4 Amendments of Esther DE LANGE related to 2022/0140(COD)
Amendment 696 #
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. Natural persons shall have the right to obtainreceive an automatic notification with information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare, and on the substance of the accessed data. The information shall be provided immediately and free of charge through electronic health data access services.
Amendment 1701 #
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
2. The health data access bodies shall always provide the electronic health data in an anonymised format, where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user.
Amendment 1713 #
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
3. WOnly in the exceptional cases where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re- identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.
Amendment 1722 #
Proposal for a regulation
Article 44 – paragraph 3 a (new)
Article 44 – paragraph 3 a (new)
3 a. The anonymisation or pseudonymisation required for sharing data sets for secondary use shall be subject to minimum quality requirements, to ensure its robustness and avoid data to be exposed for abusive purposes.