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

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dc.abstract.enThe 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.
dc.affiliationWydział Prawa w Warszawie
dc.contributor.authorKowalski, Paweł
dc.date.access2026-08-11
dc.date.accessioned2026-11-03T10:15:15Z
dc.date.available2026-11-03T10:15:15Z
dc.date.created2026
dc.date.issued2026-08-11
dc.description.abstract<jats:p>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.</jats:p>
dc.description.accesstimeat_publication
dc.description.issue1
dc.description.physical150-168
dc.description.sdgGoodHealthAndWellBeing
dc.description.sdgPeaceJusticeAndStrongInstitutions
dc.description.versionfinal_published
dc.description.volume111
dc.identifier.doi10.31338/2544-3135.si.2026-111.8
dc.identifier.eissn2544-3135
dc.identifier.issn0137-4346
dc.identifier.urihttps://share.swps.edu.pl/handle/swps/2718
dc.identifier.weblinkhttps://studiaiuridica.pl/issues/111-vol-111/informed-consent-to-algorithmic-diagnosis-in-medicine-under-schufa-and-article-22-gdpr
dc.languageen
dc.pbn.affiliationnauki prawne
dc.rightsCC-BY
dc.rights.questionYes_rights
dc.share.articleOPEN_JOURNAL
dc.subject.enartificial intelligence
dc.subject.enautomated decision-making
dc.subject.enGDPR
dc.subject.eninformed consent
dc.subject.enpatient autonomy
dc.subject.enAI Act
dc.subject.enCode of Medical Ethics
dc.subject.enlarge language models
dc.subject.enmed- ical liability
dc.subject.plsztuczna inteligencja
dc.subject.plzautomatyzowane podejmowanie decyzji
dc.subject.plRODO
dc.subject.plświad- oma zgoda
dc.subject.plautonomia pacjenta
dc.subject.plustawa o sztucznej inteligencji
dc.subject.plKodeks Etyki Lekarskiej
dc.subject.plduże modele językowe
dc.subject.plodpowiedzialność medyczna
dc.swps.sciencecloudsend
dc.titleInformed consent to algorithmic diagnosis in medicine under schufa and article 22 gdpr
dc.title.journalStudia Iuridica
dc.typeJournalArticle
dspace.entity.typeArticle