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...
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...
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...
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...
Use of Benefit Corporations to Accelerate Access to Affordable Vaccines
Julie Bateman Low- and middle-income countries face the heaviest burden from vaccine-preventable diseases, yet many of these countries cannot afford critical vaccines. Vaccines are often protected by patents so that pharmaceutical companies can recoup development costs. Consequently, vaccine manufacturers in developing countries must wait until the patents expire to produce lower-cost generic vaccines. Additionally, when the development of new vaccines relies on existing patents, such development is hindered. Benefit corporations offer an opportunity for the private and public sectors to align interests in accelerating critical vaccine development. Vaccine developers, restructured as benefit corporations, could commit to both special licensing agreements...
Get Out of My Head: An Examination of Potential Brain-Computer Interface Data Privacy Concerns
Kevin Y. Li Brain-computer interfaces (“BCI”), which interpret brain impulses and translate them into real world outputs, currently exist in a variety of forms. With the continued development of BCIs and their increasing complexity, privacy issues will arise in regards to the data that they collect. Existing federal statutes, such as HIPAA, as well as state data privacy statutes offer some protection to BCI users, but it remains to be seen whether these laws will be sufficient to accommodate the amount and sensitivity of the data likely to be generated by future BCIs. Lastly, this article explores the possibility of...
The Cancer Immunotherapy Pilot Program and Chimeric Antigen Receptor-T Cell Treatments
Ellen Shamansky The Cancer Immunotherapy Pilot Program (also known as Patents 4 Patients) provides fast-track review to patent applications describing methods of treating cancer with immunotherapy, such as chimeric antigen receptor (“CAR”)- T cell treatments. This article explores considerations for claiming CAR-T cell treatments, including court rulings and examiner guidelines on patentable subject matter in the life sciences, the Federal Circuit’s decision in NantKwest, Inc. v. Lee in 2017, and pending applications and current litigation over CAR-T cell treatments. Read Full Text Here
Interoperability’s Role in Striving for Precision Medicine
Martha Koroshetz President Obama announced the Precision Medicine Initiative in his 2015 State of the Union address, a research effort to find treatments that are tailored to specific genetic profiles and characteristics. This personalized and context-specific treatment approach will require big data analysis of patient outcomes and their genetic sequence, which must then be accessible and comprehensible to caregivers. The initiative must therefore be able to reconcile genetic data, demographic information, and health information, in the electronic health record. To achieve data interoperability, the organizations engaged in the initiative must confront questions of data privacy, standardize data exchange, and incentivize...