06 February 2015


'An Ethics Framework for a Learning Health Care System: A Departure from Traditional Research Ethics and Clinical Ethics' by Ruth R. Faden, Nancy E. Kass, Steven N. Goodman, Peter Pronovost, Sean Tunis, and Tom L. Beauchamp in  (2013) 43 s1 Hastings Center Report (Ethical Oversight of Learning Health Care Systems) comments
Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion.
The authors argue
Calls are increasing for American health care to be organized as a learning health care system, defined by the Institute of Medicine as a health care system “in which knowledge generation is so embedded into the core of the practice of medicine that it is a natural outgrowth and product of the healthcare delivery process and leads to continual improvement in care.” We applaud this conception, and in this paper, we put forward a new ethics framework for it. No such framework has previously been articulated. The goals of our framework are twofold: to support the transformation to a learning health care system and to help ensure that learning activities carried out within such a system are conducted in an ethically acceptable fashion.
A moral framework for a learning health care system will depart in important respects from contemporary conceptions of clinical and research ethics. The dominant paradigm in research ethics and in federal regulations has relied on a sharp distinction between research and practice—a segregation model that dates to the influential publications of the National Commission for the Protection of Human Subjects in the 1970s. The learning health care system, by contrast, proposes that it is acceptable and indeed essential to integrate research and practice. From this perspective, the dominant ethical paradigm from the 1970s to the present time is antithetical to and problematic for the learning health care system, at a time when clinical practice is far from optimal and learning to improve care is sorely needed. Several hundred thousand people die needlessly each year from medical mistakes. There is reason to believe that adult patients receive only approximately 50 percent of recommended therapies, and that up to 30 percent of health care spending is wasted. The need to improve health care is urgent, yet the current ethics paradigm may hinder improvement. For example, the expansion of one of the most successful quality improvement interventions ever—saving thousands of lives by preventing central line-associated bloodstream infections in intensive care units—was almost halted due to concerns about research ethics oversight. But few have come forward to express concerns and oversight for the thirty thousand or so people who will die unnecessarily each year in the United States from this type of infection.
Quality improvement and comparative effectiveness research are emblematic of the kinds of ongoing learning activities that a learning health care system is designed to promote. As we argue in the first article in this supplement to the Hastings Center Report, quality improvement and comparative effectiveness research bring into sharp relief the problems with the criteria traditionally used to distinguish research and practice. The fuzziness of the distinction, coupled with the oversight burdens that are required of research but not of practice, creates dubious incentives to redesign quality improvement and comparative effectiveness activities in ways that minimize the likelihood that they will be classified as research, even at the cost of their rigor, utility, dissemination, or value. There have been recent attempts to modify the dominant paradigm to accommodate at least some kinds of quality improvement and comparative effectiveness research, but these efforts are limited in reach and impact. Going forward, the fundamental structure and assumptions of the traditional segregation model rest too heavily on an unjustifiably sharp distinction between research and practice. The traditional model now stands to frustrate integrated, real-time learning, which is at the heart of where our health care system should be headed.
The framework we propose in this paper rejects the assumption that clinical research and clinical practice are, from an ethics standpoint, fundamentally different enterprises. It departs significantly from today's research ethics and clinical ethics paradigms in two key respects. First, the framework sets a moral priority on learning. It includes a specific, novel obligation on health professionals and health care institutions to be active contributors to learning in health care. We argue that a similar obligation extends to patients, who have traditionally not been conceived in research ethics as having a duty to contribute to the ongoing learning that is integrated with the health care they receive. Second, the framework includes an obligation to address problems of unjust inequalities in health care—an obligation that reaches beyond the demands of justice in traditional and contemporary codes of research and clinical ethics. Our view is that the time has come for these changes to be recognized as central moral obligations in health care.
We begin by briefly stating the main arguments that morally justify the transformation to a learning health care system. The justification builds upon and complements the arguments in favor of learning health care that have been provided elsewhere. We then describe what we mean by a learning activity and the structure of what we call the learning health care system ethics framework. This description is followed by an analysis of each of the framework's seven major elements. Each element is stated as an independent obligation. We consider how each element is similar to or different from requirements prevalent in contemporary research ethics and clinical ethics. We conclude with a discussion of some of the next steps needed to explicate how the framework can be used to guide the ethics of learning in a learning health care system.
They go on -
The framework we propose consists of seven obligations: 1) to respect the rights and dignity of patients; 2) to respect the clinical judgment of clinicians; 3) to provide optimal care to each patient; 4) to avoid imposing nonclinical risks and burdens on patients; 5) to reduce health inequalities among populations; 6) to conduct responsible activities that foster learning from clinical care and clinical information; and 7) to contribute to the common purpose of improving the quality and value of clinical care and health care systems.
Respecting patient rights and dignity and avoiding non-clinical risks (obligations 1 and 4) appear in most contemporary discussions of research ethics. Respecting the judgment of clinicians and providing patients with optimal clinical care (obligations 2 and 3) are presuppositions of traditional medical ethics—as, for example, in the influential catalogue of norms in Thomas Percival's classic volume, Medical Ethics. Variations of these four obligations are prominent in contemporary discussions of medical professionalism, and they remain relevant in our framework. However, we also give each an interpretation not found in codified principles of either clinical ethics or research ethics.
Obligations 5, 6, and 7 are specific to the learning health care system context. These three obligations substantially revise traditional conceptions of the moral foundations of research ethics and clinical ethics. Obligations 5 and 6 have more than one obligation-bearer, as presented in Table 1, with the obligations falling on clinicians, investigators, health care institutions, those responsible for institutional policies and practices, payers, and purchasers. Patients are the obligation-bearers in obligation 7, which proposes to sharply reform current rules and guidelines. This obligation placed on patients to contribute, under limited and appropriate conditions, to learning that is integrated with their clinical care is not present in conventional accounts of either clinical ethics or research ethics, where the assumption is that no such obligation exists. ...
Each of the seven obligations in the framework constitutes a necessary condition, within a learning health care system, of an adequate ethics. In the absence of any one of these obligations, the framework would lose a basic norm, rendering the framework deficient. However, we do not claim that this set of obligations establishes a set of sufficient conditions in a comprehensive ethical framework. Future work can be expected to specify these abstract rules to provide more granular guidance for institutions and their specific contexts and to perhaps add additional general obligations.
The seven norms presented below have some overlapping content, but no one norm can be reduced to one or more of the others. They are not morally weighted or placed in a hierarchical order of importance. Questions of weight and priority can be assessed only in specific contexts. When these norms come into conflict in particular learning activities, the goal will be to show either that one norm is of overriding importance in that context or that at least some demands of each of the conflicting norms can be satisfied, whereas others cannot.
1) The obligation to respect patients. Moral obligations to respect the rights and dignity of persons are not controversial in either clinical ethics or research ethics. Examples of respecting rights include obtaining informed consent, soliciting and accepting advance directives, protecting the confidentiality of health information, and evaluating the effectiveness of health care in terms of outcomes that matter to patients. Respecting the dignity of patients requires health professionals to express respectful attitudes and to treat patients as having an inherent moral worth by, for example, helping patients understand what is happening to them and following the lead of patients in involving their families and friends in their care.
Among the rights most discussed in research ethics and clinical ethics is the right to have one's autonomy respected.
The obligation to respect patient autonomy is also central to the framework we are proposing, but unlike some bioethics literature, the framework does not give it undue deference or overriding importance. Respecting autonomy is primarily about allowing persons to shape the basic course of their lives in line with their values and independent of the control of others. Not all health care decisions are likely to be attached to a significant autonomy interest of individual patients, and deference of the wrong sort can constitute a moral failure to take adequate care of patients rather than an instance of showing respect.
In interpreting the obligation to respect autonomy in learning health care contexts, we should assess both whether a learning activity unduly limits the choices of patients and the value of those choices to patients. Many decisions in health care—such as how often simple laboratory tests should be repeated during a hospitalization or whether medications should be dispensed by one qualified professional or another—are not likely to engage values of central importance to the patient. Learning activities that relate to such decisions can be undertaken by health professionals and institutional officials without a violation of obligations to respect the rights or dignity of patients.
2) The obligation to respect clinician judgment. The importance of clinician judgment to professional practice is well established, although what is meant by clinician judgment is not always clear. We use the term “judgment” broadly to mean the clinician's considered beliefs about how best to care for a patient in light of multiple considerations and influences, including personal professional experience, the experience of colleagues and mentors, scientific evidence, and the clinician's understanding of the patient's values and priorities. Respect for clinicians’ judgments is justified for two reasons. First, the exercise of clinical judgment can further the health interests of patients in achieving the best clinical outcome. Second, the exercise of clinical judgment can advance the autonomy interests of patients because clinicians are often well positioned to ascertain and be responsive to their values and preferences.
Not all constraints on the behavior of clinicians—such as requirements to write notes for a supervisor or to use a uniform method for dosing orders—interfere with the exercise of clinician judgment. Some other constraints interfere with the exercise of clinician judgment, but to varying degrees. For example, formularies requiring physicians to prescribe only one branded drug among several in the same class may have little if any negative impact on the health and autonomy interests of patients that respect for clinician judgment is intended to serve. Learning activities that impose constraints of these types would be compatible with the obligation to respect clinician judgment.
One problem with the obligation to respect clinician judgments is that even the most well-intentioned judgments of clinicians can be subject to some form of bias. A key precept of evidence-based medicine is that clinician judgment may not result in the best health outcomes for patients, especially when there is an absence of good empirical evidence or that evidence does not factor in the forming of the judgment. Evaluating the strength of the obligation to respect clinician judgment usually entails a contextual assessment of the likely impact of any proposed restriction on the exercise of clinician judgment on patients’ health or autonomy interests. When learning activities target areas in which there is clinical uncertainty about best practices or limited empirical evidence, the likelihood that unrestricted clinician judgment will advance the health interests of patients is lessened, and the importance of respecting clinician judgment is weakened. For example, for most patients, there is currently little empirical evidence to support a clinician's judgment that a particular first-line hypertension drug is better than another. The obligation to respect clinician judgment in this context is not as stringent as in a case where clinician judgment is based on more robust evidence or is responsive to patient preferences for different therapeutic options.
3) The obligation to provide optimal care to each patient. Obligations to promote the welfare of others take on specific forms in health care, usually formulated as role obligations. Professional codes underscore the moral responsibilities of professionals to advance the welfare interests of each patient by providing the patient with optimal care aimed at securing the best possible clinical outcome. “Clinical outcome” encompasses the interests patients have in the promotion, preservation, and restoration of their health and the mitigation of pain, suffering, and disability. During the course of clinical care, clinical risks of setbacks to the health interests of patients are often present. These risks are morally justified if they are outweighed by the prospect of corresponding clinical benefits. Accordingly, clinical care can be ethically acceptable when significant risks are present, as long as the potential or expected benefit to the patient justifies the risk.
A central moral consideration in assessing the ethical acceptability of a learning activity is how the expected net clinical benefit for the patients affected by a learning activity compares to the net benefit they likely would have experienced if their care had not been affected by that activity. In assessing net clinical benefit, the risks in routine clinical practice should be considered. Some learning activities are likely to increase the prospects for net clinical benefit, whereas others are likely to decrease it. An activity designed to evaluate the impact of a computer-generated prompt to clinicians to double-check medication dosage may itself have a positive impact on the net clinical benefits for patients; it may reduce the risk that they will be harmed by a medical error. By contrast, depending on the context, a randomized clinical trial of a first-in-class medication may decrease patients’ prospects for net clinical benefit relative to what would be expected if these patients receive approved medical therapies. Other learning activities—such as a prospective observational study that relies only on electronic health data to compare widely used interventions—are likely to have no appreciable effects on net clinical benefit. Accordingly, the impact of a learning activity on net clinical benefit is specific to the particulars of the activity and the related clinical context, but it is morally essential that such assessments be made in a learning health care context.
4) The obligation to avoid imposing nonclinical risks and burdens. Health care focuses on the health-related interests of patients and the reduction of risks of health-related harms, but obligations to avoid inflicting other kinds of harm and burden also apply in health care. Clinical care and clinical information can be provided or used in ways that affect patients’ interests in financial well-being, social standing and reputation, employment and insurance opportunities, dignity, privacy, and the joy of spending time with family and loved ones.
The impact of a learning activity in imposing nonclinical risks and burdens—in comparison to the nonclinical risks and burdens that the patients could be expected to experience if their clinical care did not involve the learning activity— is a moral consideration. For example, the risk that health information will be disclosed inappropriately sometimes increases as a result of a learning activity, and such disclosures can be monitored and reduced through security protections. Learning activities also may impose burdens beyond those needed for patients’ usual clinical care, such as extra visits to clinical facilities.
5) The obligation to address unjust inequalities. Our framework is rooted in a broader conception of obligations of justice than the conception that dominates traditional research ethics. Fundamental to traditional formulations and to the regulation of research are moral requirements that subject selection be fair and that the distribution of research benefits and burdens be just. Our framework supports the commitment to these injunctions, which are historically rooted in concerns about the abuse of disadvantaged or vulnerable subjects in research. However, these injunctions carve out only a piece of the territory of justice that needs to be considered in the ethics of a learning health care system.
In agreement with the traditional conception, our framework sets a presumptive bar against learning activities whose potential negative effects—including imposition of non-clinical burdens or the worsening of prospects for net clinical benefit—fall disproportionately on socially and economically disadvantaged patients or groups of patients. This bar protects many individuals who are homeless, poorly educated, belong to groups that have been subject to historical and continuing prejudicial treatment, or lack access to health care and physicians. Also in need of monitoring are learning activities whose positive outcomes will disproportionately benefit patients who are already socially and economically advantaged—for example, activities that rely on access to the Internet in the home. This obligation requires those who propose learning activities to consider whether the activity can be carried out in such a way that its benefits extend to the less privileged.
In ways more expansive than traditional conceptions, the learning health care system ethics framework also imposes an affirmative obligation to direct learning activities toward aggressive efforts to reduce or eliminate unfair or unacceptable inequalities in the evidence base available for clinical decision-making, in health care outcomes, and in the respectfulness with which health care is delivered. For example, it is widely acknowledged that pregnant women often respond to medications differently than other adults, but the health needs of pregnant women are rarely the focus of clinical investigation because of concerns about the impact of the medications on the fetus. A learning health care system is well positioned to identify—and should mount—ethically acceptable learning activities to address what some have identified as unjust paucity of evidence about the management of chronic illness in pregnant women.
Learning activities also should target disparities in clinical outcomes associated with widening educational differences in adult mortality from such health conditions as lung cancer and heart disease. Similarly, learning activities should find strategies to reduce the disrespectful ways in which patients in sickle-cell crisis are sometimes treated when they seek pain relief in emergency rooms. Unlike other patients presenting in severe pain, these patients, who are largely young African Americans and thus subject to unjust racial stereotyping, are often treated with suspicion by clinical staff, who view them not as people suffering from a dreadful disease but as drug users hoping to manipulate the system in search of opiates.
Although reasonable people often disagree about precisely which inequalities are unjust and for what reasons, the narrowing of inequalities and the elimination of discrimination in care between minority and majority patients, economically impoverished and economically secure patients, and poorly educated and well-educated patients is a national priority in the United States and in many other countries. The learning health care ethics framework requires that learning activities be assessed to determine whether they perpetuate or exacerbate unjust inequalities and to determine whether they can be structured to advance the goal of reducing or eliminating inequalities and discrimination in health care. This role has not traditionally been at the forefront of the list of obligations of health care institutions, where these problems of unjust inequalities have been widely overlooked.
6) The obligation to conduct continuous learning activities that improve the quality of clinical care and health care systems. The third obligation of our framework—to provide each patient optimal clinical care—has been linked to clinical ethics requirements that clinicians stay current in their knowledge and their skills. Until recently, there has been little discussion of the need to augment this obligation with an affirmative responsibility on the part of clinicians to contribute to that knowledge base. This sixth obligation makes contribution to learning morally obligatory. It also extends its reach beyond health care professionals to institutions, payers, and purchasers of health care. We envision an unprecedented transformation of responsibilities in a learning health care system that applies to physicians in private practice, pharmaceutical companies, private hospitals, and so on. Because health care professionals, officials of health care institutions, and purchasers of health care have unique access to and control over clinical care and health information, they are uniquely positioned to seek, conduct, and contribute to learning activities that can advance health care quality, economic viability, and a just health care system. No other individuals, professionals, or institutions in society have such access or control.
The learning health care system ethics framework makes this sixth obligation foundational in the structuring of health professions and health care institutions. The obligation requires that every practitioner and institution accept a responsibility to feed information into the system that increases our knowledge. Each learning activity to be conducted within the system must be individually assessed for the extent to which it holds out the prospect of contributing to the improvement of health care services and systems. This assessment should include an evaluation of the soundness of the learning activity's objectives, design, and plans for implementation or dissemination. Learning activities today may improve only the specific health care settings in which a learning activity takes place, with only some activities and new information being transportable to a wider body of health care institutions. This current limitation will gradually be transformed into a vast array of interconnected learning activities.
7) The obligation of patients to contribute to the common purpose of improving the quality and value of clinical care and the health care system. Traditional codes, declarations, and government reports in research ethics and clinical ethics have never emphasized obligations of patients to contribute to knowledge as research subjects. These traditional presumptions need to change. Just as health professionals and organizations have an obligation to learn, patients have an obligation to contribute to, participate in, and otherwise facilitate learning.
This obligation is justified by what we call a norm of common purpose. This norm of common purpose is similar to what John Rawls calls the principle of the common good, a principle presiding over matters that affect the interests of everyone. The common interest of members of a society in the health care system is that it be positioned to provide each person in the society with quality health care at a cost compatible with individual and societal economic well-being. We also have a common interest in supporting just institutions, including activities that reduce the unjust inequalities that were mentioned in obligation 5.
Securing these common interests is a shared social purpose that we cannot as individuals achieve. Our goals cannot be reached efficiently without near-universal participation in learning activities, through which patients benefit from the past contributions of other patients whose information has helped advance knowledge and improve care. Patients cannot discharge this obligation merely by paying a fee for the health care service they receive or by contributing to society through taxation or charitable contributions. No amount of money paid for health care services substitutes for direct participation in and contribution to learning activities. The knowledge necessary to secure a high-quality and just health care system cannot be obtained from information limited to a bounded number of patients at discrete points in time. A learning health care system must have continuous access to information about as many patients as possible to be efficient, affordable, fair, and of highest quality.
A related justification for obligation 7 is the reciprocal obligation that arises among strangers who occupy the role of patient over time. The philosopher David Hume expresses the general form of this duty of beneficence as follows: “All our obligations to do good to society seem to imply something reciprocal. I receive the benefits of society, and therefore ought to promote its interest.” In our framework, the discharge of obligations of reciprocity occurs through an established practice of making an appropriate and proportional return—returning benefit with proportional benefit, with all alike sharing, as a matter of moral obligation, the burdens necessary to produce these benefits.
In proposing that patients have an obligation to contribute to the common purpose of improving health care through learning, we are not proposing that patients have an affirmative moral obligation to participate in all learning activities regardless of the degree of additional risk or burden they may impose. Different learning activities will have differential effects on the rights and interests of patients and therefore will have different implications for patients’ obligations to participate in them. The first four obligations of this framework are intended to protect these rights and interests in the assessment of the overall ethical acceptability of particular learning activities. For example, some learning activities, such as randomized clinical trials of investigational new devices, would not be obligatory because of the potential to fail in meeting obligations 1 through 4. If this type of learning activity is otherwise ethically acceptable, however, then patients might choose to participate in it, though they should be informed and understand that they are under no obligation to do so. By contrast, other learning activities—such as participation in a registry, reviews of deidentified medical records, and being interviewed by health care staff to better improve the patient care experience—are likely to be instances in which patients do have an obligation to participate, assuming that the activities have a reasonable likelihood of improving health care quality and that appropriate data security protections are in place. These conditions are probably met currently in integrated health care systems that have invested in secure electronic health records and have mechanisms in place to adjust local norms of care in direct response to the results of learning activities.
The obligation of patients to contribute to health care learning is compatible with duties to inform patients about learning activities and to solicit their express consent for some learning activities, as appropriate. The first obligation in our framework requires, as a matter of respect, that health care institutions have numerous and varied policies and practices in place to inform patients about the institution's commitment to learning and about the specific learning activities that are currently underway and how they are being conducted. Activities such as randomized, controlled trials of an investigational new device could proceed only with patients’ express, affirmative agreement, obtained through a valid informed consent process.
As with the first obligation above, the obligation to contribute to learning can extend to family members, loved ones, and surrogates of patients, particularly when patients are children or adults whose competence is permanently or temporarily compromised. Whenever loved ones are intimately involved in the care of the patient, they may have information or insight critical to learning about and improving health care interventions and processes. For patients lacking cognitive or decisional capacities, loved ones and other surrogates can play a vital role in the ethics framework by representing and protecting patients’ interests of during learning activities.
It has several times been asked in the bioethics literature whether there is a duty to serve as a research subject. Some have answered the question affirmatively. Their reasons have been premised on a conception of duties to participate reciprocally in a system that produces public goods from which we all benefit and in which no one should, in this respect, be a free rider. In certain circumstances, even compulsory participation has been proposed. Although similar justice-oriented grounds are central in some of our arguments, we are proposing a more pervasive level of participation, and participation of a different type, than previous writers have recommended. We make it a condition of participating in a learning health care system as a patient that one also participates in the learning activities that are integrated, on an ongoing basis, with the clinical care patients receive. The scope of participation that we are proposing is far more extensive and notably different from than that proposed by previous writers on duties to participate in research.


'Rethinking Privacy' by William H. Simon in 20 October 2014 Boston Review comments 
Anxiety about surveillance and data mining has led many to embrace implausibly expansive and rigid conceptions of privacy. The premises of some current privacy arguments do not fit well with the broader political commitments of those who make them. In particular, liberals seem to have lost touch with the reservations about privacy expressed in the social criticism of some decades ago. They seem unable to imagine that preoccupation with privacy might amount to a “pursuit of loneliness” or how “eyes on the street” might have reassuring connotations. Without denying the importance of the effort to define and secure privacy values, I want to catalogue and push back against some key rhetorical tropes that distort current discussion and practice.
One problem is that privacy defenses often imply a degree of pessimism about the state inconsistent with the strong general public regulatory and social-welfare roles that many defenders favor. Another is a sentimental disposition toward past convention that obscures the potential contributions of new technologies to both order and justice. And a third is a narrow conception of personality that exalts extreme individual control over information at the expense of sharing and sociability.
In urban areas, most people’s activity outdoors and in the common spaces of buildings is recorded most of the time. Surveillance cameras are everywhere. When people move around, their paths are registered on building access cards or subway fare cards or automobile toll devices. Their telephone and email communications, Internet searches, and movements are tracked by telephone companies and other intermediaries. All their credit card transactions—which, for many people, means nearly all of their transactions—are documented by time, place, and substance. The health system extracts and records detailed information about their psychic and bodily functions. Anyone arrested, and many who fear arrest, in the criminal justice system typically surrender a variety of personal information and often have to submit to ongoing monitoring. Even within the home, water and energy consumption are monitored, and some people choose to install cameras to monitor children or protect against burglars.
To many people, this society looks like the panopticon—a prison designed as a circular tower so that the inmates can be easily observed by a centrally located authority figure. Jeremy Bentham originated the panopticon idea as a low-cost form of subjugation for convicted criminals. Michel Foucault adopted it as a metaphor for what he regarded as the insidiously pervasive forms of social control in contemporary society. To him, schools, hospitals, workplaces, government agencies all engaged in repressive forms of surveillance analogous to the panopticon.
In the United States, paranoid political style has been associated traditionally with the right and the less educated. But Foucault helped make it attractive to liberal intellectuals. His contribution was largely a matter of style. Foucault was the most moralistic of social theorists, but he purported to disdain morality (“normativity”) and refused to acknowledge, much less defend, the moral implications of his arguments. He gave intellectual respectability to the three principal tropes of the paranoid style.
First, there is the idea of guilt by association. The resemblance between some feature of a strikingly cruel or crackpot regime of the past or in fiction—especially in Nineteen Eighty-Four—and a more ambiguous contemporary one is emphasized in order to condemn the latter. Thus, the elaborate individualized calibration of tortures in eighteenth- and nineteenth-century penology is used to make us feel uncomfortable about the graduated responses to noncompliance in contemporary drug treatment courts. George Orwell’s image of television cameras transmitting images from inside the home to the political police is used to induce anxiety about devices that monitor electricity usage so that the hot water tank will re-heat during off-peak hours.
The paranoid political style has been associated with the right. Foucault brought it to liberals.
The second trope of the paranoid style is the portrayal of virtually all tacit social pressure as insidious. What people experience as voluntary choice is substantially conditioned by unconscious internalized dispositions to conform to norms, and a key mechanism of such conformity is the actual, imagined, or anticipated gaze of others. Almost everyone who thinks about it recognizes that such pressures are potentially benign, but people differ in their rhetorical predispositions toward them. The individualist streak in American culture tends to exalt individual choice in a way that makes social influence suspect.
Foucault disdained individualism, but he introduced a conception of power that was so vague and sinister that it could be applied to make almost any social force seem creepy. When Neil Richards writes in the Harvard Law Review that surveillance “affects the power dynamic between the watcher and the watched, giving the watcher greater power to influence or direct the subject of surveillance,” he is channeling Foucault. So is Julie Cohen, when she writes in the Stanford Law Review: “Pervasive monitoring of every first move or false start will, at the margin, incline choices toward the bland and the mainstream.”
We have come a far cry from Jane Jacobs’s idea of “eyes on the street” as the critical foundation of urban vibrancy. For Jacobs, the experience of being observed by diverse strangers induces not anxiety or timidity but an empowering sense of security and stimulation. It makes people willing to go out into new situations and to experiment with new behaviors. Eyes-on-the-street implies a tacit social pact that people will intervene to protect each other’s safety but that they will refrain from judging their peers’ non-dangerous behavior. Electronic surveillance is not precisely the same thing as Jacobean eyes-on-the-street, but it does offer the combination of potentially benign intervention and the absence of censorious judgment that Jacobs saw as conducive to autonomy.
The third trope of the paranoid style is the slippery slope argument. The idea is that an innocuous step in a feared direction will inexorably lead to further steps that end in catastrophe. As The Music Man (1962) puts it in explaining why a pool table will lead to moral collapse in River City, Iowa, “medicinal wine from a teaspoon, then beer from a bottle.” In this spirit, Daniel Solove in Nothing to Hide (2011) explains why broad surveillance is a threat even when limited to detection of unlawful activity. First, surveillance will sometimes lead to mistaken conclusions that will harm innocent people. Second, since “everyone violates the law sometimes” (think of moderate speeding on the highway), surveillance will lead to over-enforcement of low-stakes laws (presumably by lowering the costs of enforcement), or perhaps the use of threats of enforcement of minor misconduct to force people to give up rights (as for example, where police threaten to bring unrelated charges in order to induce a witness or co-conspirator to cooperate in the prosecution of another). And finally, even if we authorize broad surveillance for legitimate purposes, officials will use the authorization as an excuse to extend their activities in illegitimate ways.
Yet, slippery slope arguments can be made against virtually any kind of law enforcement. Most law enforcement infringes privacy. (“Murder is the most private act a man can commit,” William Faulkner wrote.) And most law enforcement powers have the potential for abuse. What we can reasonably ask is, first, that the practices are calibrated effectively to identify wrongdoers; second, that the burden they put on law-abiding people is fairly distributed; and third, that officials are accountable for the lawfulness of their conduct both in designing and in implementing the practices.
The capacity of broad-based electronic surveillance—the sort that collects data on large or indeterminate numbers of people who are not identified in advance—to satisfy these conditions is in some respects higher than that of the more targeted and reactive approaches that privacy advocates prefer. Such approaches rely heavily on personal observation by police and witnesses, reports by informants of self-inculpatory statements by suspects, and confessions. But these strategies have their shortcomings. Scholars in recent years have emphasized the fallibility of human memory and observation. Witness reports of conduct by strangers are often mistaken and influenced by investigators. Those who report self-inculpatory statements often have dubious motivations, and, with surprising frequency, even confessions prove unreliable.
Inferences from broad-based electronic surveillance are not infallible, but they are often more reliable than reports of personal observation, and they can be less intrusive. Computers programmed to identify and photograph red light violations make much more reliable determinations of the violation than a police officer relying on his own observation. And they are less intrusive: the camera can be set to record only when there’s a violation, whereas a police officer would observe and remember much more. Yet many civil libertarians, including some ACLU affiliates, oppose them. One of their key arguments is that the systems generate tickets in many situations where the driver might have had an excuse for not stopping in time that would have persuaded a police officer to dismiss the violation. (The case for excuse can still be made in court, but a court appearance would cost more than the ticket for many.) The argument is not frivolous, but it is a curiosity typical of this field that people concerned about the abuse of state power often oppose new technology in favor of procedures that give officials more discretion.
Broad-based surveillance distributes its burdens widely, which may be fairer. ...
Simon states
The substantive conception to which the advocates are most drawn is the notion of a right to control information about one’s self. James Whitman argues in the Yale Law Journal that this conception evolved through the democratization of aristocratic values. The aristocrat’s sense of self-worth and dignity depended on respect from peers and deference from subordinates, and both were a function of his public image. Image was thus treated as a kind of personal property. Whitman says this view continues to influence the European middle class in the age of equal citizenship. As the ideal was democratized, it came to be seen as a foundation for self-expression and individual development.
European law evolved to express this cultural change. Whitman showed that the idea of a right to control one’s public image underlies French and German privacy law, and it appears to animate European Union privacy law, which advocates admire for its stronger protections than those of U.S. law. For example, French and German law impose stricter limits on credit reporting and the use of consumer data than U.S. law. The EU directive mandates that individuals be given notice of the data collection practices of those with whom they deal and rights to correct erroneous data about them. More controversially, a proposed revision prohibits decisions based “solely on automatic data processing” for various purposes, including employment and credit. By contrast, U.S. law tends to be less protective and less general. Its privacy law tends to be sector-based, with distinctive regulations for health care, education, law enforcement, and other fields.
Whitman associates the weaker influence of the idea of personal-image control in the United States with the stronger influence here of competing libertarian notions that broadly protect speech and publication. Expansive notions of privacy require a more active state to enforce them. This was recently illustrated by a decision of the EU Court of Justice holding that the “right to be forgotten” may require removal from an Internet website of true but “no longer relevant” information about the plaintiff’s default on a debt. The prospect of courts reviewing Internet data to determine when personal information is “no longer relevant” has emphasized the potential conflict between privacy and other civil rights.
But reservations about the broad conception of dignity Whitman describes go deeper. There is a powerful moral objection to it grounded in ideals of sociability. Even in Europe, during the period in which the ideal was democratized, there was a prominent critique of it. A character in a nineteenth-century English novel preoccupied with controlling his public image is likely to be a charlatan or a loser. Not for nothing is Sherlock Holmes the most prominent hero in the canon. His talents are devoted to invading the privacy of those who would use their image-management rights to exploit others. And as he teaches that the fa├žade of self-presentation can be penetrated by observation and analysis of such matters as frayed cuffs, scratches on a watch, or a halting gait, he sets up as a competing value the capacity to know and deal with people on our terms as well as theirs.
He goes on to argue that privacy advocates
object most strongly to data collection designed to yield specific conclusions about the individual, but they persist even when anonymized data is used to assess general patterns. Since anonymization is never perfectly secure, it exposes people to risk. Moreover, the privacy norm sometimes shades into a property norm. It turns out that some people carry around economically valuable information in their bodies—for example, the DNA code for an enzyme with therapeutic potential—and that information about everyone’s conduct and physical condition can, when aggregated, be sold for substantial sums. For some, the extraction of such information without consent looks like expropriation of property. They would like to see explicit extension of property rights to require consent and compensation for use of personal information. In Who Owns the Future? (2014) Jaron Lanier develops this line of thought, suggesting that we create institutions that enable individuals to monetize their personal data—individual accounts would be credited every time a piece of data is used.
In addressing such issues, a lot depends on how we understand consent. Consent can mean clicking on an “I agree to the terms” button that refers to a mass of small-print boilerplate that hardly anyone can be expected to read. Or it may mean simply the failure to find and click on the button that says “I refuse consent.” The advocates want something more demanding. Moreover, they don’t want the cost of the decision to be too high. If insisting on privacy means exclusion from Google’s search tool or Amazon’s retail service, many proponents would view that as unfair. If Google or Amazon charged a price for not mining your data, many would call it extortion—like asking someone to pay in order not to be assaulted. So the idea of “consent” touches on deep and unresolved issues of entitlement to information.
Such issues have arisen in connection with employer-sponsored wellness programs that encourage employees to get checkups that include a “health risk assessment” designed to generate prophylactic advice. At Pennsylvania State University such a program recently provoked a wave of privacy protests, apparently directed to parts of a questionnaire that addressed marital and job-related problems, among other things. The protesters also objected that the questionnaires would be analyzed by an outside consultant, even though the information would be subject to the confidentiality provisions of the federal Health Insurance Portability and Accountability Act. The University allowed people to refuse to participate subject to a $100 per month surcharge.
The strong privacy position has disturbing implications for medical research.
No doubt such programs may be unnecessarily intrusive and may not safeguard information adequately, but the objections made in this case do not appear to have depended on such concerns. The $100 surcharge was based on an estimate of the average additional health costs attributable to refusal to participate. The premise of the protests seems to have been that the interest in not disclosing this information even under substantial safeguards is important enough that those who disclose should be asked to subsidize those who do not. ...
The reciprocity theme occasionally surfaces in privacy discussion. Lanier’s proposal to monetize data arises from a sense of injustice about the relative rewards to, on the one hand, data-mining entrepreneurs and high-tech knowledge workers, and on the other, the masses of people whose principal material endowment may be their control over their own personal information. In the health sector, doctors have been caught trying to derive patent rights from information embedded in their patients’ DNA without informing the patients.
But privacy advocates rarely acknowledge the possibility that average reciprocity of advantage will obviate over time the need for individual compensation in some areas. Might it be the case, as with airplanes and zoning laws, that people will do better if individual data (anonymized where appropriate) is made freely available except where risks to individuals are unreasonably high or gains or losses are detectably concentrated? There will always be a risk that some data will be disclosed in harmful ways, such as when personal data leaks out because of ineffective anonymization. However, the key question is whether we will make a social judgment about what level of risk is reasonable or whether we shall accord property rights that allow each individual to make her own risk calculus with respect to her own data.
The latter approach would likely preclude valuable practices in ways analogous to what would happen if airlines had to get owners’ consent for passing over private property. Moreover, strengthening rights in personal data could exacerbate, rather than mitigate, distributive fairness concerns. While it is surely unfair for doctors to earn large capital gains from DNA extracted without consent, wouldn’t it also be unfair (admittedly in a lower key) for Freedom Box users to benefit from the Center for Disease Control’s mining of Google searches for new viruses while denying access to their own Internet searches?
The strong privacy position has disturbing implications for medical research. In the past, medicine has strongly separated research from treatment. Research is paradigmatically associated with randomized controlled clinical trials. Treatment experience has been considered less useful to research because treatment records do not describe the condition of the patient or the nature of the intervention with enough specificity to permit rigorous comparisons. But information technology is removing this limitation, and, as the capacity to analyze treatment information rigorously increases, the quality of research could improve as its cost lowers.
However, this development is in some tension with expansive conceptions of privacy. A prominent group of bioethicists led by Ruth Faden of Johns Hopkins has recently argued that the emerging “learning health care system” will require a moral framework that “depart[s] in important respects from contemporary conceptions of clinical and research ethics.” A key component of the framework is a newly recognized obligation on the part of patients to contribute to medical research. The obligation involves a duty to permit disclosure and use of anonymized treatment data for research purposes and perhaps also to undergo some unburdensome and non-invasive examination and testing required for research but not for individual treatment. (Anonymization is unlikely to be effective with data made generally available online, but regimes involving selective and monitored disclosure have proven reliable.) The group justifies its proposal in terms of reciprocity values. Since everyone has a good prospect of benefiting from research, refusing to contribute to it is unfair free riding.
Of course, the reciprocity idea assumes that researchers will make the fruits of the research derived from patient information freely available. People would be reluctant to agree to make a gift of their information if researchers could use it to make themselves rich. Effective constraints on such conduct should be feasible. Much medical research, including much of the highest value research, has been and continues to be done by salaried employees of charitable corporations.
Applied in this context, Lanier’s proposal to monetize individual data looks unattractive. There is a danger that a lot of valuable information would be withheld or that the costs of negotiating for it would divert a lot of resources from research and treatment. It is not clear what the resulting redistributive effects would be. Perhaps they would approximate a lottery in which the only winners would be a small number of people with little in common except that they happened to possess personal information that had high research value at the moment. At a point where we do not know who the winners will be, we would all be better off giving up our chances for a big payoff in return for assurance that we will have free access to valuable information. We can do this by treating the information as part of a common pool.

Chills and soft power

'The Conforming Effect: First Amendment Implications of Surveillance, Beyond Chilling Speech' by Margot E. Kaminski and Shane Witnov in (2015) 49 University of Richmond Law Review comments
First Amendment jurisprudence is wary not only of direct bans on speech, but of the chilling effect. A growing number of scholars have suggested that chilling arises from more than just a threat of overbroad enforcement — surveillance has a chilling effect on both speech and intellectual inquiries. Surveillance of intellectual habits, these scholars suggest, implicates First Amendment values. However, courts and legislatures have been divided in their understanding of the extent to which surveillance chills speech and thus causes First Amendment harms.
This article brings First Amendment theory into conversation with social psychology to show that not only is there empirical support for the idea that surveillance chills speech, but surveillance has additional consequences that implicate multiple theories of the First Amendment. We call these consequences “the conforming effect.” Surveillance causes individuals to conform their behavior to perceived group norms, even when they are unaware that they are conforming. Under multiple theories of the First Amendment — the marketplace of ideas, democratic self-governance, autonomy theory, and cultural democracy — these studies suggest that surveillance’s effects on speech are broad. Courts and legislatures should keep these effects in mind.
'Who Runs the International System? Power and the Staffing of the United Nations Secretariat' (Harvard Business School BGIE Unit Working Paper No. 15-018) by Paul Novosad and Eric Werker comments 
National governments frequently pull strings to get their citizens appointed to senior positions in international institutions. We examine, over a 60 year period, the nationalities of the most senior positions in the United Nations Secretariat, ostensibly the world's most representative international institution. The results indicate which nations are successful in this zero-sum game, and what national characteristics correlate with power in international institutions. The most overrepresented countries are small, rich democracies like the Nordic countries. Statistically, democracy, investment in diplomacy, and economic/military power are predictors of senior positions ― even after controlling for the U.N. staffing mandate of competence and integrity. National control over the United Nations is remarkably sticky; however the influence of the United States has diminished as U.S. ideology has shifted away from its early allies. In spite of the decline in U.S. influence, the Secretariat remains pro-American relative to the world at large.
'Human Rights, Southern Voices, and ‘Traditional Values’ at the United Nations' (University of Michigan Public Law Research Paper No. 419) by Christopher McCrudden comments 
The ‘traditional values’ resolutions, passed by the UN Human Rights Council in 2009, 2011, and 2012, were the result of a highly controversial initiative spearheaded by Russia aiming to identify a set of traditional values that underpin international human rights law. This paper considers several critical questions that arise from these Resolutions. Do these ‘traditional values’ indeed underpin human rights? Why are traditional values valuable from the point of view of adherents to that tradition? Should the larger society take into account the fact that a practice is based on tradition in deciding whether or not to override it in the name of human rights? Put more technically, in what does the normativity of tradition lie, for adherents and non-adherents of that tradition? These are the questions that this essay explores, in the context of the recent debates over the scope and meaning of human rights stimulated by the Human Rights Council Resolutions. Much of the support for the Resolutions comes from what can broadly be called the global South. In several books, particularly “Human Rights, Southern Voices”, and “General Jurisprudence: Understanding Law from a Global Perspective” William Twining has explored the question of how to reconcile human rights norms and belief systems embedded in the global South (including ‘traditional values’), and in doing so has drawn particular attention to intellectuals from that part of the world, in particular Francis Deng, Yash Ghai, Abdullahi An-Na’im, and Upendra Baxi. I suggest that those concerned to recognize the legitimate concerns that significant sections of the global South have about the human rights project, concerns reflected in the ‘traditional values’ Resolutions would do well to pay more attention to the ‘Southern voices’ on whom Twining rightly focuses attention.

Surveillance and Snowden

'Lawful Illegality: What Snowden Has Taught Us About the Legal Infrastructure of the Surveillance State' by Lisa M. Austin comments
The Snowden revelations have revealed to us, with impressive documentation, the technical infrastructure of contemporary state surveillance. What is less obvious, but of great importance, is the revelation of the legal infrastructure of this surveillance. We need to stop thinking that the issue is illegal activity on the part of our national security agencies and instead start from the proposition that our national security agencies do understand themselves to be acting within the law. The problem, I argue, is that this legal infrastructure is best understood as one of “lawful illegality.”
Unlike other discussions of the rule of law and terrorism, which have focused on the nature of emergencies and the perceived need to preserve executive discretion to respond to exceptional circumstances, I argue that state surveillance raises a very different rule of law question. Surveillance is a mode of rational social ordering and the question is whether it is in conflict with the deepest commitments of law as a mode of rational social ordering.
I claim that the issues of secrecy, complexity, and jurisdiction work together to create “lawful” paths for state surveillance for national security purposes that are nevertheless in deep tension with a general commitment that this surveillance be subject to the oversight and accountability demanded by the rule of law. Throughout, I illustrate these issues with a set of examples largely taken from the Snowden revelations, with a Canadian perspective. These examples are not meant to provide an exhaustive overview of the issues but to highlight the importance of attending to these larger questions of legality if we are going to move forward and design a better system of oversight.
'The Vengeful State: Responses by Democratic Governments to Unauthorized Public Disclosure of National Security Information' (RegNet Research Paper No. 2014/42) by Peter Grabosky comments 
Recent disclosures by Bradley (now Chelsea) Manning and Edward Snowden have rekindled interest in the tension between state secrecy and the public’s right to know. In authoritarian political systems this is a non-issue, as there is neither pretence on the part of the state, nor expectation on the part of its citizens, that national security information should become the subject of public debate. By contrast, the difficulties faced by liberal democracies are real. While hardly anyone would suggest that national security should be managed in an environment of complete transparency, there are many who suggest that citizens of a democracy are entitled to know about acts of questionable propriety that have been committed by their government on their behalf. And prospectively, it is important for citizens to be party to informed discussion about whether the policies that may lead to these acts are misguided or not. This chapter addresses responses of democratic states to the unauthorised public disclosure of national security information. It is not concerned with espionage, the clandestine provision of one state’s confidential information to another. The analysis is based on five prominent cases, each occurring in one of five liberal democracies: France, Britain, Switzerland, Israel and the United States. Each case will examine the disclosure in question, whether the information revealed was indicative of illegality on the part of the state, and the media through which they were disclosed. It will then discuss the mobilization of law by the aggrieved government, including whether the state violated the law in the course of its response. The concluding section of this chapter will look back at the original disclosures and will address two fundamental questions: Was the information appropriately classified in the first place? What harm to national security resulted from the various disclosures?
'National Security Leaks and Constitutional Duty' by Alexander J. Kasner in (2015) 67(1) Stanford Law Review comments 
Edward Snowden’s disclosure of national security information is the newest chapter in the United States’ long and complicated history with government leaks. Such disclosures can help to root out illegal and unconstitutional behavior that might otherwise evade scrutiny. And yet, unlike the press, government leakers are often assumed to have no claim to constitutional protections. National security leaks are treated as an opportunity to discuss the constitutionality of underlying government conduct or the balance of federal powers, but there is little reflection on the leaker who made the discussion possible.
This Note addresses that oversight by focusing our attention on the Constitution’s treatment of government officials who choose to leak. In so doing, it asks us to consider the duty of executive officers to affirmatively support the Constitution, itself required by the very text of the Article VI Oath Clause. This Note presents one of the first concentrated studies of the Article VI Oath Clause, drawing upon its text, structure, and history to draw out the obligation it places on executive officers to resist unconstitutional government behavior. It also explains how recent developments in national security, secret keeping, and the doctrine of standing render the Article VI duty even more critical. At the same time, this Note departs from other literature by recognizing that unfettered disclosures of broad swaths of information are constitutionally indefensible. I contend that the Article VI duty should generally be limited to Article II executive officers, that it endorses some but not all affirmative disclosures, and that it anticipates constitutional interpretation as a shared enterprise between the judiciary and those officers. This Note concludes by discussing the implications of the duty, both suggesting potential legal and policy solutions and reflecting on our assumptions about constitutional interpretation and enforcement.


'Piracy by Approval Social Norms, Deterrence, and Copyright Compliance in China' (UC Irvine School of Law Research Paper No. 2015-03) by Benjamin Van Rooij, Yunmei Wu and Adam Dupree Fine comments 
Using a sample of 862 colleges students from China this study seeks to understand how perceived enforcement, behavior and attitudes of others, or the students’ own characteristics affect their inclination to illegally download software. The survey results show a strong influence of sanction severity, descriptive and injunctive social norms, less effect of apprehension probability, and no effect of the students’ rule conditionality. Most importantly, it finds that when social norms support piracy, deterrence is blunted. These findings have important implications for enforcement practice, showing how the prevalent Chinese mode of campaign driven deterrence-based enforcement will not work as long as social norms do not change first. Theoretically the study shows how key assumptions in the existing Western literature on enforcement and compliance may not hold true in China. Thus the study presents a warning that cross-national replication outside of Western contexts is an urgent necessity.

01 February 2015


The US President - echoing the UK 100,000 Genomes Project - has announced the large-scale Precision Medicine Initiative. It will draw on data from a million people and will involve National Institutes of Health (NIH), together with the Food and Drug Administration (FDA), and the Office of the National Coordinator for Health Information Technology (ONC) .

The announcement is another inflection point in genomics research.

The Initiative encompasses -
  • $130 million to NIH for development of a voluntary national research cohort of a million or more volunteers to propel our understanding of health and disease and set the foundation for a new way of doing research through engaged participants and open, responsible data sharing. 
  • $70 million to the National Cancer Institute (NCI), part of NIH, to scale up efforts to identify genomic drivers in cancer and apply that knowledge in the development of more effective approaches to cancer treatment. 
  • $10 million to FDA to acquire additional expertise and advance the development of high quality, curated databases to support the regulatory structure needed to advance innovation in precision medicine and protect public health. 
  •  $5 million to ONC to support the development of interoperability standards and requirements that address privacy and enable secure exchange of data across systems.
The expectation is that the Initiative will involve
  •  More and better treatments for cancer: NCI will accelerate the design and testing of effective, tailored treatments for cancer by expanding genetically based clinical cancer trials, exploring fundamental aspects of cancer biology, and establishing a national “cancer knowledge network” that will generate and share new knowledge to fuel scientific discovery and guide treatment decisions. 
  • Creation of a voluntary national research cohort: NIH, in collaboration with other agencies and stakeholders, will launch a national, patient-powered research cohort of one million or more Americans who volunteer to participate in research. Participants will be involved in the design of the Initiative and will have the opportunity to contribute diverse sources of data—including medical records; profiles of the patient’s genes, metabolites (chemical makeup), and microorganisms in and on the body; environmental and lifestyle data; patient-generated information; and personal device and sensor data.   ...
  • Public-private partnerships: The Obama Administration will forge strong partnerships with existing research cohorts, patient groups, and the private sector to develop the infrastructure that will be needed to expand cancer genomics, and to launch a voluntary million-person cohort. The Administration will call on academic medical centers, researchers, foundations, privacy experts, medical ethicists, and medical product innovators to lay the foundation for this effort, including developing new approaches to patient participation and empowerment. The Administration will carefully consider and develop an approach to precision medicine, including appropriate regulatory frameworks, that ensures consumers have access to their own health data – and to the applications and services that can safely and accurately analyze it – so that in addition to treating disease, we can empower individuals and families to invest in and manage their health.
The White House media release notes a "Commitment to protecting privacy"
  • To ensure from the start that this Initiative adheres to rigorous privacy protections, the White House will launch a multi-stakeholder process with HHS and other Federal agencies to solicit input from patient groups, bioethicists, privacy, and civil liberties advocates, technologists, and other experts in order to identify and address any legal and technical issues related to the privacy and security of data in the context of precision medicine. 
  • Regulatory modernization: The Initiative will include reviewing the current regulatory landscape to determine whether changes are needed to support the development of this new research and care model, including its critical privacy and participant protection framework. As part of this effort, the FDA will develop a new approach for evaluating Next Generation Sequencing technologies — tests that rapidly sequence large segments of a person’s DNA, or even their entire genome. The new approach will facilitate the generation of knowledge about which genetic changes are important to patient care and foster innovation in genetic sequencing technology, while ensuring that the tests are accurate and reliable.

Metrics of Pain and Damages

'Estimating Pain and Suffering Damages - Paths are Many, Loss is One' by Ronen Avraham in Oxford Handbook of Law and Economics (Forthcoming) comments -
Opponents of pain and suffering damages argue that, unlike pecuniary damages, pain and suffering damages are hard to quantify accurately. They argue that victims exaggerate their losses to receive higher damage awards, so that awarding pain and suffering damages may frustrate the function of tort law by compensating the victims too highly and arbitrarily. Another argument against pain and suffering damages is that the difficulty in objective measurement leaves the potential for enormous variance in awards at the discretion of individual judges and juries. This individual discretion may create a lack of horizontal equity and thus impede consistency among awards for like victims.
In a recent paper I argued that from a law and economics perspective pain and suffering damages should be fully compensated and should receive the same “respect” that economic damages receive (Avraham, 2015). I provided several arguments for that view. In this chapter I survey a number of solutions discussed in the literature on how to simplify the estimation of pain and suffering damages to cut administrative costs. My goal is to demonstrate the feasibility of the task of estimating the loss more than to recommend any specific path to it.
Avraham argues -
When a person is injured, tort law recognizes several types of losses: the victims’ economic loss (actual medical costs and diminished earning capacity) and non-economic loss, which serves as a catch-all for many losses, such as pain-andsuffering, mental anguish, emotional distress, and loss of enjoyment of life. Historically, the common law recognized pain and suffering losses only in intentional torts. In negligence claims, by contrast, the common law implicitly, and sometimes explicitly, expected the plaintiff to get over it. Over the years as courts have started to award pain and suffering damages in negligence cases, courts have struggled to clearly define and distinguish different aspects of these damages (Whaley, 1992).
One of the consequences of this struggle is the emergence of a confusing array of terms which are meant to elucidate the content and scope of pain and suffering damages. Courts refer, among other terms, to “mental anguish”, “emotional losses”, “emotional distress”, “loss of consortium”, “hedonic damages”, and “psychic damages” (Croley & Hanson, 1995). With so many different terms, it is no wonder that confusion has been rampant. For example, damages for loss of enjoyment of life, alternatively known as “hedonic damages,” are intended to compensate for the loss of quality of life (Schwartz, 2004). Some courts have had significant difficulties interpreting this term, and have even expressed doubts about “whether loss of enjoyment of life is compensable at all, and if so, whether it is part of pain and suffering, mental anguish, or physical impairment, or is a separate, independent category of damages.” Golden Eagle Archery, Inc. v. Jackson, 116 S.W.3d 757, 768 (Tex. 2003); (Schwartz and Silverman, 2004).
While most jurisdictions treat loss of enjoyment of life, or hedonic loss, as a part of pain and suffering, other jurisdictions allow recovery of hedonic damages as a separate category of damages. In yet other states there is either no clear ruling or hedonic damages are allowed in some instances and not in others (Schwartz and Silverman, 2004).
With respect to their content, some courts have indicated that these awards compensate for “the inability to perform activities which had given pleasure to this particular plaintiff.” McGarry v. Horlacher, 775 N.E.2d 865, 877-78 (Ohio Ct. App. 2002). Other courts have treated hedonic damages not as affirmative distress or suffering, but forgone gains, such as being unable to engage in activities that the victim valued, such as athletics or sex. Day v. Ouachita Parish School Bd., 823 So. 2d 1039, 1044 (La ct. App. 2002); Allen v. Wal-Mart Stores, Inc., 241 F.3d 1293, 1297 (10th Cir. 2001); Varnell v. Louisiana Tech University, 709 So. 2d 890, 896 (La. Ct. App. 1998). Some court have anchored them in the loss of something recognizable such as a limb or mental capacity. Pierce v. N.Y. Cent.R.R.Co., 409 F.2d 1392 (Mich. 1969); Matos v. Clarendon Nat. Ins. Co., 808 So. 2d 841, 849 (La. Ct. App. 2002); Kirk v. Wash. State Univ., 746 P.2d 285, 292 (Wash. 1987); Nemmers v. United States, 681 F. supp 567 (C.D. Ill. 1988).
With so much inconsistency and indeterminacy, one should not wonder that pain and suffering damages are under constant attack and are a major component of every tort reform.
Opponents of pain and suffering damages argue that, unlike pecuniary damages, pain and suffering damages are hard to quantify accurately (King, 2004). They argue that victims exaggerate their losses to receive higher damage awards, so that awarding pain and suffering damages may frustrate the function of tort law by compensating the victims too highly and arbitrarily.
Another argument against pain and suffering damages is that the difficulty in objective measurement leaves the potential for enormous variance in awards at the discretion of individual judges and juries (Diamond, 1998). This individual discretion may create a lack of horizontal equity and thus impede consistency among awards for like victims (Bovbjerg, 1989).
In a recent paper I argued that from a law and economics perspective pain and suffering damages should be fully compensated and should receive the same “respect” that economic damages receive (Avraham, 2015). I provided several arguments for that view.
First, I argued that the lack of horizontal equity might not represent a problem with damage calculations. Factfinders may treat like cases differently, but there is another possible explanation for heterogeneity in awards for injuries that, on the surface, appear to be “the same.” Judges and juries may be aware that there is great variation in how individuals subjectively experience pain and suffering (Chamallas & Wriggins, 2010). In other words, factfinders in individual cases are aware of facts that are not available to researchers afterward. Moreover, empirical evidence shows that observable seriousness of the injury is a reliable predictor of the size of award (Sloan & Hsieh, 1990; Vidmar, 1999; Diamond, 1998). Another indication that pain and suffering awards are not as wildly variant as some critics claim is that even though European countries have implemented rules to minimize horizontal inequity in damage awards, European pain and suffering awards are similar to those in the U.S. (Sugarman, 2005). Still, even if there is real horizontal inequity in pain and suffering awards, the conclusion that they should be abolished does not follow. Rather, the inequity merely indicates the need for a more determinate process for factfinders to follow. Just because damages are difficult to quantify does not mean they should be ignored. Tort damages have traditionally been understood to contemplate individualized pain and suffering, at least in intentional torts. The difficulty of quantification and the lack of horizontal equity it might cause does not justify setting them all at zero.
Second, pain and suffering damages are not the only kind that proves difficult to quantify. Economic damages are often equally difficult (Rabin, 1993). Lost wages and future medical expenses, for instance, have been drastically miscalculated by courts, showing that even these pecuniary losses are difficult to estimate precisely. Seffert v. Los Angeles Transit Lines, 364 P.2d 337 (Cal. 1961). There is no justification to single out for elimination pain and suffering damages from among all the difficult-to-quantify categories of damages.
Third, the mere fact that some plaintiffs may exaggerate their symptoms provides no justification to eliminate pain and suffering damages. Courts have developed methods of correcting for this possibility. They have been estimating pain and suffering losses in intentional tort cases for centuries. Fourth and perhaps most importantly, scientific developments in the field of neuroimaging are creating the possibility of understanding and even verifying both pain and some emotional conditions (Kolber, 2007). One recent study successfully used fMRI processes to identify specific neurologic signatures that identified pain sensation with very high accuracy levels (Wager, Atlas, Linquist, Roy, Woo & Kross, 2013). It is possible that science will soon be able to verify an accident victim’s subjective level of pain. Exaggeration may soon be impossible because judges and juries may have access to objective, scientific methods of quantifying pain and suffering as accurately as the quantification methods available for physical damages.
Already, depression can by objectively determined by neurobiological data. A summary of key literature in the area of Major Depressive Disorder (MDD) found that MDD is an “illness with significant neurobiological consequences involving structural, functional and molecular alterations in several areas of the brain” (Maletic, Robinson, Oakes, Lyengar, Ball & Russell, 2007). Similar strides are being made in the context of Post-Traumatic Stress Disorder (PTSD). The American Psychiatric Association has established guidelines for verifying the existence of PTSD. These include direct trauma, intrusion symptoms such as dreams or memories, avoidance symptoms, mood and cognition changes, and irritable behavior or startled responses (American Psychiatric Association, 2013). These symptoms must persist for longer than a month and cause significant personal problems. Even though diagnosis depends partly on self-reporting, the scientific progress in the area does provide an objectively verifiable method for assessing pain and suffering related to PTSD.
This kind of scientific progress is especially important as a potential response to the problem of malingering, which is when an individual continues to report pain even after it has stopped for the purpose of extending disability benefits or inflating a damage award (Cunnien, 1997). It is hard to estimate malingering, but it may be a factor in 34% to 40% of chronic pain cases (Mittenberg, 2002; Gervais, 2001; Kolber, 2007). Further, studies show that treatment outcomes are worse for people involved in personal injury litigation than for those who do not seek compensation (Mendelson, 1997). Even if the litigation is a cause of malingering, it could be because the stressors and delays of the tort system retard the healing process. Or, people who are prone to poor treatment may also be more likely to file a lawsuit. Recent scientific advances may obviate the need for this type of speculation by creating objectively verifiable pain metrics.
In sum, the best solution for dealing with the high cost of administrating pain and suffering damages and the alleged variation in horizontal quality is to reduce the cost of administration and increasing uniformity, not limit plaintiffs’ recoveries. The best way to accomplish this is via simplifying ways to estimate pain and suffering losses. In this chapter I survey a number of solutions discussed in the literature on how to simplify the estimation of pain and suffering damages to cut administrative costs. My goal is to demonstrate the feasibility of the task of estimating the loss more than to recommend any specific path to it.

Victorian FOI Changes

More changes to Victoria's Freedom Of Information regime, with the Age reporting -
In his first major interview as Special Minister of State, Labor MP Gavin Jennings outlined plans to arrest a decline in the public service, replace the Freedom of Information commissioner with a new "public access counsellor" and grant the anti-corruption watchdog long-awaited authority to examine the misconduct of MPs. ...
Vowing to be more transparent than Labor has been in the past, Mr Jennings told The Sunday Age: "We want to be a government that actually rebuilds the community's confidence in the accountability and the openness of government." "We accept the community's assessment that governments generally have been too reluctant to open decision-making processes to the community's scrutiny, and we think they have been too defensive … rather than embracing the fact that public scrutiny is appropriate."
Under the changes:
  • The FOI commissioner will be converted into a new Office of the Public Access counsellor, which will have the authority to review decisions made by ministers and departments and deemed cabinet-in-confidence. 
  • The time limit for departments to respond to FOI requests will reduce from 45 to 30 days, and the time limit to consider review decisions will be reduced from 60 to 15 days. 
  • The Independent Broad-based Anti-Corruption Commission will get the power to investigate misconduct in public office and undertake preliminary investigations before deciding whether to dismiss or pursue complaints. (This is similar to proposals introduced under the previous government, but not voted on before parliament adjourned for the election.) 
  • The auditor-general will have the authority to scrutinise public private partnerships through long-awaited "follow the dollar" laws, and will also be asked to help the government reduce wasteful taxpayer-funded advertising.
In his newly created role, Mr Jennings will be responsible for overseeing the integrity changes. He warned that legislation may not be introduced until the end of the year because of their complex nature. ...
Asked if revamping the bureaucracy meant boosting staff numbers, given thousands of jobs had been lost over the past four years, Mr Jennings replied: "Certainly capability has already been brought back in, but it may actually mean that we do, over time and within financial constraints, reinvest in the workforce across the public service".
The government's new policies come after a period of significant change to Victoria's integrity regime. Although the Baillieu/Napthine governments created IBAC and the FOI Commissioner [background here and in a Privacy Law Bulletin article last year] after Labor failed to establish either despite 11 years of office, it was widely criticised for failing to give the agencies enough power.
The office of FOI Commissioner Lynne Bertolini, for instance, was branded a toothless tiger because it did not have the ability to review decisions by ministerial offices or department heads, and at one point, was unable to meet its own review deadlines because of the volume and complexity of requests, and a general lack of staff.
IBAC has also come under scrutiny in recent years, particularly because the threshold to conduct investigations was seen as too high, prompting fears that some corruption could be falling through the cracks. Mr Jennings said the government would consult widely to work out what changes the corruption-busting agency may need.