Accounting for accountable care: Value-based population health management.

Accountable Care Organizations (ACOs) are exemplars of so-called value-based care in the US. In this model, healthcare providers bear the financial risk of their patients' health outcomes: ACOs are rewarded for meeting specific quality and cost-efficiency benchmarks, or penalized if improvements are not demonstrated. While the aim is to make providers more accountable to payers and patients, this is a sea-change in payment and delivery systems, requiring new infrastructures and practices.

Concepts of risk in nanomedicine research.

Risk takes center stage in ethical debates over nanomedical technologies. Yet concepts of risk may hold different meanings, and they are embedded within particular political, economic, and social contexts. This article discusses framings of risk in debates over medical innovations such as nanomedicine, and draws attention to organizational and institutional forms of risk which are less visible in bioethical policy debates.

Recommendations for nanomedicine human subjects research oversight: an evolutionary approach for an emerging field.

The nanomedicine field is fast evolving toward complex, "active," and interactive formulations. Like many emerging technologies, nanomedicine raises questions of how human subjects research (HSR) should be conducted and the adequacy of current oversight, as well as how to integrate concerns over occupational, bystander, and environmental exposures. The history of oversight for HSR investigating emerging technologies is a patchwork quilt without systematic justification of when ordinary oversight for HSR is enough versus when added oversight is warranted.

Characterizing human embryonic stem cells: biological and social markers of identity.

Human embryonic stem cells are elusive, recalcitrant entities that resist characterization and standardization. Without agreements about what the cells are and how best to systematize cell culture and testing, data cannot be extracted meaningfully, the nascent field will be slow to stabilize, and significantly, there may be safety risks for patients. I discuss efforts to characterize cells definitively and standardize practices across uniquely derived lines, labs, and researchers.

Science, ethics, and the "problems" of governing nanotechnologies.

Commentators continue to weigh in on whether there are ethical, social, and policy issues unique to nanotechnology, whether new regulatory schemes should be devised, and if so, how. Many of these commentaries fail to take into account the historical and political environment for nanotechnologies. That context affects regulatory and oversight systems as much as any new metrics to measure the effects of nanoscale materials, or organizational changes put in place to facilitate data analysis.

Cellular therapies for heart disease: unveiling the ethical and public policy challenges.

Cellular therapies have emerged as a potential revolutionary treatment for cardiovascular disease. Promising preclinical results have resulted in a flurry of basic research activity and spawned multiple clinical trials worldwide. However, the optimal cell type and delivery mode have not been determined for target patient populations.

Claims and disclaimers: whose expertise counts?

Medical anthropologists have long recognized that interactions between state, clinical, scientific and lay participants transform understandings of illness. There are competing claims to knowledge in such interactions, which may be in tension with concepts of jurisdictional authority and assumptions about what constitutes different types of expertise. This paper focuses on the regulatory processes of the Food and Drug Administration in order to examine the social processes involved in negotiating and sustaining domains of knowledge across various boundaries of authority.