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24 Amendments of Balázs HIDVÉGHI related to 2022/0140(COD)

Amendment 942 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 13 – paragraph 3 – subparagraph 1 a (new)
In addition to the compliance check, the national security interests of the Member States shall be also taken into account before adopting the implementing act.
2023/03/30
Committee: ENVILIBE
Amendment 1631 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
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 from 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]
2023/03/30
Committee: ENVILIBE
Amendment 1641 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 42 – paragraph 2
2. Where the data in question are not held by the data access body or a public sector body, the fees may also include compensation for part of the costs for collecting the electronic health data specifically under this Regulation in addition to the fees that may be charged pursuant to paragraph 1. The part of the fees linked to the data holder’s costs shall be paid to the data holder.
2023/03/30
Committee: ENVILIBE
Amendment 1642 #
Edina TÓTH, Balázs HIDVÉGHI
3. The electronic health data referred to in Article 33(1), point (o), shall be made available to a new user free of charge or against a fee matching the compensation for the costs of the human and technical resources used to enrich the electronic health data. That fee shall be paid to the entity that enriched the electronic health data.deleted
2023/03/30
Committee: ENVILIBE
Amendment 1645 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
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 costworkload 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, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.
2023/03/30
Committee: ENVILIBE
Amendment 1651 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
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 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].deleted
2023/03/30
Committee: ENVILIBE
Amendment 1655 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 42 – paragraph 6
6. The Commission may, by means of implementing acts, lay down principles and rules for the fee policies and fee structures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).deleted
2023/03/30
Committee: ENVILIBE
Amendment 1726 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 45 – paragraph 1
1. Any natural or legal personUnion citizens and third-country nationals legally residing in the EU or legal person established in the EU may submit a data access application for the purposes referred to in Article 34.
2023/03/30
Committee: ENVILIBE
Amendment 1763 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 45 – paragraph 3
3. Data users seeking access to electronic health data from more than one Member State shall submit a single application to one of the concerned health data access bodies of their choice which shall be responsible for sharing the request witbe able to submit the applications through other health data access bodies and authorised participants in HealthData@EU referred to in Article 52, which have been identified in the data access application. For requests to access electronic health data from more than one Member States, the health data access body shall notify the other relevant health data access bodies of the receipt of an application relevant to them within 15 days from the date of receipt of the data access application HealthData@EU referred to in Article 52 by indicating what data they request from wich Member State.
2023/03/30
Committee: ENVILIBE
Amendment 1804 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 46 – paragraph 1 a (new)
1 a. Nothwithstanding paragpraph 1, health data access bodies may, exceptionally and with due justification, refuse to grant data permit on any of the following grounds: (a) national security; (b) defence; (c) public security; (d) the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security; (e) other important objectives of general public interest of the Union or of a Member State, in particular an important economic or financial interest of the Union or of a Member State, including monetary, budgetary and taxation a matters, public health and social security; (f) the protection of the data subject or the rights and freedoms of others.
2023/03/30
Committee: ENVILIBE
Amendment 1848 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 46 – paragraph 11
11. 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 than 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 data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information 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. Where the output of the secondary use of the electronic health data is not comprehensive from the perspective of the underlying project, data users shall indicate where follow-up information is available.
2023/03/30
Committee: ENVILIBE
Amendment 1862 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 47 – paragraph 1
1. Any natural or legal person may submit a data request for the purposes referred to in Article 34. A health data access body shall only provide an answer to a data request in an anonymised statistical format and the data user shall have no access to the electronic health data used to provide this answer.deleted
2023/04/05
Committee: ENVILIBE
Amendment 1866 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 47 – paragraph 2
2. A data request shall include the elements mentioned in paragraphs 2 (a) and (b) of Article 45 and if needed may also include: (a) a description of the result expected from the health data access body; (b) a description of the statistic’s content.deleted
2023/04/05
Committee: ENVILIBE
Amendment 1868 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 47 – paragraph 2 – point a
(a) a description of the result expected from the health data access body;deleted
2023/04/05
Committee: ENVILIBE
Amendment 1869 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 47 – paragraph 2 – point b
(b) a description of the statistic’s content.deleted
2023/04/05
Committee: ENVILIBE
Amendment 1870 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
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 2 months and, where possible, provide the result to the data user within 2 months.deleted
2023/04/05
Committee: ENVILIBE
Amendment 1875 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 48
Making data available for public sector bodies and Union institutions, bodies, offices and agencies without a data permit By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe.Article 48 deleted
2023/04/05
Committee: ENVILIBE
Amendment 1894 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 49 – paragraph 1
1. Where an applicant requests access to electronic health data only from a single data holder in a single Member State, by way of derogation from Article 45(1), that applicant may file a data access application or a data request directly to the data holder. The data access application shall comply with the requirements set out in Article 45 and the data request shall comply with requirements in Article 47. Multi-country requests and requests requiring a combination of datasets from several data holders shall be addressed to health data access bodies.deleted
2023/04/05
Committee: ENVILIBE
Amendment 1895 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 49 – paragraph 2
2. In such case, the data holder may issue a data permit in accordance with Article 46 or provide an answer to a data request in accordance with Article 47. The data holder shall then provide access to the electronic health data in a secure processing environment in compliance with Article 50 and may charge fees in accordance with Article 42.deleted
2023/04/05
Committee: ENVILIBE
Amendment 1896 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 49 – paragraph 3
3. By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.deleted
2023/04/05
Committee: ENVILIBE
Amendment 1897 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 49 – paragraph 4
4. Within 3 months the data holder shall 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.deleted
2023/04/05
Committee: ENVILIBE
Amendment 1933 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 52 – paragraph 5
5. Third countries or international organisations may become authorised participants where they comply with the rules of Chapter IV of this Regulation and provide access to data users located in the Union, on equivalent terms and conditions, to the electronic health data available to their health data access bodies. The Commission may adopt implementing acts establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of HealthData@EU for the purposes of secondary use of health data, is compliant with the Chapter IV of this Regulation and provides access to data users located in the Union to the electronic health data it has access to on equivalent terms and conditions. The compliance with these legal, organisational, technical and security requirements, including with the standards for secure processing environments pursuant to Article 50 shall be checked under the control of the Commission. These implementing acts shall be adopted in accordance with the advisoryexamination procedure referred to in Article 68 (2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available. In addition to the compliance check, the national security interests of the Member States shall also be taken into account before adopting the implementing acts.
2023/04/05
Committee: ENVILIBE
Amendment 1963 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 2
Those implementing acts shall be adopted in accordance with the advisoryexamination procedure referred to in Article 68(2).
2023/04/05
Committee: ENVILIBE
Amendment 2125 #
Edina TÓTH, Balázs HIDVÉGHI
Proposal for a regulation
Article 72 – paragraph 5 a (new)
Chapter IV shall apply 2 years after the entry into force of the implementing acts referred to in Article 50(4), with the following derogations: (a) for data categories referred to in points ….of Article 33, Chapter IV shall apply 4 years after the entry into force of the implementing acts referred to in Article 50(4); (b) for data categories referred to in points …. of Article 33, Chapter IV shall apply 6 years after the entry into force of the implementing acts referred to in Article 50(4).
2023/04/05
Committee: ENVILIBE
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