Artificial intelligence in medical device software and high-risk medical devices–a review of definitions, expert recommendations and regulatory initiatives
Introduction Artificial intelligence (AI) encompasses a wide range of algorithms with risks
when used to support decisions about diagnosis or treatment, so professional and …
when used to support decisions about diagnosis or treatment, so professional and …
The role of cybersecurity in medical devices regulation: Future considerations and solutions
KR Ludvigsen - Law, Tech. & Hum., 2023 - HeinOnline
Medical devices are becoming increasingly more sophisticated in a variety of ways. This
includes having increasingly complex digital functionalities assisted by software systems. 2 …
includes having increasingly complex digital functionalities assisted by software systems. 2 …
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 …
devices that rely on network connectivity and advanced technologies. These advances bring …
[HTML][HTML] Dissecting liabilities in adversarial surgical robot failures: A national (Danish) and EU law perspective
KR Ludvigsen, S Nagaraja - Computer Law & Security Review, 2022 - Elsevier
Over the last decade, surgical robots have risen in prominence and usage. They are not
merely tools, but have also become advanced instruments with network connectivity …
merely tools, but have also become advanced instruments with network connectivity …
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 …
devices that have taken place during the COVID-19 pandemic reaffirmed how crucial it is to …
European Health Data Space–Is the Proposed Certification System Effective against Cyber Threats?
F Casarosa - European Journal of Risk Regulation, 2024 - cambridge.org
The proposal for a European Health Data Space aims at creating a common space where
individuals may control their health data in a trusted and secure way. The objective is not …
individuals may control their health data in a trusted and secure way. The objective is not …
The Design and Implementation of a National AI Platform for Public Healthcare in Italy: Implications for Semantics and Interoperability
R Reale, E Biasin, A Scardovi, S Toro - arXiv preprint arXiv:2304.11893, 2023 - arxiv.org
The Italian National Health Service is adopting Artificial Intelligence through its technical
agencies, with the twofold objective of supporting and facilitating the diagnosis and …
agencies, with the twofold objective of supporting and facilitating the diagnosis and …
Dissecting liabilities in adversarial surgical robot failures: A national (Danish) and European law perspective
KR Ludvigsen, S Nagaraja - arXiv preprint arXiv:2008.07381, 2020 - arxiv.org
Over the last decade, surgical robots have risen in prominence and usage. For surgical
robots, connectivity is necessary to accept software updates, accept instructions, and …
robots, connectivity is necessary to accept software updates, accept instructions, and …
Medtech compliance: abordagem regulatória com foco em cibersegurança e proteção de dados
FFNA Paro - 2023 - repositorio.ul.pt
O grande avanço das tecnologias disruptivas diante da chamada 4ª Revolução Industrial,
vem favorecendo o setor de healthcare, que atualmente apresenta um crescimento …
vem favorecendo o setor de healthcare, que atualmente apresenta um crescimento …
[HTML][HTML] Law, Technology and Humans
KR Ludvigsen - austlii.edu.au
Medical devices are becoming increasingly more sophisticated in a variety of ways. This
includes having increasingly complex digital functionalities assisted by software systems.[2] …
includes having increasingly complex digital functionalities assisted by software systems.[2] …