Studia Iuridica

INFORMED CONSENT TO ALGORITHMIC DIAGNOSIS IN MEDICINE UNDER SCHUFA AND ARTICLE 22 GDPR

2026, 111, No. 1

Paweł Kowalski

0000-0003-2078-7712

SWPS University of Social Sciences and Humanities in Warsaw, Department of Law

DOI

10.31338/2544-3135.si.2026-111.4

Publication date

11.08.2026

Publishing model

open access

License type

CC BY 4.0 Int.

Field

Social sciences

Discipline

law

Language of publication

English

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PDF 383 KB

Article

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Number of downloads:2

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Abstract

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.

Keywords:

artificial intelligence,automated decision-making,GDPR,informed consent,patient autonomy,AI Act,Code of Medical Ethics,large language models,medical liability

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