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TABLE OF CONTENTS I. BACKGROUND 775 A. Artificial Intelligence in Medicine 776 B. Medical Device Regulation 778 C. Off-Label Use 781 III. ANALYSIS 784 A. Federal Regulators 785 1. The [...], Through machine learning (ML) developments, medical devices are gaining more autonomous functions and taking on more central roles in medical care. Many scholars believe that artificial intelligence (AI) will revolutionize the healthcare industry, but the technology brings several concerns that implicate data privacy, patient security and safety, and professional responsibility. The Federal Drug Administration (FDA) acknowledged this fact, publishing proposed guidance in 2023 on artificial intelligence and machine learning (AI/ML) medical device approval that would tighten device regulation upfront and enhance supervision throughout the regulatory process. While some have addressed the premarket approval process or tort liability frameworks for artificial intelligence-enabled devices, this Note focuses on the regulatory concerns arising from off-label use of AI/ML-enabled medical devices. This Note agrees with FDA and other scholars that the current legal system does not support the proper use of AI/ML-enabled medical devices. To remedy that lack of systemic support, this Note considers which agencies, if any, have the proper regulatory authority to handle the matter and challenges the idea that nonbinding guidance is the proper regulatory vehicle for enforcement. Ultimately, this Note argues for a multilevel regulatory framework promulgated under the formal rulemaking process, state regulatory procedure, and private regulation.

Acquiescence is often defined as the systematic selection of agreeable ("strongly agree") or affirmative ("yes") responses to survey items, regardless of item content or directionality. This definition implies that acquiescence is immune to item characteristics; however, the influence of item characteristics on acquiescence remains largely unexplored. We examined the influence of eight item characteristics on acquiescence in a telephone survey of 400 Latinos and non-Latino Whites: qualified wording, mental comparisons, negated wording, unfamiliar terms, ambiguous wording, knowledge accessibility, item length, and polysyllabic wording. Negated and ambiguous wording was associated with reduced acquiescence for the full sample as well as subsamples stratified by ethnicity and sociodemographic characteristics. This effect was strongest among younger, more educated, and non-Latino white respondents. No other item characteristics had a significant influence on respondent acquiescence. Findings from this study suggest that acquiescence may be affected by interactions between respondent and item characteristics.

Evidence shows that adverse childhood experiences (ACEs) are a root cause of risk behaviors. Safe, stable, and nurturing relationships (SSNRs) can potentially moderate the health risks associated with ACEs. This study examines the relationships among SSNRs in childhood, ACEs, and two risk behaviors in adulthood (smoking tobacco and binge drinking). Data were obtained from the 2016 South Carolina Behavioral Risk Factor Surveillance System survey. The results show a significant decrease in odds of risk behaviors among individuals with ACEs when a SSNRs is present in childhood. This study suggests that programs and policies that promote resilience may reduce risk behaviors.

In this article, we examine progress and challenges in designing, implementing, and evaluating culturally sensitive behavioral interventions by tailoring health communication to groups or individuals. After defining common tailoring constructs (i.e., culture, race, and ethnicity), cultural sensitivity, and cultural tailoring, we examine when it is useful to culturally tailor and address cultural sensitivity in health communication by group tailoring or individual tailoring and when tailoring health communication may not be necessary or appropriate for achieving behavior change. After reviewing selected approaches to cultural tailoring, we critique the quality of research in this domain with a focus on the internal validity of empirical findings. Then we explore the ways in which cultural sensitivity, group targeting, and individual tailoring have incorporated culture in health promotion and health communication. We conclude by articulating yet unanswered questions and suggesting future directions to move the field forward. [ABSTRACT FROM AUTHOR]

Over the last decade, there has been an increase in concern about sugar arrangements, relationships in which sugar babies, typically young women, provide romantic companionship to sugar daddies, typically older men, in exchange for money and/or gifts. This concern became more pointed in 2018, when the United States Congress passed the Allow States and Victims to Fight Online Sex Trafficking Act (FOSTA), which led to a purge of “sexual” content from social networking sites. In this context, I investigated changes in sugar babies’ Tumblr posts using a mixed-methods approach. My hypothesis that there would be a statistically significant decrease in sexual posts after Tumblr’s ban on sexual content was supported by my findings. The results of this study shed light on the ways neoliberal gender, sexual, and economic discourses are both perpetuated and resisted by sugar babies online in the wake of mass surveillance, censorship, and legal discipline. [ABSTRACT FROM AUTHOR]