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Carmel Shachar

  • 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.