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.2026-111.8

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 415 KB

Article

Number of views:194

Number of downloads:102

Crossref citations:0

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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

Bibliography

American Medical Association, 2026 Physician Survey on Augmented Intelligence (AMA Center for Digital Health and AI, March 2026)

Budzowska J, comments to Art 12 and Art 14 in R Tymiński (ed), Kodeks Etyki Lekarskiej. Komentarz, LEX/el. (Warszawa 2025)

Busch F and others, ‘Multinational Attitudes Toward AI in Health Care and Diagnostics Among Hospital Patients’ (2025) 8(6) JAMA Network Open e2514452

Caban Ł, comment to Art 31 in M Kopeć (ed), Ustawa o zawodach lekarza i lekarza dentysty. Komentarz, LEX/el. (Warszawa 2016)

Cohen IG, ‘Informed Consent and Medical Artificial Intelligence: What to Tell the Patient?’ (2020) 108 Georgetown Law Journal 1425

Cohen IG, Slottje A, ‘Artificial Intelligence and the Law of Informed Consent’ in B Solaiman and IG Cohen (eds), Research Handbook on Health, AI and the Law (Cheltenham 2024)

Duffourc M, Gerke S, ‘Decoding U.S. Tort Liability in Healthcare’s Black-Box AI Era: Lessons from the European Union’ (2024) 27 Stanford Technology Law Review 1

Fajgielski P, Ogólne rozporządzenie o ochronie danych. Komentarz, LEX/el. (Warszawa 2022)

Guzowska M, ‘Prawo pacjenta do informacji o stanie zdrowia jako jedno z praw przysługujących w procesie leczenia’ (2009) 9 Przegląd Sądowy 91

Hatherley J, ‘Are clinicians ethically obligated to disclose their use of medical machine learning systems to patients?’ (2025) 51 Journal of Medical Ethics 567

Kant I, Groundwork of the Metaphysics of Morals (first published 1785, M Gregor tr, CUP 1998)

Karkowska D, comments to Art 9 in D Karkowska (ed), Prawa pacjenta i Rzecznik Praw Pacjenta. Komentarz, LEX/el. (Warszawa 2021)

Komentarz Komisji Etyki Lekarskiej Naczelnej Rady Lekarskiej do art 12 znowelizowanego Kodeksu Etyki Lekarskiej. Sztuczna inteligencja (Naczelna Izba Lekarska 2024)

Kupiec M, ‘Nowe spojrzenie na zautomatyzowane podejmowanie decyzji w rozumieniu art 22 RODO - glosa do wyroku TS z 7.12.2023 r, C-634/21’ (2024) 3 Europejski Przegląd Sądowy 33

Malczewska M, comments to Art 31 in E Zielińska (ed), Ustawa o zawodach lekarza i lekarza dentysty. Komentarz, LEX/el. (Warszawa 2022)

McGhee KN and others, ‘Patient Preferences for Artificial Intelligence in Medical Imaging: A Single-Center Cross-Sectional Survey’ (2025) Journal of Imaging Informatics in Medicine,

https://doi.org/10.1007/s10278-025-01629-w

Nesterowicz M, ‘Prawo pacjenta do informacji - glosa do wyroku SA z 11.08.2016 r, I ACa 300/16’ (2020) 2 Orzecznictwo Sądów Polskich, item 11

Obermeyer Z and others, ‘Dissecting racial bias in an algorithm used to manage the health of populations’ (2019) 366 Science 447

Pawlikowski J, ‘Znowelizowany Kodeks etyki lekarskiej. Komentarz’ (2025) 7-8 Medycyna Praktyczna (supplement)

Pilśniak JA and others, ‘Zastosowanie algorytmów sztucznej inteligencji w praktyce lekarskiej w świetle nowelizacji Kodeksu Etyki Lekarskiej’ (2025) 31(3) Medycyna Ogólna i Nauki o Zdrowiu 156

Ploug T, Holm S, ‘The right to a second opinion on Artificial Intelligence diagnosis – Remedying the inadequacy of a risk-based regulation’ (2023) 37 Bioethics 303

Ploug T and others, ‘The need for patient rights in AI-driven healthcare – risk-based regulation is not enough’ (2025) Journal of the Royal Society of Medicine (online first),

https://doi.org/10.1177/01410768251344707

Price WN II, Gerke S, Cohen IG, ‘Liability for Use of Artificial Intelligence in Medicine’ in B Solaiman and IG Cohen (eds), Research Handbook on Health, AI and the Law (Cheltenham 2024)

Sibiga G, ‘Zautomatyzowane podejmowanie decyzji na podstawie RODO’ (2022) 21 Monitor Prawniczy 1143

Skitka LJ, Mosier KL, Burdick M, ‘Does automation bias decision-making?’ (1999) 51 International Journal of Human-Computer Studies 991

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