Digital Commons Network^™

Ai Regulation Has Its Own Alignment Problem: The Technical And Institutional Feasibility Of Disclosure, Registration, Licensing, And Auditing, Neel Guha, Christie M. Lawrence, Lindsey A. Gailmard, Kit T. Rodolfa, Faiz Surani, Rishi Bommasani, Inioluwa Deborah Raji, Mariano-Florentino Cuéllar, Colleen Honigsberg, Percy Liang, Daniel E. Ho

Faculty Scholarship

Calls for regulating artificial intelligence (“AI”) are widespread, but there remains little consensus on both the specific harms that regulation can and should address and the appropriate regulatory actions to take. Computer scientists propose technical solutions that may be infeasible or illegal; lawyers propose regulation that may be technically impossible; and commentators propose policies that may backfire. AI regulation, in that sense, has its own alignment problem, in which proposed interventions are often misaligned with societal values.This Article assesses the alignment and technical and institutional feasibility of four dominant proposals for AI regulation in the United States: disclosure, registration, licensing, …

Health Law And Democracy, Wendy K. Mariner

Faculty Scholarship

Current political divisions are destabilizing existing laws affecting the health field. Major changes in the field of health law have one thing in common: changes in who holds political power ‒ Congress and state legislatures, governors, presidents, judges, and agency officials. The laws that structure financial, economic, educational, and health care systems, environmental conditions, and civil society are primarily the product of elections that populate our political institutions. These structural determinants of health in turn create laws that influence how ‒ and how well ‒ we live and whether our society functions fairly under the rule of law. Thus, who …

Common Measures Of Vaccination Intention Generate Substantially Different Estimates That Can Reduce Predictive Validity, Jessica Fishman, K. Aleks Schaefer, Daniel Scheitrum, Christopher Robertson, Dolores Albarracin

Faculty Scholarship

Surveys often estimate vaccination intentions using dichotomous ("Yes"/"No") or trichotomous ("Yes," "Unsure," "No") response options presented in different orders. Do survey results depend on these variations? This controlled experiment randomized participants to dichotomous or trichotomous measures of vaccine intentions (with “Yes” and “No” options presented in different orders). Intentions were measured separately for COVID-19, its booster, and influenza vaccines. Among a sample of U.S. adults (N = 4,764), estimates of vaccine intention varied as much as 37.5 ± 17.4 percentage points as a function of the dichotomous or trichotomous response set. Among participants who had not received the COVID-19 vaccine, …

Impact Of Body Mass Index And Vo2 Max On Symptoms, Physical Activity, And Physical Function In A Multinational Sample Of People With Hiv, Christine Horvat Davey, Deepesh Duwadi

Faculty Scholarship

People with HIV (PWH) are at increased risk for metabolic disorders affecting body mass index (BMI), chronic symptoms, and impaired physical function and capacity. Although physical activity improves health and well-being, PWH often do not meet activity recommendations necessary to achieve these benefits. Despite the known impact of symptoms, physical activity, and physical function on health, little is known about the relationships and interactions between these variables and BMI and maximum oxygen consumption during exercise (VO2 max) in a multinational population of PWH. We examined the relationship of BMI with PROMIS-29 measures, physical activity, strength, flexibility, and VO2 max in …

Changes In Revenues Associated With Antimicrobial Reimbursement Reforms In Germany, Matt Mcenany, Kevin Outterson

Faculty Scholarship

Policy declarations from the G7 and other high-level meetings call for increased incentives for antimicrobial research and development (R&D). Governments fund push incentives like CARB-X and GARDP, and G7 countries are now designing pull incentives—financial rewards given to manufacturers post-market authorization that are intended to encourage the creation and introduction of novel antimicrobials. Germany has declared previously at the G7 that it has developed a pull incentive that will increase revenues from sales of important new antimicrobials, principally by exempting them from some aspects of health technology benefit assessments and reference pricing, which should result in higher prices. This policy …

Mitigating Algorithmic Bias: Strategies For Addressing Discrimination In Data, Sonia Gipson Rankin

Faculty Scholarship

This article examines the pervasive issue of algorithmic bias, particularly within large language models (LLMs) and the legal system. It argues that unlike simple programming bugs, these biases are deeply ingrained in the design and training data of artificial intelligence (AI) systems. By understanding the historical roots of bias and its realworld consequence across various sectors, we can develop effective strategies to mitigate its impact and ensure AI serves as a tool for progress. Weaving together historical insights, case studies, and forward-looking recommendations, the article aims to equip legal professionals with the knowledge and tools necessary to lead the charge …

The Mrnacalc Webserver Accounts For The N1-Methylpseudouridine Hypochromicity To Enable Precise Nucleoside-Modified Mrna Quantification, Sarah E. Krul, Sean J. Hoehn, Carlos E. Crespo-Hernández

Faculty Scholarship

Nucleoside-modified messenger RNA (mRNA) technologies necessarily incorporate N1-methylpseudouridine into the mRNA molecules to prevent the over-stimulation of cytoplasmic RNA sensors. Despite this modification, mRNA concentrations remain mostly determined through the measurement of UV absorbance at 260 nm wavelength (A260). Herein, we report that the N1-methylpseudouridine absorbs approximately 40% less UV light at 260 nm than uridine, and its incorporation into mRNAs leads to the under-estimation of nucleoside-modified mRNA concentrations, with 5%–15% error, in an mRNA-sequence-dependent manner. We therefore examined the RNA quantification methods and developed the mRNACalc webserver. It accounts for the molar absorption coefficient of modified nucleotides at 260 …

Shea Position Statement On Pandemic Preparedness For Policymakers: Building A Strong And Resilient Healthcare Workforce, Robin L.P. Jump

Faculty Scholarship

Throughout the COVID-19 pandemic, many areas in the United States experienced healthcare personnel (HCP) shortages tied to a variety of factors. Infection prevention programs, in particular, faced increasing workload demands with little opportunity to delegate tasks to others without specific infectious diseases or infection control expertise. Shortages of clinicians providing inpatient care to critically ill patients during the early phase of the pandemic were multifactorial, largely attributed to increasing demands on hospitals to provide care to patients hospitalized with COVID-19 and furloughs.¹ HCP shortages and challenges during later surges, including the Omicron variant-associated surges, were largely attributed to HCP …

Shea Position Statement On Pandemic Preparedness For Policymakers: Introduction And Overview, Robin L.P. Jump

Faculty Scholarship

Throughout history, pandemics and their aftereffects have spurred society to make substantial improvements in healthcare. After the Black Death in 14th century Europe, changes were made to elevate standards of care and nutrition that resulted in improved life expectancy.1 The 1918 influenza pandemic spurred a movement that emphasized public health surveillance and detection of future outbreaks and eventually led to the creation of the World Health Organization Global Influenza Surveillance Network.2 In the present, the COVID-19 pandemic exposed many of the pre-existing problems within the US healthcare system, which included (1) a lack of capacity to manage a large influx …

School Nutrition Stakeholders Find Utility In Mealsim: An Agent-Based Model, Melissa Pflugh Prescott

Faculty Scholarship

Objective: To obtain feedback from school nutrition stakeholders on an agent-based model simulating school lunch to inform model refinement and future applications. Design: Qualitative study using online discussion groups. Setting: School nutrition professional stakeholders across the US. Participants: Twenty-eight school nutrition stakeholders. Phenomenon of Interest: Perceptions and applicability of MealSim for school nutrition stakeholders to help reduce food waste. Analysis: Deductive approach followed by inductive analysis of discussion group transcripts. Results: Stakeholders appreciated the customizability of the cafeteria characteristics and suggested adding additional characteristics to best represent the school meal system, such as factors relating to school staff supervision of …

Avidity Maturation Of Humoral Response Following Primary And Booster Doses Of Bnt162b2 Mrna Vaccine Among Nursing Home Residents And Healthcare Workers, Oladayo A. Oyebanji, Nicholas Sundheimer, Vaishnavi Ragavapuram, Brigid M. Wilson, Jürgen Bosch, Christopher L. King, David H. Canaday

Faculty Scholarship

Infections, despite vaccination, can be clinically consequential for frail nursing home residents (NHR). Poor vaccine-induced antibody quality may add risk for such subsequent infections and more severe disease. We assessed antibody binding avidity, as a surrogate for antibody quality, among NHR and healthcare workers (HCW). We longitudinally sampled 112 NHR and 52 HCWs who received the BNT162b2 mRNA vaccine after each dose up to the Wuhan-BA.4/5-based Omicron bivalent boosters. We quantified anti-spike, anti-receptor binding domain (RBD), and avidity levels to the ancestral Wuhan, Delta, and Omicron BA.1 & 4/5 strains. The primary vaccination series produced substantial anti-spike and RBD levels …

Review Of Treatment Of Hepatitis C Among Persons Who Are Housing Insecure And Use Substances, Kate Kelley

Faculty Scholarship

With the advent of direct-acting antiviral agents (DAA), reduction of hepatitis C infection (HCV) has become a public health priority. The World Health Organization’s goal of global elimination of HCV by 2030 has brought to light the challenges in treating certain populations. This review examines the burden of HCV infection on unhoused individuals and people who use substances in the United States in the last five years, and presents best practices in patient care and treatment.

Viral Meningitis And Encephalitis Update, Boris Garber, Jonathan Glauser

Faculty Scholarship

Purpose of Review: This review describes advances in the diagnosis, treatment, and prevention of non-bacterial meningitis and encephalitis, with a focus on emerging viral causes of central nervous system (CNS) infection. Recent Findings: The Infectious Diseases Society of America recently published new guidelines for the management of encephalitis. Multiple articles have been published detailing emerging etiologies in human CNS infections, including analyses of neurological complications in the ongoing COVID-19 pandemic. Finally, several novel viral detection methods have been described, which may improve the detection of the specific etiologies of CNS infections (Hongyan et al. Front Neurol 14, [1]). Summary: Meningitis …

The Spectrum Of Pneumonia Among Intubated Neonates In The Neonatal Intensive Care Unit, Dayle J. Bondarev, Rita M. Ryan, Devashis Mukherjee

Faculty Scholarship

We review the pathophysiology, epidemiology, diagnosis, treatment, and prevention of ventilator-associated pneumonia (VAP) in neonates. VAP has been studied primarily in adult ICU patients, although there has been more focus on pediatric and neonatal VAP (neo-VAP) in the last decade. The definition as well as diagnosis of VAP in neonates remains a challenge to date. The neonatal intensivist needs to be familiar with the current diagnostic tools and prevention strategies available to treat and reduce VAP to reduce neonatal morbidity and the emergence of antibiotic resistance. This review also highlights preventive strategies and old and emerging treatments available.

Amplon: Amplifying Dna With Multiarm Priming And Looping Optimization Of Nucleic Acid, Mert Tunca Doganay, Ethan Roman, Andrea M. Hujer, Robert A. Bonomo, Mohamed S. Draz

Faculty Scholarship

Nucleic acid amplification, the bedrock of biotechnology and molecular diagnostics, surges in applications—especially isothermal approaches—heightening the demand for advanced and precisely engineered methods. Here, a novel approach for amplifying DNA with multiarm priming and looping optimization of nucleic acid (AMPLON) is presented. AMPLON relies on a novel polymeric material with unique set of multiarm polyethylene glycol–DNA primers for efficient DNA amplification under isothermal conditions. Each arm carries single-stranded DNA complementing the sense or antisense sequence of the target DNA. The amplification reaction begins with antisense arms binding to the target DNA, forming a template for sense-carrying arms to direct multiarm …

Towards A Study Protocol: A Data-Driven Workflow To Identify Error Sources In Direct Ink Write Mechatronics, Hein Htet Aung, Quynh D. Tran, Pawan Tripathi, Roger H. French, Laura S. Bruckman

Faculty Scholarship

Using Direct Ink Write (DIW) technology in a rapid and large-scale production requires reliable quality control for printed parts. Data streams generated during printing, such as print mechatronics, are massive and diverse which impedes extracting insights. In our study protocol approach, we developed a data-driven workflow to understand the behavior of sensor-measured X- and Y-axes positional errors with process parameters, such as print velocity and velocity control. We uncovered patterns showing that instantaneous changes in the velocity, when the build platform accelerates and decelerates, largely influence the positional errors, especially in the X-axis due to the hardware architecture. Since DIW …

Towards A Study Protocol: A Data-Driven Workflow To Identify Error Sources In Direct Ink Write Mechatronics, Hein Htet Aung, Quynh D. Tran, Pawan K. Tripathi, Roger H. French, Laura S. Bruckman

Faculty Scholarship

Using Direct Ink Write (DIW) technology in a rapid and large-scale production requires reliable quality control for printed parts. Data streams generated during printing, such as print mechatronics, are massive and diverse which impedes extracting insights. In our study protocol approach, we developed a data-driven workflow to understand the behavior of sensor-measured X- and Y-axes positional errors with process parameters, such as print velocity and velocity control. We uncovered patterns showing that instantaneous changes in the velocity, when the build platform accelerates and decelerates, largely influence the positional errors, especially in the X-axis due to the hardware architecture. Since DIW …

Cell-Type Specific Molecular Expression Levels By Restricted-Dimensional Cytometry, David Kaplan, Hillard M. Lazarus

Faculty Scholarship

Background: Cytometric analysis has been commonly used to delineate distinct cell subpopulations among peripheral blood mononuclear cells by the differential expression of surface receptors. This capability has reached its apogee with high-dimensional approaches such as mass cytometry and spectral cytometry that include simultaneous assessment of 20–50 analytes. Unfortunately, this approach also engenders significant complexity with analytical and interpretational pitfalls. Methods: Here, we demonstrate a complementary approach with restricted-dimensionality to assess cell-type specific intracellular molecular expression levels at exceptional levels of precision. The expression of five analytes was individually assessed in four mononuclear cell-types from peripheral blood. Results: Distinctions in expression …

Rapid Measurement Of Hemoglobin-Oxygen Dissociation By Leveraging Bohr Effect And Soret Band Bathochromic Shift, Zoe Sekyonda, Ran An, Utku Goreke, Yuncheng Man, Karamoja Monchamp, Allison Bode, Qiaochu Zhang, Ozan Akkus, Umut A. Gurkan

Faculty Scholarship

Oxygen (O2) binds to hemoglobin (Hb) in the lungs and is then released (dissociated) in the tissues. The Bohr effect is a physiological mechanism that governs the affinity of Hb for O2 based on pH, where a lower pH results in a lower Hb-O2 affinity and higher Hb-O2 dissociation. Hb-O2 affinity and dissociation are crucial for maintaining aerobic metabolism in cells and tissues. Despite its vital role in human physiology, Hb-O2 dissociation measurement is underutilized in basic research and in clinical laboratories, primarily due to the technical complexity and limited throughput of existing methods. We present a rapid Hb-O2 dissociation …

Altered Mitochondrial Respiration In Peripheral Blood Mononuclear Cells Of Post-Acute Sequelae Of Sars-Cov-2 Infection, Sahera Dirajlal-Fargo, Jared C. Durieux, Grace A. Mccomsey

Faculty Scholarship

Peripheral blood mononuclear cells (PBMC) mitochondrial respiration was measured ex vivo from participants without a history of COVID (n = 19), with a history of COVID and full recovery (n = 20), and with PASC (n = 20). Mean mitochondrial basal respiration, ATP-linked respiration, maximal respiration, spare respiration capacity, ATP-linked respiration, and non-mitochondrial respiration were highest in COVID + PASC+ (p ≤ 0.04). Every unit increase in non-mitochondrial respiration, ATP-linked respiration, basal respiration, spare respiration capacity, and maximal respiration increased the predicted odds of PASC between 1 % and 6 %. Mitochondrial dysfunction in PBMCs may be contributing to the …

Structural Insights Into Peptidoglycan Glycosidase Etga Binding To The Inner Rod Protein Esci Of The Type Iii Secretion System Via A Designed Esci-Etga Fusion Protein, Jacob Boorman, Focco Van Den Akker

Faculty Scholarship

Bacteria express lytic enzymes such as glycosidases, which have potentially self-destructive peptidoglycan (PG)-degrading activity and, therefore, require careful regulation in bacteria. The PG glycosidase EtgA is regulated by localization to the assembling type III secretion system (T3SS), generating a hole in the PG layer for the T3SS to reach the outer membrane. The EtgA localization was found to be mediated via EtgA interacting with the T3SS inner rod protein EscI. To gain structural insights into the EtgA recognition of EscI, we determined the 2.01 Å resolution structure of an EscI (51–87)-linker-EtgA fusion protein designed based on AlphaFold2 predictions. The structure …

Time To Blood Pressure Control And Predictors Among Patients Receiving Integrated Treatment For Hypertension And Hiv Based On An Adapted Who Hearts Implementation Strategy At A Large Urban Hiv Clinic In Uganda, Willington Amutuhaire, Lewis S. Musoke, George A. Yendewa, Lewis S. Musoke, George A. Yendewa

Faculty Scholarship

In this cohort study, we determined time to blood pressure (BP) control and its predictors among hypertensive PLHIV enrolled in integrated hypertension-HIV care based on the World Health Organization (WHO) HEARTS strategy at Mulago Immunosuppression Clinic in Uganda. From August 2019 to March 2020, we enrolled hypertensive PLHIV aged ≥18 years and initiated Amlodipine 5 mg mono-therapy for BP (140–159)/(90–99) mmHg or Amlodipine 5 mg/Valsartan 80 mg duo-therapy for BP ≥ 160/90 mmHg. Patients were followed with a treatment escalation plan until BP control, defined as BP < 140/90 mmHg. We used Cox proportional hazards models to identify predictors of time to BP control. Of 877 PLHIV enrolled (mean age 50.4 years, 62.1% female), 30% received mono-therapy and 70% received duo-therapy. In the monotherapy group, 66%, 88% and 96% attained BP control in the first, second and third months, respectively. For patients on duo-therapy, 56%, 83%, 88% and 90% achieved BP control in the first, second, third, and fourth months, respectively. In adjusted Cox proportional hazard analysis, higher systolic BP (aHR 0.995, 95% CI 0.989-0.999) and baseline ART tenofovir/lamivudine/efavirenz (aHR 0.764, 95% CI 0.637–0.917) were associated with longer time to BP control, while being on ART for >10 years was associated with a shorter time to BP control (aHR 1.456, …

Renewing Products Liability With Semen, Anita Bernstein

Faculty Scholarship

No abstract provided.

Covid-19 Pediatric Vaccine Authorization, Fda Authority, And Individual Misperception Of Risk, Joanna K. Sax, Neal Doran

Faculty Scholarship

Vaccines are one component to the public health strategies to alleviate the COVID-19 pandemic. Hesitancy regarding COVID-19 vaccines in the United States has been problematic, which is not surprising given increasing overall vaccine hesitancy in recent decades. Most vaccines are administered during childhood years. Consequently, understanding hesitancy toward administration of vaccines in this age group may provide insight into possible interventions to reduce vaccine hesitancy. The present study analyzed a subset of over 130,000 public comments posted in response to a notice of meeting of the vaccine advisory group to the Food and Drug Administration. The meeting addressed whether to …

Food And Drug Regulation: Statutory And Regulatory Supplement (2024), Adam I. Muchmore

Faculty Scholarship

This Statutory and Regulatory Supplement is intended for use with its companion casebook, Food and Drug Regulation: A Statutory Approach (2021). This is not a traditional statutory supplement. Instead, it contains selected, aggressively edited provisions of the Federal Food, Drug and Cosmetic Act (FFDCA), related statutes, and the Code of Federal Regulations. The Supplement includes all provisions assigned as reading in the casebook, as well as a few additional provisions that some professors may wish to cover. The excerpts are designed to be teachable rather than comprehensive.

Sharing Pathogen Sequence Data For Global Scientific Research Under The Nagoya Protocol To The Convention On Biological Diversity, Jerome H. Reichman, Carolina Dos S. Ribeiro, George B. Haringhuizen, Paul F. Uhlir

Faculty Scholarship

The Nagoya Protocol to the Convention on Biological Diversity (CBD) has threatened to impede access to genetic resources and related data for cross-border scientific research. In principle, every use of genetic resources would require a set of contracts under the CBD, in a “bilateral” regime. The related transaction costs could overwhelm many transnational research undertakings, affecting even public health responses to outbreaks and epidemics. However, the Nagoya Protocol also offers a unique opportunity to resolve this dilemma, despite struggles to define the meaning and coverage of “digital sequence information.” The coverage of genetic sequence data under the CBD remains controversial …

Competition & Risk, Doni Bloomfield

Faculty Scholarship

No abstract provided.

Disability, Race, And Health Beyond The Carceral State, Benjamin Barsky, Craig Konnoth, Michael A. Stein

Faculty Scholarship

No abstract provided.

Internet Drug Prohibition And The Opioid Overdose Crisis, Benjamin Barsky

Faculty Scholarship

The Ryan Haight Online Pharmacy Consumer Protection Act (Ryan Haight Act) prohibits controlled substance tele-prescribing when it occurs without a preliminary in-person medical evaluation. This Article details the Ryan Haight Act’s consequences for the practice of telemedicine in general and opioid addiction treatment in particular. In doing so, it builds on literature exploring the tension between the federal criminal regulation of controlled substance prescribing and the management of large-scale public health crises, particularly the opioid overdose crisis.

By restricting the tele-prescription of certain controlled substances used for opioid addiction treatment, the Ryan Haight Act limits access to care for a …

Syndromic Antibiograms And Nursing Home Clinicians' Antibiotic Choices For Urinary Tract Infections, Brigid M. Wilson, Taissa A. Bej, Robin L.P. Jump

Faculty Scholarship

Importance: Empirical antibiotic prescribing in nursing homes (NHs) is often suboptimal. The potential for antibiograms to improve empirical antibiotic decision-making in NHs remains poorly understood. Objective: To determine whether providing NH clinicians with a urinary antibiogram improves empirical antibiotic treatment of urinary tract infections (UTIs). Design, Setting, and Participants: This was a survey study using clinical vignettes. Participants were recruited via convenience sampling of professional organization listservs of NH clinicians practicing in the US from December 2021 through April 2022. Data were analyzed from July 2022 to June 2023. Interventions: Respondents were randomized to complete vignettes using a traditional antibiogram …