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AI Act high-risk AI compliance challenge and industry impact : a multiple case study

Wagner, Matthias LU orcid ; Song, Qunying LU orcid ; Borg, Markus LU ; Engström, Emelie LU orcid and Lysek, Michal (2026) In Information and Software Technology 194.
Abstract
The AI Act marks a new chapter in AI governance, affecting companies around the world seeking to offer their services within the European Union. This study focuses on the comprehensive AI Act requirements set out for high-risk AI systems. We explored the perceived compliance challenge for the AI Act's high-risk requirements and associated contributing factors; the AI Act's impact on industry in terms of positive and negative side effects; and the sentiment of industry practitioners towards the AI Act's Codes of Conduct for the voluntary application of the act's high-risk AI requirements. A multiple case study encompassing six case companies supplemented by three independent experts with a total of 16 respondents was conducted. This... (More)
The AI Act marks a new chapter in AI governance, affecting companies around the world seeking to offer their services within the European Union. This study focuses on the comprehensive AI Act requirements set out for high-risk AI systems. We explored the perceived compliance challenge for the AI Act's high-risk requirements and associated contributing factors; the AI Act's impact on industry in terms of positive and negative side effects; and the sentiment of industry practitioners towards the AI Act's Codes of Conduct for the voluntary application of the act's high-risk AI requirements. A multiple case study encompassing six case companies supplemented by three independent experts with a total of 16 respondents was conducted. This resulted in a ranking representing the different perceived levels of challenge for each AI Act high-risk requirement. Four facilitating factors emerged that impact the perceived compliance challenge: (1) industry and brand values, (2) existing regulatory environment, (3) AI maturity level and proficiency, and (4) company size. We identified several general key factors for the AI Act's impact on industry and outlined strong arguments both for and against the AI Act voiced by practitioners. The sentiment towards the AI Act's Codes of Conduct turned out very positive. In conclusion, this study offers a valuable primary research contribution to the state-of-the-art that currently lacks compliance-oriented studies with a focus on the operationalization of certain AI Act aspects. Future work is advised to develop artifacts facilitating AI Act operationalization and to validate them with industry partners. (Less)
Please use this url to cite or link to this publication:
author
; ; ; and
organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
AI Act, Compliance challenge, Industry impact, Multiple case study, Software compliance, Regulatory compliance, Regulatory requirements, AI governance
in
Information and Software Technology
volume
194
article number
108067
pages
14 pages
publisher
Elsevier
external identifiers
  • scopus:105034487622
ISSN
0950-5849
DOI
10.1016/j.infsof.2026.108067
language
English
LU publication?
yes
id
2e12ca91-4e75-4374-b0b1-25bc3b8bd851
date added to LUP
2025-05-09 11:11:01
date last changed
2026-04-12 04:00:58
@article{2e12ca91-4e75-4374-b0b1-25bc3b8bd851,
  abstract     = {{The AI Act marks a new chapter in AI governance, affecting companies around the world seeking to offer their services within the European Union. This study focuses on the comprehensive AI Act requirements set out for high-risk AI systems. We explored the perceived compliance challenge for the AI Act's high-risk requirements and associated contributing factors; the AI Act's impact on industry in terms of positive and negative side effects; and the sentiment of industry practitioners towards the AI Act's Codes of Conduct for the voluntary application of the act's high-risk AI requirements. A multiple case study encompassing six case companies supplemented by three independent experts with a total of 16 respondents was conducted. This resulted in a ranking representing the different perceived levels of challenge for each AI Act high-risk requirement. Four facilitating factors emerged that impact the perceived compliance challenge: (1) industry and brand values, (2) existing regulatory environment, (3) AI maturity level and proficiency, and (4) company size. We identified several general key factors for the AI Act's impact on industry and outlined strong arguments both for and against the AI Act voiced by practitioners. The sentiment towards the AI Act's Codes of Conduct turned out very positive. In conclusion, this study offers a valuable primary research contribution to the state-of-the-art that currently lacks compliance-oriented studies with a focus on the operationalization of certain AI Act aspects. Future work is advised to develop artifacts facilitating AI Act operationalization and to validate them with industry partners.}},
  author       = {{Wagner, Matthias and Song, Qunying and Borg, Markus and Engström, Emelie and Lysek, Michal}},
  issn         = {{0950-5849}},
  keywords     = {{AI Act; Compliance challenge; Industry impact; Multiple case study; Software compliance; Regulatory compliance; Regulatory requirements; AI governance}},
  language     = {{eng}},
  month        = {{02}},
  publisher    = {{Elsevier}},
  series       = {{Information and Software Technology}},
  title        = {{AI Act high-risk AI compliance challenge and industry impact : a multiple case study}},
  url          = {{http://dx.doi.org/10.1016/j.infsof.2026.108067}},
  doi          = {{10.1016/j.infsof.2026.108067}},
  volume       = {{194}},
  year         = {{2026}},
}