A1 Journal article (refereed)
Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union : Industry Perspectives (2024)

Granlund, T., Stirbu, V., & Mikkonen, T. (2024). Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union : Industry Perspectives. Computer, 57(9), 24-34. https://doi.org/10.1109/mc.2024.3414368

JYU authors or editors

Publication details

All authors or editors: Granlund, Tuomas; Stirbu, Vlad; Mikkonen, Tommi

Journal or series: Computer

ISSN: 0018-9162

eISSN: 1558-0814

Publication year: 2024

Volume: 57

Issue number: 9

Pages range: 24-34

Publisher: IEEE

Publication country: United States

Publication language: English

DOI: https://doi.org/10.1109/mc.2024.3414368

Publication open access: Openly available

Publication channel open access: Partially open access channel

Publication is parallel published (JYX): https://jyx.jyu.fi/handle/123456789/98504

Publication is parallel published: https://arxiv.org/abs/2409.08006

Abstract

Despite the immense potential of artificial intelligence (AI)-powered medical devices to revolutionize health care, concerns regarding their safety in life-critical applications remain. This article proposes extending the general idea of AI lifecycle with regulatory activities relevant to AI-enabled medical systems.

Keywords: artificial intelligence; machine learning; public health service; medicine (science); safety and security

Free keywords: industries; medical devices; Europe; medical services; safety; artificial intelligence

Contributing organizations

Ministry reporting: Yes

VIRTA submission year: 2024

Preliminary JUFO rating: 2