title: 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.
authors.affiliation: Novel Tech Ethics, Intellectual Commons, Dalhousie University, Halifax, Nova Scotia, Canada. salpert@dal.ca
authors.forename: Sheri
authors.initials: S
authors.lastname: Alpert
mesh_terms: D002170:Canada; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence / Q000592:standards; D018795:Device Approval / Q000331:legislation & jurisprudence / Q000592:standards; D004867:Equipment Design; D004869:Equipment Safety; D006801:Humans; D019736:Prostheses and Implants / Q000009:adverse effects / Q000592:standards*; D018570:Risk Assessment; D012656:Self-Help Devices / Q000009:adverse effects / Q000592:standards*; D014584:User-Computer Interface