Wade Ackerman.

Meet Wade Ackerman, Petrie-Flom Center Advisory Board Member

The Petrie-Flom Center is excited to welcome Wade Ackerman to our Advisory Board!

Ackerman is a partner in Covington’s FDA Regulatory group, where he advises companies and trade associations on complex Food and Drug Administration (FDA) issues. He also co-leads Covington’s multidisciplinary Digital Health Initiative, which advises clients who are using information technology and data to innovate and improve health.

To learn more about the expertise that Ackerman will bring to the Advisory Board, we asked him a few questions about his background and current areas of practice. The conversation touches on a range of topics, from misconceptions about the FDA’s Emergency Use Authorization, to the promise that digital technologies hold in promoting health and wellness. The interview, which has been edited and condensed, follows.

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Empty classroom.

The National Anti-Vaccine Movement Heads to Hartford to Intimidate CT Legislators

By Arthur Caplan and Dorit Rubinstein Reiss

As Connecticut’s Senate prepares to vote tomorrow on whether to repeal Connecticut’s religious exemption from school immunization mandates, out-of-state anti-vaccine activists are mobilizing to threaten and intimidate legislators to vote against the bill.

The legislators should hold firm, and pass the bill the Governor says he will sign. They must not let aggressive attackers stop them from acting to make Connecticut’s children safer. Legislators should show the out-of-state anti-vaccine movement that intimidation doesn’t work here.

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Petrie-Flom Student Fellowship Now Accepting Applications

What do a MacArthur Genius award winner, several health law professors at top schools, executive directors of leading health law centers, an associate chief counsel of the FDA, and partners and associates at top health care law firms all have in common? The Petrie-Flom Center Student Fellowship!

The Petrie-Flom Center Student Fellowship is a competitive one-year program designed to support Harvard graduate students interested in pursuing independent scholarly projects related to health law policy, biotechnology, and bioethics.

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Prison watch tower.

Government Report Finds Care Deficits for Pregnant People in Federal Custody

By Elyssa Spitzer

Pregnant and postpartum people in the custody of the Bureau of Prisons (BOP) and U.S. Marshals Service receive care directed by policies that fail to meet national standards, according to a report recently issued by the Government Accountability Office (GAO). 

This, despite the fact that, incarcerated women are among the most vulnerable people, according to the American College of Obstetricians and Gynecologists. In the GAO report’s terms, incarcerated women: “often have medical and mental health conditions that make their pregnancies a high risk for adverse outcomes, which is compounded by inconsistent access to adequate, quality pregnancy care and nutrition while in custody.”

Notably, the report found that the BOP and U.S. Marshals’ policies failed to satisfy the national standards — to say nothing of the gaps that may exist between written policy and the care that is, in fact, provided. Read More

Disability with technology line icon set.

Reflecting on the Struggle for Disability Rights a Year into the Pandemic

By Amalia Sweet

On March 9, the Petrie-Flom Center and Harvard Law School Project on Disability gathered a panel to discuss the extent to which the pandemic has set back progress toward ensuring the rights of persons with disabilities.

Though calls for solidarity in March 2020 declared the emerging pandemic to be a “great equalizer,” the past 12 months have demonstrated how the pandemic has exacerbated existing social inequalities, disproportionately impacting the already marginalized.

The panel discussion, hosted by Petrie-Flom Center Senior Fellow in Global Health and Rights Alicia Ely Yamin and moderated by Harvard Law School Project on Disability Executive Director Michael Ashley Stein, provided voice to the uniquely and acutely devastating impacts of the pandemic on persons with disabilities, who are still struggling to secure protection of their basic rights.

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Los Angeles, California / USA - May 1, 2020: People in front of Los Angeles’ City Hall protest the state’s COVID-19 stay at home orders in a “Fully Open California” protest.

5 Questions About COVID-19 and Religious Exemptions

By Chloe Reichel

On February 26th, the Supreme Court of the United States issued a shadow docket decision that could foretell sweeping limitations for public health measures, both within and outside the COVID-19 pandemic context.

The Court’s ruling in the case, Gateway City Church v. Newsom, blocked a county-level ban on church services, despite the fact that the ban applied across the board to all indoor gatherings. This religious exceptionalism is emerging as a key trend in recent Supreme Court decisions, particularly those related to COVID-19 restrictions.

To better understand what these rulings might mean for public health, free exercise of religion, the future of the COVID-19 pandemic, and potential vaccine mandates, I spoke with Professor Elizabeth Sepper, an expert in religious liberty, health law, and equality at the University of Texas at Austin School of Law.

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Empty classroom.

Can Colleges and Universities Require Student COVID-19 Vaccination?

This post originally appeared on the Harvard Law Review Blog.

By I. Glenn Cohen and Dorit Rubinstein Reiss

In the last year, colleges and universities across the U.S. struggled with how to operate during the COVID-19 pandemic. The most recent data, from January 2021, shows a mix of online and in-person modes of instruction.

Pie chart of modes of instruction for higher education institutions during the pandemic.

At the same time, a study of the experience in early fall 2020 found an association between colleges and universities with in-person instruction and increased infection incidence in the counties within which the schools were located. With vaccine authorization in the U.S. and the promise of potential availability for student populations in late spring and summer 2021 (in most states’ allocation plans these students are among the last groups in prioritization), there is increasing interest by higher education institutions in moving more of their fall 2021 educational instruction and non-instructional activities to in-person modes. Vaccinating students is a key step to safely reopening campuses, in whole or in part, in a way that is safe for students, faculty, staff, and local communities. At the same time, university leaders are likely reasonably concerned about the legality of mandating COVID-19 vaccines. Not all students, faculty or staff may appreciate such a requirement, and anti-vaccine groups are more than ready to assist in litigation — as, for example, they did when the University of California required influenza vaccines for on-campus attendance (a preliminary injunction in that case was denied). In this essay, we discuss whether universities can legally require vaccination as a condition of attendance and with what accommodations.

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Person smoking cigarette.

Should Smokers be Prioritized for COVID Vaccine?

Cross-posted from Harvard Law Today, where it originally appeared on February 2, 2021. 

By Jeff Neal

Should smoking be among the pre-existing health risks that qualify people for priority access to the COVID-19 vaccine? In a Zoom interview with Harvard Law Today, public health expert Carmel Shachar J.D./M.P.H. ’10 says the answer is yes. 

CDC guidelines, which most states are following as they launch mass vaccination programs, say people with certain underlying medical conditions that put them at greater risk for hospitalization or death if they contract COVID-19 (also known as co-morbidities) should receive access to the vaccine before the general population. In Massachusetts, these individuals will be eligible to receive the vaccine in Group 4 of Phase 2 of the state’s vaccination rollout plan. But many have been surprised to see smoking listed among the qualifying conditions, alongside cancer and heart disease.

Shachar, the executive director of the Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School, says that smoking is often the result of structural and biological factors that make it more prevalent in historically marginalized communities, and that denying priority access for smokers would reinforce existing inequities. More practically, she says, “every time a person gets vaccinated, it’s good for the community.” 

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Call for Applications: Research Fellow for Diagnostic Digital Home Health

Overview

The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School is hiring a full-time post-doctoral fellow to support its newly launched Diagnostic Digital Home Health initiative. This position will likely be a three year commitment.

This sponsored research project examines the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions. This project will develop scholarship, guidelines, and proposed regulations for the ethical implementation of these products, using focus groups, virtual workshops, and interdisciplinary scholarship, with a focus on considerations of access and equity, social interconnectedness, and patient privacy.

Previous Petrie-Flom Center post-doctoral fellows have used their positions as successful launching pads for tenure-track legal, health policy, and bioethics academic careers. Our most recent post-doctoral fellow has published in leading journals such as JAMA, Science, and the Journal of Law and the Biosciences. She has been interviewed as an expert in biomedical regulation by media outlets such as Forbes and Lancet Digital Health and presented to regulators at the U.S. Department of Health and Human Services.
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Telemedicine or telehealth virtual visit / video visit between doctor and patient on laptop computer and mobile phone device.

The Petrie-Flom Center Launches New Project: Diagnosing in the Home

Diagnosing in the Home will seek to examine the ethical, social, and legal challenges of digital home health products, with a focus on home diagnosis of infectious and chronic conditions.

January 27, 2021 – The Petrie-Flom Center for Health Law Policy, Biotechnology, and Bioethics at Harvard Law School today announced a new research initiative, Diagnosing in the Home: The Ethical, Legal, and Regulatory Challenges and Opportunities of Digital Home Health. This three-year project will seek to promote the translation of diagnostic medical services into home health care through regulatory and ethical frameworks. This initiative is generously supported by a grant from the Gordon and Betty Moore Foundation.

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