MedSecurance Project: Advanced Security-for-Safety Assurance for Medical Device IoT (IoMT).

Area of Science:

• Healthcare technology
• Cybersecurity engineering
• Medical device regulation

Background:

• Emerging healthcare architectures introduce new cybersecurity challenges for medical devices.
• Existing guidance may have gaps, particularly concerning medical device regulations.
• Protecting patient safety from cyber threats is paramount in interconnected medical environments.

Purpose of the Study:

• Identify novel cybersecurity challenges for hardware and software medical devices.
• Review best practices and pinpoint gaps in current medical device cybersecurity guidance.
• Develop a robust methodology and tools for secure, interoperable medical device networks.

Main Methods:

• Analysis of current healthcare IT architectures and their security vulnerabilities.
• Comprehensive review of medical device regulations and industry best practices.
• Engineering of security-for-safety principles into medical device network design.
• Development of strategies for device certification and dynamic network composition.

Main Results:

• Identification of specific cybersecurity vulnerabilities in medical device hardware and software.
• Gaps in current regulatory guidance for medical device cybersecurity have been identified.
• A comprehensive methodology and tooling for trustworthy medical device networks are proposed.

Conclusions:

• A security-for-safety by design approach is essential for medical devices.
• Robust strategies for device certification and dynamic network composition are needed.
• Ensuring patient safety requires safeguarding against cyber actors and technological failures.