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Full-Text Articles in Law
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 …
Administrative Law In The Automated State, Cary Coglianese
Administrative Law In The Automated State, Cary Coglianese
All Faculty Scholarship
In the future, administrative agencies will rely increasingly on digital automation powered by machine learning algorithms. Can U.S. administrative law accommodate such a future? Not only might a highly automated state readily meet longstanding administrative law principles, but the responsible use of machine learning algorithms might perform even better than the status quo in terms of fulfilling administrative law’s core values of expert decision-making and democratic accountability. Algorithmic governance clearly promises more accurate, data-driven decisions. Moreover, due to their mathematical properties, algorithms might well prove to be more faithful agents of democratic institutions. Yet even if an automated state were …
The Law Of Black Mirror - Syllabus, Yafit Lev-Aretz, Nizan Packin
The Law Of Black Mirror - Syllabus, Yafit Lev-Aretz, Nizan Packin
Open Educational Resources
Using episodes from the show Black Mirror as a study tool - a show that features tales that explore techno-paranoia - the course analyzes legal and policy considerations of futuristic or hypothetical case studies. The case studies tap into the collective unease about the modern world and bring up a variety of fascinating key philosophical, legal, and economic-based questions.
Transparency And Algorithmic Governance, Cary Coglianese, David Lehr
Transparency And Algorithmic Governance, Cary Coglianese, David Lehr
All Faculty Scholarship
Machine-learning algorithms are improving and automating important functions in medicine, transportation, and business. Government officials have also started to take notice of the accuracy and speed that such algorithms provide, increasingly relying on them to aid with consequential public-sector functions, including tax administration, regulatory oversight, and benefits administration. Despite machine-learning algorithms’ superior predictive power over conventional analytic tools, algorithmic forecasts are difficult to understand and explain. Machine learning’s “black-box” nature has thus raised concern: Can algorithmic governance be squared with legal principles of governmental transparency? We analyze this question and conclude that machine-learning algorithms’ relative inscrutability does not pose a …
The Tao Of The Dao: Taxing An Entity That Lives On A Blockchain, David J. Shakow
The Tao Of The Dao: Taxing An Entity That Lives On A Blockchain, David J. Shakow
All Faculty Scholarship
In this report, Shakow explains how a decentralized autonomous organization functions and interacts with the U.S. tax system and presents the many tax issues that these structures raise. The possibility of using smart contracts to allow an entity to operate totally autonomously on a blockchain platform seems attractive. However, little thought has been given to how such an entity can comply with the requirements of a tax system. The DAO, the first major attempt to create such an organization, failed because of a programming error. If successful examples proliferate in the future, tax authorities will face significant problems in getting …
Regulating By Robot: Administrative Decision Making In The Machine-Learning Era, Cary Coglianese, David Lehr
Regulating By Robot: Administrative Decision Making In The Machine-Learning Era, Cary Coglianese, David Lehr
All Faculty Scholarship
Machine-learning algorithms are transforming large segments of the economy, underlying everything from product marketing by online retailers to personalized search engines, and from advanced medical imaging to the software in self-driving cars. As machine learning’s use has expanded across all facets of society, anxiety has emerged about the intrusion of algorithmic machines into facets of life previously dependent on human judgment. Alarm bells sounding over the diffusion of artificial intelligence throughout the private sector only portend greater anxiety about digital robots replacing humans in the governmental sphere. A few administrative agencies have already begun to adopt this technology, while others …