Activities of Beata KEMPA 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 (33)
Amendment 335 #
Proposal for a regulation
Recital 39
Recital 39
(39) The categories of electronic health data that, with the patient’s exclusive consent, can be processed for secondary use, should be broad and flexible enough to accommodate the evolving needs of data users, while remaining limited to data that are related to health or known to influence health. It can also include relevant data from the health system (electronic health records, claims data, disease registries, genomic data etc.), as well as data with an impact on health (for example consumption of different substances, homelessness, health insurance, minimum income, professional status, behaviour, including environmental factors (for example, pollution, radiation, use of certain chemical substances). They can also include person-generated data, such as data from medical devices, wellness applications or other wearables and digital health applicationshave a direct, known impact on health. The data user who benefits from access to datasets provided under this Regulation could enrich the data with various corrections, annotations and other improvements, for instance by supplementing missing or incomplete data, thus improving the accuracy, completeness or quality of data in the dataset. To support the improvement of the original database and further use of the enriched dataset, the dataset with such improvements and a description of the changes should be made available free of charge to the original data holder. The data holder should make available the new dataset, unless it provides a justified notification against it to the health data access body, for instance in cases of low quality of the enrichment. Secondary use of non-personal electronic data should also be ensured. In particular, pathogen genomic data hold significant value for human health, as proven during the COVID-19 pandemic. Timely access to and sharing of such data has proven to be essential for the rapid development of detection tools, medical countermeasures and responses to public health threats. The greatest benefit from pathogen genomics effort will be achieved when public health and research processes share datasets and work mutually to inform and improve each other.
Amendment 530 #
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
(e) ‘secondary use of electronic health data’ means the processing of electronic health data for purposes set out in Chapter IV of this Regulation. The data used may include personal electronic health data initially collected in the context of primary use, exclusively where the patient has given prior consent for such use, but also electronic health data collected for the purpose of the secondary use;
Amendment 560 #
Proposal for a regulation
Article 2 – paragraph 2 – point o
Article 2 – paragraph 2 – point o
Amendment 588 #
Proposal for a regulation
Article 2 – paragraph 2 – point aa
Article 2 – paragraph 2 – point aa
(aa) ‘data permit’ means an administrative decision issued to a data user by a health data access body or data holder to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this Regulation; this permit applies only to data for the publication of which the patient has given prior consent;
Amendment 752 #
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 754 #
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 818 #
Proposal for a regulation
Article 8
Article 8
Amendment 822 #
Proposal for a regulation
Article 8
Article 8
Amendment 931 #
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 checksapacity checks carried out by the Commission.
Amendment 932 #
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 1137 #
Proposal for a regulation
Article 33 – paragraph 1 – point a
Article 33 – paragraph 1 – point a
Amendment 1144 #
Proposal for a regulation
Article 33 – paragraph 1 – point a
Article 33 – paragraph 1 – point a
(a) non-personal EHRs;
Amendment 1153 #
Proposal for a regulation
Article 33 – paragraph 1 – point c
Article 33 – paragraph 1 – point c
(c) relevant pathogen genomic data, impacting on human health;
Amendment 1154 #
Proposal for a regulation
Article 33 – paragraph 1 – point d
Article 33 – paragraph 1 – point d
Amendment 1159 #
Proposal for a regulation
Article 33 – paragraph 1 – point e
Article 33 – paragraph 1 – point e
Amendment 1163 #
Proposal for a regulation
Article 33 – paragraph 1 – point e
Article 33 – paragraph 1 – point e
Amendment 1171 #
Proposal for a regulation
Article 33 – paragraph 1 – point f
Article 33 – paragraph 1 – point f
(f) person -generated electronic health data, including medical devices, wellness applications or other digital health applications;
Amendment 1199 #
Proposal for a regulation
Article 33 – paragraph 1 – point n
Article 33 – paragraph 1 – point n
Amendment 1204 #
Proposal for a regulation
Article 33 – paragraph 1 – point n
Article 33 – paragraph 1 – point n
Amendment 1298 #
Proposal for a regulation
Article 34 – paragraph 1 – point b
Article 34 – paragraph 1 – point b
(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandatesin the health or care sector;
Amendment 1328 #
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
(f) development and innovation activities for products or services contributing to public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;
Amendment 1330 #
Proposal for a regulation
Article 34 – paragraph 1 – point g
Article 34 – paragraph 1 – point g
Amendment 1343 #
Proposal for a regulation
Article 34 – paragraph 1 – point h
Article 34 – paragraph 1 – point h
Amendment 1421 #
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 1483 #
Proposal for a regulation
Article 37 – paragraph 1 – point i
Article 37 – paragraph 1 – point i
Amendment 1639 #
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 data holder and shall correspond to the fees’ market value.
Amendment 1640 #
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 1681 #
Proposal for a regulation
Article 43 – paragraph 8
Article 43 – paragraph 8
8. The Commission may, by means of implementing act, set out the architecture of an IT tool aimed to support and make transparent to other health data access bodies the activities referred to in this Article, especially penalties and exclusions. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). Accordingly, the Commission should provide guidance on the penalty calculation system.
Amendment 1966 #
Proposal for a regulation
Article 52 – paragraph 14
Article 52 – paragraph 14
14. The approval for individual authorised participants to join MyHealthData@EU@EU for different services, or to disconnect a participant from the infrastructure shall be issued by the Joint Controllership groupshall be issued by the EHDS board, based on the results of the compliance checks performed by the Commission.
Amendment 2111 #
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
It shall apply from 124 months after its entry into force.
Amendment 2114 #
Proposal for a regulation
Article 72 – paragraph 2
Article 72 – paragraph 2
It shall apply from 124 months after its entry into force.
Amendment 2119 #
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 2121 #
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;