Category: Carmel Shachar

Person receiving vaccine.

What You Should Know About the COVID-19 Vaccine

The Petrie-Flom Center Staff Leave a comment

Cross-posted from Harvard Law Today, where it originally appeared on December 3, 2020. 

By Jeff Neal

The race to approve and distribute a vaccine for COVID-19 got a huge shot in the arm this week.

On Tuesday, the United Kingdom approved a vaccine developed by pharmaceutical giant Pfizer. On the same day in the United States, a panel of experts advising the Centers for Disease Control and Prevention recommended a first-stage plan for distributing the vaccine to some of the most at-risk Americans. Separately, another advisory committee is set to meet twice in the coming weeks to evaluate for the U.S. Food and Drug Administration the safety and efficacy of both the Pfizer vaccine and a similar one produced by Moderna.

To better understand the impact of these developments, Harvard Law Today recently spoke with public health expert Carmel Shachar J.D./M.P.H. ’10, the executive director of the Petrie-Flom Center for Health Policy, Biotechnology, and Bioethics at Harvard Law School, about the vaccine, who is likely to get it first, and whether employers and states can require people to get vaccinated.

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Call for Abstracts: Looking Forward to a Post-Pandemic Landscape

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By Carmel Shachar and Katie Kraschel

The COVID-19 pandemic has disrupted virtually every facet of day-to-day life.

This disruption has forced us to examine baseline choices and assumptions about how to deliver health care, participate in public discourse, provide access to education, and support the workforce. This “great revision” will continue in several iterative stages: an immediate response to the crisis, a modulation as the pandemic continues, and a resolution into a “new normal.”

The Petrie-Flom Center and the Solomon Center for Health Law Policy are interested in tracking when crisis settles into the new normal and articulating how public policy and law should respond to that evolution.

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Doctors hold blood sample wearing ppe suit and face mask in hospital.

New Stark Law Waiver Opens Opportunity for Creative Physician Compensation and Benefits

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By Carmel Shachar

On March 30, 2020 the Department of Health and Human Services (HHS) announced a partial waiver of some key elements of the Stark Law, a health care fraud and abuse law. The purpose of this waiver is to relax some of the fraud and abuse requirements around physician compensation during the COVID-19 pandemic to allow hospitals and physician groups to think creatively about meeting the needs of an overworked and stressed workforce. It also provides us an opportunity to consider the post-pandemic future of the Stark Law, long thought to be an impediment to innovative payment and delivery models.

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Why Medical Device Regulation?

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By Carmel Shachar

The Petrie-Flom Center’s 2020 annual conference, Innovation and Protection: The Future of Medical Device Regulation, co-sponsored by the University of Copenhagen’s Center for Advanced Studies in Biomedical Innovation Law and the University of Arizona Health Law Program, was inspired by a growing sense that there is a need to reconsider our regulatory approach to medical devices as they become increasingly complex. Not only are medical devices becoming more mechanically complex, but they are also increasingly merging with digital technologies to expand capabilities.

Devices’ increasing complexity raises questions as to whether our regulatory pathways for medical devices are appropriate for ensuring safety and efficacy. The New York Times in a May 4, 2019 Editorial Opinion indicated that they believed the answer is no—that our current regulatory system, especially the 510(k) pathway and limited post-market surveillance, risk patient lives and health. The European Council is implementing new medical device regulations in May 2020 and 2022 to address similar concerns around safety and effectiveness in the EU. Both American and European regulators are struggling to find the best way to oversee the new hybrid medical devices that incorporate both hardware and software, as well as stand-alone algorithms.

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Is Data Sharing Caring Enough About Patient Privacy? Part II: Potential Impact on US Data Sharing Regulations

The Petrie-Flom Center Staff Leave a comment

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

Earlier, we discussed the new suit filed against Google, the University of Chicago (UC), and UChicago Medicine, focusing on the disclosure of patient data from UC to Google. This piece goes beyond the background to consider the potential impact of this lawsuit, in the U.S., as well as placing the lawsuit in the context of other trends in data privacy and security.

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Is Data Sharing Caring Enough About Patient Privacy? Part I: The Background

The Petrie-Flom Center Staff Leave a comment

By Timo Minssen (CeBIL, UCPH), Sara Gerke & Carmel Shachar

A recent US lawsuit highlights crucial challenges at the interface of data utility, patient privacy & data misuse

The huge prospects of artificial intelligence and machine learning (ML), as well as the increasing trend toward public-private partnerships in biomedical innovation, stress the importance of an effective governance and regulation of data sharing in the health and life sciences. Cutting-edge biomedical research strongly demands high-quality data to ensure safe and effective health products. It is often argued that greater access to individual patient data collections stored in hospitals’ medical records systems may considerably advance medical science and improve patient care. However, as public and private actors attempt to gain access to such high-quality data to train their advanced algorithms, a number of sensitive ethical and legal aspects also need to be carefully considered. Besides giving rise to safety, antitrust, trade secrets, and intellectual property issues, such practices have resulted in serious concerns with regard to patient privacy, confidentiality, and the commitments made to patients via appropriate informed consent processes.

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Defining and Establishing Goals for Medicare for All

Carmel Shachar Leave a comment

It is increasingly difficult to find a Democratic presidential hopeful who has not paid at least some lip service to “Medicare for all.” Indeed, ignoring this popular rhetoric would likely be political suicide for Democratic candidates.

In one poll, 73 percent of registered Democrats said they were more likely to vote for a presidential candidate who supported a Medicare for all health care policy. In response to the popularity of Medicare for all, House Democrats launched an official Medicare for All Caucus, with about 70 members.

Medicare for all, however, means many things to many people. As the fight to become the Democratic presidential candidate unfolds in 2019, it will be important to see how this term gets defined.

Many take Medicare for all to be policy shorthand for health or health care being a human right, entitling individuals to certain services and obligating the government to support access to health care.

For example, the Center for American Progress toted its proposal, Medicare Extra for All, by arguing that health care constitutes a right, as opposed to a privilege. Presidential hopeful U.S. Senator Elizabeth Warren (D-Mass.) similarly released a statement justifying her support of a Medicare for all bill by stating that “health care is a basic human right.”

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3 Things You Should Know About the Petrie-Flom Center’s 2019 Annual Conference

The Petrie-Flom Center Staff Leave a comment

Breakthroughs in genetics have often raised complex ethical and legal questions, which loom ever larger as genetic testing is becoming more commonplace, affordable, and comprehensive, and genetic editing becomes poised to be a consumer technology. As genetic technologies become more accessible to individuals, the ethical and legal questions around the consumer use of these technologies become more pressing.

We are excited, therefore, to have many major thought leaders in this space discuss these issues at the Petrie-Flom Annual Conference, “Consuming Genetics: Ethical and Legal Considerations of New Technologies,” which will take place at Harvard Law School in May. Read More