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Michelle Mello
Commentary

Legal Look at Proof of Vaccination & Ongoing Fight Against COVID-19

David Studdert, Michelle Mello
2021 July 21, 2021

Stanford health law experts Michelle Mello and David Studdert discuss the ongoing pandemic, proof of vaccination “passports” at the state and federal levels, and a July 19 ruling that Indiana University could require that its students be vaccinated.

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Journal Articles

Incorporating Health Equity Into COVID-19 Reopening Plans: Policy Experimentation in California

Emily A. Largent , Govind Persad, Michelle Mello, Danielle M. Wenner, Daniel B. Kramer , Brownsyne Tucker Edmonds, Monica Peek
American Public Health Association, 2021 June 10, 2021
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Journal Articles

Choices In a Crisis - Individual Preferences Among SARS-CoV-2 Vaccines

Daniel B. Kremer, Douglas J. Opel, Efthimios Parasidis , Michelle Mello
The New England Journal of Medicine , 2021 March 3, 2021

Now that a third COVID-19 vaccine has been given emergency-use authorization, Michelle Mello and colleagues ask whether individuals should be able to choose which vaccine they receive.

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Commentary

Far More Transparency is Needed for COVID-19 Vaccine Trials

Jennifer E. Miller , Joseph S. Ross, Michelle Mello
STAT News, 2020 November 5, 2020

With vaccines against SARS-CoV-2, the virus that causes Covid-19, on the near-term horizon, U.S. policymakers are focusing on how to ensure that Americans get vaccinated. This challenge has been compounded by reports that White House officials are exerting undue influence over the agencies that would ordinarily lead such efforts, the Food and Drug Administration and the Centers for Disease Control and Prevention.

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Journal Articles

School Reopenings and the Community During the COVID-19 Pandemic

Jeremy Goldhaber-Fiebert, David Studdert, Michelle Mello
JAMA Network, 2020 October 28, 2020

Few issues in the policy response to the coronavirus disease 2019 (COVID-19) pandemic have inspired as impassioned debate as school reopening. There is broad agreement that school closures involve heavy burdens on students, parents, and the economy, with profound equity implications, but also that the risk of outbreaks cannot be eliminated even in a partial reopening scenario with in-school precautions. Consensus largely ends there, however: the approaches states and localities have taken to integrating these concerns into school reopening plans are highly variable.

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Journal Articles

The Missing Piece -- SARS-CoV-2 Testing and School Reopening

Yasmin Rafiei, Michelle Mello
New England Journal of Medicine, 2020 October 21, 2020

On August 17, 2020, the Los Angeles Unified School District launched a program to test more than 700,000 students and staff for SARS-CoV-2. The district is paying a private contractor to provide next-day, early-morning results for as many as 40,000 tests daily. As of October 4, a total of 34,833 people had been tested at 42 sites. The program is notable not only because it’s ambitious, but also because it’s unusual: testing is conspicuously absent from school reopening plans in many other districts.

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Journal Articles

The Missing Piece -- SARS-CoV-2 Testing and School Reopening

Yasmin Rafiei, Michelle Mello
New England Journal of Medicine, 2020 October 21, 2020

On August 17, 2020, the Los Angeles Unified School District launched a program to test more than 700,000 students and staff for SARS-CoV-2. The district is paying a private contractor to provide next-day, early-morning results for as many as 40,000 tests daily. As of October 4, a total of 34,833 people had been tested at 42 sites. The program is notable not only because it’s ambitious, but also because it’s unusual: testing is conspicuously absent from school reopening plans in many other districts.

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Journal Articles

Partitioning the Curve — Interstate Travel Restrictions During the Covid-19 Pandemic

David Studdert, Mark Hall, Michelle Mello
New England Journal of Medicine, 2020 August 5, 2020

Since the onset of the Covid-19 crisis in the United States, government action taken to “flatten” the curve of disease transmission has varied dramatically among states, counties, and cities. The early epicenters — New York City, Washington State, and the San Francisco Bay Area — implemented aggressive measures in mid-March, many of which remain in place. Other states and localities opted for milder restrictions, acted much later, or barely intervened at all. Many states began unwinding restrictions weeks ago, although surging case numbers are prompting some to change course.

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Journal Articles

Attacks on Public Health Officials During COVID-19

Michelle Mello, Jeremy A. Greene , Joshua M. Sharfstein
JAMA Network, 2020 August 5, 2020

In June 24, 2020, California Governor Gavin Newsom remarked on a disturbing phenomenon: health officers are “getting attacked, getting death threats, they’re being demeaned and demoralized.” At least 27 health officers in 13 states (including Nichole Quick of Orange County in southern California, Ohio Health Director Amy Acton, and West Virginia Health Officer Cathy Slemp) have resigned or been fired since the start of the coronavirus disease 2019 (COVID-19) pandemic.

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Journal Articles

Respecting Disability Rights — Toward Improved Crisis Standards of Care

Michelle Mello, Govind Persad , Douglas B. White
New England Journal of Medicine, 2020 July 30, 2020

In times of emergency, many legal strictures can flex. For example, to enable hospitals to respond to Covid-19, the Department of Health and Human Services (HHS) recently waived a swath of federal regulatory requirements. But though officials’ emergency powers are extensive, the ability to discard antidiscrimination protections is not among them. A hallmark of our legal system is that our commitment to prohibiting invidious discrimination remains steadfast even in times of emergency.

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Journal Articles

The Legal Authority for States’ Stay-at-Home Orders

Mark A. Hall, Michelle Mello, David Studdert
New England Journal of Medicine , 2020 July 30, 2020

In March 2020, when many U.S. states and localities issued their first emergency orders to address Covid-19, there was widespread acceptance of the government’s legal authority to respond quickly and aggressively to this unprecedented crisis. Today, that acceptance is fraying. As initial orders expire and states move to extend or modify them, legal challenges have sprouted. The next phase of the pandemic response will see restrictions dialed up and down as threat levels change.  As public and political resistance grows, further legal challenges are inevitable.

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Journal Articles

Ensuring Uptake of Vaccines against SARS-CoV-2

Michelle Mello, Ross D. Silverman, Saad B. Omer
New England Journal of Medicine, 2020 June 26, 2020

As Covid-19 continues to exact a heavy toll, development of a vaccine appears the most promising means of restoring normalcy to civil life. Perhaps no scientific breakthrough is more eagerly anticipated. But bringing a vaccine to market is only half the challenge; also critical is ensuring a high enough vaccination rate to achieve herd immunity. Concerningly, a recent poll found that only 49% of Americans planned to get vaccinated against SARS-CoV-2.

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Journal Articles

Ethics and Governance for Digital Disease Surveillance

Michelle Mello, C. Jason Wang
Science Magazine , 2020 May 29, 2020

Digital epidemiology—the use of data generated outside the public health system for disease surveillance—has been in use for more than a quarter century [see supplementary materials (SM)]. But several countries have taken digital epidemiology to the next level in responding to COVID-19. Focusing on core public health functions of case detection, contact tracing, and isolation and quarantine, we explore ethical concerns raised by digital technologies and new data sources in public health surveillance during epidemics.

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Journal Articles

Thinking Globally, Acting Locally — The U.S. Response to Covid-19

Rebecca L. Haffajee, Michelle Mello
New England Journal of Medicine, 2020 May 28, 2020

Covid-19 has exposed major weaknesses in the United States’ federalist system of public health governance, which divides powers among the federal, state, and local governments. SARS-CoV-2 is exactly the type of infectious disease for which federal public health powers and emergencies were conceived: it is highly transmissible, crosses borders efficiently, and threatens our national infrastructure and economy. Its prevalence varies around the country, with states such as Washington, California, and New York hit particularly hard, but cases are mounting nationwide with appalling velocity.

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Commentary

Standing Up against Gender Bias and Harassment — A Matter of Professional Ethics

Michelle Mello, Reshma Jagsi
New England Journal of Medicine, 2020 April 9, 2020

“We believe health professionals have a moral duty to practice `upstanding’ — intervening as bystanders — in response to sexual harassment and general bias and that this obligation should be described in codes of medical professional ethics and supported within institutional training,” the authors write. While many medical professional societies now mention sexual harassment in their ethical codes, these guidelines fall short in that they do not encourage professionals to respond to the behaviors and intervene when they become aware of discrimination or harassment.

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Journal Articles

Diagnostic Testing for the Novel Coronavirus

Joshua M. Sharfstein, Scott J. Becker, Michelle Mello
JAMA Network, 2020 March 9, 2020

Controversies over diagnostic testing have dominated US headlines about severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), the novel coronavirus responsible for coronavirus disease 2019 (COVID-19). Technical challenges with the first test developed by the Centers for Disease Control and Prevention (CDC) left the nation with minimal diagnostic capacity during the first few weeks of the epidemic. The CDC also initially limited access to testing to a narrow group of individuals with known exposure.

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Journal Articles

Drug Companies’ Liability for the Opioid Epidemic

Rebecca L. Haffejee, Michelle Mello
The New England Journal of Medicine, 2017 December 14, 2017

The opioid epidemic has claimed more than 300,000 lives in the United States since 20001

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Journal Articles

The Evolving Story of Overlapping Surgery

Michelle Mello, Edward H. Livingston, Edward H. Livington
JAMA, 2017 June 28, 2017

In December 2015, a Boston Globe investigation of Massachusetts General Hospital (MGH) sparked investigations into concurrent and overlapping surgery. Overlapping surgery refers to operations performed by the same primary surgeon such that the start of one surgery overlaps with the end of another. A qualified practitioner finishes noncritical aspects of the first operation while the primary surgeon moves to the next operation.

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Commentary

Medical Liability — Prospects for Federal Reform

Michelle Mello, Allen Kachalia, David Studdert
The New England Journal of Medicine, 2017 March 29, 2017

Medical malpractice reform appears to be back on the federal policy agenda. The appointment of Tom Price, a long-time proponent of tort reform, as secretary of health and human services, in conjunction with Republican control of both houses of Congress, has created fertile conditions for several Republican proposals that have languished for years without the requisite support. Although it has been debated many times, a major federal foray into medical liability, a state-based area of law, would be unprecedented. The prospect raises several questions: Which reforms are on the table?

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Journal Articles

Legal and Policy Interventions to Improve Patient Safety

Allen Kachalia, Michelle M. Mello, Brahmajee K. Nallamothu, David M. Studdert
Circulation, 2016 February 1, 2016

Twenty years ago, few systematic efforts to make health care safer existed. Today, patient safety is a priority for patients, providers, payers, and policy makers. The Institute of Medicine’s 1999 report on medical error prompted a flurry of activity, including widespread adoption of error detection and reporting programs, movement toward systems approaches for addressing error, development of new clinical interventions to reduce error, and efforts to foster stronger safety cultures within healthcare organizations.

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Journal Articles

Prevalence and Characteristics of Physicians Prone to Malpractice Claims

David Studdert, Marie M. Bismark, Michelle M. Mello, Harnam Singh, Matthew J. Spittal
The New England Journal of Medicine, 2016 January 28, 2016

Background

The distribution of malpractice claims among physicians is not well understood. If claim-prone physicians account for a substantial share of all claims, the ability to reliably identify them at an early stage could guide efforts to improve care.

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Commentary

Shifting Vaccination Politics — The End of Personal-Belief Exemptions in California

David Studdert, Michelle Mello, Wendy Parmet
The New England Journal of Medicine, 2015 July 22, 2015

Stanford Health Policy's David Studdert and Michelle Mello discuss SB 277, a new California law that ends exceptions to vaccination mandates based on religious and philosophical beliefs, leaving only medical exemptions as a path to avoid the vaccinations children are required to have before entering school.  Their report highlights the factors that lead to the law's passage, potential legal and enforcement challenges the law may face, and the possibility that this law may set a precedent for similar laws in other states.

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Journal Articles

Searching for Public Health Law’s Sweet Spot: The Regulation of Sugar-Sweetened Beverages

David Studdert, Michelle M. Mello, Jordan Flanders
PLOs, 2015 July 7, 2015

David Studdert and colleagues explore how to balance public health, individual freedom, and good government when it comes to sugar-sweetened drinks. Over the last decade, many national, state, and local governments have introduced laws aimed at curbing consumption of sugar-sweetened beverages (SSBs), especially by children.

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