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ZENODO
Preprint . 2026
License: CC BY
Data sources: ZENODO
ZENODO
Preprint . 2026
License: CC BY
Data sources: Datacite
ZENODO
Preprint . 2026
License: CC BY
Data sources: Datacite
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A Systematic Analysis of the EU Artificial Intelligence Act: Risk Classification, Governance Obligations, and Post-Deployment Challenges in High-Risk Clinical and Social Care Contexts

Authors: Valente, Stefano;

A Systematic Analysis of the EU Artificial Intelligence Act: Risk Classification, Governance Obligations, and Post-Deployment Challenges in High-Risk Clinical and Social Care Contexts

Abstract

The European Union Artificial Intelligence Act (AI Act) represents the first comprehensive, binding regulatory framework for artificial intelligence systems based on a risk-oriented approach. While the regulation provides a detailed set of ex-ante obligations for high-risk AI systems, its implications for real-world deployment—particularly in longitudinal clinical and social care contexts—remain complex and partially underexplored. This paper offers a systematic and article-by-article analysis of the EU AI Act, with a specific focus on risk classification, governance obligations, conformity assessment, and post-deployment monitoring. Particular attention is paid to high-risk use cases in mental health, addiction services, and dual diagnosis settings, where AI systems may influence decision-making processes affecting vulnerable populations over extended time horizons. Without advancing normative or prescriptive positions, the paper identifies structural strengths, ambiguities, and implementation challenges inherent in the AI Act, especially regarding post-inference governance, cumulative risk, and the management of uncertainty in fragile populations. The analysis aims to support policymakers, regulators, and practitioners in understanding the operational consequences of the AI Act in high-risk clinical and social care environments.

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    popularity
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    influence
    This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
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selected citations
These citations are derived from selected sources.
This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
0
Average
Average
Average