Here you can find a collection of legal instruments and ethical sources on the topic of health data reuse, which in the future could be used by you other scholars to compare the ethical and legal framework in Italy, The Netherlands, and Spain.
EUROPEAN LAW
GDPR https://eur-lex.europa.eu/eli/reg/2016/679/oj/eng
AI ACT https://eur-lex.europa.eu/eli/reg/2024/1689/oj/eng
DATA ACT https://eur-lex.europa.eu/eli/reg/2023/2854
DATA GOVERNANCE ACT https://eur-lex.europa.eu/eli/reg/2022/868/oj/eng
OPEN DATA DIRECTIVE https://eur-lex.europa.eu/eli/dir/2019/1024/oj/eng
EUROPEAN HEALTH DATA SPACE https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:52022PC0197
EDPB GUIDANCE ON PSEUDONYMIZATION https://www.edpb.europa.eu/our-work-tools/documents/public-consultations/2025/guidelines-012025-pseudonymisation_en
EDPB GUIDANCE ON AI https://www.edpb.europa.eu/system/files/2024-12/edpb_opinion_202428_ai-models_en.pdf
WP ARTICLE 29 OPINION ON ANONYMIZATION TECHNIQUES https://ec.europa.eu/justice/article-29/documentation/opinion-recommendation/files/2014/wp216_en.pdf
ITALY
DISEGNO DI LEGGE – ARTIFICIAL INTELLIGENCE ACT https://www.fiscoetasse.com/files/18248/ddl-intelligenza-artificiale-post-precdm-23-04-2024.pdf?_gl=1*rhjrvz*_up*MQ..*_ga*MTM3MjIyMjk2MS4xNzQwNTg2NzA3*_ga_EE64P4Z01K*MTc0MDU4NjcwNy4xLjAuMTc0MDU4NjcwNy4wLjAuMA..*_ga_9HD1K76044*MTc0MDU4NjcwNy4xLjAuMTc0MDU4NjcwNy4wLjAuMA..
RISORSE DEL GARANTE SU SANItA’ E RICERCA SCIENTIFICA https://www.garanteprivacy.it/temi/sanita-e-ricerca-scientifica
FAQ GARANTE IRCSS https://www.garanteprivacy.it/temi/sanita-e-ricerca-scientifica/irccs
LINEE GUIDA GARANTE SU DOSSIER SANITARIO https://www.garanteprivacy.it/web/guest/home/docweb/-/docweb-display/docweb/4084632
LINEE GUIDA GARANTE SU SITI WEB SALUTE https://www.garanteprivacy.it/web/guest/home/docweb/-/docweb-display/docweb/1870212
LINEE GUIDA GARANTE SU COSTUMER SATISFACTION IN AMBITO SALUTE https://www.garanteprivacy.it/web/guest/home/docweb/-/docweb-display/docweb/3853781
LINEE GUIDA GARANTE REFERTI ONLINE https://www.garanteprivacy.it/web/guest/home/docweb/-/docweb-display/docweb/1679033
LINEE GUIDA GARANTE FASCICOLO SANITARIO ELETTRONICO https://www.garanteprivacy.it/web/guest/home/docweb/-/docweb-display/docweb/1634116
LINEE GUIDA GARANTE CLINICAL TRIALS https://www.garanteprivacy.it/web/guest/home/docweb/-/docweb-display/docweb/1533155
GARANTE GUIDANCE ON TELEMEDICINE: https://www.garanteprivacy.it/web/guest/home/docweb/-/docweb-display/docweb/9997624
DECRETO LEGISLATIVO 10 agosto 2018, n. 101 https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2018;101~art20-com4
DECRETO 8 novembre 2021, n. 200 https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2021-11-08;200
CODICE PRIVACY https://www.normattiva.it/uri-res/N2Ls?urn:nir:stato:decreto.legislativo:2003-06-30;196!vig=
THE NETHERLANDS
GOVERNMENT GUIDANCE ON HELATH DATA https://www.government.nl/topics/patients-rights-and-privacy/accessing-updating-or-deleting-medical-records
HEALTHCARE ACT https://wetten.overheid.nl/BWBR0023864/2023-07-01/#Hoofdstuk3a_Artikel15d
CIVIL CODE PROVISIONS https://wetten.overheid.nl/BWBR0005290/2016-04-01
MEDICAL TREATMENT AGREEMENT ACT https://wetten.overheid.nl/BWBR0007021/2006-02-01
GDPR IMPLEMENTATION ACT https://wetten.overheid.nl/BWBR0040940/2021-07-01
SPAIN
SPANISH DPA GUIDANCE ON ANONYMIZATION https://www.aepd.es/sites/default/files/2019-09/guia-orientaciones-procedimientos-anonimizacion.pdf
LAW ON PATIENT AUTONOMY https://www.aepd.es/sites/default/files/2019-09/guia-orientaciones-procedimientos-anonimizacion.pdf
SPANISH DATA PROTECTION ACT https://www.boe.es/buscar/act.php?id=BOE-A-2018-16673
SPANISH DIGITAL RIGHT CHARTER https://espanadigital.gob.es/lineas-de-actuacion/carta-de-derechos-digitales
GUIDELINES FOR PATIENTS https://www.aepd.es/guias/guia-pacientes-usuarios-sanidad.pdf