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- David Kaye (2)
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Articles 1 - 18 of 18
Full-Text Articles in Law
Genetic Duties, Jessica L. Roberts, Alexandra L. Foulkes
Genetic Duties, Jessica L. Roberts, Alexandra L. Foulkes
William & Mary Law Review
Most of our genetic information does not change, yet the results of our genetic tests might. Labs reclassify genetic variants in response to advances in genetic science. As a result, a person who took a test in 2010 could take the same test with the same lab in 2020 and get a different result. However, no legal duty requires labs or physicians to inform patients when a lab reclassifies a variant, even if the reclassification communicates clinically actionable information. This Article considers the need for such duties and their potential challenges. In so doing, it offers much-needed guidance to physicians …
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Opting Into Device Regulation In The Face Of Uncertain Patentability, Rebecca S. Eisenberg
Marquette Intellectual Property Law Review
This article examines the intersection of patent law, FDA regulation, and Medicare coverage in a particularly promising field of biomedical innovation: genetic diagnostic testing. First, I will discuss current clinical uses of genetic testing and directions for further research, with a focus on cancer, the field in which genetic testing has had the greatest impact to date. Second, I will turn to patent law and address two recent Supreme Court decisions that called into question the patentability of many of the most important advances in genetic testing. Third, I will step outside patent law to take a broader view of …
Please, Let's Bury The Junk: The Codis Loci And The Revelation Of Private Information, David H. Kaye
Please, Let's Bury The Junk: The Codis Loci And The Revelation Of Private Information, David H. Kaye
David Kaye
This Northwestern University Law Review Colloquy paper describes the four possible ways in which genetic loci could possess predictive or diagnostic value with regard to diseases and explains why these mechanisms have not led, and probably cannot lead, to useful screening tests with the Convicted Offender DNA Index System (CODIS) profiles in national, state, and local databases. It then considers the phenotypes and familial relationships that the CODIS STRs can be used to identify. The profiles carry limited information about an individual's race and familial relationships, and the article places the resulting privacy issues in perspective. Finally, the paper comments …
Gina's Genotypes, David H. Kaye
Gina's Genotypes, David H. Kaye
David Kaye
In August 2009, the Board of Trustees of the University of Akron added to the university's employment policy the following proviso: "any applicant may be asked to submit fingerprints or DNA sample for purpose of a federal criminal background check." Although the federal government does not do background checks with DNA, the policy is significant because it highlights a largely unexplored feature of the Genetic Information Nondiscrimination Act of 2008 (GINA). GINA generally prohibits employers from asking for "genetic information." The faculty senate and outside commentators have declared that the Akron policy is "of doubtful legality" because it "appears to …
23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely
23andme, The Food And Drug Administration, And The Future Of Genetic Testing, Patricia Zettler, Jacob S. Sherkow, Henry Greely
Other Publications
On November 22, 2013, the US Food and Drug Administration (FDA) effectively halted health-related direct-to-consumer genetic testing in the United States by sending a warning letter to 23andMe, the leading company in the field, directing it to stop providing such testing. The FDA acted as the era of widespread, clinical use of DNA sequencing rapidly approaches. The agency’s action will contribute to changes in which genetic tests are offered to patients and how testing is provided.
Does The Constitution Protect Abortions Based On Fetal Anomaly?: Examining The Potential For Disability-Selective Abortion Bans In The Age Of Prenatal Whole Genome Sequencing, Greer Donley
Michigan Journal of Gender & Law
This Note examines whether the state or federal government has the power to enact a law that prevents women from obtaining abortions based on their fetus’s genetic abnormality. Such a ban has already been enacted in North Dakota and introduced in Indiana and Missouri. I argue below that this law presents a novel state intrusion on a woman’s right to obtain a pre-viability abortion. Moreover, these pieces of legislation contain an outdated understanding of prenatal genetic testing—-the landscape of which is quickly evolving as a result of a new technology: prenatal whole genome sequencing. This Note argues that the incorporation …
There Will Be Blood ... Testing: The Intersection Of Professional Sports And The Genetic Information Nondiscrimination Act Of 2008, Jesse A. Bland
There Will Be Blood ... Testing: The Intersection Of Professional Sports And The Genetic Information Nondiscrimination Act Of 2008, Jesse A. Bland
Vanderbilt Journal of Entertainment & Technology Law
Genetic testing, professional baseball, and employment discrimination seldom intersect. This Note changes that. Thanks to scientific breakthroughs in genetic research over the past half-century, genetic testing is a powerful tool for producing rich, individualized information. Progress comes at a price, however. As genetic testing has advanced and become more prevalent, so too has the potential misuse of genetic information. A recently enacted federal law--the Genetic Information Nondiscrimination Act of 2008 (GINA)--seeks to eliminate one such threat by prohibiting the improper use of genetic information in employment decisions. While the law gained congressional momentum after tales of abuse in blue-collar industries, …
Gina's Genotypes, David H. Kaye
Gina's Genotypes, David H. Kaye
Journal Articles
In August 2009, the Board of Trustees of the University of Akron added to the university's employment policy the following proviso: "any applicant may be asked to submit fingerprints or DNA sample for purpose of a federal criminal background check." Although the federal government does not do background checks with DNA, the policy is significant because it highlights a largely unexplored feature of the Genetic Information Nondiscrimination Act of 2008 (GINA). GINA generally prohibits employers from asking for "genetic information." The faculty senate and outside commentators have declared that the Akron policy is "of doubtful legality" because it "appears to …
Please, Let's Bury The Junk: The Codis Loci And The Revelation Of Private Information, David H. Kaye
Please, Let's Bury The Junk: The Codis Loci And The Revelation Of Private Information, David H. Kaye
Journal Articles
This Northwestern University Law Review Colloquy paper describes the four possible ways in which genetic loci could possess predictive or diagnostic value with regard to diseases and explains why these mechanisms have not led, and probably cannot lead, to useful screening tests with the Convicted Offender DNA Index System (CODIS) profiles in national, state, and local databases. It then considers the phenotypes and familial relationships that the CODIS STRs can be used to identify. The profiles carry limited information about an individual's race and familial relationships, and the article places the resulting privacy issues in perspective. Finally, the paper comments …
Technological Advancement And International Human Rights: Is Science Improving Human Life Or Perpetuating Human Rights Violations?, Christine A. Khalili-Borna
Technological Advancement And International Human Rights: Is Science Improving Human Life Or Perpetuating Human Rights Violations?, Christine A. Khalili-Borna
Michigan Journal of International Law
This Note assesses the practices of pre-implantation and prenatal genetic screening and sex-determination through an international human rights framework founded in the Universal Declaration of Human Rights (Universal Declaration), the Convention on the Rights of the Child (CRC), and the Convention on the Elimination of All Forms of Discrimination Against Women (CEDAW).
Note: Exclusive Licensing Of Dna Diagnostics: Is There A Negative Effect On Quantity And Quality Of Healthcare Delivery That Compels Nih Rulemaking?, Edward Weck
William Mitchell Law Review
This comment surveys the costs of deoxyribonucleic acid (DNA) diagnostic tests and argues in favor of non-exclusive licensing as a means to provide broad access to affordable DNA diagnostic testing. Part II provides background information on genetic testing, patenting genes as applied to genetic testing, the Bayh-Dole Act, and technology transfer. In addition, Part II summarizes academic commentary regarding the implications of exclusive licensing for biotechnology. Scholars propose a number of solutions, including expanding the experimental use exception. Part III details proposed rulemaking for DNA diagnostics. Part IV reviews anecdotal examples of genetic testing for breast cancer, hereditary hemochromatosis, and …
Direct-To-Consumer Genetic Tests, Government Oversight, And The First Amendment: What The Government Can (And Can't) Do To Protect The Public's Health, Gail H. Javitt, Erica Stanley, Kathy Hudson
Direct-To-Consumer Genetic Tests, Government Oversight, And The First Amendment: What The Government Can (And Can't) Do To Protect The Public's Health, Gail H. Javitt, Erica Stanley, Kathy Hudson
Oklahoma Law Review
No abstract provided.
Reproductive Genetics 1991-2002: A Selected Annotated Legal Bibliography Of Genetic Testing, Gene Transfer And Reproductive Cloning, Gail H. Javitt
Reproductive Genetics 1991-2002: A Selected Annotated Legal Bibliography Of Genetic Testing, Gene Transfer And Reproductive Cloning, Gail H. Javitt
Journal of Health Care Law and Policy
No abstract provided.
Before It's Too Late- Addressing Fear Of Genetic Information, Karen H. Rothenberg, Sharon F. Terry
Before It's Too Late- Addressing Fear Of Genetic Information, Karen H. Rothenberg, Sharon F. Terry
Faculty Scholarship
No abstract provided.
Genetics, Genetic Testing, And The Specter Of Discrimination: A Discussion Using Hypothetical Cases, Richard H. Underwood, Ronald G. Cadle
Genetics, Genetic Testing, And The Specter Of Discrimination: A Discussion Using Hypothetical Cases, Richard H. Underwood, Ronald G. Cadle
Kentucky Law Journal
No abstract provided.
Solving The Insurance/Genetic Fair/Unfair Discrimination Dilemma In Light Of The Human Genome Project, Eric Mills Holmes
Solving The Insurance/Genetic Fair/Unfair Discrimination Dilemma In Light Of The Human Genome Project, Eric Mills Holmes
Kentucky Law Journal
No abstract provided.
Whose Genes Are These Anyway?: Familial Conflicts Over Access To Genetic Information, Sonia M. Suter
Whose Genes Are These Anyway?: Familial Conflicts Over Access To Genetic Information, Sonia M. Suter
Michigan Law Review
This Note argues first that courts and legislatures should follow a presumption against mandating disclosure of a person's genetic information to third parties. Second, genetic testing for the benefit of a third party should not, and constitutionally cannot, be compelled. Part I presents an overview of genetics and discusses the special legal and ethical issues genetic testing poses. Part II examines the issue of nonconsensual disclosure to family members, who could potentially use the information from tests that have already been performed. This Part concludes that there should be a presumption against disclosure. Part III examines a related, but different, …