Elisabetta Biasin

Artificial intelligence in medical device software and high-risk medical devices – a review of definitions, expert recommendations and regulatory initiatives

2023 · 63 Zit. · Expert Review of Medical Devices

Regulatory Approaches Towards AI-Based Medical Device Cybersecurity: A Transatlantic Perspective

2024 · 8 Zit. · European Journal of Risk Regulation

CORE-MD clinical risk score for regulatory evaluation of artificial intelligence-based medical device software

2025 · 8 Zit. · npj Digital Medicine

Cybersecurity of AI medical devices: risks, legislation, and challenges

2023 · 4 Zit. · arXiv (Cornell University)

The Design and Implementation of a National AI Platform for Public Healthcare in Italy: Implications for Semantics and Interoperability

2023 · 3 Zit. · arXiv (Cornell University)

Cybersecurity of Medical Devices: New Challenges Arising from the AI Act and NIS 2 Directive Proposals

2021 · 2 Zit. · SSRN Electronic Journal

“What about viruses doctors cannot treat?” Medical devices, cybersecurity and a duty to provide cyber-trainings

2020 · 0 Zit. · Lirias (KU Leuven)

Accuracy in healthcare AI and its associated harms. Reframing existing concepts to renew forms of patients’ redress

2025 · 0 Zit. · Lirias (KU Leuven)

The perils and promise of data-driven medicine

2026 · 0 Zit.

Regulatory challenges and liability pathways for AI-powered robots in EU medical practice

2026 · 0 Zit. · AI & Society