6 Amendments of Arba KOKALARI related to 2022/0140(COD)
Amendment 174 #
Proposal for a regulation
Article 37 – paragraph 1 – point i
Article 37 – paragraph 1 – point i
(i) supportthe data access bodies shall support with expertise the development of AI systems, the training, testing and validating of AI systems and the development of harmonised standards and guidelines under Regulation […] [AI Act COM/2021/206 final] for the training, testing and validation of AI systems in health;.
Amendment 176 #
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Where aA data holder is obliged to make electronic health data available under Article 33 or under other Union law or national legislation implementing Union law, it shall cooperate in good faitha methodical and supervised process with the health data access bodies, where relevant and other involved actors.
Amendment 178 #
Proposal for a regulation
Article 42 – paragraph 1
Article 42 – paragraph 1
1. Health data access bodies and single data holders may charge fees for making electronic health data available for secondary use. Any fees shall include and be derived frombe proportionate in relation to the costs related to conducting the procedure for requests, including for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, in accordance with Article 6 of Regulation […] [Data Governance Act COM/2020/767 final]
Amendment 186 #
Proposal for a regulation
Article 46 – paragraph 11
Article 46 – paragraph 11
11. DHealth data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later if possible, withain 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The health data users shall inform the health data access bodies from which a data permit was obtained and support them to make the informationresults or output provided by the health data users public on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.
Amendment 188 #
Proposal for a regulation
Article 52 – paragraph 1
Article 52 – paragraph 1
1. Each Member State shallmay designate a national contact point for secondary use of electronic health data,. The national contact point shall be an organisational and technical gateway, enabling and responsible for making electronic health data available for secondary use in a cross- border context and shall communicate their names and contact details to the Commiss. The national contact point shall be constructed in close consultation with the data holders and data users of that specific Member State. Each Member State shall notify the Commission the name and contact details of the national contact point by the date of application of this Regulation. The national contact point may be the coordinator health data access body pursuant to Article 36. The Commission and the Member States shall make this information publicly available.
Amendment 190 #
Proposal for a regulation
Article 63 – paragraph 1
Article 63 – paragraph 1
In the context of international access and transfer of personal electronic health data, Member States may maintain or introduce further conditions, including limitations, in accordance with and under the conditions of article 9(4) of the Regulation (EU) 2016/679. Such limitations shall not entail storage requirements for health data that can be lawfully transferred to third countries in accordance with the requirements under Regulation […] [Data Governance Act COM/2020/767 final] and Chapter V of Regulation (EU) 2016/679 or stricter conditions under national law.