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Glenn Cohen

  • U.S. Supreme Court building

    Harvard Law School professors call potential abortion rights rollback ‘unprecedented’

    May 16, 2022

    The Petrie-Flom Center hosted ‘Roe in limbo: A town hall on the leaked Dobbs opinion.’

  • Legal experts express shock at rare Supreme Court leak on major abortion rights case: ‘Highly disturbing’

    May 3, 2022

    Legal experts expressed shock and concern on Monday evening after Politico released what it says is a draft opinion on a major abortion rights case that's still pending, representing a rare breach of Supreme Court protocol, and a sign that the justices are ready to undo abortion rights. "The fact that it leaked is, to me, the most surprising thing," I. Glenn Cohen, a professor at Harvard Law School, told Insider, adding that it's "very unusual."

  • Australia Moves Ahead Cautiously With ‘3-Parent IVF’

    April 29, 2022

    Australia has become the second country after the United Kingdom to legalize a fertility procedure that mixes genetic material from three people. The technique is meant to prevent couples from having children with certain debilitating disorders caused by faulty mitochondria, the energy-generating structures in our cells. But it’s controversial because it involves a genetic change that can be passed to future generations, so its rollout in Australia will be extremely cautious. ... “There was a lot of excitement when the UK first legalized this several years ago, so it's surprising that there haven't been reports of failures or successes one way or the other,” says I. Glenn Cohen, director of Harvard Law School's Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, who has been following the international landscape of mitochondrial donation closely.

  • Collage of portraits of four students against green and pink color blocks.

    Focusing on well-being

    April 19, 2022

    Students on Harvard Law School’s Student Well-Being Working Group care about sharing mental health resources available with their peers.

  • How NFTs could transform health information exchange

    February 4, 2022

    An article co-authored by Glenn Cohen: Personal (sometimes called “protected”) health information (PHI) is highly valued (1) and will become centrally important as big data and machine learning move to the forefront of health care and translational research. The current health information exchange (HIE) market is dominated by commercial and (to a lesser extent) not-for-profit entities and typically excludes patients. This can serve to undermine trust and create incentives for sharing data (2). Patients have limited agency in deciding which of their data is shared, with whom, and under what conditions. Within this context, new forms of digital ownership can inspire a digital marketplace for patient-controlled health data. We argue that nonfungible tokens (NFTs) or NFT-like frameworks can help incentivize a more democratized, transparent, and efficient system for HIE in which patients participate in decisions about how and with whom their PHI is shared.

  • Colorful illustration featuring mushrooms a microscope and other scientific devices and a man walking along a path

    Reassessing Psychedelics

    January 31, 2022

    A new Harvard Law initiative examines the legal and ethical aspects of therapeutic psychedelics

  • An illustration of a large transparent globe with DNA strands floating inside as two scientist and two others observe.

    Faculty Books in Brief: Winter 2022

    January 31, 2022

    A wide range of books by faculty, from a collection of essays on the ethics of consumer genetic testing to a look at the fate of constitutional institutions in populist regimes to a delightful children's book by a legal philosopher

  • Two people walking in a hallway with other people walking along behind and next to them.

    Weighing President Biden’s first year

    January 18, 2022

    In this series, Harvard Law experts turn a critical eye to the Biden administration’s efforts on health care, the economy, criminal justice reform, and other areas important to Americans — and share their thoughts on its agenda for the future.

  • Fact check: False claim that Nuremberg Code prohibits mask mandates

    January 14, 2022

    The claim: The Nuremberg Code says 'mandating masks on the citizens of a nation' is a war crime. As the highly contagious omicron coronavirus variant spreads around the country, several states have mask mandates in place. Some social media users say they violate a set of research ethics dating back to World War II. As evidence, a Jan. 3 Instagram post claims to show a section of the Nuremberg Code. ... “The claim that this violates the Nuremberg Code is 100% false," I. Glenn Cohen, deputy dean of the Harvard Law School, said in an email.

  • The Danger of the Supreme Court Undercutting Biden’s Vaccination Rules

    January 11, 2022

    An op-ed by Carmel Shachar and I. Glenn Cohen: “There are three quarters of a million new [COVID] cases yesterday. . . [t]hat is 10 times as many as when OSHA put in this ruling. The hospitals are today, yesterday, full. . . . Can you ask us—is that what you are doing now—to stop this vaccination rule with nearly one million people, nearly three quarters of a million people, new cases every day?” This was the dramatic question asked on Friday by Supreme Court Justice Stephen Breyer of Scott Keller, one of the attorneys seeking a stay of an Emergency Temporary Standard (ETS) promulgated by Occupational Safety and Health Administration (OHSA) in the case of National Federation of Independent Business v. Department of Labor. This so called “Test-or-Vaccinate” mandate requires employers across the country with more than 100 employees to implement either vaccination or testing and masking policies for their employees. A majority of the Justices seem poised to endorse not only a temporary stay of the standard, but a permanent injunction against OSHA’s power to act, and the country will be worse for it.

  • Line of people outside wearing face masks and winter coats. Sign with arrow reads: COVID TESTING.

    Weighing President Biden’s first year: Health care and the pandemic

    January 7, 2022

    Glenn Cohen and Carmel Shachar reflect on the administration’s successes, failures, and agenda for the future.

  • The Pandemic Preparedness Program: Reimagining Public Health

    January 7, 2022

    An article by Eli Y. Adashi and Glenn Cohen: On September 2, 2021, the White House released its long-awaited pandemic preparedness proposal titled American Pandemic Preparedness: Transforming Our Capabilities.1 Called for by presidential executive order 13987 and National Security Memorandum 1, the proposal, 8 months in the making, comprises a whole-of-government review and update of US national biopreparedness policies.2,3 The pandemic preparedness proposal is ambitious and all-encompassing and acknowledges that the transformation of “our medical defenses” will require “extensive scientific and technological efforts.”1 In this Viewpoint, we review the leading objectives of the pandemic preparedness proposal, discuss the outcome of comparable past federal efforts, and emphasize the imperative of intragovernmental coordination.

  • Trump’s Supreme Court picks Amy Coney Barrett and Brett Kavanaugh could decide the fate of Roe v. Wade

    December 1, 2021

    Mississippi on Wednesday is challenging Roe v. Wade, the law of the land for nearly 50 years. Nine Supreme Court justices will hear arguments on whether to preserve or undo abortion rights, but, experts say, Americans should pay close attention to two members of the court: Justices Brett Kavanaugh and Amy Coney Barrett. Legal scholars anticipate that either one of them could have an outsize impact in the case of Dobbs v. Jackson Women's Health Organization and determine the fate of reproductive rights in the United States. ... "It's very clear where Justice Kagan, Justice Sotomayor, and Justice Breyer are," I. Glenn Cohen, a professor at Harvard Law School, told Insider. "They are going to vote to strike down the Mississippi law as unconstitutional … They don't want to reverse Roe v. Wade. This has been consistent in their jurisprudence." ... "Justice Thomas and Justice Alito are pretty clear from their prior votes that they are on the side of thinking that the right to abortion in the Constitution is wrong. It doesn't exist," Cohen said. "So their votes are pretty set."

  • Court’s interest in Texas could signal end of Roe

    November 1, 2021

    Since 2013, more than a dozen states have tried to ban abortion as soon as a sonogram can pick up the thump-thump of an embryonic heartbeat. That’s about six weeks, an egregious constitutional affront under Roe vs. Wade. No court has allowed a ban so early in pregnancy to stand. The Supreme Court never even granted an appeal — until Texas concocted Senate Bill 8. ... “We may get some tea leaves from [Monday’s] argument, but I would be very surprised if there were major changes that come directly out of it,” said I. Glenn Cohen, deputy dean of Harvard Law School and an expert on medical ethics and the law. “If there is going to be a big change in abortion law itself, i.e., what the Constitution prohibits states from doing, that’s likely to come at least initially in Dobbs.”

  • Vaccine Mandates Withstand Challenges as Suits Surge Across U.S.

    October 14, 2021

    Workplace Covid-19 vaccination mandates have largely survived a first wave of legal challenges even as the number of lawsuits over them has soared with their expanded use. ...Two months later, regulators upgraded the vaccine made by Pfizer Inc. and its partner BioNTech SE from “Emergency Use Authorization” to full “Biologics License Application” approval. “Once the Pfizer vaccine made it from EUA to BLA, that took the winds out of the sails of an argument that seemed more rhetorically if not legally powerful,” said Glenn Cohen, director of Harvard University’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. “Without that card to play, the challengers have much weaker-sounding arguments.”

  • Henrietta Lacks’ family sues biotech company for profiting from ‘stolen’ cells

    October 14, 2021

    The estate of Henrietta Lacks has filed a lawsuit against Thermo Fisher Scientific, which sells a commercial line of HeLa tissue, accusing the corporation of profiting from Lacks' "stolen" cells. ... Yasmin Amer:: A spokesman for Thermo Fisher Scientific told NPR the company has no official response yet. What happened to Lacks became more widely known after Rebecca Skloot's 2010 book and an HBO movie starring Oprah. Glenn Cohen teaches law and bioethics at Harvard and says what happened to Lacks wasn't unusual. Glenn Cohen: Certainly historically, everybody agrees that what was done to Henrietta Lacks, as it was done to many Black women who sought hospital care at that time, was a moral wrong.  ... Cohen: There's a legal matter at the time in which the tissue was taken. It was not the ethical rules of the day to require informed consent.

  • Why lawsuits against COVID-19 vaccine mandates will likely fail: Experts

    October 8, 2021

    From teachers to airlines workers, some employees who have faced termination for not complying with their company's COVID-19 vaccine mandates have gone to court to fight the decisions. Some of the plaintiffs, such as New York City Department of Education employees, a handful of Los Angeles county public employees and United Airlines workers, have argued that the mandates should be removed, questioning the rules' constitutionality and some contending their religious rights weren't observed. ... Glenn Cohen, a health law and bioethics professor at Harvard Law School, told ABC News that strong legal precedent dating back to the early 20th century gives businesses and governments the legal backing to enforce the mandates. "They're pretty weak," Cohen said of the lawsuits. "The judges that have denied them have come from across the political spectrum, and from across the country, because the plaintiffs' arguments don't have any weight."

  • Labor Department Officials Frustrated With White House Over COVID-19 Vaccine and Testing Mandate

    September 27, 2021

    When President Joe Biden directed the Occupational Safety and Health Administration (OSHA) on Sept. 9 to impose strict COVID-19 vaccination and testing protocols on large businesses, the OSHA employees were ready. ... Public opinion may not have been behind the original ETS, either. Support for a widespread federal response is higher now than it was at the start of Biden’s term, says N’dea Moore-Petinak, a doctoral candidate at the University of Michigan and coauthor of the book Coronavirus Politics. And businesses may be more open to a vaccine and testing mandate than they would be to a masking mandate like the one included in the original ETS, says Glenn Cohen, an expert on health law and bioethics at Harvard Law School. “While I think masking is terrific, politically it’s a harder sell and the compliance rates may be lower,” he says. “With vaccination, it’s easier to ensure compliance.”

  • FDA deploying ‘fast-track’ arsenal against COVID-19

    September 23, 2021

    Food and Drug Administration officials said in July that Pfizer’s application for full approval of its COVID-19 vaccine would enjoy “priority review,” and set a target deadline for finishing by January 2022. They beat the deadline easily, licensing the shots in late August. That’s faster than other vaccines and drugs that have been marked as priorities for the agency. ... “EUAs were used pretty sparingly till recently. There was some use in 2009 related to H1N1, but other than that you don’t see many notable uses,” said I. Glenn Cohen, a health expert at Harvard Law School. “In terms of its pre-history, you might trace it to some of the pressure FDA faced during the AIDS crisis at being too slow to meet the needs of the infected, which among other things prompted it to introduce a priority review designation and accelerated-approval program in 1992.”

  • Biden careful not to play favorites, but Pfizer enjoys some ‘comparative advantage’ in mandate era

    September 17, 2021

    The COVID-19 vaccine from Pfizer and BioNTech was the first to reach American arms, and it accounts for more than half of the 380 million doses administered in the U.S. so far. ... Still, analysts don’t expect Mr. Biden to speak on behalf of Pfizer. His team spent months saying a similar vaccine from Moderna and a one-shot option from Johnson & Johnson were highly effective against COVID-19. “Why the ecumenical attitude? First off, they don’t want to tell Americans who received one up until now they have to be revaccinated. Second, J&J, with its one-dose regimen, for example, has been preferred by some communities. And when people are hard to reach or mildly vaccine skeptical, the ability to provide only one, not two, doses may be a big plus,” said I. Glenn Cohen, a health care expert at Harvard Law School. He said emerging data suggests the vaccines perform differently for fighting the delta variant or maintaining immune responses. “So we may reach a point where the administration will more strongly endorse one over the other. But at the moment, I don’t see them going there, and I think it would take a lot for them to get to that point,” he said.

  • Biden Orders Shots for Millions, Calling Unvaccinated a Threat

    September 10, 2021

    President Joe Biden said he’d order all executive branch employees, federal contractors and millions of health-care workers to be vaccinated against the coronavirus, and that his administration would issue rules requiring large private employers to mandate shots or testing. ... The executive branch is on strong footing to require staff vaccinations, particularly since the Pfizer Inc.-BioNTech vaccine received full approval, rather than just emergency authorization, according to Glenn Cohen, a law professor at Harvard Law School. The OSHA rule is likely to face the most legal challenges, with likely litigation over whether the agency is exceeding its authority.

  • VACCINE Fact-checking 3 claims about proof of vaccination requirements

    September 8, 2021

    As the highly contagious delta variant continues to spread across the United States, many businesses and cities have been rethinking their COVID-19 vaccination requirements. In August, New York City became the first major U.S. city to announce that people who are fully vaccinated against COVID-19 need to show proof of vaccination in order to dine indoors, work out at the gym or go see a movie. Can private businesses ask customers for proof of COVID-19 vaccination? ... Glenn Cohen, a professor at Harvard Law School, told VERIFY that private businesses asking for proof of vaccination is not a violation of the Health Insurance Portability and Accountability Act, or HIPAA.  According to the U.S. Department of Health and Human Services, HIPAA only applies to covered entities, such as health care providers and health insurers, and their business associates. “Because the average business is not a covered entity or a business associate of a covered entity within the meaning of HIPAA, the statute does not prohibit them from asking them about vaccination status,” said Cohen.

  • A community of belonging

    September 2, 2021

    At this year's First Class dinner, Harvard Law School Dean John F. Manning, faculty, and students offer support and advice to first-generation students.

  • Can Your Employer Require That You Get Vaccinated? It Depends Where You Live

    August 2, 2021

    An op-ed by I. Glenn Cohen: The COVID-19 pandemic not over for the U.S., but the Delta variant means the “war has changed,” as leaked CDC slides made clear. The development and production of COVID-19 vaccines are an achievement on the scale of the Manhattan Project, but unless and until more of the U.S. public is vaccinated infections, hospitalizations, and deaths are likely to increase in scale across much of the country. After an impressive roll out, our vaccination rates have stalled. Canada, which faced challenges early on getting enough doses and thus started later than the U.S., by mid-July had surpassed the U.S. both in first-dose and full vaccinated and enters August much better poised to confront Delta.

  • A line of trees with a blue sky in the background

    Petrie-Flom Center announces new research initiative on psychedelics law and regulation

    July 7, 2021

    The Petrie-Flom Center at Harvard Law School has announced a new research initiative, the Project on Psychedelics Law and Regulation, to promote safety, innovation, and equity in psychedelics research, commerce, and therapeutics.

  • Books aligned on window sill with a seaside sunset background.

    Harvard Law faculty summer 2021 book recommendations

    July 1, 2021

    Looking for a new book to enjoy at the beach, park, or on your couch? Six HLS faculty members share what they’re reading this summer. 

  • For a second year, Harvard Law to offer pre-term ‘Zero-L’ course to other law schools for free

    May 25, 2021

    Harvard Law School today announced plans to make its online, pre-term course for incoming law students, Zero-L, available to other U.S. law schools for free again for a second year as law schools emerge from the pandemic. Beginning in the summer of 2022, HLS will return to its pre-pandemic plan to offer Zero-L as an educational tool that other law schools can purchase for a reasonable fee to share with their students... “We created Zero-L several years ago to help incoming Harvard Law students from all backgrounds gain a common baseline of knowledge as they begin their law school careers,” said Harvard Law School Dean John F. Manning ’85. “As the first in my family to graduate from college and the first to go to law school, I often had the feeling that everyone around me just got law school as soon as they walked through the door, and that I didn’t. Zero-L aims to help all new students feel prepared to succeed on day one.” Zero-L’s faculty director, Professor I. Glenn Cohen ’03, recalled his experience as a new law student similarly. “Like many law students, I found the first few months of law school daunting,” Cohen explained last May. “We built this program to substitute a ‘smooth on-ramp’ for the ‘steep climb’ I and many others encountered upon starting law school.”

  • Explaining HIPAA: No, it doesn’t ban questions about your vaccination status

    May 24, 2021

    As the Centers for Disease Control and Prevention continues to relax safety measures for people who are fully vaccinated against the coronavirus and the country begins to reopen, many employers, businesses, families and friend groups are finding themselves in the at-times uncomfortable position of having to ask about others’ vaccination statuses. Some Americans, including Rep. Marjorie Taylor Greene (R-Ga.), are balking at such questions and are claiming that asking about or requiring proof of vaccination is a violation of the HIPAA federal privacy law...HIPAA has become one of the “most misunderstood statutes in existence,” said Glenn Cohen, a Harvard Law School professor who is an expert on health law and bioethics. “People think it does a lot more than it’s actually doing.” ... Employers are also legally allowed to ask about or require proof of vaccination from employees. In a December guidance, the Equal Employment Opportunity Commission, which enforces federal workplace anti-discrimination laws, essentially confirmed that “there’s no indication that there’s any federal law that would be violated by the employer asking this question,” Cohen said.

  • New normal: Can employers, businesses require COVID-19 vaccines?

    May 21, 2021

    Can your employer require a vaccine? The short answer is yes. As we continue to push toward a new normal, many employers are weighing whether or not to require employees to receive a COVID-19 vaccine in order to return to work. This week Delta Airlines became the largest U.S. company to announce all new employees must be vaccinated. Producers of the Broadway hit Hamilton have also mandated cast and crew be vaccinated. What rights or recourse do employees have? If your company requires it, there’s not much you can do about it—with a few exceptions. “Employers can demand proof of vaccination,” said Harvard Law Professor Glenn Cohen. “You, as an employer, can set conditions for work.” Cohen is an expert on health law and bioethics. He says that while many employees believe HIPAA laws may protect them from having to provide proof of vaccination, that’s just not the case. “HIPAA is largely irrelevant [in this case],” Cohen said. “Most of these employers are not going to be covered entities under the statutes, so they’re not even covered.” Cohen says HIPAA only applies in health care settings. “Health information generated in an encounter with a physician [would be covered by HIPAA],” he said. “That’s not what a vaccination card is.”

  • Common knowledge 3

    For a second year, Harvard Law to offer pre-term ‘Zero-L’ course to other law schools for free

    May 20, 2021

    Harvard Law School today announced plans to make its online, pre-term course for incoming law students, Zero-L, available to other U.S. law schools for free again for a second year as law schools emerge from the pandemic.

  • No, most businesses won’t violate HIPAA by asking customers if they’ve been vaccinated

    May 17, 2021

    The Centers for Disease Control and Prevention (CDC) on May 13 updated its guidance regarding mask-wearing for people who are fully vaccinated against COVID-19...The question: Is a business asking a customer about their vaccination status a violation of HIPAA? No, most businesses would not violate HIPAA by asking about a customer’s vaccination status...HHS says protected health information under HIPAA includes information that relates to a person’s past, present or future physical or mental health or condition. HHS has a list of what information is protected on its website. While HIPAA rules apply to covered entities and specific business associates, the rules don’t extend to most businesses, according to Glenn Cohen, a professor at Harvard Law School. “Because the average business is not a covered entity or a business associate of a covered entity within the meaning of HIPAA, the statute does not prohibit them asking them about vaccination status,” Cohen said in an email to the VERIFY team.

  • This startup says it can predict the health of your future child

    May 14, 2021

    A startup called Orchid is offering a spit test that tells a couple the odds that their children will grow up to have certain conditions...It’s sending the message that people affected by these diseases are not desired by society, says Glenn Cohen, a professor at Harvard Law School who specialises in bioethics. “What the company is really saying is, we're going to help determine if your child has schizophrenia, and then we’re going to affirm your view that having a child who has some risk of schizophrenia is not a child you want to have, and we're going to empower you to replace it with a child you prefer.” Cohen refers to this as “liberal eugenics” – the idea that individuals are empowered to voluntarily choose what kind of children they want to have. “If you're really concerned about what the life of a person with schizophrenia looks like in America or the UK, the solution is not to empower more parents to avoid children with schizophrenia – the solution ought to be to find ways to improve the lives of people with schizophrenia,” Cohen says. “I would love to hear what kind of work the company is doing to contextualise these polygenic risk scores in a way that actually helps people understand the disorders in question, rather than merely says, here's your number – good luck.” Siddiqui and Orchid failed to respond to multiple requests for an interview or comment. The company does have a number of blog posts on its website that feature the perspective of people whose loved ones suffered from some of these conditions.

  • ‘Approved’ or ‘authorized’? When it comes to COVID-19 vaccines, words matter.

    May 10, 2021

    Pfizer and partner BioNTech have asked the Food and Drug Administration for full approval for their COVID-19 vaccine, a regulatory benchmark beyond the current emergency use authorization granted during the pandemic. Moderna and Johnson + Johnson are expected to submit similar requests before too long. Many are eager for COVID-19 vaccines to advance to full-approval status as they believe this will reassure those who are vaccine hesitant while also helping employers and universities to enforce vaccine mandates...Courts around the United States are reviewing challenges to these vaccine mandates on the grounds that they're authorized, not fully approved. A full approval, however, could effectively end those legal challenges, many of which, legal scholars have said, were dubious to begin with. "I don't think it makes a difference legally, as to mandates, whether the vaccine is EUA or BLA," I. Glenn Cohen, a professor and deputy dean at Harvard Law school, told ABC News, referring to a Biologics License Application. "I do think for many employers and universities it will make them much more comfortable with mandating vaccination, subject to disability and perhaps religious exemption."

  • Could waiving patents increase the global supply of COVID-19 vaccines?

    April 30, 2021

    Members of the World Trade Organization are scheduled to meet Friday to discuss a proposal by India and South Africa to temporarily suspend patents on COVID-19 vaccines. Backers of the plan say it would increase the supply of vaccines around the world by allowing more countries to produce them. There’s now enough supply in the U.S that any adult who wants a shot should be able to get one soon...I. Glenn Cohen at Harvard Law School said the U.S. government had some leverage when it was making deals with drug companies as part of Operation Warp Speed. “One could have imagined a version of this where, as part of a condition of receiving the funding, there was more done to ensure access for less developed countries and sharing of technology and sharing of intellectual property,” Cohen said. More than 100 countries have backed the proposal to temporarily waive COVID-19 vaccine patents. The U.S isn’t one of them, but the White House has said it’s considering the idea.

  • Florida colleges likely to face uphill battle with COVID-19 vaccine mandates, says legal expert

    April 30, 2021

    No vaccination, no class: That’s the message being sent to some Tampa Bay college students. A growing number of colleges and universities, more than 100 nationwide, say a COVID-19 vaccine will be mandatory this fall, according to a list maintained by The Chronicle for Higher Education...But is this legal? More than 115 years ago, the Supreme Court held that states can compel vaccinations. “The 1905 decision in Jacobson versus Massachusetts recognizes that states have significant powers under the Constitution,” said Professor I. Glenn Cohen, a Harvard Law professor and leading expert on medical ethics. “A state can definitely introduce a vaccination mandate should they so decide to do.” We know colleges require proof of vaccines for measles, mumps, and meningitis but the coronavirus is a bit different. The COVID-19 vaccines only have Emergency Use Authorization rather than the standard, full U.S. Food and Drug Administration approval. Some legal experts believe the shots, approved only for emergency use, can’t be mandated. Professor Cohen disagrees. “The statute is intended to tell people that they have a choice whether to get vaccinated or not but really has no meaning as to whether a private employer or a private university can require you to be vaccinated,” Cohen said. “It’s your choice, but if you choose not to be vaccinated, this is one of the consequences.”

  • American flag on the wall in the background; President Joe Biden at a podium with Vice President Kamala Harris and House Speaker Nancy Pelosi sitting behind him.

    Evaluating President Biden’s first 100 days

    April 28, 2021

    As President Joe Biden approached his 100th day in office, Harvard Law Today asked faculty members and researchers from across Harvard Law School to weigh in on the new administration’s agenda, actions, accomplishments, and failures to date.

  • Male patient getting an injection in the upper arm from a doctor wearing blue gloves.

    Evaluating President Biden’s first 100 days: Health care and the pandemic

    April 28, 2021

    I. Glenn Cohen ’03 and Carmel Shachar J.D./M.P.H. ’10 of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics discuss the Biden administration's healthcare agenda.

  • Travelers are crossing borders for vaccines. Is that okay?

    April 27, 2021

    Enno Lenze, a German entrepreneur, journalist, and museum director, had what felt like another job looking for a vaccination, a hunt he had been on since December...Finally, an option came through. World Visitor, a Norwegian travel agency, offered a package that included flying to Moscow to get Sputnik V, the Russian vaccine. Lenze and 50 other Germans jumped at the chance and traveled there earlier this month for their first jabs...Traveling for treatments with either limited availability or cheaper options than ones’ home country is not new according to I. Glenn Cohen, a professor at Harvard Law School and director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics. A thriving medical tourism market has existed for years. In the case of COVID-19 vaccines, as long as at-risk groups have first been protected, countries with surplus vaccines could use them to jumpstart travel, if it is done carefully. “What matters is where the net benefit goes,” he says. “It should benefit the poorest in the community and not just the rich.” While two-dose vaccinations might tempt countries to keep visitors for longer, since it takes time to build an immune response, most post-jab tourism activities should not be rushed. “I’d be a little concerned,” he says. “I hope these people aren’t going to markets and bazaars right away.”

  • How Colleges Are Approaching Student Covid-19 Vaccinations

    April 16, 2021

    About a dozen colleges have said they will require students to receive a Covid-19 vaccine before returning for in-person instruction this fall. The mandate from this small but growing number of schools inserts them into the increasingly politically charged debate over whether businesses and other institutions should be able to make inoculation a condition of participating in events in person. Here’s what we know about colleges and student Covid-19 vaccinations. ... Glenn Cohen, a professor at Harvard Law School, said some schools are likely getting tripped up by legal language requiring the federal government to inform people they have the right to refuse a vaccine approved under an emergency-use authorization. The three vaccines that have been approved by the Food and Drug Administration—manufactured by Pfizer Inc., Moderna Inc. and Johnson & Johnson — were only approved for emergency use.

  • More Colleges to Require Student Covid-19 Vaccinations

    April 15, 2021

    A small but growing number of colleges will require students to receive a Covid-19 vaccine, saying it is the most assured way of returning to some semblance of pre-pandemic campus life. ... Glenn Cohen, a professor at Harvard Law School, said schools are likely getting tripped up by legal language requiring the federal government to inform people they have the right to refuse a vaccine approved under an emergency-use authorization.

  • Vaccine tourism: Why are people crossing borders for a jab?

    April 14, 2021

    One Saturday morning in late March, Milicia Praca and her roommate grabbed their passports and a bag of crisps and drove towards the border between Bosnia and Herzegovina (BiH) and the Republic of Serbia. They were keen to accomplish an important task – enter Serbia, pull up their sleeves, and get vaccinated against COVID-19... “In Europe, for a person to literally drive to another country, get a vaccine and return home or to their place of residency, strikes me as unethical tourism,” said Glenn Cohen, a professor at Harvard Law School, who has specialised in health law policy, biotechnology and bioethics. “It increases the risk of the spread of COVID-19 and you may be taking a vaccine from someone who is entitled to it under that country’s law. People are putting themselves and others at risk as vaccine tourists,” he said...Most European countries require people to show proof of residency, citizenship or share details about their national health insurance, to get vaccinated. Professor Cohen believes these legal requirements may discourage vulnerable communities, such as undocumented migrants, from trying to get a jab. “To tackle the pandemic, everybody should be eligible to get the vaccine in the region they live in,” he said.

  • US colleges divided over requiring student vaccinations

    April 12, 2021

    U.S. colleges hoping for a return to normalcy next fall are weighing how far they should go in urging students to get the COVID-19 vaccine, including whether they should — or legally can — require it. Universities including Rutgers, Brown, Cornell and Northeastern recently told students they must get vaccinated before returning to campus next fall. They hope to achieve herd immunity on campus, which they say would allow them to loosen spacing restrictions in classrooms and dorms...Harvard Law professor Glenn Cohen, who teaches health law and bioethics, said there's no legal reason colleges wouldn't be allowed to require COVID-19 vaccinations. It makes no difference that the shots haven't been given full approval, he said, noting that many colleges already require students to take coronavirus tests that are approved under the same FDA emergency authorization. But there’s also no federal guidance explicitly permitting vaccination mandates. The biggest clashes could come in states taking a stance against vaccination requirements, he said.

  • ‘Authorization’ status is a red herring when it comes to mandating Covid-19 vaccination

    April 5, 2021

    An op-ed by Dorit R. Reiss, I. Glenn Cohen, and Carmel ShacharCovid-19 vaccines offer a way out of the global crisis that has upended — and cut short — lives for more than a year. Three vaccines have now received emergency use authorization (EUA) from the FDA. One question that employers and universities must rapidly consider and act upon is whether to mandate that returning employees and students be vaccinated. Some employers are starting to require Covid-19 vaccines, and Rutgers University became the first university to mandate them for students and employees. One argument against mandates is that individuals cannot be required to get a vaccine that is being distributed under an EUA, as opposed to a full license, an argument made in a recent First Opinion. That would potentially delay Covid-19 vaccine mandates until the FDA approved the first vaccine under a biologics license application (BLA) — and so far the timing of that is unknown. Important nuances lead us to a very different conclusion: There are few to no legal barriers to employers or schools requiring vaccines being distributed under EUAs.

  • Time for U.S. to share more COVID vaccines?

    March 23, 2021

    Oxford University and AstraZeneca announced Monday that their COVID-19 vaccine is 79% effective overall and 100% effective at preventing severe disease, according to preliminary results from U.S. clinical trials. The Biden administration said last week that it will send about 4 million doses of the vaccine to Canada and Mexico, but it’s holding on to several million more, even though the AstraZeneca vaccine is not yet authorized in the U.S. and the administration has already secured more than enough doses of COVID vaccine for everyone in the country... “In a world where COVID is running rampant across the world and not in the United States, unless we’re going to be a fortress nation that’s not going to let anybody travel here ever, you’re going to have variants emerge elsewhere in the world, in such a way that they pose a danger to the United States,” said Glenn Cohen, a professor of health law and bioethics at Harvard Law School. Both healthwise and economically. “If we’re living in a world where large parts of the world don’t get fully vaccinated until 2022 or 2023, those are people who can’t travel to our shores. There are people who will not be able to consume our goods. There are people who will be in situations of political instability and suffering, and there’s going to be major economic loss,” Cohen said.

  • ‘We are on a collision course’: As virtual care booms, experts call for new health data privacy protections

    March 9, 2021

    A drop in your daily step count. A missed period. A loss of hearing. If it’s collected by a smartwatch or wearable, that health data isn’t protected the same way your medical records are. And as wearables like smartwatches and headphones sweep up an increasing amount of health data — flagging potential medical issues that could be used for ad targeting or to discriminate against someone — some lawmakers and researchers are calling for a reconsideration of the current approach. In a sign of the increasing urgency of the problem during the current virtual care boom, U.S. senators last month reintroduced a bill that would make it illegal for companies like Apple, Amazon, or Google to sell or share the data collected by wearables...Legal experts consider the move a step in the right direction, but caution that further action is needed to address the vast amounts of information being absorbed by health tech startups and technology giants alike. “We are on a collision course with how to regulate health data as all the different types of wearables and health tech explode,” said Carmel Shachar, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard. “HIPAA doesn’t extend to the world of health tech, and it should,” she added...Harvard law professor Glenn Cohen likens the situation to an iceberg, where the tip represents the data covered by HIPAA and the rest represents all the information that is not shielded by the law. Today, there is nothing stopping an employer or insurer from using that unprotected data to price its products or deny someone a job. “I like to remind people that the ‘P’ in HIPAA isn’t privacy,” Cohen said. “The law made sense when we were talking about health care information, not health information” more broadly.

  • Collage of people working from home

    Going remote

    March 3, 2021

    Ten Harvard Law School faculty share a behind-the-scenes look at their Zoom studios and the innovative approaches they employed to connect with students.

  • The U.S. could double its COVID-19 vaccine availability overnight. What’s the holdup?

    February 26, 2021

    What if we could instantly double COVID-19 vaccine availability in America? This is the tantalizing prospect raised by data collected while testing the double-dose regimen for the Moderna and Pfizer vaccines. As two Canadian researchers highlighted in a letter to the New England Journal of Medicine this month, both vaccines have been found to achieve 92 percent efficacy 14 days after a recipient has been given just one dose. The second dose, administered three to four weeks after the first, offers comparatively small gains by this measure: It boosts the Pfizer vaccine's efficacy to 95 percent, and the Moderna vaccine's to 94 percent, differences of just three and two points, respectively...I reached out to I. Glenn Cohen, a professor of health law and bioethics at Harvard University, and Holly Fernandez Lynch, an assistant professor of medical ethics at the University of Pennsylvania. Together they edited FDA in the Twenty-First Century: The Challenges of Regulating Drugs and New Technologies, which explores the FDA's function, successes, and failures...If the companies do apply for a change, Cohen said he would expect the FDA to move quickly enough to give an answer within the critical period of vaccine shortages this spring. "As agencies go, FDA is appropriately careful in their review of these matters," he said, "but given the amount of data experience they have with Pfizer and Moderna thus far, if provided appropriate data, I think they could probably make a determination of whether such a change was warranted fairly quickly."