3D rendering of COVID-19 virus.

Consider the Fundamentals of Viruses When Crafting Law and Policy Responses

By Jennifer S. Bard

Lawyers and law professors are very much part of the ongoing efforts to make policy in response to the COVID-19 pandemic. Like everyone else involved, we face the particular challenge of being confronted daily with what seems to be an ever-changing flow of information about a newly emerged and rapidly mutating virus.

But what may help us better make or evaluate policy is a better understanding of some typical characteristics of viruses that make all of them very difficult to contain, rather than just the unique features of the one threatening us now.

Knowing more about the ways that viruses spread could help us avoid the pitfalls of declaring victory too early, rolling back existing infection control measures, and ending up worse off than we have been at any stage of this pandemic.

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Highway alert: Covid-19 checkpoint ahead, overhead sign in Florida on state border.

Amending the Public Health Service Act to Encourage CDC Action to Stop COVID-19

By Jennifer S. Bard

The U.S. Centers for Disease Control and Prevention (CDC) already has all the power it needs to limit the movement of people in order to slow the spread of COVID-19.

Yet, throughout this pandemic, they have taken no steps beyond issuing stark warnings, which have been only marginally effective. For example, this Thanksgiving, estimates indicate that almost 5 million flew and up to 50 million drove to join others. Dr. Deborah Birx is warning that everyone who did so should consider themselves infected.

The CDC’s historic reluctance to institute the politically unpopular measure of restricting travel could be countered by adding a self-executing amendment to 42 U.S. Code 264 requiring that the option be assessed at the beginning of an outbreak and periodically reviewed. More specifically, this amendment should create a review committee and set metrics for travel restrictions.

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Box of Hydroxychloroquine Tablets

Human Subjects Research in Emergencies: The Texas Nursing Home “Study” (Part II)

By Jennifer S. Bard

This post is the second in a series about conducting human subjects research in emergencies. These posts are being written in response to a rapidly evolving situation and will reflect the state of knowledge at the time of writing.

In April 2020, Dr. Robin Armstrong, medical director of the Resort, a nursing home in Texas City, Texas, reported “signs of improvement” after he gave hydroxychloroquine, a drug approved by the FDA to treat malaria, to 39 of his nursing home patients who were diagnosed with COVID-19.

At about the same time, information was emerging that now represents the current understanding that hydoxychloroquine isn’t only ineffective in treating COVID-19, but also may cause serious harm to patients. Tensions were raised even higher by the seemingly inexplicable enthusiasm for this treatment by the President and some media outlets.

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Researcher works at a lab bench

Human Subjects Research in Emergencies: An Ethical and Legal Guide (Part I)

By Jennifer S. Bard

This post is the first in a series about conducting human subjects research in emergencies. These posts are being written in response to a rapidly evolving situation and will reflect the state of knowledge at the time of writing.

The world is facing a medical emergency in the form of the rapid spread of a new virus, COVID-19, for which there is no known effective treatment and no preventive vaccine.

Without minimizing the need for haste or the significance of the threat, it is still important to remain aware of the risks inherent in rushing to treat patients with anything that might work and simultaneously conducting the research necessary to identify safety and effective interventions.

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DNA sequence

How the Internet and The Mapping of the Human Genome Disrupted the Teaching of Health Law: Does The 21st Century Really Change Everything?

This piece was part of a symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. The symposium was originally posted through the Northeastern University Law Review Online Forum.

Promises and Perils of Emerging Health Innovations Blog Symposium

We are pleased to present this symposium featuring commentary from participants in the Center for Health Policy and Law’s annual conference, Promises and Perils of Emerging Health Innovations, held on April 11-12, 2019 at Northeastern University School of Law. As a note, additional detailed analyses of issues discussed during the conference will be published in the forthcoming issue of the Northeastern University Law Review.

Throughout the two-day conference, speakers and attendees discussed how innovations, including artificial intelligence, robotics, mobile technology, gene therapies, pharmaceuticals, big data analytics, tele- and virtual health care delivery, and new models of delivery, such as accountable care organizations (ACOs), retail clinics, and medical-legal partnerships (MLPs), have entered and changed the healthcare market. More dramatic innovations and market disruptions are likely in the years to come. These new technologies and market disruptions offer immense promise to advance health care quality and efficiency, as well as improve provider and patient engagement. Success will depend, however, on careful consideration of potential perils and well-planned interventions to ensure new methods ultimately further, rather than diminish, the health of patients, especially those who are the most vulnerable.

In her post for the Promises and Perils of Emerging Health Innovations blog symposium, Jennifer S. Bard addresses many of the negative impacts of new health technologies, particularly as they apply to patient privacy. Bard points to special concerns in how we use health information related to DNA, mental health, and chronic illness. Throughout her piece, Bard also highlights the fact that law has not caught up to changes in technology and privacy issues, which causes more concern about how society and the healthcare system use these innovations.

How the Internet and The Mapping of the Human Genome Disrupted the Teaching of Health Law: Does The 21st Century Really Change Everything?

By Jennifer S. Bard

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Illustration of buttons that read "Vote 2020"

What You Need to Know About “Medicare and Medicaid-for-all” to Survive the Current Election Cycle

By Jennifer S. Bard

Just as medical students find themselves being asked at parties to look at rashes, this year health law students (and professors) are being asked about the proposals to fix our broken health care system being offered by the many candidates vying for the Democratic Party’s nomination for president. Talk about these issues are certain to continue through the primaries as 81% of Democrats agree that “the federal government has a responsibility to make sure all Americans have health coverage.” While Republicans are less sure about who should pay, health care remains a top issue for 69% of the electorate.

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A white hospital hallway

The ‘Nazi Problem’ in Human Subject Research Regulation

As Holocaust Martyrs’ and Heroes’ Remembrance Day draws near, it is heartening to note that our collective horror against Nazis and Nazism is still sufficiently strong as to make them the archetype evil villains in movies, TV, and dystopian literature. The evil doctor conducting fiendish experiments lives on in fiction because we recall the all-too-real horrific acts of torture conducted by Nazi physicians against children held captive and killed in the millions.

(Here are the Personal Statements of people who survived to tell their stories.)

Yet, as important as it is to never forget these crimes, we should resist the temptation of letting these memories lead us to a false story about the origin of human subject research regulation in the United States. Read More

Image from the movie Groundhog Day where man is looking at a groundhog

Regulating Human Subject Research: Like Being an Unwilling Participant in a Very Nerdy Version of Groundhog Day

This is the first in a series of blog posts highlighting how I am developing an overview of some of the significant gaps in regulation of human subject research. I will be looking at the use of living human beings as participants in experiments conducted by academics to advance knowledge, as well as by biomedical companies to test new products.

My goal is two-fold: I hope to develop the first Nutshell in Human Subject Regulation as a valuable handbook for those studying and working in this field. In addition, I hope to bring together two issues that are often separate: providing greater protection to people who participate in research as subjects, and increasing the quality of the information generated. Read More

Ebola in the United States—Some Resources for the Law School Curriculum

By Jennifer Bard
[Cross-post (with some updates) from Prawfsblawg.]

Law students have lots of things competing for their attention, but one topic I’ve found of general interest this fall is Ebola. Although the topic is obvious low-hanging fruit for those of us in the health law crowd, I’d suggest there’s plenty to keep Constitutional Law, Torts (information is coming out that the patient was sent home from the emergency room, even though he said he had been to Liberia and that his contacts are being monitored including five school children), Commercial Law, International Law, immigration, etc. going as well. An infectious disease like Ebola triggers concerns about shipping, air travel, and, of course, quarantine, search, and seizure.

Today’s news that a Texas hospital has diagnosed a patient already in the United States was inevitable-and provides an opportunity to throw a legal spotlight on the laws of quarantine and isolation.   As a matter of Constitutional Law, the President of the United States can take any measure necessary to protect the nation’s security, remember President Bush’s plan to use the military to control pandemic flu (see an overview from the CRS or the plan itself), or interstate commerce, but only individual states have the power to take action addressing health issues that do not threaten the safety of the country as a whole.   That’s because individual states, but not the federal government, retain “police power” to promote the health of their citizens even in the absence of a threat to others. Here’s a helpful article. This overview of emergency legal powers, specific to Ebola, comes from the Robert Wood Johnson foundation supported Network for Public Health. Here is some more general information comparing state and federal authority from the CDC and a great overview from the Congressional Research Service. While Ebola itself is low on the list of the scariest diseases we in the U.S. risk catching (here’s a list from for those who don’t have enough to worry about), it is interesting to see how quickly it happened given that estimates of only a few weeks ago were that the probability was no more than 25%. Here’s how Vox explained it using visuals.  This is an on-going story-and should test the resources and skills of the Dallas County Health Department–and provide a live public health lesson to the country.

Waiting for Hobby Lobby–A brief refresher of the issues

Cross post from healthlawprof blog

Jennifer S. Bard

Since the likelihood is that many readers of this blog will be asked to comment when the Supreme Court, some time this week, announces its decision in Hobby Lobby and Conestoga Wood Specialty cases here’s a brief refresher and some links.  The cases are challenges to the Affordable Care Act’s requirement that employers who choose to offer health insurance to their employees must provide policies that include ten essential benefits-including contraception.  The U.S. Supreme Court has heard oral arguments and read the briefs—it’s likely that whatever opinion is issued will reflect at least some of the arguments presented to the Court.

This case is about the Affordable Care Act’s requirement that employers who offer their employees health insurance must include ten essential benefits, including contraception.  Hobby Lobby and Conestoga Wood are privately held, for-profit companies whose owners have sincerely held religious objections to providing four specific kinds of contraception.  They believe these contraceptives terminate rather than prevent pregnancy.  Many religious organizations and companies have gotten exemptions to these requirements, but this case considers whether private, for-profit companies should qualify as well.

The cases raise three major issues:

  1. Does the Religious Freedom Restoration Act apply to corporations even though it uses the word “person?” (Can companies have religious beliefs?)
  2. Is providing insurance that covers birth control a “substantial burden?” on these two company’s’ religious beliefs?
  3. Does the government have a compelling reason for requiring companies that provide insurance to have it cover birth control?

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