Sittings · Document

Draft report (COM(2022)0197 – C9-0167/2022 – 2022/0140(COD)) 2023-03-29

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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Amendment 1539

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 38 – title

Text proposed by the Commission

Amendment

Obligations of health data access bodies towards natural persons

Obligations of bodies involved in accessing health data towards natural persons

Or. de

Amendment 1540

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 38 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall make publicly available and easily searchable the conditions under which electronic health data is made available for secondary use, with information concerning:

1. Health data access bodies shall make publicly available and easily searchable and accessible the conditions under which electronic health data is made available for secondary use, with information concerning:

Or. en

Amendment 1541

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 38 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall make publicly available and easily searchable the conditions under which electronic health data is made available for secondary use, with information concerning:

1. Application processing bodies shall make publicly available and easily searchable the conditions under which electronic health data is made available for secondary use, with information concerning:

Or. de

Amendment 1542

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 38 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the applicable rights of natural persons in relation to secondary use of electronic health data, in particular the right to opt-out pursuant to Article 33(5), including detailed and understandable information on how to exercise those rights;

Or. en

Amendment 1543

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

Proposal for a regulation

Article 38 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the applicable rights of natural persons in relation to secondary use of electronic health data, including the right to opt-out referred to in Article 33(5a) and the right to opt-in for the categories of data referred to in Article 33(5b);

Or. en

Amendment 1544

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

Proposal for a regulation

Article 38 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the applicable rights of natural persons in relation to secondary use of electronic health data, in particular the right to opt-out pursuant to Article 33, including detailed information on how to exercise them;

Or. en

Amendment 1545

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 38 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the applicable rights of natural persons in relation to secondary use of electronic health data, including the rights laid down in Chapter III of Regulation (EU) 2016/679;

Or. en

Amendment 1546

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 38 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the applicable rights of natural persons in relation to secondary use of electronic health data, including the rights pursuant to Regulation (EU) 2016/679;

Or. en

Amendment 1547

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 38 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) the arrangements for natural persons to exercise their rights in accordance with Chapter III of Regulation (EU) 2016/679;

(d) the modalities for natural persons to exercise their rights in accordance with Chapter III of Regulation (EU) 2016/679;

Or. en

Amendment 1548

Konstantinos Arvanitis

Proposal for a regulation

Article 38 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) the identity and the contact details of the health data access body and, where applicable, other information required pursuant to Article 13(1), point (a), of Regulation (EU) 2016/679;

Or. en

Amendment 1549

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 38 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) the identity and the contact details of the health data access body and, where applicable, other information required pursuant to Article 13(1), point (a), of Regulation (EU) 2016/679.

Or. en

Amendment 1550

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

Proposal for a regulation

Article 38 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) the record on who has been granted access to the data, the legal basis and the purpose, in accordance with Union and national law;

Or. en

Amendment 1551

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 38 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) the record on who has been granted access to which sets of electronic health data and a justification regarding the purposes for processing them as referred to in Article 34(1), Union and national law.

Or. en

Amendment 1552

Konstantinos Arvanitis

Proposal for a regulation

Article 38 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1553

Kateřina Konečná

Proposal for a regulation

Article 38 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) The record on who has been granted access to the data, the legal basis and the purpose, in accordance with Union and national law.

Or. en

Justification

Currently, the proposal states that the health data access bodies are not required to provide specific

information to each natural person about the use of their data. This exemption from Article 14 of the GDPR may also have unintended consequences for patients’ fundamental rights and freedoms, including their right to information. Therefore, in line with GDPR exemptions, patients should be informed about who has had access to their data, on what basis and for what purpose.

Amendment 1554

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

Proposal for a regulation

Article 38 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) The mention to whom has been granted access to the data and the purpose of the use.

Or. en

Amendment 1555

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 38 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

As per the opinion by the EDPB and EDPS: such exemption undermines the possibility for data subjects to exercise an effective control over their personal data rather than strengthen it and thus appears to be at odds with the objective laid down in Article 1(2)(a) of the Proposal.

Amendment 1556

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 38 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall comply with the obligations laid down in Article 14(1) to (4) of Regulation (EU) 2016/679. Natural persons shall have the possibility to choose whether to receive notifications when their data are being used for secondary purpose, as well as the periodicity of such notifications.Where, with regards to obligations laid down in Article 14(1) to (4) of Regulation (EU) 2016/679 a health data access body decides to make use of the exception laid down in Article 14(5), point (b), of the same Regulation, it shall make sure to make the information as referred to in Article 14(1) to (4) of Regulation (EU) 2016/679 publicly available on its website in an aggregated form, allowing natural persons to understand whether their data are being made available for secondary use pursuant to data permits.

Or. en

Amendment 1557

Margarita de la Pisa Carrión

Proposal for a regulation

Article 38 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall not be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46. Health data access bodies shall establish protocols to facilitate access for all natural persons to the specific information concerning the use of their data, especially in the case of pseudonymised or anonymised data where the lack of information could affect the fundamental rights of the natural person.

Or. es

Amendment 1558

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

Proposal for a regulation

Article 38 – paragraph 2

Text proposed by the Commission

Amendment

2. At the request of a natural person or a group representing natural persons, health data access bodies shall not be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.

Or. en

Amendment 1559

Konstantinos Arvanitis

Proposal for a regulation

Article 38 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1560

Kateřina Konečná

Proposal for a regulation

Article 38 – paragraph 2

Text proposed by the Commission

Amendment

2. At the request of a natural person or a group representing natural persons, health data access bodies shall be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 concerning the use of their health data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.

Or. en

Amendment 1561

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 38 – paragraph 2

Text proposed by the Commission

Amendment

2. Bodies involved in accessing health data shall not be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit. Application processing bodies shall provide general public information on all the data permits issued pursuant to Article 46.

Or. de

Amendment 1562

Rob Rooken

Proposal for a regulation

Article 38 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.

Or. en

Amendment 1563

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 38 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.

Or. en

Amendment 1564

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 38 – paragraph 3

Text proposed by the Commission

Amendment

3. Where a health data access body is informed by a data user of a finding that may impact on the health of a natural person, the health data access body may inform the natural person and his or her treating health professional about that finding.

3. Where a health data access body is informed by a health data user of a clinically significant finding that may influence the health status of a natural person, as referred to in Article 41a(5) of this Regulation, the health data access body shall inform, where applicable, the treating health professional of the natural person concerned about that finding. Where relevant, the treating health professional shall take due regard to the expressed wish of the natural person not to be informed.

Or. en

Amendment 1565

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 38 – paragraph 3

Text proposed by the Commission

Amendment

3. Where a health data access body is informed by a data user of a finding that may impact on the health of a natural person, the health data access body shall inform the natural person and his or her treating health professional about that finding, while respecting the principles of medical confidentiality and professional secrecy. In accordance with Article 23(1), point (i), of Regulation (EU) 2016/679, Member States may by law restrict the scope of the obligation to inform the natural person whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their information for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have an impact on them.

Or. en

Justification

Alignment with art. 3

Amendment 1566

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

Proposal for a regulation

Article 38 – paragraph 3

Text proposed by the Commission

Amendment

3. Data users shall inform the health data access bodies of conclusive findings that arise from the secondary use of natural persons’ health data. Health data access bodies shall provide an accessible and easily understandable mechanism for natural persons to express their explicit will to be informed by a data user of a finding that may impact on the health of that natural person. Electronic health records shall notify the health professionals with the appropriate competence to communicate to the natural person about that finding to better evaluate the finding and its consequences.

Or. en

Amendment 1567

Traian Băsescu

Proposal for a regulation

Article 38 – paragraph 3

Text proposed by the Commission

Amendment

3. Where a health data access body is informed by a data user of a finding that may impact on the health of a natural person, the health data access body shall inform the natural person, if that person has given their prior consent for this, along with his or her treating health professional, that this finding exists, and shall give that natural person the opportunity to authorise or prohibit the exchange of information on that finding and on future findings.

Or. ro

Amendment 1568

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 38 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1569

Konstantinos Arvanitis

Proposal for a regulation

Article 38 – paragraph 3

Text proposed by the Commission

Amendment

3. Where a health data access body is informed by a data user of a finding that may impact on the health of a natural person, the health data access body shall notify the data holder in order for them to inform the natural person and his or her treating health professional about that finding.

Or. en

Amendment 1570

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 38 – paragraph 3

Text proposed by the Commission

Amendment

3. Where an application processing body is informed by a data user of a finding that may impact on the health of a natural person, it may, together with the pseudonymisation body and the data holder, inform the natural person and his or her treating health professional about that finding.

Or. de

Amendment 1571

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

Proposal for a regulation

Article 38 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies.

4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies, as well as the risks and consequences linked with individual and collective digital health data rights arising from this Regulation.

Or. en

Amendment 1572

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

Proposal for a regulation

Article 38 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies.

Or. en

Amendment 1573

Kateřina Konečná

Proposal for a regulation

Article 38 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies.

Or. en

Justification

Informed consent requires clear, transparent, easily accessible information on the use of patients’ data. As the right to information under Article 14 of the GDPR is challenged in the Regulation, it is essential that Member States conduct extensive information campaigns not only on the role and benefits of health data access bodies, but also on the potential consequences of sharing health data and on the individual and collective digital rights arising from this Regulation.

Amendment 1574

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

Proposal for a regulation

Article 38 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies.

Or. en

Amendment 1575

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 38 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies.

4. Member States shall regularly inform the public at large about the role of the health data access bodies and the benefits and risk of sharing health data for research and decision-making.

Or. en

Amendment 1576

Konstantinos Arvanitis

Proposal for a regulation

Article 38 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies.

4. Member States shall regularly inform the public at large about the role, risks and benefits of the secondary use of health data and the role of health data access bodies.

Or. en

Amendment 1577

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 38 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies.

4. Member States and, where applicable, regions shall regularly inform the public at large about the role and benefits of health data access bodies.

Or. en

Amendment 1578

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 38 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies.

4. Member States shall regularly inform the public at large about the role and benefits of bodies involved in accessing health data.

Or. de

Amendment 1579

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 38 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Health data access bodies shall introduce easy and accessible means for natural persons to lodge complaints, both individually and collectively. Health data access bodies shall inform the complainants at all stages of the process. Health data access bodies shall duly inform about this right in the most visible manner through electronic means.

Or. en

Amendment 1580

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 38 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4 b. Natural persons shall be able to seek an effective judicial remedy against a legally binding decision of a health data access body concerning them. Health data access bodies shall duly inform about this right in the most visible manner through electronic means.

Or. en

Amendment 1581

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 38 a (new)

Text proposed by the Commission

Amendment

Article 38 a

Right to lodge a complaint with a health data access body

1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the health data access body, where their rights laid down in this Regulation are affected. Where the complaint concerns the rights of natural persons pursuant to Article 38(1), point (d), of this Regulation, the health data access body shall inform and send a copy of the complaint to the supervisory authorities under Regulation (EU) 2016/679.

2. The health data access body with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken.

3. Health data access body shall cooperate to handle and resolve complaints, including by exchanging all relevant information by electronic means, without undue delay.

Or. en

Amendment 1582

Konstantinos Arvanitis

Proposal for a regulation

Article 38 a (new)

Text proposed by the Commission

Amendment

Article 38 a

Right to lodge a complaint with a health data access body

1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the health data access body, where their rights laid down in this Regulation are affected. Where the complaint concerns the rights of natural persons pursuant to Article 38(1), point (d), of this Regulation, the health data access body shall send a copy of the complaint to the supervisory authorities under Regulation (EU) 2016/679.

2. The health data access body with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken.

3. Health data access body shall cooperate to handle and resolve complaints, including by exchanging all relevant information by electronic means, without undue delay.

Or. en

Amendment 1583

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 38 a (new)

Text proposed by the Commission

Amendment

Article 38 a

Right to lodge a complaint with a health data access body

2. The health data access body with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken.

Or. en

Amendment 1584

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 38 b (new)

Text proposed by the Commission

Amendment

Article 38 b

Right to an effective remedy against a health data access body

1. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to an effective judicial remedy against a legally binding decision of a health data access body concerning them.

2. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to an effective judicial remedy where the health data access body which is competent pursuant to Article 37 does not handle a complaint or does not inform the natural or legal person within three months on the progress or outcome of the complaint lodged pursuant to Article 38a.

3. Proceedings against a health data access body shall be brought before the courts of the Member State where the health data access body is established.

Or. en

Amendment 1585

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 38 b (new)

Text proposed by the Commission

Amendment

Article 38 b

Right to an effective remedy against a health data access body

3. Proceedings against a health data access body shall be brought before the courts of the Member State where the health data access body is established.

Or. en

Amendment 1586

Konstantinos Arvanitis

Proposal for a regulation

Article 38 b (new)

Text proposed by the Commission

Amendment

Article 38 b

Right to an effective remedy against a health data access body

3. Proceedings against a health data access body shall be brought before the courts of the Member State where the health data access body is established.

Or. en

Amendment 1587

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 38 c (new)

Text proposed by the Commission

Amendment

Article 38 c

Right to compensation

1. 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 from the entity responsible for the infringement.

2. Any entity processing electronic health data shall be liable for the damage caused by infringing this Regulation.

Or. en

Amendment 1588

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 39 – title

Text proposed by the Commission

Amendment

Reporting by health data access bodies

Reporting by bodies involved in accessing health data

Or. de

Amendment 1589

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 39 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Each health data access body shall publish an annual activity report which shall contain at least the following:

1. Each body involved in accessing health data shall publish an annual activity report which shall contain at least the following in relation to its respective tasks:

Or. de

Amendment 1590

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 39 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Each health data access body shall publish an annual activity report which shall contain at least the following:

1. Each health data access body shall publish an annual activity report that shall include summary data only which shall contain at least the following:

Or. en

Amendment 1591

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

Proposal for a regulation

Article 39 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) information relating to the data access applications for electronic health data access submitted, such as the types of applicants, number of data permits granted or refused, purposes of access and categories of electronic health data accessed, and a summary of the results of the electronic health data uses, where applicable;

(a) information relating to the data access applications and data requests submitted, such as the types of applicants, number of data permits granted or refused, purposes of access and categories of electronic health data accessed, and a summary of the results of the electronic health data uses, where applicable;

Or. en

Amendment 1592

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 39 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) a list of data permits involving access to electronic health data processed by the health data access body based on data altruism and a summary description of the general interests purposes pursued, where applicable, including the outcomes of the data permits granted;

deleted

Or. de

Amendment 1593

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

Proposal for a regulation

Article 39 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) information on the fulfilment of regulatory and contractual commitments by data users and data holders, as well as penalties imposed;

(c) information on the fulfilment of regulatory and contractual commitments by data users and data holders, as well as the number and amount of penalties imposed by health data access bodies or supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725;

Or. en

Amendment 1594

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

Proposal for a regulation

Article 39 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) information on audits carried out on data users to ensure compliance of the processing with this Regulation,

(d) information on audits carried out on data users to ensure compliance of the processing in the secure processing environment as referred to in Article 50 of this Regulation,

Or. en

Amendment 1595

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

Proposal for a regulation

Article 39 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) information on audits on compliance of secure processing environments with the defined standards, specifications and requirements;

(e) information on third party audits on compliance of secure processing environments with the defined standards, specifications and requirements, as referred to in Article 50(3) of this Regulation;

Or. en

Amendment 1596

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

Proposal for a regulation

Article 39 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) satisfaction from applicants requesting access to data;

deleted

Or. en

Amendment 1597

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 39 – paragraph 1 – point n a (new)

Text proposed by the Commission

Amendment

(n a) a list of data users whose data permits had to be terminated due to their infringement of Article 35.

Or. en

Amendment 1598

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 39 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Data holders should be consulted prior to any results or output of the secondary use being made publicly available to allow for vetting for any unauthorised disclosure related to the IP rights, trade secrets and confidential information of data holders.

Or. en

Amendment 1599

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 39 – paragraph 2

Text proposed by the Commission

Amendment

2. The report shall be transmitted to the Commission.

2. The report shall be transmitted to the Commission, the Council and the European Parliament and made publicly available.

Or. en

Amendment 1600

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 39 – paragraph 2

Text proposed by the Commission

Amendment

2. The report shall be transmitted to the Commission.

2. The report shall be transmitted to the Commission, which shall make it publicly available on its website.

Or. en

Amendment 1601

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 39 – paragraph 2

Text proposed by the Commission

Amendment

2. The report shall be transmitted to the Commission.

2. The reports shall be transmitted to the Commission.

Or. de

Amendment 1602

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 39 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to modify the content of the annual activity report.

deleted

Or. en

Justification

It is unclear why the Commission should be given the power to modify the report.

Amendment 1603

Kateřina Konečná

Proposal for a regulation

Article 39 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to modify the content of the annual activity report.

deleted

Or. en

Justification

The Commission’s powers to modify the content of the annual activity report should be limited to ensure full transparency regarding the activities, tasks and data permits applications submitted, granted or refused by Health Data Access Bodies. Transparency is key for patients and consumers to be aware of and understand the secondary uses of their health data.

Amendment 1604

Konstantinos Arvanitis

Proposal for a regulation

Article 39 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to modify the content of the annual activity report.

deleted

Or. en

Amendment 1605

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 39 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to modify the content of the annual activity report.

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to modify the content of annual activity reports.

Or. de

Amendment 1606

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 40 – paragraph 1

Text proposed by the Commission

Amendment

1. When processing personal electronic health data, data altruism organisations shall comply with the rules set out in Chapter IV of Regulation […] [Data Governance Act COM/2020/767 final]. Where data altruism organisations process personal electronic health data using a secure processing environment, such environments shall also comply with the requirements set out in Article 50 of this Regulation.

1. This Regulation shall be without prejudice to the processing of datasets based on consent, including in particular altruistic consent pursuant to [Data Governance Act COM/2020/767 final].

Or. de

Amendment 1607

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

Proposal for a regulation

Article 40 – paragraph 1

Text proposed by the Commission

Amendment

1. In addition to rules regarding data altruism estabished by Regulation (EU) 2022/868, where recognised data altruism organisations under Chapter IV of that Regulation process personal electronic health data using a secure processing environment, such environments shall also comply with the requirements set out in Article 50 of this Regulation.

Or. en

Amendment 1608

Konstantinos Arvanitis

Proposal for a regulation

Article 40 – paragraph 1

Text proposed by the Commission

Amendment

1. When processing personal electronic health data, data altruism organisations shall comply with the rules set out in Chapter IV of Regulation […] [Data Governance Act COM/2020/767 final]. When processing electronic health data, data altruism organisations shall make use of a secure processing environment, and also comply with the requirements set out in Article 50 of this Regulation.

Or. en

Amendment 1609

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

Proposal for a regulation

Article 40 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall support the competent authorities designated in accordance with Article 23 of Regulation […] [Data Governance Act COM/2020/767 final] in the monitoring of entities carrying out data altruism activities.

2. Health data access bodies shall support the competent authorities designated in accordance with Article 23 of Regulation (EU) 2022/868 in the monitoring of entities carrying out data altruism activities, where electronic health data are concerned.

Or. en

Amendment 1610

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

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a data holder is obliged to make electronic health data available under Article 33 or under other Union law or national legislation implementing Union law, it shall cooperate in good faith with the health data access bodies, where relevant.

1. (1) Health data holders shall make relevant electronic health data under Article 33 available upon request to the health data access body pursuant to a data permit issued or data request granted by such a body. Health data holders shall cooperate in good faith with the health data access bodies, where relevant.

Or. en

Amendment 1611

Lukas Mandl

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a health data holder is obliged to make electronic health data available under Article 33 or under other Union law or national legislation implementing Union law, it shall cooperate, in compliance with the requirements set out in Article 32 of Regulation (EU) 2016/679, and in good faith with the health data access bodies, where relevant.

Or. en

Amendment 1612

Rob Rooken

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a data holder is obliged to make electronic health data available under Article 33 or under other Union law or national legislation implementing Union law, it shall cooperate in compliance with the requirements set out in Article 32 of Regulation (EU) 2016/679, and in good faith with the health data access bodies, where relevant.

Or. en

Amendment 1613

Jessica Polfjärd

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a data holder is obliged to make electronic health data available under Article 33 or under other Union law or national legislation implementing Union law, it shall, where relevant, cooperate in good faith with the health data access bodies and other relevant actors involved.

Or. en

Amendment 1614

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the Commission

Amendment

Or. de

Amendment 1615

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 41 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a data holder is obliged to make electronic health data available to a health data access body under Article 33, it shall cooperate in good faith with the health data access bodies, where relevant.

Or. en

Amendment 1616

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

Proposal for a regulation

Article 41 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The health data holder shall put the electronic health data at the disposal of the health data access body within 2 months from receiving the request from the health data access body. In justified cases, after consultation with the health data holder concerned, that period may be extended by the health data access body for a maximum of 2 months. The extention might be shorter than 2 months.

Or. en

Amendment 1617

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

Proposal for a regulation

Article 41 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. Paragraphs 1 and 1a constitute a legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 and/or Article 5(1) point (b) of Regulation (EU) 2018/1725 for the health data holder to make available the electronic health data to the health data acces body, in line with Article 9(2) point (h), (i) and (j) of Regulation (EU) 2016/679 and/or Article 10(2) point (h), (i) and (j) of Regulation (EU) 2018/1725.

Or. en

Amendment 1618

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 41 – paragraph 2

Text proposed by the Commission

Amendment

2. The data holder shall communicate to the health data access body a general description of the dataset it holds in accordance with Article 55.

2. The data holder shall communicate to the application processing body a general description of the dataset it holds in accordance with Article 55.

Or. de

Amendment 1619

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 41 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Paragraph 1 constitutes a legal obligation in the sense of Article 6(1)(c) of Regulation 2016/679 for the data holder to disclose personal electronic health data to the health data access body, in combination with Article 9(2), points (h), (i) and (j), of Regulation 2016/679.

Or. en

Justification

It is important to clarify the interplay between the EHDS and the GDPR as well as the rights and obligations that are imposed on health data holders.

Amendment 1620

Konstantinos Arvanitis

Proposal for a regulation

Article 41 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Paragraph 1 constitutes a legal obligation in the sense of Article 6(1)(c) of Regulation 2016/679 for the data holder to disclose personal electronic health data to the health data access body, in accordance with Article 9(2), points (h), (i) and (j), of Regulation 2016/679.

Or. en

Amendment 1621

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 41 – paragraph 3

Text proposed by the Commission

Amendment

3. Where a data quality and utility label accompanies the dataset pursuant to Article 56, the data holder shall provide sufficient documentation to the health data access body for that body to confirm the accuracy of the label.

3. Where a data quality and utility label accompanies the dataset pursuant to Article 56, the data holder shall provide sufficient documentation to the application processing body for that body to confirm the accuracy of the label.

Or. de

Amendment 1622

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 41 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Where the health data access body finds that the purpose pursuant to the data access application under Article 45 can be fulfilled with anonymised data, the health data access body shall anonymise the data. Where the health data access body finds that the purpose pursuant to the data access application under Article 45 cannot be fulfilled with anonymised data, because it requires combination of data from different data holders, the data holder shall request the explicit consent from each data subject. Only data for which explicit consent has been given shall be put at the disposal of health data access bodies. Both anonymisation and pseudonymisation shall be done following the procedures and requirements pursuant to Article 44(3a). After having anonymised or pseudonymised the data, the health data access body shall delete the fully identifiable data.

Or. en

Amendment 1623

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 41 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. By derogation from paragraph 3a, where the anonymisation can be done in an automated procedure that does not require an unreasonable effort, the data holder shall anonymise the data following the procedures and requirements pursuant to Article 44(3a), before putting it at the disposal of the health data access body.

Or. en

Amendment 1624

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

Proposal for a regulation

Article 41 – paragraph 4

Text proposed by the Commission

Amendment

4. The data holder shall put the electronic health data at the disposal of the health data access body within 2 months from receiving the request from the health data access body. In exceptional cases, that period may be extended by the health data access body for an additional period of 2 months.

deleted

Or. en

Justification

Moved to paragraph (1a) of this Article, as it is necessary for the provisions in paragraph (1b).

Amendment 1625

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 41 – paragraph 4

Text proposed by the Commission

Amendment

4. Where the data holder has a processing environment that meets the conditions of the secure processing environment in accordance with Article 50, the data holder shall make the electronic health data available to the data user through that processing environment, using the pseudonymisation body as an intermediary; where the data holder does not have such a processing environment, the data holder shall put the electronic health data at the disposal of the health data access body, using the pseudonymisation body as an intermediary. The electronic health data shall be made available by the data holder within two months of receipt of the application from the application processing body. In exceptional cases, the two-month period may be extended by a further two months by the application processing body.

Or. de

Amendment 1626

Jessica Polfjärd

Proposal for a regulation

Article 41 – paragraph 4

Text proposed by the Commission

Amendment

4. The data holder shall put the electronic health data referred to in paragraph 1 at the disposal of the health data access body within 3 months from receiving the request from the health data access body, taking into account the different technical features between the categories referred to in Article 33(1) and how those can affect the timeframe for the delivery of the data. In exceptional cases, that period may be extended by the health data access body for an additional period of 3 months.

Or. en

Amendment 1627

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

Proposal for a regulation

Article 41 – paragraph 4

Text proposed by the Commission

Amendment

4. The data holder shall put the electronic health data at the disposal of the health data access body within 3 months from receiving the request from the health data access body. In exceptional cases, that period may be extended by the health data access body for an additional period of 2 months.

Or. en

Amendment 1628

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 41 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the duties of the data holders in this Article, to reflect the evolution of activities performed by data holders.

deleted

Or. de

Amendment 1629

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

Proposal for a regulation

Article 41 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. This Article shall not apply to health data holders that qualify as microenterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC.Microentreprises may, however, notify the relevant data access body about their wish to voluntarily contribute to the secondary use of health data.

This Article shall apply to small enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC 1 year from entry into force of this Regulation.

Or. en

Justification

Amended and moved to this Art. 41 from Art. 33(2) as it concerns duties of health data holders. Moreover, a deferred application is added for small enterprises added to make sure that they can prepare to fulfill their duties under EHDS.

Amendment 1630

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

Proposal for a regulation

Article 41 a (new)

Text proposed by the Commission

Amendment

Article 41 a

Duties of health data users

1. Health data users may access and process the electronic health data for secondary use referred to in Article 33 only in accordance with the data permit issued by the health data access body in line with Article 46 of this Regulation.

2. Health data users shall not seek access to and process electronic health data obtained via a data permit issued in line with Article 46 of this Regulation for the purposes referred to in Article 35.

3. Health data users shall not re-identify or seek to re-identify the natural persons to which the electronic health data belong which they obtained based on the data permit or data request. Such conduct shall be considered a serious breach of this Regulation.

4. Health data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. In justified cases, especially cases referred to in Article 34(1), point (e), this period may be extended by the relevant health data access body, after consultation with the health data user. The health data users shall inform the health data access bodies from which a data permit was obtained about the results or output and provide them with necessary support in order to make them public also on health data access bodies’ websites, without prejudice to IP rights, the confidentiality of trade secrets and relevant Union legislation. Whenever the health data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.

5. Without prejudice to paragraph 2, health data users shall inform the health data access body of any clinically significant findings that may influence the health status of the natural persons whose data are included in the dataset.

6. ECDC and EMA shall, in consultation and cooperation with relevant stakeholders, including representatives of patients, health professionals and researchers, create guidelines in order to help health data users to fulfil their obligation under paragraph 3, especially to determine whether their findings are clinically significant.

7. Health data users shall cooperate in good faith with the health data access bodies, where relevant.

Or. en

Justification

This amendment is necessary to streamline the text and stipulate duties of health data users in one single article. In the Commission proposal, the duties of health data users were scattered across several articles. The relevant provisions across different articles were identified and put here into one, and new provisions were also added.

Amendment 1631

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 42 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies and single data holders may charge fees for making electronic health data available for secondary use. Any fees shall include and be derived from the costs related to conducting the procedure for requests, including for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, in accordance with Article 6 of Regulation […] [Data Governance Act COM/2020/767 final]

1. Health data access bodies and single data holders may charge fees for making electronic health data available for secondary use.

Or. en

Amendment 1632

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

Proposal for a regulation

Article 42 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies may charge fees for making electronic health data available for secondary use. Any fees shall include and be derived from the costs related to set up, data enrichment, maintainance or updating of the dataset and conducting the procedure for requests, including for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, in accordance with Article 6 of Regulation […] [Data Governance Act COM/2020/767 final]. No fees should be charged to public health authorities, at local, regional or national level or to address public health research, including but not limited to, epidemiological surveillance or monitoring of health projects and programmes.

Or. en

Amendment 1633

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

Proposal for a regulation

Article 42 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies and single data holders may charge fees to health data users for making electronic health data available for secondary use.

In the case of health data access bodies, any fees shall be derived from the costs related to conducting the procedure for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, gathering, combining, preparing, anonymisation or pseudonymisation of the electronic health data or commercially confidential data for secondary use and maintaining of the secure processing environment;

Or. en

Amendment 1634

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 42 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies may charge fees for making electronic health data available for secondary use. Any fees shall include and be derived from the costs related to conducting the procedure for requests, including for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, in accordance with Article 6 of Regulation […] [Data Governance Act COM/2020/767 final], as well as the technical and operational costs to prepare the data sets, including anonymization and pseudonymization, and to make them available.

Or. en

Justification

Linked to the proposed deletion of Article 49.

Amendment 1635

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 42 – paragraph 1

Text proposed by the Commission

Amendment

1. Application processing bodies, health data access bodies and single data holders may charge fees for making electronic health data available for secondary use. Any fees shall include and be derived from the costs related to conducting the procedure for requests, including for assessing a data application or a data request, granting, refusing or amending a data permit pursuant to Articles 45 and 46 or providing an answer to a data request pursuant to Article 47, in accordance with Article 6 of Regulation […] [Data Governance Act COM/2020/767 final]

Or. de

Amendment 1636

Konstantinos Arvanitis

Proposal for a regulation

Article 42 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1637

Joanna Kopcińska

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

2. Where the data in question are not held by the data access body or a public sector body, the fees may also include compensation for part of the costs for collecting the electronic health data specifically under this Regulation in addition to the fees that may be charged pursuant to paragraph 1. The part of the fees linked to the data holder’s costs shall be paid to the data holder.

2. Where the data in question are not held by the health data access body, the fees may also include compensation for collecting the electronic health data in addition to the fees that may be charged pursuant to paragraph 1. The part of the fees linked to the health data holder’s costs shall be paid to the health data holder and shall also reflect market value of the data in question.

Or. en

Amendment 1638

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

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

2. In the case of health data holders, where the data in question are not held by the data access body or a public sector body, the fees may be derived from the costs for gathering and preparing the electronic health data for secondary use specifically under this Regulation.

Or. en

Amendment 1639

Beata Kempa

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

2. Where the data in question are not held by the health data access body or a public sector body, the fees may also include compensation for part of the costs for collecting the electronic health data specifically under this Regulation in addition to the fees that may be charged pursuant to paragraph 1. The part of the fees linked to the health data holder’s costs shall be paid to the data holder and shall correspond to the fees’ market value.

Or. pl

Amendment 1640

Beata Kempa

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

2. Where the data in question are not held by the health data access body the fees may also include compensation for collecting the electronic health data in addition to the fees that may be charged pursuant to paragraph 1. The part of the fees linked to the health data holder’s costs shall be paid to the health data holder and shall also reflect market value of the data in question.

Or. en

Amendment 1641

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 42 – paragraph 2

Text proposed by the Commission

Amendment

2. Where the data in question are not held by the data access body or a public sector body, the fees may also include compensation for collecting the electronic health data specifically under this Regulation in addition to the fees that may be charged pursuant to paragraph 1. The part of the fees linked to the data holder’s costs shall be paid to the data holder.

Or. en

Amendment 1642

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 42 – paragraph 3

Text proposed by the Commission

Amendment

3. The electronic health data referred to in Article 33(1), point (o), shall be made available to a new user free of charge or against a fee matching the compensation for the costs of the human and technical resources used to enrich the electronic health data. That fee shall be paid to the entity that enriched the electronic health data.

deleted

Or. en

Amendment 1643

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 42 – paragraph 3

Text proposed by the Commission

Amendment

3. The electronic health data referred to in Article 33(1), point (o), shall be made available to a new user against a fee matching the compensation for the costs of the human and technical resources used to enrich the electronic health data. That fee shall be paid to the entity that enriched the electronic health data.

Or. en

Amendment 1644

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 42 – paragraph 4

Text proposed by the Commission

Amendment

4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update tat dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.

4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The fees shall be calculated according to objective criteria, in particular the completeness and representativeness of the data, the number of patients concerned, the scarcity of the data and the cost of any processes used to make the data accessible, such as anonymisation. The support received by the data holder from donations, public national or Union grants, to set up, develop or update tat dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.

Or. fr

Amendment 1645

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 42 – paragraph 4

Text proposed by the Commission

Amendment

4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate workload of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees.

Or. en

Amendment 1646

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

Proposal for a regulation

Article 42 – paragraph 4

Text proposed by the Commission

Amendment

4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting, set up, data enrichment, maintainance or updating of the dataset and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update that dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.

Or. en

Amendment 1647

Javier Zarzalejos

Proposal for a regulation

Article 42 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 1648

Peter Liese

Proposal for a regulation

Article 42 – paragraph 4

Text proposed by the Commission

Amendment

4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update tat dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, academic and educational institutions, non-commercial entities and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.

Or. en

Justification

Academic research and non-commercial clinical trials are crucial for driving therapeutic innovation in the health space. Academic institutions and non-commercial entities, including those involved in cancer research, should not be faced with excessive fees when requesting access to data through the European Health Data Space.

Amendment 1649

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

Proposal for a regulation

Article 42 – paragraph 4

Text proposed by the Commission

Amendment

4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent, non-discriminatory, proportionate to the cost of making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update tat dataset shall be excluded from this calculation. The specific interests and needs of SMEs and start-ups, public bodies, Union institutions, bodies, offices and agencies involved in scientific research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.

Or. en

Amendment 1650

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 42 – paragraph 4

Text proposed by the Commission

Amendment

4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update that dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by aligning those fees proportionately with their size or budget.

Or. en

Amendment 1651

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 42 – paragraph 5

Text proposed by the Commission

Amendment

5. Where data holders and data users do not agree on the level of the fees within 1 month of the data permit being granted, the health data access body may set the fees in proportion to the cost of making available electronic health data for secondary use. Where the data holder or the data user disagree with the fee set out by the health data access body, they shall have access to dispute settlement bodies set out in accordance with Article 10 of the Regulation […] [Data Act COM/2022/68 final].

deleted

Or. en

Amendment 1652

Peter Liese

Proposal for a regulation

Article 42 – paragraph 5

Text proposed by the Commission

Amendment

5. Where data holders and data users do not agree on the level of the fees within 1 month of the data permit being granted, the health data access body may set the fees in proportion to the cost of making available electronic health data for secondary use. Where the data users are non-commercial entities, their size and financial resources shall be taken into account when the fees are set. Where the data holder or the data user disagree with the fee set out by the health data access body, they shall have access to dispute settlement bodies set out in accordance with Article 10 of the Regulation […] [Data Act COM/2022/68 final].

Or. en

Justification

Amendment 1653

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 42 – paragraph 5

Text proposed by the Commission

Amendment

5. Where data holders and data users do not agree on the level of the fees within 1 month of the data permit being granted, the application processing body may set the fees in proportion to the cost of making available electronic health data for secondary use. Where the data holder or the data user disagree with the fee set out by the application processing body, they shall have access to dispute settlement bodies set out in accordance with Article 10 of the Regulation […] [Data Act COM/2022/68 final].

Or. de

Amendment 1654

Kateřina Konečná

Proposal for a regulation

Article 42 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. The profits generated from the collection or use of health data shall be put to the benefit of Member States’ health systems.

Or. en

Justification

It is only just that the returns from the secondary uses of health data are adequately reinvested into the healthcare systems that allowed for this data to be collected.

Amendment 1655

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 42 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission may, by means of implementing acts, lay down principles and rules for the fee policies and fee structures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

deleted

Or. en

Amendment 1656

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 42 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall, by means of delegated acts, lay down principles and rules for the fee policies and fee structures. Those delegated acts shall be adopted in accordance with the procedure referred to in Article 67.

Or. en

Amendment 1657

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

Proposal for a regulation

Article 42 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall, by means of implementing acts, lay down principles and rules for the fee policies and fee structures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 1658

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 43 – title

Text proposed by the Commission

Amendment

Penalties by health data access bodies

Enforcement by health data access bodies

Or. en

Amendment 1659

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

Proposal for a regulation

Article 43 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies shall monitor and supervise compliance by data users and data holders with the requirements laid down in this Chapter.

deleted

Or. en

Justification

This provision was put in Article 37 as it concerns one of the tasks that the health data access body should carry out. This Article should only concern provisions on penalties and not further tasks for health data access bodies.

Amendment 1660

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

Proposal for a regulation

Article 43 – paragraph 2

Text proposed by the Commission

Amendment

2. When requesting from data users and data holders the information that is necessary to verify compliance with this Chapter, the health data access bodies shall be proportionate to the performance of the compliance verification task.

2. When carrying out its monitoring and supervisory tasks to verify compliance with this Chapter, as referred to in Article 37(1), point (ra), the health data access bodies shall request information from data holders and users that is necessary for the performance of the task.

Or. en

Amendment 1661

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 43 – paragraph 2

Text proposed by the Commission

Amendment

2. When requesting from data users and data holders as well as other bodies involved in accessing health data the information that is necessary to verify compliance with this Chapter, the health data access bodies shall be proportionate to the performance of the compliance verification task.

Or. de

Amendment 1662

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 43 – paragraph 3

Text proposed by the Commission

Amendment

3. Where health data access bodies find that a data user or data holder does not comply with the requirements of this Chapter, they shall immediately notify the data user or data holder of those findings and shall give it the opportunity to state its views within 2 months.

Where the finding of non-compliance concerns personal electronic health data, the health data access body shall immediately inform supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of this finding to ensure application and enforcement of this Regulation and relevant provisions of the aforementioned Regulations, including penalties;

Or. en

Amendment 1663

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 43 – paragraph 4

Text proposed by the Commission

Amendment

4. Health data access bodies shall have the power to revoke the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non-compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able, where appropriate, to fine up to 10% of the data user's annual turnover for the previous financial year or revoke the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years. Where an EU institution, body or agency is the data user, the power to impose such penalties shall rest with the European Data Protection Supervisor, after notification from the health data access body.

Or. en

Amendment 1664

Konstantinos Arvanitis

Proposal for a regulation

Article 43 – paragraph 4

Text proposed by the Commission

Amendment

4. Notwithstanding the right for Member States to impose penalties in accordance with Article 69, health data access bodies shall have the power to revoke the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non-compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able, where appropriate, to revoke the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years.

Or. en

Amendment 1665

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

Proposal for a regulation

Article 43 – paragraph 4

Text proposed by the Commission

Amendment

4. Health data access bodies shall have the power to revoke the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non-compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able, where appropriate, to revoke the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years, and fines shall be imposed in accordance with Article 83 of the Regulation (EU) 2016/679.

Or. en

Amendment 1666

Kateřina Konečná

Proposal for a regulation

Article 43 – paragraph 4

Text proposed by the Commission

Amendment

4. Health data access bodies shall have the power to revoke the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non-compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able, where appropriate, to revoke the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years, and fines shall be imposed in accordance with Article 83 of the Regulation (EU) 2016/679

Or. en

Justification

The draft regulation only mentions the revocation of permits for a maximum of 5 years. In order to build trust, misuse of health data must be accompanied by strong sanctions that deter data users from violating the licence, including, but not limited to, fines. Fines should be transparent, proportionate, effective, and harmonised between Member States to ensure the same level of protection for all patients.

Amendment 1667

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 43 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 1668

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 43 – paragraph 4

Text proposed by the Commission

Amendment

4. Health data access bodies shall have the power to declare the data permit issued pursuant to Article 46 invalid and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non-compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able, where appropriate, to declare the data permit invalid and to exclude the data user from any access to electronic health data for a period of up to 5 years.

Or. de

Amendment 1669

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 43 – paragraph 4

Text proposed by the Commission

Amendment

4. Health data access bodies shall have the power to terminate the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non-compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able to terminate the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years.

Or. en

Amendment 1670

Kateřina Konečná

Proposal for a regulation

Article 43 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Any natural person affected by a breach of the data permit issued pursuant to Articles 35 and 46 shall have the right to an effective judicial remedy before a tribunal in accordance with Article 47 of the Charter of Fundamental Rights of the European Union.

Or. en

Amendment 1671

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

Proposal for a regulation

Article 43 – paragraph 5

Text proposed by the Commission

Amendment

5. Where data holders withhold the electronic health data from health data access bodies with the manifest intention of obstructing the use of electronic health data, or do not respect the deadlines set out in Article 41, the health data access body shall have the power to fine the data holder 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. In case of repeated breaches by the data holder of the obligation of loyal cooperation with the health data access body, that body can exclude the data holder from participation in the EHDS for a period of up to 5 years. Where a data holder has been excluded from the participation in the EHDS pursuant to this Article, following manifest intention of obstructing the secondary use of electronic health data, it shall not have the right to provide access to health data in accordance with Article 49.

Or. en

Amendment 1672

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

Proposal for a regulation

Article 43 – paragraph 5

Text proposed by the Commission

Amendment

Or. en

Amendment 1673

Konstantinos Arvanitis

Proposal for a regulation

Article 43 – paragraph 5

Text proposed by the Commission

Amendment

Or. en

Justification

Consequence of the proposed deletion of Article 49.

Amendment 1674

Lukas Mandl

Proposal for a regulation

Article 43 – paragraph 5

Text proposed by the Commission

Amendment

Each Member State may lay down the rules on whether and to what extent fines may be imposed on public authorities and bodies established in that Member State.

Or. en

Amendment 1675

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 43 – paragraph 5

Text proposed by the Commission

Amendment

5. Where data holders withhold the electronic health data from health data access bodies with the manifest intention of obstructing the use of electronic health data, or do not respect the deadlines set out in Article 41, the health data access body shall have the power to fine the data holder 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. In case of repeated breaches by the data holder of the obligation of loyal cooperation with the health data access body, that body can exclude the data holder from submitting data access applications pursuant to Chapter IV for a period of up to 5 years, while still being obliged to make data accessible pursuant to Chapter IV, where applicable.

(Deletion of last sentence linked to the proposed deletion of Article 49)

Or. en

Amendment 1676

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 43 – paragraph 5

Text proposed by the Commission

Amendment

5. Where data holders withhold the electronic health data from health data access bodies with the manifest intention of obstructing the use of electronic health data, or do not respect the deadlines set out in Article 41, the health data access body shall have the power to fine the data holder 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 in accordance with the tasks of the EHDS Board, set out in Article 65 of this Regulation. In case of repeated breaches by the data holder of the obligation of loyal cooperation with the health data access body, that body can exclude the data holder from participation in the EHDS for a period of up to 5 years. Where a data holder has been excluded from the participation in the EHDS pursuant to this Article, following manifest intention of obstructing the secondary use of electronic health data, it shall not have the right to provide access to health data in accordance with Article 49.

Or. fr

Amendment 1677

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

Proposal for a regulation

Article 43 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Any natural person affected by a breach of the data permit issued pursuant to Articles 35 and 46 should have the right to an effective judicial remedy before a tribunal in accordance with Article 47 of the Charter of Fundamental Rights of the European Union.

Or. en

Amendment 1678

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

Proposal for a regulation

Article 43 – paragraph 6

Text proposed by the Commission

Amendment

6. The health data access body shall communicate the measures imposed pursuant to paragraph 4 and the reasons on which they are based to the data user or holder concerned, without delay, and shall lay down a reasonable period for the data user or holder to comply with those measures.

6. The health data access body shall communicate the measures imposed pursuant to paragraphs 4 and 5 and the reasons on which they are based to the data user or holder concerned, without delay, and shall lay down a reasonable period for the data user or holder to comply with those measures.

Or. en

Amendment 1679

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 43 – paragraph 7

Text proposed by the Commission

Amendment

7. Any penalties and measures imposed pursuant to paragraph 4 shall be made available to other health data access bodies.

7. Any penalties and measures imposed pursuant to paragraph 4 shall be made available to other health data access bodies and publicly available on the Commission’s website.

Or. en

Amendment 1680

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

Proposal for a regulation

Article 43 – paragraph 7

Text proposed by the Commission

Amendment

7. Any penalties and measures imposed pursuant to paragraph 4 shall be made available to other health data access bodies.

7. Any penalties and measures imposed pursuant to paragraph 4 shall be notified to other health data access bodies.

Or. en

Amendment 1681

Beata Kempa

Proposal for a regulation

Article 43 – paragraph 8

Text proposed by the Commission

Amendment

8. The Commission may, by means of implementing act, set out the architecture of an IT tool aimed to support and make transparent to other health data access bodies the activities referred to in this Article, especially penalties and exclusions. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Accordingly, the Commission should provide guidance on the penalty calculation system.

Or. pl

Amendment 1682

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 43 – paragraph 9

Text proposed by the Commission

Amendment

9. Any natural or legal person affected by a decision of a health data access body shall have the right to an effective judicial remedy against such decision.

deleted

Or. en

Justification

This paragraph is now covered by new art. 38b

Amendment 1683

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 43 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission may issues guidelines on penalties to be applied by the health data access bodies.

10. The Commission shall issue guidelines on penalties to be applied by the health data access bodies, in line with the principles set out in Article 69.

Or. en

Amendment 1684

Joanna Kopcińska

Proposal for a regulation

Article 43 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission may issues guidelines on penalties to be applied by the health data access bodies.

10. The Commission, without undue delay, shall issue guidelines on penalties to be applied by the health data access bodies.

Or. en

Amendment 1685

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

Proposal for a regulation

Article 43 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission may issues guidelines on penalties to be applied by the health data access bodies.

10. The Commission shall issues guidelines on penalties to be applied by the health data access bodies.

Or. en

Amendment 1686

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 43 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission may issues guidelines on penalties to be applied by the health data access bodies.

10. The Commission shall issues guidelines on penalties to be applied by the health data access bodies.

Or. en

Amendment 1687

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 43 – paragraph 10

Text proposed by the Commission

Amendment

10. The Commission may issues guidelines on penalties to be applied by the health data access bodies.

10. The Commission shall issue guidelines on penalties to be applied by the health data access bodies.

Or. fr

Amendment 1688

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 43 – paragraph 10 a (new)

Text proposed by the Commission

Amendment

10 a. Data holders lawfully protecting their IP rights and commercial property shall not be subject to fines while any disputes concerning the protection of industrial and commercial property are being resolved, in order to avoid conflicting obligations.

Or. en

Justification

See CJEU case law on the consistency of EU law as a whole, C-621/18, Wightman.

Amendment 1689

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 43 – paragraph 10 b (new)

Text proposed by the Commission

Amendment

10 b. Data holders that breach the Regulation are subject to fines.

Or. en

Amendment 1690

Sophia in 't Veld, Emma Wiesner, Abir Al-Sahlani

Proposal for a regulation

Article 44 – paragraph 1

Text proposed by the Commission

Amendment

1. The health data access body shall ensure that access is only provided to requested electronic health data relevant for the purpose of processing indicated in the data access application by the data user and in line with the data permit granted.

Or. en

Amendment 1691

Konstantinos Arvanitis

Proposal for a regulation

Article 44 – paragraph 1

Text proposed by the Commission

Amendment

1. The health data access body shall ensure that access is only provided to requested electronic health data that are adequate, relevant and limited to what is necessary in relation to the purpose of processing indicated in the data access application by the data user and in line with the data permit granted.

Or. en

Amendment 1692

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 44 – paragraph 1

Text proposed by the Commission

Amendment

1. The health data access body shall ensure that access is only provided to requested electronic health data necessary and relevant and as long as needed for the purpose of processing indicated in the data access application by the data user and in line with the data permit granted.

Or. en

Amendment 1693

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 44 – paragraph 1

Text proposed by the Commission

Amendment

1. The health data access body shall ensure that access is only provided to requested electronic health data that is necessary and relevant for the purpose of processing indicated in the data access application by the data user and in line with the data permit granted.

Or. en

Amendment 1694

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 44 – paragraph 1

Text proposed by the Commission

Amendment

1. The health data access body or the data holder shall ensure that access is only provided to requested electronic health data relevant for the purpose of processing indicated in the data access application by the data user and in line with the data permit granted.

Or. de

Amendment 1695

Joanna Kopcińska

Proposal for a regulation

Article 44 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Data anonymisation shall be carried out as much as possible by health data holders, following a common methodology, ensuring that the process is reduced at the level of health data access bodies.

Or. en

Amendment 1696

Joanna Kopcińska

Proposal for a regulation

Article 44 – paragraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1697

Konstantinos Arvanitis

Proposal for a regulation

Article 44 – paragraph 2

Text proposed by the Commission

Amendment

2. The health data access bodies shall provide the electronic health data in an anonymised format, where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user. The health data access bodies shall indicate the entity in charge of the anonymization and the anonymization standard applied. Special safeguards shall be applied in the case of rare diseases. Data users shall not attempt to re-identify the data subject of the anonymised data.

Or. en

Amendment 1698

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 44 – paragraph 2

Text proposed by the Commission

Amendment

2. The health data access bodies shall provide the electronic health data in an anonymised format, where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user. The health data access bodies shall specify which entity has been tasked with anonymisation and which anonymisation standard has been applied. Specific provisions shall be put in place for data on rare diseases.

Or. fr

Amendment 1699

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 44 – paragraph 2

Text proposed by the Commission

Amendment

2. The health data access bodies shall provide the electronic health data in an anonymised format:

Or. en

Amendment 1700

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 44 – paragraph 2

Text proposed by the Commission

Amendment

2. The health data access bodies or data holders shall provide the electronic health data in an anonymised format, where appropriate using the pseudonymisation body as an intermediary, where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user.

Or. de

Amendment 1701

Jeroen Lenaers, Esther de Lange

Proposal for a regulation

Article 44 – paragraph 2

Text proposed by the Commission

Amendment

2. The health data access bodies shall always provide the electronic health data in an anonymised format, where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user.

Or. en

Amendment 1702

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 44 – paragraph 2 – point a (new)

Text proposed by the Commission

Amendment

(a) where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user, or

Or. en

Amendment 1703

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 44 – paragraph 2 – point b (new)

Text proposed by the Commission

Amendment

(b) where the data subject has not given explicit consent for the secondary use of their personal data.

Or. en

Amendment 1704

Rob Rooken

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

deleted

Or. en

Amendment 1705

Konstantinos Arvanitis

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. For that purpose, health data access points shall verify in advance the compliance of the pseudonymisation of the data for processing by the data user with Article 6 and, where relevant, Article 9 of Regulation (EU) 2016/679. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

Or. en

Amendment 1706

Lukas Mandl

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. For that purpose, health data access points shall verify in advance the compliance of the pseudonymisation of the data for processing by the data user with Article 6 or Article 9 of Regulation (EU) 2016/679. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

Or. en

Amendment 1707

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 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the data user has demonstrated that the purpose of processing cannot be achieved with anonymised data, in line with Article 46(1c), the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be considered a particularly serious breach of this Regulation and shall be subject to effective, proportionate and dissuasive penalties.

Or. en

Amendment 1708

Cristian-Silviu Buşoi

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, or for the purpose of the evaluation of the benefits and risks of medicinal products or of the identification and assessment of threats to human health posed by infectious diseases, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information required to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

Or. en

Amendment 1709

Mathilde Androuët

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

Or. fr

Amendment 1710

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format where the data subject has given their explicit consent. The information necessary to reverse the pseudonymisation shall be available only to data holder. Data users shall not re-identify the electronic health data provided to them in anonymised or pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring anonymisation or pseudonymisation shall be subject to appropriate penalties.

Or. en

Amendment 1711

Javier Zarzalejos

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information required to reverse the pseudonymisation shall be available only to the health data access body, which will eliminate it after pseudonymisation completion. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

Or. en

Amendment 1712

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies or the data holder shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the pseudonymisation body or the data holder. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the pseudonymisation body’s or the data holder’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

Or. de

Amendment 1713

Jeroen Lenaers, Esther de Lange

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Only in the exceptional cases where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

Or. en

Amendment 1714

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring anonymisation and pseudonymisation shall be subject to appropriate penalties.

Or. en

Amendment 1715

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

Proposal for a regulation

Article 44 – paragraph 3

Text proposed by the Commission

Amendment

3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data holder. Data users shall not re-identify the electronic health data provided to them in pseudonymised format. The data user’s failure to respect the health data access body’s measures ensuring pseudonymisation shall be subject to appropriate penalties.

Or. en

Amendment 1716

Christel Schaldemose

Proposal for a regulation

Article 44 – paragraph 3 – point 1 (new)

Text proposed by the Commission

Amendment

(1) 4. The health data access body may, where necessary, provide personally identifiable electronic health data in accordance with Regulation (EU) 2016/679 and national law.

Or. da

Justification

In exceptional circumstances – but still in compliance with the GDPR – it might be necessary to provide access to personally identifiable electronic health data for secondary use, for example in connection with socially beneficial research.

Amendment 1717

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 44 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Taking into account the state of the art and the nature, scope, context and purposes of processing as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons, the health data access body shall apply appropriate anonymisation or pseudonymisation techniques to ensure a high level of security, appropriate to the risk of re-identification.

Or. en

Amendment 1718

Kateřina Konečná

Proposal for a regulation

Article 44 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

Or. en

Justification

Given the possible risks of ineffectively anonymised and pseudonymised data processed and shared for secondary purposes, minimum quality requirements for mandatory anonymisation and pseudonymisation are necessary to prevent re-identification risks and ensure a harmonised level of protection across the EU.

Amendment 1719

Konstantinos Arvanitis

Proposal for a regulation

Article 44 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1720

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 44 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The Commission shall, by means of implementing acts, set out the procedures and requirements, and provide technical tools, for a unified and irreversible procedure for anonymising and pseudonymising the electronic health data. Those implementing act sshall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 1721

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

Proposal for a regulation

Article 44 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. In providing anonymised and pseudonymised datasets, health data access bodies shall follow the state-of-the-art in anonymisation and pseudonymisation technologies. The European Health Data Space Board, together with the digital health authorities, shall discuss and create norms and standards for data holders to apply.

Or. en

Amendment 1722

Jeroen Lenaers, Esther de Lange

Proposal for a regulation

Article 44 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The anonymisation or pseudonymisation required for sharing data sets for secondary use shall be subject to minimum quality requirements, to ensure its robustness and avoid data to be exposed for abusive purposes.

Or. en

Amendment 1723

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 44 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The failure by the data user to respect the measures of the health data access body ensuring anonymisation and pseudonymisation shall be subject to appropriate penalties pursuant Article 43.

Or. en

Amendment 1724

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

Proposal for a regulation

Article 45 – paragraph 1

Text proposed by the Commission

Amendment

1. Any natural or legal person may submit a data access application for the purposes referred to in Article 34.

1. Any natural or legal person with a demonstrable link to the health or care sector and specifically activities relevant for the purposes listed in Article 34(1) of this Regulation may submit a data access application for the purposes referred to in Article 34.

Or. en

Amendment 1725

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 45 – paragraph 1

Text proposed by the Commission

Amendment

1. Any natural or legal person may submit a data access application for the purposes referred to in Article 34.

1. Any entity active in the area of health care, public health, or scientific or medical research may submit a data access application for the purposes referred to in Article 34.

Or. en

Amendment 1726

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 45 – paragraph 1

Text proposed by the Commission

Amendment

1. Any natural or legal person may submit a data access application for the purposes referred to in Article 34.

1. Union citizens and third-country nationals legally residing in the EU or legal person established in the EU may submit a data access application for the purposes referred to in Article 34.

Or. en

Amendment 1727

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

Proposal for a regulation

Article 45 – paragraph 2 – point -a (new)

Text proposed by the Commission

Amendment

(-a) the applicant´s identity, description of professional functions and operations, including the identity of the concrete persons who will have access to electronic health data, if a data permit is granted;

Or. en

Amendment 1728

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 45 – paragraph 2 – point -a (new)

Text proposed by the Commission

Amendment

(-a) a description of the applicant's identity, professional function and operation, including the identity of who will have access to the electronic health data;

Or. en

Amendment 1729

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 45 – paragraph 2 – point -a a (new)

Text proposed by the Commission

Amendment

(-a a) a data protection impact assessment pursuant to Article 35 of Regulation (EU) 2016/679, unless the data access application only concerns aggregated data that makes the re-identification of a natural person impossible;

Or. en

Amendment 1730

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 45 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) a detailed explanation of the intended use of the electronic health data, including for which of the purposes referred to in Article 34(1) access is sought;

(a) a detailed explanation of the intended use of the electronic health data including:

(i) the purposes referred to in Article 9(2), points (i) and (j), of Regulation (EU) 2016/679, combined with Article 34(1);

(ii) demonstrable evidence that the stated purpose is of public interest.

Or. en

Justification

We suggest that data access applications are supported by demonstrable evidence of public interest. Mere claim of public interest is insufficient.

Amendment 1731

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 45 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) a detailed explanation of the intended use of the electronic health data, including for which of the purposes referred to in Article 34(1) access is sought;

(a) a detailed explanation of the intended use of the electronic health data, including for which of the purposes referred to in Article 9(2) of Regulation (EU) 2016/679, in combination with Article 34(1), access is necessary;

Or. en

Amendment 1732

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 45 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) a detailed explanation of the intended use of the electronic health data, including for which of the purposes referred to in Article 34(1) access is sought;

(a) a detailed plan and explanation of the intended use of the electronic health data, including for which of the purposes referred to in Article 34(1) access is sought;

Or. en

Amendment 1733

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) a detailed explanation of the intended use of the electronic health data, including for which of the purposes referred to in Article 34(1) access is sought;

(a) a detailed explanation of the intended use and benefit related to that use of the electronic health data, including:

Or. en

Amendment 1734

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point a – point i (new)

Text proposed by the Commission

Amendment

i) the purposes referred to in Article 9 (2), points (i) and (j), of Regulation 2016/679, combined with Article 34(1);

Or. en

Amendment 1735

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point a – point ii (new)

Text proposed by the Commission

Amendment

ii) demonstrable evidence that the stated purpose is of public interest.

Or. en

Amendment 1736

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 45 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) a declaration that the applicant has sufficient experience to manage the intended uses of the data requested, consistent with ethical practice and applicable laws and regulations;

Or. en

Amendment 1737

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 45 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) a description of the applicant’s identity, professional function and operation, including the identity of who will have access to the electronic health data;

Or. en

Amendment 1738

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) a description of the applicant's identity, professional function and operation, including the identity of anyone with access to the electronic health data;

Or. en

Amendment 1739

Kateřina Konečná

Proposal for a regulation

Article 45 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) demonstrable evidence that the stated purpose is of public interest;

Or. en

Amendment 1740

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 45 – paragraph 2 – point a b (new)

Text proposed by the Commission

Amendment

(a b) a detailed explanation of the expected benefits related to the use;

Or. en

Amendment 1741

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 45 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) a description of the requested electronic health data, their format and data sources, where possible, including geographical coverage where data is requested from several Member States;

(b) a description of the requested electronic health data, their timeframe, format and data sources, where possible, including geographical coverage where data is requested from several Member States;

Or. en

Amendment 1742

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) an indication whether electronic health data need to be made available in a pseudonymised format and the reason why the envisaged purpose for processing cannot be pursued using anonymised data;

Or. en

Amendment 1743

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 45 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) an indication whether electronic health data need to be made available in a pseudonymised format and the reason why the envisaged purpose for processing cannot be pursued using anonymised data;

Or. en

Amendment 1744

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 45 – paragraph 2 – point c

Text proposed by the Commission

Amendment

Or. en

Justification

The anonymisation should be the default option. If the applicant needs pseudonymised data, they should explicitly state so in the data access application.

Amendment 1745

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 45 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) where applicable, an explanation of the reasons for seeking access to electronic health data in a pseudonymised format;

deleted

Or. en

Justification

Merged with point c)

Amendment 1746

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 45 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) a description of the safeguards planned to prevent any other use of the electronic health data;

(e) a description of the safeguards planned to prevent any other use or misuse of the electronic health data, including attempts to re-identify natural persons whose data are part of the dataset;

Or. en

Amendment 1747

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 45 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) a description of the safeguards planned to prevent any other use of the electronic health data;

(e) a description of the safeguards planned to prevent any other use or any misuse of the electronic health data, including the re-identification of natural persons in the dataset;

Or. en

Amendment 1748

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) a description of the safeguards planned to prevent any other use of the electronic health data;

(e) a description of the safeguards planned to prevent any other misuse of the electronic health data, including the re-identification of natural persons in the dataset;

Or. en

Amendment 1749

Lukas Mandl

Proposal for a regulation

Article 45 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) a description of the safeguards planned to protect the rights and interests of the data holder and of the natural persons concerned;

(f) a description of the necessary technical and organizational measures pursuant to Article 32 of Regulation (EU) 2016/679;

Or. en

Amendment 1750

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point f a (new)

Text proposed by the Commission

Amendment

(f a) a description of the necessary technical and organizational measures pursuant to Article 32 of Regulation (EU) 2016/679;

Or. en

Amendment 1751

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point f b (new)

Text proposed by the Commission

Amendment

(f b) a description of how the data applicant is qualified vis-à-vis the intended purposes of data use, such as professional qualifications to demonstrate appropriate expertise;

Or. en

Amendment 1752

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

Proposal for a regulation

Article 45 – paragraph 2 – point g

Text proposed by the Commission

Amendment

(g) an estimation of the period during which the electronic health data is needed for processing;

(g) a justified estimation of the period during which the electronic health data is needed for processing;

Or. en

Amendment 1753

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 45 – paragraph 2 – point h

Text proposed by the Commission

Amendment

(h) a description of the tools and computing resources needed for a secure environment.

(h) a description of the free and open-source tools and computing resources needed for a secure environment.

Or. en

Amendment 1754

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 45 – paragraph 2 – point h a (new)

Text proposed by the Commission

Amendment

(h a) where applicable, information on the assessment of ethical aspects of the processing and evidence of ethics approval obtained by the competent ethics committee in line with national law;

Or. en

Amendment 1755

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point h a (new)

Text proposed by the Commission

Amendment

(h a) all information under Article 14 of Regulation (EU) 2016/679 and information regarding the exercise of the rights of natural persons according to Chapter III of Regulation (EU) 2016/67;

Or. en

Amendment 1756

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

Proposal for a regulation

Article 45 – paragraph 2 – point h a (new)

Text proposed by the Commission

Amendment

(h a) a communication plan defining audiences and tools to publicly inform on the results or outcomes of the access to the data in accordance with Article 46(11);

Or. en

Amendment 1757

Kateřina Konečná

Proposal for a regulation

Article 45 – paragraph 2 – point h a (new)

Text proposed by the Commission

Amendment

(h a) a communication plan defining audiences and tools to publicly inform on the results or outcomes of the access to the data in accordance with Article 46(11).

Or. en

Justification

This amendment is an additional safeguard to ensure that patients are informed about the results or findings of projects for which electronic health data have been used. While most patients agree that their health data should be used for the public benefit, they also want access to the results of research that uses their data. Under Article 38(1)(e) of the draft Regulation, data users are required to make these results publicly available. However, in their requests for access to the data, data users are not obliged to indicate how they will communicate these results.

Amendment 1758

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 – point h b (new)

Text proposed by the Commission

Amendment

(h b) a signed agreement pledging to respect the common code of ethical conduct for the secondary uses of personal health data as developed by the EHDS Board in accordance with Article 65(2), point (g).

Or. en

Amendment 1759

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 45 – paragraph 2 – point h b (new)

Text proposed by the Commission

Amendment

(h b) a declaration that the intended uses of the data requested do not pose a risk of stigmatisation or dignitary harm to both individuals and the groups implicated in the dataset requested;

Or. en

Amendment 1760

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

Proposal for a regulation

Article 45 – paragraph 2 – point h b (new)

Text proposed by the Commission

Amendment

(h b) provide the specified information under Article 14 of Regulation (EU) 2016/679 and facilitate the exercise of the rights of natural persons with Chapter III of Regulation (EU) 2016/67.

Or. en

Amendment 1761

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

Proposal for a regulation

Article 45 – paragraph 2 – point h c (new)

Text proposed by the Commission

Amendment

(h c) information, such as but not limited to professional qualifications, which justify the data applicant's suitability to use the requested data for the intended purpose.

Or. en

Amendment 1762

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Data users that are private entities shall have a proven track-record of trustworthy and successful involvement in medical research or education. They shall submit a declaration setting out their vested interest in the processing as described in point a of paragraph 1.

Or. en

Amendment 1763

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 45 – paragraph 3

Text proposed by the Commission

Amendment

3. Data users seeking access to electronic health data from more than one Member State shall submit a single application to one of the concerned health data access bodies of their choice which shall be responsible for sharing the request with other health data access bodies and authorised participants in HealthData@EU referred to in Article 52, which have been identified in the data access application. For requests to access electronic health data from more than one Member States, the health data access body shall notify the other relevant health data access bodies of the receipt of an application relevant to them within 15 days from the date of receipt of the data access application.

3. Data users seeking access to electronic health data from more than one Member State shall be able to submit the applications through the HealthData@EU referred to in Article 52 by indicating what data they request from wich Member State.

Or. en

Amendment 1764

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 45 – paragraph 3

Text proposed by the Commission

Amendment

3. Data users seeking access to electronic health data from more than one Member State shall submit a single application to one of the concerned application processing bodies of their choice which shall be responsible for sharing the request with other application processing bodies and authorised participants in HealthData@EU referred to in Article 52, which have been identified in the data access application. For requests to access electronic health data from more than one Member States, the application processing body shall notify the other relevant application processing bodies of the receipt of an application relevant to them within 15 days from the date of receipt of the data access application.

Or. de

Amendment 1765

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

Proposal for a regulation

Article 45 – paragraph 3

Text proposed by the Commission

Amendment

3. Data users seeking access to electronic health data from more than one Member State shall submit a single application to one of the concerned health data access bodies of their choice which shall be responsible for sharing the application with the other health data access bodies and authorised participants in HealthData@EU referred to in Article 52, which have been identified in the data access application. In such a case, the health data access body shall notify the other relevant health data access bodies of the receipt of an application relevant to them within 15 days from the date of receipt of the data access application.

Or. en

Amendment 1766

Lukas Mandl

Proposal for a regulation

Article 45 – paragraph 3

Text proposed by the Commission

Amendment

3. Data users seeking access to electronic health data from more than one Member State shall submit a single application to one of the concerned health data access bodies of their choice which shall be responsible for sharing the request with other health data access bodies and authorised participants in HealthData@EU referred to in Article 52, which have been identified in the data access application. For requests to access electronic health data from more than one Member States, the health data access body shall notify the other relevant health data access bodies of the receipt of an application relevant to them within 30 days from the date of receipt of the data access application.

Or. en

Amendment 1767

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

Proposal for a regulation

Article 45 – paragraph 4 – introductory part

Text proposed by the Commission

Amendment

4. Where the applicant intends to access the personal electronic health data in a pseudonymised format, the following additional information shall be provided together with the data access application:

4. Where the applicant intends to access the personal electronic health data in a pseudonymised format or non-personal data, the following additional information shall be provided together with the data access application:

Or. en

Amendment 1768

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 4 – introductory part

Text proposed by the Commission

Amendment

4. Where the applicant requests to access the personal electronic health data in a pseudonymised format, the following additional information shall be provided together with the data access application:

Or. en

Amendment 1769

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 45 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679;

(a) a description of how the processing would comply with applicable Union and national law on data protection and privacy, notably Regulation (EU) 2016/679 and, where relevant, Regulation (EU) 2018/1725;

Or. en

Amendment 1770

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

Proposal for a regulation

Article 45 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679;

(a) a description of how the processing would comply with Article 6(1) and 9(2) of Regulation (EU) 2016/679 or Articles 5(1) and 10(2) of Regulation (EU) 2018/1725;

Or. en

Amendment 1771

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679;

(a) a description of how the processing would comply with Article 6(1) and, where applicable, Article 9 of Regulation (EU) 2016/679;

Or. en

Amendment 1772

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 45 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679;

(a) a description of the legal basis on which the processing is to be carried out within the meaning of Article 6(1) of Regulation (EU) 2016/679;

Or. de

Amendment 1773

Lukas Mandl

Proposal for a regulation

Article 45 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679;

(a) a description of how the processing would comply with Article 6(1) or Article 9 of Regulation (EU) 2016/679;

Or. en

Amendment 1774

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 45 – paragraph 4 – point a

Text proposed by the Commission

Amendment

(a) a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679;

(a) a description of how the processing would comply with Regulation (EU) 2016/679;

Or. en

Amendment 1775

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

Proposal for a regulation

Article 45 – paragraph 4 – point a a (new)

Text proposed by the Commission

Amendment

(a a) a detailed demonstration that the purpose of processing cannot be achieved with anonymised data;

Or. en

Amendment 1776

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

Proposal for a regulation

Article 45 – paragraph 4 – point b

Text proposed by the Commission

Amendment

(b) information on the assessment of ethical aspects of the processing, where applicable and in line with national law.

deleted

Or. en

Justification

Moved to paragraph 2 of this Article as it might concern not only pseudonymised, but also anonymised data.

Amendment 1777

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 45 – paragraph 4 – point b

Text proposed by the Commission

Amendment

(b) information on the assessment of ethical aspects of the processing, where applicable and in line with national law.

(b) information on the assessment of ethical aspects of the processing.

Or. en

Amendment 1778

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 5 – subparagraph 1

Text proposed by the Commission

Amendment

For the implementation of the tasks referred to in Article 37(1), points (b) and (c), the public sector bodies and the Union institutions, bodies, offices and agencies shall provide the same information as requested under Article 45(2), except for point (g), where they shall submit information concerning the period for which the data can be accessed, the frequency of that access or the frequency of the data updates.

Or. en

Amendment 1779

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

Proposal for a regulation

Article 45 – paragraph 5 – subparagraph 2

Text proposed by the Commission

Amendment

Where the public sector bodies and the Union institutions, bodies, offices and agencies intend to access the electronic health data in pseudonymised format, a description of how the processing would comply with Article 6(1) of Regulation (EU) 2016/679 or Article 5(1) of Regulation (EU) 2018/1725, as applicable, shall also be provided.

deleted

Or. en

Justification

Unnecessary provision, as this is already covered in paragraph 4 of this Article.

Amendment 1780

Konstantinos Arvanitis

Proposal for a regulation

Article 45 – paragraph 5 – subparagraph 2

Text proposed by the Commission

Amendment

Where the public sector bodies and the Union institutions, bodies, offices and agencies intend to access the electronic health data in pseudonymised format, a description of how the processing would comply with Article 6(1) and Article 9 of Regulation (EU) 2016/679, or Article 5(1) and Article 10 of Regulation (EU) 2018/1725, as applicable, shall also be provided.

Or. en

Amendment 1781

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 45 – paragraph 5 – subparagraph 2

Text proposed by the Commission

Amendment

Where the public sector bodies and the Union institutions, bodies, offices and agencies intend to access the electronic health data in pseudonymised format, a description of the legal basis on which the processing is to be carried out within the meaning of Article 6(1) of Regulation (EU) 2016/679 shall also be provided.

Or. de

Amendment 1782

Peter Liese

Proposal for a regulation

Article 45 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission may, by means of implementing acts, set out the templates for the data access application referred to in this Article, the data permit referred to in Article 46 and the data request referred to in Article 47. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 68(2).

6. The Commission may, by means of implementing acts, set out the templates for the data access application referred to in this Article, the data permit referred to in Article 46 and the data request referred to in Article 47. These templates shall be developed with the aim to limit unnecessary bureaucratic burden for applicants to the greatest possible extent. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 68(2).

Or. en

Justification

Unnecessary bureaucratic burden impact the ability of clinical researchers to conduct research in the health space, especially when such research is carried out by academic and non-commercial entities that often work with more limited financial resources. The templates for data access applications should therefore be user-friendly and not result in severe administrative burden impacting the research projects of clinical researchers.

Amendment 1783

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 45 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall, by means of implementing acts, set out the templates for the data access application referred to in this Article, the data permit referred to in Article 46 and the data request referred to in Article 47. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 68(2) and shall be limited to what is strictly necessary to avoid any unnecessary administrative burden.

Or. fr

Amendment 1784

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 45 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission, assisted by the EHDS Board set out in Article 64, shall, by means of implementing acts, set out the templates for the data access application referred to in this Article, the data permit referred to in Article 46 and the data request referred to in Article 47. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 68(2).

Or. en

Amendment 1785

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

Proposal for a regulation

Article 45 – paragraph 6

Text proposed by the Commission

Amendment

6. The Commission shall, by means of implementing acts, set out the templates for the data access application referred to in this Article, the data permit referred to in Article 46 and the data request referred to in Article 47. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68(2a).

Or. en

Amendment 1786

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

Proposal for a regulation

Article 45 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list of information in paragraphs 2, 4, 5 and 6 of this Article, to ensure the adequacy of the list for processing a data access application at national or cross-border level.

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list of information in paragraphs 2, 4, 5 of this Article, to ensure the adequacy of the list for processing a data access application at national or cross-border level.

Or. en

Amendment 1787

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 46 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies shall grant access to electronic health data only if the application fulfils all of the following criteria:

(a) the purposes described in the data access application correspond to at least one of the purposes listed in Article 9(2) of Regulation (EU) 2016/679, combined with Article 34(1) of this Regulation;

(b) the requested data is necessary and relevant for the purpose described in the data access application;

(c) the processing complies with applicable Union and national data protection law. The health data access bodies shall consult the relevant data protection authorities on this matter;

(d) the information provided in the application demonstrates sufficient safeguards to protect the rights and interests of the data holder and of the natural persons concerned and to prevent any other use or misuse of the data, including the re-identification of natural persons.

Or. en

Amendment 1788

Tomislav Sokol

Proposal for a regulation

Article 46 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies shall assess if the application fulfils one of the purposes listed in Article 34(1) of this Regulation, if the requested data is necessary for the purpose listed in the application and if the requirements in this Chapter are fulfilled by the applicant. If that is the case, and only after any data sharing agreement(s) on mutually agreed terms required by this Regulation, such as set out in Article 46a, are signed, the health data access body shall issue a data permit. However, any assessments by health data access bodies of an application concerning any data under Article 33(4) shall require the health data access bodies to consult the data holder(s).

Or. en

Amendment 1789

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 46 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 1790

István Ujhelyi

Proposal for a regulation

Article 46 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies shall assess if the application fulfils one of the purposes listed in Article 34(1) of this Regulation, if the requested data is necessary, adequate, and proportionate for the purpose listed in the application, if it received a favourable opinion from an authorised ethics committee, where applicable, or after conducting a data protection impact assessment, and if the requirements in this Chapter are fulfilled by the applicant. If that is the case, the health data access body shall issue a data permit.

Or. en

Amendment 1791

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies shall assess if the application fulfils all of the following criteria:

Or. en

Amendment 1792

Konstantinos Arvanitis

Proposal for a regulation

Article 46 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies shall assess if the application fulfils one of the purposes listed in Article 34(1) of this Regulation, if the requested data is necessary for the purpose listed in the application and if the requirements in this Chapter are fulfilled by the applicant. They shall also assess if the entity applying for the permit has a proven track record of genuine activity in the field of medical research or education. If that is the case, the health data access body shall issue a data permit.

Or. en

Amendment 1793

Rob Rooken

Proposal for a regulation

Article 46 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Justification

Natural persons should also be able to opt out with respect to the secondary use of their health data.

Amendment 1794

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

Proposal for a regulation

Article 46 – paragraph 1

Text proposed by the Commission

Amendment

1. When health data access bodies decide whether to grant or refuse a data permit, they shall assess if the health data access application referred to in Article 45 fulfils the following criteria:

Or. en

Amendment 1795

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 46 – paragraph 1

Text proposed by the Commission

Amendment

1. Application processing bodies shall assess if the application fulfils one of the purposes listed in Article 34(1) of this Regulation, if the requested data is necessary for the purpose listed in the application and if the requirements in this Chapter are fulfilled by the applicant. If that is the case, the application processing body shall issue a data permit.

Or. de

Amendment 1796

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 1 – point a (new)

Text proposed by the Commission

Amendment

(a) the purposes described in the application match one of the purposes listed in Article 9(2) of Regulation (EU) 2016/679 in combination with Article 34(1) of this Regulation;

Or. en

Amendment 1797

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 1 – point b (new)

Text proposed by the Commission

Amendment

(b) the requested data is necessary, adequate and proportionate for the purpose listed in the application;

Or. en

Amendment 1798

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 1 – point c (new)

Text proposed by the Commission

Amendment

(c) the processing complies with applicable Union and national data protection law. The health data access bodies shall seek the advice from the competent data protection authorities for this matter;

Or. en

Amendment 1799

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 1 – point d (new)

Text proposed by the Commission

Amendment

(d) the information provided in the application demonstrates sufficient safeguards planned to protect the rights and interests of the health data holder and of the natural persons concerned and to prevent any misuse;

Or. en

Amendment 1800

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 1 – point e (new)

Text proposed by the Commission

Amendment

(e) the information on the assessment of ethical aspects of the processing, where applicable, is in line with national law;

Or. en

Amendment 1801

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 1 – point f (new)

Text proposed by the Commission

Amendment

(f) other requirements in this Chapter.

Or. en

Amendment 1802

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

Proposal for a regulation

Article 46 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. (a) the purpose described in the health data access application is one of the purposes listed in Article 34(1) of this Regulation, regardless of whether the health data access application concerns anonymised or pseudonymised data;

(b) the requested data is necessary for the purpose or purposes listed in the health data access application;

(c) where electronic health data is requested in pseudonymised format, the information provided by the applicant demonstrates that the purposes of processing described in the application, and which are in line with point (a) of this paragraph, cannot be achieved with electronic health data in anonymised format;

(d) the processing of pseudonymised electronic health data, if the data permit would be granted, will be in line with Articles 6(1) and 9(2) of Regulation (EU) 2016/679 or Articles 5(1) and 10(2) of Regulation (EU) 2018/1725;

(e) the applicant demonstrates sufficient safeguards to prevent any other use or misuse of the electronic health data and to protect the rights and interests of the data holder and of the natural persons concerned;

(f) all other requirements in this Chapter are fulfilled by the applicant.

In this process, the health data access bodies shall also take into consideration the history of applications from the same applicant.

The health data access bodies shall ensure that the data will not be used for something a reasonable participant would find objectionable, or uses that health data access bodies would have reason to believe participants within the dataset would find objectionable.

Or. en

Amendment 1803

Konstantinos Arvanitis

Proposal for a regulation

Article 46 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Furthermore, when the health data access bodies make their decisions to grant or refuse access to electronic health data, they shall assess if the applicant fulfils the following criteria:

(a) the purposes described in the data access application match one or more of the purposes listed in Article 34(1) of this Regulation;

(b) the requested data is necessary for the purpose described in the data access application;

(c) the processing complies with applicable Union and national data protection law.The health data access bodies shall seek the advice from the competent data protection authorities for this matter;

(e) the information on the assessment of ethical aspects of the processing, where applicable, is in line with national law;

(f) the option of individuals to opt-out with respect to the secondary use of their personal health data;

(g) other requirements in this Chapter.

Or. en

Amendment 1804

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 46 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Nothwithstanding paragpraph 1, health data access bodies may, exceptionally and with due justification, refuse to grant data permit on any of the following grounds:

(a) national security;

(b) defence;

(d) the prevention, investigation, detection or prosecution of criminal offences or the execution of criminal penalties, including the safeguarding against and the prevention of threats to public security;

(e) other important objectives of general public interest of the Union or of a Member State, in particular an important economic or financial interest of the Union or of a Member State, including monetary, budgetary and taxation a matters, public health and social security;

(f) the protection of the data subject or the rights and freedoms of others.

Or. en

Amendment 1805

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 46 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met.

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35, all applications that do not fulfill the criteria referred to in paragraph 1 or where requirements in this Chapter are not met. The data authorisation shall not be granted for personal electronic health data where the data subject has not given consent pursuant to Article 33(5).

Or. en

Amendment 1806

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

Proposal for a regulation

Article 46 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met.

2. If the health data access body in its independent assessment concludes that the requirements listed in paragraph 1 of this Article are met, as well as all other requirements of this Chapter, the health data access body shall grant the health data permit. Health data access bodies shall refuse all applications where the requirements in this Chapter are not met.

Or. en

Amendment 1807

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met.

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35, applications where the necessity of processing for the intended purpose has not been sufficiently demonstrated, applications that do not sufficiently provide safeguards on re-identification, and applications where requirements in this Chapter are not met.

Or. en

Amendment 1808

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 46 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met.

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met. The data authorisation shall not be granted where the data subject opted-out to the processing pursuant to Article 33(5).

Or. en

Amendment 1809

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 46 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met.

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met, including in the event a data holder permissibly refuses to give access to its data under Article 33(1).

Or. en

Amendment 1810

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 46 – paragraph 2

Text proposed by the Commission

Amendment

2. Health data access bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met.

2. Application processing bodies shall refuse all applications including one or more purposes listed in Article 35 or where requirements in this Chapter are not met.

Or. de

Amendment 1811

Lukas Mandl

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

3. A health data access body shall issue or refuse a data permit within 2 months of receiving 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 for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall be issued.

3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. If the health data access body finds that the data access application is incomplete, it shall notify the data user and indicate the documents to be filed subsequently. If the data user does not fullfill this request within 4 weeks, a permit will not be granted. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall be issued.

Or. en

Amendment 1812

Mathilde Androuët

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

Or. fr

Amendment 1813

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

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

3. A health data access body shall issue or refuse a data permit within 6 months of receiving 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 for responding to a data access application where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay.

Or. en

Amendment 1814

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 46 – paragraph 3

Text proposed by the Commission

Amendment

3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. By way of derogation from that Regulation (EU) 2022/868, the health data access body may extend the period for responding to a data access application by a maximum of 3 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay.

Or. en

Amendment 1815

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1816

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. By way of derogation from Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay..

Or. en

Amendment 1817

Kateřina Konečná

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1818

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Justification

This provision undermines the principles of the rule of law, the rights and freedoms of consumers as well as the importance of the tasks of the health data access bodies to protect them. Given the likelihood that data access bodies will be overburdened with requests and the sensitivity of electronic health data, it is not appropriate to apply positive administrative silence in this context.

Amendment 1819

Konstantinos Arvanitis

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 1820

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

3. An application processing body shall issue or refuse a data permit within 2 months of receiving 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 for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the application processing body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where an application processing body fails to provide a decision within the time limit, the data permit shall be issued.

Or. de

Amendment 1821

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 46 – paragraph 3

Text proposed by the Commission

Amendment

Or. fr

Amendment 1822

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 46 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 shall have the possibility to scrutinise and, if necessary, overturn any data permit request issued by a health data access body, in line with the powers conferred to them by the respective Regulations.

Or. en

Justification

In line with EDPB-EDPS opinion

Amendment 1823

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 46 – paragraph 4

Text proposed by the Commission

Amendment

4. Following the issuance of the data permit, the health data access body shall immediately request the electronic health data from the data holder. 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 the health data access body specifies that it will provide the data within a longer specified timeframe.

4. Following the issuance of the data permit, the application processing body shall call on the data holder to transmit the electronic health data to the health data access body, or to make it available to the data user, via the pseudonymisation body without delay. The health data access body or the data holder shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless the health data access body specifies that it will provide the data within a longer specified timeframe.

Or. de

Amendment 1824

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 4

Text proposed by the Commission

Amendment

4. Following the issuance of the data permit, the health data access body shall immediately request the electronic health data from the data holder and inform them whether the data shall be made accessible in anonymised or pseudonymised form. 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 the health data access body specifies that it will provide the data within a longer specified timeframe due to circumstances beyond its control.

Or. en

Amendment 1825

Konstantinos Arvanitis

Proposal for a regulation

Article 46 – paragraph 4

Text proposed by the Commission

Amendment

4. Following the issuance of the data permit, the health data access body shall, without undue delay, request the electronic health data from the data holder. 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.

Or. en

Amendment 1826

Mathilde Androuët

Proposal for a regulation

Article 46 – paragraph 4

Text proposed by the Commission

Amendment

Or. fr

Amendment 1827

Pernille Weiss

Proposal for a regulation

Article 46 – paragraph 4

Text proposed by the Commission

Amendment

4. Following the issuance of the data permit, the health data access body shall immediately request the electronic health data from the data holder. 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, except where the health data access body can duly justify the need for an extension. In this case, a longer specified timeframe shall be decided.

Or. en

Amendment 1828

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 46 – paragraph 5

Text proposed by the Commission

Amendment

5. When the health data access body refuses to issue a data permit, it shall provide a justification for the refusal to the applicant.

5. When the application processing body refuses to issue a data permit, it shall provide a justification for the refusal to the applicant.

Or. de

Amendment 1829

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

Proposal for a regulation

Article 46 – paragraph 6 – point a

Text proposed by the Commission

Amendment

(a) types and format of electronic health data accessed, covered by the data permit, including their sources;

(a) categories and format of electronic health data accessed, covered by the data permit, including their sources;

Or. en

Amendment 1830

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

Proposal for a regulation

Article 46 – paragraph 6 – point b

Text proposed by the Commission

Amendment

(b) purpose for which data are made available;

(b) a detailed description of the purpose for which data are made available;

Or. en

Amendment 1831

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 46 – paragraph 6 – point b a (new)

Text proposed by the Commission

Amendment

(b a) the identity of the applicant as well as the concrete persons who are authorised to have access to the electronic health data in the secure processing environment;

Or. en

Amendment 1832

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

Proposal for a regulation

Article 46 – paragraph 6 – point e

Text proposed by the Commission

Amendment

(e) fees to be paid by the data user;

(e) fees to be paid by the data user to the health data access body;

Or. en

Amendment 1833

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 46 – paragraph 6 – point f a (new)

Text proposed by the Commission

Amendment

(f a) when required, signed data sharing agreements, as set out in Article 46a;

Or. en

Amendment 1834

Tomislav Sokol

Proposal for a regulation

Article 46 – paragraph 6 – point f a (new)

Text proposed by the Commission

Amendment

(f a) When required, signed data sharing agreements, as set out in Article 46a;

Or. en

Amendment 1835

Konstantinos Arvanitis

Proposal for a regulation

Article 46 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. Relevant bodies or authorities competent pursuant to applicable data protection legislation shall have the possibility to scrutinise and, if necessary, overturn the assessment of the data processing legal basis of data permit requests made to the health data access bodies.

Or. en

Amendment 1836

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 46 – paragraph 7

Text proposed by the Commission

Amendment

7. Data users shall have the right to access and process the electronic health data in accordance with the data permit delivered to them on the basis of this Regulation.

7. Data users shall have the right to access and process the electronic health data in accordance with the data permit delivered to them on the basis of this Regulation. Pursuant to Article 9)(1), point (j), of Regulation (EU)2016/679, where the permit allows data users to process personal electronic health data, data users shall have a right to process such data, subject to the safeguards and limitations set out in this Regulation and the permit.

Or. en

Amendment 1837

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 7

Text proposed by the Commission

Amendment

7. Data users shall have the right to access and process the electronic health data in accordance with the data permit delivered to them on the basis of this Regulation.

7. Data users shall have the right to access and process the electronic health data in accordance with the data permit delivered to them on the basis of this Regulation, after they have demonstrated that the security measures pursuant to in Article 52, points (e) and (f), are effectively implemented.

Or. en

Amendment 1838

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 46 – paragraph 7

Text proposed by the Commission

Amendment

7. Data users shall have the right to access and process the electronic health data in accordance with the data permit delivered to them on the basis of this Regulation.

7. Data users shall have the right to access and process the electronic health data in accordance with the data permit delivered to them on the basis of this Regulation only after they have demonstrated the effective implementation of their security measures referred to in Article 45(2), points (e) and (f).

Or. en

Amendment 1839

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

Proposal for a regulation

Article 46 – paragraph 8

Text proposed by the Commission

Amendment

8. The Commission is empowered to adopt delegated acts to amend the list of aspects to be covered by a data permit in paragraph 7 of this Article, in accordance with the procedure set out in Article 67.

8. The Commission is empowered to adopt delegated acts to amend the list of aspects to be covered by a data permit in paragraph 6 of this Article, in accordance with the procedure set out in Article 67.

Or. en

Amendment 1840

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

Proposal for a regulation

Article 46 – paragraph 9

Text proposed by the Commission

Amendment

9. A data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 5 years. This duration may be extended once, at the request of the data user, based on arguments and documents to justify this extension provided, 1 month before the expiry of the data permit, for a period which cannot exceed 5 years. By way of derogation from Article 42, the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 5 years. In order to reduce such costs and fees, the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. The data within the secure processing environment shall be deleted within 6 months following the expiry of the data permit. Upon request of the data user, the formula on the creation of the requested dataset shall be stored by the health data access body.

9. A data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 5 years. This duration may be extended once, at the request of the data user, based on arguments and documents to justify this extension provided, 1 month before the expiry of the data permit, for a period which cannot exceed 5 years. By way of derogation from Article 42, the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 5 years. In order to reduce such costs and fees, the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. The data within the secure processing environment shall be deleted following the expiry of the data permit. Upon request of the data user, the formula on the creation of the requested dataset shall be stored by the health data access body for a period of 5 years.

Or. en

Amendment 1841

Pernille Weiss

Proposal for a regulation

Article 46 – paragraph 9

Text proposed by the Commission

Amendment

9. A data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 10 years. This duration may be extended once, at the request of the data user, based on arguments and documents to justify this extension provided, 1 month before the expiry of the data permit, for a period which cannot exceed 2 years. By way of derogation from Article 42, the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 5 years. In order to reduce such costs and fees, the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. The data within the secure processing environment shall be deleted within 6 months following the expiry of the data permit. Upon request of the data user, the formula on the creation of the requested dataset shall be stored by the health data access body.

Or. en

Amendment 1842

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 46 – paragraph 9

Text proposed by the Commission

Amendment

9. A data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 5 years. This duration may be extended once, at the request of the data user, based on arguments and documents to justify this extension provided, 1 month before the expiry of the data permit, for a period which cannot exceed 5 years. By way of derogation from Article 42, the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 5 years. In order to reduce such costs and fees, the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. The data within the secure processing environment shall be deleted immediately after the expiry of the data permit. Upon request of the data user, the formula on the creation of the requested dataset shall be stored by the health data access body.

Or. en

Amendment 1843

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

Proposal for a regulation

Article 46 – paragraph 9

Text proposed by the Commission

Amendment

9. A data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 5 years. This duration may be extended once, at the request of the data user, based on arguments and documents to justify this extension provided, 1 month before the expiry of the data permit, for a period which cannot exceed 5 years. By way of derogation from Article 42, the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 5 years. In order to reduce such costs and fees, the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. The data within the secure processing environment shall be deleted immediately after the expiry of the data permit. Upon request of the data user, the formula on the creation of the requested dataset shall be stored by the health data access body.

Or. en

Amendment 1844

Christel Schaldemose

Proposal for a regulation

Article 46 – paragraph 9

Text proposed by the Commission

Amendment

9. A data permit shall be issued for the duration necessary to fulfil the requested purposes which shall not exceed 10 years. This duration may be extended once for no more than 2 years at the request of the data user based on arguments and documents to justify this extension provided 1 month before the expiry of the data permit. By way of derogation from Article 42, the health data access body may charge increasing fees to reflect the costs and risks of storing electronic health data for a longer period of time exceeding the initial 10 years. In order to reduce such costs and fees, the health data access body may also propose to the data user to store the dataset in storage system with reduced capabilities. The data within the secure processing environment shall be deleted within 6 months following the expiry of the data permit. Upon request of the data user, the formula on the creation of the requested dataset shall be stored by the health data access body.

Or. da

Justification

In many research projects, data will need to be kept for more than 5 years. In providing for a storage period of up to 10 years, this amendment provides more scope when it comes to assessing what ‘the duration necessary’ actually is. The extension period, on the other hand, is shorter than the proposed 5 years.

Amendment 1845

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

Proposal for a regulation

Article 46 – paragraph 11

Text proposed by the Commission

Amendment

11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.

deleted

Or. en

Justification

This provision represents a duty of health data users, therefore it was moved to a standalone Article 41a that lists all the duties of health data users. Originally, the duties of health data holders were scattered through various articles of the proposed Regulation.

Amendment 1846

Tomislav Sokol

Proposal for a regulation

Article 46 – paragraph 11

Text proposed by the Commission

Amendment

11. Data users shall make public the results or output (in accordance with the definition of results/outputs under Article 2) of the secondary use of electronic health data, including information relevant for the provision of healthcare and in compliance with minimum requirements of what needs to be published, but such that this will not prejudice the IP rights in the secondary use results/outputs, particularly if the secondary use is for development or innovation as referred to in Article 34(f) , no later than 18 months after the completion of the electronic health data processing with a possible extension to 24 months if requested by data users due to sensitivity of health data in relation to IP rights. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.

Or. en

Amendment 1847

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 46 – paragraph 11

Text proposed by the Commission

Amendment

11. Data users shall make public the results or output (in accordance with the definition of results /outputs under Article 2) of the secondary use of electronic health data on a voluntary basis, including information relevant for the provision of healthcare and in compliance with minimum requirements of what needs to be published, but such that this will not prejudice the IP rights in the secondary use results/outputs, particularly if the secondary use is for development or innovation as referred to in Article 34(f), no later than 18 months after the completion of the electronic health data processing with a possible extension to 24 months. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.

Or. en

Amendment 1848

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 46 – paragraph 11

Text proposed by the Commission

Amendment

Or. en

Amendment 1849

Pernille Weiss

Proposal for a regulation

Article 46 – paragraph 11

Text proposed by the Commission

Amendment

11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. Data users shall not be obliged to make public results or output in a way that compromises intellectual property rights contained therein. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.

Or. en

Amendment 1850

Andreas Glück

Proposal for a regulation

Article 46 – paragraph 11

Text proposed by the Commission

Amendment

11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites without compromising on IP rights and trade secrets defined in relevant Union legislation. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.

Or. en

Justification

The publication of results/output should not be in conflict with existing Union legislation regarding the protection of IP and trade secrets.

Amendment 1851

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

Proposal for a regulation

Article 46 – paragraph 11

Text proposed by the Commission

Amendment

11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 12 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public in lay summaries on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.

Or. en

Amendment 1852

Kateřina Konečná

Proposal for a regulation

Article 46 – paragraph 11

Text proposed by the Commission

Amendment

11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 12 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public in lay summaries on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.

Or. en

Justification

Simply providing the results or output of secondary use of electronic health data is not enough if the information provided is not easily understandable by patients. Data users should ensure that information is communicated in a way that facilitates understanding, for example using a lay language. Effective and patient-friendly communication is of utmost importance, and it contributes to the health and digital health literacy of patients. Unclear information on how their data is used could undermine the willingness of patients to share their data, which is indispensable for the EHDS

Amendment 1853

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 46 – paragraph 11

Text proposed by the Commission

Amendment

11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the application processing bodies from which a data permit was obtained and support them to make the information public on the application processing bodies’ websites or on a central website. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.

Or. de

Amendment 1854

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

Proposal for a regulation

Article 46 – paragraph 12

Text proposed by the Commission

Amendment

12. Data users shall inform the health data access body of any clinically significant findings that may influence the health status of the natural persons whose data are included in the dataset.

deleted

Or. en

Justification

Amendment 1855

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 46 – paragraph 12

Text proposed by the Commission

Amendment

12. Data users shall inform the health data access body of any clinically significant findings that may influence the health status of the natural persons whose data are included in the dataset.

12. Data users shall inform the health data access body of any clinically significant findings that may influence the health status of the natural persons whose data are included in the dataset and where natural persons have explicitly given their consent.

Or. en

Amendment 1856

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 46 – paragraph 12

Text proposed by the Commission

Amendment

12. Data users shall inform the health data access body of any clinically significant findings that may influence the health status of the natural persons whose data are included in the dataset.

12. Data users shall inform the application processing body of any clinically significant findings that may influence the health status of the natural persons whose data are included in the dataset.

Or. de

Amendment 1857

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 46 – paragraph 14

Text proposed by the Commission

Amendment

14. The liability of health data access bodies as joint controller is limited to the scope of the issued data permit until the completion of the processing activity.

14. The liability of health data access bodies or of the data holder as joint controller, depending on who makes the data available to the data user, is limited to the scope of the issued data permit until the completion of the processing activity.

Or. de

Amendment 1858

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

Proposal for a regulation

Article 46 – paragraph 14

Text proposed by the Commission

Amendment

14. The liability of health data access bodies as joint controller is limited to the scope of the issued data permit until the completion of the processing activity.

14. The liability of health data access bodies as controller is limited to the scope of the issued data permit and in accordance with Article 51.

Or. en

Justification

The joint controllership in Article 51 was modified to better address the process.

Amendment 1859

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 46 – paragraph 14 a (new)

Text proposed by the Commission

Amendment

14 a. The authorities competent pursuant to applicable data protection legislation shall have the possibility to scrutinise and, if necessary, overturn the assessment of the data processing legal basis of data permit requests made to the health data access bodies.

Or. en

Amendment 1860

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 46 a (new)

Text proposed by the Commission

Amendment

Article 46 a

Data sharing agreement for electronic health data

1. In order for electronic health data entailing IP rights, including trade secrets, and commercial property from private enterprises to be made available for secondary use, the data user must sign a data sharing agreement with each private enterprise data holder. Such electronic health data shall not be made available to any data user for the purposes of secondary use unless and until the data user has signed the data sharing agreement.

2. The data sharing agreement shall set out all necessary measures to protect all IP rights, including trade secrets, and commercial property entailed in the electronic health data and additional conditions of access requested by the data holder. In particular, without limitations, it may include any or all of:

a. a restriction on any use of the electronic health data outside the scope of the secondary use purposes specified in the data permit, including for any prohibited secondary use as set out in this Regulation, including Article 35;

b. an undertaking by the data user to preserve and not infringe or misappropriate the IP rights, including trade secrets, of the data holder, including to (i) preserve the confidentiality of the data holder’s confidential information, including trade secrets, and (ii) not perform or enable any reverse engineering or other activity to identify the confidential information, including trade secrets, of the data holder;

c. provisions to ensure the confidentiality of the electronic health data and confidential information, including trade secrets, of the data holder. For example, (i) a right of prior review by the data holder of any public disclosures or applications for registerable IP rights, including patent applications, intended by or on behalf of the data user(s), including under this Regulation, that relates to or arises from the use of the electronic health data, including the results or outputs, including the right to delay or prohibit the publication, and (ii) data security requirements reasonably required by the data holder;

d. a requirement for the data user to notify the data holder of the creation of any new IP right from its use of the electronic health data and for granting the data holder non-exclusive, fully-paid up and royalty-free licence rights enabling the data holder and its affiliates to use any new IP right, results and outputs for its own business purposes. Such licence shall only be sub-licensable to third parties working in collaboration with, or on behalf of, the data holder or one of its affiliates for the aforesaid purposes. Such a licence shall be non-transferable, except where needed in order to commercialise an existing product of the data holder or any of its affiliates;

e. audit rights for the data holder to ensure compliance of the processing with the data sharing agreement;

f. the data holder to own all and any derived data created by the data user(s), a requirement for the data user to assign to and notify the data holder of any derived data and to enable the data holder to obtain a copy of it, and the rights, obligations and undertakings of, and the restrictions on, the data user as it relates to the electronic health data and confidential information, (including trade secrets, of the data holder to apply mutatis mutandis to any and all derived data. [‘Derived data’ means the improved, corrected, or enriched dataset provided to the data holder in accordance with Article 37(1)(p), as well as any new or different form of the original electronic health data created by the data user(s), including any alternative or different representation or abstraction of the original data or any new form which would enable the original data to be identified or reverse engineered];

g. the right of the data holder to terminate the data sharing agreement, and of the right to use the data, in the event of a breach of the terms of the data sharing agreement by the data user.

Or. en

Amendment 1861

Tomislav Sokol

Proposal for a regulation

Article 46 a (new)

Text proposed by the Commission

Amendment

Article 46 a

c. provisions to ensure the confidentiality of the electronic health data and confidential information, including trade secrets, of the data holder. For example, (i) a right of prior review by the data holder of any public disclosures or applications for registerable IP rights, including patent applications, intended by or on behalf of the data user(s), including under this Regulation, that relates to or arises from the use of the electronic health data,(including the results or outputs, including the right to delay or prohibit the publication, and (ii) data security requirements reasonably required by the data holder;

d. a requirement for the data user to notify the data holder of the creation of any new IP from its use of the electronic health data and for granting the data holder non-exclusive, fully-paid up and royalty-free licence rights enabling the data holder and its affiliates to use any new IP, results and outputs for its own business purposes. Such licence shall only be sub-licensable to third parties working in collaboration with, or on behalf of, the data holder or one of its affiliates for the aforesaid purposes. Such a licence shall be non-transferable, except where needed in order to commercialise an existing product of the data holder or any of its affiliates;

e. audit rights for the data holder to ensure compliance of the processing with the data sharing agreement;

Or. en