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.

Keywords:

• brain–computer interface
• Health Canada
• investigational testing
• medical device
• regulations
• risk

Acknowledgements

The author is grateful to Françoise Baylis, Andrew Fenton, and the anonymous reviewers for their insightful comments on earlier drafts of this article.

Notes

¹Other recent research on DBS aims to produce insulated nanoscale wire electrodes that would be threaded to the brain through the body's capillaries, after being inserted through an artery in the arm or groin (Llinas et al., 2005).

²Because BCIs are comprised of several components, only one of which is implanted in the brain, the discussion below refers to “devices” and/or “systems.” Both words are intended to convey all the components of the BCI.

³A neurotrophic electrode is a “tiny device implanted onto a target area on the outer layer for the brain to detect neural activity there” (Neural Signals, 2006).

⁴Note that this section partly summarizes a prior article by the author (Alpert, 2007).

⁵For a more in-depth discussion of both the pre-and post-market activities and the A.G.'s report, see (Alpert, 2007).

⁶Note that “good clinical practices” are required to be followed for medical device testing in the U.S.

Food and Drugs Act. 1985 R.S.C. 1985, c. F-27. Canada.

Caplan A. 2007 Personal communication. January 12, 2007. (S. Alpert)

MDR 1998 Medical Device Regulations. SOR/98–282. Canada.

Ross C. 2001 Paralyzed football star vows to fight on. Quincy, MA: The Patriot Ledger.

TPD 1999 Preparation of an application for investigational testing—Medical devices (Guidance document). Therapeutic Products Directorate, Health Canada.

TPD 2007 Discussion paper for consultation: Investigational testing of medical devices (Guidance document). Therapeutic Products Directorate, Health Canada. Ottawa. July 25.