10 Amendments of Jessica POLFJÄRD related to 2022/0140(COD)
Amendment 577 #
Proposal for a regulation
Article 2 – paragraph 2 – point y
Article 2 – paragraph 2 – point y
(y) ‘data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, with the exception of personal data processors as defined in Article 28 of Regulation (EU) 2016/679, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data;
Amendment 1130 #
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. Data holders shall make the following categories of electronic data available, taking into account the differences in administrative, logistical and resource requirements for each category in the member states, for secondary use in accordance with the provisions of this Chapter:
Amendment 1239 #
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall only be made available for secondary use. Where such data is made available for secondary use, when all measures necessary to preserve the confidentiality of IP rights and trade secrets shallve been taken.
Amendment 1360 #
Proposal for a regulation
Article 34 – paragraph 4
Article 34 – paragraph 4
4. Public sector bodies or Union institutions, agencies and bodies that obtain access to electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, shallmust take all specific measures necessary to preserve the confidentiality of such data.
Amendment 1487 #
Proposal for a regulation
Article 37 – paragraph 1 – point i
Article 37 – paragraph 1 – point i
(i) provide with expertise to support 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 1613 #
Proposal for a regulation
Article 41 – paragraph 1
Article 41 – paragraph 1
1. Where a 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, where relevant, cooperate in good faith with the health data access bodies, w and othere relevant actors involved.
Amendment 1626 #
Proposal for a regulation
Article 41 – paragraph 4
Article 41 – paragraph 4
4. The data holder shall put the electronic health data referred to in paragraph 1 at the disposal of the health data access body within 23 months from receiving the request from the health data access body, taking into account the different technical features between the categories referred to in Article 33(1) and how those can affect the timeframe for the delivery of the data. In exceptional cases, that period may be extended by the health data access body for an additional period of 23 months.
Amendment 1872 #
Proposal for a regulation
Article 47 – paragraph 3
Article 47 – paragraph 3
3. Where an applicant has requested a result in an anonymised form, including statistical format, based on a data request, the health data access body shall assess, within 23 months and, where possible, provide the result to the health data user within 23 months.
Amendment 1898 #
Proposal for a regulation
Article 49 – paragraph 4
Article 49 – paragraph 4
4. Within 3 months the data holder shallThe single data holder, referred to in paragraph 1, shall in due time inform the relevant health data access body by electronic means of all data access applications filed and all the data permits issued and the data requests fulfilled under this Article in order to enable the health data access body to fulfil its obligations under Article 37(1) and Article 39.
Amendment 1926 #
Proposal for a regulation
Article 52 – paragraph 1
Article 52 – paragraph 1
1. Each Member State shall designate a national contact point for secondary use of electronic health data, responsible for making electronic health data available for secondary use in a cross-border context and shall communicate their. The national contact point shall work as an organisational and technical gateway, enabling and being responsible for making electronic health data available for secondary use in a cross-border context. When constructing a national contact point, it shall be in close consultation with the holders and users of data for the specific Member State. Every Member State shall inform the Commission of the names and contact details to the Commissof their respective 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.