An increasing number of medical devices incorporate digital features - for example, in order to detect diseases earlier by analyzing the patient's data. Hardware and software manufacturers must comply with strict regulations and legal requirements to ensure that sensitive data is protected. The MEDISEC project of the Fraunhofer Cluster of Excellence Cognitive Internet Technologies CCIT demonstrates how a model application can be implemented securely, using a smart textile that records the patient's ECG data via long-term monitoring in order to prevent cardiological diseases.

Due to demographic change, the increasing digitalization of healthcare and structural changes, medical care at home is playing an increasingly important role. Telemedical concepts and networked sensor technology constitute the backbone of this digital health care. Secure transmission and protection against unauthorized access or misuse of data must be guaranteed. In the MEDISEC project, Fraunhofer CCIT shows which concepts and technological features must be implemented so that a wirelessly networked, medical sensor application is reliable and secure.


From the sensor to the cloud to the attending physician

In the IoT-COMMs Technology Hub, the Fraunhofer Institutes for Applied and Integrated Security AISEC and for Integrated Circuits IIS are collaborating on the topic of secure communication for networked medical devices. Initially, the research team identified the new normative requirements for secure software for medical devices resulting from the newly applicable Medical Device Regulation (MDR). For secure medical communication, the researchers conduct a bad practice analysis to identify potential hazards and pitfalls for security risks. Finally, a demonstrator is built that implements the requirements for a tamper-proof sensor system by choosing a trustworthy microcontroller platform and implementing secure communication.


Smart wearable for long-term ECG monitoring

The demonstrator is a textile-integrated multi-channel ECG with dry electrodes to which sensor electronics are connected, featuring a trusted processor platform and the implementation of secure state-of-the-art medical communication. The smart textile captures ECG signals in the everyday life of the patient and allows early detection of cardiological diseases, such as atrial fibrillation, through long-term monitoring.


Main Features


  • Wireless networked medical sensor application
  • IVD control systems/lab-on-chip evaluation technology
  • Rapid prototyping for discrete sensor systems
  • Biosignal analysis


  • trusted microcontroller platform
  • trusted processor platform
  • security requirement and risk analysis


  • Multichannel ECG with dry electrodes
  • Captures ECG signals during the patient's daily routine
  • Long-term monitoring allows early detection of heart disease
  • Wearable sensors (body-worn/textile-integrated)