Law Commons^™

Private Certifiers And Deputies In American Health Care, Frank Pasquale

Frank A. Pasquale

So-called “public programs” in U.S. health care pervasively contract with private entities. The contracting does not merely involve the purchase of drugs, devices, information technology, insurance, and medical care. Rather, government agencies are increasingly outsourcing decisions about the nature and standards for such goods and services to private entities. This Article will examine two models of outsourcing such decisions. In private licensure, firms offer a stamp of approval to certify that a given technology or service is up to statutory or regulatory standards. Via deputization, firms can pursue a regulatory or law enforcement role to correct (and even punish) providers …

Accountable Care Organizations In The Affordable Care Act, Frank Pasquale

Frank A. Pasquale

No abstract provided.

The Three Faces Of Retainer Care: Crafting A Tailored Regulatory Response, Frank Pasquale

Frank A. Pasquale

Retainer care arrangements allow patients to pay a retainer directly to a physician's office in order to obtain special access to care. Practices usually convert to retainer status by focusing their attention on those willing to pay a retainer fee, and dropping the majority of their patients, who are left to be absorbed by other practices. Also known as "boutique medicine," "concierge care," or "innovative practice design," retainer practices have drawn thousands of enthusiastic patients. They have also provoked scrutiny from politicians and consumer groups. Few recent developments in the business of medicine provoke emotional conflicts like retainer care does. …

Access To Medicine In An Era Of Fractal Inequality, Frank Pasquale

Frank A. Pasquale

Those in the richest countries have far more income and wealth than those in poor countries. Moreover, the most fortunate in the richest countries – particularly those in the top centile of the income distribution – are far richer than those around them. Most dramatically, even within that top centile, the richest of the rich have far more resources than even their elite peers. Like fractals, the patterns of distribution repeat at various levels. This pattern of fractal inequality ensures that spending that seems trivial to those at the top of an income distribution can overwhelm the purchasing power of …

Restoring Transparency To Automated Authority, Frank Pasquale

Frank A. Pasquale

Leading finance, health care, and internet firms shroud key operations in secrecy. Our markets, research, and life online are increasingly mediated by institutions that suffer serious transparency deficits. When a private entity grows important enough, it should be subject to transparency requirements that reflect its centrality. The increasing intertwining of governmental, business, and academic entities should provide some leverage for public-spirited appropriators and policymakers to insist on more general openness. However well an "invisible hand" coordinates economic activity generally, markets depend on reliable information about the practices of core firms that finance, rank, and rate entities in the rest of …

William H. Sorrell, Attorney General Of Vermont, Et Al. V. Ims Health Inc., Et Al. - Amicus Brief In Support Of Petitioners, Kevin Outterson, David Orentlicher, Christopher Robertson, Frank Pasquale

Frank A. Pasquale

On April 26, 2011, the US Supreme Court will hear oral arguments in the Vermont data mining case, Sorrell v. IMS Health Inc. Respondents claim this is the most important commercial speech case in a decade. Petitioner (the State of Vermont) argues this is the most important medical privacy case since Whalen v. Roe. The is an amicus brief supporting Vermont, written by law professors and submitted on behalf of the New England Journal of Medicine

Ending The Specialty Hospital Wars: A Plea For Pilot Programs As Information-Forcing Regulatory Design, Frank Pasquale

Frank A. Pasquale

This chapter focuses on the need for more targeted assessment of the impact of market forces on communities. Pilot programs encourage experimentation in the delivery system without risking widespread disruption of care for the uninsured and emergency services. The Center for Medicare & Medicaid Services (CMS) has already embraced the idea of pilot programs in other contexts, and they could be especially appropriate if specialty hospitals were permitted in markets where general hospitals had a demonstrably poor record of community service. In such markets, cross-subsidization is probably already low, and specialty hospital threats to it are not as much of …

The Future Of Hipaa In The Cloud, Frank Pasquale, Tara Adams Ragone

Frank A. Pasquale

This white paper examines how cloud computing generates new privacy challenges for both healthcare providers and patients, and how American health privacy laws may be interpreted or amended to address these challenges. Given the current implementation of Meaningful Use rules for health information technology and the Omnibus HIPAA Rule in health care generally, the stage is now set for a distinctive law of “health information” to emerge. HIPAA has come of age of late, with more aggressive enforcement efforts targeting wayward healthcare providers and entities. Nevertheless, more needs to be done to assure that health privacy and all the values …

Cognition-Enhancing Drugs: Can We Say No?, Frank Pasquale

Frank A. Pasquale

Normative analysis of cognition-enhancing drugs frequently weighs the liberty interests of drug users against egalitarian commitments to a "level playing field." Yet those who would refuse to engage in neuroenhancement may well find their liberty to do so limited in a society where such drugs are widespread. To the extent that unvarnished emotional responses are world-disclosive, neurocosmetic practices also threaten to provide a form of faulty data to their users. This essay examines underappreciated liberty-based and epistemic rationales for regulating cognition-enhancing drugs.

Grand Bargains For Big Data: The Emerging Law Of Health Information, Frank Pasquale

Frank A. Pasquale

No abstract provided.

Intellectual Property And Public Health – A White Paper, Ryan G. Vacca, Jim Chen, Jay Dratler Jr., Tom Folsom, Timothy Hall, Yaniv Heled, Frank Pasquale, Elizabeth Reilly, Jeff Samuels, Kathy Strandburg, Kara Swanson, Andrew Torrance, Katharine Van Tassel

Frank A. Pasquale

On October 26, 2012, the University of Akron School of Law’s Center for Intellectual Property and Technology hosted its Sixth Annual IP Scholars Forum. In attendance were thirteen legal scholars with expertise and an interest in IP and public health who met to discuss problems and potential solutions at the intersection of these fields. This report summarizes this discussion by describing the problems raised, areas of agreement and disagreement between the participants, suggestions and solutions made by participants and the subsequent evaluations of these suggestions and solutions.

Led by the moderator, participants at the Forum focused generally on three broad …