File folders in a filing cabinet.

Strengthening the Freedom of Information Act in 2023

By Mitchell Berger, MPH

While the Freedom of Information Act (FOIA) (5 U.S.C. § 552) and agency implementing regulations generally are fairly concise, FOIA still has led to considerable litigation.

What is an agency record? Should contractors be covered by FOIA? How and under what circumstances should a given FOIA exemption apply? How should FOIA search and duplication fees be charged by agencies, and what level of fees are reasonable? Debate continues about these and many other issues, but even amidst this debate opportunities abound to support FOIA implementation in the year ahead.

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Adderall bottle on shelf.

Losing Control of Controlled Substances? The Case of Telehealth Prescriptions 

By Minsoo Kwon

Telehealth services that specialize in the treatment of mental health concerns, such as Cerebral Inc., highlight the ongoing challenge of appropriately balancing accessibility of care with patient safety.

While increased accessibility of mental health care services through telehealth is a valuable goal, if our aim is the well-being of patients, safety must be paramount.

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Supreme Court of the United States.

What the Supreme Court’s Expected Ruling on Affirmative Action Might Mean for US Health Care

By Gregory Curfman

Affirmative action in higher education may soon be abolished by the Supreme Court, resulting from its review of Students for Fair Admissions v. Harvard and Students for Fair Admissions v. University of North Carolina.

The consequences for the physician workforce may be dire. Diversity among physicians is a compelling interest in our increasingly diverse society. Without affirmative action in higher education, our physician workforce may become less diverse, and the quality of health care may suffer.

This article explains the history of affirmative action in the U.S., past Supreme Court decisions, and the key arguments being considered in the two cases currently under review.

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Black and white exterior of Legislative chambers of Washington State with inscription and pillars.

Tracking Public Health Authority Changes from 2021 & 2022 Legislative Sessions

By Temple University Center for Public Health Law Research

COVID-19 called for quick, decisive action by public health authorities to support communities and prevent infections. Since the pandemic began, legislators around the country have been acting to change the way authorities may respond to future public health emergencies — expanding or limiting officials’ authority to act in an emergency, changing who has authority to act, and the actions they may have the authority to take.

New research by the Center for Public Health Law Research at Temple University’s Beasley School of Law, in collaboration with the Association for State and Territorial Health Officials and the Network for Public Health Law, capture details of legislation that addresses emergency health authority introduced between January 1, 2021, and May 20, 2022, in all 50 states and the District of Columbia.

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ACCRA, GHANA: April 23, 2020 - The testing of samples for the coronavirus in a veterinary lab in Accra, Ghana.

Does It Really Matter How the COVID-19 Pandemic Started?

By Barbara Pfeffer Billauer

Throughout the COVID-19 pandemic, much air time and social media space has been allocated to the lab leak vs. natural spillover dispute regarding the origins of SARS-CoV-2.

To summarize briefly, the question is whether the pandemic was caused by a leak from a biosafety level (BSL) four lab in Wuhan, China, or whether it arose naturally as a consequence of a virus jumping from a bat to an animal and then to humans.

Given that the “truth” will likely never be known, and certainly not provable, the question becomes: is it important to seriously consider the lab leak theory?

The answer, I suggest, is an unabashed yes — but not for the reason you might think. The question is important prospectively, not retrospectively. Debating the origins of the COVID-19 pandemic is a fool’s errand. Considering laboratory accidents writ large, however, is important, as they remain a potent threat to international biosecurity.

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Bill of Health - Globe and vaccine, covid vaccine

Biotech Companies Are Opening Manufacturing Sites in Africa: Will This Help Vaccine Equity?

By Sarah Gabriele

Two pharmaceutical giants of the pandemic, Moderna and BioNTech, are taking steps for increasing the manufacturing capacity for the COVID-19 vaccine in Africa. Last March, Moderna announced its plan to set up a manufacturing facility in Kenya to produce messenger RNA (mRNA) vaccines, including COVID-19 shots. Similarly, in 2021, BioNTech started planning its own manufacturing plant in Africa, which will be composed of modular shipping containers.

Measures to address global vaccine inequity could not come sooner. As of December 15, 2022, only 34% of the population in Africa has received at least one dose of the COVID-19 vaccine, with Moderna and BioNTech having provided fewer doses compared to Oxford-AstraZeneca and Johnson & Johnson. After failing to successfully deliver vaccines equitably during the first two years of the pandemic, Moderna and BioNTech appear now to be taking steps to shoulder greater responsibility for vaccine equity.

However, if companies are ethically required to address the availability of vaccines, these well-intended efforts might still fail to fulfill their moral obligations. Indeed, while the construction of these new sites might sound like great news for fostering the delivery of vaccines in low- and middle-income countries, we should be aware that these manufacturing sites, as well as the existence of manufacturing capacity, might not be enough to achieve desired outcomes.

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Grayslake, IL - January 30, 2021: Drive-through indoor COVID-19 vaccination facility at the Lake County Fairgrounds in Grayslake. The facility is dispensing both the Moderna and Pfizer vaccine.

COVID-19 Vaccine Patent Infringement? The Battle Between Moderna and Pfizer/BioNTech Continues

By Aparajita Lath

Last month, the patent battle between COVID-19 mRNA vaccine manufacturers continued with BioNTech/Pfizer filing a strong defense and counter-claim to Moderna’s allegations of patent infringement.

In their initial August 2022 complaint, Moderna alleged that three of its mRNA patents were infringed by Pfizer/BioNTech. Interestingly, as of January 12, 2023, Moderna has listed 10 patents covering Spikevax (its mRNA vaccine) on its website. Since biotechnology inventions can be covered by several patents, each of which may not be easy to identify through public searches, the decision to publish a consolidated list of patents is a move in the right direction. However, the list is an evolving one, and, as it happens, one of three patents at issue, i.e., patent no. 10,933,127 (‘127) has not been listed.

The following article explains the key patents at stake in the intellectual property dispute.

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File folders containing medical records.

How Dobbs Threatens Health Privacy

By Wendy A. Bach and Nicolas Terry

Post-Dobbs, the fear is visceral. What was once personal, private, and one hoped, protected within the presumptively confidential space of the doctor-patient relationship, feels exposed. In response to all this fear, the Internet exploded – delete your period tracker; use encrypted apps; don’t take a pregnancy test. The Biden administration too, chimed in, just days after the Supreme Court’s decision, issuing guidance seeking to reassure both doctors and patients that the federal Health Privacy Rule (HIPAA) was robust and that reproductive health information would remain private. Given the history of women being prosecuted for their reproductive choices and the enormous holes in HIPAA that have long allowed prosecutors to rely on healthcare information as the basis for criminal charges, these assurances rang hollow (as detailed at length in our forthcoming article, HIPAA v. Dobbs). From a health care policy perspective, what is different now is not what might happen. All of this has been happening for decades. The only difference today is the sheer number of people affected and paying attention.

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African American patient explaining issues to Asian doctor using tablet.

How New Anxiety Screening Guidelines Can Reduce Inequities in Mental Health Care for Black Women

By Krista Cezair

Black women are less likely to receive mental health diagnosis, treatment, and care than their white counterparts.

To begin to address these disparities, I suggest building on the recent proposal drafted by the United States Preventive Services Task Force (USPSTF), which calls for primary care physicians to screen all adults aged 64 years or younger, including pregnant and postpartum persons, for anxiety disorders as part of their routine care.

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Stethoscope with blue suitcase on a table with American flag as background.

Is a Federal Medical License Constitutional?

By Timothy Bonis

Although three in four doctors support scrapping state medical boards in favor of a single federal license, such sweeping reform is likely far off. It is not just state boards’ political obstructionism standing in the way. Basic constitutional federalism limits Congress’s ability to assume powers traditionally held by the states, leaving medical licensure (a state matter since its 19th-century inception) difficult to federalize.

This post will explore potential constitutional arguments for and against federal licensure, investigate the constitutionality of more moderate legislative approaches, and speculate on how the late Roberts Court might respond to reform attempts.

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