Health Law and Policy Commons^™

Tort Immunity In The Pandemic, Betsy J. Grey, Samantha Orwoll

Indiana Law Journal

The Covid-19 pandemic set off a public health emergency that quickly brought doctors and other health care providers to the front line, while shuttering businesses throughout the United States. In response to the emergency, the federal and state governments rapidly created broad protections from tort liability for health care providers. To encourage businesses to reopen, some states have also provided liability protection for businesses from personal injury suits brought by patrons and employees. Congress is considering similar protections for businesses as it contemplates further aid packages. Some industries, like nursing homes and universities, are lobbying for specific immunity. This Essay …

Association For Molecular Pathology V. Myriad Genetics: A Critical Reassessment, Jorge L. Contreras

Michigan Technology Law Review

The Supreme Court’s 2013 decision in Association for Molecular Pathology v. Myriad Genetics is an essential piece of the Court’s recent quartet of patent eligibility decisions, which also includes Bilski v. Kappos, Mayo v. Prometheus, and Alice v. CLS Bank. Each of these decisions has significantly shaped the contours of patent eligibility under Section 101 of the Patent Act in ways that have been both applauded and criticized. The Myriad case, however, was significant beyond its impact on Section 101 jurisprudence. It was seen, and litigated, as a case impacting patient rights, access to healthcare, scientific freedom, …

Transgender Healthcare Is Medically Necessary, Molly Nunn

Mitchell Hamline Law Review

No abstract provided.

Finding Parity Through Preclusion: Novel Mental Health Parity Solutions At The State Level, Ryan D. Kingshill

Dickinson Law Review (2017-Present)

Recently, the federal government has taken numerous steps to promote the equal treatment (also known as parity) of mental and physical health issues. The two most impactful actions are the Mental Health Parity and Addiction Act of 2008 and the Affordable Care Act. These acts focus on the traditional avenue for parity change—insurance regulation. While these acts have improved parity, major gaps in coverage and treatment between mental health/substance use disorder treatment and medical/surgical treatment persist. ERISA Preemption, evasive insurer behavior, lack of enforcement, and lack of consumer education continue to plague patients and healthcare professionals. On its own, federal …

Achieving Better Care In Pennsylvania By Allowing Pharmacists To Practice Pharmacy, Travis Murray

Dickinson Law Review (2017-Present)

Traditionally, state legislatures implemented Prescription Drug Monitoring Programs (“PDMPs”) to assist prescribers, pharmacists, and law enforcement in identifying patients likely to misuse, abuse, or divert controlled substances. PDMP databases contain a catalog of a patient’s recent controlled substances that pharmacies have filled, including the date, location, the quantity of medication filled, and the prescribing health care provider. Prescribers in Pennsylvania have a duty to query the PDMP before prescribing controlled substances in most clinical settings. Pharmacists have a similar duty in Pennsylvania to dispense safe and effective medication therapy to patients and to screen patients for potential signs of misuse, …

Redefining Healthcare To Address Racial Health Disparities & Inequities, Abdur Rahman Amin

Mitchell Hamline Law Journal of Public Policy and Practice

No abstract provided.

Should The U.S. Government Actively Assert Its Own Patents?, Christopher J. Morten, Barry Datlof, Amy Kapczynski, Donna Meuth, Zain Rizvi

Faculty Scholarship

On March 10, 2021, our journal partnered with the Engelberg Center on Innovation Law and Policy to host a symposium addressing the role and impact of U.S. innovation policy on access to medicine. Our 2021 Symposium Issue — Volume 11, Issue 1 — captures that event.

The following article represents the second of four panels. This panel asked, “Should the U.S. government actively assert its own patents?” The panel was moderated by Christopher Morten, Deputy Director of NYU Law’s Technology Law & Policy Clinic. The panelists included Barry Datlof, Chief of Business Development and Commercialization in the Office of Medical …

Hacking Hipaa: "Best Practices" For Avoiding Oversight In The Sale Of Your Identifiable Medical Information, Riyad A. Omar

Journal of Law and Health

In light of the confusion invited by applying the label "de-identified" to information that can be used to identify patients, it is paramount that regulators, compliance professionals, patient advocates and the general public understand the significant differences between the standards applied by HIPAA and those applied by permissive "de-identification guidelines." This Article discusses those differences in detail. The discussion proceeds in four Parts. Part II (HIPAA’s Heartbeat: Why HIPAA Protects Identifiable Patient Information) examines Congress’s motivations for defining individually identifiable health information broadly, which included to stop the harms patients endured prior to 1996 arising from the commercial sale of …

The Early Impact Of The Affordable Care Act Upon Colorectal Cancer Screening Utilization In Florida, Aldenise P. Ewing, Laura Baum, Rosalyn Roker, Marlene Joannie Bewa, Tali Schneider, Claudia F. Parvanta, Clement K. Gwede, Cathy D. Meade, Dinorah Martinez Tyson

Journal of Health Disparities Research and Practice

Background: Colorectal cancer is the second leading cause of cancer-related deaths in the United States. Although preventable and curable through screening, early detection and treatment, a lack of health insurance is a major obstacle to receiving colorectal cancer screening (CRCS). Despite the Affordable Care Act (ACA) increasing access to health insurance by mandating coverage of CRCS, disparities in utilization rates continue. Therefore, researchers sought to better understand ACA related facilitators and impediments that affect the utilization of CRCS and collect specific recommendations from healthcare professionals to increase screening utilization rates in Florida.

Methods: Researchers conducted in-depth interviews with …

Striving For The Mountaintop: The Elimination Of Health Disparities In A Time Of Retrenchment (1968-2018), Gwendolyn R. Majette

Law Faculty Articles and Essays

Health disparities in the United States are real. People of color are the adverse beneficiaries of these facts-lower life expectancy, higher rates of morbidity and mortality, and poorer health outcomes in general. This Article analyzes the laws and policies that improve and create barriers to improving people of color's health since the death of Reverend Martin Luther King, Jr. in 1968. The Article builds upon my earlier scholarship and considers the effectiveness of the "PPACA Framework to Eliminate Health Disparities" since the Patient Protection and Affordable Care Act (PPACA) was enacted in 2010.

The Article also explores the impact of …

Reclaiming Access To Truth In Reproductive Healthcare After National Institute Of Family & Life Advocates V. Becerra, Diane Kee

Michigan Law Review

Crisis Pregnancy Centers (CPCs) are antiabortion organizations that seek to “intercept” people with unintended pregnancies to convince them to forego abortion. It is well documented that CPCs intentionally present themselves as medical professionals even when they lack licensure, while also providing medically inaccurate information on abortion. To combat the blatant deception committed by CPCs, California passed the Reproductive FACT Act in 2015. The Act required CPCs to post notices that disclosed their licensure status and informed potential clients that the state provided subsidized abortion and contraceptives. Soon after, CPCs brought First Amendment challenges to these disclosure requirements, claiming that the …

Keeping The Patient At The Center Of Machine Learning In Healthcare, Jessica Findley, Andrew Woods, Christopher Robertson, Marvin J. Slepian

Faculty Scholarship

Char et al. (2020) aspire to provide "a systematic approach to identifying ... ethical concerns" around machine learning healthcare applications (ML-HCAs), which includes artificial intelligence and big data. Their approach, styled around the development "pipeline" for new technologies, has valuable insights, but we think it over-emphasizes technical design questions and under-emphasizes core ethical questions. There is little ethical debate about whether to maximize accuracy, evaluation, and oversight, at reasonable cost. Of course those goals should be pursued, but these are design challenges about feasibility more than ethical concerns.

Preventing The Corruption Of Healthcare Algorithms, Philip M. Nichols

Notre Dame Journal on Emerging Technologies

The intersection of technology and healthcare will radically change the provision of healthcare services. The full extent of the changes cannot be known now, but the direction is clear: collection of voluminous data and tools powerful enough to analyze that data will facilitate the design of algorithms that will enable machines to make important decisions regarding diagnoses and treatments. In addition to the possible benefits, policymakers and scholars have focused on issues of privacy and potential bias. The potential for corruption of the design of healthcare algorithms has been ignored, but the potential for corruption is real and dangerous. This …

Proceeding Without Consent: The Ethics Of Disregarding Patient Preference For Paternalistic Reasons, Nicholas Munsey

Undergraduate Theses and Capstone Projects

Within the last few decades, modern medical regulations have brought the practicing medical community to an unprecedented level of accountability. Laws and regulations governing the practice of medicine were once, at best, loosely enforced guidelines; practices such as experimental surgeries, dangerous health testing, end of life care, and treatment of mental illness were left comparatively unregulated. The introduction of patient rights and new standards for practicing have left the medical community with a novel dilemma: how might one approach a patient who, according to medical advice, is in need of treatment if that patient is unable to express preference or …

Telehealth For An Aging Population: How Can Law Influence Adoption Among Providers, Payors, And Patients?, Tara Sklar, Christopher Robertson

Faculty Scholarship

Telehealth continues to experience substantial investment, innovation, and unprecedented growth. However, telehealth has been slow to transform healthcare. Recent developments in telehealth technologies suggest great potential for chronic care management, mental health services, and care delivery in the home—all of which should be particularly impactful for an aging population with physical and cognitive limitations. While this alignment of technological capacity and market demand is promising, legal barriers remain for telehealth operators to scale up across large geographic areas. To better understand how federal and state law can be reformed to enable greater telehealth utilization, we review and extract lessons from …

Mhpaea & Marble Cake: Parity & The Forgotten Frame Of Federalism, Taleed El-Sabawi

Dickinson Law Review (2017-Present)

No abstract provided.

Distinguishing Moral Hazard From Access For High-Cost Healthcare Under Insurance, Christopher Robertson, Andy Yuan, Wendan Zhang, Keith Joiner

Faculty Scholarship

Health policy has long been preoccupied with the problem that health insurance stimulates spending (“moral hazard”). However, much health spending is costly healthcare that uninsured individuals could not otherwise access. Field studies comparing those with more or less insurance cannot disaggregate moral hazard versus access. Moreover, studies of patients consuming routine low-dollar healthcare are not informative for the high-dollar healthcare that drives most of aggregate healthcare spending in the United States.
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/="/">We test indemnities as an alternative theory-driven counterfactual. Such conditional cash transfers would maintain an opportunity cost for patients, unlike standard insurance, but also guarantee access to …

Returning Results In The Genomic Era: Initial Experiences Of The Emerge Network, Ellen W. Clayton, Georgia L. Wiesner, Alanna K. Rahm, Et Al.

Vanderbilt Law School Faculty Publications

A goal of the 3rd phase of the Electronic Medical Records and Genomics (eMERGE3) Network was to examine the return of results (RoR) of actionable variants in more than 100 genes to consenting participants and their healthcare providers. Each of the 10 eMERGE sites developed plans for three essential elements of the RoR process: Disclosure to the participant, notification of the health care provider, and integration of results into the electronic health record (EHR). Procedures and protocols around these three elements were adapted as appropriate to individual site requirements and limitations. Detailed information about the RoR procedures at each site …

Pisc In The Wind? Holding Healthcare Organizations Liable For Publicly Issued Statements Of Conduct, Joshua E. Perry, Timothy L. Fort

American University Law Review

Has the moment arrived when we can no longer permit a company, that espouses value statements and ethical programs professing a dedication to help and to heal, to act in ways that are contrary and harmful to individual or collective goods? Fully acknowledging that we, two legally trained business ethics professors, are pursuing a line of inquiry rooted in the aspiration of a more robustly just marketplace, we are convinced that it is time for serious reflection upon the question: Should healthcare companies be held accountable for ways in which they deviate from publicly issued statements of conduct (PISC)?

The Healthcare Privacy-Artificial Intelligence Impasse, Charlotte A. Tschider

Faculty Publications & Other Works

With the advent of the Internet, wireless technologies, advanced computing, and, ultimately, the integration of mobile devices into patient care, medical device technologies have revolutionized the healthcare sector. What once was a highly personal, one-to-one relationship between physician and patient has now been expanded, including medical device manufacturers, third party healthcare system providers, even physician-as-a-service for interpreting the data complex systems churn out. The introduction of technology to the healthcare field has, at an ever-increasing rate, transformed human health management.

Reworking privacy commitments in an AI world is an important endeavor. It may mean that we reconceptualize what these rights …

The Pharma Perspective: The Double-Edged Sword Of Direct-To-Consumer Advertising, Ela H. Yalcin

Health Law Outlook

No abstract provided.

Elevating Physician-Patient Relationships In The Shadow Of Metric Mania, Benjamin Sundholm

Faculty Publications

Today, medical and health institutions devote significant time and resources to documenting, measuring, and reporting various metrics. These metrics are used to improve various aspects of care, from efficiency and quality to safety and access. Unfortunately, too often, medical and health institutions overemphasize metrics that are easily captured but too simplistic. As a result, insufficient attention is devoted to crucial, albeit complex and difficult to measure, facets of care. Physician-patient relationships are among the primary casualties resulting from the widespread penchant for overly simplistic metrics. This Article develops a strategy for improving such relationships. I suggest that enhancing physicians' interpersonal …

Covid-19 Vaccines As Global Public Goods, Jason W. Nickerson, Matthew Herder

Articles, Book Chapters, & Popular Press

Vulnerable: The Law, Policy and Ethics of COVID-19 confronts the vulnerabilities that have been revealed by the pandemic and its consequences. It examines vulnerabilities for people who have been harmed or will be harmed by the virus directly and those harmed by measures taken to slow its relentless march; vulnerabilities exposed in our institutions, governance, and legal structures; and vulnerabilities in other countries and at the global level where persistent injustices affect us all. COVID-19 has forced us to not only reflect on how we govern and how we set policy priorities, but also to ensure that pandemic preparedness, precautions, …

Sb 18 - Direct Primary Care, Valentin H. Dubuis, Juliana Mesa

Georgia State University Law Review

This legislation allows physicians to offer specified care for a specific time pursuant to a fixed fee. The physician cannot require more than one year’s payment upfront, and the agreement has to be terminable by either party with thirty days’ notice. Physicians do not have to provide care if the fee has not been paid or the patient has committed fraud, failed to adhere to treatment, or is in physical danger.

Hb 481 - Heartbeat Bill, Michael G. Foo, Taylor L. Lin

Georgia State University Law Review

The Act adds an unborn child with a detectable human heartbeat to the definition of a natural person and includes such unborn child in state population counts. The Act defines abortion, prescribes when abortions may be performed, provides exceptions to abortion performance limitations, establishes requirements for performing an abortion, and provides for a right of action, damages, and affirmative defenses. The Act permits alimony and child support payments starting when an unborn child has a detectable human heartbeat. Parents have the right to recover the full value of a child’s life when a detectable human heartbeat exists. The Act requires …

Sb 106 - Patients First Act, Jasmine Nicole Becerra, Leanne E. Livingston

Georgia State University Law Review

The Patients First Act amends both Title 49 and Title 33 of the Official Code of Georgia Annotated, which allows the state to apply for two federal waivers. One being the Section 1115 waiver to the Social Security Act. The second being the Section 1332 waiver to the Affordable Care Act. Section 1115 waivers apply to Medicaid and may be sought to include a maximum income threshold up to 100% of the Federal Poverty Level. The Section 1332 innovation waiver applies to insurance coverage generally.

10th Annual Pegalis Law Group Health Law Colloquium, New York Law School

Health Law Society Publications

Federalism, ERISA, and State Single-Payer Health Care. How to Make Sense of Future Legislation and the Impact on Population Health

(CLE Presentation on Oct. 24th 2019)

Moderator:

Adam S. Herbst, Esq., Senior Vice President, Chief Legal and Strategic Planning Officer of Blythedale’s Children Hospital; Adjunct Professor at New York Law School teaching Health Law and Policy; Co-director of the NYLS Health Law and Patient Safety Project; Lecturer, Mailman School of Public Health at Columbia University

Panelists:

Honorable Richard N. Gottfried, New York State Assembly (District 75) & Chairman of the Assembly's Committee on Health and Sponsor of …

Contracting For Healthcare: Price Terms In Hospital Admission Agreements, George A. Nation Iii

Dickinson Law Review (2017-Present)

This article discusses the application of contract law principles to the relationship between hospitals and patients to determine how much patients owe for the health care they receive. For patients who are covered by in-network health insurance the exact nature of the contract created with the hospital usually is not relevant to the patient’s financial obligation because the patient’s contract with the hospital is superseded by the contract between the patient’s health insurer and the hospital. Nevertheless, even in-network patients are financially impacted, via increased insurance premiums, by the contract analysis discussed here, and for the increasing number of patients …

Bearing Hospital Tax Breaks: How Non-Profits Benefit From Your Surprise Medical Bills, Taylor N. Armstrong

Georgia State University Law Review

This Note addresses the growing issue of surprise medical bills and how the United States Tax Code can be used to prevent many patients from receiving these bills. Part I provides a background on surprise billing and market factors that have led to an increase in the bills as well as current legislative solutions to the problem. Part II analyzes the role that hospitals play in the insurance market, the current standards for nonprofit hospitals to receive tax exemption under Internal Revenue Code (IRC) § 501, and how these legal standards fall short of accomplishing the goals of the tax …

The Ever-Changing Landscape Of Informed Consent And Whether The Obligation To Explain A Procedure To The Patient May Be Delegated, Samuel D. Hodge, Maria Zambrano Steinhaus

Arkansas Law Review

Informed consent is an integral part of the shared decision making process and requires a patient be informed of the benefits, risks and alternatives to a medical procedure. This information, which requirement has been codified into the law and practice of every healthcare provider, helps a patient decide whether to proceed with the recommended treatment plan. Informed consent has its foundation in the ethical notion of patient autonomy and fundamental human rights. After all, it is the patient’s decision to determine what may be done to his or her body and to ascertain the risks and benefits before undertaking a …