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Carmel Shachar

  • 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.

  • Grocery store employee Leilani Jordan died of covid-19 at the start of the pandemic. Her mom wants justice.

    January 11, 2022

    Zenobia Shepherd can’t wrap her mind around her daughter’s death. Her heart won’t let her. Leilani Jordan, who had developmental challenges and was diagnosed with cerebral palsy, died in April 2020 of complications from covid-19. She was 27 and working in a Maryland grocery store when she fell ill and days later became one of the first faces of the pandemic’s devastating death toll. ... Carmel Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, said the question of whether an employer is liable if a worker is exposed to the coronavirus in the workplace is “is still fairly novel because the pandemic is still a fairly new phenomenon.” “Litigation around covid-19 workplace exposure has been increasing over the last year, and will likely continue to increase with the omicron explosion of cases,” Shachar 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.

  • Census: COVID-19 Vaccine Mandates for Small Business Employees Vary by State

    December 17, 2021

    Chris Lambert, a small business owner in Indiana, says he has encouraged his eight employees to get vaccinated against COVID-19. But for a variety of reasons – including the fact that 90% of them are already inoculated – he has not taken the step that so many in his position are grappling with across the country. ... Only 3.3% of small businesses in Indiana required employees to have proof of COVID-19 vaccination before physically coming to work over a recent weeklong stretch – the smallest percentage among the more than 30 states that reported data, according to a report released on Thursday by the U.S. Census Bureau’s Small Business Pulse Survey. Nationwide, only about 13% of such businesses require workers to show proof of inoculation, according to the census statistics, which were collected between Dec. 6 to 12. ... States in the Northeast and on the West Coast are more likely to see small businesses mandate employee vaccination, while Southern and Midwestern states are less likely, according to the bureau. ... The regional trend doesn’t surprise Carmel Shachar, executive director of Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics. The differences follow the same pattern seen with other pandemic public health measures, she says, in which states where there are fewer mask requirements or lower vaccination rates are also the ones “that are being really supportive of employee pushback against vaccine mandates.” She adds: “I think the politicization of public health has a lot to do with it. But then I think some of it also goes to different areas of our country have different traditions and different cultural assumptions when it comes to balancing public health, individual liberties, respect for scientific expertise.”

  • 12 Questions About COVID Vaccine Mandates at Work—Answered

    October 12, 2021

    The science is clear: COVID-19 vaccines drastically reduce the chance of hospitalization or death from the disease and will help us get out of the pandemic that’s claimed hundreds of thousands of lives in the U.S. But even so, months after the shots became available for all adults in the country, tens of millions remained unvaccinated. ... Though school and healthcare workers have long been required to get vaccinated for a number of diseases—like measles, mumps, and rubella (the MMR vaccination) or even the flu—the upcoming COVID requirements are much more extensive in nature. “We’ve had vaccine mandates before, but they haven’t been quite as broadly applied,” says Carmel Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Because of this, it’s not immediately clear how they’ll work.

  • 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.

  • Are COVID-19 vaccine mandates for college students legal?

    May 17, 2021

    Dozens of colleges and universities across the country have announced COVID-19 vaccine mandates for returning students...The question: Can colleges and universities legally require students to get vaccinated for COVID-19? The answer: In general yes, with a few exceptions for medical and religious exemptions...Our experts say that federal laws like the Americans with Disabilities Act (ADA) require that schools make reasonable accommodations for those with medical conditions. There are also some arguments for religious exemptions, but that’s going to depend on the state and how courts apply existing statutes. "Some colleges and universities may say, all right, if you don't want the vaccine, we have a reasonable accommodation, which is you will continue to be on Zoom every day," Carmel Shachar said. Shachar and David Bloomfield said that even though the vaccines are only authorized under emergency use, rather than full FDA approval, it shouldn't change much legally.

  • Full FDA Approval Of Pfizer’s Covid Shot Could Make Vaccine Mandates More Likely

    May 10, 2021

    Pfizer and BioNTech began the process of applying for full FDA approval of their Covid-19 vaccine Friday, an expected move that could force the issue of whether vaccine mandates—proposed for schools, colleges and even some workplaces—will be a legal way to combat the virus...A full license adds a new dimension to the debate over whether organizations, schools and universities are allowed to require vaccination, with many opponents arguing that people cannot be required to get a vaccine licensed under an emergency use authorization. Legally speaking, there hasn’t really been a test as to whether a temporarily authorized vaccine can be mandated, Carmel Shachar, executive director of Harvard’s Petrie-Flom Center, told Forbes, though a fully licensed vaccine would certainly “be less controversial to mandate.” While any mandate would have to take account of legally protected medical and religious exemptions, Shachar said any further accommodations—such as an opposition to vaccination—would be decided by the organization implementing it and relevant local laws. Shachar added that it “would not be that much of a stretch” to add a Covid-19 vaccine to the “long list” of vaccines children need to get in order to attend school or daycare.

  • Bay Area employers more likely to ask workers to get COVID-19 vaccine than other U.S. employers

    May 10, 2021

    Bay Area employers are more likely to ask workers to get vaccinated against COVID-19 than employers in other parts of the U.S., according to a new survey. Despite privacy concerns, the law could side with employers. Looking at a U.S. Census small business survey done in mid-April, only 3% of businesses nationwide were requiring workers to show proof of vaccination, but in the Bay Area that more than doubled to 7.5%...Carmel Shachar is the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. “The way that we structure the employee/employer relationship in this country, employers have a lot of leeway to ask their employees to get vaccinated,” she told KCBS Radio. “They usually don’t because it’s not worth their while. Most employers who are employing their employees at-will would be able to say ‘I want you to get this vaccine,’ even if it’s under emergency use authorization, with the exception of if somebody needed a medical accommodation or needed a religious belief accommodation.”

  • 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.

  • A Look at Covid-19 Vaccine ‘Passports,’ Passes and Apps Around the Globe

    April 27, 2021

    It is the latest status symbol. Flash it at the people, and you can get access to concerts, sports arenas or long-forbidden restaurant tables. Some day, it may even help you cross a border without having to quarantine. The new platinum card of the Covid age is the vaccine certificate. It is a document that has existed for more than two centuries, but it has rarely promised to hold so much power over culture and commerce. Many versions of these certificates now come with a digital twist. “It’s been a long time since we’ve had a pandemic that has impacted every facet of society so thoroughly, and then a vaccine,” said Carmel Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School. “There is no precedent since 1918, and we definitely didn’t have smartphones in 1918.” Ramesh Raskar, a professor at M.I.T. Media Lab, has been leading an effort to develop a solution that includes both a paper certificate that anyone can easily carry as well as a free digital pass that works even without cell service.

  • Will a passport be required? As more people get their shots, the thorny issue of whether to prove coronavirus vaccination is growing

    April 19, 2021

    Some companies are using persuasion, insisting that employees who don’t get a COVID-19 vaccine wear a mask at all times once they return to the workplace. A growing number of colleges are taking a firmer stance, saying they will require shots for all students. Many sports and entertainment venues, however, are taking a wait-and-see approach about requiring patrons to prove they’re vaccinated...States have long had the legal right to mandate vaccinations, such as for enrolling children in school. But the ability to carry around digital proof of vaccination status is new. And now the push to return to a more normal life has triggered a lot of discussion about vaccine passports, in which users can upload proof of vaccination on a smartphone app for potential entry into work, school, or other venues. That phenomenon has sparked a debate about equity, security, and privacy. “Not everybody has smartphone access, so how do you build a system without smartphone access to still prove someone has been vaccinated or it’s not appropriate for them to be vaccinated,” said Carmel Shachar, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

  • Vaccine Requirements Spread in U.S., Sowing Concern on Overreach

    April 12, 2021

    Covid-19 vaccination requirements are fast becoming facts of life in the U.S., spreading business by business even as politicians and privacy advocates rail against them. Brown, Notre Dame and Rutgers are among universities warning students and staff they’ll need shots in order to return to campus this fall. Some sports teams are demanding proof of vaccination or a negative test from fans as arenas reopen. Want to see your favorite band play indoors in California? At bigger venues, the same rules apply...Given the fraught politics, many companies are “not necessarily wanting to be the first in their sector to take the plunge,” said Carmel Shachar, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School. Still, “we’re going to see employers start to require vaccinations if you want to come into the office, if you will have a public-facing job.” ... Some legal experts have cautioned that because vaccines have only emergency federal approval, businesses can’t require them. But that issue is “a bit of a red herring,” Harvard’s Shachar said, because the vaccine data is so strong, the shots are so effective and the virus is so dangerous.

  • ‘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.

  • Should we judge COVID-19 vaccine line-cutters?

    March 29, 2021

    Harvard Law School’s Carmel Shachar weighs in on the morality nuances of those who are cutting vaccine lines.

  • You Asked For Shots, Tuna, Metal, and Money

    March 29, 2021

    Planet Money listeners email, tweet, and DM us questions about the economy every day. Everything from big-hitter "what does it all mean" questions to everyday economic oddities. Today on the show, we call the experts, crunch the numbers, and come back with the answers to questions about vaccines, canned tuna, scrap metal, and every dollar in the world. Featuring Carmel Shachar.

  • Some people are lying to get the vaccine, and it’s testing their friendships

    March 25, 2021

    As soon as she tapped the link, Kristin Thornburg knew something was amiss. It was earlier this month, and Thornburg, 31, had been strategizing with a friend via text to try to get leftover doses of the coronavirus vaccine...The friend sent over a link to an unfamiliar page and said she had signed up there. An acquaintance had gotten a vaccine that way, the friend said. Perhaps Thornburg should sign up, too. But it was not just a way to get leftovers. “At first I thought I had gotten it wrong, because it was obviously an appointment sign-up page,” said Thornburg, a business manager at a start-up. After her name, the form asked her to identify which qualifying condition or occupation she had...The blame for some of the heartache should land partly on the vaccine distribution system, according to Carmel Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology and Bioethics at Harvard Law School. Certainly, those perfectly healthy people who lie on their intake forms “should not feel good about themselves,” Shachar said. “Ultimately, the prioritization schemes are well-intentioned and do serve a valuable purpose, in that we’re trying to find people who are uniquely vulnerable.” But Shachar does sympathize with those tempted to fib about a health problem or use an old address to qualify for a vaccine — especially when different areas have different rules. “The more you finely slice and dice prioritization categories and do certain occupations but not others, the more you risk somebody saying, ‘Well, there’s no benefit to me for waiting, and the system is not looking out for my interest,’ ” Shachar said.

  • Martha Minow and Emily Broad Leib

    COVID and the law: What have we learned?

    March 17, 2021

    The effect of COVID-19 on the law has been transformative and wide-ranging, but as a Harvard Law School panel pointed out on the one-year anniversary of campus shutdown, the changes haven’t all been for the worse.

  • Many West Virginians still struggle to access health care. Here’s how Certificate of Need laws fit into the conversation

    March 12, 2021

    Many West Virginians lack access to the health care services they need, as hospitals around the state struggle financially. Three community hospitals closed in the last two years. A fourth ended inpatient services. Others declared bankruptcy and began reorganizations in order to stay afloat. These closures have been devastating to patients...But so far this legislative session, when it comes to hospitals and health care, West Virginia lawmakers have focused on a very narrow — and disputed — form: the deregulation of the health care market through proposed changes to Certificate of Need laws (CON)...As of December 2019, 35 states had some form of CON process in place. But the way those processes work in each state varies drastically. That can make evaluating the overall effectiveness of these programs tricky, said Carmel Shachar, director of the health law policy center at Harvard Law School. “Not every certificate of need process is exactly the same, so that may be why the data is mixed,” Shachar said...Shachar said that we can think about health care like a tree. In states with effective certificate of need laws, the process might act as a landscaper. “If we let plants grow everywhere, sometimes they grow in ways that are unhealthy,” Shachar said. “So certificate of need programs could be used to distinguish between care that is needed, versus care which might have a good return for investors, but don’t necessarily serve the best interests of the community.”

  • ‘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.

  • Andrew Cuomo’s Covid-19 nursing home fiasco shows the ethical perils of pandemic policymaking

    February 26, 2021

    The humbling of New York Gov. Andrew Cuomo on pandemic policy has been spectacular and swift. Within a matter of days, one of America’s most trusted voices in the early days of the Covid-19 pandemic became a political pariah. Outrage over Cuomo’s decisions — first, to require nursing homes to accept Covid-19-positive patients when New York’s hospitals were overflowing, and then, to hide data about deaths of nursing home residents — has engulfed Albany in recent weeks. Court orders, leaks, and investigations revealed that Cuomo dramatically and intentionally understated the pandemic’s toll on nursing home residents in New York...Cuomo on March 25 issued the controversial directive that told nursing homes they couldn’t deny patients coming from hospitals admission based on a Covid-19 diagnosis. Evaluating the ethics of that directive is a little more complicated than evaluating your average executive order. In the midst of a crisis, public health ethicists said, policymakers don’t have the luxury of time to do typical outreach and data analysis, but they do have a responsibility to be as thorough as they can. Carmel Shachar, the executive director of Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics, said it was ultimately Cuomo’s responsibility to ensure his staff was analyzing potential consequences.

  • Vaccination sprint threatens to leave behind minority communities

    February 22, 2021

    The race to vaccinate as many people as possible while more contagious coronavirus variants march across America is colliding with lagging efforts to steer shots to people of color and underserved communities bearing the brunt of the pandemic. Though the Biden administration has prioritized equitable vaccine distribution, putting that goal into practice is difficult. Local public health officials are under pressure to quickly distribute their limited supplies and reach high-risk groups first in line. So far, limited data continues to show that people in hard-hit minority communities are getting vaccinated at a much slower pace than people in wealthier white ones... After the initial slow vaccine rollout, many states with Washington’s encouragement began offering vaccines to people from age 65, rather than limiting eligibility to people 75-plus and frontline workers as the Centers for Disease Control and Prevention originally recommended. That meant millions more were seeking shots than were available. States and the Biden administration have set up megasites to help pick up the vaccination pace, but those aren’t all easily accessible for people who don’t have cars or internet connections to make appointments. Disparities in the vaccine rollout remain stark...The variants do likely mean more cases — and more deaths. While new infections and hospitalizations have been declining for weeks, case counts remain high. Health experts have warned that the variants could bring a new surge as they gain a foothold across the country. “Every day that somebody doesn’t have the vaccine they are that much more vulnerable,” said Carmel Shachar, who heads Harvard Law School’s bioethics center. “We’ve lost some of the cushion,” she said. “And we didn’t have a great cushion.”

  • Closeup of man smoking and wearing a mask

    Should smokers be prioritized for COVID vaccine?

    February 2, 2021

    Should smoking be among the pre-existing health risks that qualify people for priority access to the COVID-19 vaccine? Harvard Law public health expert Carmel Shachar says the answer is yes. 

  • Harvard and Yale health law centers partner for COVID-19 seminar series

    January 28, 2021

    The Petrie-Flom Center at Harvard Law School is joining forces with the Solomon Center for Health Law and Policy, its counterpart at Yale Law School, to host a seminar series reflecting on ethical and legal issues raised by the COVID-19 pandemic.

  • Now That COVID-19 Vaccines Are Here, So Is the Prospect of Digital Immunity Passports

    January 4, 2021

    This week, the first doses of the Pfizer COVID-19 vaccine were administered in the U.S. With the FDA expected to approve Moderna’s vaccine imminently, people are already looking forward to a world where travel and gatherings are possible. But for those activities to be maximally safe, the country will either need to reach herd immunity—unlikely until mid-2021 at the earliest, assuming essentially flawless vaccine roll-out and widespread adoption—or to find ways to verify people’s negative tests or vaccination status in advance. Some companies are looking to digital solutions. Airlines like JetBlue, United, and Virgin Atlantic have begun using CommonPass, an app developed by the Commons Project and the World Economic Forum that shows whether users have tested negative for COVID-19 for international travel...The first major hurdle towards a culture that uses digital immunity passports: ensuring widespread availability of the vaccine. Requiring someone to show proof they’ve been vaccinated when the vaccine is not yet available to them is a recipe for injustice. It will take months for the vaccine to become available to the general public, and up until then, we’re likely to see more demand for the vaccine than supply. After that initial surge of vaccinations, we could see a second “phase” in vaccine rollout. “At a certain point I think things are going to flip,” says Carmel Shachar, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Focus will turn from vaccinating people clamoring for it toward those who may have reservations. “That’s when you’re going to see states perhaps mandating the vaccine, school systems mandating vaccines, or employers like hospitals.”

  • 2 countries welcome travelers with COVID ‘immunity passports’ despite WHO guidance

    December 7, 2020

    With miles of barbed wire and electric fencing along its border and open government hostility to migrants, Hungary's borders aren't always the friendliest place for foreigners. That's during normal times. Amid the pandemic, Hungary has shut its doors to almost everyone, even its European neighbors. Unless, they've had COVID-19. It's not the place you'd expect to find such a novel exception to otherwise tough entry rules. The policy, which came into force in early September, opens the door to visitors who can provide evidence that they've recovered from COVID-19 -- proof of both a positive and negative test in the past six months...The World Health Organization (WHO) advised against immunity passports in April. "There is currently no evidence that people who have recovered from COVID-19 and have antibodies are protected from a second infection," read its scientific brief. On Thursday, the WHO confirmed it has not changed its position, but, Regional Advisor Dr. Siddhartha Sankar Datta said it was looking to help countries implement electronic vaccination certificates. Other experts have also raised concerns about immunity passports. "I think the worst-case scenario is that you see a spike in cases that happens because people are incentivized to try to get COVID to demonstrate immunity," Carmel Shachar, a Harvard University bioethics and health law expert, tells CNN. "So, all of a sudden, you'd see people not wearing masks, not respecting social distancing, because they want to get COVID. Especially if more and more countries adopted a similar scheme."

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

    What you should know about the COVID-19 vaccine

    December 3, 2020

    Public health expert Carmel Shachar discusses the COVID-19 vaccine, who is likely to get it first, and whether people can be required to get vaccinated.

  • Head silhouette with jigsaw puzzle pieces

    Detecting dementia

    November 21, 2020

    Experts gathered this week to discuss the ethical, social, and legal implications of technological advancements that facilitate the early detection of dementia.

  • FDA headquarters in Washington DC

    Building public trust in a coronavirus vaccine

    October 6, 2020

    In an interview with Harvard Law Today, Carmel Shachar, executive director of the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School, says that political interference in the FDA’s process for ensuring that a vaccine is both safe and effective “opens the door to a public health disaster.”

  • book cover

    Faculty Books in Brief: Summer 2020

    July 23, 2020

    From human rights in a time of populism to a comparative look at capital punishment to a focus on disability, healthcare and bioethics

  • Coronavirus has forced doctors, insurers to embrace telemedicine like never before

    July 7, 2020

    When pain radiated from Fred Thomas' neck down his arm and he couldn't feel his fingers anymore, he knew it was time to talk to a doctor. After getting an MRI ordered by his primary-care doctor, the 49-year-old land surveyor had several phone conversations with a Rothman Orthopedic Institute specialist he'd never met to discuss the problem and treatment options. He was scheduled for a cervical fusion to replace three damaged disks in his spine a couple weeks later...Months ago, few patients or doctors would have considered surgery without so much as an in-person consultation, but the coronavirus pandemic has forced the health-care system to embrace telemedicine like never before. With no other way to see a doctor as the virus shuttered all but the most essential health-care services, regulatory hurdles that hamstrung the growth of telemedicine for decades were wiped away: Private insurers, Medicare and Medicaid agreed to pay the same rates for telemedicine visits they would have for in-person appointments. The federal government loosened privacy regulations that had in the past restricted how patients and doctors communicate virtually...But the changes that made its widespread adoption possible were intended to be temporary. A permanent change will require more work. "It was a sensible thing in a pandemic to say just 'make it happen.' But it's not sensible to say 'there are no rules,'" said Carmel Shachar, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School.

  • Hands holding prison bars

    Pandemic has exacerbated longstanding problems with the prison system

    June 9, 2020

    COVID-19 presents a unique threat to people in prisons and jails, agreed panelists at “Incarcerated Populations and COVID-19: Public Health, Ethical, and Legal Concerns,” a webinar hosted by Harvard Law School’s Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics.

  • ‘Immunity passports’ won’t reopen America

    May 18, 2020

    Antibody tests and “immunity passports” were supposed to be the great hope for safely reopening the economy. The problem is many of the more than 120 tests on the market are inaccurate. And scientists don’t really yet understand how much immunity antibodies confer or how long it lasts. But these tests — and the apps to promote them — are gaining traction among businesses and consumers eager to know who has been exposed to the virus, raising the risk that people will be relying on faulty results to promote their immunity from the coronavirus... “The appeal is obvious for employers. They would have no outbreak in their workplace, and for the more public facing businesses, it can be a selling point. ‘Our workers are immune, you can come to our restaurant,‘” said Carmel Shachar, executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School. Like other legal experts, privacy advocates and bioethicists, Shachar said using “passports” or apps that are unregulated, unreliable and rife with errors to decide who can work, travel or eat out raises troubling questions about privacy, discrimination, risk and fairness...Harvard’s Shachar said an ethical framework would have to take access to testing into account; they can't only be for the well-to-do, or the well-connected. Insurers are resisting covering all of the tests for free — and the economic crash has left millions unemployed and uninsured. “If tests are going to be used to make broad decisions about work, they have to be widely available,” she said. “It can’t be ‘My dad knows a guy who knows a guy who knows a guy.’ It has to be available, no cost to employees." “If it’s not accessible to the grocery worker, it’s not ethical,” Shachar added.

  • Petrie-Flom 2020 student fellows

    At year-end celebration, Petrie-Flom student fellows present their independent research projects

    April 27, 2020

    Student fellows at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics recently celebrated their fellowships’ end virtually when their capstone meeting moved to Zoom due to the COVID-19 pandemic.

  • A hospital bill for $36,000 with a line item of various charges with a credit card and a ballpoint pen.

    ‘Medical debt is a violation of human rights’

    April 7, 2020

    At a March 27 Petrie-Flom event on medical debt and universal health coverage, health experts and journalists raise serious concerns about the affordability of testing and hospital care.

  • Life-or-Death Hospital Decisions Come With Threat of Lawsuits

    April 2, 2020

    Doctors and hospitals overwhelmed in the pandemic will have to make their excruciating life-or-death decisions meticulously or they risk being second-guessed by a jury when the onslaught is over. Lawyers who defend health care providers are already giving advice on how their clients can avoid liability if they’re forced to choose between patients. How they prepare for this battlefield triage now -- and how they practice it in the chaos of peak infections -- will determine whether negligence cases against them are dismissed or lead to trials or settlements over the death of a parent or spouse...There is an established standard of care in the industry, however, and providers could be accused of breaching their duty to patients by violating it and of negligence for failing to have enough ventilators on hand, for example. It’s a tough case to make in a pandemic. “I would expect hospitals to argue that their obligations are to make sure they have adequate equipment in ordinary times, not in pandemic times, and that seems quite persuasive to me,” said I. Glenn Cohen, a bioethics expert at Harvard Law School...In the wake of the pandemic, providers may be accused of failing to foresee a crisis that the Centers for Disease Control and Prevention and others have warned was inevitable, said Carmel Shachar, executive director of the Petrie-Flom Center for Health Law Policy at Harvard Law School. That’s especially so after the recent drumbeat of outbreaks from SARS to swine flu to Ebola.

  • Protecting rights in a global crisis

    March 25, 2020

    In a Q&A, scholars at the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School raise important legal and ethical questions about health care delivery and the enactment of extraordinary public health measures in response to the ongoing epidemic.

  • Glenn Cohen with Chris Bavitz at Petrie-Flom Center General Counsel Roundtable

    Health care general counsels explore pressing health policy and legal issues at Harvard Law School

    December 11, 2019

    The General Counsels Roundtable helps influential health law attorneys stay on top of or even ahead of changes in health law and policy. The roundtable connects GC to experts at HLS and the broader university, while also strengthening ties between faculty and legal practice.

  • What Tomorrow Holds for U.S. Health Care

    April 29, 2019

    Problems with the U.S. health care system—including the rising costs of prescription drugs, the current opioid abuse crisis, and continued gaps in access to care—have moved front and center in national policy debates. But despite the urgency of these problems, politicians have not reached any consensus on how to solve them. The Trump Administration has sought to empower states to craft solutions to health care problems that affect their own populations, while Democrats like Senator Bernie Sanders (I-Vt.) and Representative Premila Jayapal (D-Wash.) have advocated for a national health insurance system they call “Medicare for All.” ... Against this backdrop, The Regulatory Review has invited numerous experts to analyze pressing concerns with the current U.S. health care system and offer their ideas for the future. "Defining and Establishing Goals for Medicare for All" by Carmel Shachar, Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics: "It is increasingly difficult to find a Democratic presidential hopeful who has not paid at least some lip service to “Medicare for all.” Medicare for all, however, means many things to many people. As the fight to become the Democratic presidential candidate unfolds, it will be important to see how this term gets defined."

  • Outbreak Week: How prepared are we for the next health crisis?

    Outbreak Week: How prepared are we for the next health crisis?

    October 5, 2018

    Last week, Harvard commemorated the centennial of the 1918 influenza pandemic that killed more than 50 million people worldwide with Outbreak Week, a series of events across the university.

  • Don’t Expect Brett Kavanaugh To Protect The Affordable Care Act

    July 12, 2018

    An op-ed by Carmel Shachar, executive director of The Petrie-Flom Center. Thanks to Brett Kavanaugh’s 12 years as a judge on the D.C. Court of Appeals, we have a well-developed record of the Supreme Court nominee’s positions on key issues, including his views on American health care policy. In two high profile cases in 2011 and 2015, Kavanaugh upheld key parts of the Affordable Care Act (ACA). But these cases, taken out of context, are misleading. They should not distract anyone evaluating his long record, nor overly inform how he might decide in future cases when it comes to health care.