Malaphor: Digital Health Law in Canada

health + tech in law = mixing chalk + cheese

UN Special Rapporteur makes health-data protection recommendations

In 2015, the Human Rights Council of the United Nations appointed its first Special Rapporteur on the right to privacy, Professor Joseph Cannataci. Under his mandate, Prof. Cannataci produced this Recommendation for health-data protection (the “Recommendation”), along with an Explanatory Memorandum (the “Memo”). (See also this page for other related documents.)

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Health Canada’s Draft Guidance on SaMD shows the medical devices laws need to be updated for digital health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a Scientific Advisory Panel with respect to Software-as-a-Medical-Device (SaMD), Health Canada has now released a Draft Guidance Document for public comment until March 29, 2019.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Health Canada has commenced a public consultation on its Draft Guidance Document for “Pre-market Requirements for Medical Device Cybersecurity.”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 The Draft Guidance appears to address both IVDD and non-IVDD devices. Interestingly, however, the Draft Guidance focuses on pre-market/pre-license application activities, and explicitly excludes actual post-market activities.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earlier this year to strengthen post-market surveillance and risk management of devices before releasing another Draft Guidance on such activities.

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