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Full-Text Articles in Law
A Private Right Of Action For Informed Consent In Research, Valerie Gutmann Koch
A Private Right Of Action For Informed Consent In Research, Valerie Gutmann Koch
All Faculty Scholarship
No abstract provided.
A Policy In Flux: New York State’S Evolving Approach To Human Subjects Research Involving Individuals Who Lack Consent Capacity (Forthcoming), Valerie Gutmann Koch
A Policy In Flux: New York State’S Evolving Approach To Human Subjects Research Involving Individuals Who Lack Consent Capacity (Forthcoming), Valerie Gutmann Koch
All Faculty Scholarship
No abstract provided.
“Of Vital Importance”: The New York State Task Force On Life And The Law’S Report And Recommendations For Research With Human Subjects Who Lack Consent Capacity (With Susie A. Han), Valerie Gutmann Koch
“Of Vital Importance”: The New York State Task Force On Life And The Law’S Report And Recommendations For Research With Human Subjects Who Lack Consent Capacity (With Susie A. Han), Valerie Gutmann Koch
All Faculty Scholarship
No abstract provided.
Why Broccoli? Limiting Principles And Popular Constitutionalism In The Health Care Case, Mark D. Rosen, Christopher W. Schmidt
Why Broccoli? Limiting Principles And Popular Constitutionalism In The Health Care Case, Mark D. Rosen, Christopher W. Schmidt
All Faculty Scholarship
Crucial to the Court’s disposition in the constitutional challenge to the Affordable Care Act (ACA) was a hypothetical mandate to purchase broccoli, which Congress never had considered and nobody thought would ever be enacted. For the five Justices who concluded the ACA exceeded Congress’s commerce power, a fatal flaw in the government’s case was its inability to offer an adequate explanation for why upholding that mandate would not entail also upholding a federal requirement that all citizens purchase broccoli. The minority insisted the broccoli mandate was distinguishable. This Article argues that the fact that all the Justices insisted on providing …
Unique Proposals For Limiting Legal Liability And Encouraging Adherence To Ventilator Allocation Guidelines In An Influenza Pandemic, Valerie Gutmann Koch
Unique Proposals For Limiting Legal Liability And Encouraging Adherence To Ventilator Allocation Guidelines In An Influenza Pandemic, Valerie Gutmann Koch
All Faculty Scholarship
No abstract provided.
Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch
Incentivizing The Utilization Of Pharmacogenomics In Drug Development, Valerie Gutmann Koch
All Faculty Scholarship
Pharmacogenomics, the study and development of compounds according to how an individual’s genes affects the body’s response to drugs, holds enormous promise for increasing the safety and efficiency of drug development while decreasing adverse reactions and the trial-and-error nature of drug prescription. However, pharmacogenomics may not be the panacea for all development and prescription problems. This article explores some of the obstacles to pharmacogenomic advancement including industry reluctance to pursue research because of potentially prohibitive costs associated with developing products and legal liability concerns. The implications pharmacogenomics has for drug research and development as well as various areas of law …
Pgtandme: Social Networking-Based Genetic Testing And The Evolving Research Model, Valerie Gutmann Koch
Pgtandme: Social Networking-Based Genetic Testing And The Evolving Research Model, Valerie Gutmann Koch
All Faculty Scholarship
The opportunity to use extensive genetic data, personal information, and family medical history for research purposes may be naturally appealing to the personal genetic testing (PGT) industry, which is already coupling its direct-to-consumer (DTC) products with social networking technologies, as well as to potential industry or institutional partners. This article evaluates the transformation in research that the hybrid of PGT and social networking will bring about, and – highlighting the challenges associated with a new paradigm of “patient-driven” genomic research – focuses on the consequences of shifting the structure, locus, timing, and scope of research through genetic crowd-sourcing. This article …
Changing Expectations For Board Oversight Of Healthcare Quality: The Emerging Paradigm, Valerie Gutmann Koch
Changing Expectations For Board Oversight Of Healthcare Quality: The Emerging Paradigm, Valerie Gutmann Koch
All Faculty Scholarship
Within healthcare institutions, leadership is an essential driver of expectations, performance, and culture. Yet boards of directors traditionally played a limited role in overseeing healthcare quality, providing final approval of credentialing decisions but deferring to the medical staff to set standards for the institution. Case law and standards provide little guidance for board performance in verseeing quality of care. Recent developments — the availability of comparative quality data, public reporting, and financial incentives for higher quality — have transformed expectations for board oversight. Enforcement of fraud and abuse laws based on poor quality of care, as well as federal standards …
Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch
Conflicts Of Interest In Clinical Trial Recruitment & Enrollment: A Call For Increased Oversight, Valerie Gutmann Koch
All Faculty Scholarship
This White Paper makes several policy recommendations to eliminate or manage the conflicts of interest that arise pursuant to the compensation arrangements between investigators and their institutions with drug and medical device manufacturers as they affect the recruitment and enrollment of human research subjects in clinical trials. The paper seeks to accomplish overall financial neutrality as between treatment and research, so that physicians' decisions regarding inclusion of patients in clinical trials is unaffected by their own financial interests.
Public-Private Partnerships And Insurance Regulation, Alexander A. Boni-Saenz
Public-Private Partnerships And Insurance Regulation, Alexander A. Boni-Saenz
All Faculty Scholarship
A public-private partnership (PPP) is an institutional arrangement that embodies a collaborative approach to policy and regulation; it is a joint venture between the government and one or more private sector entities. Joint financing partnerships link public financing and private insurance to pay for certain social goods. Where the financing for social goods is fragmented and overlapping, as it is for health and social care, joint financing PPPs may help organize existing financing streams. This piece argues that partnerships of this type also present an opportunity for consumer-protective regulation of the insurance industry if certain conditions are met. Private insurers …
Tales From The Crypt: Scientific, Ethical, And Legal Considerations For Biohistorical Analysis Of Deceased Historical Figures, Lori B. Andrews, Jordan K. Paradise
Tales From The Crypt: Scientific, Ethical, And Legal Considerations For Biohistorical Analysis Of Deceased Historical Figures, Lori B. Andrews, Jordan K. Paradise
All Faculty Scholarship
Biohistorical analysis involves using historic specimens of human remains or human material extracted or derived from historical artifacts to gather evidence about specimens that are identifiable or at least attributed to a historic figure at the time of the research. Biohistorical studies are being undertaken for myriad reasons, such as identification and authentication of remains, investigation into alleged criminal behavior, investigation into medical or psychological conditions, and even for purposes of commercialization. This article analyzes federal statutes, case law, and codes and guidelines from twenty-six professional organizations and societies informative to the field of biohistory. We surveyed the field, identified …
Brave New Babies, Lori B. Andrews
Newsgathering In Light Of Hipaa, Alexander A. Boni-Saenz
Newsgathering In Light Of Hipaa, Alexander A. Boni-Saenz
All Faculty Scholarship
This short piece examines the interaction between the Health Insurance Portability and Accountability Act (HIPAA), a federal law designed to protect the privacy of individuals’ health information, and state Freedom of Information (FOI) laws, which are designed to ensure public access to government documents. It describes three recent cases from different states that addressed difficult issues about where and how to draw the line between the public’s right to know and individuals’ rights to keep their medical information secret. It concludes that questions about the interaction of state FOI laws and HIPAA should be guided by the framework suggested in …
Studying Medical Error In Situ: Implications For Malpractice Law And Policy, Lori B. Andrews
Studying Medical Error In Situ: Implications For Malpractice Law And Policy, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Ethical, Legal, And Social Issues In Genetic Testing For Complex Genetic Diseases (With E. Zuiker), Lori B. Andrews
Ethical, Legal, And Social Issues In Genetic Testing For Complex Genetic Diseases (With E. Zuiker), Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Protecting The Endangered Human: Toward An International Treaty Prohibiting Cloning And Inheritable Alterations, Lori B. Andrews
Protecting The Endangered Human: Toward An International Treaty Prohibiting Cloning And Inheritable Alterations, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Nord Issues Gene Patenting Statement, Valerie Gutmann Koch
Nord Issues Gene Patenting Statement, Valerie Gutmann Koch
All Faculty Scholarship
No abstract provided.
A Conceptual Framework For Genetic Policy, Lori B. Andrews
A Conceptual Framework For Genetic Policy, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Banning The Clone, Lori B. Andrews
Reproductive Technology Comes Of Age, Lori B. Andrews
Reproductive Technology Comes Of Age, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Adoption, Reproductive Technologies And Genetic Information, Lori B. Andrews
Adoption, Reproductive Technologies And Genetic Information, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Is There A Right To Clone? Constitutional Challenges To Bans On Human Cloning, Lori B. Andrews
Is There A Right To Clone? Constitutional Challenges To Bans On Human Cloning, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Do The Dead Have Interests? Policy Issues For Research After Life (With D. Nelkin), Lori B. Andrews
Do The Dead Have Interests? Policy Issues For Research After Life (With D. Nelkin), Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Body Science, Lori B. Andrews
Prenatal Screening And The Culture Of Motherhood, Lori B. Andrews
Prenatal Screening And The Culture Of Motherhood, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
The Shadow Health Care System: Regulation Of Alternative Health Care Providers, Lori B. Andrews
The Shadow Health Care System: Regulation Of Alternative Health Care Providers, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Beyond Doctrinal Boundaries: A Legal Framework For Surrogate Motherhood, Lori B. Andrews
Beyond Doctrinal Boundaries: A Legal Framework For Surrogate Motherhood, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Alternative Reproduction (With L. Douglass), Lori B. Andrews
Alternative Reproduction (With L. Douglass), Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Torts And The Double Helix: Malpractice Liability For Failure To Warn Of Genetic Risks, Lori B. Andrews
Torts And The Double Helix: Malpractice Liability For Failure To Warn Of Genetic Risks, Lori B. Andrews
All Faculty Scholarship
No abstract provided.
Confidentiality Of Genetic Information In The Workplace (With A. Jaeger), Lori B. Andrews
Confidentiality Of Genetic Information In The Workplace (With A. Jaeger), Lori B. Andrews
All Faculty Scholarship
No abstract provided.