Informed consent to algorithmic diagnosis in medicine under schufa and article 22 gdpr

StatusVoR
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Authors
Kowalski, Paweł
Monograph
Monograph (alternative title)
Date
2026-08-11
Publisher
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Studia Iuridica
Issue
1
Volume
111
Pages
Pages
150-168
ISSN
0137-4346
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Access date
2026-08-11
Abstract PL
Abstract EN
The CJEU judgment in SCHUFA (C-634/21) redefines the ‘decision’ of Article 22 GDPR: if a score generated by one entity effectively determines another entity’s decision, the data subject is entitled to the protections of Article 22, regardless of whether a human formally signs off. This article asks what that reasoning means for medicine: when an algorithm’s output shapes a physician’s clinical judgment, does the patient have a right to know, and what must they be told? The discussion confronts the SCHUFA doctrine with informed consent requirements under Polish law and the new Article 12 of the Code of Medical Ethics, situates it against the international debate, distinguishes diagnostic from cognitive uses of AI through operational criteria, examines liability for algorithmic harm after Directive (EU) 2024/2853, and addresses the problem of large language models – tools physicians already use but which cannot be meaningfully certified.
Abstract other
Keywords PL
sztuczna inteligencja
zautomatyzowane podejmowanie decyzji
RODO
świad- oma zgoda
autonomia pacjenta
ustawa o sztucznej inteligencji
Kodeks Etyki Lekarskiej
duże modele językowe
odpowiedzialność medyczna
Keywords EN
artificial intelligence
automated decision-making
GDPR
informed consent
patient autonomy
AI Act
Code of Medical Ethics
large language models
med- ical liability
Keywords other
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cc-by
Except as otherwise noted, this item is licensed under the Attribution licence | Permitted use of copyrighted works
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