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Kaspar Ludvigsen's Outputs (8)

Medical diagnostic artificial intelligence; medical, safety, security, and legal considerations (2024)
Presentation / Conference Contribution
Ludvigsen, K. (2024, July). Medical diagnostic artificial intelligence; medical, safety, security, and legal considerations. Presented at TILTING Perspectives 2024, Tilburg University

The role, specifications, and the legal branches which artificial intelligence (AI) currently rests on is thin. In many fields, AI bears striking resemblance to existing software, often diverging by the inclusion of machine learning, whether it uses... Read More about Medical diagnostic artificial intelligence; medical, safety, security, and legal considerations.

The Role of Cybersecurity in Medical Devices Regulation: Future Considerations and Solutions (2023)
Journal Article
Ludvigsen, K. R. (2023). The Role of Cybersecurity in Medical Devices Regulation: Future Considerations and Solutions. Law, Technology and Humans, 5(2), 59-77. https://doi.org/10.5204/lthj.3080

The cybersecurity of medical devices is paramount in a world where everything is increasingly digitised. Attention to how this important defence against malicious actors is regulated must, therefore, also increase. This paper uncovers how the cyberse... Read More about The Role of Cybersecurity in Medical Devices Regulation: Future Considerations and Solutions.

When is the processing of data from medical implants lawful? The legal grounds for processing health-related personal data from ICT implantable medical devices for treatment purposes under EU data protection law (2022)
Journal Article
Lindstad, S., & Ludvigsen, K. R. (2023). When is the processing of data from medical implants lawful? The legal grounds for processing health-related personal data from ICT implantable medical devices for treatment purposes under EU data protection law. Medical Law Review, 31(3), 317-339. https://doi.org/10.1093/medlaw/fwac038

Medicine is one of the biggest use cases for emerging information technologies. Data processing brings huge advantages but forces lawmakers and practitioners to balance between privacy, autonomy, accessibility, and functionality. ICT-connected Implan... Read More about When is the processing of data from medical implants lawful? The legal grounds for processing health-related personal data from ICT implantable medical devices for treatment purposes under EU data protection law.

Dissecting liabilities in adversarial surgical robot failures: A national (Danish) and EU law perspective (2022)
Journal Article
Ludvigsen, K. R., & Nagaraja, S. (2022). Dissecting liabilities in adversarial surgical robot failures: A national (Danish) and EU law perspective. Computer Law and Security Review, 44, Article 105656. https://doi.org/10.1016/j.clsr.2022.105656

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. Connectivity is necessary to accept software updates, accept instructions, and t... Read More about Dissecting liabilities in adversarial surgical robot failures: A national (Danish) and EU law perspective.

When Is Software a Medical Device? Understanding and Determining the “Intention” and Requirements for Software as a Medical Device in European Union Law (2021)
Journal Article
Ludvigsen, K., Nagaraja, S., & Daly, A. (2022). When Is Software a Medical Device? Understanding and Determining the “Intention” and Requirements for Software as a Medical Device in European Union Law. European Journal of Risk Regulation, 13(1), 78-93. https://doi.org/10.1017/err.2021.45

The role of software in society has changed drastically since the start of the twenty-first century. Software can now partially or fully facilitate diagnosis and treatment of a disease, regardless of whether it is psychological or pathological. Conse... Read More about When Is Software a Medical Device? Understanding and Determining the “Intention” and Requirements for Software as a Medical Device in European Union Law.