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 …

From State To Nation: A Federal Framework For Breast Cancer Primary Prevention Informed By California's Paths To Prevention, Serena Padda

Master's Projects and Capstones

The United States’ federal government should adopt a primary prevention framework for breast cancer modeled after Breast Cancer Prevention Partners’ (BCPP) Paths to Prevention: the California Breast Cancer Primary Prevention Plan. The plan focuses on systemic actions to reduce breast cancer risk through a social and racial justice lens. Breast cancer is the leading diagnosed cancer among women in the United States, with incidence rates increasing annually by 1% since 2012. Disparities persist in communities disproportionately burdened by chemical and environmental exposures, contributing to unequal and preventable risk. Current federal policy focuses primarily on secondary prevention through screenings, which does …

On The Need To Recognize The Erga Omnes Effect In Fundamental Rights In Chilean Law, José Luis Guerrero Becar

Latin American & Caribbean Law Review

This article refers to the Chilean legal tradition of the relative effect of judgments, that is, their effects apply only to the parties involved in the litigation. This principle has an express exception in the Consumer Rights Protection Act, which mentions the erga omnes effect. Since 2010, this principle has come under scrutiny due to constitutional injunctions in social security matters administered by private companies known as ISAPRES (National Health Insurance Companies). These companies have increased the prices of health plans, using tables that apply factors based on age and sex. This has led to the filing of thousands of …

Oct. 2026 - Dentistry And The Law: Dealing With An Unlicensed Employee, Daniel Schulte Jd

The Journal of the Michigan Dental Association

This legal column addresses the severe regulatory and legal risks of employing a dental hygienist whose license has lapsed. MDA Legal Counsel explains that under Michigan law (MCL 333.16222(1)), licensed health care professionals are mandatory reporters and must notify the Michigan Department of Licensing and Regulatory Affairs (LARA) upon learning of unlicensed practice. Continuing to employ an unlicensed hygienist exposes the dental practice to administrative sanctions, loss of licensure, and liability. Practice owners are advised to verify employee licenses regularly and screen for unresolved administrative complaints

Oct. 2026 From The Editor - Advocacy Works. We've Seen It., Romesh Nalliah

The Journal of the Michigan Dental Association

In this editorial, the Editor-in-Chief emphasizes the vital role of professional advocacy in protecting patients and sustaining dental practices. Drawing inspiration from historical advocacy efforts, such as Benjamin Ricci's fight for institutionalized care standards, the article highlights recent victories achieved by the Michigan Dental Association. Key achievements include securing increased Medicaid reimbursement rates after decades of stagnation and advocating for the passage of Senate Bill 105 to eliminate burdensome virtual credit card fees. The author underscores that health policy change requires active engagement from dentists advocating on behalf of their patients and profession.

J Mich Dent Assoc Oct. 2026

The Journal of the Michigan Dental Association

The October 2026 issue of the Journal of the Michigan Dental Association highlights advocacy, leadership, clinical practice, and practice management for Michigan dentists. The cover story examines how MDA advocacy led to the passage of Senate Bill 105, prohibiting forced virtual credit card transaction fees. Features include a profile on Dr. Raymond Gist, first Black ADA president; clinical guidance on caries management with Dr. Melissa Seibert; insights from the LEAD leadership program; and surgical mindfulness by Dr. Anish Gupta. Regular departments cover unlicensed employee legalities, supporting caregiver employees, open health insurance enrollment, and MDA organizational updates.

The Coming Health Insurance Transition, Brendan S. Maher

Faculty Scholarship

For decades, the dominant form of private health insurance in the United States—by far—has been employment-based group health insurance. Somewhere in the range of 175 million employees and their families receive health care coverage through a system in which employers serve as financiers, procurers, administrators, and fiduciaries of the health insurance promise. An overwhelming percentage of those health insurance arrangements are governed by ERISA, with little room for state law.

That is going to change.

This Article explains—for the first time anywhere—why and how. Because of the tremendous and as-yet unrecognized power of an obscure-sounding funding arrangement called the Individual …

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.

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

Fda In 2050: Best- And Worst-Case Scenarios, Michael S. Sinha

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 …

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

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 J.D.

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 …

Post-Approval Problems, Anjali D. Deshmukh M.D., J.D.

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 …

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.

Medical Liability In The Age Of Ai-Driven Healthcare: Ethical Challenges And Legal Framework Recommendations, Rani Tiyas Budiyanti, Roro Isyawati Permata Ganggi, Penggalih Mahardika Herlambang

The Indonesian Journal of Socio-Legal Studies

The integration of artificial intelligence (AI) in healthcare is progressing rapidly and is applied to various aspects of medical practice, including diagnosis, treatment planning, and patient care. However, the integration of AI in healthcare raises complex legal and ethical issues, particularly regarding medical liability. The growing development of AI technology is blurring the concepts of responsibility and accountability in medical practice. Furthermore, with AI systems becoming increasingly autonomous in their decision-making processes, it becomes increasingly difficult to determine responsibility in cases of medical errors or actions that harm patients. In view of this situation this article argues that it is …