Cybersecurity and data breaches are topics of high concern for
Canadians. As discussed in
previous blog articles, data breaches in Canada, North America
and Europe have illustrated how financially motivated hackers and
human error can put personal data at risk, thereby causing
potential reputational and financial harms such as identity theft,
fraud and humiliation. Immediate physical harm resulting from
cybersecurity risks have been less frequently highlighted as acute
areas of concern but as this entry will discuss, they are certainly
not going unnoticed as they relate to medical devices.
To address cybersecurity risks in medical devices, Health Canada
has recently released a Guidance Document:
"Pre-market requirements for Medical Device
Cybersecurity." Canada is not alone. The US Food and Drug
Administration ("FDA") had previously
released similar guidance, and, just a few weeks ago, the French
authorities, Agence Nationale de Sécurité du
Médicament et des
