Health Law and Policy Commons^™

Expanding Equity And Innovation In Pharmaceutical Law And Drug Development: Paying Clinical Trial Participants For Their Data, Steve Calandrillo, Bernadette Tosti, Jefferson Smith, Jamison Koeman

Articles

Bringing a drug to market is exceedingly expensive and exposes pharmaceutical manufacturers to significant legal risk. But when companies are successful, their profits make the PowerBall jackpot look like petty cash. Staggering rewards measure in the billions or millions for the firms, CEOs, pharmacies, drug benefit managers, data brokers, and many more actors in the pharmaceutical-to-patient pipeline. The only individuals who don’t get paid handsomely are the clinical trial participants, whose voluntary participation and data helped make those successes possible. It is long past time that we reform the legal and regulatory roadblocks to paying clinical trial participants in the …

Good Faith Estimates And The No Surprises Act, Stuart L. Segelnick Dds, Ms

The New York State Dental Journal

Federal law requires dentists to be up front with self-pay patients about the cost of their treatment. Surprises may lead to penalties.

The No Surprises Act (NSA) went into effect on Jan. 1, 2022. This is a federal law that applies to all health-care providers, including dentists. The law gives certain rights to patients to help protect them from receiving surprise medical bills. These surprises usually occur when a person has no control over who treats them, such as during an emergency or when they are treated unknowingly by an out-of-network provider.

The Indian Pharmacopoeia: Enabling Open Access And Crafting A ‘Sovereign Function Exception’ For Government Works, Aparajita Lath

National Law School Journal

Standardisation of drugs and access to such standards are important levers for effective drug regulation. The Indian Pharmacopoeia, the official book of standards for drugs in the country prescribed by the Union government under the Drugs and Cosmetics Act 1940, are legally binding and enforceable. Not only do the standards have the force of law but are also government-created. The Indian Pharmacopoeia Commission (IPC), a division of the Union Department of Health and Family Welfare, has a legal monopoly over creating and publishing this compendium. Though it is legally binding, the Indian Pharmacopoeia is neither in the public domain …

What To Know About Release Of Information, Authorization, And Records Requests, Jennifer Cosey

The Journal of the Michigan Dental Association

This article clarifies HIPAA regulations regarding the disclosure of protected health information (PHI). It distinguishes between a "Right of Access" request, where a patient directly seeks their own record (no authorization needed), and an "Authorization," which is required for disclosures beyond treatment, payment, or health care operations, or to third parties for ongoing access. The author details activities permissible without authorization, such as coordination of care, billing, and quality improvement. Specific examples are provided for situations requiring authorization, like disclosing PHI to attorneys or for marketing. The article also outlines seven essential elements for a HIPAA-compliant authorization form

News You Need July 2025

The Journal of the Michigan Dental Association

News You Need for July 2025 includes a listing of MDA members who have completed service on committees; a link to recent MDA Board actions; news about two dental journalism awards won by the MDA Journal; how younger patients are negatively influenced by social media; a letter to the editor regarding dental insurance; information about MDA Foundation scholarships; members receiving awards; a calendar of events; a patient fact sheet; and more.

Examining Pricing And Availability For Neglected Tropical Disease Therapies In The Us, Maple Goh, Kevin Outterson, Aaron S. Kesselheim

Faculty Scholarship

Background

Neglected tropical diseases primarily affect vulnerable populations in low-resource settings worldwide. In the US, neglected tropical diseases such as Chagas, soil-transmitted helminthiases, and other infections historically impacted immigrants but are increasingly relevant for US residents with climate change. We examined the pricing, prescribing rates, and supply of therapies used to treat neglected tropical diseases in the US and their implications for accessibility and patient care. Methods

A retrospective analysis of prescription rates, wholesale acquisition costs, and shortages was conducted for 11 treatment products from 2019 to 2024, aggregating data from Symphony Metys, First Databank, NAVLIN, Red Book, and the …

Purdue’S Side Effects: Using Due Process To Realign Mass Tort Bankruptcies, William A. Organek

BYU Law Review

In Harrington v. Purdue Pharma, the United States Supreme Court held that victims of the opioid crisis could not be forced to release their independent claims against the Sacklers, who owned and controlled Purdue, without the victims’ consent. Such releases had become a controversial mainstay of mass tort bankruptcy filings. Yet Purdue was decided on narrow, textualist grounds, leaving as a side effect many seemingly disparate and difficult questions unanswered. This Article argues that Purdue and its open issues should be analyzed through a broader due process lens in tension with some aspects of current bankruptcy practice but consistent with …

Kebijakan Cukai Konsumsi Minuman Berpemanis Dalam Kemasan (Mbdk) Dalam Mengendalikan Masalah Kesehatan: Tinjauan Literatur Sistematis Dan Meta Analisis, Risky Kusuma Hartono, Fitria Aryani Susanti

Jurnal Ekonomi Kesehatan Indonesia

Globally, the consumption of sugar-sweetened beverages (SSBs) has increased by nearly 16%. The imposition of taxes on sugary drinks is considered one of the strategic measures to control diseases associated with their consumption. This study aims to conduct a meta-analysis of the correlation between SSB taxation and health issues. The systematic review and meta-analysis were carried out following the Preferred Reporting Items for Systematic Reviews and MetaAnalyses (PRISMA) guidelines. Literature from various countries published since January 1, 2014, was collected using databases such as Google Scholar, PubMed, and Science Direct. The meta-analysis process was performed using a funnel plot. A …

The Impact Of The Chevron Ruling On Medicare, Sana Sherali

DePaul Journal of Health Care Law

The Supreme Court’s historic decision to overturn the Chevron doctrine in June 2024 received national attention due to its implications for how much power agencies will hold in the years to come. The Chevron doctrine originally comes from the Supreme Court’s 1984 decision in Chevron, U.S.A., Inc. v. Natural Resources Defense Council.Chevron addressed the requirements imposed on states by The Clean Air Act Amendments of 1977. This decision set the precedent that if federal legislation is unclear or leaves an administrative gap, courts have to follow the regulatory agency’s interpretation of the law, as long as the interpretation is …

Heterogeneity In Hospital Consolidation, Christina Depasquale

DePaul Journal of Health Care Law

This paper examines the heterogeneity between two types of hospital consolidations—mergers and system-joinings. I examine changes in admissions, employment outcomes, beds in different medical units, surgeries, costs, case mix, and discharges. I find that hospital mergers and system-joiners are fundamentally different among almost all outcomes examined. Additionally, I extend my analysis by examining those hospitals that, at the time of consolidation, are closer to either their fellow merging hospital or a fellow system-member hospital. I find no meaningful correlation between distance and outcomes.

The Opioid Crisis: How The United States And Countries Abroad Are Making Strides, Maura Mcginnity

DePaul Journal of Health Care Law

The opioid epidemic has been an ongoing problem in the United States since the 1980s. The United States has had a very negative attitude towards individuals suffering from addiction. This attitude is clearly shown through the United States’ handling of the opioid crisis. Hundreds of thousands of individuals have died due to opioids. In the forty years since this epidemic became prevalent, the United States has still failed to implement a country-wide solution to combat the crisis. Certain states, like New York and Illinois, have made strides toward helping individuals suffering from opioid use disorder, but nationally, the country is …

Lost Without A Cause: The Sixth Circuit’S But-For Standard For False Claims Act Violations Harms Healthcare Fraud Enforcement, Margo Chapin

Villanova Law Review (1956 - )

No abstract provided.

Vandy Earns Top Prize In Auwcl National Health Law Writing Competition, James Owsley Boyd

Keep Up With the Latest News from the Law School (blog)

Nicholle Vandy, a rising 3L from Knox, Ind., has become the first Indiana University Maurer School of Law student to earn top honors at the American University Washington College of Law National Health Writing Competition.

Vandy’s paper, “True Man, Captive Mother: Abortion as a Fundamental Self-Defense Right,” was named the winning entry of the 10th annual competition, which encourages law students from across the country to write scholarly papers on current topics of interest relevant to health, food, and/or drug law.

Presentations: Pennsylvania's Environmental Rights Amendment And Environmental Justice, Samantha Phillps Beers, John C. Dernbach, Emma H. Bast, Margaret O. Murphy

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Climate Change And Digital Nations: Harnessing The Metaverse To Perpetuate Small Island Statehood, Nicole Bessette

Villanova Environmental Law Journal (1991 - )

No abstract provided.

Education In Advance Care Planning: A Novel Equity-Based, Interprofessional Service-Learning Approach, Dorothy Yam, Sriya Kudaravalli, Elizabeth A. Mulvaney, Leslie Scheunemann, Grace W. Orsatti

Journal of Innovation in Health Sciences Education

Introduction: Despite health sciences graduate schools emphasizing service-learning and interprofessionalism, they often struggle to integrate these values into the curricula effectively. Advance care planning is inherently interdisciplinary and presents an opportunity to address equity gaps through service-learning. This report describes a novel interdisciplinary service-learning initiative for graduate student trainees, focused on advance care planning in underserved communities.

Methods: After targeted training, teams of medical, law, and social work students, and professionals from their respective fields, took part in two Life Planning Fairs in historically underserved neighborhoods in Pittsburgh, Pennsylvania. Using a form developed by the Allegheny County Bar Association …

The Mda's Impact: Going Beyond Insurance Reimbursements, Todd Christy D.D.S.

The Journal of the Michigan Dental Association

Dr. Todd Christy, MDA Immediate Past President, acknowledges that inadequate insurance reimbursement rates are a major concern for dental practices. He explains that federal antitrust laws restrict the MDA from directly intervening to "fix" these rates. However, the article emphasizes that the MDA provides significant value and advocacy in many other areas crucial to dentists. Key achievements include eliminating the tax on dental prosthetics, legislating network leasing protections, expanding kindergarten oral health assessments, and regulating mobile dentistry. The MDA also offered vital support during the COVID-19 pandemic, advocated for increased Medicaid facility fees for anesthesia procedures, and assists members with …

Dentistry And The Law: Can I Use Patient Information To Respond To Internet Criticism?, Daniel Schulte J.D.

The Journal of the Michigan Dental Association

This legal guidance addresses dentists' inability to respond to negative online reviews using patient information. The article explains that HIPAA and Michigan's Dentist-Patient Privilege Statute prohibit healthcare professionals from disclosing patient information without authorization, even when defending against false or defamatory online posts. Unlike patients who can freely share information about their treatment, dentists face significant legal restrictions. The author notes that legal recourse is often difficult due to challenges in proving poster identity, distinguishing factual statements from opinions, and demonstrating specific damages. The recommended approach is to avoid responding to negative posts and instead focus on reputation management through …

Why Medicaid Is Addressing Homelessness With Section 1115 Waivers: A Critical Examination Of The United States' Federalist Mental Health System, Joshua Haas

Washington Law Review

Housing and health care are deeply interconnected, and their systemic relationship profoundly affects individual and societal well-being. Inadequate funding has undermined the American mental health system for decades, leading to gaps in care that have caused lasting harm to vulnerable individuals and society as a whole. This Comment examines the historical connections between homelessness and the American mental health system. It explores the benefits and criticisms of the United States’ federalist approach to health care, particularly focusing on Medicaid and its “section 1115 waivers,” which grant states flexibility to develop innovative, state-specific Medicaid programs. Recently, states began to utilize section …

Regulating Healthcare Coverage Algorithms, Jennifer D. Oliva

Indiana Law Journal

American healthcare facilities and providers increasingly rely on algorithmic tools to support clinical decision-making, standards of care, and institutional practices related to patient diagnosis and treatment. This development has been characterized as both “promising” and “peril[ous].” Healthcare algorithms are intended to improve and standardize healthcare decision-making, but they also are capable of exacerbating bias and discrimination and, thus, contributing to the delivery of inequitable care for already disadvantaged groups.

J Mich Dent Assoc June 2025

The Journal of the Michigan Dental Association

The Journal of the Michigan Dental Association is the leading monthly digital publication serving Michigan’s oral health community and the MDA’s 6,200+ members. Distributed globally through the searchable ADA Commons publishing platform, it is the primary channel for news, clinical insights, and professional resources for Michigan dentists.

June Issue Highlights:

• Cover Feature: An in-depth report on the MDA’s advocacy efforts beyond insurance reimbursement, highlighting recent legislative wins and member services that support practice profitability and success.
• Workforce Well-being: A special feature on the stages of stress and burnout, with strategies and resources to support mental health and resilience.
• Compliance Update: …

Symposium Introduction: Illuminating Public Health Struggles Behind Bars, Justin Iverson, Javiera Sothers

Nevada Law Journal

No abstract provided.

Keynote: Promoting Disability Equality Behind Bars, Margo Schlanger

Nevada Law Journal

No abstract provided.

Secretive Sheriffs: Opacity And Variation In California's Jail Responses To Covid-19, Aparna Komarla, Hadar Aviram

Nevada Law Journal

No abstract provided.

Decades Of Indifference And Failures In Accountability In The Provision Of Medical Care In Federal Prisons, Nicole B. Godfrey

Nevada Law Journal

No abstract provided.

Be Aware Of These Hazard Communication Standard Changes, Jennifer Cosey

The Journal of the Michigan Dental Association

Executive Summary: This regulatory update outlines OSHA's revised Hazard Communication Standard published on May 20, 2024, with staggered compliance dates ranging from 18 to 42 months after publication. The changes primarily affect manufacturers and distributors, who must now provide Safety Data Sheets (SDSs) with their first shipments and updates. For dental practices, the standard applies to products containing 1% hazardous ingredients or 0.1% carcinogens, such as disinfectants, medications, amalgam, and adhesives. Key changes include new definitions for liquids, solids, and physical hazards, updated labeling requirements for small containers (≤100 ml), and improved accessibility requirements for SDSs. Manufacturers must now provide …

Menstrual Math: The Price Of Bleeding, Gabrielle Langston

Dissertations, Theses, and Capstone Projects

This project examines the landscape of menstrual equity in the United States through a data storytelling lens, focusing on state-level policies regarding taxation and access to menstrual products. The analysis explores which states impose sales tax on menstrual products, if state schools provide free menstrual products, and which states ensure access for incarcerated individuals using publicly available datasets from advocacy groups. Additionally, there is an investigation into potential correlations between the gender wage gap and states that tax menstrual products, shedding light on economic and policy disparities.

Through its data visualizations, this project aims to provide a clear, although not …

The Activists’ Choice: Ballot Initiatives As A Step Towards Pro-Choice Efforts, Levi C. Mahler

Culture, Society, and Praxis

Following the overturn of Roe V. Wade, many U.S. state legislatures failed to implement abortion rights that satisfy the general population. When the public disapproves of legislative law, some U.S. states allow citizens and activists the right to pursue a ballot initiative. With enough voter signatures, these ballots can turn into new laws. However, with ballot initiatives being a multi-step, lengthy process, what ultimately pushes activists to pursue this path? My research analyzes this novel intersection of political science and sociology fields to contribute to the current lack of literature on activists' decisions to pursue ballot measures for abortion rights. …

Dialing In Or Dialing Out? The Relationship Between State Telemedicine Law And Access To Buprenorphine, Stacey A. Tovino

Texas A&M Law Review

This Article begins by reporting the results of a comprehensive 50-state survey assessing state laws and other state sources governing the telemedicine induction (“tele-induction”) and subsequent telemedicine prescription (“tele-prescription”) of buprenorphine for the treatment of opioid use disorder (“OUD”) following the expiration of the COVID-19 public health emergency (“PHE”). Original, concrete findings include: (1) the glaring patchwork of state law governing the tele-induction and subsequent tele-prescription of buprenorphine for the treatment of OUD in the United States; (2) the variety of primary authorities and secondary sources that house relevant permissions, prohibitions, and affiliated requirements; (3) the number of primary authorities …

The Hidden Revolution: How Patent Law Is Shaping Women's Health Tech, Daniel Mendoza

Tennessee Journal of Race, Gender, & Social Justice

No abstract provided.