Health Law and Policy Commons^™

Addressing The Challenges Of Cognitive Decline In The Physician Workforce, Sharona Hoffman

Faculty Publications

This book chapter examines the growing challenge of cognitive decline among aging physicians and analyzes various approaches to addressing it. In 2024, twenty percent of working physicians were sixty-five or older, and evidence suggests that 12-14% of older clinicians have cognitive deficits that may affect job performance. The chapter evaluates two primary approaches to cognitive assessment: employer-initiated programs and programs operated by state medical boards. Employer "late career practitioner policies" (LCPP) that require older physicians to undergo testing are becoming increasingly popular among health care organizations. But they are vulnerable to challenge under disability and age discrimination laws, as evidenced …

Department Of Health Exerts Strong Control Over Cbct In Dental Offices: Regulations, Adopted Over Objection From Nysda, Take Effect Immediately., Lance Plunkett Jd, Llm

The New York State Dental Journal

On July 22, the New York State Department of Health finally adopted an entire set of new regulations covering all aspects of ionizing radiation. Contained in Article 16 of Title 10 of the Official Compilation of Codes, Rules and Regulations of the State of New York (10 NYCRR), the new regulations repealed and replaced the old Article 16. It is important to note that the new regulations are in effect only in counties outside of New York City. Dentists in New York City should still rely on guidance from the city Department of Mental Health and Hygiene. The regulations contain …

Dentistry And The Law - Understanding ‘Rollover Equity’ When Selling Your Practice, Daniel Schulte Jd

The Journal of the Michigan Dental Association

Daniel J. Schulte, MDA Legal Counsel, addresses the legal and tax implications of 'rollover equity' when dentists sell their practices to private equity-backed buyers. The article outlines typical shareholder and buy-sell agreement restrictions, noting how equity is often subject to vesting and employment covenants. Schulte explains the critical importance of making an Internal Revenue Code Section 83(b) election within 30 days of closing. Failing to file this election results in taxation at high ordinary income rates as the stock vests, whereas a timely election accelerates tax payments but secures lower capital gains tax rates upon eventual sale.

Patient-Centered Imaging In Dentistry, Erika Benavides Dds, Phd, Fabiana Naomi Soki, James R. Geist Dds, Ms, Angela M. Hoikka, Dds, Ms

The Journal of the Michigan Dental Association

This clinical feature discusses joint guidelines by the ADA and AAOMR for patient-centered dental radiography and cone-beam computed tomography (CBCT), emphasizing individual risk-based needs rather than routine schedules. It covers the principles of radiation safety: justification, optimization (ALARA/ALADA), and dose limitation. The article maps out specific imaging modalities recommended for caries, periodontal disease, endodontics, orthodontics, implants, and TMJ disorders. Additionally, it summarizes Michigan's administrative rules for X-ray installation shielding, equipment alignment, stable mechanical support, operator positioning, and the mandatory radiography training program requirements for dental assistants.

When Dentists Spoke Up, The Law Changed, Timothy Rath

The Journal of the Michigan Dental Association

This article details how grassroots member advocacy led to the passage of Michigan Senate Bill 105. Championed by the Michigan Dental Association, the law requires insurers to offer at least one fee-free payment method for dental reimbursements, protecting practices from being forced to pay transaction fees of 3% to 5% to access virtual credit card payments. Once a dentist opts out under the new law, insurers must maintain the alternative payment method. This legislative victory highlights the power of organized dentistry in relieving the administrative and financial burdens faced by individual practitioners amid rising operational overhead costs.

Fireproofing The Fda: Power, Politics, And Public Health, Daniel G. Aaron

Utah Law Review

On September 26, 2025, the S.J. Quinney College of Law hosted the Lee E. Teitelbaum Utah Law Review Symposium — Fireproofing the FDA: Power, Politics, and Public Health. The symposium is available on YouTube. Participants discussed problems longstanding and new in an attempt to chart a path for this vital agency. Topics included (1) What is the purpose of FDA?; (2) In what ways are the current Administration’s actions precedented or unprecedented?; (3) What is the current and ideal relationship between law and politics?; (4) How can law serve as an agent of public health?; and (5) How do we …

Fda Policymaking In The Trump Deregulation Era, Jordan Paradise

Utah Law Review

This Article endeavors to contribute to and continue the conversation about how the Trump deregulatory agenda is impacting a vital national public health agency, the FDA, and our national collective public health in ways that deviate from longstanding agency policy and practice. Various other FDA policy actions deserve concerted attention by legal scholars, including the agency’s recent moves in the direct-to-consumer marketing (DTC) drug space through targeted warning letters and publicity about reforming the “adequate provision” standards, food additives and generally recognized as safe (GRAS) listing processes and directives to industry, adjustments to the biosimilar interchangeability requirements through guidance document, …

Medical Device Regulation: We Can’T Just Go Back (Nor Should We), George Horvath

Utah Law Review

For much of the twentieth century, the federal Food and Drug Administration maintained its reputation as the preeminent regulatory agency, renowned for providing vigilant and scientifically rigorous oversight that ensured the safety and effectiveness of drugs and medical devices. But a former FDA commissioner recently lamented that “[t]he FDA as we’ve known it is finished.” Many commentators have raised concerns that reductions in force will leave the Agency understaffed, that these shortages will prolong review times, and that the standards applied to premarket evaluations of medical products will allow unsafe and ineffective products to reach the market. But in the …

The Fda’S New Clinical Decision Support Software Guidance And Its Implications For Artificial Intelligence, Sara Gerke

Utah Law Review

Artificial Intelligence (AI) is transforming healthcare. While the U.S. Food and Drug Administration (FDA) has authorized the marketing of more than 1,400 AI-based products classified as devices under Section 201(h)(1) of the Federal Food, Drug, and Cosmetic Act, many other AIbased products, including certain clinical decision support (CDS) software tools that provide recommendations to health care professionals about diagnosis, treatment, or prevention of a disease or condition, have been placed on the U.S. market without FDA premarket review. On January 6, 2026, the FDA issued a revised CDS Guidance, which superseded the September 28, 2022 CDS Guidance. Shortly after, the …

Fda In 2050: Best- And Worst-Case Scenarios, Michael Sinha M.D., J.D., M.P.H.

Utah Law Review

In 2025, the Trump administration disrupted many critical aspects of the biomedical research infrastructure in the United States. The Food and Drug Administration (FDA) was not spared. Robert F. Kennedy, Jr., a known vaccine denier with no health care experience, was confirmed as Secretary of the U.S. Department of Health and Human Services (HHS) in February 2025, followed by the confirmation of Dr. Martin Makary as Commissioner of the FDA in April. Departures of long-time FDA scientists, coupled with appointments of key personnel, seemingly because of their public stances on COVID-19 mRNA vaccines, have resulted in a tumultuous year for …

Post-Approval Problems, Anjali Deshmukh

Utah Law Review

Sitting across from 4-year-old Jessica’s parents, I whispered the truth: the most promising drug to fight their daughter’s disease was a therapy approved for adults, not for children her age. We could estimate the dose, monitor her organs, and hope the toxicity would not outpace the benefits, but there was no high-quality clinical trial data proving it was safe for kids like her yet, despite congressional mandates. Unexpected safety issues are often identified after drugs are approved and used outside of a closely controlled clinical trial, especially in understudied populations like children, the elderly, and pregnant women. When I asked …

Evaluating The Case Against Fda Independence, Patricia J. Zettler, Rachel Sachs

Utah Law Review

Many former FDA officials, both politically-appointed leaders and those from the career ranks, as well as numerous FDA scholars have advocated for increased FDA independence in varied forms, and for good reason. At the same time, there are advantages to FDA’s current structure, and there may be ways to insulate career scientific experts’ decisions from political influence and to address other problems by generating independence, without overhauling the agency’s design. Policymakers should consider all options, as particular independence features may, or may not, be the best way, to address concerns about FDA’s capacity to carry out its vital public health …

A Primer Of Medical Device Regulation: How To Go From Reactive To Proactive To Better Protect Patient Safety, Sneha Dave, Rita Redberg

Utah Law Review

FDA oversight of medical devices has too often been reactive, following preventable disasters rather than based on a proactive commitment to patient safety. The history of the device framework, the expansion of expedited pathways, weak postmarket surveillance, broad preemption, and conflicted patient advocacy together create a perfect storm of a regulatory environment that tolerates uncertainty and externalizes costs onto patients. Reforms such as time‑limited breakthrough status, mandatory and enforceable postmarket studies, requirements for more robust safety and efficacy data, and strengthened reporting duty for clinicians would move device regulation closer to FDA’s statutory mandate to protect public health. It would …

Masthead

Seattle University Law Review

No abstract provided.

Table Of Contents

Seattle University Law Review

No abstract provided.

Converting Buildings Is Hard: Why Seattle’S Municipal Government Should Streamline Commercial-To-Residential Conversions, Tyler M. King

Seattle University Law Review

The conversion of commercial buildings into housing is a promising solution to the growing housing crisis in many urban areas. However, despite its potential benefits, the process of repurposing commercial spaces is often stymied by complex zoning codes, high conversion costs, and bureaucratic hurdles. This Article argues that the local and state governments in Seattle should adopt more streamlined policies and offer greater incentives to developers to facilitate these conversions. By reforming zoning regulations and providing targeted financial support, municipalities can reduce the barriers to conversion and unlock the potential of underutilized commercial properties. This article examines the legal and …

Legal Malpractice In Washington: Use Of The Rules Of Professional Conduct, Angelo Tadrous

Seattle University Law Review

Legal malpractice claims are difficult to prove. They are difficult to prove because many jurisdictions require that a plaintiff prove that, but for the lawyer’s misconduct, the client would have fared better. Thus, in a malpractice suit, a plaintiff must try a case within a case. Despite this difficulty, many jurisdictions prohibit the use of the Rules of Professional Conduct when litigating a malpractice case. Washington State is one of these jurisdictions. The Washington Supreme Court held in Hizey v. Carpenter that the Rules of Professional Conduct may not be referred to during trial. This Note argues that this prohibition …

Who Decides The Dead? Interpreting Washington’S Disposition Of Remains Statute, Wyatt Young

Seattle University Law Review

Washington’s disposition-of-remains statute, RCW 68.50.160, is designed to honor a decedent’s expressed wishes regarding the control and disposition of their body after death. Yet recent litigation reveals a critical gap between the statute’s intent-centered design and its practical enforceability. In Larotonda v. Blackburn, a trial court acknowledged that irreparable harm would occur if a decedent’s burial wishes were ignored but nonetheless denied relief on the grounds that the individual designated to carry out those wishes lacked standing. The result was a legal paradox: a statute that recognizes decedent autonomy in theory but withholds any meaningful mechanism for its enforcement …

Getting Money Out Of Politics By Putting Money Into Politics: A Few Modest Proposals To Reform Seattle’S Democracy Voucher Program, Decker O’Donnell

Seattle University Law Review

Seattle’s Democracy Voucher Program offers an unconventional response to the growing influence of money in American elections: rather than restricting political spending, it seeks to amplify the participation of ordinary voters by providing publicly funded vouchers that residents may assign to participating candidates. This Article examines the program’s development, operation, and constitutional foundation within the modern campaign-finance framework established by Buckley v. Valeo and subsequent Supreme Court decisions. It argues that democracy vouchers provide a constitutionally viable means of broadening participation in campaign financing while mitigating the influence of wealthy donors. The Article identifies two weaknesses in the current system: …

Lessons Learned For The Independent Panel For Evidence For Action Against Amr From Previous International Science Panels: Stakeholder Views From The 2025 Lagos Workshop, Iruka N. Okeke, Anthony Mcdonnell, Ayodele A. Akinyele, Javier Guzman, Kevin Outterson

Faculty Scholarship

In September, 2024, the UN General Assembly assigned the Quadripartite Joint Secretariat on Antimicrobial Resistance (AMR) the task of establishing an Independent Panel for Evidence for Action against AMR (IPEA). To promote stakeholder views and input around the constitution and functioning of this Panel, which could feed into the Quadripartite Joint Secretariat’s consultation process, we independently commissioned seven papers to examine the lessons that could be learned from other high-level scientific panels. We then convened 85 stakeholders, primed with the background papers. The Workshop, held in Lagos, Nigeria in April, 2025, drew representation from around the world, particularly low-income or …

J Mich Dent Assoc August 2026

The Journal of the Michigan Dental Association

Each month, the Journal of the Michigan Dental Association delivers news, information, and features about Michigan dentistry to our state's oral health community and the MDA's 6,200-plus members. It remains the main publication reaching Michigan dentists and is available worldwide through ADA Commons.

The August 2026 (Volume 108, No. 8) issue of the Journal is published in print format to provide updates and insights for Michigan's oral health community and MDA members. Print editions occur every other month beginning with January.

The August 2026 issue of the Journal of the Michigan Dental Association explores clinical, professional, legal, leadership, and public …

Dentistry And The Law: Is A Lake Of Understanding Of Billing Procedures Fraud?, Daniel Schulte Jd

The Journal of the Michigan Dental Association

This legal column addresses whether improper dental billing resulting from misunderstanding plan requirements constitutes fraud. The author explains the legal elements necessary to establish fraud, including knowledge, intent, and damages. The article distinguishes billing errors and contract violations from fraudulent conduct and encourages dentists to review participation agreements and billing policies to minimize compliance risks.

The Power Of The Tripartite: Defending Fluoridation Together, Sarah Stuefen Dds

The Journal of the Michigan Dental Association

This article describes a successful grassroots effort to preserve community water fluoridation in Vinton, Iowa. The author details how local dental professionals, state dental associations, the American Dental Association, public health experts, and community stakeholders collaborated to educate decision makers and advocate for evidence-based public health policy. The experience demonstrates the importance of coordinated advocacy and organized dentistry in protecting oral health initiatives.

Paediatricians' Liability To Patients' Parents For Negligent Genetic Testing, Anthony Sangiuliano

Osgoode Hall Law Journal

The Ontario Superior Court of Justice has recently held that a paediatrician might owe a duty of care to a patient’s parents when performing genetic testing on the patient and communicating test results to the parents. The parents may be able to claim damages against the paediatrician for breach of this duty if, in reliance on a miscommunication about the test results, they conceive a subsequent child who is later born with a disability. I call the tort alleged by the parents in these circumstances a subspecies of “paediatric triangular torts.” In this article, I demonstrate the conceptual feasibility of …

Brief Of Public Health And Health Law Scholars As Amici Curiae Urging Affirmance In Support Of Plaintiffs-Appellees, Rachel L. Zacharias, Zeinab Bakhet, Kevin Costello, Maya Manian

Amicus Briefs & Court Filings

INTRODUCTION: Physicians’ use of their judgment and expertise to prescribe drugs and devices for purposes other than those approved by the Food and Drug Administration (“FDA”)—colloquially known as off-label use—is an indispensable feature of modern medicine. The FDA approves drugs as “safe and effective for specific indications.” Christopher M. Wittich, Christopher M. Burkle & William L. Lanier, Ten Common Questions (and Their Answers) About OffLabel Drug Use, 87 Mayo Clinic Procs. 982, 982 (2012). Federal law then generally leaves prescribing decisions, including off-label use of FDA-approved drugs and devices for a patient’s particular indication, to physicians acting under state law …

July 2026 Mda At Your Service — Who Can Supervise Dental Assistant Radiography Training In Michigan?, Mda Membership Department Staff

The Journal of the Michigan Dental Association

This Q&A feature provides practical guidance on common professional and licensing questions for Michigan dentists. It clarifies that any licensed dentist can supervise required dental assistant radiography training, highlighting the MDA's online program. The article also offers advice for new dentists looking to connect with colleagues through local societies and the "New Doc Connection" online hub. Additionally, it outlines the mandatory steps for updating a professional license after a legal name change and directs members to valuable MDA resources for navigating dental insurance contracts and third-party payer agreements.

A Qualitative Study Of Key “Regulatory” Factors Influencing Patient Access To Medical Assistance In Dying In Canada, Ruthie Jeanneret, Eliana Close, Jocelyn Downie, Ben P. White

Dalhousie Law Journal

Medical assistance in dying (“MAiD”) was legalized federally in Canada after the landmark case, Carter v Canada (AG), 2015 SCC 5. Bill C-14 introduced a federal legislative framework for MAiD in 2016, which was amended by Bill C-7 in 2021. Some Bill C-7 amendments directly responded to the decision in Truchon c Canada (PG), 2019 QCCS 3792. Other amendments responded to several factors identified as barriers to patient access, including the requirement for two independent witnesses, the 10-day reflection period, and the requirement to provide final consent at the time of administration of MAiD medication. However, emerging literature identifies that …

Privacy, Paternalism, And Standing In Health Professions Regulation, Anthony Sangiuliano

Dalhousie Law Journal

When investigating whether a doctor has behaved unethically while treating a patient, professional regulatory colleges may search patients’ confidential medical records without patients’ consent. I argue that this practice is not paternalistic, nor does it usurp patients’ standing to decide for themselves whether to sacrifice their privacy to hold the doctor to account for professional wrongdoing. College investigations that non-consensually invade patient privacy do not express disrespect for patients’ agency because they aim to mitigate harm to the broader public. Unlike criminal prosecutions of doctors which uphold moral values pervading the public at large, college investigations enforce ethical standards within …

Litigating The Youth Mental Health Crisis: Mechanisms To Regulate Addictive Social Media Design, Talia Elliott

Washington and Lee Law Review

While social media offers real benefits to users, such as providing access to information and facilitating the free exchange of ideas, excessive social media use is associated with increases in anxiety, depression, and other serious mental-health harms. Social media platforms are designed to maximize profit by capturing user attention, resulting in interfaces that are dangerously addictive and prone to exposing users to harmful content. Currently, social media users alone bear the burden of navigating the dangers of social media. This is untenable. Young users, whose less developed brains leave them more vulnerable to addictive design features, find self-regulation especially challenging. …

Pragmatic Conceptualism, Public Nuisance, And The American Opioid Litigation, Benjamin C. Zipursky

Washington and Lee Law Review

Public nuisance as a part of American tort law has been as high profile in the first decades of this century as products liability law was in the last several decades of the twentieth century. The American opioid litigation over the past decades is a spectacular example, filling headlines and generating billions of dollars of settlements. There is a plausible argument, however, that the doctrinal core of the opioid litigation is meritless because there simply is no “interference with public right” as required by public nuisance law. The first aim of this Article is to articulate and assess that argument. …