@article{ alpert_brain-computer_2008,
  title = {Brain-Computer Interface devices: risks and Canadian regulations},
  volume = {15},
  issn = {0898-9621},
  shorttitle = {Brain-Computer Interface devices},
  doi = {10.1080/08989620701783774},
  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.},
  language = {eng},
  number = {2},
  journal = {Accountability in research},
  author = {Alpert, Sheri},
  month = {June},
  year = {2008},
  pmid = {18593098},
  keywords = {Canada, Consumer Product Safety, Device Approval, Equipment Design, Equipment Safety, Humans, Prostheses and Implants, Risk Assessment, Self-Help Devices, User-Computer Interface},
  pages = {63--86}
}

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