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...
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...
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...
Privacy Rights of College Athletes: Controls on the Use of Technology to Collect Player Medical Data
Armen Grigorian College athletic departments are always looking to gain an edge over their competitors. Recently, these athletic departments have been gathering player medical data through various new technologies designed to track player performance in the hopes of better preparing for game day, but this raises many privacy concerns. College athletes are often asked to waive privacy protections for their medical data. This is problematic as there are currently no controls on what the universities can do with said data. For student-athletes to retain their privacy rights, the field must develop and implement restrictions on the accessibility of their personal...
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
Obtaining Marijuana Patents
Natali De Corso In the midst of a boom in the marijuana industry, marijuana breeders and companies have increasingly sought protection of their unique marijuana strains through patents. Their success, however, is limited given the fact that marijuana remains illegal under federal law and the United States Patent and Trademark Office has been reluctant to grant such patents. This article explores the current patentability of marijuana strains, discusses the difficulties marijuana breeders and companies face in patenting their product, and introduces successful marijuana-related patent applications. Read Full Text Here
The Patent Utility Requirement and Its Impact on Alternative Medical Treatments for Lyme Disease
Sarah Murphy Alternative medicine has made its way to the forefront of medical innovation, changing the way both doctors and patients approach complex health issues. Patenting medical inventions promotes advancement by increasing the exchange of vital information. This crucial benefit to society is particularly important for patients suffering from chronic illnesses who are dissatisfied with conventional medicine. Though the patent system requires that patented inventions are “useful,” there is no guarantee that the product is effective or even safe to use. The medical field must grapple with this trade-off between the benefit of new treatments made easily available to people...
Telemedicine & the Courts: Teladoc v. Texas Medical Board as a Case Study
Mary Delsener Today, health insurance companies such as Aetna and United Healthcare have partnered with telemedicine companies in order to provide the service for its members. Teladoc, Inc., which markets itself as the first and largest telehealth provider in the United States, is one such company. Of all of business generated by Teladoc’s 11.5 million members, one quarter comes from Texas. Over the course of the past year, however, Teladoc’s ability to continue its services in the state has been on legally tenuous ground due to repeated steps taken by the Texas Medical Board to oust the company from its...