Imagine your medical devices are like smartphones that need constant updates to stay safe from hackers. This project creates a digital safety kit to stop bad actors from messing with hospital equipment or stealing patient data. It also teaches the doctors and nurses using these machines how to avoid being the 'weak link' that lets a virus in.
Medical devices are increasingly connected via AI and 5G, but they are vulnerable to cyberattacks. Human error by healthcare staff remains a critical security gap that threatens patient safety and data privacy.
A cybersecurity toolbox and risk assessment tool based on ISO 14971:2019, along with staff training modules and regulatory guidelines for connected medical devices.
If you are a manufacturer dealing with complex security requirements for connected devices — this project developed a toolbox and risk assessment schemes that ensure your products meet safety standards and protect patient data.
If you are a software developer dealing with the risks of AI and cloud integration in health apps — this project developed guidelines and a risk management tool based on ISO 14971:2019 to keep your software secure.
If you are a hospital administrator dealing with the threat of cyberattacks on patient monitoring systems — this project developed training and awareness measures tailored to healthcare staff needs to prevent human error.
Based on available project data, no specific pricing or commercial cost for the toolbox is mentioned; the project received an EU contribution of EUR 3,489,625 for development.
Yes, the project includes 6 industry partners and tests the tools in real-world hospital scenarios, including COVID-19 monitoring and pediatric telemonitoring.
Based on available project data, specific licensing terms are not provided, but the project focuses on creating 'technologically sovereign' methodologies for the ecosystem.
Yes, it provides a risk management process following ISO 14971:2019 and offers suggestions to enhance the MDCG 2019-16 regulatory framework.
The project runs from 2022-12-01 to 2025-11-30, with initial requirements and guidelines finalized within the first 18 months.
The consortium is heavily weighted toward commercial application, with a 55% industry ratio comprising 6 companies, including 4 SMEs. This balance, combined with 2 universities and 3 research centers across 7 countries, suggests the output is designed for market adoption rather than purely academic study.
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