.

The primary framework for the regulation of dietary supplements is the Dietary Supplement Health and Education Act of 1994 (“DSHEA”). Underlying DSHEA is the congressional intent to support two goals: “(1) to facilitate consumer access to dietary supplements, given that many dietary supplements are used by consumers to help them maintain and improve their health; and (2) to give the Food and Drug Administration (“FDA”) the authority to step in where safety problems arise and to ensure proper labeling.”

What mother or father does not want to give his or her child the best chance of leading a happy and successful life? Infertile couples today enlist assisted reproductive technologies (ARTs) such as in vitro fertilization (IVF) and preimplantation genetic diagnosis (PGD) to handpick from among available gamete donors or embryo arrays to implant for gestation. As advances in genetic science permit increasing prenatal control over offspring traits, even fertile couples may choose to relocate procreation from the bedroom into the laboratory.

The development of safe genetic therapies capable of curing debilitating conditions in embryos or fetuses would be unequivocal cause for celebration. Less straightforwardly worthy of embrace would be techniques that make it possible to choose offspring genes for non-health related characteristics, such as strength, intelligence, and memory. At present, neither state nor federal law regulates ARTs.