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Approval Of New Pharmacogenomic Tests: Is The Canadian Regulatory Process Adequate?, Yann Joly, Emma Ramos-Paque
Approval Of New Pharmacogenomic Tests: Is The Canadian Regulatory Process Adequate?, Yann Joly, Emma Ramos-Paque
Canadian Journal of Law and Technology
In the first part of our analysis, we will examine the impact which pharmacogenomics is expected to have on drug research and development, on the drug approval process and on post-marketing surveillance and clinical practice. This will allow us to show how pharmacogenomic testing could be beneficial to drug companies, regulatory bodies, and patients. The second part of our analysis will focus on the regulatory framework applicable to the approval of pharmacoge- nomic tests in Canada, although we are aware of the fact that most manufacturers decide to approve their tests outside of Canada. As mentioned, the applicable regu- lations …
Canadian Personal Data Protection Legislation And Electronic Health Records: Transfers Of Personal Health Information In It Outsourcing Agreements, Dara Lambie
Canadian Journal of Law and Technology
Personal data protection and privacy of personal health information in the electronic era is a broad topic that includes consent, security measures and access considerations. The focus of this article is on one component of the larger picture: data transfers of personal health information that occur in the context of informa- tion technology (“IT”) outsourcing. If the societal good envisioned by an inter-jurisdictional EHR is to be fully realized, then the necessity of outsourcing is a reality that must be addressed.