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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 …
Electronic Health Record Regulation In Canada: What The Patient Experience Reveals About The Pursuit Of Legislative Harmonization, Patricia M. Goodman
Electronic Health Record Regulation In Canada: What The Patient Experience Reveals About The Pursuit Of Legislative Harmonization, Patricia M. Goodman
Electronic Thesis and Dissertation Repository
This thesis examines Canadian provincial and territorial personal data protection legislation as it relates to electronic health records (“EHRs”). The research categorizes Canadian jurisdictions’ approaches to EHR regulation and three models are identified. Using five criteria, the patient experience when interacting with each of the three models and a combination of the models is described, analyzed and reconciled. A fictional patient scenario is used as a tool to analyze patient interaction with the Canadian jurisdictions and the models. It is shown that, although Canadian jurisdictions use one of three separate modes of incorporating EHR-specific rules into legislation, the outcome of …