Masterarbeit MSTR-2025-08

Bibliograph.
Daten
Bouallaoui, Walid: Development of an efficient test procedure for assessing the cybersecurity of patient monitors in compliance with regulatory requirements.
Universität Stuttgart, Fakultät Informatik, Elektrotechnik und Informationstechnik, Masterarbeit Nr. 8 (2025).
86 Seiten, englisch.
Kurzfassung

The growing number of connected medical devices in the healthcare sector has raised significant cybersecurity challenges, directly affecting patient safety. Given that many medical devices require a network connection to transmit and share measured patient data, facilitating the work of healthcare professionals, this has made these devices vulnerable to cyberattacks that can compromise patient data and disrupt essential medical functions. Major incidents in recent years have highlighted the serious consequences of these vulnerabilities. As a result, regulatory authorities have developed and issued regulatory frameworks to strengthen cybersecurity in the healthcare sector. The aim of this thesis is to assess the compliance of patient monitors towards cybersecurity standard requirements. During this work, an analysis of the evolution of these requirements is highlighted, focusing on regulatory standards that aim to meet the specific security needs of medical devices. This research aims to identify how medical device manufacturers can better protect themselves against cyber threats by examining relevant standards and their implementation in a company’s quality management system. It addresses potential gaps in line with the introduced requirements and suggests ways to fill them. Additionally, this study proposes best practice recommendations for integrating cybersecurity measures into the research and development of medical devices. These recommendations ensure compliance with regulatory requirements while protecting patient safety in an increasingly connected healthcare environment. This work is intended to help the product security engineers in charge of ensuring the cybersecurity of medical devices in the face of these constant growing threats, and to place an interpretation and implementation of these regulatory requirements by translating them more concretely into risk management guidelines through processes and optimizing mitigations and documenting the path that industry engineers follow through the Software development lifecycle and its continuity after release by ensuring a continuity of work and contribute to a noble cause: helping, directly or indirectly, to save human lives.

Abteilung(en)Universität Stuttgart, Institut für Informationssicherheit
BetreuerKüsters, Prof. Ralf; Rausch, Dr. Daniel; Mitschke, Nils
Eingabedatum19. Mai 2025
   Publ. Informatik