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Implementing Canada's Data Exclusivity Obligations And Protecting Personal Information In Clinical Trials, Alison Wong
Implementing Canada's Data Exclusivity Obligations And Protecting Personal Information In Clinical Trials, Alison Wong
Electronic Thesis and Dissertation Repository
This thesis explores, in the context of pharmaceutical clinical trials, Canadian federal, provincial and territorial personal data protection laws (which are consistent with Canada’s membership in the international Organization for Economic Cooperation and Development). This thesis establishes that, despite scholarly concerns over de-identifiability of data, these laws govern collection, use, dissemination, and disposal of data about individuals in clinical trials right through and including applications made by innovator pharmaceutical companies to the federal government for approval to market new drugs. At this latter point, federal data exclusivity regulations also apply (as required by international trade agreements). This thesis establishes that …
A Comment On Privacy And Accountability In Black-Box Medicine, Carl E. Schneider
A Comment On Privacy And Accountability In Black-Box Medicine, Carl E. Schneider
Michigan Telecommunications & Technology Law Review
Human institutions and activities cannot avoid failures. Anxiety about them often provokes governments to try to prevent those failures. When that anxiety is vivid and urgent, government may do so without carefully asking whether regulation’s costs justify their benefits. Privacy and Accountability in Black Box Medicine admirably labors to bring discipline and rationality to thinking about an important development — the rise of “black-box medicine” — before it causes injuries regulation should have prevented and before it is impaired by improvident regulation. That is, Privacy and Accountability weighs the costs against the benefits of various forms of regulation across the …