Imagine your heart monitor or insulin pump is like a smartphone that can be hacked. This project builds a digital security shield and a set of clear rules to stop bad actors from interfering with these devices. It's like creating a universal safety manual and a high-tech lock for all medical gadgets used at home or in hospitals.
Medical device manufacturers struggle to meet evolving cybersecurity regulations, and existing guidelines are too vague to ensure devices are safe from hacks in home-care settings.
A cybersecurity benefit-risk analysis toolbox, secure gateway middleware for 5G/cloud, and a 'fleet' management review system for networked devices.
If you are a device developer dealing with outdated security guidelines like MDCG 2019-16 — this project developed a cybersecurity benefit-risk analysis toolbox that helps you prove your device is safe for regulators.
If you are a provider dealing with insecure data transmission in home care — this project developed secure gateway middleware for 5G and cloud computing that protects patient data from attacks.
If you are a manufacturer dealing with the struggle to keep pace with digital innovation — this project developed a new IoMT cybersecurity standard to streamline your path to market approval.
Based on available project data, the tools are being developed as Open-Source resources for manufacturers and regulatory bodies, suggesting no direct licensing cost for the toolbox.
Yes, the project validates solutions in complex infrastructures like 5G and cloud computing and includes a 'fleet' management review for large-scale device oversight.
The project follows an Open Science approach, providing open-source tools and FAIR datasets to the public.
It provides a cybersecurity-focused benefit-risk analysis toolbox and contributes to a CEN Workshop Agreement to update regulatory guidance.
The project runs from 2023-11-01 to 2027-10-31, with early results already including regulatory gap analyses and attack models.
The consortium is well-balanced for commercial translation, featuring 12 partners across 8 countries. With a 33% industry ratio (4 companies, including 2 SMEs), there is a strong link between academic research from 2 universities and 3 research centers and actual market needs, ensuring the tools are practical for the EU digital health industry.
Contact Technische Universität Dresden regarding the IoMT cybersecurity toolbox.
Contact us to find the open-source cybersecurity toolbox for your medical device pipeline.
