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Given the fast pace of innovation in digital health technologies specifically in relation to medical devices, Health Canada is undertaking an initiative to adapt its approach to support better access to therapeutic products based on healthcare system needs.

Health Canada considers cybersecurity a component of the medical device's design and lifecycle that can affect the safety and effectiveness of the medical device. Manufacturers should consider cybersecurity when designing their medical device.

The guidance document provides medical device manufacturers with advice on the practices, responses and mitigation measures which can improve the cybersecurity of their device.

On 11 March 2020, the World Health Organization (WHO) officially declared the novel coronavirus disease 2019 (COVID-19) a global pandemic. In a previous Cyber Threat Bulletin, we assessed that cyber threat actors have taken advantage of this context to conduct a range of cyber threat activities....