Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union: Industry Perspectives

Tuomas Granlund; Vlad Stirbu; Tommi Mikkonen

doi:10.1109/MC.2024.3414368

Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union: Industry Perspectives

Tuomas Granlund
, Vlad Stirbu
, Tommi Mikkonen

Tietotekniikka

Tutkimustuotos: Artikkeli › Tieteellinen › vertaisarvioitu

1 Sitaatiot (Scopus)

17 Lataukset (Pure)

Abstrakti

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.

Alkuperäiskieli	Englanti
Sivut	24-34
Sivumäärä	11
Julkaisu	Computer
Vuosikerta	57
Numero	9
DOI - pysyväislinkit	https://doi.org/10.1109/MC.2024.3414368
Tila	Julkaistu - syysk. 2024
OKM-julkaisutyyppi	A1 Alkuperäisartikkeli tieteellisessä aikakauslehdessä

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Pääsy asiakirjaan

10.1109/MC.2024.3414368Lisenssi: CC BY

Toward_a_Regulatory-Compliant_Lifecycle_for_Artificial-Intelligence-Based_Medical_Devices_in_the_European_Union_Industry_PerspectivesFinal published version, 2,08 MBLisenssi: CC BY

https://urn.fi/URN:NBN:fi:tuni-2024122011477Lisenssi: CC BY

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title = "Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union: Industry Perspectives",

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.",

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author = "Tuomas Granlund and Vlad Stirbu and Tommi Mikkonen",

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AB - 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.

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KW - Europe

KW - Medical services

KW - Safety

KW - Artificial intelligence

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Toward a Regulatory-Compliant Lifecycle for Artificial-Intelligence-Based Medical Devices in the European Union: Industry Perspectives

Abstrakti

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