Implantable Brain-Computer Interface (BCI) devices are currently in clinical trials in the U.S., and their introduction into the Canada could follow in the next few years. This article provides an overview of the research, developments, design issues, and risks in BCIs and an analysis of the adequacy of the regulatory framework in place for the approval of medical devices in Canada, emphasizing device investigational testing. The article concludes that until better safeguards are in place, to best protect potential research subjects, BCIs should not be approved for investigational testing in Canada.
Brain-Computer Interface Devices: Risks and Canadian Regulations
Abstract
Implantable Brain-Computer Interface (BCI) devices are currently in clinical trials in the U.S., and their introduction into the Canada could follow in the next few years. This article provides an overview of the research, developments, design issues, and risks in BCIs and an analysis of the adequacy of the regulatory framework in place for the approval of medical devices in Canada, emphasizing device investigational testing. The article concludes that until better safeguards are in place, to best protect potential research subjects, BCIs should not be approved for investigational testing in Canada.Preview Only. This article cannot be rented because we do not currently have permission from the publisher.
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Brain-Computer Interface Devices: Risks and Canadian Regulations
Follow Accountability in Research
, Volume 15 (2): 63-86
Taylor & Francis – Apr 1, 2008
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