Open Access. Powered by Scholars. Published by Universities.®
Articles 1 - 3 of 3
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 …
Risks And Remedies For Artificial Intelligence In Healthcare, W. Nicholson Price Ii
Risks And Remedies For Artificial Intelligence In Healthcare, W. Nicholson Price Ii
Other Publications
Artificial intelligence (AI) is rapidly entering health care and serving major roles, from automating drudgery and routine tasks in medical practice to managing patients and medical resources. As developers create AI systems to take on these tasks, several risks and challenges emerge, including the risk of injuries to patients from AI system errors, the risk to patient privacy of data acquisition and AI inference, and more. Potential solutions are complex but involve investment in infrastructure for high-quality, representative data; collaborative oversight by both the Food and Drug Administration and other health-care actors; and changes to medical education that will prepare …