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On April 13, 2000, the Canadian Parliament enacted by Royal Assent the Personal Information Protection and Electronic Documents Act (PIPEDA). The Act requires private organizations to comply with a code of “fair information practice,” which mandates individual consent for the collection, use, and disclosure of personal information. PIPEDA complements the Federal Privacy Act, which places similar obligations on government institutions. On January 1, 2002, the Act began to apply to personal information (including personal health information) collected, used, or disclosed by a federal work, undertaking, or business, and personal information (including personal health information) disclosed by any organization for consideration outside the province in which it was collected.

This article describes PIPEDA and explains how it will apply to pharmaceutical companies and device manufacturers operating in Canada. Section I provides an overview of privacy legislation in Canada. Section II discusses the new Act's scope, the obligations it imposes, and the rights it creates. Section III discusses enforcement of the Act. Section IV considers the relationship between PIPEDA and other privacy laws in Canada, the European Union (EU), and the United States. Finally, Section V describes the transition periods before the Act is fully effective.

It is not entirely clear how PIPEDA will affect pharmaceutical and device manufacturers in Canada. PIPEDA is based on a privacy code drafted by private industry. The healthcare sector was not a significant participant in the drafting of that code, and the statute, therefore, is not tailored to address the specific concerns of pharmaceutical and device manufacturers. Also, the new Privacy Commissioner, who lacks a medical or scientific background, has said little about how he intends to apply the legislation to the healthcare sector. This article offers some speculation. Guidance and decisions issued in the next year may resolve some of the uncertainties.



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