Activities of Joanna KOPCIŃSKA related to 2022/0140(COD)
Plenary speeches (1)
European Health Data Space (debate)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the European Health Data Space
Amendments (20)
Amendment 753 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – introductory part
Article 5 – paragraph 1 – subparagraph 1 – introductory part
Where data is processregistered in electronic format, Member States shall implement access to and exchange of personal electronic health data for primary use fully or partially falling under the following categories:
Amendment 769 #
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 3
Article 5 – paragraph 1 – subparagraph 3
Amendment 819 #
Proposal for a regulation
Article 8
Article 8
Amendment 927 #
Proposal for a regulation
Article 12 – paragraph 7
Article 12 – paragraph 7
7. The national contact points for digital health shall act as joint controllers of the electronic health data communicated through ‘MyHealth@EU’ for the processing operations in which they are involved. The Commission shall act as processor, with the limitation to the central platform MyHealth@EU to provide services supporting and facilitating the electronic exchange of health data between national digital health contact points.
Amendment 933 #
Proposal for a regulation
Article 12 – paragraph 9
Article 12 – paragraph 9
9. The approval for individual authorised participants to join MyHealth@EU for different services, or to disconnect a participant shall be issued by the Joint Controllership groupEHDS board, based on the results of the compliance checks performed by the Commission .
Amendment 952 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter and following the transitional periods laid down in Article 72.
Amendment 1164 #
Proposal for a regulation
Article 33 – paragraph 1 – point e
Article 33 – paragraph 1 – point e
Amendment 1201 #
Proposal for a regulation
Article 33 – paragraph 1 – point n
Article 33 – paragraph 1 – point n
Amendment 1215 #
Proposal for a regulation
Article 33 – paragraph 1 a (new)
Article 33 – paragraph 1 a (new)
1 a. This Regulation shall not apply to activities concerning public security, defence and national security.
Amendment 1420 #
Proposal for a regulation
Article 35 – paragraph 1 a (new)
Article 35 – paragraph 1 a (new)
This Regulation shall not apply to activities concerning public security, defence and national security.
Amendment 1637 #
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
2. Where the data in question are not held by the health data access body or a public sector body, the fees may also include compensation for part of the costs for collecting the electronic health data specifically under this Regulation in addition to the fees that may be charged pursuant to paragraph 1. The part of the fees linked to the health data holder’s costs shall be paid to the health data holder and shall also reflect market value of the data in question.
Amendment 1684 #
Proposal for a regulation
Article 43 – paragraph 10
Article 43 – paragraph 10
10. The Commission may, without undue delay, shall issues guidelines on penalties to be applied by the health data access bodies.
Amendment 1695 #
Proposal for a regulation
Article 44 – paragraph 1 a (new)
Article 44 – paragraph 1 a (new)
1 a. Data anonymisation shall be carried out as much as possible by health data holders, following a common methodology, ensuring that the process is reduced at the level of health data access bodies.
Amendment 1696 #
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
Amendment 1965 #
Proposal for a regulation
Article 52 – paragraph 14
Article 52 – paragraph 14
14. The approval for individual authorised participant to join HealthData@EU orSubject to a positive outcome of this compliance check, the Commission shall, by means of implementing acts, take decisions to disconnect a participant from the infrastructure shall be issued by the Joint Controllership group, based on the results of the compliance checksindividual authorised participants to join the respective infrastructure or to disconnect them. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68.
Amendment 2112 #
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
It shall apply from 124 months after its entry into force.
Amendment 2116 #
Proposal for a regulation
Article 72 – paragraph 3 – point a
Article 72 – paragraph 3 – point a
(a) from 13 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process such categories of data.;
Amendment 2118 #
Proposal for a regulation
Article 72 – paragraph 3 – point b
Article 72 – paragraph 3 – point b
(b) from 35 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;
Amendment 2123 #
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from 35 years after date of entry into application.
Amendment 2124 #
Proposal for a regulation
Article 72 – paragraph 4 a (new)
Article 72 – paragraph 4 a (new)
Chapter IV shall apply 4 years after the date of entry into force of this Regulation.