Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

5 Questions About COVID-19 and Religious Exemptions

By Chloe Reichel

On February 26th, the Supreme Court of the United States issued a shadow docket decision that could foretell sweeping limitations for public health measures, both within and outside the COVID-19 pandemic context.

The Court’s ruling in the case, Gateway City Church v. Newsom, blocked a county-level ban on church services, despite the fact that the ban applied across the board to all indoor gatherings. This religious exceptionalism is emerging as a key trend in recent Supreme Court decisions, particularly those related to COVID-19 restrictions.

To better understand what these rulings might mean for public health, free exercise of religion, the future of the COVID-19 pandemic, and potential vaccine mandates, I spoke with Professor Elizabeth Sepper, an expert in religious liberty, health law, and equality at the University of Texas at Austin School of Law.

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Empty classroom.

Can Colleges and Universities Require Student COVID-19 Vaccination?

This post originally appeared on the Harvard Law Review Blog.

By I. Glenn Cohen and Dorit Rubinstein Reiss

In the last year, colleges and universities across the U.S. struggled with how to operate during the COVID-19 pandemic. The most recent data, from January 2021, shows a mix of online and in-person modes of instruction.

Pie chart of modes of instruction for higher education institutions during the pandemic.

At the same time, a study of the experience in early fall 2020 found an association between colleges and universities with in-person instruction and increased infection incidence in the counties within which the schools were located. With vaccine authorization in the U.S. and the promise of potential availability for student populations in late spring and summer 2021 (in most states’ allocation plans these students are among the last groups in prioritization), there is increasing interest by higher education institutions in moving more of their fall 2021 educational instruction and non-instructional activities to in-person modes. Vaccinating students is a key step to safely reopening campuses, in whole or in part, in a way that is safe for students, faculty, staff, and local communities. At the same time, university leaders are likely reasonably concerned about the legality of mandating COVID-19 vaccines. Not all students, faculty or staff may appreciate such a requirement, and anti-vaccine groups are more than ready to assist in litigation — as, for example, they did when the University of California required influenza vaccines for on-campus attendance (a preliminary injunction in that case was denied). In this essay, we discuss whether universities can legally require vaccination as a condition of attendance and with what accommodations.

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people waiting in a line.

How the Government Can Prevent Individuals from Using Wealth to Cut the Vaccine Line

Cross-posted from COVID-19 and The Law, where it originally appeared on January 27, 2021. 

By

Since the Food & Drug Administration granted emergency use authorization for the COVID-19 vaccines produced by Pfizer-BioNTech and Moderna in December 2020, there have been many debates on vaccine allocation and prioritization.

As noted by Harvard Law School Professor Glenn Cohen in a recent interview with Annie Kapnick for the COVID-19 and The Law series, the issue of vaccine distribution is “complicated” because of competing factors decision-makers must consider. The relative weights placed on these factors has led to very different prioritization schemes. Initially, the Centers for Disease Control and Prevention (CDC) recommended a hybrid plan that appeared to prioritize individuals who were most likely to contract the virus (e.g., first responders, grocery store workers) over individuals most vulnerable to severe symptoms or death from the virus if contracted (e.g., individuals over the age of 65 not in long-term care facilities). In the United Kingdom, the prioritization groups were primarily based on vulnerability. Similarly, when looking more narrowly at the various plans being implemented at the state level in the United States, there are high degrees of variation.

This post does not seek to evaluate the merits of these or other specific vaccine allocation plans. Rather, it will address a risk that all plans likely face: the potential of individuals using their wealth and access to “cut the line” and be vaccinated ahead of schedule.
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Patient receives Covid-19 vaccine.

Can Employers Mandate a Vaccine Under Emergency Use Authorization?

By Dorit Rubinstein Reiss

Several months ago, I wrote a post asking whether employers can mandate the uptake of a vaccine under an Emergency Use Authorization (EUA). My view then was that there was substantial legal uncertainty, but that the balance indicated that at the least, they may be possible, at the discretion of the Secretary of the Department of Health and Human Services (HHS).

Much of that discussion is still relevant, but developments and new points brought to my attention since have changed my view.

At this point, while there is still legal uncertainty, my view is that the balance of factors supports the ability of employers (or states) to require EUA vaccines. Courts vary, but my current assessment is that most courts would be inclined to uphold an employer mandate for an EUA COVID-19 vaccine.

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Code on computer.

Building Trust Through Transparency? FDA Regulation of AI/ML-Based Software

By Jenna Becker

To generate trust in artificial intelligence and machine learning (AI/ML)-based software used in health care, the U.S. Food and Drug Administration (FDA) intends to regulate this technology with an eye toward user transparency. 

But will transparency in health care AI actually build trust among users? Or will algorithm explanations go ignored? I argue that individual algorithm explanations will likely do little to build trust among health care AI users.

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Person receiving vaccine.

Complex Regulations Push Employers Toward Voluntary Vaccination Programs, Not Mandates

By Lauren Hammer Breslow, JD, MPH

As COVID-19 vaccines become increasingly available, employers have been thrust into the spotlight on the public health question of whether or not to mandate vaccination for employees.

Despite strong evidence that mandatory vaccines best serve public health, a rubric of laws making mandatory programs complicated to deploy is leading many employers to favor vaccine encouragement policies.

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AI concept art.

A Closer Look at FDA’s Newly Released AI/ML Action Plan

By Vrushab Gowda

The U.S. Food and Drug Administration (FDA or “the Agency”) recently issued its long awaited AI/ML (Artificial Intelligence/Machine Learning) Action Plan.

Announced amid the closing days of Stephen Hahn’s term as Commissioner, it takes steps toward establishing a dedicated regulatory strategy for AI products intended as software as a medical device (SaMD), versus those embedded within physical hardware. The FDA has already approved a number of such products for clinical use; however, AI algorithms’ self-learning capabilities expose the limitations of traditional regulatory pathways.

The Action Plan further outlines the first major objectives of the Digital Health Center of Excellence (DHCoE), which was established to much fanfare but whose early moves have remained somewhat unclear. This document presents a policy roadmap for its years ahead.

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Person smoking cigarette.

Should Smokers be Prioritized for COVID Vaccine?

Cross-posted from Harvard Law Today, where it originally appeared on February 2, 2021. 

By Jeff Neal

Should smoking be among the pre-existing health risks that qualify people for priority access to the COVID-19 vaccine? In a Zoom interview with Harvard Law Today, public health expert Carmel Shachar J.D./M.P.H. ’10 says the answer is yes. 

CDC guidelines, which most states are following as they launch mass vaccination programs, say people with certain underlying medical conditions that put them at greater risk for hospitalization or death if they contract COVID-19 (also known as co-morbidities) should receive access to the vaccine before the general population. In Massachusetts, these individuals will be eligible to receive the vaccine in Group 4 of Phase 2 of the state’s vaccination rollout plan. But many have been surprised to see smoking listed among the qualifying conditions, alongside cancer and heart disease.

Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, says that smoking is often the result of structural and biological factors that make it more prevalent in historically marginalized communities, and that denying priority access for smokers would reinforce existing inequities. More practically, she says, “every time a person gets vaccinated, it’s good for the community.” 

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Washington, USA- January13, 2020: FDA Sign outside their headquarters in Washington. The Food and Drug Administration (FDA or USFDA) is a federal agency of the USA.

Weaknesses in Medical Device Regulation Worsened by Trump Administration

By Jacob Howard

In the waning days of the Trump administration, a final push was made to fundamentally weaken regulation of medical devices.

Lambasted as a “full frontal assault on public health” by U.S. Food and Drug Administration (FDA) officials, key policy changes include proposed emergency exemptions to bring a multitude of devices to market without the necessary scientific backing. Justified as a strategy to expedite the delivery of life-saving products, this speed comes at a risk to millions of patients.

As the third most prevalent cause of death in the U.S., medical error continues to be a critical issue that is exacerbated by weakening integrity of the regulatory process. This issue is further compounded by the fact that past regulatory failures in the medical device sphere have not been adequately addressed. The surgical stapler offers an illustrative example.

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A calculator, a stethoscope, and a stack of money rest on a table.

In Defense of Medicare Coverage of Innovative Technologies

By Abe Sutton

On January 12th, the Centers for Medicare & Medicaid Services (CMS) finalized a prior proposal to establish Medicare coverage for breakthrough medical devices approved by the U.S. Food and Drug Administration (FDA).

While some have expressed concerns about the proposal, I believe it is a balanced attempt to encourage innovation and CMS was right to finalize it.

In this post, I give an overview of the general regulatory standards, walk through what the Medicare Coverage of Innovative Technologies (MCIT) proposal does, and lay out a case for why it deserved to be finalized.

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