A Trip to Inequity: How the TRIPS Agreement Hinders Access to Needed COVID-19 Therapeutics
Ruchita Jain The COVID-19 pandemic continues to rage on in much of the world, severely affecting the health of millions. But citizens of high-income nations have accepted the pandemic to be over. The key to ending the pandemic globally across all nations is equal and efficient access to necessary COVID-19 therapeutics, including vaccines. This Article argues that least developed nations and their access to COVID-19 therapeutics, including vaccines, is negatively impacted by the TRIPS Agreement. International human rights law and the TRIPS Agreement remain incompatible, leading to disproportionate access of necessary therapeutics as systemic racism is perpetuated. Along with considering...
Transparency is a Misplaced Regulatory Focus for Holding Adaptive Software as Medical Devices (SaMDs) Accountable
Quy Mai Adaptive Software as Medical Devices (SaMDs) play an increasingly critical role within clinical settings, assisting physicians with illness detection, diagnosis, and analysis. Use of Artificial Intelligence/Machine Learning (AI/ML) techniques, such as deep machine learning and neural networks, lends adaptive SaMDs unparalleled analytical power, but not without risks. Adaptive SaMDs are typically “black-box,” meaning that they compute data such that no one can determine how it rendered outputs. “Transparency,” in the form of explainability, is frequently raised in policy discussions as a solution to track when the SaMD has erred in computing outputs. The FDA, in seeking to uphold...
BLOG POST: DR. AMAZON: SHINING A LIGHT ON HIPAA INADEQUACIES THROUGH AMAZON’S EXPANSION INTO THE HEALTHCARE INDUSTRY*
*This writing is a blog post. It is not a published IPTF Journal Article. Alexa Dawid Technology giants are spending billions to enter the healthcare space.[1] Offerings like Apple’s health monitoring functions on the iPhone, Microsoft’s cloud computing services for healthcare companies, and Meta’s fitness applications through its virtual reality goggles have transformed traditional notions of doctor’s offices and paper records into convenient digital systems.[2] Amazon has been one of the most ambitious within the space, debuting six HIPAA-compliant skills for Alexa in April 2019.[3] These skills mark the first time Alexa has surpassed HIPAA requirements in utilizing HIPAA-compliant...
Antitrust Implications of the Banning Surveillance Advertising Act
Alisha Parker-Martell The Banning Surveillance Advertising Act, proposed in the 117th Congress of the House of Representatives by Congresswoman Eshoo, would improve consumer data protection but would also have negative consequences on market competition in sectors that utilize user data. This Act is indicative of a growing conflict between antitrust policy and consumer data privacy. This essay argues that future federal consumer data privacy legislation should attempt to balance the competing interests of market health and consumer privacy rights by prohibiting exploitative uses of consumer data and mandating consumer data sharing and a period of exclusive use of collected data....
Health-Tech Apps: Unclear Regulations and Their Effects on Progress
Emily Dieli The increased emphasis on creating a more streamlined healthcare system in the United States has led to a rise in digital health-tech apps and devices. To protect the privacy of personal health data on these technologies, policymakers have turned towards regulation. The Federal Trade Commission’s (FTC) recent statement on the Health Breach Notification (HBN) Rule has extended the scope of the 2009 regulation to include previously unregulated health-tech entities. Nevertheless, the statement is vague and will have a negative impact on health-tech innovation. Policymakers should consider the implications of their regulations on health-tech progress before making such hasty...
Square Peg in a Round Hole: Manipulating Patent Law to Reduce the Prices of Pharmaceutical Products
Jasmine Daniel Pharmaceutical companies are commonly criticized for charging exorbitantly high prices for their products which can make it difficult for many patients to access life-saving drugs. Competitors, such as generic manufacturers, often cannot manufacture cheaper alternatives to these drugs due to strong patents which protect against product copying. Both the Bayh-Dole Act and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) include provisions which allow competitors to circumvent pharmaceutical patent protection under limited circumstances. Although there are instances in which such circumvention is necessary, ambiguities in these statutes allow countries to bypass pharmaceutical patents and encourage production...
Mind over Data: A Case for Increased Privacy Protections in Mobile Mental Health Apps
Marian Lemont As mobile mental health apps gain popularity as an emotional support alternative, privacy concerns regarding how consumers’ sensitive health data is handled are at an all-time high. Current federal privacy provisions provide insufficient consumer protection and thus render consumers’ sensitive information vulnerable to unwanted third-party sharing practices. The recently passed California Privacy Rights Act of 2020 (CPRA) includes new provisions governing businesses’ handling and deletion of sensitive user data. This article discusses how these new CPRA provisions provide a helpful framework to begin addressing this regulatory gap and identifies ways future privacy legislation can continue to strengthen mobile...
Expanding the Patent Eligibility of Diagnostic Tests and Their Methods
Jo-an Chen There is ongoing debate over whether diagnostic tests and their methods should be patent eligible. As it stands today, these tests are largely unpatentable given the restrictive interpretation of patent eligibility laws in the United States. Some argue that patent claims directed to observing a law of nature, such as diagnostic tests, should remain patent ineligible to prevent an inventor from monopolizing basic tools of science. Others argue that diagnostic tests should be patent eligible to incentivize and encourage similar types of socially beneficial discoveries and inventions. This Essay agrees with the policy rationale for expanding the patent...
The Case for Prohibiting the Sale of Individual Genetic Testing Data to Third Parties
Nathaniel Jaffe Genetic technology is getting cheaper, and millions of individuals are using direct-to-consumer genetic testing (DTC-GT) services. At the same time, the scientific understanding of genetics is improving, making sequencing information more valuable for predictive medicine, research, forensics, and many other fields. In turn, genetic information has become more valuable for third parties like insurers, researchers, and pharmaceutical companies. DTC-GT providers are in a position to provide increasingly low-cost services to a growing consumer base, while stockpiling data of increasing commercial value. The sale of genetic data threatens the privacy of the individuals who provided it and opens them...
Can a Two-Pronged Attack from Congress and the FDA Make Up for the BPCIA’s Limitations?
Guodong Fu The Biologic Product Competition and Innovation Act (BPCIA) of 2009, modeled after the Hatch-Waxman Act of 1984, has been largely criticized as ineffective in promoting significant competition in the pharmaceutical industry. Biosimilar sponsors lack guidance from the U.S. Food and Drug Administration (FDA) on how to obtain interchangeable designation for follow-on biologics. In addition, biosimilar sponsors face patent infringement litigation from reference drug companies as part of the “patent dance” set forth by the Supreme Court in 2017 in Sandoz v. Amgen. The FDA’s Biosimilar Action Plan (BAP) and a proposed bill from Congress, the Biologic Patent Transparency...