The Scope and Legal Implications of Tracking Technologies on Hospital Websites.

This Viewpoint analyzes the scope and legal implications of tracking on hospital websites, including potential HIPAA and state privacy law violations, and suggests that hospitals limit such tracking.

Ethical and Regulatory Issues for Embedded Pragmatic Trials Involving People Living with Dementia.

Embedded pragmatic clinical trials (ePCTs) present an opportunity to improve care for people living with dementia (PLWD) and their care partners, but they also generate a complex constellation of ethical and regulatory challenges. These challenges begin with participant identification. Interventions may be delivered in ways that make it difficult to identify who is a human subject and therefore who needs ethical and regulatory protections. The need for informed consent, a core human subjects protection, must be considered but can be in tension with the goals of pragmatic research design. Thus it is essential to consider whether a waiver or alteration of informed consent is justifiable. If informed consent is needed, the question arises of how it should be obtained because researchers must acknowledge the vulnerability of PLWD due in part to diminished capacity and also to increased dependence on others. Further, researchers should recognize that many sites where ePCTs are conducted will be unfamiliar with human subjects research regulations and ethics. In this report, the Regulation and Ethics Core of the National Institute on Aging Imbedded Pragmatic Alzheimer's disease (AD) and AD-related dementias (AD/ADRD) Clinical Trials (IMPACT) Collaboratory discusses key ethical and regulatory challenges for ePCTs in PLWD. A central thesis is that researchers should strive to anticipate and address these challenges early in the design of their ePCTs as a means of both ensuring compliance and advancing science. J Am Geriatr Soc 68:S37-S42, 2020.

The ACA's Choice Problem.

The Affordable Care Act (ACA) is in many ways a success. Millions more Americans now have access to health care, and the ACA catalyzed advances in health care delivery reform. Simultaneously, it has reinforced and bolstered a problem at the heart of American health policy and regulation: a love affair with choice. The ACA's insurance reforms doubled down on the particularly American obsession with choice. This article describes three ways in which that doubling down is problematic for the future of US health policy. First, pragmatically, health policy theory predicts that choice among health plans will produce tangible benefits that it does not actually produce. Most people do not like choosing among health plan options, and many people-even if well educated and knowledgeable-do not make good choices. Second, creating the regulatory structures to support these choices built and reinforced a massive market bureaucracy. Finally, and most important, philosophically and sociologically the ACA reinforces the idea that the goal of health regulation should be to preserve choice, even when that choice is empty. This vicious cycle seems likely to persist based on the lead up to the 2020 presidential election.

Reimagining the Risk of Long-Term Care.

U.S. law and policy on long-term care fail to address the insecurity American families face due to prolonged illness and disability-a problem that grows more serious as the population ages and rates of disability rise. This Article argues that, even worse, we have focused on only part of the problem. It illuminates two ways that prolonged disability or illness can create insecurity. The first arises from the risk of becoming disabled or sick and needing long-term care, which could be called "care-recipient" risk. The second arises out of the risk of becoming responsible for someone else's care, which I call "next-friend" risk. The law and social welfare policy has focused on the first, but this Article argues that the second equally threatens the wellbeing of American families. While attempting to mitigate care-recipient risk, in fact, the law has steadily expanded next-friend risk, by reinforcing a structure of long-term care that relies heavily on informal caregiving. Millions of informal caregivers face financial and nonmonetary harms that deeply threaten their own long-term security. These harms are disproportionately experienced by people who are already vulnerable-women, minorities, and the poor. Scholars and policymakers have catalogued and critiqued these costs but treat them as an unfortunate byproduct of an inevitable system of informal care. This Article argues that if we, instead, understand becoming responsible for the care of another as a social risk-just as we see the chance that a person will need long-term care as a risk-it could fundamentally shift the way we approach long-term care policy. In risk-theory terms, this Article proposes we reimagine the risk of long-term care.

Retiree out-of-pocket healthcare spending: a study of consumer expectations and policy implications.

Even though most American retirees benefit from Medicare coverage, a mounting body of research predicts that many will face large and increasing out-of-pocket expenditures for healthcare costs in retirement and that many already struggle to finance these costs. It is unclear, however, whether the general population understands the likely magnitude of these out-of-pocket expenditures well enough to plan for them effectively. This study is the first comprehensive examination of Americans' expectations regarding their out-of-pocket spending on healthcare in retirement. We surveyed over 1700 near retirees and retirees to assess their expectations regarding their own spending and then compared their responses to experts' estimates. Our main findings are twofold. First, overall expectations of out-of-pocket spending are mixed. While a significant proportion of respondents estimated out-of-pocket costs in retirement at or above expert estimates of what the typical retiree will spend, a disproportionate number estimated their future spending substantially below what experts view as likely. Estimates by members of some demographic subgroups, including women and younger respondents, deviated relatively further from the experts' estimates. Second, respondents consistently misjudged spending uncertainty. In particular, respondents significantly underestimated how much individual health experience and changes in government policy can affect individual out-of-pocket spending. We discuss possible policy responses, including efforts to improve financial planning and ways to reduce unanticipated financial risk through reform of health insurance regulation.

Oil and water: mixing individual mandates, fragmented markets, and health reform.

The 2010 federal health insurance reform act includes an individual mandate that will require Americans to carry health insurance. This article argues that even if the mandate were to catalyze universal health insurance coverage, it will fall short on some of the policy objectives many hope to achieve through a mandate if implemented in a fragmented insurance market. To uncover this problem, this article sets forth a novel framework that disentangles three different policy objectives the individual mandate can serve. Namely, supporters of the mandate might hope for it to: (1) facilitate greater health and financial security for the uninsured ("paternalism"); (2) eliminate inefficiencies in health care delivery and financing ("efficiency"); and/or (3) require the healthy to buy insurance to help fund medical care for the sick ("health redistribution"). Health redistribution--the primary focus of this article--is a shifting of wealth from the healthy to the sick through the mechanism of risk pooling. Many see health redistribution as a means to enable all Americans to more equitably access medical care on the basis of need, rather than on the basis of ability or willingness to pay. Drawing on evidence from the implementation of an individual mandate in Massachusetts's health reform in 2006, this article reveals that the fragmented American health insurance market will thwart the mandate's ability to achieve these objectives- in particular the goal of health redistribution. Fragmentation is an atomization of the insurance market into numerous risk pools that has been driven by market competition and regulation. It prevents Americans from sharing broadly in the risk of poor health and, in doing so, entrenches a system where access to medical care remains tied to ability to pay and individualized characteristics. The final section of this article examines how various policies, including some in the new law (e.g., insurance regulation and exchanges) and others not (e.g., expanded public insurance), can reduce fragmentation so that the mandate can successfully serve all desired objectives and in the process gain greater legitimacy over time.