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Articles 1 - 30 of 36
Full-Text Articles in Science and Technology Law
Reconnecting The Patient: Why Telehealth Policy Solutions Must Consider The Deepening Digital Divide, Laura C. Hoffman
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
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 …
Open-Source Clinical Machine Learning Models: Critical Appraisal Of Feasibility, Advantages, And Challenges, Keerthi B. Harish, W. Nicholson Price Ii, Yindalon Aphinyanaphongs
Open-Source Clinical Machine Learning Models: Critical Appraisal Of Feasibility, Advantages, And Challenges, Keerthi B. Harish, W. Nicholson Price Ii, Yindalon Aphinyanaphongs
Articles
Machine learning applications promise to augment clinical capabilities and at least 64 models have already been approved by the US Food and Drug Administration. These tools are developed, shared, and used in an environment in which regulations and market forces remain immature. An important consideration when evaluating this environment is the introduction of open-source solutions in which innovations are freely shared; such solutions have long been a facet of digital culture. We discuss the feasibility and implications of open-source machine learning in a health care infrastructure built upon proprietary information. The decreased cost of development as compared to drugs and …
Machine Learning-Based Medical Devices: The Fda’S Regulation, Requirements, And Restrictions, Charli Beam
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
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
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
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.
Blocking Nature's Vulnerable Calls For Help: The Tenth Circuit Dials Into The Telecommunications Act's Federal Environmental Preemption Clause In Santa Fe Alliance V. City Of Santa Fe, Samantha Speiss
Villanova Environmental Law Journal
No abstract provided.
Pertanggungjawaban Hukum Pengelola Sistem Elektronik Kesehatan Di Indonesia Sebagai Penyelenggara Elektronik Sehubungan Dengan Perlindungan Data, Jessy Annastasia Aruan
Pertanggungjawaban Hukum Pengelola Sistem Elektronik Kesehatan Di Indonesia Sebagai Penyelenggara Elektronik Sehubungan Dengan Perlindungan Data, Jessy Annastasia Aruan
"Dharmasisya” Jurnal Program Magister Hukum FHUI
A healthy society will improve the quality of a nation. Therefore, an integrated and integrated national health system to optimize public health is necessary to keep the community productive and healthy. One of the functions of a health information system is to collect data from health and other related sectors, analyse the data and ensure its overall quality, relevance and timeliness, and transform the data into information for health-related decision making. Health data will not only contain public health conditions but will also contain a person's personal data. Data leaks that occur are mostly due to an inadequate electronic security …
Making Your Robotic Surgery Systems General Purpose: A Possible Preventive Measure For Induced And Contributory Infringement Liability Arising In Medical Procedures, Mengmeng Du
Minnesota Journal of Law, Science & Technology
No abstract provided.
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
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 …
Preimplantation Genetic Testing: A Fundamental Right, Julianna S. Swann
Preimplantation Genetic Testing: A Fundamental Right, Julianna S. Swann
William & Mary Journal of Race, Gender, and Social Justice
Unlike many European countries of similar economic, social, scientific, and political advancement, there is virtually no regulation of preimplantation genetic testing in the United States. This Note will explore preimplantation genetic testing and demonstrate that potential parents in the United States have a right to conduct said testing under the umbrella of the fundamental right to privacy. This Note will demonstrate the need for the regulation for preimplantation genetic testing that will comply with the Undue Burden Test set out in Planned Parenthood v. Casey, while acknowledging and supporting the fundamental right of potential parents to conduct testing. This …
Slowing Down Accelerated Approval: Examining The Role Of Industry Influence, Patient Advocacy Organizations, And Political Pressure On Fda Drug Approval, Stephanie Diu
Fordham Law Review
The U.S. Food and Drug Administration (FDA) has been revered as the gold standard in pharmaceutical safety and efficacy review since the 1960s. More recently, partly in response to the HIV/AIDS epidemic and the pressing need for new treatments, the FDA established an accelerated approval process to hasten the review of new drug applications so that drugs could be approved and brought to market as soon as possible. Although accelerated approval has led to the availability of new treatments for patients with few other options, this Note argues that, today, the FDA grants accelerated approval too hastily and may be …
Ai Insurance: How Liability Insurance Can Drive The Responsible Adoption Of Artificial Intelligence In Health Care, Ariel Dora Stern, Avi Goldfarb, Timo Minssen, W. Nicholson Price Ii
Ai Insurance: How Liability Insurance Can Drive The Responsible Adoption Of Artificial Intelligence In Health Care, Ariel Dora Stern, Avi Goldfarb, Timo Minssen, W. Nicholson Price Ii
Articles
Despite enthusiasm about the potential to apply artificial intelligence (AI) to medicine and health care delivery, adoption remains tepid, even for the most compelling technologies. In this article, the authors focus on one set of challenges to AI adoption: those related to liability. Well-designed AI liability insurance can mitigate predictable liability risks and uncertainties in a way that is aligned with the interests of health care’s main stakeholders, including patients, physicians, and health care organization leadership. A market for AI insurance will encourage the use of high-quality AI, because insurers will be most keen to underwrite those products that are …
Distributed Governance Of Medical Ai, W. Nicholson Price Ii
Distributed Governance Of Medical Ai, W. Nicholson Price Ii
Law & Economics Working Papers
Artificial intelligence (AI) promises to bring substantial benefits to medicine. In addition to pushing the frontiers of what is humanly possible, like predicting kidney failure or sepsis before any human can notice, it can democratize expertise beyond the circle of highly specialized practitioners, like letting generalists diagnose diabetic degeneration of the retina. But AI doesn’t always work, and it doesn’t always work for everyone, and it doesn’t always work in every context. AI is likely to behave differently in well-resourced hospitals where it is developed than in poorly resourced frontline health environments where it might well make the biggest difference …
New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg
New Innovation Models In Medical Ai, W Nicholson Price Ii, Rachel E. Sachs, Rebecca S. Eisenberg
Articles
In recent years, scientists and researchers have devoted considerable resources to developing medical artificial intelligence (AI) technologies. Many of these technologies—particularly those that resemble traditional medical devices in their functions—have received substantial attention in the legal and policy literature. But other types of novel AI technologies, such as those related to quality improvement and optimizing use of scarce facilities, have been largely absent from the discussion thus far. These AI innovations have the potential to shed light on important aspects of health innovation policy. First, these AI innovations interact less with the legal regimes that scholars traditionally conceive of as …
The Gatekeepers Of Research: Why A Data Protection Authority Holds The Key To Research In The New York Privacy Acts, Eric B. Green
The Gatekeepers Of Research: Why A Data Protection Authority Holds The Key To Research In The New York Privacy Acts, Eric B. Green
Brooklyn Law Review
Biometric data is among the most sensitive of personal data because it is biologically tied and unique to the individual. Nonetheless, biometric data is an invaluable facet of the research that enables progressive scientific, technological, and medical innovation. Because a comprehensive federal data privacy act does not appear to be on the horizon, the torch has been passed to the states to create their own personal data protection regimes. New Yorkers’ personal biometric data is not aptly protected, partially because neither the New York Privacy Act nor the Biometric Privacy Act (collectively, the NY Privacy Acts) have matured to the …
The Art Of Regulating Art, Naomi Cahn, Sonia M. Suter
The Art Of Regulating Art, Naomi Cahn, Sonia M. Suter
Chicago-Kent Law Review
No abstract provided.
Embryonic Injuries: Can You Use If You Wouldn't Have Been Born, Or Born Different?, David Heyd
Embryonic Injuries: Can You Use If You Wouldn't Have Been Born, Or Born Different?, David Heyd
Chicago-Kent Law Review
No abstract provided.
Savior Siblings, Protective Progeny, And Parental Determinism In The Age Of Crispr-Cas, Barbara Pfeffer-Billauer
Savior Siblings, Protective Progeny, And Parental Determinism In The Age Of Crispr-Cas, Barbara Pfeffer-Billauer
Chicago-Kent Law Review
No abstract provided.
A Wrong Without A Remedy: Leaving Parents And Children With A Hollow Victory I Nlawsuits Against Unscrupulous Sperm Banks, Yaniv Heled, Timothy Lytton, Liza Vertinsky
A Wrong Without A Remedy: Leaving Parents And Children With A Hollow Victory I Nlawsuits Against Unscrupulous Sperm Banks, Yaniv Heled, Timothy Lytton, Liza Vertinsky
Chicago-Kent Law Review
No abstract provided.
Genetically-Engineered Begots, Have-Nots, And Tinkered Tots: (High Scoring Polygenic Kids As A Heredity-Camelot)-An Introduction To The Legalities And Bio-Ethics Of Advanced Ivf And Genetic Testing, Barbara Pfeffier-Billaeuer
Genetically-Engineered Begots, Have-Nots, And Tinkered Tots: (High Scoring Polygenic Kids As A Heredity-Camelot)-An Introduction To The Legalities And Bio-Ethics Of Advanced Ivf And Genetic Testing, Barbara Pfeffier-Billaeuer
Chicago-Kent Law Review
No abstract provided.
Does A Custodial Rights Understanding Of The Gdpr Justify Fraudulent Misrepresentation By Sperm Donors?, Dov Greenbaum
Does A Custodial Rights Understanding Of The Gdpr Justify Fraudulent Misrepresentation By Sperm Donors?, Dov Greenbaum
Chicago-Kent Law Review
No abstract provided.
Causation And Compensation For Intergenerational Harm, Dov Fox
Causation And Compensation For Intergenerational Harm, Dov Fox
Chicago-Kent Law Review
No abstract provided.
From Consent To Empowerment In Support Of Decision-Making In Embryonic Genetic Design, Pamela Laufer-Ukeles
From Consent To Empowerment In Support Of Decision-Making In Embryonic Genetic Design, Pamela Laufer-Ukeles
Chicago-Kent Law Review
No abstract provided.
Learning From South Korea’S Covid-19 Response: Why Centralizing The United States Public Health System Is Essential For Future Pandemic Responses, Meghan Ricci
Seattle Journal of Technology, Environmental & Innovation Law
The COVID-19 pandemic revealed stark differences in governmental preparedness across the globe. The United States, once thought of as a global leader in public health, had the theoretical skill and efficiency to handle the pandemic but failed to utilize those skills and resources during an actual health crisis. In the spring of 2020, everyone watched the U.S.’s reaction to the unfolding of the COVID-19 pandemic due to its historic placeholder as a global leader and innovator. However, the performance of the U.S. in response to the global pandemic disappointed both global commentators and U.S. citizens. This paper will compare the …
Fostering Production Of Pharmaceutical Products In Developing Countries, William Fisher, Ruth L. Okediji, Padmashree Gehl Sampath
Fostering Production Of Pharmaceutical Products In Developing Countries, William Fisher, Ruth L. Okediji, Padmashree Gehl Sampath
Michigan Journal of International Law
The ways in which pharmaceutical products are currently developed, manufactured, and distributed fail to meet the needs of developing countries. The recent emergence of new infectious diseases, the associated surge of healthcare nationalism, and the prevalence of substandard and falsified drugs have strengthened substantially the net benefits of augmenting the capacity of developing countries to produce such products locally. Most previous efforts to do so have foundered. The chance of success in the future would be maximized by the adoption of five strategies : (a) clarifying the zones of discretion created by the relevant treaties to ensure that local firms …
The Negative Impact Of Service Member And Veteran Post Traumatic Stress Disorder (Ptsd) Rating Or Specter Of Ptsd On Child Custody Arrangements, Erhan Bedestani
The Negative Impact Of Service Member And Veteran Post Traumatic Stress Disorder (Ptsd) Rating Or Specter Of Ptsd On Child Custody Arrangements, Erhan Bedestani
Catholic University Journal of Law and Technology
No abstract provided.
Liability For Use Of Artificial Intelligence In Medicine, W. Nicholson Price, Sara Gerke, I. Glenn Cohen
Liability For Use Of Artificial Intelligence In Medicine, W. Nicholson Price, Sara Gerke, I. Glenn Cohen
Law & Economics Working Papers
While artificial intelligence has substantial potential to improve medical practice, errors will certainly occur, sometimes resulting in injury. Who will be liable? Questions of liability for AI-related injury raise not only immediate concerns for potentially liable parties, but also broader systemic questions about how AI will be developed and adopted. The landscape of liability is complex, involving health-care providers and institutions and the developers of AI systems. In this chapter, we consider these three principal loci of liability: individual health-care providers, focused on physicians; institutions, focused on hospitals; and developers.
Congressional Myopia In Biomedical Innovation Policy, W. Nicholson Price Ii
Congressional Myopia In Biomedical Innovation Policy, W. Nicholson Price Ii
Reviews
Innovation policy is hard. Getting it right requires balancing incentives for developers, consumer access, rewards for later innovators, safety concerns, and other factors. This balance is vitally important and wickedly difficult—even when it’s the focus of concerted, careful, informed effort. How well should we expect it to go when innovation policy is made by accident? Enter The Accidental Innovation Policymakers, an illuminating new project by Professor Rachel Sachs. Sachs persuasively shows how Congress has repeatedly made substantial changes to innovation policy, seemingly without talking about, seriously considering, or even recognizing that it is doing so. There’s an asymmetry to this …