The Future of Personalized Medicine: How Should Genomic Sequencing Be Regulated?

Background Healthcare is currently making a historic transition towards personalized medicine, a new and emerging healthcare model for treatment and prevention strategies tailored towards the client’s specific genetic variation, lifestyle, and environment. Among the tools used in this model, genomic sequencing is one that is quintessential to the creation and effectiveness of these strategic plans. Breakthroughs in science and technology allow laboratories to sequence an entire human genome within 24 hours and at a reasonably Continue Reading →

HHS and Treasury Issue New Guidance on PPACA Waivers

On Monday, October 22, 2018 the Departments of Health and Human Services (HHS) and the Treasury issued new guidance pertaining to state waivers under Section 1332 of the Patient Protection and Affordable Care Act (PPACA). Section 1332 waivers (formerly “State Innovation Waivers” and now “State Relief and Empowerment Waivers”) allow states to apply for waivers for specific ACA health care plan requirements. Under the terms of the PPACA, the HHS Secretary can request waivers only Continue Reading →

State Vaccine Mandates vs. Federal Vaccine Regulation

The results of a 2017 survey from the Centers for Disease Control and Prevention (CDC) were released earlier this month, finding that the percent of U.S. children under two years old who have not been vaccinated has quadrupled since 2001, resulting in 1.3% of children today not receiving any of their recommended vaccines. There are four main reasons why parents don’t vaccinate their children: religious beliefs, personal beliefs or philosophical reasons, safety concerns, and a Continue Reading →

Human Germline Modification Is Coming

Introduction Inside a decade, the U.S. Food & Drug Administration (FDA) will approve clinical trials for the genomic modification of a viable human embryo in order to prevent disease. That seems a real possibility in light of significant developments in policy and research this year. While such trials are currently barred in the United States by federal law, the prospect of future trials gained key support from the National Academies of Sciences, Engineering, and Medicine Continue Reading →

January 2017 Amendment to the WTO Agreement on Trade-Related Intellectual Property Rights

In 1948, General Agreement on Tariffs and Trade (“GATT”) established the rules for international commerce, with agreements signed by governments of the majority of global trading nations. The World Trade Organization (“WTO”) sprang from the de facto negotiating forum under the same name, GATT, through the Marrakesh Agreement Establishing the World Trade Organization. While GATT focused primarily on liberalizing the trade of goods, the WTO Agreement on Trade-Related Intellectual Property Rights (“TRIPs”) extended to cover Continue Reading →

Why we should say “yes” to GMOs.

America is currently in the midst of a non-GMO craze. Genetically modified organisms—known as GMOs—attracted little public attention when they were first introduced into the U.S. commercial food supply in the mid-1990s. This changed in 2003, when a California natural food store launched a grassroots campaign to persuade natural food companies to reveal whether their products contain GMOs. This campaign led many organic food proponents to decry GMOs as impure, unnatural, and a threat to Continue Reading →

Interpreting the BPCIA – Is the “Patent Dance” Mandatory?

Background Biologics are a type of therapeutics derived from, or made by, the biological processes of a living organism, such as human cells, animals, microorganisms, or yeast.1 Examples of biologics include some vaccines, blood or blood components, hormones, and antibodies. Unlike standard chemical drugs, which are relatively small molecules, biologics are often large and complex molecules that are not easily produced through synthetic manufacturing pathways. Due to their production mechanism, it is difficult to create Continue Reading →

Legally Mandated Vaccinations

The recent measles outbreak that started at Disneyland and quickly spread to different parts of the country, with 107 cases in 14 states, has reignited debate over requiring laws that require parents to vaccinate their children. Currently, 48 states allow parents to forego vaccinating their children for religious reasons, while 19 states allow exemptions for personal or philosophical reasons.  Only two states — Mississippi and West Virginia — ban all nonmedical exemptions.  While there is Continue Reading →

The Conflict in Electronic Medical Records

As physicians and hospitals increasingly move away from physical record-keeping to electronic health record (EHR) systems, the push and pull between the need for healthcare privacy/security on one hand, and the necessity of sharing healthcare information on the other, continues to grow as well. One example of how this problem plays out is that moving sensitive healthcare information to the cloud makes it easier to share and access patient information, but it also makes it Continue Reading →

Use of Athletes as Science Experiments: Are We Next?

John Calipari, University of Kentucky basketball coach, is a renowned and often controversial figure. He is also one of the first coaches to implement the use of heart-rate monitors during team practices to push his players beyond their comfort zones into complete physical exhaustion. Not only do the heart-rate monitors measure players’ exertion rates, but they also keep track of caloric burn. While the original purpose of these devices was to measure player exhaustion and Continue Reading →