Since the fourth century, B.C.E., the Oath of Hippocrates has been the starting point in analyzing the obligations of physicians to protect the privacy and confidentiality interests of their patients. The pertinent provision of the Oath reads as follows: “What I may see or hear in the course of the treatment or even outside of the treatment in regard to the life of men, which on no account must be spread abroad, I will keep to myself, holding such things shameful to be spoken about.”

This part of the Oath is subject to more than one interpretation, but its commonly accepted meaning provides the ethical foundation for the physician’s duty of confidentiality. The Oath expressly declares that a physician’s obligation of confidentiality applies beyond matters of medical care. At a time when there were no hospitals or physician offices, patients received medical care in their homes or in public places. Physicians treating patients in their homes could be expected to see and hear a wide range of activities that might be considered embarrassing, immoral, or even illegal.

On April 1, 2001, I joined the world of Health Information Technology. I started a solo gynecology practice with no income and only expenses. I hired a medical assistant to be my front desk person and my clinical helper. I rented a smaller space than most physicians could use for this purpose because my plan was to use technology to avoid both chart storage as well as the people needed to maintain a medical record library.

I hired a hospital employee to put together my “network.” He helped me install my software and set up an automatic backup system. I purchased a single robust desktop computer and brought in an older computer from home for the front desk. I bought a scanner and an inexpensive laser printer. The hardware including a router for my “network” of two computers cost me about $6000. The software, a combined practice management system with an associated EMR requiring only single entry of patient demographics, cost me about $7000.

The hypothetical case of Mr. Jenkins illustrates innovations in digital health information technology that may profoundly change medical care and the doctorpatient relationship. The Internet contains enormous amounts of health information, and about threequarters of Internet users look online for health information. 1 Sometimes patients bring information they found on the Internet to their physicians. Physicians and patients can also now communicate by e-mail rather than by telephone or office visits, although these e-mail communications may not be integrated into the patient’s medical record. Furthermore, electronic medical records are slowly being adopted, particularly in hospitals and large integrated health systems. Funding to promote the adoption of electronic medical records (EMRs) has been included in the 2009 federal stimulus package under the Obama Administration.

As policy makers place great hope in health information technology (HIT) as a means to lower costs and achieve improvements in health care quality, safety, and efficiency, organizations at the forefront of building health information exchange (HIE) networks attempt to weave the concept and function of informed consent into an evolving information-driven health care system. The vast amount of information that will become available to both health professionals and patients in the new HIT-driven environment can reasonably be expected to affect the relationship between them in many ways, particularly in the area of informed consent. During this early stage of HIT adoption, it is critical that we engage in discussions regarding informed consent’s proper role in a heretofore unknown health care environment — one in which electronic information sharing holds primary (and possibly rightful) importance. The central and largely unexamined question of whether and how the legal and ethical underpinnings of informed consent will fit into the context of HITenabled treatment is critical to both public policy and clinical practice.

The United States, like other countries facing rising health care costs, is pursuing a commitment to interoperable electronic health records. Electronic records, it is thought, have the potential to reduce the risks of error, improve care coordination, monitor care quality, enable patients to participate more fully in care management, and provide the data needed for research and surveillance. Interoperable electronic health records on a national scale — the ideal of a national health information network (or NHIN) — seem likely to magnify these advantages. Thus, the recent economic stimulus package contains considerable funding for the development of “health information technology architecture that will support the nationwide electronic exchange and use of health information in a secure, private, and accurate manner.”

Patients and their physicians frequently make important health care decisions with incomplete information. Memory fails; records are incomplete; the onset of significant events is confused with other life stories; and even the most basic information about medications, laboratory tests, allergies, and problems is often the result of guesswork. As providers and as patients, we suffer because information vital to health care is not available when and where it is needed. Data required for care are dispersed across various settings and represented in a range of formats; incentives to bring these data together do not exist.

In recent years, four specific approaches have emerged to address patient-centered information access. The first model attempts to consolidate all care into a single care delivery and financing system. This model — prevalent in many European countries — is to some degree extant at Kaiser-Permanente and other integrated care and financing systems. This model is ideal if and when one organization is responsible for all care delivery and financing. Such models present “one-stop shopping” for managing health information, coordinating care, communicating with providers and support groups, and ensuring both payment and accountability.

One of the largest, oldest, and most interesting challenges in health care is the balancing act in which clinicians have generally uncontroversial duties both to individual patients and to communities. Physicians and nurses must — so we teach them — put patients first, and at the same time recognize that individuals are members of communities. Individuals affect the health of communities, and communities affect the health of individuals. Thus, the moral and professional duties that result are sometimes in conflict.

Moreover, the traditional, prosaic clinical encounter is evolving in an environment increasingly shaped (albeit too slowly according to some) by electronic health records, personal health records, pharmacogenomics and vast networks of data collection and storage for public health surveillance, human subjects research, health services evaluation, and comparative effectiveness research. Health information technology is changing everything. It would be perverse otherwise: imagine large amounts of data and information either ignored, missed, or collected and then ignored.

The term “Electronic Health Records” (EHR) means something different to each of the stakeholders in health care, but it always seems to carry a degree of emotional baggage. Increasingly, EHRs are advertized as a nearly unmitigated good that will transform medical care, improve safety and efficiency, allow better patient engagement, and open the door to an era of cheap, effective, timely, and patient-centered care. Indeed, for some EHR proponents the benefits of adopting them are so obvious that adoption has become an end in itself. But for others — and especially for a number of skeptical practitioners and patients — EHR is a code word that portends the corporate transformation of health care delivery, the loss of patient privacy, the demand that patients bear more responsibility in health care, and the unreflective takeover of the health care system by people who do not understand medical care or how health care relationships unfold.

Pharmaceutical companies have long relied on direct marketing of their drugs to physicians through one-on-one meetings with sales representatives. This practice of “detailing” is substantial in its costs and its number of participants. Every year, pharmaceutical companies spend billions of dollars on millions of visits to physicians by tens of thousands of sales representatives.

Critics have argued that drug detailing results in sub-optimal prescribing decisions by physicians, compromising patient health and driving up spending on medical care. In this view, physicians often are unduly influenced both by marketing presentations that do not accurately reflect evidence from the medical literature and by the gifts that sales representatives deliver in conjunction with their presentations.

Medical practice should evolve alongside medical ethics. As our understanding of the ethical implications of physician-patient interactions becomes more nuanced, physicians should integrate those lessons into practice. As early as the 1930s, epidemiological studies began to identify that the rates of medical procedures varied significantly along geographic and socioeconomic lines. Dr. J. Alison Glover recognized that tonsillectomy rates in school children in certain school districts in England and Wales were in some cases eight times the rates of children in other districts, with the only significant predictive factors being the current chief medical officer in the area and the socioeconomic well-being of the child's parents. Unfortunately, Dr. Glover's work revealed that the increase in tonsillectomies did not improve the health of adolescent patients and appeared to be performed “as a routine prophylactic ritual for no particular reason and with no particular result.”

In response to the obesity epidemic, much discussion in the public health and child advocacy communities has centered on restricting food and beverage marketing practices directed at children. A common retort to appeals for government regulation is that such advertising and marketing constitutes protected commercial speech under the First Amendment. This perception has allowed the industry to function largely unregulated since the Federal Trade Commission (FTC)'s foray into the topic, termed KidVid, was terminated by an act of Congress in 1981. The FTC has since focused on self-regulation as a potential solution to such concerns. However, this method of control has proven ineffective to protect children, and has led to growing recognition that federal regulation may be necessary.

Since KidVid, the evidence has only mounted that children are uniquely vulnerable to the effects of advertising. Over the same time period, the exposition of commercial speech jurisprudence has plateaued, as the Supreme Court has not decided a pure commercial speech case since 2002.

With improved diagnostic capability and accuracy, the fields of medicine, neuroscience, psychiatry, and psychology have benefitted remarkably from the dramatic advancements in neuroimaging technology. Not only can surface and subsurface structures of the brain be mapped with incredible anatomical detail (with magnetic resonance imaging), now neural activity can be imaged across time as the brain responds to different stimuli (with functional magnetic resonance imaging). These sophisticated techniques have been a vital element in the recent increase in neuroimaging-based research. This increase, while producing new diagnostic techniques and improved treatment mechanisms for neurological disease, has also led to a new dilemma for human subjects researchers: how should incidental findings be managed? An incidental finding (IF) is a finding concerning an individual research participant that has potential health or reproductive importance and is discovered in the course of conducting research but is beyond the aims of this study.

Medical liability remains a major concern among U.S. physicians, and according to the American Medical Association (AMA) the United States is currently experiencing its third fullblown medical liability crisis with many physicians limiting their practices as a result of rising malpractice costs. The AMA, many in the medical community, and several prominent politicians including former president George W. Bush have called for medical liability reform including caps on non-economic damages. Some researchers argue that the medical liability crisis has been overdrawn. Several studies have shown that the vast majority of patients injured through medical malpractice do not sue, that the insurance cycle is likely major contributor to rising malpractice insurance premiums, and that defensive medicine likely plays a minor role in rising health care costs. Further, evidence shows that malpractice damage caps may lead to a crossover effect where juries increase the amount of economic damages they award to offset limitations in non-economic damages available.

Recently, the discussion regarding the physicians’ “Right of Conscience” (ROC) has been on the rise. This issue is often confined to the “reproductive health” arena (abortions, birth control, morning-after pills, fertility treatments, etc.) within the political context. The recent dispute of the Bush-Obama administrations regarding the legal protections of health workers who refuse to provide care that violates their personal beliefs is an example of the political aspects of this dispute. The involvement of the political system (motivated by specific interests and values) automatically shifts the discussion regarding physicians’ ROC into the narrow area of “reproductive health laws.” Indeed, the immediate association that comes to mind when thinking about the practical implications of this dispute is related to the reproductive health arena. This is partly because of the historical context of the first “conscience clauses,” initially enacted by Congress and state legislatures in the mid-1970s; in fact, most of these clauses provided specific exemptions for abortion and few exempted sterilization as well.

The World Medical Association's (WMA) Declaration of Helsinki is one of the most important and influential international research ethics documents. Launched in 1964, when ethical guidance for research was scarce, the Declaration comprised eleven basic principles and provisions on clinical research. The document has since evolved to a complex set of principles, norms, and directions for action of varying degrees of specificity, ranging from specific rules to broad aspirational statements. It has been revised six times in an effort to maintain its influence. While all revisions were the result of vigorous debate, the 2000 revision and two subsequent notes of clarification spurred particular controversy surrounding the use of placebo in clinical research and the standard of care and post-trial obligations in research in developing countries. Several institutions opted to cite earlier versions of the Declaration, and the U.S. Food and Drug Administration (FDA) recently removed all reference to the Declaration in its approval requirements for drugs and biological products that are studied outside the United States.

There is widespread concern among public health and emergency response officials that there could be a shortage of health care providers in a public health emergency. At least the following three factors could cause an inadequate supply of physicians, nurses, and other health care providers: (1) the severity of the emergency might greatly increase the demand for health services and outstrip the available supply; (2) health care providers might become unavailable because of their own high rates of illness, as was the case in the SARS epidemic; and (3) many health care providers might not report for duty for personal, family, or professional reasons.

One way of addressing the shortage is to encourage health care providers from unaffected areas or parts of the country to volunteer their services. A variety of measures have been enacted to facilitate the use of such volunteers.

Last summer, I was thinking about a public service project for my disability discrimination law course. I teach the course in fall, and try to incorporate a project each year. Integrating a public service project into a traditional doctrinal course fits within the trend toward expanding teaching techniques beyond the case method in order to better prepare students for the practice of law. It was also inspired in part by the Carnegie Foundation's 2007 report, “Educating Lawyers: Preparation for the Profession of Law,” as a way to foster “civic professionalism,” and to “[link] the interests of legal educators with the needs of legal practitioners and with the public the profession is pledged to serve.” That link is especially important to disability discrimination law, as issues critical to the lives of people with disabilities often go unnoticed and unaddressed by people without disabilities.

In September 2009, the First Circuit Court of Appeals decided Blue Cross & Blue Shield v. AstraZeneca Pharmaceuticals LP, part of the class action suit known as In re Pharmaceutical Industry Average Wholesale Price Litigation. The First Circuit upheld a Massachusetts District Court finding that AstraZeneca violated Massachusetts’ consumer protection laws by manipulating the “average wholesale price” of its physician-administered injectable cancer drug Zoladex, leading to overpayment by the government, third-party payers, and consumers. This case, which highlights the persistent tension between pharmaceutical pricing flexibility and consumer protection, has important implications for similar pending class actions.

Between 1991 and 2003, Medicare, as well as many private insurance companies, pegged reimbursement for certain pharmaceutical products to a national “average wholesale price” (AWP) for each drug. Although the amended 1991 Medicare Part B regulations3 that introduced the term “average wholesale price” failed to define it explicitly, there is some indication in the legislative history that AWP was intended to refer to the prices that physicians and pharmacists actually pay to the drug manufacturers.