Sittings · Document

Draft report (COM(2022)0197 – C9-0167/2022 – 2022/0140(COD)) 2023-04-05

European Health Data Space

Committee on the Environment, Public Health and Food Safety Committee on Civil Liberties, Justice and Home Affairs

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AM_Com_LegReport

Amendment 1862

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 47 – paragraph 1

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1863

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 47 – paragraph 1

Text proposed by the Commission

Amendment

1. Any natural or legal person may submit a data request for the purposes referred to in Article 34 with the aim of obtaining an answer only in anonymised statistical format.

A health data access body shall not provide an answer to a data request in any other format and the data user shall have no access to the electronic health data used to provide this answer.

Or. en

Amendment 1864

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 47 – paragraph 1

Text proposed by the Commission

Amendment

1. Any entity active in the area of health care, public health, or scientific or medical research 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.

Or. en

Amendment 1865

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 47 – paragraph 1

Text proposed by the Commission

Amendment

(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.

(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 which is transmitted to it by the application processing body in an anonymised statistical format and the data user shall have no access to the electronic health data used to provide this answer.

Or. de

Amendment 1866

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 47 – paragraph 2

Text proposed by the Commission

Amendment

2. A data request shall include the elements mentioned in paragraphs 2 (a) and (b) of Article 45 and if needed may also include:

deleted

(a) a description of the result expected from the health data access body;

(b) a description of the statistic’s content.

Or. en

Amendment 1867

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 47 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. A data request shall include the elements mentioned in paragraphs 2 (a) and (b) of Article 45 and if needed may also include:

2. A data request shall include the elements mentioned in paragraphs 2 (-a), (a) and (b) of Article 45 and if needed may also include:

Or. en

Amendment 1868

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 47 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) a description of the result expected from the health data access body;

deleted

Or. en

Amendment 1869

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 47 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) a description of the statistic’s content.

deleted

Or. en

Amendment 1870

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 47 – paragraph 3

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1871

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 47 – paragraph 3

Text proposed by the Commission

Amendment

3. The health data access body shall assess the health data request within 2 months and, where possible, provide the result to the data user within 2 months.

Or. en

Amendment 1872

Jessica Polfjärd

Proposal for a regulation

Article 47 – paragraph 3

Text proposed by the Commission

Amendment

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 3 months and, where possible, provide the result to the health data user within 3 months.

Or. en

Amendment 1873

Mathilde Androuët

Proposal for a regulation

Article 47 – paragraph 3

Text proposed by the Commission

Amendment

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 provide the result to the data user within 2 months.

Or. fr

Amendment 1874

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 48

Text proposed by the Commission

Amendment

Article 48

deleted

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.

Or. de

Amendment 1875

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 48

Text proposed by the Commission

Amendment

Article 48

deleted

Making data available for public sector bodies and Union institutions, bodies, offices and agencies without a data permit

Or. en

Amendment 1876

Cristian-Silviu Buşoi

Proposal for a regulation

Article 48 – title

Text proposed by the Commission

Amendment

Making data available for public sector bodies and Union institutions, bodies, offices and agencies without a data permit

Making data available for Union agencies without a data permit

Or. en

Amendment 1877

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 48 – title

Text proposed by the Commission

Amendment

Making data available for public sector bodies and Union institutions, bodies, offices and agencies without a data permit

Making data available for national public health authorities and European Union public health agencies without a data permit

Or. en

Amendment 1878

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1879

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

The requirement for a data permit shall be without prejudice to the right to access the electronic health data of public sector bodies and Union institutions, bodies, offices and agencies that carry out relevant activities within their mandate pursuant to Union or Member State law, where this mandate provides for such data access under this Regulation. By derogation from Article 46 of this Regulation, the data permit for public authorities may allow for data access for unlimited periods and for the possibility for periodic updates of data under a single data access application. 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 that shall not be longer than 2 additional months. Accelerated timelines shall be established in exceptional circumstances, including public health emergencies.

Or. en

Amendment 1880

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article. Where electronic health data involving protected intellectual property and trade secrets are made available, it shall be ensured that all necessary measures are taken to protect the confidentiality of intellectual property rights and trade secrets. 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.

Or. en

Amendment 1881

Véronique Trillet-Lenoir, Fabienne Keller, Max Orville, Frédérique Ries

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

By derogation from Article 46 of this Regulation, Member States may allow national and European public institutions, agencies bodies and offices, under specific conditions, to access data without requiring a data permit 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.

Or. en

Amendment 1882

Cristian-Silviu Buşoi

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article for any of the purposes under Article 34(1), points (a) or (b). When carrying out those tasks under Article 37 (1), points (b) and (c), and upon request from the Union agencies, in duly justified cases the health data access body shall make the electronic health data available within 1 month of the data access application. However, data shall be shared as soon as it is available in the context of a Public Health Emergency of International Concern (PHEIC) or when a public health emergency has been declared at Union level.

By derogation from Article 42 of this Regulation, no fees shall be payable by ECDC and EMA to the health data access body to access the data under this Article.

Or. en

Amendment 1883

Konstantinos Arvanitis

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

When carrying out the 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.

Or. en

Amendment 1884

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Ondřej Knotek, Ondřej Kovařík, María Soraya Rodríguez Ramos, Michal Šimečka

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

By derogation from Article 46 of this Regulation, a data permit shall not be required by the European Medicines Agency (EMA), European Centre for Disease Prevention and Control (ECDC) and Health Emergency Preparedness and Response Authority (HERA) to access the electronic health data under this Chapter. The health data access body shall inform EMA, ECDC, or HERA about the availability of data within 2 months of the data access application. 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.

Or. en

Justification

Amendment necessary to limit the broad scope of the possibility to bypass the health data access bodies and the data permit procedure.

Amendment 1885

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 48 – paragraph 1

Text proposed by the Commission

Amendment

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 national public health authorities and the European Union health agencies, 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.

Or. en

Amendment 1886

Mathilde Androuët

Proposal for a regulation

Article 49

Text proposed by the Commission

Amendment

Article 49

deleted

Access to electronic health data from a single data holder

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.

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.

3. By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.

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.

Or. fr

Amendment 1887

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 49

Text proposed by the Commission

Amendment

Article 49

deleted

Access to electronic health data from a single data holder

(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.

(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.

(3) By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.

(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.

Or. de

Amendment 1888

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 49

Text proposed by the Commission

Amendment

Article 49

deleted

Access to electronic health data from a single data holder

3. By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.

Or. en

Amendment 1889

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 49

Text proposed by the Commission

Amendment

Article 49

deleted

Access to electronic health data from a single data holder

3. By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.

Or. en

Justification

The role and tasks of the health data access bodies are key to guarantee compliance with the EHDS and protect electronic health data. It should not be possible to have access to the data for secondary uses without passing through the health data access bodies.

Amendment 1890

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, István Ujhelyi, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 49

Text proposed by the Commission

Amendment

Article 49

deleted

Access to electronic health data from a single data holder

3. By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.

Or. en

Amendment 1891

Konstantinos Arvanitis

Proposal for a regulation

Article 49

Text proposed by the Commission

Amendment

Article 49

deleted

Access to electronic health data from a single data holder

3. By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.

Or. en

Amendment 1892

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 49

Text proposed by the Commission

Amendment

Article 49

deleted

Access to electronic health data from a single data holder

3. By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.

Or. en

Justification

The lack of supervision by health data access bodies can have a detrimental impact to the rights of data subjects.

Amendment 1893

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 49

Text proposed by the Commission

Amendment

Article 49

deleted

Access to electronic health data from a single data holder

3. By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.

Or. en

Justification

Single health data holders are not in a position to decide on data access applications and to grant a data access permit. Moreover, they might not be able to guarantee the same level of data protection, including anonymisation and pseudonymisation, as data access bodies. Therefore, to guarantee a high level of data protection, the health data access bodies should remain the central part of the secondary use health data.

Amendment 1894

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 49 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1895

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 49 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1896

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 49 – paragraph 3

Text proposed by the Commission

Amendment

3. By way of derogation from Article 51, the single data provider and the data user shall be deemed joint controllers.

deleted

Or. en

Amendment 1897

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 49 – paragraph 4

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1898

Jessica Polfjärd

Proposal for a regulation

Article 49 – paragraph 4

Text proposed by the Commission

Amendment

4. The 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.

Or. en

Amendment 1899

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 50 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The health data access bodies shall provide access to electronic health data only through a secure processing environment, with technical and organisational measures and security and interoperability requirements. In particular, they shall take the following security measures:

1. The health data access bodies shall provide access to electronic health data only through a secure processing environment, with technical and organisational measures and security and interoperability requirements and protection of intellectual property and trade secrets. In particular, they shall take the following security measures:

Or. en

Amendment 1900

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 50 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Subject to the issuance of a data permit, the health data access bodies shall provide access to electronic health data only through a secure processing environment, with technical and organisational measures and security and interoperability requirements. In particular, they shall take the following security measures:

Or. en

Amendment 1901

Konstantinos Arvanitis

Proposal for a regulation

Article 50 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) minimise the risk of the unauthorised reading, copying, modification or removal of electronic health data hosted in the secure processing environment through state-of-the-art technological means;

(b) minimise the risk of the unauthorised reading, copying, modification or removal of electronic health data hosted in the secure processing environment through state-of-the-art technological and organisational means;

Or. en

Amendment 1902

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 50 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) minimise the risk of the unauthorised reading, copying, modification or removal of electronic health data hosted in the secure processing environment through state-of-the-art technological means;

Or. en

Amendment 1903

Marian-Jean Marinescu

Proposal for a regulation

Article 50 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) keep identifiable logs of access to the secure processing environment for the period of time necessary to verify and audit all processing operations in that environment;

(e) keep identifiable logs of access that include data access holders to the secure processing environment for the period of time necessary to verify and audit all processing operations in that environment;

Or. en

Amendment 1904

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 50 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) keep identifiable logs of access to the secure processing environment for the period of time necessary to verify and audit all processing operations in that environment;

(e) keep identifiable logs of access to the secure processing environment for the period of time necessary to verify and audit all processing operations in that environment and not shorter than one year;

Or. en

Amendment 1905

Traian Băsescu

Proposal for a regulation

Article 50 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) ensure compliance and monitor the security measures referred to in this Article to mitigate potential security threats.

(f) ensure compliance and monitor the security measures referred to in this Article to minimise potential security threats.

Or. ro

Amendment 1906

Véronique Trillet-Lenoir, Fabienne Keller, Max Orville, Frédérique Ries

Proposal for a regulation

Article 50 – paragraph 1 – point f a (new)

Text proposed by the Commission

Amendment

(fa) ensure that the secure processing environment is located within the European Economic Area. Where personal health data are accessed remotely, including where hosting managed services are used, from a territory located outside of the European Economic Area that does not ensure an adequate level of data protection within the meaning of Article 45 of Regulation (EU) 2016/679, the health data access body shall ensure that this transfer is compliant with that Regulation.

Or. en

Amendment 1907

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 50 – paragraph 2

Text proposed by the Commission

Amendment

(2) The health data access bodies shall ensure that electronic health data can be uploaded by data holders and can be accessed by the data user in a secure processing environment. The data users shall only be able to download non-personal electronic health data from the secure processing environment. Initially personal data may only be downloaded by data users if anonymised in accordance with this Regulation; this is usually the case only for aggregated data from at least 100 individual datasets.

Or. de

Amendment 1908

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 50 – paragraph 2

Text proposed by the Commission

Amendment

2. The health data access bodies shall ensure that electronic health data can be uploaded by data holders and can be accessed by the data user in a secure processing environment. The data users shall only be able to download non-personal electronic health data from the secure processing environment.

2. The health data access bodies shall ensure that electronic health data from data holders in the format determined by the data permit can be uploaded by data holders and can be accessed by the data user in a secure processing environment. The data users shall only be able to download non-personal electronic health data from the secure processing environment.

Or. en

Amendment 1909

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 50 – paragraph 2

Text proposed by the Commission

Amendment

2. The health data access bodies shall ensure that electronic health data can be uploaded by data holders and can be accessed by the data user in a secure processing environment. The data users shall only be able to download or copy non-personal electronic health data from the secure processing environment.

Or. en

Amendment 1910

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 50 – paragraph 3

Text proposed by the Commission

Amendment

3. The health data access bodies shall ensure regular audits of the secure processing environments.

3. The health data access bodies shall ensure regular audits of the secure processing environments and take immediate corrective action of any shortcomings, risks or vulnerabilities identified in the secure processing environments

Or. en

Amendment 1911

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 50 – paragraph 3

Text proposed by the Commission

Amendment

3. The health data access bodies shall ensure regular audits of the secure processing environments.

3. The health data access bodies shall ensure regular third party audits of the secure processing environments.

Or. en

Amendment 1912

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 50 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3a. The tools and computing resources provided in the secure processing environment shall be based on free and open-source software.

Or. en

Amendment 1913

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 50 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, provide for the technical, information security and interoperability requirements for the secure processing environments. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The EHDS Board shall ensure consistent provision of the secure processing environment compliant with the technical information security and interoperability requirements and enforce compliance across the Member States.

Or. en

Amendment 1914

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, Ondřej Knotek, Ondřej Kovařík, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 50 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, provide for the technical, information security, confidentiality, data protection and interoperability requirements for the secure processing environments, in consultation with ENISA. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68(2a).

Or. en

Amendment 1915

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 50 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, provide for the technical, organisational, information security and interoperability requirements for the secure processing environments. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 1916

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 51 – title

Text proposed by the Commission

Amendment

Joint controllers

Controllership

Or. en

Amendment 1917

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 51 – title

Text proposed by the Commission

Amendment

Joint controllers

Controllership

Or. en

Amendment 1918

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 51 – paragraph 1

Text proposed by the Commission

Amendment

1. The health data access bodies and the data users, including Union institutions, bodies, offices and agencies, shall be deemed joint controllers of electronic health data processed in accordance with data permit.

1. Data user, including Union institutions, bodies, offices and agencies, shall be deemed controller for the processing of personal of electronic health data in the secure processing environment pursuant to a data permit. In this case, the health data access body shall be deemed a processor.

The health data access body shall be considered a controller for the processing of personal electronic health data while carrying out its task referred to in Article 37(1), point (d).

The health data holder shall be considered a controller for the processing of personal electronic health data while carrying out its obligation under Article 41(1) and (1a).

Or. en

Justification

The joint controllership was modified to better address the process.

Amendment 1919

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 51 – paragraph 1

Text proposed by the Commission

Amendment

1. The data holder shall be deemed controller for the disclosure of the requested personal electronic health data to the health data access body pursuant to Article 33(1). The health data access body shall be deemed controller for the processing of the personal electronic health data when fulfilling its tasks pursuant to Article 37(1), point (d). The data user shall be deemed controller for the processing of personal electronic health data in pseudonymised form in the secure processing environment pursuant to the data permit. The health data access body shall act as a processor for the health data user's processing pursuant to a data permit in the secure processing environment.

Or. en

Amendment 1920

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 51 – paragraph 1

Text proposed by the Commission

Amendment

(1) The health data access bodies and the data users, including Union institutions, bodies, offices and agencies, shall be deemed joint controllers of electronic health data processed in accordance with data permit. In the event that the data holder provides access to the electronic health data to the data user without going through the health data access bodies, the data holder and data user shall be joint controllers of the electronic health data processed in accordance with the data permit.

Or. de

Amendment 1921

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 51 – paragraph 1

Text proposed by the Commission

Amendment

1. In addition to data holders, the health data access bodies shall be deemed a controller for the processing of personal electronic health data in accordance with Article 37(1)(d). The data users shall be deemed controller for the processing of personal electronic health data in pseudonymised form in the secure processing environment pursuant to the data permit. The health data access body shall act as a processor for the health data user´s processing pursuant to a data permit in the secure processing environment.

Or. en

Amendment 1922

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 51 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, establish a template for the joint controllers’ arrangement. Those implementing acts shall be adopted in accordance with the advisory procedure set out in Article 68(2).

2. The Commission shall, by means of implementing acts, establish a template for the joint controllers’ arrangement that meets the requirements laid down in Article 28(3) of Regulation (EU) 2016/679. Those implementing acts shall be adopted in accordance with the advisory procedure set out in Article 68(2). The use of that template shall not relieve the health data access bodies or the data users from any of their duties and responsibilities.

Or. en

Amendment 1923

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 51 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, establish a template for a contract or other legal act for the purpose of paragraph 1 in line with Article 28(3) of Regulation (EU) 2016/679. Those implementing acts shall be adopted in accordance with the examination procedure set out in Article 68(2a).

Or. en

Amendment 1924

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 51 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1925

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 51 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, establish a template for the controllers’ arrangement. Those implementing acts shall be adopted in accordance with the advisory procedure set out in Article 68(2).

Or. en

Amendment 1926

Jessica Polfjärd

Proposal for a regulation

Article 52 – paragraph 1

Text proposed by the Commission

Amendment

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 names and contact details to the Commission. 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.

1. Each Member State shall designate a national contact point for secondary use of electronic health data. 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 name and contact details of 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.

Or. en

Justification

The proposal should clarify whether data users can submit data received from different sources to the national contact point for secondary use of data. When the national contact point is to be developed and implemented in each Member State, it should be constructed in close consultation with the data holders and data users. A well-functioning and efficient health data area is based on close cooperation where each actor understands its own and others' roles and responsibilities.

Amendment 1927

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 52 – paragraph 2

Text proposed by the Commission

Amendment

2. The national contact points referred to in paragraph 1 shall be authorised participants in the cross-border infrastructure for secondary use of electronic health data (HealthData@EU). The national contact points shall facilitate the cross-border access to electronic health data for secondary use for different authorised participants in the infrastructure and shall cooperate closely with each other and with the Commission.

2. The contact points referred to in paragraph 1 shall be authorised participants in the cross-border infrastructure for secondary use of electronic health data (HealthData@EU). The contact points shall facilitate the cross-border access to electronic health data for secondary use for different authorised participants in the infrastructure and shall cooperate closely with each other and with the Commission.

Or. en

Amendment 1928

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 52 – paragraph 3

Text proposed by the Commission

Amendment

(3) Union institutions, bodies, offices and agencies involved in research, health policy or analysis, shall be authorised participants of HealthData@EU.

(3) Union institutions, bodies, offices and agencies in the health sector involved in research, health policy or analysis, shall be authorised participants of HealthData@EU.

Or. de

Amendment 1929

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 52 – paragraph 3

Text proposed by the Commission

Amendment

3. Union institutions, bodies, offices and agencies involved in research, health policy or analysis, shall be authorised participants of HealthData@EU.

3. Union institutions, bodies, offices and agencies involved in health research, health policy or analysis, shall be authorised participants of HealthData@EU.

Or. en

Amendment 1930

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 52 – paragraph 4

Text proposed by the Commission

Amendment

(4) Health-related research infrastructures or similar structures whose functioning is based on Union law and which support the use of electronic health data for research, policy making, statistical, patient safety or regulatory purposes shall be authorised participants of HealthData@EU.

(4) Health-related research infrastructures or similar structures which support the use of electronic health data in the health sector for research, policy making, statistical, patient safety or regulatory purposes shall be authorised participants of HealthData@EU.

Or. de

Amendment 1931

Rob Rooken

Proposal for a regulation

Article 52 – paragraph 5

Text proposed by the Commission

Amendment

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 advisory procedure referred to in Article 68 (2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available.

deleted

Or. en

Amendment 1932

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 52 – paragraph 5

Text proposed by the Commission

Amendment

5. Third countries or international organisations may become authorised participants where they comply with the rules of Chapter IV of this Regulation, where they have set up a body equivalent to the health data access bodies as referred to in Article 36 and where they ensure that Chapter V of Regulation (EU) 2016/679 will be complied with after the connection to the HealthData@EU 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 as well as with Chapter V of Regulation (EU) 2016/679 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 advisory procedure referred to in Article 68 (2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available.

Or. en

Amendment 1933

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 52 – paragraph 5

Text proposed by the Commission

Amendment

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 examination 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.

Or. en

Amendment 1934

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 52 – paragraph 5

Text proposed by the Commission

Amendment

5. Third countries or international organisations may become authorised participants where they comply with the rules of Chapter IV of this Regulation and whereby the transfer of electronic health data is compliant with the provisions laid down in Chapter V of Regulation (EU) 2016/679 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 Chapter V of Regulation 2016/679 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 advisory procedure referred to in Article 68 (2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available.

Or. en

Amendment 1935

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 5

Text proposed by the Commission

Amendment

Or. en

Amendment 1936

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 52 – paragraph 5

Text proposed by the Commission

Amendment

5. Third countries or international organisations may become authorised participants where they comply with the rules of Chapter IV of this Regulation, the transfer stemming from such connection complies with the rules in Chapter V of Regulation (EU) 2016/679 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 Chapter V of Regulation (EU) 2016/679 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 advisory procedure referred to in Article 68 (2). The Commission shall make the list of implementing acts adopted pursuant to this paragraph publicly available.

Or. en

Amendment 1937

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 52 – paragraph 7

Text proposed by the Commission

Amendment

(7) The Commission is empowered to adopt delegated acts in accordance with Article 67 in order to amend this Article to add or remove categories of authorised participants in HealthData@EU, taking into account the opinion of the joint controllership group pursuant to Article 66 of this Regulation.

(7) The Commission is empowered to adopt delegated acts in accordance with Article 67 in order to amend this Article to add or remove categories of authorised health sector participants in HealthData@EU, taking into account the opinion of the joint controllership group pursuant to Article 66 of this Regulation.

Or. de

Amendment 1938

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 52 – paragraph 8

Text proposed by the Commission

Amendment

8. The Member States and the Commission shall set up HealthData@EU to support and facilitate the cross-border access to electronic health data for secondary use, connecting the national contact points for secondary use of electronic health data of all Member States and authorised participants in that infrastructure.

Or. en

Amendment 1939

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 52 – paragraph 8

Text proposed by the Commission

Amendment

8. The Member States and the Commission shall set up HealthData@EU to support and facilitate the cross-border access to electronic health data for secondary use, connecting the national or, where applicable, regional contact points for secondary use of electronic health data of all Member States and authorised participants in that infrastructure.

Or. en

Amendment 1940

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 52 – paragraph 8

Text proposed by the Commission

Amendment

(8) The Member States and the Commission shall set up HealthData@EU to support and facilitate the cross-border access to electronic health data for secondary use, connecting the national contact points for secondary use of electronic health data of all Member States and authorised participants in that infrastructure.

(8) The Member States and the Commission shall set up HealthData@EU to support and facilitate the cross-border access to electronic health data for secondary use in the health sector, connecting the national contact points for secondary use of electronic health data of all Member States and authorised participants in that infrastructure.

Or. de

Amendment 1941

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 9

Text proposed by the Commission

Amendment

9. The Commission shall develop, deploy and operate a core platform for HealthData@EU by providing information technology services needed to facilitate the connection between health data access bodies as part of the cross-border infrastructure for the secondary use of electronic health data. The Commission shall only process electronic health data on behalf of the joint controllers as a processor.

Or. en

Justification

Since the Commission develops the platform for HealthData@EU, it determines the means of processing. It is therefore by definition a data controller in GDPR terms.

Amendment 1942

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 10

Text proposed by the Commission

Amendment

10. Where requested by two or more health data access bodies, the Commission may provide a secure processing environment for data from more than one Member State compliant with the requirements of Article 50. Where two or more health data access bodies put electronic health data in the secure processing environment managed by the Commission, they shall be joint controllers and the Commission shall be processor.

deleted

Or. en

Amendment 1943

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 11

Text proposed by the Commission

Amendment

11. The authorised participants shall act as joint controllers of the processing operations in which they are involved carried out in HealthData@EU and the Commission shall act as a processor.

deleted

Or. en

Amendment 1944

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 12

Text proposed by the Commission

Amendment

12. Member States and the Commission shall seek to ensure interoperability of HealthData@EU with other relevant common European data spaces as referred to in Regulations […] [Data Governance Act COM/2020/767 final] and […] [Data Act COM/2022/68 final].

deleted

Or. en

Amendment 1945

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission may, by means of implementing acts, set out:

The Commission shall, by means of implementing acts, set out:

Or. en

Amendment 1946

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission may, by means of implementing acts, set out:

The Commission may, by means of delegated acts, set out:

Or. en

Amendment 1947

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) requirements, technical specifications, the IT architecture of HealthData@EU, conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU which shall ensure state-of-the-art data security, confidentiality, and protection of electronic health data in the cross border infrastructure;

Or. en

Amendment 1948

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Michal Šimečka

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) requirements, technical specifications, the IT architecture of HealthData@EU, conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU, with stricter criteria and an accelerated procedure for third countries and international organisations;

Or. en

Amendment 1949

Konstantinos Arvanitis

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) requirements, technical specifications, the IT architecture of HealthData@EU, which shall guarantee a high level of data security, confidentiality and protection of electronic data;

Or. en

Amendment 1950

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) requirements, technical specifications, the IT architecture of HealthData@EU, which shall guarantee a high level of data security, confidentiality and protection of electronic data pursuant to the state-of-the-art;

Or. en

Amendment 1951

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(aa) conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU;

Or. en

Justification

Split between (a) for technical specifications and (aa) conditions for participants

Amendment 1952

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(aa) conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU;

Or. en

Amendment 1953

Konstantinos Arvanitis

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) the minimum criteria that need to be met by the authorised participants in the infrastructure;

deleted

Or. en

Amendment 1954

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1955

Konstantinos Arvanitis

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1956

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) the responsibilities of the joint controllers and processor(s) for the secure environment managed by the Commission;

deleted

Or. en

Amendment 1957

Konstantinos Arvanitis

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) the responsibilities of the joint controllers and processor(s) for the secure environment managed by the Commission;

deleted

Or. en

Amendment 1958

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point e

Text proposed by the Commission

Amendment

(e) common specifications for the interoperability and architecture concerning HealthData@EU with other common European data spaces.

deleted

Or. en

Amendment 1959

Konstantinos Arvanitis

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(ea) conditions and compliance checks for authorised participants to join and remain connected to HealthData@EU and conditions for temporary or definitive exclusion from HealthData@EU;

Or. en

Amendment 1960

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, Ondřej Knotek, Ondřej Kovařík, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

In case of a serious misconduct or repeated violations of the applicable rules by a third country or an international organisation, the Commission shall immediately act upon and take appropriate sanctions, including deciding on the definitive exclusion from healthData@EU.

Or. en

Amendment 1961

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 2

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The Commission shall consult with and involve the European Union Agency for Cyber Security (ENISA) in the aforementioned process.

Or. en

Amendment 1962

Konstantinos Arvanitis

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 2

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The European Union Agency for Cyber Security (ENISA) shall be consulted and closely involved in the process.

Or. en

Amendment 1963

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 2

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68(2).

Or. en

Amendment 1964

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 52 – paragraph 13 – subparagraph 2

Text proposed by the Commission

Amendment

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Those delegated acts shall be adopted in accordance with the procedure referred to in Article 67.

Or. en

Amendment 1965

Joanna Kopcińska

Proposal for a regulation

Article 52 – paragraph 14

Text proposed by the Commission

Amendment

14. The approval for individual authorised participant to join HealthData@EU or to disconnect a participant from the infrastructure shall be issued by the Joint Controllership group, based on the results of the compliance checks.

14. Subject to a positive outcome of this compliance check, the Commission shall, by means of implementing acts, take decisions to connect individual authorised participants to join the respective infrastructure or to disconnect them. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68.

Or. en

Amendment 1966

Beata Kempa

Proposal for a regulation

Article 52 – paragraph 14

Text proposed by the Commission

Amendment

14. The approval for individual authorised participants to join MyHealth@EU for different services, or to disconnect a participant shall be issued by the EHDS board, based on the results of the compliance checks performed by the Commission.

Or. en

Amendment 1967

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Michal Šimečka

Proposal for a regulation

Article 53 – title

Text proposed by the Commission

Amendment

Access to cross-border sources of electronic health data for secondary use

Access to cross-border registries and databases for secondary use

Or. en

Amendment 1968

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 53 – paragraph 1

Text proposed by the Commission

Amendment

(1) In the case of cross-border registries and databases, the health data access body in which the data holder is registered shall be competent to decide on data access applications to provide access to electronic health data. Where the registry has joint controllers, the health data access body that shall provide access to electronic health data shall be the body in the Member State where one of the joint controllers is established.

(1) In the case of cross-border registries and databases, the application processing body in which the data holder is registered shall be competent to decide on data access applications and to arrange access to electronic health data through the health data access body. Where the registry has joint controllers, the health data access body that shall provide access to electronic health data shall be the body in the Member State where one of the joint controllers is established.

Or. de

Amendment 1969

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 53 – paragraph 2

Text proposed by the Commission

Amendment

(2) Where registries or databases from a number of Member States organise themselves into a single network of registries or databases at Union level, the associated registries may designate one of their members as a coordinator to ensure the provision of data from the registries’ network for secondary use. The health data access body of the Member State in which the coordinator of the network is located shall be competent to decide on the data access applications to provide access to electronic health data for the network of registries or databases.

(2) Where registries or databases from a number of Member States organise themselves into a single network of registries or databases at Union level, the associated registries may designate one of their members as a coordinator to ensure the provision of data from the registries’ network for secondary use. The application processing body of the Member State in which the coordinator of the network is located shall be competent to decide on the data access applications to arrange access to electronic health data for the network of registries or databases.

Or. de

Amendment 1970

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 53 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission may, by means of implementing acts, adopt the necessary rules for facilitating the handling of data access applications for HealthData@EU, including a common application form, a common data permit template, standard forms for common electronic health data access contractual arrangements, and common procedures for handling cross-border requests, pursuant to Articles 45, 46, 47 and 48. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

3. The Commission may, by means of delegated acts, adopt the necessary rules for facilitating the handling of data access applications for HealthData@EU, including a common application form, a common data permit template, standard forms for common electronic health data access contractual arrangements, and common procedures for handling cross-border requests, pursuant to Articles 45, 46, 47 and 48. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 67.

Or. en

Amendment 1971

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 54 – title

Text proposed by the Commission

Amendment

54 Mutual recognition

54 Cross-border access and mutual recognition of data permits

Or. en

Amendment 1972

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 54 – paragraph 1

Text proposed by the Commission

Amendment

1. When handling an access application for cross-border access to electronic health data for secondary use, health data access bodies and relevant authorised participants shall remain responsible for taking decisions to grant or refuse access to electronic health data within their remit in accordance with the requirements for access laid down in this Chapter. After a decision is made regarding the granting or refusal of the health data permit, the health data access body shall inform the other health data bodies concerned by the same application about the decision. These decisions may be taken into consideration by the other health data access bodies when deciding on the granting or refusal of the data permit.

Or. en

Amendment 1973

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 54 – paragraph 1

Text proposed by the Commission

Amendment

(1) When handling an access application for cross-border access to electronic health data for secondary use, health data access bodies and relevant authorised participants shall remain responsible for taking decisions to grant or refuse access to electronic health data within their remit in accordance with the requirements for access laid down in this Chapter.

(1) When handling an access application for cross-border access to electronic health data for secondary use, application processing bodies and relevant authorised participants shall remain responsible for taking decisions to grant or refuse access to electronic health data within their remit in accordance with the requirements for access laid down in this Chapter.

Or. de

Amendment 1974

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 54 – paragraph 2

Text proposed by the Commission

Amendment

(2) A data permit issued by one concerned health data access body may benefit from mutual recognition by the other concerned health data access bodies.

(2) A data permit issued by one application processing body may benefit from mutual recognition by the other concerned application processing bodies.

Or. de

Amendment 1975

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 54 – paragraph 2

Text proposed by the Commission

Amendment

2. A data permit issued by one concerned health data access body may benefit from mutual recognition by the other concerned health data access bodies.

2. The same data permit issued by one concerned health data access body shall benefit from mutual recognition by the other concerned health data access bodies.

Or. en

Amendment 1976

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 54 – paragraph 2

Text proposed by the Commission

Amendment

2. A data permit issued by one concerned health data access body may benefit from mutual recognition by the other concerned health data access bodies.

2. The same data permit issued by one concerned health data access body shall benefit from mutual recognition by the other concerned health data access bodies.

Or. en

Amendment 1977

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 55 – title

Text proposed by the Commission

Amendment

Dataset description

Dataset description and dataset catalogue

Or. en

Amendment 1978

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 55 – paragraph 1

Text proposed by the Commission

Amendment

(1) The health data access bodies shall inform the data users about the available datasets and their characteristics through a metadata catalogue. Each dataset shall include information concerning the source, the scope, the main characteristics, nature of electronic health data and conditions for making electronic health data available.

(1) The application processing bodies shall inform the data users about the available datasets and their characteristics through a metadata catalogue. Each dataset shall include information concerning the source, the scope, the main characteristics, nature of electronic health data and conditions for making electronic health data available.

Or. de

Amendment 1979

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 55 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, set out the minimum information elements data holders are to provide for datasets and their characteristics. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

2. The Commission shall, by means of delegated acts, set out the minimum information elements data holders are to provide for datasets and their characteristics. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 67.

Or. en

Amendment 1980

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 56 – paragraph 1

Text proposed by the Commission

Amendment

1. Datasets made available through health data access bodies may have a Union data quality and utility label provided by the data holders.

1. Datasets made available through health data access bodies may have a Union data quality and utility label provided by the health data access bodies.

Or. en

Amendment 1981

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 57 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish an EU Datasets Catalogue connecting the national catalogues of datasets established by the health data access bodies and other authorised participants in HealthData@EU taking into consideration the health interoperability resources already developed across the Union.

Or. en

Amendment 1982

Marian-Jean Marinescu

Proposal for a regulation

Article 59 – paragraph 1

Text proposed by the Commission

Amendment

The Commission shall support sharing of best practices and expertise, aimed to build the capacity of Member States to strengthen digital health systems for primary and secondary use of electronic health data. To support capacity building and to guarantee the correct implementation of the European Health Data Space system, the Commission shall draw up benchmarking guidelines for the primary and secondary use of electronic health data.

The Commission shall include in the guidelines how Member States can access EU funds in the context of the EHDS.

Or. en

Amendment 1983

Pernille Weiss

Proposal for a regulation

Article 59 – paragraph 1

Text proposed by the Commission

Amendment

The Commission shall support sharing of best practices and expertise, aimed to build the capacity of Member States to strengthen digital health systems for primary and secondary use of electronic health data. To support capacity building, the Commission shall draw up benchmarking guidelines for the primary and secondary use of electronic health data. Additionally, with reference to Article 33(1), point (i), guidance shall be made available to support compliance, particularly for non-profit organisations, researchers and medical societies, who act as data holders in relation to registries.

Or. en

Amendment 1984

Traian Băsescu

Proposal for a regulation

Article 59 – paragraph 1

Text proposed by the Commission

Amendment

Or. ro

Amendment 1985

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 59 – paragraph 1

Text proposed by the Commission

Amendment

The Commission shall support sharing of best practices and expertise, aimed to build the capacity of Member States to strengthen digital health literacy and systems for primary and secondary use of electronic health data. To support capacity building, the Commission shall draw up benchmarking guidelines for the primary and secondary use of electronic health data.

Or. en

Amendment 1986

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, Ondřej Knotek, Ondřej Kovařík, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 59 a (new)

Text proposed by the Commission

Amendment

Article 59 a

Digital health literacy and digital health access

1. In order to ensure successful implementation of the EHDS, Member States shall put in place educational programmes aimed at increasing digital health literacy and relevant competences and skills. Those programmes shall be tailored to the needs of specific groups, including patients and health professionals, and shall be developed and reviewed, and where necessary updated, on a regular basis in consultation and cooperation with relevant experts and stakeholders.

2. Member States shall measure, on a regular basis, the digital health literacy of health professionals, patients as well as persons in general.

3. Member States shall organise awareness-raising campaigns to ensure that all specific groups are informed about the importance of digital health literacy as well as educational programmes available to them pursuant to paragraph 1.

4. Member States as well as the Commission shall take all the necessary measures to ensure that natural persons, and specifically patients and health professionals, are informed about the EHDS, its primary and secondary components, functionalities and conditions as well as their rights within EHDS.

5. Member States shall ensure that all natural persons have access to the infrastructure necessary for the effective management of their electronic health data, both within primary and secondary use.

Or. en

Amendment 1987

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 60 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Public procurers, national, regional and local competent authorities, including digital health authorities and health data access bodies, and the Commission shall require, as a condition to procure or fund services provided by controllers and processors established in the Union processing personal electronic health data, that such controllers and processors:

(a) will store this data in the Union, in accordance with Article 60a of this Chapter, and

(b) have duly demonstrated that they are not subject to third country legislation conflicting with Union data protection rules.

Or. en

Amendment 1988

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 60 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Public procurers, national competent authorities, including digital health authorities and health data access bodies, and the Commission shall require, as a condition to procure or fund services provided by controllers and processors established in the Union processing personal electronic health data, that such controllers and processors:

(a) will store this data in the Union, in accordance with Article 60a of this Chapter, and

(b) have duly demonstrated that they are not subject to third country legislation conflicting with Union data protection rules.

Or. en

Amendment 1989

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 60 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Two additional requirements shall be established and required as a condition for the procurement or funding of services for processing personal electronic health data:

(a) storing of personal electronic health data in the Union, in line with Article 60a of this Regulation; and

(b) duly demonstrating that applicants are not subject to third country legislation conflicting with EU data protection rules.

Or. en

Justification

Amendment in line with the recommendation of the EDPB/EDPS joint opinion.

Amendment 1990

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 60 a (new)

Text proposed by the Commission

Amendment

Article 60a

Storage of electronic health data

For the purposes of primary and secondary use of electronic health data, Member States shall ensure that the storage, processing and analysis of electronic health data shall be carried out exclusively within a secure location or locations within the territory of the Union, without prejudice to the possibility to transfer personal electronic health data in compliance with Chapter V of Regulation (EU) 2016/679.

Or. en

Amendment 1991

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 60 a (new)

Text proposed by the Commission

Amendment

Article 60a

Storage of electronic health data

Or. en

Amendment 1992

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 60 a (new)

Text proposed by the Commission

Amendment

Article 60a

Electronic health data storage in the Union

1. The personal electronic health data within the scope of this Regulation shall be stored only within the territory of the Union.

2. Paragraph 1 is without prejudice to the possibility of transfers of personal electronic health data in line with Chapter V of the Regulation (EU) 2016/674 or in line with Articles 61 and 62 of this Regulation.

Or. en

Justification

Amendment in line with the recommendation of the EDPB/EDPS joint opinion.

Amendment 1993

Traian Băsescu

Proposal for a regulation

Article 61 – title

Text proposed by the Commission

Amendment

Third country transfer of non-personal electronic data

Third country transfer of anonymous data

Or. ro

Amendment 1994

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

1. Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.

Or. en

Amendment 1995

Konstantinos Arvanitis

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1996

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

The sensitivity of the data must be evaluated on the data merits and not on the destination, therefore the article needs to be clarified

Amendment 1997

Kateřina Konečná

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1998

Christian Doleschal

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

(1) Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.

(1) Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (b) and (f) through to (i)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future. This shall be without prejudice to Article 50(2), third sentence.

Or. de

Amendment 1999

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

1. Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.

Or. en

Amendment 2000

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

1. Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.

Or. en

Amendment 2001

Traian Băsescu

Proposal for a regulation

Article 61 – paragraph 1

Text proposed by the Commission

Amendment

(1) Anonymous electronic data made available by health data access bodies, that are based on a natural person’s electronic health data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.

Or. ro

Amendment 2002

Kateřina Konečná

Proposal for a regulation

Article 61 – paragraph 2

Text proposed by the Commission

Amendment

2. The protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization techniques and shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].

2. The protective measures for the categories of data mentioned in paragraph 1 shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].

Or. en

Amendment 2003

Konstantinos Arvanitis

Proposal for a regulation

Article 61 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 2004

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 61 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 2005

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 61 – paragraph 2

Text proposed by the Commission

Amendment

2. Additional protective measures for the categories of data mentioned in paragraph shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].

Or. en

Justification

Data based on health data is always highly sensitive.

Amendment 2006

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 61 – paragraph 2

Text proposed by the Commission

Amendment

2. The protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization and pseudonymisation techniques and shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].

Or. en

Amendment 2007

Konstantinos Arvanitis

Proposal for a regulation

Article 61 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Where a health data access body has reason to believe that the transfer or access to non-personal data may lead to the risk of re-identification of non-personal or anonymised data, the health data access body shall request the relevant bodies or authorities competent pursuant to applicable data protection legislation for authorisation before transferring or giving access to data.

Or. en

Amendment 2008

Kateřina Konečná

Proposal for a regulation

Article 61 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Where a health data access body has reason to believe that the transfer or access to non-personal data may lead to a risk of re-identification of non-personal or anonymised data, the health data access body shall request the relevant bodies or authorities competent pursuant to applicable data protection legislation for authorisation before transferring or giving access to data.

Or. en

Justification

To ensure alignment with Article 5(13) of the Data Governance Act, the definition of highly sensitive data shall not require further delineation in the current Regulation.

Amendment 2009

Traian Băsescu

Proposal for a regulation

Article 62 – title

Text proposed by the Commission

Amendment

International access and transfer of non-personal electronic health data

International access and transfer of anonymous electronic health data

Or. ro

Amendment 2010

Traian Băsescu

Proposal for a regulation

Article 62 – paragraph 1

Text proposed by the Commission

Amendment

(1) The digital health authorities, health data access bodies, the authorised participants in the cross-border infrastructures provided for in Articles 12 and 52 and data users shall take all reasonable technical, legal and organisational measures, including contractual arrangements, in order to prevent international transfer or governmental access to non-personal electronic health data held in the Union where such transfer or access would create a conflict with Union law or the national law of the relevant Member State, without prejudice to paragraph 2 or 3 of this Article.

(1) The digital health authorities, health data access bodies, the authorised participants in the cross-border infrastructures provided for in Articles 12 and 52 and data users shall take all reasonable technical, legal and organisational measures, including contractual arrangements, in order to prevent international transfer or governmental access to anonymous electronic health data held in the Union where such transfer or access would create a conflict with Union law or the national law of the relevant Member State, without prejudice to paragraph 2 or 3 of this Article.

Or. ro

Amendment 2011

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Michal Šimečka

Proposal for a regulation

Article 62 – paragraph 2

Text proposed by the Commission

Amendment

2. Any judgment of a third-country court or tribunal and any decision of a third-country administrative authority requiring a digital health authority, health data access body or data users to transfer or give access to non-personal electronic health data within the scope of this Regulation held in the Union shall be recognised or enforceable in any manner only if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or any such agreement between the requesting third country and a Member State.

2. Any judgment of a third-country court or tribunal and any decision of a third-country administrative authority requiring a digital health authority, health data access body or data users to transfer or give access to non-personal electronic health data within the scope of this Regulation held in the Union may only be recognised or enforceable in any manner if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or any such agreement between the requesting third country and a Member State.

Or. en

Amendment 2012

Traian Băsescu

Proposal for a regulation

Article 62 – paragraph 2

Text proposed by the Commission

Amendment

(2) Any judgment of a third-country court or tribunal and any decision of a third-country administrative authority requiring a digital health authority, health data access body or data users to transfer or give access to non-personal electronic health data within the scope of this Regulation held in the Union shall be recognised or enforceable in any manner only if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or any such agreement between the requesting third country and a Member State.

(2) Any judgment of a third-country court or tribunal and any decision of a third-country administrative authority requiring a digital health authority, health data access body or data users to transfer or give access to anonymous electronic health data within the scope of this Regulation held in the Union shall be recognised or enforceable in any manner only if based on an international agreement, such as a mutual legal assistance treaty, in force between the requesting third country and the Union or any such agreement between the requesting third country and a Member State.

Or. ro

Amendment 2013

Traian Băsescu

Proposal for a regulation

Article 62 – paragraph 3 – introductory part

Text proposed by the Commission

Amendment

(3) In the absence of an international agreement as referred to in paragraph 2 of this Article, where a digital health authority, a health data access body, data users is the addressee of a decision or judgment of a third-country court or tribunal or a decision of a third-country administrative authority to transfer or give access to non-personal data within the scope of this Regulation held in the Union and compliance with such a decision would risk putting the addressee in conflict with Union law or with the national law of the relevant Member State, transfer to or access to such data by that third-country authority shall take place only where:

(3) In the absence of an international agreement as referred to in paragraph 2 of this Article, where a digital health authority, a health data access body, data users is the addressee of a decision or judgment of a third-country court or tribunal or a decision of a third-country administrative authority to transfer or give access to anonymous data within the scope of this Regulation held in the Union and compliance with such a decision would risk putting the addressee in conflict with Union law or with the national law of the relevant Member State, transfer to or access to such data by that third-country authority shall take place only where:

Or. ro

Amendment 2014

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 62 – paragraph 5

Text proposed by the Commission

Amendment

(5) The digital health authorities, health data access bodies, data users shall inform the data holder about the existence of a request of a third-country administrative authority to access its data before complying with that request, except where the request serves law enforcement purposes and for as long as this is necessary to preserve the effectiveness of the law enforcement activity.

(5) The digital health authorities, bodies involved in accessing health data, data users shall inform the data holder about the existence of a request of a third-country administrative authority to access its data before complying with that request, except where the request serves law enforcement purposes and for as long as this is necessary to preserve the effectiveness of the law enforcement activity.

Or. de

Amendment 2015

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 63 – paragraph 1

Text proposed by the Commission

Amendment

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.

deleted

Or. en

Amendment 2016

Konstantinos Arvanitis

Proposal for a regulation

Article 63 – paragraph 1

Text proposed by the Commission

Amendment

Controllers and processors located in the EU who process personal electronic health data within the scope of this Regulation shall process that data within the territory of the EU.

Or. en

Amendment 2017

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 63 – paragraph 1

Text proposed by the Commission

Amendment

Persons responsible and processors located in the EU who process personal electronic health data in the scope of this Regulation shall store the respective data within the territory of the EU. In the context of international access and transfer of personal electronic health data, shall be granted in accordance with Chapter V of the Regulation (EU) 2016/679.

Or. en

Amendment 2018

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 63 – paragraph 1

Text proposed by the Commission

Amendment

International access and transfer of personal electronic health data shall be granted in accordance with Chapter V of Regulation (EU) 2016/679. 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.

Or. en

Amendment 2019

Konstantinos Arvanitis

Proposal for a regulation

Article 63 – paragraph 1 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

Where a controller that processes personal data in accordance with this Regulation and uses a processor for the purposes referred to in Article 28(3) of Regulation (EU) 2016/679, no transfer of personal data by the processor to a third country shall take place.

Or. en

Amendment 2020

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 63 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Access to electronic health data for entities from third countries, for secondary use purposes, shall be possible only if the third country where an entity is established, allows access to health data of its residents for entities from the Union.

Or. en

Amendment 2021

Cristian-Silviu Buşoi

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor may be invited to the meetings, where the issues discussed are of relevance for them. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.

1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of:

(a) one high level representative of digital health authorities and one high level representative of health data access bodies appointed by each Member State;

(b) one representative of the European Data Protection Board (EDPB) and one representative of the European Data Protection Supervisor (EDPS);

(d) one representative of the European Centre for Disease Prevention and Control (ECDC);

(e) one member and one alternate member appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent healthcare professionals;

(f) one member and one alternate member appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent patient organisations;

(g) one member and one alternate member appointed by the Commission, on the basis of a public call for expressions of interest, after consulting the European Parliament, in order to represent the health industry;

Or. en

Amendment 2022

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, Ondřej Knotek, Ondřej Kovařík, María Soraya Rodríguez Ramos, Frédérique Ries, Andreas Glück, Michal Šimečka

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. A European Health Data Space Board (EHDS Board) is hereby established.

The EHDS Board shall be composed of:

(a) one high level representative of digital health authorities of all the Member States; and

(b) one high level representative of health data access bodies of all the Member States. Where a Member State has designated several health data access bodies, the coordinating health data access body shall be part of the EHDS Board; and

The EHDS Board shall be aided by an advisory forum as referred to in Article 65a.

EMA, ECDC, ENISA shall be invited by the Board to join the meeting where the issues discussed are of relevance to their respective mandates or tasks. Other national authorities, including market surveillance authorities referred to in Article 28, may be invited to the meetings, where the issues discussed are of relevance for them. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.

Or. en

Amendment 2023

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor shall be invited to the meetings, where the issues discussed are of relevance for them. The Board shall also consult on a regular basis European level patient organisations and European level healthcare professional organisations and may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.

Or. en

Amendment 2024

Mathilde Androuët

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

Or. fr

Amendment 2025

Véronique Trillet-Lenoir, Fabienne Keller, Max Orville, Frédérique Ries

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States, as well as representatives of stakeholders, including health professionals, patients and consumers' organisations. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor may be invited to the meetings, where the issues discussed are of relevance for them. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.

Or. en

Amendment 2026

Pernille Weiss

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor may be invited to the meetings, where the issues discussed are of relevance for them. The Board shall, where relevant, invite experts and other relevant stakeholders to attend its meetings and to cooperate on aspects of its work. Such stakeholders may include actors of the public and private sector, patients, health professionals, and researchers. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.

Or. en

Amendment 2027

Kateřina Konečná

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States, as well as representatives of health stakeholders, including patient organisations. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor may be invited to the meetings, where the issues discussed are of relevance for them. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.

Or. en

Justification

The participation of patient representatives in the meetings of the EHDS Board should not be conditional on the topics discussed and their degree of sensitivity. The unique experience that patients can bring is fundamental to driving the implementation of the EHDS, building a high level of trust and ensuring that patients’ needs are fully taken into consideration. In shaping the governance of the EHDS at European level, inspiration could be taken from the EMA, which has a long-standing commitment to and appropriate structures for engaging with civil society stakeholders.

Amendment 2028

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States, and high-level representatives of the European Data Protection Board and the European Data Protection Supervisor. Other national authorities, including market surveillance authorities referred to in Article 28, shall be invited to the meetings as permanent observers. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an ad hoc observer role where the issues discussed are of relevance for them.

Or. en

Amendment 2029

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States and of the European Data Protection Board and the European Data Protection Supervisor. Other national authorities, including market surveillance authorities referred to in Article 28, may be invited to the meetings, where the issues discussed are of relevance for them. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.

Or. en

Amendment 2030

Konstantinos Arvanitis

Proposal for a regulation

Article 64 – paragraph 1

Text proposed by the Commission

Amendment

1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor shall be invited to the meetings, where the issues discussed are of relevance for them. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.

Or. en

Amendment 2031

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 64 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Permanent and alternate members of the EHDS Board shall act independently, in the public interest and free from any external influence. EHDS Board permanent and alternate members shall have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Permanent and alternate members of the EHDS Board shall make an annual declaration of their interests, which shall be available on the Commission’s web-portal.

Or. en

Amendment 2032

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 64 – paragraph 3

Text proposed by the Commission

Amendment

3. The composition, organisation, functioning and cooperation of the sub-groups shall be set out in the rules of procedure put forward by the Commission.

3. The composition, organisation, functioning and cooperation of the sub-groups shall be set out in the rules of procedure put forward by the Commission. The Commission shall make publicly available the membership and observers of the EHDS Board and its outputs, including rules of procedure, guidance, minutes, and meeting agendas.

Or. en

Amendment 2033

Mathilde Androuët

Proposal for a regulation

Article 64 – paragraph 3

Text proposed by the Commission

Amendment

3. The composition, organisation, functioning and cooperation of the sub-groups shall be set out in the rules of procedure put forward by the Commission.

3. The composition, organisation, functioning and cooperation of the sub-groups shall be set out in the rules of procedure put forward by the Commission to high-level representatives of the digital health authorities and organisations responsible for health data access in all Member States.

Or. fr

Amendment 2034

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, María Soraya Rodríguez Ramos, Andreas Glück, Michal Šimečka

Proposal for a regulation

Article 64 – paragraph 4

Text proposed by the Commission

Amendment

4. Stakeholders and relevant third parties, including patients’ representatives, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.

deleted

Or. en

Justification

Deletion necessary because a new structure, an advisory forum composed of relevant stakeholders, is created in Article 65a to facilitate the work of the EHDS Board.

Amendment 2035

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 64 – paragraph 4

Text proposed by the Commission

Amendment

4. Stakeholders and relevant third parties, including patients’, consumers’ and healthcare professionals’ representatives, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity. All invited stakeholders shall provide a declaration of all direct and indirect economic, financial or personal interests ahead of the meeting to the EHDS Board.

Or. en

Amendment 2036

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 64 – paragraph 4

Text proposed by the Commission

Amendment

4. Relevant stakeholders, including patients' and healthcare professional's organisations and academia, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.

Or. en

Amendment 2037

Véronique Trillet-Lenoir, Fabienne Keller, Max Orville, Frédérique Ries

Proposal for a regulation

Article 64 – paragraph 4

Text proposed by the Commission

Amendment

4. Stakeholders and relevant third parties, including health professionals, patients and consumers' representatives, shall attend meetings of the EHDS Board and to participate in its work.

Or. en

Amendment 2038

Kateřina Konečná

Proposal for a regulation

Article 64 – paragraph 4

Text proposed by the Commission

Amendment

4. Health stakeholders, including patients’ representatives, and relevant third parties, shall attend meetings of the EHDS Board and participate in its work.

Or. en

Justification

Amendment 2039

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 64 – paragraph 5

Text proposed by the Commission

Amendment

5. The EHDS Board shall cooperate with other relevant bodies, entities and experts, such as the European Data Innovation Board referred to in Article 26 of Regulation […] [Data Governance Act COM/2020/767 final], competent bodies set up under Article 7 of Regulation […] [Data Act COM/2022/68 final], supervisory bodies set up under Article 17 of Regulation […] [eID Regulation], European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679 and cybersecurity bodies.

Or. en

Amendment 2040

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 64 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. The EHDS Board, in conjunction with the European Commission, shall publish an annual report covering the implementation status of the European Health Data Space and other relevant points of development, including with respect to cross-border health data interoperability, and implementation challenges.

Or. en

Amendment 2041

Konstantinos Arvanitis

Proposal for a regulation

Article 64 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall chair the meetings of the EHDS Board.

deleted

Or. en

Amendment 2042

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 64 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall chair the meetings of the EHDS Board.

6. A representative of the Commission and a representative of the European Parliament shall co-chair the meetings of the EHDS Board.

Or. en

Amendment 2043

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, Sophia in 't Veld, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 64 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7a. The EHDS Board shall operate in a transparent manner with open publication of meeting dates and minutes of the discussions and produce and annual report on its activities.

Or. en

Amendment 2044

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, Ondřej Knotek, Ondřej Kovařík, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 64 a (new)

Text proposed by the Commission

Amendment

Article 64a

Advisory forum

1. An advisory forum shall be established by the EHDS Board to advise it in the fulfilment of its tasks by providing stakeholder input in matters pertaining to this Regulation.

2. EMA, ECDC, JRC shall be permanent members of the advisory forum.

3. The advisory forum shall be composed of representatives of patients, health professionals, industry, scientific researchers and academia. The advisory forum shall have a balanced composition and represent the views of different relevant stakeholders. The composition of the advisory forum shall be balanced between commercial and non-commercial interests and, within the commercial interests, it shall be balanced between large companies, SMEs and start-ups. Focus on primary and secondary use of electronic health data shall also be balanced.

4. Members of the advisory forum shall be appointed by the Commission following a public call for interest and a transparent selection procedure, in consultation with the European Parliament.

5. The term of office of the members of the advisory forum shall be two years and it shall not be renewable more than twice consecutively.

6. The advisory forum may establish standing or temporary subgroups as appropriate for the purpose of examining specific questions related to the objectives of this Regulation.

7. The advisory forum shall draw up its rules of procedure and elect two co-Chairs from among its members, one of them being from its permanent members. Their term of office shall be two years, renewable once.

8. The advisory forum shall hold regular meetings. The advisory forum can invite relevant experts and other relevant stakeholders to its meetings. The Chair of the EHDS Board may attend, ex officio, the meetings of the advisory forum.

9. In fulfilling its role as set out in paragraph 1, the advisory forum may prepare opinions, recommendations or written contributions.

10. The advisory forum shall prepare an annual report of its activities. That report shall be made publicly available.

Or. en

Amendment 2045

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 65 – paragraph 1 – point -a (new)

Text proposed by the Commission

Amendment

(-a) to exercise oversight over the implementation and proper enforcement of Chapter II, without prejudice to the competences of EDPB where personal electronic health data are concerned;

Or. en

Amendment 2046

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 65 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) to assist Member States in coordinating practices of digital health authorities;

(a) to assist Member States and, where appropriate, regions in coordinating practices of digital health authorities;

Or. en

Amendment 2047

Tomislav Sokol

Proposal for a regulation

Article 65 – paragraph 1 – point b – introductory part

Text proposed by the Commission

Amendment

(b) to issue written contributions and to exchange best practices on matters related to the coordination of the implementation at Member State level of this Regulation and of the delegated and implementing acts adopted pursuant to it, in particular as regards:

Or. en

Amendment 2048

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 65 – paragraph 1 – point b – point iii

Text proposed by the Commission

Amendment

(iii) other aspects of the primary use of electronic health data.

(iii) other aspects of the primary use of electronic health data, with the exception of aspects concerning the protection of natural persons when processing their personal data.

Or. en

Amendment 2049

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 65 – paragraph 1 – point b – point iii

Text proposed by the Commission

Amendment

(iii) other aspects of the primary use of electronic health data.

(iii) other aspects of the primary use of electronic health data, with the exception of all matters related to personal data protection.

Or. en

Justification

The Board cannot issue opinions on matter of data protection given the exclusive competences of DPAs in that field.

Amendment 2050

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 65 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(ba) All aspects under point (b) related to data protection rights and issues shall be left to the EDPB in order to ensure consistent application of the existing data protection framework.

Or. en

Amendment 2051

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 65 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) to share information concerning risks posed by EHR systems and serious incidents as well as their handling;

(d) to share information between members of the EHDS Board concerning risks posed by EHR systems and serious incidents as well as how they were handled. The EDPB shall be responsible for identifying all possible data protection risks posed by EHR systems and provide guidance for their handling;

Or. en

Amendment 2052

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 65 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) to share information concerning risks posed by EHR systems and serious incidents as well as their handling;

(d) to share information concerning risks posed by EHR systems and serious incidents as well as their handling, without prejudice to the obligation to inform competent supervisory authorities pursuant to Regulation (EU) 2016/679;

Or. en

Amendment 2053

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 65 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) to facilitate the exchange of views on the primary use of electronic health data with the relevant stakeholders, including representatives of patients, health professionals, researchers, regulators and policy makers in the health sector.

(e) to facilitate the exchange of views on the primary use of electronic health data with the relevant stakeholders, including representatives of patients, consumers, health professionals, regulators and policy makers in the health sector.

Or. en

Amendment 2054

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 65 – paragraph 2 – point -a (new)

Text proposed by the Commission

Amendment

(-a) to exercise oversight over the implementation and proper enforcement of Chapter IV, without prejudice to the competences of EDPB where personal electronic health data are concerned;

Or. en

Amendment 2055

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 65 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) to assist Member States in coordinating practices of health data access bodies in the implementation of provisions set out in Chapters IV, to ensure a consistent application of this Regulation;

(a) to assist Member States and, where appropriate, regions in coordinating practices of health data access bodies in the implementation of provisions set out in Chapters IV, to ensure a consistent application of this Regulation;

Or. en

Amendment 2056

Pernille Weiss

Proposal for a regulation

Article 65 – paragraph 2 – point b – point iii

Text proposed by the Commission

Amendment

(iii) incentives policy for promoting data quality and interoperability improvement;

(iii) incentives policy for promoting data quality and interoperability improvement, including facilitating the development of harmonised guidance for anonymisation and pseudonymisation of health data;

Or. en

Amendment 2057

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 65 – paragraph 2 – point b – point v

Text proposed by the Commission

Amendment

(v) the establishment and application of penalties;

(v) the establishment, calculation and application of penalties;

Or. fr

Amendment 2058

Mathilde Androuët

Proposal for a regulation

Article 65 – paragraph 2 – point b – point v

Text proposed by the Commission

Amendment

(v) the establishment and application of penalties;

(v) the establishment of penalties;

Or. fr

Amendment 2059

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 65 – paragraph 2 – point b – point vi

Text proposed by the Commission

Amendment

(vi) other aspects of the secondary use of electronic health data.

(vi) other aspects of the secondary use of electronic health data, with the exception of aspects concerning the protection of natural persons when processing their personal data.

Or. en

Amendment 2060

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 65 – paragraph 2 – point b – point vi

Text proposed by the Commission

Amendment

(vi) other aspects of the secondary use of electronic health data.

(vi) other aspects of the secondary use of electronic health data, with the exception of all matters related to personal data protection.

Or. en

Justification

The Board cannot issue opinions on matter of data protection given the exclusive competences of DPAs in that field.

Amendment 2061

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 65 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(ba) All aspects under point (b) related to data protection rights and issues shall be left to the EDPB in order to ensure consistent application of the existing data protection framework.

Or. en

Amendment 2062

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 65 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) to facilitate cooperation between health data access bodies through capacity-building, establishing the structure for annual activity reporting, peer-review of annual activity reports and exchange of information;

(c) to facilitate cooperation and exchange of best practices between health data access bodies through capacity-building, establishing the structure for annual activity reporting, peer-review of annual activity reports and exchange of information pursuant to the obligations laid down in Article 37(1), point (q);

Or. en

Amendment 2063

Pernille Weiss

Proposal for a regulation

Article 65 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

(ca) to provide expertise for amending the list of minimum categories of electronic data for secondary use in accordance with Article 33(7);

Or. en

Amendment 2064

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 65 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) to share information concerning risks and data protection incidents related to secondary use of electronic health data, as well as their handling;

(d) to share information between members of the EHDS Board concerning risks and data protection incidents related to secondary use of electronic health data, as well as how they were handled. The EDPB shall be responsible for identifying all possible data protection risks and provide guidance for their handling;

Or. en

Amendment 2065

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 65 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(da) Propose updates of the concepts of personal health data, non-personal health data and anonymisation techniques in line with Regulation (EU) 2016/679 and the existing recommendations at EU and international level;

Or. fr

Justification

The aim is to make this regulatory framework more agile by ensuring that the concepts of personal health data, non-personal health data and anonymisation techniques are implemented effectively. These updates fall within the remit of the EHDS Board, as they will allow for more cooperation between the Member States.

Amendment 2066

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 65 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) to facilitate the exchange of views on the secondary use of electronic health data with the relevant stakeholders, including representatives of patients, health professionals, researchers, regulators and policy makers in the health sector to support the design of aligned implementation strategies, guidance and standards and to assess the needs for further improvement.

Or. en

Amendment 2067

Pernille Weiss

Proposal for a regulation

Article 65 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) to facilitate the exchange of views on the secondary use of electronic health data with the relevant stakeholders, including representatives of patients, health professionals, researchers, industry representatives, regulators and policy makers in the health sector.

Or. en

Amendment 2068

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 65 – paragraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(fa) to publish an annual report to include the implementation status of the European Health Data Space and other relevant points of development, including the respect to the opt-out mechanism, cross-border health data interoperability, implementation challenges, guidance and recommendations to digital health authorities, and its conclusions on the implementation and enforcement of this Regulation.

Or. en

Amendment 2069

Konstantinos Arvanitis

Proposal for a regulation

Article 65 – paragraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(fa) to elaborate and monitor the implementation of a common code of ethical conduct for the secondary uses of personal health data.

Or. en

Amendment 2070

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 66 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish two groups dealing with joint controllership for the cross-border infrastructures provided for in Articles 12 and 52. The groups shall be composed of the representatives of the national contact points and other authorised participants in those infrastructures.

1. The Commission shall establish two groups dealing with joint controllership for the cross-border infrastructures provided for in Articles 12 and 52. The groups shall be composed of the representatives of the contact points and other authorised participants in those infrastructures.

Or. en

Amendment 2071

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 66 – paragraph 3

Text proposed by the Commission

Amendment

3. Stakeholders and relevant third parties, including patients’ representatives, may be invited to attend meetings of the groups and to participate in their work.

3. Stakeholders and relevant third parties, including patients’, consumers’ and healthcare professionals’ representatives and data protection experts, may be invited to attend meetings of the groups and to participate in their work.

Or. en

Amendment 2072

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 66 – paragraph 3

Text proposed by the Commission

Amendment

3. Stakeholders and relevant third parties, including patients’ representatives, may be invited to attend meetings of the groups and to participate in their work.

3. Stakeholders and relevant third parties, including patients’ and healthcare professionals’ representatives, may be invited to attend meetings of the groups and to participate in their work.

Or. fr

Amendment 2073

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 66 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6a. The groups shall consult relevant experts when carrying out their tasks as well as on technical implementing measures related to cybersecurity, confidentiality and data protection, especially ENISA and EDPB and EDPS.

Or. en

Amendment 2074

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 67 – paragraph 2

Text proposed by the Commission

Amendment

2. The power to adopt delegated acts referred to in Articles 5(2), 10(3), 25(3), 32(4), 33(7), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

2. The power to adopt delegated acts referred to in Articles 7(3), 9(2), 25(3), 26(4a) 32(4), 39(3), 41(7), 42(6) 45(7), 46(8), 52(7), 52(13), 53(3), 55(2), 56(4) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

Or. en

Amendment 2075

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 67 – paragraph 2

Text proposed by the Commission

Amendment

2. The power to adopt delegated acts referred to in Articles 5(2), 10(3), 25(3), 32(4), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

Or. en

Amendment 2076

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 67 – paragraph 2

Text proposed by the Commission

Amendment

2. The power to adopt delegated acts referred to in Articles 5(2), 7(3), 25(3), 32(4), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

Or. en

Amendment 2077

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 67 – paragraph 2

Text proposed by the Commission

Amendment

(2) The power to adopt delegated acts referred to in Articles 5(2), 10(3), 25(3), 32(4), 33(7), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

(2) The power to adopt delegated acts referred to in Articles 5(2), 10(3), 25(3), 32(4), 33(7), 37(4), 39(3), 45(7), 46(8), 52(7), 56(4) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

Or. de

Amendment 2078

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 67 – paragraph 3

Text proposed by the Commission

Amendment

3. The power to adopt delegated acts referred to in Articles 5(2), 10(3), 25(3), 32(4), 33(7), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

3. The power to adopt delegated acts referred to in Articles 7(3), 9(2), 25(3), 26(4a), 32(4), 39(3), 41(7), 42(6), 45(7), 46(8), 52(7), 52(13), 53(3), 55(2), 56(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Or. en

Amendment 2079

Konstantinos Arvanitis

Proposal for a regulation

Article 67 – paragraph 3

Text proposed by the Commission

Amendment

3. The power to adopt delegated acts referred to in Articles 5(2), 10(3), 25(3), 32(4), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Or. en

Amendment 2080

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 67 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 2081

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 67 – paragraph 3

Text proposed by the Commission

Amendment

3. The power to adopt delegated acts referred to in Articles 5(2), 7(3), 25(3), 32(4), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

Or. en

Amendment 2082

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 67 – paragraph 4

Text proposed by the Commission

Amendment

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making. In accordance with Article 42 of Regulation (EU) 2018/1725, the Commission shall consult the European Data Protection Board and European Data Protection Supervisor where the delegated acts concern data protection.

Or. en

Amendment 2083

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 67 – paragraph 4

Text proposed by the Commission

Amendment

4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State and targeted stakeholders, including health professionals and patients’ organisations, in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making.

Or. en

Amendment 2084

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 67 – paragraph 6

Text proposed by the Commission

Amendment

6. A delegated act adopted pursuant to Articles 5(2), 10(3), 25(3), 32(4), 33(7), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 3 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or of the Council.

6. A delegated act adopted pursuant to Articles 7(3), 9(2), 25(3), 26(4a), 32(4), 39(3), 41(7), 42(6), 45(7), 46(8), 52(7), 52(13), 53(3), 55(2), 56(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 3 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or of the Council.

Or. en

Amendment 2085

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 67 – paragraph 6

Text proposed by the Commission

Amendment

6. A delegated act adopted pursuant to Articles 5(2), 10(3), 25(3), 32(4), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 56(4) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 3 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or of the Council.

Or. en

Amendment 2086

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 68 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. In accordance with the Inter-Institutional Agreement of 13 April 2016 on Better Law-Making, the Commission shall make use of expert groups, consult targeted stakeholders and carry out public consultations to gather broader expertise in the early preparation of draft implementing acts.

Or. en

Amendment 2087

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 68 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Or. en

Justification

Amendment necessary to make reference to the examination procedure, which we suggest to introduce in several cases in the text of the Regulation.

Amendment 2088

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, Ondřej Knotek, Ondřej Kovařík, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 69 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.

1. Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties shall be effective, proportionate and dissuasive. Specific attention shall be given to penalties for serious breaches of this Regulation, as referred to in Article 41a(3) and Article 44(3). Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.

2. Penalties referred to in paragraph 1 shall be without prejudice to the penalties established pursuant to Regulation (EU) 2016/679 and Regulation (EU) 2018/1725.

3. The Commission shall provide Member States with guidelines and recommendations on the types and levels of penalties in order to prevent forum shopping and ensure fair enforcement, especially in cross-border cases.

4. Member States are encouraged to consider criminalising re-identification of anonymised data.

Or. en

Amendment 2089

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 69 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall lay down the rules on penalties applicable to infringements of this Regulation, for all public and private stakeholders, in particular for the non-respect of data access and usage provisions with intent or by negligence, and shall take all measures necessary to ensure that they are properly and effectively implemented. The penalties shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them. Penalties shall cover infringements not addressed by Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) No 536/2014 and Regulation (EU) 2016/679.

Or. en

Amendment 2090

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 69 – paragraph 1

Text proposed by the Commission

Amendment

Penalties shall cover infringements not addressed by Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) No 536/2014 and Regulation (EU) 2016/679 and shall depend on the circumstances of each individual case. When deciding whether to impose a penalty and deciding on the amount of the penalty in each individual case, due regard shall be given to the criteria stated in Article 83(2) of Regulation (EU) 2016/679, where applicable.

Or. en

Amendment 2091

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 69 – paragraph 1

Text proposed by the Commission

Amendment

Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are implemented. The penalties shall be effective, proportionate, dissuasive and encouraging corrective action to the infringements. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.

Or. en

Amendment 2092

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 69 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

When deciding on the amount of the penalty in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following:

(a) the nature, gravity and duration of the infringement and of its consequences, taking into account the nature, scope as well as the number of users affected and the level of damage suffered by them;

(b) whether penalties have been already applied by other competent authorities to the same infringing party;

(d) the intentional or negligent character of the infringement;

(e) any action taken by the infringing party to mitigate the damage of the infringement;

(f) the degree of responsibility of the infringing party taking into account technical and organisational measures implemented to prevent the infringement;

(g) the degree of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement;

(h) the manner in which the infringement became known to the competent authorities, in particular whether, and if so to what extent, the infringing party notified the infringement;

(i) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement, or a violation of Article 35(2).

Or. en

Amendment 2093

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 69 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

The non-compliance of an entity with any requirements or obligations under this Regulation, including the supply of incorrect, incomplete or misleading information to national competent authorities, shall be subject to penalties of up to 20 million EUR or, or in the case of an undertaking, up to 10% of its total worldwide annual turnover for the preceding financial year, whichever is higher. In case the non-compliance is still going on, the health data access body shall have the power to fine the entity with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the health data access body pursuant to paragraph 1a.

Or. en

Amendment 2094

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 69 a (new)

Text proposed by the Commission

Amendment

Article 69a

Right to an effective judicial remedy against a controller or processor

In accordance with Article 79 of Regulation (EU) 2016/679, without prejudice to any available administrative or non-judicial remedy, including the right to lodge a complaint with a digital health authority pursuant to Article 11 or with a health data access body pursuant to Article 38a, each natural person shall have the right to an effective judicial remedy where he or she considers that his or her rights under this Regulation have been infringed as a result of the processing of his or her personal data in non-compliance with the Regulation.

Or. en

Amendment 2095

Konstantinos Arvanitis

Proposal for a regulation

Article 69 a (new)

Text proposed by the Commission

Amendment

Article 69a

Right to compensation

Any person who has suffered material or non-material damage as a result of an infringement of this Regulation shall have the right to receive compensation, in accordance to national and Union law, from the data holder, data user, data recipient, health professional, healthcare provider, EHR system manufacturer, EHR system importer, EHR system distributor, EHR system authorised representative or Health Data Access Body responsible for the infringement.

Or. en

Amendment 2096

Kateřina Konečná

Proposal for a regulation

Article 69 a (new)

Text proposed by the Commission

Amendment

Article 69a

Right to compensation

Or. en

Justification

Besides the right to lodge a collective complaint with the digital health authority, as foreseen in Article 11 of the proposal, the Regulation should also foresee the right to compensation for material or non-material damages suffered as a result of infringement of this Regulation.

Amendment 2097

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 69 b (new)

Text proposed by the Commission

Amendment

Article 69b

Right to receive compensation

Any person who has suffered material or non-material damage as a result of an infringement of this Regulation shall have the right to receive compensation, in accordance with national and Union law.

Or. en

Amendment 2098

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, Ondřej Knotek, Ondřej Kovařík, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 70 – paragraph 1

Text proposed by the Commission

Amendment

1. After 5 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of the self-certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies.

1. After 5 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III, including the need to extend interoperability possibilities between EHR systems and electronic health data access services other than those established by the Member States, the possibility to expand the access to MyHealth@EU infrastructure to third countries and international organisations, the implementation and use by natural persons of the opt-out mechanism in secondary use as referred to in Article -33a, the use and implementation of the right referred to in Article 3(9), the implementation of Articles 33 and 34 as well as the application of fees as referred to in Article 42, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment.

Or. en

Amendment 2099

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 70 – paragraph 1

Text proposed by the Commission

Amendment

1. After 5 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III and IV, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of the self-certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies, as well as the need to designate a public testing facility of a Member State as a Union testing facility, pursuant to Article 21 of Regulation (EU) 2019/1020. The evaluation shall also assess the added value, associated risks and feasibility of adding wellness applications and other digital health applications in the scope of primary and secondary use of the EHDS.

Or. en

Amendment 2100

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 70 – paragraph 1

Text proposed by the Commission

Amendment

1. After 3 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment.

Or. en

Amendment 2101

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 70 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 2102

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 70 – paragraph 1

Text proposed by the Commission

Amendment

1. After 5 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapters III and IV, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of the self-certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies. It shall also include an evaluation of the opt-out mechanism laid down in Article 33(5) and recommendations on how to strengthen it.

Or. en

Amendment 2103

Mathilde Androuët

Proposal for a regulation

Article 70 – paragraph 1

Text proposed by the Commission

Amendment

1. No later than after 2 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of the self-certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies.

Or. fr

Amendment 2104

Konstantinos Arvanitis

Proposal for a regulation

Article 70 – paragraph 1

Text proposed by the Commission

Amendment

1. After 5 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of the certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies.

Or. en

Amendment 2105

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 70 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. After two years from the entry into force of this Regulation, the Commission shall carry out an evaluation on the Union funding attributed to the setting up and working of the EHDS, notably as to the ability of Union bodies to carry out their tasks under this Regulation and of Member States to apply the Regulation in a uniform and coherent manner. The Commission shall submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by legislative proposals. Stakeholders shall be consulted in the preparation of the evaluation report.

Or. en

Amendment 2106

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, Ondřej Knotek, Ondřej Kovařík, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Article 70 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. After 2 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of the Union funding made available for the setting up of the European Health Data Space as well as an evaluation of funding allocated to this end by Member States, and where appropriate, consider further measures in this regard.

Or. en

Amendment 2107

Mathilde Androuët

Proposal for a regulation

Article 70 – paragraph 2

Text proposed by the Commission

Amendment

2. After 7 years from the entry into force of this Regulation, the Commission shall carry out an overall evaluation of this Regulation, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment.

2. No later than after 5 years from the entry into force of this Regulation, the Commission shall carry out an overall evaluation of this Regulation, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment.

Or. fr

Amendment 2108

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 70 a (new)

Text proposed by the Commission

Amendment

Article 70a

Amendments to Directive 2020/1828/EC

In the Annex of Directive (EU) 2020/1828, the following point is added: (XX) Regulation (EU) XXX of the European Parliament and of the Council on the European Health Data Space.

Or. en

Justification

To ensure that individuals can benefit from all the redress mechanisms envisaged in the EU Representative Actions Directive, the EHDS regulation must be referenced in the Annex of the directive.

Amendment 2109

Konstantinos Arvanitis

Proposal for a regulation

Article 71 a (new)

Text proposed by the Commission

Amendment

Article 71a

Amendments to Directive (EU) 2020/1828

In the Annex of Directive (EU) 2020/1828, the following point is added:

(XX) Regulation (EU) XXX of the European Parliament and of the Council on the European Health Data Space.

Or. en

Amendment 2110

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 71 a (new)

Text proposed by the Commission

Amendment

Article 71a

Amendment to Directive (EU) 2020/1828

In the Annex of Directive (EU) 2020/1828, the following point is added:“(XX) Regulation (EU) XXX of the European Parliament and of the Council on the European Health Data Space”

Or. en

Justification

To ensure that individuals can benefit from all the redress mechanisms envisaged in the Representative Actions Directive (RAD), the EHDS Regulation must be referenced in the Annex of the RAD.

Amendment 2111

Beata Kempa

Proposal for a regulation

Article 72 – paragraph 2

Text proposed by the Commission

Amendment

It shall apply from 12 months after its entry into force.

It shall apply from 24 months after its entry into force.

Or. en

Amendment 2112

Joanna Kopcińska

Proposal for a regulation

Article 72 – paragraph 2

Text proposed by the Commission

Amendment

It shall apply from 12 months after its entry into force.

It shall apply from 24 months after its entry into force.

Or. en

Amendment 2113

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, María Soraya Rodríguez Ramos, Michal Šimečka

Proposal for a regulation

Article 72 – paragraph 2

Text proposed by the Commission

Amendment

It shall apply from 12 months after its entry into force.

It shall apply from 24 months after its entry into force.

Or. en

Amendment 2114

Beata Kempa

Proposal for a regulation

Article 72 – paragraph 2

Text proposed by the Commission

Amendment

It shall apply from 12 months after its entry into force.

It shall apply from 24 months after its entry into force.

Or. pl

Amendment 2115

Javier Zarzalejos

Proposal for a regulation

Article 72 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) from 1 year after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process such categories of data.;

(a) from two years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process such categories of data.;

Or. en

Amendment 2116

Joanna Kopcińska

Proposal for a regulation

Article 72 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) from 3 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process such categories of data.;

Or. en

Amendment 2117

Javier Zarzalejos

Proposal for a regulation

Article 72 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) from 3 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;

(b) from four years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;

Or. en

Amendment 2118

Joanna Kopcińska

Proposal for a regulation

Article 72 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) from 5 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;

Or. en

Amendment 2119

Beata Kempa

Proposal for a regulation

Article 72 – paragraph 3 – point b

Text proposed by the Commission

Amendment

Or. en

Amendment 2120

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 72 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) from 2 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (d), (e) and (f), and to EHR systems intended by the manufacturer to process such categories of data;

Or. en

Amendment 2121

Beata Kempa

Proposal for a regulation

Article 72 – paragraph 3 – point b

Text proposed by the Commission

Amendment

Or. pl

Amendment 2122

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Article 72 – paragraph 4

Text proposed by the Commission

Amendment

Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from 3 years after date of entry into application.

Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from 2 years after date of entry into application.

Or. en

Amendment 2123

Joanna Kopcińska

Proposal for a regulation

Article 72 – paragraph 4

Text proposed by the Commission

Amendment

Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from 3 years after date of entry into application.

Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from 5 years after date of entry into application.

Or. en

Amendment 2124

Joanna Kopcińska

Proposal for a regulation

Article 72 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

Chapter IV shall apply 4 years after the date of entry into force of this Regulation.

Or. en

Amendment 2125

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 72 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

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).

Or. en

Amendment 2126

István Ujhelyi

Proposal for a regulation

Annex I – subheading 1

Text proposed by the Commission

Amendment

Main characteristics of electronic health data categories

Main characteristics of electronic health data categories Electronic health data that includes important clinical facts related to an identified person and that is essential for the provision of safe and efficient healthcare to that person. The following information is part of a patient summary: 1. Personal details 2. Contact information 3. Allergies 4. Medical alerts 5.Vaccination/prophylaxis information, possibly in the form of a vaccination card 6. Current, resolved, closed or inactive problems 7. Medical devices and implants 8. Medical Procedures 9. Functional status 10. Current and relevant past medicines 11. Social history observations related to health on which the healthcare provider/ health professional bases their care or which are useful for the continuity of care or the management of the patient by another healthcare professional 12. Pregnancy history 13. Observation results pertaining to the health condition on which the /healthcare provider/ health professional bases his care or which are useful for the continuity of care or the management of the patient by another healthcare professional. 14. Plan of care 15. Information on a rare disease such as details about the impact or characteristics of the disease

Or. en

Amendment 2127

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex II – point 2 – point 2.3

Text proposed by the Commission

Amendment

2.3. An EHR system that includes a functionality for entering structured personal electronic health data shall enable the entry of data structured in a structured way that supports the data sharing in a structured, commonly used and machine-readable format, enabling system to system communication.

2.3. An EHR system that includes a functionality for entering structured personal electronic health data shall enable the entry of data structured in a structured way that supports the data sharing in a structured, commonly used, open and machine-readable format, enabling system to system communication.

Or. en

Amendment 2128

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Annex II – point 2 – point 2.4

Text proposed by the Commission

Amendment

2.4. An EHR system shall not include features that prohibit, restrict or place undue burden on authorised access, personal electronic health data sharing, or use of personal electronic health data for permitted purposes, in particular on the basis of commercial considerations and beyond security and legal safeguards requirements.

Or. en

Justification

Enhancing the portability provisions

Amendment 2129

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Annex II – point 2 – point 2.5

Text proposed by the Commission

Amendment

2.5. An EHR system shall not include features that prohibit, restrict or place undue burden on authorised exporting of personal electronic health data for the reasons of replacing the EHR system by another product. Authorised exporting of personal electronic health data shall be free of charge, without undue delay, or in in any event within one month from the request and in a structured, commonly used and machine-readable format, in line with the interoperability and security requirements to be developed according to Articles 23 and 50.

Or. en

Amendment 2130

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Annex II – point 2 – point 2.5 a (new)

Text proposed by the Commission

Amendment

2.5a. An EHR system shall be developed in interoperable format that enables data portability.

Or. en

Amendment 2131

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Nicolás González Casares, Heléne Fritzon

Proposal for a regulation

Annex II – point 3 – point 3.1

Text proposed by the Commission

Amendment

3.1. An EHR system shall be designed and developed in such a way that it ensures safe and secure processing of electronic health data, and that it prevents unauthorised access to such data.

3.1. An EHR system shall be designed and developed in such a way that it ensures highly safe and secure processing of electronic health data, and that it prevents unauthorised access to such data.

Or. en

Amendment 2132

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Véronique Trillet-Lenoir, María Soraya Rodríguez Ramos, Frédérique Ries, Michal Šimečka

Proposal for a regulation

Annex II – point 3 – point 3.8

Text proposed by the Commission

Amendment

3.8. An EHR system designed for the storage of electronic health data shall support different retention periods and access rights that take into account the origins and categories of electronic health data.

Or. en

Justification

Amendment in line with EDPB/EDPS joint opinion recommendation.

Amendment 2133

Sara Cerdas, Monika Beňová, Tudor Ciuhodaru, Romana Jerković, Heléne Fritzon

Proposal for a regulation

Annex IV a (new)

Text proposed by the Commission

Amendment

ANNEX IVa

1. EU type-examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an EHR system and verifies and attests that the technical design of the EHR system meets the applicable requirements of this Regulation.

2. EU type-examination shall be carried out by assessment of the adequacy of the technical design of the EHR system through examination of the technical documentation, plus examination of a specimen of the EHR system that is representative of the production envisaged (production type).

3. Application for EU type-examination

The manufacturer shall lodge an application for EU type-examination with a single notified body of his or her choice. The application shall include:

(a) the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of that authorised representative;

(b) a written declaration that the same application has not been lodged with any other notified body;

(d) the specimen(s) of the EHR system representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme.

4. EU type-examination

The notified body shall:

(a) examine the technical documentation to assess the adequacy of the technical design of the EHR system;

(b) verify that the EHR system has been manufactured in conformity with the technical documentation, and identify the elements that have been designed in accordance with the applicable provisions of the relevant harmonised standards or technical specifications adopted by the Commission;

(c) carry out appropriate examinations and tests, or have them carried out, to check whether, where the manufacturer has chosen to apply the solutions in the relevant harmonised standards, those have been applied correctly;

(e) carry out appropriate examinations and tests, or have them carried out, to check whether, where the solutions in the relevant harmonised standards or technical specifications adopted by the Commission, the solutions adopted by the manufacturer, including those in other technical specifications applied, meet the corresponding essential requirements and have been applied correctly.

5. Evaluation report

The notified body shall draw up an evaluation report that records the activities undertaken in accordance with point 4 and their outcomes. Without prejudice to its obligations vis-à-vis the notifying authorities, as mentioned in Article 27, point (j), the notified body shall release the content of that report, in full or in part, only with the agreement of the manufacturer.

6. EU type-examination certificate

6.1. Where the type meets the applicable essential requirements, the notified body shall issue an EU type-examination certificate to the manufacturer. The period of validity of a newly issued certificate and, where appropriate, of a renewed certificate shall not exceed five years.

6.2. The EU type-examination certificate shall contain at least the following information:

(a) the name and identification number of the notified body;

(b) the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of that authorised representative;

(d) a statement that the EHR system complies with the applicable essential requirements;

(e) where harmonised standards or technical specifications adopted by the Commission have been fully or partially applied, the references of those standards or parts thereof;

(f) where other technical specifications have been applied, the references of those technical specifications;

(g) where applicable, the performance level(s) or protection class of the machinery product;

(h) the date of issue, the date of expiry and, where appropriate, the date(s) of renewal; (i) any conditions attached to the issuing of the certificate.

6.3. Where the type does not satisfy the applicable essential requirements, the notified body shall refuse to issue an EU type-examination certificate and shall inform the applicant accordingly, giving detailed reasons for its refusal.

7. Review of the EU type-examination certificate

7.1. The notified body shall keep itself apprised of any changes in the generally acknowledged state of the art, which indicate that the approved type may no longer comply with the applicable essential requirements, and shall determine whether such changes require further investigation. If so, the notified body shall inform the manufacturer accordingly.

7.2. The manufacturer shall inform the notified body that holds the technical documentation relating to the EU type- examination certificate of all modifications to the approved type and of all modifications to the technical documentation that may affect the conformity of the EHR system with the applicable essential health and safety requirements or the conditions for validity of that certificate. Such modifications shall require additional approval in the form of an addition to the original EU type-examination certificate.

7.3. The manufacturer shall ensure that the EHR system continues to fulfil the applicable essential requirements in light of the state of the art.

7.4. The manufacturer shall ask the notified body to review the EU type-examination certificate either:

(a) in the case of a modification to the approved type referred to in point 7.2;

(b) in the case of a change in the state of the art referred to in point 7.3;

(c) at the latest, before the date of expiry of the certificate. In order to allow the notified body to fulfil its tasks, the manufacturer shall submit his or her application at the earliest 12 months and at the latest 6 months prior to the expiry date of the EU type-examination certificate.

7.5. The notified body shall examine the EHR system type and, where necessary in the light of the changes made, carry out the relevant tests to ensure that the approved type continues to fulfil the applicable essential requirements. If the notified body is satisfied that the approved type continues to fulfil the applicable essential requirements, it shall renew the EU type-examination certificate. The notified body shall ensure that the review procedure is finalised before the expiry date of the EU type-examination certificate.

7.6. Where the conditions referred to in points (a) and (b) of point 7.4 are not met, a simplified review procedure shall apply. The manufacturer shall supply the notified body with the following:

(a) His or her name and address and data identifying the EU type-examination certificate concerned;

(b) confirmation that there has been no modification to the approved type as referred to in point 7.2, nor to the relevant harmonised standards or technical specifications adopted by the Commission or other technical specifications applied;

7.7. If, following the review, the notified body concludes that the EU type-examination certificate is no longer valid, the body shall withdraw it and the manufacturer shall cease the placing on the market of the EHR system concerned.

8. Each notified body shall inform its notifying authority concerning the EU type-examination certificates and/or any additions thereto which it has issued or withdrawn, and shall, periodically or upon request, make available to its notifying authority the list of such certificates and/or any additions thereto refused, suspended or otherwise restricted. Each notified body shall inform the other notified bodies concerning the EU type-examination certificates and/or any additions thereto, which it has refused, withdrawn, suspended or otherwise restricted, and, upon request, concerning the EU type-examination certificates and/or additions thereto which it has issued.

The Commission, the Member States and the other notified bodies may, on request, obtain a copy of the EU type-examination certificates and/or additions thereto. On request, the Commission and the Member States may obtain a copy of the technical documentation and the results of the examinations carried out by the notified body. The notified body shall keep a copy of the EU type-examination certificate, its annexes and additions, as well as the technical file including the documentation submitted by the manufacturer, for a period of five years after the expiry of the validity of that certificate.

9. The manufacturer shall keep a copy of the EU type-examination certificate together with the technical documentation at the disposal of the national authorities, for 10 years after the EHR system has been placed on the market.

10. The manufacturer's authorised representative may lodge the application referred to in point 3 and fulfil the obligations set out in points 7.2, 7.4 and 9, provided that they are specified in the mandate.

Or. en