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Biomedical Engineering and Bioengineering Commons™
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- Artificial intelligence (2)
- Medical device regulation (2)
- Medical devices (2)
- Administrative law (1)
- Biochemstry (1)
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- Contractual arrangements (1)
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- Informed consent (1)
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- Medical device (1)
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- Oil and gas (1)
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Articles 1 - 11 of 11
Full-Text Articles in Biomedical Engineering and Bioengineering
Volume Introduction, I. Glenn Cohen, Timo Minssen, W. Nicholson Price Ii, Christopher Robertson, Carmel Shachar
Volume Introduction, I. Glenn Cohen, Timo Minssen, W. Nicholson Price Ii, Christopher Robertson, Carmel Shachar
Other Publications
Medical devices have historically been less regulated than their drug and biologic counterparts. A benefit of this less demanding regulatory regime is facilitating innovation by making new devices available to consumers in a timely fashion. Nevertheless, there is increasing concern that this approach raises serious public health and safety concerns. The Institute of Medicine in 2011 published a critique of the American pathway allowing moderate-risk devices to be brought to the market through the less-rigorous 501(k) pathway,1 flagging a need for increased postmarket review and surveillance. High-profile recalls of medical devices, such as vaginal mesh products, along with reports globally …
Part I - Ai And Data As Medical Devices, W. Nicholson Price Ii
Part I - Ai And Data As Medical Devices, W. Nicholson Price Ii
Other Publications
It may seem counterintuitive to open a book on medical devices with chapters on software and data, but these are the frontiers of new medical device regulation and law. Physical devices are still crucial to medicine, but they – and medical practice as a whole – are embedded in and permeated by networks of software and caches of data. Those software systems are often mindbogglingly complex and largely inscrutable, involving artificial intelligence and machine learning. Ensuring that such software works effectively and safely remains a substantial challenge for regulators and policymakers. Each of the three chapters in this part examines …
The Challenge Of Regulatory Excellence, Cary Coglianese
The Challenge Of Regulatory Excellence, Cary Coglianese
All Faculty Scholarship
Regulation is a high-stakes enterprise marked by tremendous challenges and relentless public pressure. Regulators are expected to protect the public from harms associated with economic activity and technological change without unduly impeding economic growth or efficiency. Regulators today also face new demands, such as adapting to rapidly changing and complex financial instruments, the emergence of the sharing economy, and the potential hazards of synthetic biology and other innovations. Faced with these challenges, regulators need a lodestar for what constitutes high-quality regulation and guidance on how to improve their organizations’ performance. In the book Achieving Regulatory Excellence, leading regulatory experts …
Reviewing The American University Law Review On Extraterritoriality: A Critical Response To Viki Economides, Note, Tianrui Group Co. V. Itc: The Dubious Status Of Extraterritoriality And The Domestic Industry Requirement Requirement Of Section 337(Link), Jonathan Stroud
Articles in Law Reviews & Other Academic Journals
Recently, the Federal Circuit upheld the Commission’s decision to exclude goods based on a trade secret violation that largely happened abroad. The American University Law Review critiqued that decision on two grounds: First, that a presumption against extraterritorial application of U.S. law applied; and second, that licensing alone could not establish a domestic industry. The American University Law Review's critique remains incomplete, however, as the Federal Circuit correctly decided the case for at least two reasons. first, the Federal Circuit correctly applied the “extraterritorial presumption” canon of construction; and second, the recent Federal Circuit decision in InterDigital Communications LLC v. …
Licenses, Leases And Other Contractual Arrangements For The Exploration And Production Of Petroleum A Comparative Study Between Nigeria And The United States, Omolara Elumelu
LLM Theses and Essays
Much has been written about Oil and Gas leases. This paper focuses on the various Oil and Gas leases and other contractual arrangements for oil and gas exploration and production in Nigeria and the United States. The paper examines the origin, structure, development and mode of operations in both jurisdictions and concludes with a comparative analysis of both jurisdictions.
The Nature Of Blacks' Skepticism About Genetic Testing, Dorothy E. Roberts
The Nature Of Blacks' Skepticism About Genetic Testing, Dorothy E. Roberts
All Faculty Scholarship
No abstract provided.
Biology, Justice, And Women's Fate, Dorothy E. Roberts
Biology, Justice, And Women's Fate, Dorothy E. Roberts
All Faculty Scholarship
No abstract provided.
The Genetic Tie, Dorothy E. Roberts
Crime, Race And Reproduction, Dorothy E. Roberts
Crime, Race And Reproduction, Dorothy E. Roberts
All Faculty Scholarship
No abstract provided.
Lecture Draft On Sensory Recall Device - 1980, Wendy J. Gordon
Lecture Draft On Sensory Recall Device - 1980, Wendy J. Gordon
Scholarship Chronologically
Perception is a bodily function. The brain “sees” according to the orders which the optic nerve relays from its position at the back of the eye. Similarly, it is the brain which also "hears." As we know from our dreaming and our remembering, neither eye nor ear is indispensable to having the sensations of seeing and hearing.
Informed Consent And The Investigational Use Of Medical Devices: A Comparison Of Common Law Duties With Those Imposed On Researchers Under Section 520(G) Of The Medical Device Amendments Of 1976, Thomas G. Field Jr., Dominic Piacenza
Informed Consent And The Investigational Use Of Medical Devices: A Comparison Of Common Law Duties With Those Imposed On Researchers Under Section 520(G) Of The Medical Device Amendments Of 1976, Thomas G. Field Jr., Dominic Piacenza
Law Faculty Scholarship
This paper will deal with with exemption granted [under the Medical Device Amendments Act of 1976] for the investigational use of devices subject to premarket testing, and more particularly, with the obligation of an investigator seeking such exemption to secure an informed consent agreement from human subjects (or their representatives) under § 520(g)(3)(D) of the Act. It will also consider the relationship between the statutory obligation and that which might be imposed by the common law of negligence.