Malaphor: Digital Health Law in Canada

health + tech in law = mixing chalk + cheese

Health Canada’s Draft Guidance on SaMD shows the medical devices laws need to be updated for digital health

About a year after it convened a Scientific Advisory Panel with respect to Software-as-a-Medical-Device (SaMD), Health Canada has now released a Draft Guidance Document for public comment until March 29, 2019.

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Health Canada has commenced a public consultation on its Draft Guidance Document for “Pre-market Requirements for Medical Device Cybersecurity.”

With all the recent reports on the hacking of pacemakers, it’s timely that Health Canada confirms that it “considers cybersecurity a component of the medical device’s design and life-cycle that can impact safety and effectiveness.” The Draft Guidance appears to address both IVDD and non-IVDD devices. Interestingly, however, the Draft Guidance focuses on pre-market/pre-license application activities, and explicitly excludes actual post-market activities. Perhaps Health Canada is waiting for changes to the Medical Devices Regulations it announced earlier this year to strengthen post-market surveillance and risk management of devices before releasing another Draft Guidance on such activities.

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