Report on the proposal for a regulation of the European Parliament and of the Council on the European Health Data Space

Amendement n°70 (europe)

Données personnelles

Santé

Institutions publiques

Déposé le Dimanche 14 avril 2024 à 22h00

Déposé par : M. Bernd LANGE, M. Udo BULLMANN, Mme Lara WOLTERS, Mme Kathleen VAN BREMPT, Mme Margrete AUKEN, Mme Sophia IN 'T VELD, M. Georg MAYER, Mme Anna CAVAZZINI, Mme Catherine GRISET, M. Pascal CANFIN, M. Bas EICKHOUT, Mme Ska KELLER, M. François ALFONSI, M. Juan Fernando LÓPEZ AGUILAR, Mme Marisa MATIAS, M. Jens GEIER, Mme Petra KAMMEREVERT, Mme Cornelia ERNST, Mme Karima DELLI, Mme Birgit SIPPEL, Mme Sylvie GUILLAUME, Mme Marie TOUSSAINT, M. Daniel FREUND, M. Gilles LEBRETON, M. Jean-François JALKH, Mme Dominique BILDE, M. Martin SONNEBORN, Mme Rosa D'AMATO, Mme Maria NOICHL, M. Joachim SCHUSTER, M. Gerolf ANNEMANS, M. Harald VILIMSKY, M. Paul TANG, Mme Agnes JONGERIUS, Mme Clara AGUILERA, M. Markus BUCHHEIT, M. Jordan BARDELLA, M. Gunnar BECK, Mme Annika BRUNA, M. Jakop G. DALUNDE, Mme Alexandra GEESE, M. Tiemo WÖLKEN, M. Tom VANDENDRIESSCHE, Mme France JAMET, M. Thomas WAITZ, Mme Tilly METZ, Mme Alice KUHNKE, M. Pär HOLMGREN, M. Patrick BREYER, Mme Katarina BARLEY, Mme Gabriele BISCHOFF, M. Damian BOESELAGER, Mme Delara BURKHARDT, M. Rasmus ANDRESEN, M. Sergey LAGODINSKY, M. Erik MARQUARDT, Mme Jutta PAULUS, Mme Saskia BRICMONT, M. Filip DE MAN, M. Nicolaus FEST, M. Maximilian KRAH, M. Joachim KUHS, Mme Sylvia LIMMER, M. Guido REIL, M. Bernhard ZIMNIOK, Mme Marina KALJURAND, M. Mounir SATOURI, M. David CORMAND, Mme Caroline ROOSE, M. Jarosław DUDA-LATOSZEWSKI, M. Benoît BITEAU, Mme Beata KEMPA, Mme Gwendoline DELBOS-CORFIELD, M. Mikuláš PEKSA, M. Marcel KOLAJA, Mme Markéta GREGOROVÁ, M. Ivan DAVID, Mme Karen MELCHIOR, M. Damien CARÊME, M. Thierry MARIANI, Mme Virginie JORON, M. Jean-Paul GARRAUD, M. Francisco GUERREIRO, M. Cristian TERHEŞ, Mme Sarah WIENER, Mme Aurélia BEIGNEUX, M. Philippe OLIVIER, M. André ROUGÉ, Mme Mathilde ANDROUËT, M. Pierre LARROUTUROU, M. Konstantinos ARVANITIS, M. Robert ROOS, Mme Clare DALY, Mme Vera TAX, M. Eugen JURZYCA, Mme Tineke STRIK, M. Rob ROOKEN, M. Mohammed CHAHIM, Mme Francesca DONATO, M. Jorge BUXADÉ VILLALBA, M. Hermann TERTSCH, Mme Kim VAN SPARRENTAK, M. Ivan Vilibor SINČIĆ, Mme Mazaly AGUILAR, M. Roman HAIDER, M. Emmanouil FRAGKOS, Mme Alviina ALAMETSÄ, Mme Margarita DE LA PISA CARRIÓN, M. Claude GRUFFAT, M. Jean-Lin LACAPELLE, Mme Manuela RIPA, Mme Sara MATTHIEU, M. Cyrus ENGERER, M. Karsten LUCKE, M. Malte GALLÉE, M. Matjaž NEMEC, Mme Marie DAUCHY, M. Eric MINARDI, Mme Patricia CHAGNON, M. Matthias ECKE, Mme Theresa BIELOWSKI, M. Thomas RUDNER, Mme Lydie MASSARD,

Recital 66 c (new)

Version initale

Amendement

(66c) Any natural or legal person has the right to bring an action for annulment of decisions of the EHDS Board before the Court of Justice under the conditions provided for in Article 263 TFEU. As addressees of such decisions, the digital health authorities or health data access bodies concerned which wish to challenge them have to bring an action within two months of being notified of them, in accordance with Article 263 TFEU. In accordance with Article 263 TFEU, a health data holder, a health data applicant, a health data user or a complainant can bring an action for annulment against the decisions of the EHDS Board which concern them within two months of their publication on the website of the EHDS Board. Without prejudice to this right under Article 263 TFEU, each natural or legal person should have an effective judicial remedy before the competent national court against a decision of a digital health authority or health data access body which produces legal effects concerning that person. Such a decision concerns in PE756.668/ 68 particular the exercise of investigative, corrective and authorisation powers by the health data access body or the dismissal or rejection of complaints. However, the right to an effective judicial remedy does not encompass measures taken by digital health authorities and health data access bodies which are not legally binding, such as opinions issued or advice provided. Proceedings against a digital health authority or health data access body should be brought before the courts of the Member State where the digital health authority or health data access body is established and should be conducted in accordance with that Member State's procedural law. Those courts should exercise full jurisdiction, which should include jurisdiction to examine all questions of fact and law relevant to the dispute before them. Where a complaint has been rejected or dismissed by a digital health authority or health data access body, the complainant can bring proceedings before the courts in the same Member State.

Report on the proposal for a regulation of the European Parliament and of the Council on the European Health Data Space

Amendement n°70 (europe)

Recital 66 c (new)

Version initale

Amendement

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