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Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance) article 76 CELEX: 02024R1938-20240717 3. Personal data, including data concerning health, required for the application of Articles 33, 34, 39, 42 and 44, Article 53(1), points (e) and (f), Article 53(3), and Article 58(13), (14) and (15), shall only be processed for the purpose of ensuring quality and safety of SoHO and protecting the concerned SoHO donors, SoHO recipients and offspring from medically assisted reproduction. Those data shall be directly related to the performance of the supervisory activities and SoHO activities concerned and be limited to the extent necessary and proportionate for that purpose. 4. All information shall be processed by the Commission, Member States, SoHO competent authorities, including SoHO national authorities, delegated bodies, SoHO entities and any third party contracted by a SoHO entity, as applicable, in such a way that the personal data of the subjects remain protected in accordance with the applicable legislation on personal data protection. They shall, in particular, minimise the risk that subjects can be identified and shall limit the information processed to elements necessary and appropriate for carrying out their tasks and fulfilling their obligations under this Regulation. |
Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance) article 76 CELEX: 02024R1938-20240717 5. The Commission, Member States, SoHO competent authorities, including SoHO national authorities, delegated bodies, SoHO entities and any third party contracted by a SoHO entity, shall implement appropriate technical and organisational measures to protect information and personal data processed, including health data, against unauthorised or unlawful access, disclosure, dissemination, alteration, destruction or accidental loss, in particular where the processing involves transmission over a network. 6. In relation to their responsibilities to process personal data to comply with the obligations of this Regulation, SoHO entities and SoHO competent authorities of the Member States shall be regarded as controllers as defined in Article 4, point (7), of Regulation (EU) 2016/679. 7. In relation to its responsibility to establish and manage the EU SoHO Platform, as referred to in Article 73 of this Regulation and the processing of personal data, including health data, that might result from that activity, the Commission shall be regarded as a controller as defined in Article 3, point (8), of Regulation (EU) 2018/1725. |
Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance) article 76 CELEX: 02024R1938-20240717 8. For the purposes of this Article, the Commission is empowered to adopt delegated acts in accordance with Article 77 to supplement this Regulation by laying down the retention periods for personal data, including health data, as appropriate to their purpose and specific criteria that would allow identification of data relevant for public health protection as referred to in paragraph 2 of this Article. |
Regulation (EU) 2024/1938 of the European Parliament and of the Council of 13 June 2024 on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC (Text with EEA relevance) article 76 CELEX: 02024R1938-20240717 Data protection
1. Personal data required for the application of Article 5(5), Article 9(4), Articles 33 and 34, Article 35(3), points (a) and (b), Article 36(3), Article 39(2), point (a), Article 46(2), Article 64 and Article 68(3) shall be collected for the purpose of identifying the relevant contact persons within the relevant SoHO entities, SoHO competent authorities or delegated bodies, and shall only be processed further for the purpose of ensuring the administration and transparency of the SoHO supervisory activities and SoHO activities concerned. 2. Personal data, including data concerning health, exchanged through the EU SoHO Platform and required for the application of Articles 73 and 74 shall, where necessary, be processed in the interest of public health and for the following purposes: (a) to help to identify and evaluate risks associated with a particular SoHO donation or SoHO donor; (b) to process relevant information on clinical-outcome monitoring. |