INTRODUCTION
This topic contains items that are not usually part of a clinical workup. They are, however, essential to the description and resolution of a case in clinical ethics. Contextual features address the ways in which professional, family, religious, financial, legal, and institutional factors influence clinical decisions. These factors are the context in which the clinical case occurs. Although clinical ethics focuses on the medical indications, patient preferences, and quality of life in a particular case of patient care, medical decisions are not simply individual choices by two autonomous agents (the physician and the patient), but choices that are influenced and constrained by the context in which they take place.
The patient-physician relationship is an intense personal encounter, enclosed in privacy. Yet, that encounter does not take place in a closed world. It occurs within more complex institutional and economic structures than ever before; these structures intrude, sometimes wrongly, sometimes rightfully, on the privacy of the patient-physician relationship. Doctors in their work have multiple relationships with other physicians, nurses, allied health professionals, health care administrators, insurers, professional organizations, and state and federal agencies. Similarly, the relationship between a patient and a physician is surrounded by the patient’s family and friends, other health professionals, and the hospital as an institution. The complex relationships between medicine and the pharmaceutical industry may create conflicts of interest for physicians. Physicians and patients are also subject to the varying influence of community and professional standards, legal rules, governmental and institutional policies about financing and access to health care, computerized methods of storage and retrieval of medical information, the relationship between research and practice, and other factors.
Physicians often perceive these contextual features as conflicting with their primary commitment to individual patients—and they often do. Some physicians might believe that contextual factors have, or should have, little or no relevance in an ethical decision about patient care in which the doctor’s duties should be narrowly focused on the patient. We consider this view obsolete and theoretically incorrect. Many of the factors mentioned previously impose genuine responsibilities and duties on both patients and physicians. The ethical task is to determine how to correctly assess the importance of these contextual features in a particular case.
Health policy influences many of the contextual features. The health care system and the complexities of institutional care and its financing have significant impact on the physician-patient relationship. Witness the constant complaint that health reform legislation, up to the Affordable Care Act (ACA) of 2010, will disrupt the personal relationship between individuals and their doctors. The broad field of bioethics does address questions of health policy, which are subjected to ethical analysis under the rubric of justice. This book, devoted to clinical ethics, does not directly deal with health policy.
Still, clinicians and clinical ethicists will encounter cases in which the structures and policies of existing health or institutional policy create a clinical ethical problem. For example, they will often be faced with a case in which a patient should be discharged from the hospital but still required specialized care, which is unavailable in their community. Changes and reforms are the preconditions for the solution of such problems; we shall see examples in the following pages. Cases caught in these situations may sometimes motivate reform but often must be managed with less than optimal resolution. In general, the focus of this book is on clinical cases that arise and must be managed medically and ethically within extant structures. Those who desire to learn more about the ethics of health policy may consult the extensive bioethical literature on justice and health care.
We do not select a single ethical principle as relevant to all contextual features. In all the questions examined in Topic Four, we are faced with decisions that confront doctors and patients because they encounter each other within the complex and often misshapen structures of health care, and within social and cultural institutions over which they may have little control.
The principles that dominate the other topics, namely, beneficence and respect for autonomy, intersect with contextual features. However, bioethicists commonly add the ethical principle of justice to their list of significant principles. Justice refers to those moral and social theories that attempt to distribute the benefits and burdens of a social system in a fair and equitable way among all participants in the system. This conception of justice is highly relevant to health policy and health care reform. For the contextual problems that occur in clinical ethics, we select a narrow part of this broad idea of justice, namely, fairness. Fairness is a moral characteristic relevant to transactions and relationships between individuals. In games, fairness requires “playing by the rules”; in business, fairness requires “a level playing field.” In general, fairness demands that transactions and relationships give to each participant that which they deserve and can reasonably expect. In addition, it is obviously unfair to exploit by deceit, manipulation, or discrimination. Other ethical norms, such as veracity, privacy, and fidelity, may be pertinent in particular cases.
Conflict of interest is a theme that runs through the ethics of contextual features. The various structures in which a therapeutic relationship takes place can often give rise to conflicts of interest. Indeed, the therapeutic relationship itself involves a potential conflict of interest: the physician has knowledge and skill needed by a vulnerable person, the patient, and has the power to benefit personally by exploiting that vulnerability. However, the basic ethics of the therapeutic relationship, beneficence, and respect for autonomy are intended to preserve that relationship from exploitation. When we view the relationship within the larger picture of contextual features, we see conflicts of interest that must be eliminated or managed in ways that do not damage the relationship. Thus, in this chapter, conflict of interest appears as a consistent theme.
The term conflict of interest is used to describe a situation in which a person might be motivated to perform actions that his or her professional role makes possible but that are at variance with the acknowledged duties of that role. The term was first applied to political office holders and judges whose power to dispense money, power, or punishment might be enticed away from the public good or the law by the lure of personal profit. More recently, the concept has been applied to other professions, including medicine.
A potential conflict of interest is not in itself unethical. When an individual is provided the opportunity to gain personal benefit by acting contrary to duty, he or she should never take advantage of that opportunity, despite incentives that may be difficult to resist. If a potential conflict of interest does not result in unfair treatment, no ethical violation has occurred. It should be noted that, while we treat conflict of interest as a matter of fairness, violations that arise from conflicts of interest can also be seen as doing harm (maleficence) and as unprofessional behavior deserving of sanctions.
Fairness demands that those values most associated with the professional duty of the decision maker should rank highly in resolving the conflict. For example, judges are publicly expected to make equitable decisions based on the facts and the law; defendants and plaintiffs should expect a fair hearing in which law and facts will be honestly exposed and adjudicated. Similarly, physicians should honor their professional commitment to place the welfare of their patients above other considerations; patients have a right to honest diagnosis and indicated treatment, as well as to be treated with respect. Commitment to fairness in relationships is the primary means to control conflicts of interest. However, in situations where conflicts of interest may be pervasive and powerful, certain public measures such as disclosure, recusal from the case, or legal prohibitions with sanctions, may be useful and necessary.
Under the topic of contextual features, we ask ten questions about contextual features that are relevant to the analysis of an ethical problem.
Are there professional, interprofessional, or business interests that might create conflicts of interest in clinical treatment of patients?
Are there parties other than clinician and patient, such as family members, who have a legitimate interest in clinical decisions?
What are the limits imposed on patient confidentiality by the legitimate interests of third parties?
Are there financial factors that create conflicts of interest in clinical decisions?
Are there problems of allocation of resources that affect clinical decisions?
Are there religious factors that might influence clinical decisions?
What are the legal issues that might affect clinical decisions?
Are there considerations of clinical research and medical education that affect clinical decisions?
Are there considerations of public health and safety that influence clinical decisions?
Does institutional affiliation create conflicts of interest that might influence clinical decisions?
4.1 HEALTH PROFESSIONS
4.1.1 Question One—Are There Professional, Interprofessional, or Business Interests That Might Create Conflicts of Interest in the Clinical Treatment of Patients?
A profession is an occupation requiring special learning or science, together with competency utilized in the service of others. Its members profess commitment to competence, integrity, and dedication to the good of their clients and the public. In return, society grants professions a wide scope of self-regulation in admission of members, their education, their discipline, and standards of practice. The health professions state their commitments in oaths and codes of ethics. A renewed interest in professionalism has led major medical organizations to formulate the Physician Charter discussed in Topic One (see Section 1.0.4). This document states three fundamental principles of professionalism: the principle of primacy of patient welfare, the principle of patient autonomy, and the principle of social justice. The principles of patient welfare and of patient autonomy are treated in Topics One and Two of this book. This topic discusses the way in which the primacy of the principle of patient welfare, which requires loyalty between patient and physician, can be realized within the constraints of broad social arrangements of health care.
The ethics of medicine has traditionally directed the physician to attend primarily to the needs of the patient. It is clearly unethical for a physician in a treatment situation to do anything to a patient that is not intended to benefit the patient but only to benefit the physician or some other party. For example, a physician who performs diagnostic or therapeutic procedures that are not indicated, under pretense of caring for the patient but with the intent only of collecting a fee, clearly acts unethically. In recent years, the absorption of the once very private relationship between physicians and patients into large organizations that employ or contract with physicians and that enroll and insure patients has added a new dimension to the physician’s duties. These dimensions may create conflicts of interest. Similarly, many opportunities to profit from professional identity and knowledge are presented by association with pharmaceutical companies and by investment in equipment and in organizations that provide clinical services. Another ethical problem is posed when multiple responsibilities make it difficult to determine which responsibilities have priority in a particular case, such as when the duty to one’s patient is in conflict with duties to others, as when a physician feels that the health of her family is threatened by her work with infectious patients.
The Physician Charter states, “The principle of the primacy of patient welfare is based on a dedication to serving the interest of the patient. Altruism contributes to the trust that is central to the physician-patient relationship. Market forces, societal pressures, and administrative exigencies must not compromise this principle.” The dictionary defines “altruism” as “unselfish concern for the welfare of others; selflessness” (Merriam Webster). We consider the term “altruism” to be a rather exaggerated expression of the nature of a professional relationship. It implies that a physician must always act out of selfless motives and that duties toward patients always supersede other obligations and responsibilities. We prefer to use the term allegiance, that is, a particularly compelling, though not exclusive, commitment to a cause, a community, or a person. All persons have multiple allegiances or loyalties—to family, to friends, to a religious faith, to a community, to a nation, to a cause—and usually these can be managed without conflict. At times, different loyalties will pull a person in opposite directions, and a choice must be made. Also, there are allegiances that are immoral, such as to a violent cause. The tradition of medical ethics, the expectations of the public, and the common law assign a high priority to the physician’s allegiance to his or her patients. Still, other allegiances and moral duties may put constraints on the physician’s allegiance to individual patients. When policies are fairly and justly developed for the distribution of some good, such as transplantable organs or medicines in epidemics, individual physicians are obliged to adhere to these rules even if such adherence compromises the interests of his or her own patients.
Physicians interact with other health professionals, in particular with nurses. Nursing is a profession that has its own ethical traditions and standards, which stress a strong loyalty toward their patients. Ideally, the relationship between physicians and nurses is cooperative and collaborative. However, on occasion, nurses may believe that a patient is not being well served by the attending physicians. This can often be clarified by respectful conversation. Yet, the difference in status between physicians and nurses can inhibit this sort of solution. In such situations, ethicists speak of “moral distress…when one knows the right thing to do but institutional constraints make it nearly impossible to pursue the right course of action” (Jameton). Many studies show that moral distress is common in the clinical setting where nurses feel constrained by the hierarchy of power relationships or by administrative structures. These studies show that presence of moral distress negatively affects the care of patients. Although moral distress has been most fully explored in nursing, it also applies to other interprofessional relations involving differences in status, such as between medical students, house officers, and attendings. It can appear among physicians who work within highly controlling institutional structures. It is imperative to recognize this problem and to take interpersonal and institutional steps to remedy it. It is often helpful to use an ethics consultation or an ethics committee deliberation. This may help to reduce the adverse effects of hierarchical relations among professionals.
The associations that physicians may have with medically related businesses are rife with potential conflicts of interest. Physicians may interact with businesses in many ways. Their relationship with their hospitals, their financial investments in health care activities, or their contacts with pharmaceutical industry may influence clinical decisions.
EXAMPLE I. Physicians in a small city are regularly invited to lunches and dinners at fine restaurants by a pharmaceutical firm. The gatherings are billed as “Gourmet Knowledge” and feature a distinguished speaker addressing issues in health care. The sponsor’s products are mentioned but only together with competing products in a “scientific and impartial commentary.”
EXAMPLE II. A group of internists in a small, semirural city intend to invest in a clinical laboratory to which they can refer their patients, instead of sending them for tests to the laboratories of the two local hospitals.
EXAMPLE III. A university general medicine practice provides care for many patients who are capitated under federal and state programs. The practice recruits physicians by financially rewarding the practice of evidence-based medicine. The practice offers a generous incentive program, with bonuses up to 30% of base salary, if physicians avoid high-cost interventions that have not been determined to be cost effective in caring for a group of capitated patients.
COMMENT. Each of these cases presents a conflict of interest. Some conflicts of interest can be defined or prohibited by law. The physicians in Example II know that federal legislation prohibits physicians from referring Medicare or Medicaid patients to an entity that furnishes designated health services (including laboratory services) in which the physician has a financial interest. This law (Stark Law, 1989, 1993, 1994) virtually outlaws self-referral. However, the Stark Law is extremely complex and does allow a variety of exceptions. In this case, the physicians seek legal advice whether they can use two of these exemptions, namely, the ancillary services and the rural practitioner provisions. Other conflicts that are lawful can be discouraged. For example, a hospital may discourage drug representatives from providing food for meetings, but does not sanction that behavior, leaving implementation to individual departments. One of the most common ways of dealing with conflicts of interest is to require that they be clearly disclosed to the parties involved as well as appropriately managed. If a party involved in a conflict of interest discloses it, the second party can take some protective action, such as leaving the relationship or guarding against some action contrary to his or her interests. In professional relationships, where one party, the professional person, often possesses the advantage of special knowledge, this disclosure may not be effective. It may be necessary for the professional to recuse him or herself from the relationship or discard the conflicting aspects of it.
RECOMMENDATION. In Example I, Gourmet Knowledge provides a subtle but highly effective influence on physicians to view favorably the products of the sponsor. Many studies demonstrate that, despite physicians’ honest belief that they are not influenced, they are swayed by such attention. Example II, the prospect of profit to the physician-owners of the laboratory may influence their clinical judgments about the need for diagnostic testing for their patients. Because their plan clearly raises the application of the Stark laws, they may attempt to avoid it by manipulation of the terms of the exceptions. If they succeed in so doing, they constitute themselves in a moral, if not legal, conflict of interest. They must scrupulously abide by the regulations governing the exceptions. They should declare their ownership to patients for whom they prescribe testing. They should follow the advice of the American Medical Association Council on Ethics and Legal Affairs (AMA Code of Ethics, 2009; Opinion 8.0321). This statement asks whether some social need justifies establishment of such an entity. This places a heavy ethical burden on the consciences of the physicians. They may ignore it and run the risk of being branded as unethical, or they may take seriously the problem of exploiting patients and establish some sort of impartial record review to assure appropriateness of referrals. In Example III, the organization that devised the incentive program has an obligation to design the program in a way that assures the freedom of clinicians to order appropriate care. The program should be explained to patients as a means of effective and efficient care that does not limit or ration appropriate treatment.
CrossRef [PubMed: 16434633]
[JAMA and JAMA Network Journals Full Text]
Another area of potential conflict concerns physicians’ need to attend to their personal well-being and to that of their family. Every physician, like every human being, has certain moral duties to self, to spouse and children, and to colleagues. Every health professional must find the balances and compromises that reconcile duties to patients with these personal and familial responsibilities. Failure to manage these relationships leads to personal distress, declines in health, family crises, and diminished ability to care for patients. It is likely that making time for personal relaxation and family recreation improves the quality of professional performance. Many professional organizations have established programs to educate and support professionals who find themselves torn between these duties.
4.2 OTHER INTERESTED PARTIES
4.2.1 Question Two—Are There Parties Other Than Clinicians and Patients, Such as Families of Patients, Who Have a Legitimate Interest in Clinical Decisions?
The primary parties in a clinical relationship are the patient and the physician, along with nurses and other health professionals caring for the patient. However, other parties may also claim a legitimate role, such as the patient’s family, hospital and managed care administrators, public health authorities, federal, state, and local government regulators, third-party payers, pharmaceutical manufacturers, employers, litigants, police, lawyers, and so on. They may seek information, exercise oversight, esta blish policies that affect care decisions, offer inducements to provide care in certain ways, and even attempt to dictate care. The justification of the legitimacy of these various claims raises ethical issues.
Traditionally, patient’s families have an interest in the care of the patient, and physicians have recognized the legitimacy of that interest. It is common in the specialty of family medicine to say, “The family is the patient.” This phrase designates an important strategy of care, recognizing that in all illness, causal and curative factors can be found in the personal relationships that surround the patient. Family and friends provide emotional support, contribute information, and serve as interpreters of the patient’s wishes and values. They may also contribute to the patient’s ill health and even exacerbate it. The competent physician understands and works with those personal relationships as he or she works with the patient.
At times, when a patient suffers from diminished capacity, family members may act as surrogates, a role that has been discussed in Section 2.4. At times, family interests may conflict with the patient’s interests: financial concerns or interfamilial disputes may spill into clinical care. Family members may demand forms of treatment that physicians believe are not indicated, or insist on stopping treatment that is indicated. Families may disagree about whom among their members should be designated as surrogate. The cooperation of relatives should be sought and encouraged; when families pose problems about the care of the patient, it is necessary to seek and understand the reasons for their behavior and to attempt conciliation, if possible. Ethics consultation may be helpful.
EXAMPLE. An 80-year-old man has severe osteoarthritis and congestive heart failure. He requires constant care and assistance with ambulation. His primary caregiver is his 82-year-old wife, who is troubled with moderately severe asthma. She finds herself unable to provide her husband with the care he requires and encourages him to consider an assisted care facility. He refuses.
COMMENT. Any decision about this gentleman’s care is clearly related to his wife’s ability and willingness to provide the care he requires. It is clear that interests and medical needs among family members are in conflict. Physicians responsible for the husband’s health must be aware that medical decisions are being taken within the context of this conflict. Social work must be engaged to help conciliate this conflict and try to devise mutually suitable arrangements for care. Often conflicts like these are not recognized until there is a crisis that requires changing the care arrangements.
Different cultures define the role of the family in very different ways. In many cultures, families play a large role in decisions about the patient. This may cause conflicts about appropriate care.
CASE. A Japanese American family brings their maternal grandmother to their primary care physician. The grandmother is 72 years old, came to the United States 10 years ago, and speaks no English. She complains of weakness, weight loss, nausea, and fever of several months’ duration. Her grandson, a computer engineer, tells the doctor, “In case you find cancer, we prefer that she not be told. That is the way with our older people. But we do want her to have full treatment.” Studies reveal acute lymphocytic leukemia with renal failure, a condition that has a 5% chance for clinical response to aggressive and prolonged chemotherapy.
RECOMMENDATION. In Japanese, and many other cultures, great authority is given to family and especially to senior members, to make decisions about other family members regarding lifestyle, occupation, marriage, etc. This authority extends to health care decisions. In Topic Two (see Section 2.2.8), we stated the major significance of patient’s preferences and, at the same time, the importance of respecting cultural values. In this case, we recommend that the patient be informed, through a reliable translator, that she is very sick, that decisions must be made about her care, and then asked whether she wishes to make these decisions for herself or prefers to have them made by another. An authorized delegation of decisional authority instead of simple acceptance of the culture’s purported customs is an appropriate compromise. Still, the delegated choice must reflect the best interests of the patient (see Section 3.0.7).
The use of pharmacogenetics and pharmacogenomics, sometimes called “personalized medicine,” to select a beneficial drug treatment based on the genetic makeup of a patient is gradually being introduced into individual patient care. Some recent advances in medical genetics, however, while unquestionably beneficial, introduce many complexities and potential conflicts of interest into the care of patients. The principal goals of medicine concern the detection of disease conditions and their causes, followed by appropriate therapy. Usually, diagnosis begins from observation of signs and symptoms in a patient who comes to the physician for advice. However, molecular medicine has generated many tests for the detection of genetic mutations. Some tests have been incorporated into clinical practice; considerable uncertainty about their clinical utility remains. Many other tests are in commercial development by companies eager to promote their use. The availability of these tests poses many problems to clinicians. In particular, primary care physicians, lacking detailed know ledge of the genetics and the nature of the tests, may be asked to order a genetic test by a patient anxious about hereditary disease.
These tests are not only done in symptomatic patients to confirm present disease; they can also be done in asymptomatic patients to detect the possibility of future disease. A positive genetic test does not necessarily predict that the person will develop the disease or, if they do, the tests do not predict the timing or severity of the condition. Many diseases known to have a genetic component are currently not amenable to treatment or to preventive measures. Also, genetic tests not only show the probability of future disease in the person tested but also the possibly that the mutation is present in the tested person’s relatives who share the same genetic heritage. This explains why this section appears here rather than in Topic One: genetic testing must always be considered within the family context. When a mutation is detected in one member of the family, the question of testing other members may arise. Conflicts of interest between family members, and between the physician and his or her particular patient may arise in genetic testing.
CASE. Mrs. Comfort, who was diagnosed with breast cancer at the age of 45 years, suspects a history of breast cancer in her family. She knows her aunt and her grandmother died of breast cancer. She asks her primary care physician whether she should be tested for hereditary breast cancer (mutations in two genes, BRCA1 and BRCA2). She has two adult sisters, two daughters, age 23 years and 15 years, and one granddaughter, age 2 years. She wonders whether her sisters, daughters, and grandchild should also be tested.
COMMENT. Primary care physicians may encounter cases such as this one. Many tests are available on the market and can be purchased. These tests always contain brochures that advise genetic counseling, for which a primary care physician may not be adequately trained. To ensure adequate informed consent, pre- and postcounseling with a qualified health care professional, such as a genetic counselor, is recommended when predictive genetic testing is considered. In considering whether or not to recommend genetic testing, the following points should be considered:
The nature of the genetic disease associated with the mutation, that is, the pattern of inheritance (dominant or recessive), the penetrability, the variability, and the epidemiologic and clinical course of the disease.
The accuracy of the test: its sensitivity, specificity, and predictive value.
Options for treatment or prevention of future disease.
Implications for one’s genetic kinship.
Questions of confidentiality, insurance discrimination, and treatment availability and access.
The educated and informed preferences of the person requesting the test and of other persons affected by the results.
RECOMMENDATION. The test for BRCA1 and BRCA2 is indicated when a family pedigree suggests a hereditary breast and ovarian cancer syndrome, such as a family with multiple individuals with breast and/or ovarian cancer in several generations, or early onset breast cancer. Mrs. Comfort’s family history is suggestive but the details are not sufficient to confirm this. A more detailed pedigree might confirm the possibility of a hereditary cancer syndrome; if so, genetic testing could be considered. If the patient does test positive for BRCA1 or BRCA2 mutations, testing of other genetically related women should be considered. In addition, those who test negative without a known mutation in the family should be counseled that, because this particular mutation is only one among many possible causes of hereditary breast cancer, hereditary breast cancer cannot be excluded.
Even individuals who test negative for a known mutation in the family (true negative) are not free of risk: they remain at risk for sporadic breast cancer, which has an incidence of 1 in 8 women in the general population. Preventive options, such as increased surveillance including breast self-examination, mammography and/or breast MRI, or, most drastically, prophylactic mastectomy, must be clearly explained. The predictive genetic testing of minor children for any adult-onset disease is controversial: it is not currently recommended because of the potential to affect children’s views of themselves, the attitude of their parents, and other psychosocial risks. It is advisable to wait until minors are old enough to make the decision themselves. Finally, it should not be assumed that Mrs. Comfort’s siblings and other at-risk family members will be interested in being tested or in learning Mrs. Comfort’s test results. Mrs. Comfort should be counseled about this possibility and should be encouraged to inquire about family members’ interests before disclosing her genetic information to family members. As molecular medicine advances, many complex ethical problems about obtaining and using genetic information may appear in daily medical practice.
4.3 CONFIDENTIALITY OF MEDICAL INFORMATION
4.3.1 Question Three—What Are the Limits Imposed on Patient Confidentiality by the Legitimate Interests of Third Parties?
Information that a patient discloses to a physician is ethically and legally protected by confidentiality. Physicians are obliged to refrain from divulging confidential information obtained from patients and to take reasonable precautions to ensure that such information is not inappropriately divulged to third parties. The duty of medical confidentiality is an ancient one. The Hippocratic Oath states, “what I may see or hear in or outside the course of treatment…which on no account must be spread abroad, I will keep to myself, holding it reprehensible to speak about such things.” Modern medical ethics bases this duty on respect for the autonomy of the patient, on the loyalty owed the patient by the physician, and on the possibility that disregard of confidentiality would discourage patients from revealing useful, but sensitive or embarrassing diagnostic information. Disclosure may harm the patient or third parties and may encourage use of medical information to exploit patients. Also federal and state laws stringently limit disclosure (see Section 4.3.2).
Despite these principles and rules, confidentiality is sometimes treated rather carelessly by providers. They may speak about patients in public places, such as hospital elevators or cafeterias; cell phone conversations can broadcast confidential information to adjacent parties. Records are not well secured and are accessible to many persons. Technologic developments in information storage, retrieval, and access poses significant problems of confidentiality. Electronic medical records enhance statistical information and facilitate administrative tasks. However, the availability of medical record information to interested third parties, such as employers, government agencies, payers, family members, and others, threatens patient and physician control over sensitive information. For example, growing use of screening for genetic diseases produces information that may be of interest, not only to patients and their physicians, but to the patient’s relatives, employers, and insurers. Lack of consensus about how to regulate access to such information poses a continuing problem for health care institutions and policy makers.
Confidentiality is a strict but not unlimited, ethical obligation. Certain parties outside the patient-physician relationship may make ethically valid claims to gain access to otherwise confidential information. When other parties do claim legitimate interests in patient information, the ethical issue is to determine what principles and circumstances justify exception to the rule. When the patient may derive some benefit from disclosure, the principle of beneficence would justify an exception; when some other party may be harmed because information is withheld, the principle of nonmaleficence may mandate exceptions to protect the safety of other persons or to protect the health of the public. The general rules for confidentiality are spelled out in the Health Insurance Portability and Accountability Act (HIPAA) of 1996. Although HIPAA is a law passed by Congress, its provisions about confidentiality in general track the ethical dimensions of this moral obligation. It does not, however, account for certain problematic exceptions that we will treat below.
Confidentiality is mandated by state and federal laws. Federal regulations implementing the Health Insurance Portability and Accountability Act (HIPAA) of 1996 create a comprehensive system defining the value, scope, and limits of confidentiality. These regulations are very complex. Most health care institutions have produced explanations of their applicability. Questions about their interpretation should be addressed to the appropriate institutional departments. According to the HIPAA regulations, “covered entities,” that is, health plans, hospitals, clinics, and health departments, must make a reasonable effort to limit the use and disclosure of individually identifiable information to the minimum necessary to accomplish the purpose of its use or disclosure. Protected health information includes any information, in verbal, written, or recorded form, about a patient that has been received, created, or stored and which includes information that may be used to identify a patient. In general, individually identifiable information obtained by these covered entities should not be used or disclosed without written authorization by the patient.
There are exceptions: clinicians may share information necessary for the treatment of their patients; the institution may use information to obtain or provide reimbursement or payment for services; the institution may use or disclose information for a variety of policy and assessment activities, such as quality assurance, outcomes evaluation, etc. Patients also have the right to access their records and, in some cases, to amend incorrect or incomplete information. Covered entities must provide patients with a statement of its privacy policy. Patients are also entitled to receive a list of the situations in which their health care providers and health plans have disclosed their information. Covered entities may be subject to civil and criminal penalties for violations. State laws also exist to safeguard privacy; these may be more stringent than federal law.
In general, the federal regulations do not require the patient’s authorization when clinicians must share information about them for proper treatment. This includes the coordination of care and consultation between clinicians as well as information necessary for referral of patients between providers. Information may be disclosed to surrogates and family members but only with the patient’s consent. It is also permitted to disclose limited information to other inquiring parties, such as friends, clergy, or press. This limited information may include a description of the patient’s condition in general terms that do not communicate specific medical information about the patient. The death of a patient may be disclosed by a statement of the event without further explanation except to authorized persons. Patients, however, may explicitly refuse the release of any information to inquiring parties or limit release to certain persons.
Confidential information may be divulged to appropriate persons when a physician is aware that some identifiable person is endangered by lack of that information. The ethical problem in such cases concerns the meaning, nature, and seriousness of the risk of harm.
CASE I. A 61-year-old man is diagnosed with metastatic cancer of the prostate. He refuses hormonal therapy and chemotherapy. He instructs his physician not to inform his wife and says he does not intend to tell her himself. The next day, the wife calls the physician to inquire about her husband’s health.
CASE II. A 32-year-old man is diagnosed presymptomatically with Huntington disease. This is an autosomal dominant genetic disease (50% chance of transmitting the gene and the disease to offspring). He tells his physician that he does not want his wife, whom he has recently married, to know. The physician knows that the wife is eager to have children.
CASE III. A 27-year-old gay man is diagnosed as HIV positive. He tells his physician that he cannot face the prospect that his partner will learn of the infection.
CASE IV. A woman arrives at the emergency department with serious contusions on the right side of her face and two teeth missing. Her nose appears to be broken. Her husband accompanies her. He explains that she tripped on the carpet and fell down a flight of stairs. She affirms his story. The emergency department resident suspects spousal abuse. He does not know the couple, but judges by their dress and manner that they appear to be respectable citizens.
RECOMMENDATION. In Case I, the physician should not divulge the husband’s diagnosis. While the wife has a moral right to know of her husband’s condition, which will certainly affect her deeply, it is her husband’s obligation to inform her. The physician, while disturbed about the situation, cannot justify disclosure because his legal obligation and his ethical duty to respect his patient’s preferences outweigh possible harm to the wife from not knowing her husband’s diagnosis. The physician’s ethical concerns for the best interests of his patient (as well as the patient’s wife) are also relevant. Many physicians would strongly encourage the husband to reveal his condition but should not divulge the diagnosis to his wife. Under HIPPA regulations, the patient has the right to restrict information to any party, including his spouse.
In Case II, a stronger rationale is present for divulging the diagnosis to the patient’s wife, namely, the possibility of harm to future children and serious burdens of caretaking that fall upon her when her husband becomes symptomatic. Arguments against disclosure are that, although risk of harm to future children is high (50%), the risk is statistical and might not occur. Disclosure will not protect any specific, existing individual. Finally, under HIPAA regulations, the physician is prohibited from disclosing diagnostic information to others. The physician should urge his patient to seek genetic counseling and to urge him to discuss the matter with his wife. For example, they should explore the use of preimplantation genetic diagnosis and in vitro fertilization. If the wife is also a patient, the physician may encourage her to talk seriously with her husband about his health and their plans for children. Should these efforts fail, we believe that, given the seriousness of Huntington disease, and the serious burdens it imposes on all parties, disclosure would be an appropriate ethical choice, once all efforts to resolve the issue by counseling have failed. While HIPPA places stringent limits on disclosure of diagnostic information, its provisions do not envision situations in which nondisclosure would pose a risk to other parties.
In Case III, the physician has a duty to ensure that the partner is informed of his serious risk, first by urging the patient to do so and, if this fails, by taking the steps prescribed in public health law and practice regarding contact tracing and notification. Provisions of local law should be consulted. HIPAA does permit contact tracing and notification if performed in accordance with state and local laws.
In Case IV, the resident must make the required report to authorities. The clinical standard for reporting child, spousal, or elder abuse is reasonable suspicion. State laws usually do not grant physicians the discretion not to report suspected abuse. It is the duty of trained investigators in departments of child abuse and family violence protection to determine whether abuse has occurred. An emergency department physician should be familiar with the characteristic physical signs of abuse that can frequently be distinguished from other accidental trauma. The apparent respectability of the parties is irrelevant.
Information obtained from a patient may suggest that he or she might be a danger to others, without identifying specific endangered persons or occasions. Traditionally, certain communicable diseases have belonged in this category, and laws have been enacted that require physicians to report cases of communicable disease to health authorities. Many jurisdictions require persons and sometimes their physicians to report health defects, such as seizures and cardiac diseases, that might render operators of vehicles dangerous to others. Where reporting laws do not exist, and even where they do, ethical problems may arise.
In a precedent-setting case, Tarasoff v. Regents of the University of California (Cal., 1976), a college student informed his psychotherapist that he intended to kill a woman who had rejected his attentions. This threat was not communicated to the woman, whom the student sub sequently murdered. The court ruled that the psychotherapist had a positive duty to take reasonable steps to protect third parties from harm, stating “the protective privilege (of confidentiality) ends where the public peril begins.” In the opinion of the court, the serious danger of violence to an identifiable person was a consideration that overrode the obligation to preserve confidential information obtained in the course of therapy. It is unclear how this decision would apply to practitioners other than psychotherapists who obtain similar information in the course of providing general medical care. Further, the Tarasoff rule is not accepted law in all jurisdictions. Faced with such a situation, a physician would be wise to seek ethics consultation and legal advice.
CASE I. Mr. Cure, with bacterial meningitis, refuses therapy and insists on returning to his college dormitory room.
CASE II. A 28-year-old man who has been under a physician’s care for peptic ulcer impresses his doctor as somewhat bizarre in attitude and behavior. He suspects that his patient suffers from a psychotic disorder and asks him whether he is seeing a psychiatrist. He calmly responds that he was once under treatment for schizophrenia but has been well for years. Then, in the course of an office visit, he casually states that he would like to see all politicians dead and was going to attend a political rally “to see what he could do.” Should the physician report the patient to the police?
CASE III. A nephrology fellow working in a dialysis unit learns that he is hepatitis C antigen positive. He approaches another physician, an infectious disease specialist, for advice. After being advised to tell the relevant parties, including the hospital’s infection control team, he states that he does not intend to disclose his diagnosis. He insists on confidentiality. Should the infectious disease specialist take steps to have the nephrology fellow’s clinical activities restricted?
CASE IV. A 45-year-old woman with a history of idiopathic seizures is diligent about taking antiseizure medication. Her last major seizure was 16 months ago. To qualify for a driver’s license, state law requires a physician’s declaration that the patient has been free of seizures for 24 months. She pleads with her doctor for this certification because she needs to drive in order to keep her job.
COMMENT. Most jurisdictions have statutes requiring physicians to report cases of certain types, such as sexually transmitted diseases, gunshot and knife wounds, and suspected child, partner, and elder abuse. The purpose of these statutes is to protect public health and safety, and their ethical justi fication arises from obligations of social justice. These statutes should be obeyed when the physician believes the legal criteria for making a report are met. The phrase “danger to self and/or others” is frequently found in law, regulation, and common discourse. This phrase is very general: it may refer to persons who have a volatile, threatening disposition, to those with diagnosed psychiatric conditions that are associated with violence or to persons who are actively attacking others or initiating harm to themselves. For the purposes of clinical ethics, we suggest that danger to self or others be interpreted in a narrow sense, that is, there should be some reliable evidence that a harmful act is imminent or highly likely to occur.
Many jurisdictions have special legislation about confidentiality of HIV testing. The legislation is intended to protect HIV-positive persons from the prejudice that often is directed at them when their condition is known. Usually, this legislation does not permit the testing of persons without their explicit consent and requires their consent to share the results with any other party. Exceptions usually allow other health professionals caring for the patient to access the information and permit health officers’ use of such information for the protection of others. Some states have laws that give physicians the discretion to notify sexual partners of HIV-positive persons. Physicians should be aware of the exact provisions of this legislation in their area.
RECOMMENDATIONS. In Case I, bacterial meningitis is an infectious disease. Because this patient’s final diagnosis is not clear, it could be meningococcal meningitis, which is contagious, spreads rapidly in closed settings, and is a reportable disease. The physician has the duty to communicate the information to college authorities and recommend that Mr. Cure be isolated in the college infirmary, pending the culture results.
In Case II, the danger to others is less specific. No victim is identified, and the likelihood of violence is uncertain. The threat is vague and, as is often the case, possibly empty. However, the occurrence of many mass shootings by persons who are apparently mentally disturbed (some of whom even signal their intent to acquaintances or in blogs) suggests an increased vigilance in such cases. The physician should probe for specific details: Where is the rally? What politician? What does he mean by “see what he can do?” The practitioner may ask more general questions such as “why are you telling me this?” An answer such as “Oh, I was just blowing off steam” suggests that the threatening words are innocuous; a response such as “boy, I may be losing it,” is more troubling.
While practitioners may not be expert on the psychological characteristics associated with threats of this sort, they can be sensitive to certain features, for example, the presence of narcissistic expressions, such as “those guys in Congress know I am dangerous and they are out to get me.” This patient is obviously in need of psychiatric treatment and should be persuaded to seek it. The usual strict ban on revealing patient information may yield as suspicion of danger to others accumulates. Too low a standard for reporting may be detrimental to persons whose psychological or psychiatric condition will never result in harmful activities. The consequences of being reported on the basis of suspicions aroused in medical care might associate health care with police surveillance and discourage them from seeking care. However, too high standard may lead to disaster. In the current circumstances, we are inclined to recommend the lower standard, in favor or reporting after supporting suspicion with reasonable inquiry.
In Case III, the nephrology fellow may infect others and the possibilities for contact are extensive and difficult to limit. Risky contact takes place, for example, when lines are replaced or biopsies performed. These risks are greater because fellows are trainees and may lack experience with these and other procedures. “Do no harm” is the premier ethical obligation of physicians. This physician has a direct obligation to protect his patients from harm. If he refuses to do this by reporting himself and by restricting his activities voluntarily, the physician whom he consulted is exempted from confidentiality. She too has a general professional responsibility for the safety of patients. She has a duty to report the nephrologist to Occupational Medicine or to the hospital infection control authorities. Generally, health care workers with blood-borne pathogens like hepatitis C and HIV have few restrictions from practice if they are compliant with treatment and cooperate with Occupational Medicine. Their confidentiality can usually be protected. However, laws about this vary from state to state and clinicians should be aware of their state requirements.
In Case IV, the patient is asking the doctor to lie in order to provide a benefit for the patient, which may place others at risk. While some physicians are prepared to “bend the law” in cases like these, the safety of the patient herself, of other innocent parties, the integrity of the medical profession, and the utility of the law oblige the physician to refuse her request.
4.4 ECONOMICS OF CLINICAL CARE
4.4.1 Question Four—Are There Financial Factors That Create Conflicts of Interest in Clinical Decisions?
Costs are incurred whenever medical care is provided. Those costs are paid by patients, by their families, by public or private insurers, or they are subsidized by institutions or individuals. Methods of payment are complex, involve many parties, encounter many controls and regulations and are, in general, opaque to most patients, and to many physicians. The recently implemented Affordable Care Act (ACA, 2010; see Section 4.4.4) which aims to reduce medical costs by developing innovative methods of payment reform and by incentivizing providers to contain costs (eg, through accountable care organizations) are likely to increase payment complexity. Such complexity provides many opportunities for conflicts of interest and other unfair manipulations. Health care reform debates are centered on this issue. Our book refrains from participating in these health policy debates. We limit ourselves to the financial matters that might directly affect patient care decisions under the presently common reimbursement systems.
The ethical question for practitioners and institutions is how financial arrangements should influence medical decisions in particular cases. How should the legitimate interests of third parties—health care institutions, insurance companies, labor unions, corporations, and government—affect clinical decisions about appropriate care?
Some physicians say that these interests should not be considered and that a physician’s allegiance is to individual patients; societal or institutional costs are not relevant to clinical decisions. Whatever is required by medical indications and personal preferences should be provided. Noble as it is, this view is highly unrealistic. Physicians must consider not only the benefits and safety of an intervention and the patient’s preferences, but also its financial implications for their patients. This suggests that physicians should be aware of the costs and comparative effectiveness of the diagnostic and treatment proposals that they make to patients. Because patients are increasingly responsible for their own health care costs through co-payments and deductibles, they should be informed of the costs so that they can consider this information when deciding which course is best for them. This approach would include, for example, a discussion of the costs of alternative treatments that could be properly recommended for the same medical condition. Regrettably, this sort of discussion does not often occur. Physicians rarely know the costs of what they prescribe and order. Even if they do know and disclose this information, most patients are ill-equipped to evaluate medical efficacy in comparison with costs. In the midst of this confused setting, many conflicts of interest arise.
CASE. Mrs. S., a 70-year-old woman, presents with new onset of headaches and a CT angiogram shows a 7-mm aneurysm of the anterior communicating artery. The neurosurgeon recommends an open craniotomy and clipping of the aneurysm. The neurosurgeon is aware of another neurosurgery program at a local hospital that offers patients the possibility of an FDA-approved treatment using an endovascular coiling procedure that is less invasive than the craniotomy. Should Mrs. S.’s neurosurgeon tell her about the alternative, less invasive procedure, even though it is offered only at a competing hospital?
