5 Amendments of Christel SCHALDEMOSE related to 2022/0140(COD)
Amendment 558 #
Proposal for a regulation
Article 2 – paragraph 2 – point n
Article 2 – paragraph 2 – point n
(n) ‘EHR system’ (electronic health record system) means any appliance or software intended by the manufacturhealthcare provider to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records;
Amendment 749 #
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 electronicose health data without prior authorisation by the natural person, including where t. The provider or professional is informed of the existence and nature of the restricted electronic health datashall however be able to see that there is health data to which access has been restricted. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, or an obvious public interest, the healthcare provider or health professional may getobtain 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 825 #
Proposal for a regulation
Article 8 – paragraph 1
Article 8 – paragraph 1
Amendment 1716 #
Proposal for a regulation
Article 44 – paragraph 3 – point 1 (new)
Article 44 – paragraph 3 – point 1 (new)
(1) 4. The health data access body may, where necessary, provide personally identifiable electronic health data in accordance with Regulation (EU) 2016/679 and national law.
Amendment 1844 #
Proposal for a regulation
Article 46 – paragraph 9
Article 46 – paragraph 9
9. A data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 510 years. This duration may be extended once, for no more than 2 years at the request of the data user, based on arguments and documents to justify this extension provided, 1 month before the expiry of the data permit, for a period which cannot exceed 5 years. By way of derogation from Article 42, the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 510 years. In order to reduce such costs and fees, the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. The data within the secure processing environment shall be deleted within 6 months following the expiry of the data permit. Upon request of the data user, the formula on the creation of the requested dataset shall be stored by the health data access body.