11 Amendments of Peter LIESE related to 2022/0140(COD)
Amendment 364 #
Proposal for a regulation
Recital 41 a (new)
Recital 41 a (new)
(41 a) Cross-border research collaborations are of great importance across medical research fields, including for research into childhood cancer and rare diseases. As such, the use of electronic health data for secondary purposes through the European Health Data Space should empower the development of collaborative research by supporting the use of data between two or more teams within the same Member State or cross-border.
Amendment 623 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Natural persons shall have the right to receive an electronic copy, in the European electronic health record exchange format referred to in Article 6, of at least their electronic health data in the priority categories referred to in Article 5. Member States shall provide manufacturers with uniform templates to ensure conformity with the referred Articles.
Amendment 684 #
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms, including the terms of medical liability. It shall be clearly indicated in the EHR when access to information has been restricted by a natural person or by his or her representative.
Amendment 738 #
Proposal for a regulation
Article 4 – paragraph 3 a (new)
Article 4 – paragraph 3 a (new)
3 a. Member States shall establish policies aimed at providing health professionals with the digital skills, competences, infrastructures and tools required to fulfill the obligations set out in paragraph 1 of this Article.
Amendment 745 #
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Where access to electronic health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person, including where the provider or professional is informed of the existence and nature of t. It shall be clearly indicated in the EHR when access to information has been restricted by a natural person or by his or her restricted electronic health datapresentative. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.
Amendment 1038 #
Proposal for a regulation
Article 24 – paragraph 2 a (new)
Article 24 – paragraph 2 a (new)
2 a. To ensure conformity, templates for technical documentation are provided by the market surveillance authority of a Member State.
Amendment 1242 #
Proposal for a regulation
Article 33 – paragraph 4 a (new)
Article 33 – paragraph 4 a (new)
4 a. Given its ability to further decode confidential patient information, constitutional (germline) genomic data must be strongly protected, and it should be processed separately from somatic molecular data.
Amendment 1362 #
Proposal for a regulation
Article 34 – paragraph 4 a (new)
Article 34 – paragraph 4 a (new)
4 a. Neither the use nor registration of electronic health data for secondary purposes in the European Health Data Space shall hinder the development of research programmes by curtailing the use of shared data between two or more teams within the same country or across several countries.
Amendment 1648 #
Proposal for a regulation
Article 42 – paragraph 4
Article 42 – paragraph 4
4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update tat dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, academic and educational institutions, non-commercial entities and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.
Amendment 1652 #
Proposal for a regulation
Article 42 – paragraph 5
Article 42 – paragraph 5
5. Where data holders and data users do not agree on the level of the fees within 1 month of the data permit being granted, the health data access body may set the fees in proportion to the cost of making available electronic health data for secondary use. Where the data users are non-commercial entities, their size and financial resources shall be taken into account when the fees are set. Where the data holder or the data user disagree with the fee set out by the health data access body, they shall have access to dispute settlement bodies set out in accordance with Article 10 of the Regulation […] [Data Act COM/2022/68 final].
Amendment 1782 #
Proposal for a regulation
Article 45 – paragraph 6
Article 45 – paragraph 6