Carmel Shachar

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.”

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."

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.

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.

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.

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."

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.