Expanded FDA regulation of health and wellness apps.

This paper argues that the Food and Drug Administration's (FDA) policy for health and wellness apps is ethically problematic. Currently, the FDA does not regulate health and wellness apps that are not intended for medical use. As a result of this hands-off policy, preventing harm to consumers is left primarily to developers and app marketplaces. We argue that the FDA's duties to prevent harm and maintain accountability to the American public require that they play a much stronger role. We also discuss concerns about efficiency and fostering innovation, and argue that while they should help shape FDA regulation of health and wellness apps, they do not justify complete absence of FDA involvement.

A Primer on Social Media Use by Young Plastic Surgeons.

Similar to the outcry over the ethics of website marketing by physicians in the 1990s, the resistance to plastic surgeons' use of social media has been loud and vehement. Many physicians, although receptive to website marketing, view social media as too radical or unprofessional. Despite the controversy, the value of social media as a communication tool for interacting with and educating patients is supported by studies showing that 65 percent of Americans and 90 percent of young adults use social media. Many plastic surgeons have been early adopters, as reflected by the articles written to help board-certified plastic surgeons use social media in academic medicine and for their practice. However, there is little guidance for young plastic surgeons who wish to use social media for professional purposes. In this study, the authors discuss the ethics and current literature on social media use by young plastic surgeons and make recommendations for how to use social media during training and after residency graduation.

The Dark Data Quandary.

The digital universe remains a black box. Despite attaining high-technology capabilities like artificial intelligence and cognitive computing, "Big Data" analytics have failed to keep pace with surging data production. At the same time, the falling costs of cloud storage and distributed systems have made mass data storage cheaper and more accessible. These effects have produced a chasm between data that is stored and data that can be readily analyzed and understood. Enticed by the promise of extracting future value from rising data stockpiles, organizations now retain massive quantities of data that they cannot presently know or effectively manage. This rising sea of "dark data" now represents the vast majority of the digital universe. Dark data presents a quandary for organizations and the judicial system. For organizations, the inability to know the contents of retained dark data produces invisible risk under a spreading patchwork of digital privacy and data governance laws, most notably in the medical and consumer protection areas. For courts increasingly confronted with Big Data-derived evidence, dark data may shield critical information from judicial view while embedding subjective influences within seemingly objective methods. To avoid obscuring organizational risk and producing erroneous outcomes in the courtroom, decision-makers must achieve a new awareness of dark data's presence and its ability to undermine Big Data's vaunted advantages.

The Protection of Patients Under the Clayton Act.

The vast consolidation among health-care providers in the aftermath of the Affordable Care Act's enactment has led to much debate over the benefits of mergers in the health-care industry. In 2016, the Federal Trade Commission filed motions in federal court to enjoin three hospital mergers in various parts of the country. This amounted to more challenges to hospital mergers in a single year than any year in recent history. Though two of these motions succeeded at the district court level, both were overturned on appeal, which led many to wonder what the effect of these decisions would be on future health-care mergers. While many fear that hospital mergers lead to higher prices for consumers, there are also those who contend that mergers lead to efficiencies, which allow merging parties to utilize resources more effectively, increase the quality of patient care and coordination, and potentially save lives. This Note argues that the possibility of quality-enhancing or life-saving efficiencies is worth the risk that consumers see increased prices. To allow mergers that may realize these types of efficiencies, antitrust enforcement agencies and courts must begin placing greater weight on merging parties' efficiency arguments by easing the current standard. Additionally, in light of new research suggesting that cross-market health-care mergers, or mergers between providers in different geographic markets, affect bargaining dynamics between providers and insurers, this Note argues that parties' relative bargaining power must be considered in agencies' and courts' analyses of the competitive landscape relevant to a merger.

Origins of the prohibition against off-label promotion.

The statute and regulations administered by the Food and Drug Administration ("FDA") do not explicitly prohibit the promotion of drugs and medical devices for unapproved uses, yet the government has collected billions of dollars in penalties for such "off-label" promotion. The statutory interpretations and regulatory provisions relied on by the government to take enforcement action against off-label promotion are the incidental by-products of initiatives undertaken by FDA through administrative action and litigation early in its implementation of the Federal Food, Drug, and Cosmetic Act. The actions were designed to obtain FDA authority over therapeutic claims made in advertising, even though Congress had assigned authority over advertising to the Federal Trade Commission, and to establish a prescription-only drug system, even though FDA lacked statutory authority for such a system. The principal purpose of both efforts was to prevent inappropriate self-medication. This article describes the history of those strategies, including expansion of the definition of the term "labeling" to encompass matter that was initially regarded as advertising; creation of the rule that the labeling of drugs must have adequate directions for all "intended" uses; and construction of the prescription-only drug system in a manner that allowed FDA to use the statutory requirement for labeling to have "adequate directions for use" to prohibit the off-label promotion of prescription drugs.

Supreme Court ruling may determine the future of state-based professionai licensing.

The U.S. Supreme Court heard oral arguments this fall in a case involving the North Carolina State Board of Dental Examiners that could have a dramatic impact on how states license and regulate professionals in America. This paper briefly describes the facts of the case and the history of professional licensing in America and then discuses and evaluates the potential impact of the various legal arguments presented by the parties in the case.