Open Access. Powered by Scholars. Published by Universities.®
- Institution
- Publication
- Publication Type
Articles 1 - 5 of 5
Full-Text Articles in Law
Regulation Of Health-Related Artificial Intelligence In Medical Devices: The Canadian Story, Michael Da Silva, Colleen M. M. Flood, Matthew Herder
Regulation Of Health-Related Artificial Intelligence In Medical Devices: The Canadian Story, Michael Da Silva, Colleen M. M. Flood, Matthew Herder
Articles, Book Chapters, & Popular Press
Artificial Intelligence (AI) may transform Canadian healthcare. The hope is that AI will enable more accurate and efficient care, thereby solving many access, quality, and safety problems. Yet, despite this tantalizing prospect, there are risks of unsafe AI harming patients, algorithmic bias, and threats to privacy. This work begins analysis of whether applicable Canadian laws are up to the task of ensuring Canadians can benefit from effective health-related AI while minimizing AI-related risks. It focuses on Health Canada’s regulation of medical devices, a ‘first line of defence’ that decides which devices are safe, effective, and thus permitted for trade in …
Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder
Optimizing The Data Available Via Health Canada's Clinical Information Portal, Alexander C. Egilman, Joseph S. Ross, Matthew Herder
Articles, Book Chapters, & Popular Press
Through its Public Release of Clinical Information initiative, Health Canada has provided public access to a vast repository of data that have been submitted to support market authorization of drugs and medical devices. Health Canada has released data from more than 160 submissions for drugs, biologics, vaccines and medical devices. The regulator is currently in its third year of a 4-year phase-in schedule to release clinical data proactively from submissions for all new active substances, new clinical indications, generic drugs and higher-risk devices that are approved, withdrawn or rejected. Substantial clinical data submitted by the industry sponsor of the application, …
Thirty-Eight Years And Counting: The Fda’S Misuse Of The 510(K) Notification Process And Consequent Under-Regulation Of Implantable Medical Devices, Mayo B. Alao
Saint Louis University Journal of Health Law & Policy
No abstract provided.
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Cgmp Violations Should Not Be Used As A Basis For Fca Actions Absent Fraud, Kyle Faget
Seattle University Law Review
Since Congress amended the False Claims Act (FCA) in 1986, the statute has evolved into a seemingly boundless weapon for enforcing other statutes and regulations applicable to every industry that accepts any form of government funding. Use of the FCA by the Department of Justice (DOJ) and by private citizens bringing actions on behalf of the U.S. government to enforce other statutes and regulations is particularly evident in the field of health care. The FCA has been utilized in actions where the allegations include off-label promotion of drugs, kickbacks, and violations of current good manufacturing practices (cGMPs) by linking the …
Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd
Could A Hub And Spoke, Homegrown Ceo Strategy Boost The Success Of University Start-Ups?, Brendan O. Baggot, Martin R. Graf Phd
Brendan O. Baggot
How can universities make more money with their spinout company (SpinCo)‐suitable technologies? By “growing” their own CEOs to improve both the quality and quantity of startup company leaders available, that’s how. Surprisingly, however, at most universities little or no effort is made to interweave this critical need into tech transfer efforts.