Cybersecurity of medical devices: new challenges arising from the AI Act and NIS 2 Directive proposals

E Biasin, E Kamenjašević - International Cybersecurity Law Review, 2022 - Springer
Cyberattacks on the IT infrastructure of hospitals, electronic health records or medical
devices that have taken place during the COVID-19 pandemic reaffirmed how crucial it is to …

Cybersecurity of medical devices: regulatory challenges in the EU

E Biasin, E Kamenjasevic - 2020 - papers.ssrn.com
This book chapter assesses the EU medical devices legal framework in light of the EU
cybersecurity policy objectives and the complexity aspects inherently characterizing the …

The governance of safety and security risks in connected healthcare

IM Skierka - Living in the Internet of Things: Cybersecurity of …, 2018 - ieeexplore.ieee.org
As healthcare is increasingly digitized and interconnected, medical systems are exposed to
cybersecurity threats that can endanger patient health and safety. This paper examines how …

Healthcare critical infrastructures protection and cybersecurity in the EU: regulatory challenges and opportunities

E Biasin - Proceedings of the 1st European Cluster for Securing …, 2020 - papers.ssrn.com
Abstract 2020 marks a crucial year for the EU agenda on critical infrastructure protection and
cybersecurity, as EU policy-makers which will have to re-consider key pieces of legislation …

New cybersecurity requirements for medical devices in the EU: the forthcoming European health data space, data act, and artificial intelligence act

E Biasin, B Yasar, E Kamenjasevic - Law, Tech. & Hum., 2023 - HeinOnline
In recent years, the healthcare sector has undergone a digital transformation due to medical
devices that rely on network connectivity and advanced technologies. These advances bring …

Cybersecurity challenges in healthcare

R Sendelj, I Ognjanovic - Achievements, Milestones and …, 2022 - ebooks.iospress.nl
Cyber security attacks evidence has shown that many sectors and industries are still at an
insufficient level of readiness to counter these threats, including healthcare organizations …

Cybersecurity of Internet of Things in the health sector: Understanding the applicable legal framework

F Casarosa - Computer Law & Security Review, 2024 - Elsevier
Although the digitalisation of healthcare is an ongoing process that dates back to more than
two decades ago, it has gained more momentum with the COVID-19 pandemic. Recent …

Towards a healthcare cybersecurity certification scheme

K Hovhannisyan, P Bogacki… - … on Cyber Situational …, 2021 - ieeexplore.ieee.org
The EU Cybersecurity Act introduces cybersecurity certification framework for ICT products,
services and processes. Following ENISA's EUCC (the Common Criteria based European …

On medical device cybersecurity compliance in EU

T Granlund, J Vedenpää, V Stirbu… - 2021 IEEE/ACM 3rd …, 2021 - ieeexplore.ieee.org
The medical device products at the European Union market must be safe and effective. To
ensure this, medical device manufacturers must comply to the new regulatory requirements …

Cybersecurity vulnerability analysis of medical devices purchased by national health services

L Bracciale, P Loreti, G Bianchi - Scientific Reports, 2023 - nature.com
The growing integration of software within medical devices introduces the potential for
cybersecurity threats. How significant is this risk, and to what extent are citizens currently …