Article 32i
Amendments as tabled
Five amendments, each tabled separately · IMCO amendments 125–328 to the draft opinion
296 ~Alternative Sophia KircherEPP · IMCO “including clinical research data generated through publicly funded research programmes, clinical trials, registries and other scientific research…”
(c) research data pursuant to the conditions set out in Article 32t, including clinical research data generated through publicly funded research programmes, clinical trials, registries and other scientific research activities.
- Tabled by
- Sophia Kircher
- Group
- EPP
- Targets
- Data Act Article 32i(1)(c)
- Document
- IMCO amendments 125–328 to the draft opinion
- Source
- Official text, page 139
- Printed header
- Article 1 – paragraph 1 – point 18 / Regulation (EU) 2023/2854 / Article 32i – paragraph 1 c
297 +Addition Virginie JoronPfE · IMCO “Public sector bodies permitting the re-use of data and documents under this Chapter shall apply appropriate technical and organisational measures to…” numbered 1a
1a.Public sector bodies permitting the re-use of data and documents under this Chapter shall apply appropriate technical and organisational measures to prevent the re-identification of pseudonymised data, personal data breaches, and any unlawful acquisition, use, disclosure or transfer of the data. Where the data are made available in pseudonymised or anonymised form, state-of-the-art techniques aimed at preserving and reinforcing privacy protection shall be applied for that purpose. Data and documents relating to natural persons, or protected as trade secrets or through a legal obligation of confidentiality applicable to legal persons shall only be made available for re-use purposes when they have been anonymised or, where anonymisation is not possible, subject to appropriate safeguards, including such techniques and binding conditions imposed on the re-user preventing any re-identification or any misuse.
- Tabled by
- Virginie Joron
- Group
- PfE
- Targets
- Data Act Article 32i
- Document
- IMCO amendments 125–328 to the draft opinion
- Printed header
- Article 1 – paragraph 1 – point 18 / Regulation (EU) 2023/2854 / Article 32 i
298 +Addition Virginie JoronPfE · IMCO “A public sector body having allowed the re-use of data and documents in accordance with this Chapter and having applied the measures referred to in…” numbered 1b
1b.A public sector body having allowed the re-use of data and documents in accordance with this Chapter and having applied the measures referred to in paragraph 11 shall not be held liable for any unlawful use, re-identification, disclosure or onward transfer of data carried out by the re-user or by any third party to which the re-user has made the data available. The re-user shall ensure that its re-use of data, and any onward transfer of data, complies with this Chapter and Union and national law, including Regulation (EU) 2016/679. The re-user shall be responsible for any misuse, any unlawful re-identification or any unauthorised transfer of data carried out by it or by such third parties. This paragraph shall be without prejudice to the liability of the public sector body in the event of breach of its obligations under this Chapter.
- Tabled by
- Virginie Joron
- Group
- PfE
- Targets
- Data Act Article 32i
- Document
- IMCO amendments 125–328 to the draft opinion
- Printed header
- Article 1 – paragraph 1 – point 18 / Regulation (EU) 2023/2854 / Article 32 i
299 +Addition Virginie JoronPfE · IMCO “data or documents whose disclosure would reveal trade secrets within the meaning of Directive (EU) 2016/943, or information otherwise protected by a…”
(aa)data or documents whose disclosure would reveal trade secrets within the meaning of Directive (EU) 2016/943, or information otherwise protected by a legal obligation of confidentiality applicable to legal persons.
- Tabled by
- Virginie Joron
- Group
- PfE
- Targets
- Data Act Article 32i
- Document
- IMCO amendments 125–328 to the draft opinion
- Source
- Official text, page 141
- Printed header
- Article 1 – paragraph 1 – point 18 / Regulation (EU) 2023/2854 / Article 32 i
300 +Addition Virginie JoronPfE · IMCO “data or documents containing personal data relating to the health, fiscal or financial situation, domicile or civil status of natural persons, and…”
(ga)data or documents containing personal data relating to the health, fiscal or financial situation, domicile or civil status of natural persons, and personal data covered by a legal or professional obligation of confidentiality, in particular medical confidentiality or the confidentiality of court judgments, whose re-use may be detrimental to the rights and freedoms of the data subjects or may enable them to be identified.
- Tabled by
- Virginie Joron
- Group
- PfE
- Targets
- Data Act Article 32i(3)
- Document
- IMCO amendments 125–328 to the draft opinion
- Printed header
- Article 1 – paragraph 1 – point 18 / Regulation (EU) 2023/2854 / Article 32 i – paragraph 3