Carmel Shachar

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.