DIA Annual Canadian Meeting

Increases in the level of interconnectedness and data exchange between medical devices have large benefits to patients and the healthcare system but can leave devices vulnerable to unauthorized access. These vulnerabilities can negatively impact safety by causing diagnostic or therapeutic errors, or by affecting clinical operations. Health Canada, as the federal regulator of medical device safety and effectiveness, will now be considering cybersecurity vulnerabilities in medical devices as a potential risk to patients that manufacturers of medical devices must mitigate or eliminate. This session will describe the regulatory approach Health Canada is taking, what safety standards are relevant for this topic, and examples of industry approaches to medical device cybersecurity.