As medical professionals, we outline the science underlying disorders or differences of sexual development (DSD), discuss the nuances of sex and gender and how terminology can differ based on medical vs. non-medical context, briefly review the evidence of the ergogenic effects of hyperandrogenism, and discuss the medical complications with the hormonal contraceptive use currently dictated by World Athletics to allow DSD athletes to compete in the female category.

Human trafficking is associated with a variety of adverse health and mental health consequences, which should be accurately addressed and documented in electronic health records.

Based on an analysis of relevant laws and policies, regulator data portals, and information requests, we find that clinical data, including clinical study reports, submitted to the European Medicines Agency and Health Canada to support approval of medicines are routinely made publicly available.

Surveillance capitalism companies, such as Google and Facebook, have substantially increased the amount of information collected, analyzed, and monetized, including health information increasingly used in precision medicine research, thereby presenting great challenges for health privacy.

Workplace exposure to SARS-CoV-2 has sickened workers and, subsequently, their family members. Family members might be able to recover from the employer in a negligence action using “take-home” liability theory.

A series of denialist state laws thwart efficacious public health emergency response efforts despite escalating impacts of the spread of the Delta variant during the COVID-19 pandemic.

Egilman et al. review the current data sharing practices of three global regulatory agencies — Health Canada, the European Medicines Agency and the Food and Drug Agency. While there has been progress towards increasing transparency over the past decade, progress has been slow.

Escalating demands for limited food supplies at America’s food banks and pantries during the COVID-19 pandemic have raised ethical concerns underlying “first-come, first-served” distributions strategies. A series of model ethical principles are designed to guide ethical allocations of these resources to assure greater access among persons facing food insecurity.

The new NIH data sharing policy, effective January 2023, requires researchers to submit a data management and data sharing plan in their grant application. Expanded data sharing, encouraged by NIH to facilitate secondary research, will require informed consent documents to explain data sharing plans, limitations, and procedures.

Employers and governments are interested in the use of serological (antibody) testing to allow people to return to work before there is a vaccine for SARS-CoV-2. We articulate the preconditions needed for the implementation of antibody testing, including the role of the U.S. Food & Drug Administration.

Brand-name prescription drug manufacturers use various strategies to extend their market exclusivity periods by delaying generic or biosimilar competition. Recent Congressional legislation has targeted four such tactics. We analyze these proposals and assess their likely effect on competition in the U.S. drug market.

Based on hierarchical classification and logistic regression of early US and French COVID-19 clinical trials we show that despite the registration of a large number of trials, only a minority had characteristics usually associated with providing robust and relevant evidence.

In principle, mandatory vaccination in employment could be justified in certain circumstances. These include: (1) the availability of safe and effective vaccination; (2) if alternative, less coercive strategies did not work; and, (3) the costs to the individual were proportionate. However, in COVID-19, the long term safety of vaccines is yet to be established. Vaccines should be made available by employers, and voluntary vaccination encouraged.

Antimicrobial resistance (AMR) is one of the defining global health threats of our time, but no international legal instrument currently offers the framework and mechanisms needed to address it. Fortunately, the actions needed to address AMR have considerable overlap with the actions needed to confront other pandemic threats.

Immunizing hundreds of millions against COVID- 19 through the most extensive national vaccine campaign ever undertaken in the United States has generated significant law and policy challenges.