Table 1 Next steps for industry and policymakers

From: How secure are your health devices—stopping wearables becoming a personal and national security risk?

1

Clarify and extend cybersecurity requirements within existing medical device regulations, such as the EU’s MDR and the US’s FD&C Act, guidance documents by regulatory authorities, and the applicable medical device-specific standards.

2

Implement robust security measures from the earliest stages of medical device manufacturing, like adhering to the principle of least authority for secure-by-design systems, integration of Roots of Trust, and deployment of Zero Trust architectures.

3

Improve transparency and traceability within complex global medical device supply chains through secure tracking systems and formal verification methods.

4

Increase awareness and proactive monitoring of cybersecurity threats throughout the lifecycle of IoMT products.

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