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Health Law Diagnosed – A Discussion on the Regulatory Requirements for LDTs

In this episode of Health Law Diagnosed, host Bridgette Keller is joined by Mintz Health Law attorneys Joanne Hawana and Benjamin Zegarelli to discuss the FDA’s long-awaited proposed rules that actively regulate laboratory...more

Health Law Diagnosed — Mintz Health Law Team: Reflecting on What We Are Grateful For

As the Mintz Health Law team welcomes the beginning of 2024, many of its members take a moment to reflect on the exciting growth of the Health Law Practice, opportunities to partner with clients on complex legal issues, and...more

Bioethics in a Pandemic: Final Framework for Equitable Allocation of a COVID-19 Vaccine

Earlier this month, the National Academies Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released its Final Framework to guide US distribution and administration of a COVID-19 vaccine, once available....more

Bioethics in a Pandemic: Vaccine Research and Clinical Trials

After exploring some of the ethical questions involved in allocating and distributing a potential COVID-19 vaccine and the basic tenets of bioethics, we continue by delving into the ethical issues relating to the vaccine...more

Bioethics in a Pandemic: Uncertainties in Applying the Draft Framework

Continuing with our review of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”), this post highlights a number of uncertainties that will be faced in implementing the...more

Bioethics in a Pandemic: The Public’s Role in COVID-19 Vaccination

As we noted in our previous post, the Johns Hopkins University Center for Health Security (Center) has been hard at work studying and providing thought leadership regarding the COVID-19 pandemic from a variety of angles. The...more

Bioethics in a Pandemic: Laying the Foundation for the Draft Framework for Equitable Allocation of a COVID-19 Vaccine

With the release of the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) on Tuesday and only a matter of days to provide comments, our next posts in the Bioethics in a Pandemic...more

Bioethics in a Pandemic: Johns Hopkins Offers Ethics Framework to Support Vaccine Distribution Decisions

The Johns Hopkins University Center for Health Security (the “Center”) has been providing thought leadership related to the novel coronavirus and the COVID-19 pandemic since the beginning of the year. Two of the Center’s...more

Bioethics in a Pandemic: Draft Framework for Equitable Allocation of COVID-19 Vaccine

As you know, the Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine (the “Draft Framework”) was released earlier this week, and we are highlighting its major sections as stakeholders prepare to submit...more

Hot off the Presses! Draft Preliminary Framework for Equitable Allocation of COVID-19 Vaccine Just Released

Earlier today, the Committee on Equitable Allocation of Vaccine for the Novel Coronavirus released preliminary guidelines on the allocation of initial and limited supplies of a forthcoming COVID-19 vaccine. Once finalized,...more

Bioethics in a Pandemic: Learning from the Past

As we continue to discuss the ethical considerations related to the distribution of a safe and effective coronavirus vaccine, it is important to consider lessons learned from other pandemics. Though the particular facts of...more

Bioethics in a Pandemic: The Basics

Before we continue our Bioethics in a Pandemic series, we thought it would be helpful to provide a quick overview of the various principles that inform ethical decision-making in the health care setting. As you might...more

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