Science and Technology Law Commons^™

Defining Genetic Information Under Gina, Shane Padilla

Cleveland State Law Review

The Genetic Information Nondiscrimination Act (GINA) was enacted to prevent discrimination based on an employee’s genetic information. Although GINA undoubtedly provides employees protection from unjust genetic discrimination by employers, varying interpretations of what constitutes “genetic information” has raised legal uncertainties in how GINA is applied. Consequently, the genetic information of an employee’s family may be unduly placed at risk as a result of misinterpreting the statutory language and legislative intent of GINA. It is of the utmost importance that the definition of “genetic information” be construed with respect to the Act’s legislative history, which supports a broad interpretation and application …

Reconnecting The Patient: Why Telehealth Policy Solutions Must Consider The Deepening Digital Divide, Laura C. Hoffman

Journal of Law and Health

This Article attempts to untangle the complicated web of providing telehealth to those populations it is potentially capable of further alienating from access to healthcare including: 1) race/minority populations, 2) aging adults, 3) individuals with disabilities, 4) non-English speakers, 5) individuals living in rural areas, 6) socioeconomic class, and 7) children, in order to advance the argument that telehealth can be successful in providing healthcare access to these populations. Rather than suggesting that telehealth simply “cannot work” for these populations, instead this Article considers how telehealth can and must meet the needs of these individuals through technology, access, and policy …

Don't Tread On My Ip Rights: A Law And Economics Analysis Of "March-In Rights" Under The Bayh-Dole Act, Caitlin Grow

Cleveland State Law Review

The Bayh-Dole Act has been imperative to the development of the United States’ dynamic pharma-biotech sector. However, the use of march-in rights under the Bayh- Dole Act has remained controversial. On the one hand, there is the idea of market equilibrium with a need to secure health care for the public. Many believe march-in rights should be used to create this balance by regulating the pricing of drugs that were developed using federally funded research. On the other hand, some advocates recognize that the current relationship between public-sector institutions and business as the developers of basic research, and private-sector biotechnology …

Machine Learning-Based Medical Devices: The Fda’S Regulation, Requirements, And Restrictions, Charli Beam

Journal of Law and Health

The FDA should create functional regulations for the growing number of machine learning medical devices. The healthcare system is increasingly using these devices for diagnosis. Machine learning devices trained on biased data sets are susceptible to furthering certain types of bias and generating flawed outcomes. The FDA should require ML medical devices to include a label that describes the demographics of the tested population. If manufacturers fail to include this information, the FDA could determine the label false or misleading under §502 of the FD&C Act and stop sales of the device. After approval, the FDA should use §814.89(2) and …

Transcript: Presentation On Artificial Intelligence And Discrimination In Healthcare, Sharona Hoffman

Journal of Law and Health

The following is a transcription from The Digital Health and Technology Symposium presented at Cleveland-Marshall College of Law by The Journal of Law & Health on Friday, April 8, 2022. This transcript has been lightly edited for clarity.

Transcript: Presentation On Individual Autonomy In Ai Healthcare, Charlotte Tschider

Journal of Law and Health

The following is a transcription from The Digital Health and Technology Symposium presented at Cleveland-Marshall College of Law by The Journal of Law & Health on Friday, April 8, 2022. This transcript has been lightly edited for clarity.

Transcript: Presentation On Data Privacy Questions In The Digital Health World, Sara Gerke

Journal of Law and Health

The following is a transcription from The Digital Health and Technology Symposium presented at Cleveland-Marshall College of Law by The Journal of Law & Health on Friday, April 8, 2022. This transcript has been lightly edited for clarity.

Flattening The Curve While Protecting Our Right To Privacy: How The United States Can Implement The Digital Contract Tracing Efforts Used In East Asia, Evan Morris

Global Business Law Review

This paper looks at the digital contact tracing efforts implemented by other nations and assesses how similar measures could operate under enacted and proposed United States laws. Part I overviews the history of contact tracing and its effectiveness in prior disease outbreaks. Part II delves into the digital contact tracing efforts implemented by South Korea and Singapore. These summaries include: the digital contact tracing efforts taken, the laws that authorize these efforts, the public’s reception, and the overall effectiveness of the efforts. Part III overviews the digital contact tracing efforts in the United States, including proposed legislation aimed at user …

Designing An Americans With Abilities Act: Consciousness, Capabilities, And Civil Rights, Laura C. Hoffman, Zachary E. Shapiro, Allison Rabkin Golden, Gregory E. Antill, Katherine Fang, Chaarushena Deb, Elizabeth Clarke, Alexis Kallen, Hanya M. Qureshi, Kai Shulman, Caroline V. Lawrence, Megan S. Wright, Joseph J. Fins

Law Faculty Articles and Essays

The Americans with Disabilities Act (ADA) is a seminal piece of legislation aimed at protecting those with disabilities from discrimination. The ADA, however, has not been consistently able to integrate people with disabilities successfully into society. With a specific focus on individuals with serious brain injuries, this Article aims to provide insight into the shortcomings of the ADA, specifically focusing on lackluster enforcement of the legislation and its failure to incorporate promising new technologies. These limitations of the ADA are made even more clear in light of the evolution occurring in the understanding of rights and capabilities. As such, the …

Reconnecting The Patient: Why Telehealth Policy Solutions Must Consider The Deepening Digital Divide, Laura C. Hoffman

Law Faculty Articles and Essays

This Article will attempt to untangle the complicated web of providing telehealth to those populations it is potentially capable of further alienating from access to healthcare including: 1) race/minority populations, 2) aging adults, 3) individuals with disabilities, 4) non-English speakers, 5) individuals living in rural areas, 6) socioeconomic class, and 7) children, in order to advance the argument that telehealth can be successful in providing healthcare access to these populations. Rather than suggesting that telehealth simply "cannot work" for these populations, instead consideration can and must meet these individuals through technology, access, and policy developments.

First, this Article will explain …