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 466

Erik Poulsen, Asger Christensen

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation establishes the European Health Data Space (‘EHDS’) by providing for rules, common standards and practices, infrastructures and a governance framework for the primary and secondary use of electronic health data. The European Health Data Space (‘EHDS’) shall, with respect for the principle of subsidiarity, complement and not replace Member States' national rules and policy principles for the use of both primary and secondary health data.

Or. en

Amendment 467

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

Proposal for a regulation

Article 1 – paragraph 1

Text proposed by the Commission

Amendment

1. This Regulation establishes the European Health Data Space (‘EHDS’) by providing for rules, interoperable common standards, practices, and infrastructures and a governance framework for the primary and secondary use of electronic health data.

Or. en

Amendment 468

István Ujhelyi

Proposal for a regulation

Article 1 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. This Regulation:

a) strengthens the rights of natural persons in relation to the availability and control of their electronic health data;

b) lays down rules for the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the Union;

c) lays down rules and mechanisms supporting the secondary use of electronic health data;

d) establishes a mandatory cross-border infrastructure enabling the primary use of electronic health data across the continuum of care in the Union for patient safety, research and policy-making.

e) establishes a mandatory cross-border infrastructure for the secondary use of electronic health data across the health care continuum in the Union for patient safety, research and policy-making.

Or. en

Amendment 469

Mathilde Androuët

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) strengthens the rights of natural persons in relation to the availability and control of their electronic health data;

(a) strengthens the protection and rights of natural persons in relation to the availability, sharing and control of their electronic health data, which must remain mainly anonymous and thus non-personal, except in the event of a life-threatening emergency or with the express agreement of the natural person;

Or. fr

Amendment 470

Rob Rooken

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) strengthens the rights of natural persons in relation to the availability and control of their electronic health data;

(a) strengthens the rights of natural persons in relation to the availability and control of their electronic health data, both in the primary as in the secondary use thereof;

Or. en

Amendment 471

Tudor Ciuhodaru

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) strengthens the rights of natural persons in relation to the availability and control of their electronic health data;

(a) strengthens the rights of natural persons in relation to the availability, control and security of their electronic health data;

Or. ro

Amendment 472

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

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) strengthens the rights of natural persons in relation to the availability and control of their electronic health data;

(a) strengthens the rights of natural persons in relation to the availability, sharing and control of their electronic health data;

Or. en

Amendment 473

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) strengthens the rights of natural persons in relation to the availability and control of their electronic health data;

(a) specifies the rights of natural persons in relation to the availability and control of their electronic health data;

Or. en

Amendment 474

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

Proposal for a regulation

Article 1 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) strengthens the rights of natural persons in relation to the availability and control of their electronic health data;

(a) outlines the rights of natural persons in relation to the availability and control of their electronic health data;

Or. en

Amendment 475

Dolors Montserrat

Proposal for a regulation

Article 1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) lays down rules for the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the Union;

(b) lays down rules for the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the Union for all electronic health applications that use data and produce wearables, health apps, telemedicine platforms, etc., with those data;

Or. es

Amendment 476

Tudor Ciuhodaru

Proposal for a regulation

Article 1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) lays down rules for the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the Union;

(b) lays down rules for the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the Union, with the appropriate security measures;

Or. ro

Amendment 477

Maria Grapini

Proposal for a regulation

Article 1 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) lays down rules for the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the Union;

Or. ro

Amendment 478

Maria Grapini

Proposal for a regulation

Article 1 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) establishes a mandatory cross-border infrastructure enabling the primary use of electronic health data across the Union;

(d) establishes a mandatory cross-border infrastructure enabling the primary use of electronic health data across the Union that complies with the GDPR;

Or. ro

Amendment 479

Maria Grapini

Proposal for a regulation

Article 1 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) establishes a mandatory cross-border infrastructure for the secondary use of electronic health data.

(e) establishes a mandatory cross-border infrastructure for the secondary use of electronic health data that complies with the GDPR.

Or. ro

Amendment 480

Javier Zarzalejos

Proposal for a regulation

Article 1 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) manufacturers and suppliers of EHR systems and wellness applications placed on the market and put into service in the Union and the users of such products;

(a) manufacturers and suppliers of EHR systems, medical devices, wellness applications and other digital health applications that are able to process electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health and that are placed on the market and put into service in the Union and the users of such products;

Or. en

Amendment 481

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

Proposal for a regulation

Article 1 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) manufacturers and suppliers of EHR systems and wellness applications placed on the market and put into service in the Union and the users of such products;

(a) manufacturers and suppliers of EHR systems and products claiming interoperability with EHR systems, including medical devices, high-risk AI systems and wellness applications placed on the market and put into service in the Union and the users of such products;

Or. en

Amendment 482

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) manufacturers and suppliers of EHR systems and wellness applications placed on the market and put into service in the Union and the users of such products;

(a) manufacturers and suppliers of EHR systems and of medical devices placed on the market and put into service in the Union and the users of such products;

Or. en

Amendment 483

Konstantinos Arvanitis

Proposal for a regulation

Article 1 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) manufacturers and suppliers of EHR systems and wellness applications placed on the market and put into service in the Union and the users of such products;

(a) manufacturers and suppliers of EHR systems placed on the market and put into service in the Union and the users of such products;

Or. en

Amendment 484

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 1 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) manufacturers and suppliers of EHR systems and wellness applications placed on the market and put into service in the Union and the users of such products;

(a) manufacturers and suppliers of EHR systems placed on the market and put into service in the Union and the users of such products;

Or. en

Justification

Wellness applications to be removed throughout the whole text.

Amendment 485

Rob Rooken

Proposal for a regulation

Article 1 – paragraph 3 – point a

Text proposed by the Commission

Amendment

(a) manufacturers and suppliers of EHR systems and wellness applications placed on the market and put into service in the Union and the users of such products;

(a) manufacturers and suppliers of EHR systems placed on the market and put into service in the Union and the users of such products;

Or. en

Amendment 486

Konstantinos Arvanitis

Proposal for a regulation

Article 1 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) controllers and processors established in the Union processing electronic health data of Union citizens and third-country nationals legally residing in the territories of Member States;

(b) controllers and processors established in the Union processing electronic health data of persons in the EU;

Or. en

Amendment 487

Javier Zarzalejos

Proposal for a regulation

Article 1 – paragraph 3 – point b

Text proposed by the Commission

Amendment

(b) controllers and processors established in the Union processing electronic health data of Union citizens and third-country nationals legally residing in the territories of Member States;

(b) data holders and data users established in the Union processing electronic health data of Union citizens and third-country nationals legally residing in the territories of Member States;

Or. en

Amendment 488

Rob Rooken

Proposal for a regulation

Article 1 – paragraph 3 – point c

Text proposed by the Commission

Amendment

(c) controllers and processors established in a third country that has been connected to or are interoperable with MyHealth@EU, pursuant to Article 12(5);

deleted

Or. en

Amendment 489

Javier Zarzalejos

Proposal for a regulation

Article 1 – paragraph 3 – point d

Text proposed by the Commission

Amendment

(d) data users to whom electronic health data are made available by data holders in the Union.

(d) data users to whom electronic health data are made available by data holders in the Union or third countries or international institutions.

Or. en

Amendment 490

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 1 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. This Regulation shall not affect the application of Regulations (EU) 2016/679, (EU) 2018/1725, (EU) No 536/2014 and Directive 2002/58/EC.

Or. en

Amendment 491

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 1 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. References to the provisions of Regulation (EU) 2016/679 shall be understood also as references to the corresponding provisions of Regulation (EU) 2018/1725 for Union institutions and bodies, where relevant.

Or. en

Amendment 492

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 1 – paragraph 4

Text proposed by the Commission

Amendment

4. This Regulation shall be without prejudice to other Union legal acts regarding access to, sharing of or secondary use of electronic health data, or requirements related to the processing of data in relation to electronic health data, in particular Regulations (EU) 2016/679, (EU) 2018/1725, […] [Data Governance Act COM/2020/767 final] and […] [Data Act COM/2022/68 final].

Or. en

Amendment 493

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 4

Text proposed by the Commission

Amendment

4. This Regulation shall be without prejudice to other Union legal acts regarding access to, sharing of or secondary use of electronic health data, or requirements related to the processing of data in relation to electronic health data, in particular Regulations (EU) 2016/679, (EU) 2018/1725, (EU) 2022/868 and […] [Data Act COM/2022/68 final].

(This amendment applies throughout the text)

Or. en

Amendment 494

Konstantinos Arvanitis

Proposal for a regulation

Article 1 – paragraph 4

Text proposed by the Commission

Amendment

4. This Regulation shall be without prejudice to other Union legal acts regarding access to, sharing of or secondary use of electronic health data, or requirements related to the processing of data in relation to electronic health data, in particular Regulations (EU) 2016/679, (EU) 2018/1725, (EU) 2022/868, Directive 2002/58/EC, and […] [Data Act COM/2022/68 final].

Or. en

Justification

For the sake of legal certainty, the EHDS regulation should explicitly refer to all relevant data protection legislation, also in line with the EDPS-EDPB Joint Opinion 03/2022.

Amendment 495

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 1 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Pursuant to Article 9(4) of Regulation (EU) 2016/679, Member States may impose further restrictions on the processing of personal health data laid down in Chapters II and IV of this Regulation.

Or. en

Amendment 496

Javier Zarzalejos

Proposal for a regulation

Article 1 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. This regulation shall be without prejudice to the Directive on the Protection of Trade Secrets (Directive (EU) 2016/943) which shall take precedence.

Or. en

Amendment 497

Maria Grapini

Proposal for a regulation

Article 1 – paragraph 6

Text proposed by the Commission

Amendment

6. This Regulation shall not affect the rights and obligations laid down in Union or national law concerning data processing for the purposes of reporting, complying with information requests or demonstrating or verifying compliance with legal obligations.

Or. ro

Amendment 498

Javier Zarzalejos

Proposal for a regulation

Article 1 – paragraph 6 a (new)

Text proposed by the Commission

Amendment

6 a. This Regulation shall not apply to activities concerning defence and national security.

Or. en

Amendment 499

Javier Zarzalejos

Proposal for a regulation

Article 1 – paragraph 6 b (new)

Text proposed by the Commission

Amendment

6 b. This Regulation shall be without prejudice to Regulations (EU) 2016/679, (EU) 2018/1725, (EU) No 536/2014 and Directive 2022/58/EC.

Or. en

Amendment 500

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. For the purposes of this Regulation, following definitions shall apply:

1. For the purposes of this Regulation, the following definitions shall apply:

Or. en

Amendment 501

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

Proposal for a regulation

Article 2 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the definitions in Regulation (EU) 2016/679;

(a) the definitions of ‘personal data’, ‘processing’, ‘pseudonymisation’, ‘controller’, ‘processor’, ‘genetic data’, ‘data concerning health’, ‘cross-border processing’, ‘international organisation’ pursuant to Article 4 (1), (2), (5), (7), (8), (13), (15), (23), and (26) of Regulation (EU) 2016/679;

Or. en

Amendment 502

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 2 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the definitions in Regulation (EU) 2016/679;

(a) the definitions, including those of ‘personal data’, ‘processing’, ‘pseudonymisation’, ‘controller’, ‘processor’, ‘third party’, ‘consent’, ‘genetic data’, ‘data concerning health’, ‘supervisory authority’, ‘international organisation’ in Regulation (EU) 2016/679;

Or. en

Amendment 503

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 2 – paragraph 1 – point f a (new)

Text proposed by the Commission

Amendment

(f a) the definitions of ‘One Health’ and ‘Health in All Policies’ pursuant to Article 3 of the Regulation (EU) No 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU;

Or. en

Amendment 504

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ‘personal electronic health data’ means data concerning health and genetic data as defined in Regulation (EU) 2016/679, as well as data referring to determinants of health, or data processed in relation to the provision of healthcare services, processed in an electronic form;

(a) ‘personal electronic health data’ means data concerning health and genetic data as defined in Regulation (EU) 2016/679 processed in an electronic form;

Or. en

Justification

See joint opinion paragraph 40.

Amendment 505

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

Proposal for a regulation

Article 2 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ‘personal electronic health data’ means data concerning health and genetic data as defined in Regulation (EU) 2016/679, processed in an electronic form;

Or. en

Amendment 506

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 2 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ‘personal electronic health data’ means data concerning health and genetic data as defined in Regulation (EU) 2016/679, processed in an electronic form;

Or. en

Justification

Alignment with the GDPR

Amendment 507

Lídia Pereira

Proposal for a regulation

Article 2.º – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ‘personal electronic health data’ means data concerning health and genetic data as defined in Regulation (EU) 2016/679, processed in an electronic form;

Or. pt

Amendment 508

Javier Zarzalejos

Proposal for a regulation

Article 2 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ‘personal electronic health data’ means data concerning health and genetic data as defined in Regulation (EU) 2016/679 that are processed in an electronic form;

Or. en

Amendment 509

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

Proposal for a regulation

Article 2 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ‘personal electronic health data’ means data concerning health and genetic data as defined in Regulation (EU) 2016/679, that are processed in an electronic form;

Or. en

Amendment 510

Mathilde Androuët

Proposal for a regulation

Article 2 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ‘personal electronic health data’ means data constituting health data and genetic data as defined in Regulation (EU) 2016/679, as well as data referring to determinants of health, or data processed in relation to the provision of healthcare services, processed in an electronic form;

Or. fr

Amendment 511

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ‘personal electronic health data’ means data concerning physical or mental health, and genetic data as defined in Regulation (EU) 2016/679, as well as data referring to determinants of health, that are processed in an electronic form;

Or. en

Amendment 512

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ‘non-personal electronic health data’ means data concerning health and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679; where such data are part of a mixed dataset where personal and non-personal data are inextricably linked, the entire dataset shall be considered as personal electronic health data;

Or. en

Amendment 513

Andreas Glück

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ‘non-personal electronic health data’ means data concerning health and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679; and on a case by case basis pseudonymised data according to Article 4(5) of Regulation (EU) 2016/679;

Or. en

Justification

For research purposes, pseudonymised data could be considered as non-personal data on a case by case basis. Article 4(5) of Regulation (EU) 2016/679: ‘pseudonymisation’ means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person;

Amendment 514

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ‘non-personal electronic health data’ means data concerning health and aggregated genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;

Or. en

Amendment 515

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

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ‘non-personal electronic health data’ means data relevant for health research in electronic format that have been irreversibly anonymised and data that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;

Or. en

Amendment 516

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

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ‘non-personal electronic health data’ means data concerning mental and physical health and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;

Or. en

Amendment 517

Mathilde Androuët

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ‘non-personal electronic health data’ means data constituting health data and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;

Or. fr

Amendment 518

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 2 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ‘non-personal electronic health data’ means data concerning health in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;

Or. en

Amendment 519

Tomislav Sokol

Proposal for a regulation

Article 2 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) ‘electronic health data’ means personal or non-personal electronic health data processed by providers in the context of healthcare. Such data may include actionable health data, which is collected and processed by providers in the context of healthcare which provides clinical measurements/values that are usable by patients, healthcare professionals and researchers.

Or. en

Amendment 520

Traian Băsescu

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ca) ‘anonymous electronic health data’ means health-related electronic data which do not refer to an identified or identifiable natural person or personal data processed in such a way that the data subject is not, or is no longer, identifiable;

Or. ro

Amendment 521

Traian Băsescu

Proposal for a regulation

Article 2 – paragraph 2 – point c b (new)

Text proposed by the Commission

Amendment

(cb) 'consent' means any freely given, specific, informed and unambiguous indication of the wishes of the data subject or of their representative by which they agree, in the form of a statement or clear affirmative action, to the processing of the personal data relating to them; where the processing has multiple purposes, consent must be given for each of those purposes;

Or. ro

Amendment 522

Traian Băsescu

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(cc) 'genetic data' means personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question;

Or. ro

Amendment 523

Margarita de la Pisa Carrión

Proposal for a regulation

Article 2 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) ‘primary use of electronic health data’ means the processing of personal electronic health data for the provision of health services to assess, maintain or restore the state of health of the natural person to whom that data relates, including the prescription, dispensation and provision of medicinal products and medical devices, as well as for relevant social security, administrative or reimbursement services;

(d) 'primary use of electronic health data' means the processing of personal electronic health data for the provision of health services to assess, maintain or restore the state of health of the natural person to whom that data relates, including the prescription, dispensation and provision of medicinal products and medical devices, improvement of personalised care, as well as for relevant social security, administrative or reimbursement services;

Or. es

Amendment 524

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

Proposal for a regulation

Article 2 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) ‘primary use of electronic health data’ means the processing of personal electronic health data for the provision of health services to assess, maintain or restore the state of health of the natural person to whom that data relates, including the prescription, dispensation and provision of medicinal products and medical devices, as well as for administration relevant for the provision of healthcare services;

Or. en

Justification

Clarifying the scope of primary use of data, and in turn who has access to EHRs. For the full picture, please see Art. 3(8).

Amendment 525

Kateřina Konečná

Proposal for a regulation

Article 2 – paragraph 2 – point d

Text proposed by the Commission

Amendment

Or. en

Justification

Reimbursement services do not fall under the scope of the EHDS, especially of primary uses of health data.

Amendment 526

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 2 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) ‘secondary use of electronic health data’ means the processing of electronic health data for purposes set out in Chapter IV of this Regulation. The data used may include personal electronic health data initially collected in the context of primary use, but also electronic health data collected for the purpose of the secondary use;

(e) ‘secondary use of electronic health data’ means:

(i) the processing of electronic health data which was personal electronic health data initially collected in the context of primary use, for purposes set out in Chapter IV of this Regulation, thereby constituting further processing within the meaning of Regulation (EU) 2016/679; or

(ii) the processing of electronic health data which does not fall under (i) and was originally collected for the purposes set out in Chapter IV of this Regulation.

Or. en

Justification

Clarification in line with EDPB/EDPS opinion.

Amendment 527

Traian Băsescu

Proposal for a regulation

Article 2 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) ‘secondary use of electronic health data’ means the processing of electronic health data for purposes set out in Chapter IV of this Regulation.

Or. ro

Amendment 528

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 2 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) ‘secondary use of electronic health data’ means the compatible further processing of electronic health data for purposes set out in Chapter IV of this Regulation, and, where such electronic health data is personal data, in accordance with Article 5(1)(b) of Regulation (EU) 2016/679. The data used may include personal electronic health data initially collected in the context of primary use, but also electronic health data collected for the purpose of the secondary use;

Or. en

Amendment 529

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 2 – paragraph 2 – point e

Text proposed by the Commission

Amendment

Or. en

Justification

There should be no ambiguity about the lawful basis of the processing. Article 2(2)(e) of the proposed regulation should be made consistent with Regulation (EU) 2016/679 (GDPR), and with the objective of strengthening rights and control over data as expressed in Article 1(2)(a) of the proposed regulation. The clarity of legal basis across the Union will harmonise the applicable data subject rights under the GDPR.

Amendment 530

Beata Kempa

Proposal for a regulation

Article 2 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) ‘secondary use of electronic health data’ means the processing of electronic health data for purposes set out in Chapter IV of this Regulation. The data used may include personal electronic health data initially collected in the context of primary use, exclusively where the patient has given prior consent for such use, but also electronic health data collected for the purpose of the secondary use;

Or. pl

Amendment 531

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) ‘secondary use of electronic health data’ means the processing of electronic health data for purposes set out in Chapter IV of this Regulation. Secondary use of personal electronic health data shall have Article 6(1)(e) of Regulation (EU) 2016/679 as its legal basis.

Or. en

Justification

The deleted reference seems misplaced in this provision. The issue should be dealt with in Chapter IV.

Amendment 532

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point e

Text proposed by the Commission

Amendment

(e) ‘secondary use of electronic health data’ means the further processing of electronic health data for purposes set out in Chapter IV of this Regulation. The data used may include personal electronic health data initially collected in the context of primary use, but also electronic health data collected for other purposes;

Or. en

Amendment 533

Traian Băsescu

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ea) ‘pseudonymisation’ means the processing of personal data in such a manner that the personal data can no longer be attributed to a specific data subject without the use of additional information, provided that such additional information is kept separately and is subject to technical and organisational measures to ensure that the personal data are not attributed to an identified or identifiable natural person;

Or. ro

Amendment 534

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

Proposal for a regulation

Article 2 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals, involving the exchange of information and knowledge without changing the content of the data between these organisations, software applications or devices, through the processes they support;

(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals, involving the exchange of information and knowledge without changing the content or quality of the data between these organisations, software applications or devices, through the processes they support, enabling data portability across data holders and health care providers for data recipients and data users;

Or. en

Amendment 535

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals using commonly accepted open standards and open data formats, involving the exchange of information and knowledge without changing the content of the data between these organisations, software applications or devices, through the processes they support;

Or. en

Justification

A reference to common standards is needed, otherwise this definition refers only to compatibility, or using the dominant player standard.

Amendment 536

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

Proposal for a regulation

Article 2 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to process, exchange and use data in order to perform their functions in an accurate, effective and consistent manner without changing the content of the data between these organisations, software applications or devices, through the processes they support;

Or. en

Amendment 537

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 2 – paragraph 2 – point g

Text proposed by the Commission

Amendment

(g) ‘European electronic health record exchange format’ means a structured, commonly used and machine-readable format that allows transmission of personal electronic health data between different software applications, devices and healthcare providers; that format shall be easy to read, consolidated and accessible when sent to a natural person in accordance with Article 3 of this Regulation;

Or. fr

Amendment 538

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

Proposal for a regulation

Article 2 – paragraph 2 – point g

Text proposed by the Commission

Amendment

Or. en

Amendment 539

Rob Rooken

Proposal for a regulation

Article 2 – paragraph 2 – point h

Text proposed by the Commission

Amendment

(h) ‘registration of electronic health data’ means the recording of health data in an electronic format, through manual entry of data, through the collection of data by a device, or through the conversion of non-electronic health data into an electronic format, to be processed in an EHR system or a wellness application;

Or. en

Amendment 540

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point h

Text proposed by the Commission

Amendment

Or. en

Amendment 541

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

Proposal for a regulation

Article 2 – paragraph 2 – point j

Text proposed by the Commission

Amendment

(j) ‘health professional access service’ means a service, supported by an EHR system, that enables health professionals to access data of natural persons under their treatment;

(j) ‘health professional access service’ means a service, supported by an EHR system, that enables health professionals to access data of natural persons under their care and with authorised permission to do so;

Or. en

Amendment 542

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point k

Text proposed by the Commission

Amendment

(k) ‘data recipient’ means a natural or legal person that receives data from another controller in the context of the primary use of electronic health data;

deleted

Or. en

Justification

"Recipient" is already defined in the GDPR for personal data, covered by para 1(a).

Amendment 543

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point k

Text proposed by the Commission

Amendment

(k) ‘data recipient’ means a natural or legal person that receives data from another controller in the context of the primary use of electronic health data;

(k) ‘health data recipient’ means a natural or legal person that receives data from another controller in the context of the primary use of electronic health data;

Or. en

Amendment 544

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

Proposal for a regulation

Article 2 – paragraph 2 – point k

Text proposed by the Commission

Amendment

(k) ‘data recipient’ means a natural or legal person that receives data from another controller in the context of the primary use of electronic health data;

(k) ‘health data recipient’ means recipient as defined in Article 4(9) of Regulation (EU) 2016/679, in the context of the primary use of electronic health data;

Or. en

Justification

This term should apply throughout the whole text.

Amendment 545

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point l

Text proposed by the Commission

Amendment

(l) ‘telemedicine’ means the provision of healthcare services, including remote care and online pharmacies, through the use of information and communication technologies, in situations where the health professional and the patient (or several health professionals) are not in the same location;

deleted

Or. en

Justification

Telemedicine is out of scope of the EHDS proposal

Amendment 546

Dolors Montserrat

Proposal for a regulation

Article 2 – paragraph 2 – point l

Text proposed by the Commission

Amendment

(l) ‘telemedicine’ means the provision of healthcare services, through the use of information and communication technologies, in situations where the health professional and the patient (or several health professionals) are not in the same location;

Or. es

Amendment 547

Margarita de la Pisa Carrión

Proposal for a regulation

Article 2 – paragraph 2 – point l

Text proposed by the Commission

Amendment

Or. es

Amendment 548

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

Proposal for a regulation

Article 2 – paragraph 2 – point l

Text proposed by the Commission

Amendment

(l) ‘telemedicine’ means the provision of healthcare services, including remote care, through the use of information and communication technologies, in situations where the health professional and the patient (or several health professionals) are not in the same location;

Or. en

Amendment 549

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

Proposal for a regulation

Article 2 – paragraph 2 – point m

Text proposed by the Commission

Amendment

(m) ‘EHR’ (electronic health record) means a collection of electronic health data related to a natural person and collected in the health system, processed for healthcare purposes;

(m) ‘EHR’ (electronic health record) means any collection of the past or present electronic mental and physical health data related to a natural person and collected in the health system, processed for the purpose of the provision of healthcare services or research purposes;

Or. en

Amendment 550

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

Proposal for a regulation

Article 2 – paragraph 2 – point m

Text proposed by the Commission

Amendment

(m) ‘EHR’ (electronic health record) means a collection of electronic health data related to a natural person and collected in the health system, processed for healthcare purposes;

(m) ‘EHR’ (electronic health record) means a collection of electronic health data related to a natural person and collected in the health system, processed for the purpose of the provision of healthcare services;

Or. en

Amendment 551

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point m

Text proposed by the Commission

Amendment

(m) ‘EHR’ (electronic health record) means a collection of electronic health data related to a natural person and collected in the health system, processed for healthcare purposes;

Or. en

Amendment 552

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 2 – paragraph 2 – point m

Text proposed by the Commission

Amendment

(m) ‘EHR’ (electronic health record) means a collection of electronic health data related to a natural person and collected in the health system, processed for healthcare purposes;

Or. en

Amendment 553

Javier Zarzalejos

Proposal for a regulation

Article 2 – paragraph 2 – point m

Text proposed by the Commission

Amendment

(m) ‘EHR’ (electronic health record) means a collection of electronic health data related to a natural person and collected in the health system, processed for healthcare purposes;

(m) ‘EHR’ (electronic health record) means a collection of dataset related to a natural person and collected in the health system, processed for healthcare purposes;

Or. en

Amendment 554

Mathilde Androuët

Proposal for a regulation

Article 2 – paragraph 2 – point n

Text proposed by the Commission

Amendment

(n) ‘EHR system’ (electronic health record system) means any appliance or software intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records; with a view to ensuring that data are completely secure, they must be stored and backed up entirely in an EU Member State;

Or. fr

Justification

Health data are ultra sensitive and must never be stored or backed up outside the EU.

Amendment 555

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

Proposal for a regulation

Article 2 – paragraph 2 – point n

Text proposed by the Commission

Amendment

(n) ‘EHR system’ (electronic health record system) means any appliance or other article whose primary purpose intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records or that can be reasonably expected by the manufacturer to be used for these purposes;

Or. en

Amendment 556

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

Proposal for a regulation

Article 2 – paragraph 2 – point n

Text proposed by the Commission

Amendment

(n) ‘EHR system’ (electronic health record system) means any appliance or software the primary purpose of which, intended by the manufacturer, is storing, intermediating, importing, exporting, converting, editing or viewing electronic health records between health professionals;

Or. en

Amendment 557

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point n

Text proposed by the Commission

Amendment

(n) ‘EHR system’ (electronic health record system) means any product (hardware or software) primarily intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records;

Or. en

Amendment 558

Christel Schaldemose

Proposal for a regulation

Article 2 – paragraph 2 – point n

Text proposed by the Commission

Amendment

(n) ‘EHR system’ (electronic health record system) means any appliance or software intended by the healthcare provider to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records;

Or. da

Justification

As the text currently stands

it is the companies/manufacturer that set

the standard for what an EHR system is,

not the health service. It should be

the healthcare provider that sets

the standard for what an EHR system is.

Amendment 559

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 2 – paragraph 2 – point n

Text proposed by the Commission

Amendment

(n) ‘EHR system’ (electronic health record system) means any appliance or software whose primary purpose is to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records;

Or. fr

Amendment 560

Beata Kempa

Proposal for a regulation

Article 2 – paragraph 2 – point o

Text proposed by the Commission

Amendment

(o) ‘wellness application’ means any appliance or software intended by the manufacturer to be used by a natural person for processing electronic health data for other purposes than healthcare, such as well-being and pursuing healthy life-styles;

deleted

Or. pl

Amendment 561

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point o

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 562

Rob Rooken

Proposal for a regulation

Article 2 – paragraph 2 – point o

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 563

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 2 – paragraph 2 – point o

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 564

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

Proposal for a regulation

Article 2 – paragraph 2 – point o

Text proposed by the Commission

Amendment

(o) ‘wellness application’ means any appliance or software intended by the manufacturer to be used by a natural person for processing electronic health data for a healthy lifestyle, well-being purposes or that can be reasonably expected by the manufacturer for these purposes;

Or. en

Amendment 565

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point q – introductory part

Text proposed by the Commission

Amendment

(q) ‘serious incident’ means any malfunction or deterioration in the characteristics or performance of an EHR system made available on the market that directly or indirectly leads, might have led or might lead to any of the following:

(q) ‘serious incident’ means any malfunction or deterioration in the characteristics or performance of an EHR system made available on the market that directly or indirectly led, leads, was or is likely to lead to any of the following:

Or. en

Amendment 566

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point q – point i

Text proposed by the Commission

Amendment

(i) the death of a natural person or serious damage to a natural person’s health;

(i) the death of a natural person or serious damage to a natural person’s health or rights;

Or. en

Justification

Fundamental and economic rights can be impacted by serious incidents, therefore this need to be included

Amendment 567

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 2 – paragraph 2 – point s

Text proposed by the Commission

Amendment

(s) ‘central platform for digital health’ means an interoperability platform providing services to support and facilitate the exchange of electronic health data between national contact points for digital health;

Or. en

Amendment 568

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(u a) ‘regional contact point for secondary use of electronic health data’ means an organisational and technical gateway enabling the cross-border secondary use of electronic health data, under the responsibility of a region with health competences within a Member State;

Or. en

Amendment 569

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 2 – paragraph 2 – point v

Text proposed by the Commission

Amendment

(v) ‘central platform for secondary use of electronic health data’ means an interoperability platform established by the Commission, providing services to support and facilitate the exchange of information between national contact points for secondary use of electronic health data;

(v) ‘central platform for secondary use of electronic health data’ means an interoperability platform established by the Commission, providing services to support and facilitate the exchange of information between contact points for secondary use of electronic health data;

Or. en

Amendment 570

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 2 – paragraph 2 – point x

Text proposed by the Commission

Amendment

(x) ‘HealthData@EU’ means the infrastructure connecting national contact points for secondary use of electronic health data and the central platform;

(x) ‘HealthData@EU’ means the infrastructure connecting national or, where applicable, regional contact points for secondary use of electronic health data and the central platform;

Or. en

Amendment 571

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(y) ‘data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data;

(y) ‘data holder’ means any natural or legal person who has the right or obligation to make available the relevant and appropriate data pursuant to the relevant requirements laid down in this Regulation. This should be in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or, in the case of non-personal data, through control of the technical design of a product and related services.

This definition should be supported by Annex [xxx] with the following specifications:

a) The definition of "data holder" shall not include all entities that have an obligation to share data for any purpose (e.g. an obligation to share data with regulators to ensure rugulatory compliance);

b) The definition of "data holder" shall not include all entities which simply process data for technical reasons (e.g. if an entity only holds data transiently in order to process it on the instructions of others);

c) In the context of a clinical trial, the sponsor of the clinical trial will always be the sole data holder of electronic clinical trial data. Where the sponsor is located outside of the EU, its EU legal representative will assume the role of data holder or other designated entity established within the Community.

Or. en

Amendment 572

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

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(y) ‘data holder’ means a controller as set out in Regulation (EU) 2016/679 in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies which are a controller as set out in Regulation (EU) 2018/1725 which have the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, to process personal electronic health data or in the case of non-personal health data, through control of the technical design of the product and related services and as allowed by contract with natural or legal person owning, renting or leasing the product or related service, the ability to make the relevant and appropriate data pursuant to the relevant requirements laid down in this Regulation available, including to register, provide, restrict access or exchange certain data;

Or. en

Amendment 573

Lukas Mandl

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(i) the right or obligation, in accordance with applicable Union law or national legislation, to process personal electronic health data for the provision of health or care or for public health, research, innovation, policy making, official statistics, patient safety or regulatory purposes, in its capacity as a controller; or

(ii) the ability to make available, including to register, provide, restrict access or exchange electronic health data that do not constitute personal data in the meaning of Article 4 (1) of Regulation (EU) 2016/679, through control of the technical design of a product and related services;

Or. en

Amendment 574

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

Or. en

Amendment 575

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(y) ‘data holder’ means a controller in the meaning of Regulation (EU) 2016/679 in the health or care or social security sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies which are a controller in the meaning of Regulation (EU) 2018/1725, which has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, to process personal health data, or in the case of non-personal health data, through control of the technical design of a product and related services, the lawful ability to make available, including to register, provide, restrict access or exchange certain data;

Or. en

Amendment 576

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(y) ‘data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, to make available, including to register, provide, restrict access or exchange certain data;

Or. de

Amendment 577

Jessica Polfjärd

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(y) ‘data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, with the exception of personal data processors as defined in Article 28 of Regulation (EU) 2016/679, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data;

Or. en

Justification

No obligations or rights are imposed on personal data processors under this regulation. It is therefore necessary to exclude them from the definition of "data holder". However, under the instruction of a data holder, they do enforce the disclosure of health data.

Amendment 578

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

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(i) has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law to process electronic health data; or

(ii) the ability to make available, including to register, provide, restrict access or exchange non-personal electronic health data through control of the technical design of a product and related services.

Or. en

Justification

This term should apply throughout the whole text.

Amendment 579

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(y) ‘health data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data;

Or. en

Justification

Horizontal amendment proposal. "Data holder" should be replaced throughout the text by "health data holder" to indicate clear distinction from "regular" data holders under DA and DGA.

Amendment 580

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 2 – paragraph 2 – point y

Text proposed by the Commission

Amendment

(y) ‘data holder’ means any natural or legal person, which is a public entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data;

Or. en

Amendment 581

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point y – point i (new)

Text proposed by the Commission

Amendment

i) the right or obligation, in accordance with applicable Union law or national legislation, to process personal electronic health data for the provision of health or care or for public health, research, innovation, policy making, official statistics, patient safety or regulatory purposes, in its capacity as a controller; or

Or. en

Amendment 582

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point y – point ii (new)

Text proposed by the Commission

Amendment

ii) the ability to make available, including to register, provide, restrict access or exchange electronic health data that do not constitute personal data in the meaning of Article 4 (1) of Regulation (EU) 2016/679, through control of the technical design of a product and related services;

Or. en

Amendment 583

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

Proposal for a regulation

Article 2 – paragraph 2 – point z

Text proposed by the Commission

Amendment

(z) ‘data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use;

(z) ‘health data user’ means a natural or legal person as well as Union institutions, bodies, offices and agencies, who has been granted access, in accordance with this Regulation, to one or more of the categories of personal or non-personal electronic health data for secondary use;

Or. en

Justification

Clarification in line with EDPB/EDPS opinion. This term should apply throughout the whole text.

Amendment 584

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point z

Text proposed by the Commission

Amendment

(z) ‘data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use;

(z) ‘data user’ means a natural or legal person, including public authorities and EU institutions, bodies or agencies, who has lawful access to personal or non-personal electronic health data for secondary use, pursuant to a data permit in accordance with this Regulation;

Or. en

Amendment 585

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point z

Text proposed by the Commission

Amendment

(z) ‘data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use;

(z) ‘health data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use pursuant to a health data permit or a health data request in accordance with this Regulation;

Or. en

Justification

As regards the "data user/data permit/data request" etc. vs "health data user/etc." issue, we propose a horizontal amendment proposal: "data user/etc." should be replaced throughout the text by "health data user/etc." to indicate clear distinction from "regular" data users/etc. under DA and DGA.

Amendment 586

Traian Băsescu

Proposal for a regulation

Article 2 – paragraph 2 – point z

Text proposed by the Commission

Amendment

(z) ‘data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use;

(z) ‘health data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data for secondary use;

Or. ro

Amendment 587

Konstantinos Arvanitis

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(z a) ‘health data applicant’ means a natural or legal person who has submitted a health data access application for access to personal or non-personal electronic health data for secondary use in accordance with this Regulation;

Or. en

Amendment 588

Beata Kempa

Proposal for a regulation

Article 2 – paragraph 2 – point aa

Text proposed by the Commission

Amendment

(aa) ‘data permit’ means an administrative decision issued to a data user by a health data access body or data holder to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this Regulation;

Or. pl

Amendment 589

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point aa

Text proposed by the Commission

Amendment

(aa) ‘health data permit’ means an administrative decision issued to a data user by a health data access body or data holder to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this Regulation;

Or. en

Amendment 590

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

Proposal for a regulation

Article 2 – paragraph 2 – point aa

Text proposed by the Commission

Amendment

(aa) ‘health data permit’ means an administrative decision issued to a data user by a health data access body to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this Regulation;

Or. en

Justification

This term should apply throughout the whole text.

Amendment 591

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 2 – paragraph 2 – point aa

Text proposed by the Commission

Amendment

(aa) ‘data permit’ means an administrative decision issued to a data user by an application processing body or data holder to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this Regulation;

Or. de

Amendment 592

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 2 – paragraph 2 – point aa

Text proposed by the Commission

Amendment

(aa) ‘data permit’ means an administrative decision issued to a data user by a health data access body to process the electronic health data specified in the data permit for the secondary use purposes specified in the data permit based on conditions laid down in this Regulation;

Or. en

Amendment 593

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point ab

Text proposed by the Commission

Amendment

(ab) ‘dataset’ means a structured collection of electronic health data;

(ab) ‘health dataset’ means a structured collection of electronic health data;

Or. en

Amendment 594

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

Proposal for a regulation

Article 2 – paragraph 2 – point ac

Text proposed by the Commission

Amendment

(ac) ‘dataset catalogue’ means a collection of datasets descriptions, which is arranged in a systematic manner and consists of a user-oriented public part, where information concerning individual dataset parameters is accessible by electronic means through an online portal;

(ac) ‘dataset catalogue’ means a collection of datasets descriptions, which is arranged in a systematic manner;

Or. en

Amendment 595

Konstantinos Arvanitis

Proposal for a regulation

Article 2 – paragraph 2 – point ac

Text proposed by the Commission

Amendment

(ac) ‘health dataset catalogue’ means a collection of datasets descriptions, which is arranged in a systematic manner and consists of a user-oriented public part, where information concerning individual dataset parameters is accessible by electronic means through an online portal;

Or. en

Amendment 596

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ae a) ‘public sector body’ means national, regional or local authorities of the Member States, and bodies governed by public law of the Member States, or associations formed by one or more such authorities or one or more such bodies and Union institutions, bodies, offices and agencies when carrying out tasks enshrined in their mandate;

Or. en

Amendment 597

Christian Doleschal, Angelika Niebler

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(aea) ‘anonymised data’ or ‘data in anonymised format’ means personal data that have been anonymised in such a way as to prevent the data subject from being re-identified, including by drawing on state-of-the-art and future technologies and methods or other data.

Or. de

Amendment 598

Kateřina Konečná

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ae a) ‘innovation activities’ means new products, services and models foreseen to improve health outcomes, cost efficiency and any other areas as recognised by the end-users of the innovation such as patients, healthcare professionals and health administrators.

Or. en

Justification

‘Innovation activities’, which constitute a purpose for re-use, are not properly delineated in the draft regulation, which opens the door to interpretation and creates new bases for the secondary processing of health data, such as for commercial purposes that do not add value for patients or society. Although there is no universally accepted definition of ‘innovation’, it should refer to the extent to which the activity makes a tangible and positive difference to patients. Identifying this benefit is only possible in partnership with patients.

Amendment 599

Stelios Kympouropoulos

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ae a) 'innovation activities’ means the processes and actions taken to generate new or improve products, services, methods, practices and models expected, among others, to improve health outcomes, cost efficiency, quality, and reliability;

Or. en

Amendment 600

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ae a) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to an EHR system.

Or. en

Amendment 601

Tomislav Sokol

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ae a) “real-world data” means routinely collected data relating to patient health status or the delivery of health care from a variety of sources other than traditional clinical trials.

Or. en

Amendment 602

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ae a) ‘ real world evidence’ (RWE) means data that are collected outside the constraints of conventional randomised clinical trials.

Or. en

Amendment 603

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

Proposal for a regulation

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

Text proposed by the Commission

Amendment

(ae a) "notified body’ means a conformity assessment body notified in accordance with Article 27f of this Regulation;

Or. en

Amendment 604

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 2 – paragraph 2 – point ae b (new)

Text proposed by the Commission

Amendment

(ae b) ‘innovation activities’ means actions taken to create new products or services, or improve existing products, services, methods and models to expand health results and quality, based on good practices and lessons learned;

Or. en

Amendment 605

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 2 – paragraph 2 – point ae b (new)

Text proposed by the Commission

Amendment

(aeb) ‘application processing body’ means a body set up in accordance with Article 36(1), fourth sentence, point (a), whose tasks include, in particular, checking data applications and issuing data permits.

Or. de

Amendment 606

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

Proposal for a regulation

Article 2 – paragraph 2 – point ae b (new)

Text proposed by the Commission

Amendment

(ae b) ‘real-world data’ (RWD) means routinely collected data relating to patient health status or the delivery of healthcare from a variety of sources other than traditional clinical trials.

Or. en

Amendment 607

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

Proposal for a regulation

Article 2 – paragraph 2 – point ae b (new)

Text proposed by the Commission

Amendment

(ae b) ‘conformity assessment’ means the process demonstrating whether the essential requirements of this Regulation relating to EHR systems have been fulfilled;

Or. en

Amendment 608

Tomislav Sokol

Proposal for a regulation

Article 2 – paragraph 2 – point ae b (new)

Text proposed by the Commission

Amendment

(ae b) 'real-world evidence' means information derived from analysis of real-world data.

Or. en

Amendment 609

Tomislav Sokol

Proposal for a regulation

Article 2 – paragraph 2 – point ae c (new)

Text proposed by the Commission

Amendment

(ae c) ‘online pharmacy’ means a pharmacy legally established as such in a Member State for which a pharmacist within the meaning of Directive 2005/36/EC is responsible, which, by means of information society services directed to the public dispenses prescriptions, offers medicinal products for sale or provides other pharmaceutical services.

Or. en

Amendment 610

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 2 – paragraph 2 – point ae c (new)

Text proposed by the Commission

Amendment

(ae c) ‘languages’ in this Regulation means the use of all the languages of the Union, notwithstanding their official status in the Union, which are official in a Member State, in regional entities of the Member State, especially in those regions with legislative and health executive competences.

Or. en

Amendment 611

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 2 – paragraph 2 – point ae c (new)

Text proposed by the Commission

Amendment

(aec) ‘pseudonymisation body’ means a body established in accordance with Article 36(1), fourth sentence, point (b), whose tasks include, in particular, the pseudonymisation of electronic health data.

Or. de

Amendment 612

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

Proposal for a regulation

Article 2 – paragraph 2 – point ae c (new)

Text proposed by the Commission

Amendment

(ae c) ‘conformity assessment body’ means a body that performs conformity assessment activities, including testing, certification and inspection;

Or. en

Amendment 613

Tomislav Sokol

Proposal for a regulation

Article 2 – paragraph 2 – point ae d (new)

Text proposed by the Commission

Amendment

(ae d) ‘Derived data’ means the improved, corrected, or enriched dataset provided to the data holder in accordance with Article 37(1)(p) of this Regulation, 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.

Or. en

Amendment 614

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 2 – paragraph 2 – point ae d (new)

Text proposed by the Commission

Amendment

(aed) ‘health data access body’ means a body established in accordance with Article 36(1), fourth sentence, point (c), whose tasks include, in particular, the provision of a secure data processing environment.

Or. de

Amendment 615

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

Proposal for a regulation

Article 2 – paragraph 2 – point ae d (new)

Text proposed by the Commission

Amendment

(ae d) ‘data sharing’ means the provision defined in Article 2 (10) of the Regulation (EU) 2022/868;

Or. en

Amendment 616

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 2 – paragraph 2 – point ae e (new)

Text proposed by the Commission

Amendment

(aee) ‘bodies involved in accessing health data’ means bodies within the meaning of points (ag), (ah) and (ai) in so far as, in a specific case, they are involved in enabling secondary use.

Or. de

Amendment 617

Javier Zarzalejos

Proposal for a regulation

Article 2 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. “Legitimate legal representative of the patient” means a natural person of the patient’s choice, such as to their relatives or other close natural persons, legitimately authorised under the national rules of the Member State to access or control access to their personal electronic health data or to use digital health services on their behalf. Under no circumstances will the legitimate legal representative be a legal entity, without prejudice to the protection that may be provided by the judicial authorities. Such authorisations may also be useful for convenience reasons in other situations. Proxy services should be established by Member States to implement these authorisations, and they should be linked to personal health data access services, such as patient portals on patient-facing mobile applications.

Or. en

Amendment 618

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

Proposal for a regulation

Article -3 (new)

Text proposed by the Commission

Amendment

Article -3

Scope

For the purpose of this Chapter, health data holder shall be understood only as data holder from health sector providing healthcare.

Or. en

Justification

Clarification necessary as the definition of the “health data holder” in Article 2 is broad to cover also health data holders in secondary use. Therefore, it needs to be explicitly stated that in primary use the meaning is narrower.

Amendment 619

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 1

Text proposed by the Commission

Amendment

1. Natural persons shall have the right to access their personal electronic health data processed in the context of primary use of electronic health data, immediately, free of charge and in an easily readable, consolidated and accessible form.

1. Natural persons shall have the right to access their personal electronic health data processed in the context of primary use of electronic health data, and any available information as to their origin, immediately, free of charge and in an easily readable, consolidated and accessible form, in accordance with Article 14 of Regulation (EU) 2016/679.

Or. en

Amendment 620

Javier Zarzalejos

Proposal for a regulation

Article 3 – paragraph 1

Text proposed by the Commission

Amendment

1. Natural persons shall have the right to access their personal electronic health data processed in the context of primary use of electronic health data, without undue delay, free of charge and in an easily readable, consolidated and accessible form.

Or. en

Amendment 621

István Ujhelyi

Proposal for a regulation

Article 3 – paragraph 1

Text proposed by the Commission

Amendment

1. Natural persons shall have the right to access their personal electronic health data processed in the context of primary use of electronic health data, without delay, free of charge and in an easily readable, consolidated and accessible form.

Or. en

Amendment 622

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 3 – paragraph 2

Text proposed by the Commission

Amendment

2. Natural persons shall have the right to receive an electronic copy or a hard copy of their electronic health data upon request to a health professional, in the European electronic health record exchange format referred to in Article 6, of at least their electronic health data in the priority categories referred to in Article 5;

Or. fr

Amendment 623

Peter Liese

Proposal for a regulation

Article 3 – paragraph 2

Text proposed by the Commission

Amendment

2. Natural persons shall have the right to receive an electronic copy, in the European electronic health record exchange format referred to in Article 6, of at least their electronic health data in the priority categories referred to in Article 5. Member States shall provide manufacturers with uniform templates to ensure conformity with the referred Articles.

Or. en

Justification

A template for an electronic copy can significantly reduce the overall burden for companies, especially SMEs.

Amendment 624

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 2

Text proposed by the Commission

Amendment

2. Natural persons shall have the right to receive an electronic copy, in the European electronic health record exchange format referred to in Article 6, of their electronic health data, or a printed copy thereof, in accordance with paragraph 3 of Article 15 of Regulation (EU) 2016/679.

Or. en

Justification

This amendment is necessary to protect vulnerable groups of society, especially those with low digital literacy

Amendment 625

Traian Băsescu

Proposal for a regulation

Article 3 – paragraph 2

Text proposed by the Commission

Amendment

2. Natural persons shall have the right to receive an electronic or paper copy, in the European electronic health record exchange format referred to in Article 6, of at least their electronic health data in the priority categories referred to in Article 5.

Or. ro

Amendment 626

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Paragraphs 1 and 2 shall be without prejudice to Article 15 of Regulation (EU) 2016/679 and Article 17 of Regulation (EU) 2018/1725.

Or. en

Amendment 627

Mathilde Androuët

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of this right whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.

deleted

Or. fr

Justification

Natural persons' access to their own health data must be immediate and permanent and not be subject to any derogation.

Amendment 628

Rob Rooken

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 629

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

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of the rights referred to in paragraphs 1 and 2 whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.

Or. en

Amendment 630

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3. In accordance with paragraph 1, point (i) of Article 23 of Regulation (EU) 2016/679, Member States may by law restrict the scope of this right whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on this person.

Or. en

Amendment 631

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of the rights under paragraphs 1 and 2 whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.

Or. en

Amendment 632

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of the right provided for in paragraph 1 whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.

Or. fr

Amendment 633

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

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of these rights whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.

Or. en

Amendment 634

István Ujhelyi

Proposal for a regulation

Article 3 – paragraph 3

Text proposed by the Commission

Amendment

3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of this right whenever necessary for the protection of the natural person based on patient safety and ethics by imposing their access to their personal electronic health data be made only through a health professional who will properly communicate and explain to the natural person information that can have a significant impact on his or her health.

Or. en

Amendment 635

István Ujhelyi

Proposal for a regulation

Article 3 – paragraph 4

Text proposed by the Commission

Amendment

4. Where the personal health data have not been registered electronically prior to the application of this Regulation, Member States may require that such data is made available in electronic format pursuant to this Article. This shall not affect the obligation to make personal electronic health data registered after the application of this Regulation available in electronic format pursuant to this Article.

deleted

Or. en

Amendment 636

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

Proposal for a regulation

Article 3 – paragraph 4

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Moved to Art. 7 which focuses on registration of personal health data.

Amendment 637

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 4

Text proposed by the Commission

Amendment

4. Where the personal health data have not been registered electronically, Member States may require that such data is made available in electronic format pursuant to this Article, where the data subject consents to such electronic processing.

Or. en

Amendment 638

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

Proposal for a regulation

Article 3 – paragraph 4

Text proposed by the Commission

Amendment

4. Where the personal health data have not been registered electronically prior to the application of this Regulation, Member States shall require that such data is made available in electronic format. This shall not affect the obligation to make personal electronic health data registered after the application of this Regulation available in electronic format pursuant to this Article.

Or. en

Amendment 639

Margarita de la Pisa Carrión

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) establish one or more electronic health data access services at national, regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2;

(a) establish one or more electronic health data access services at national, regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2, incorporating health professionals’ experience and knowledge within the framework of the exercise of the rights set out in paragraph 7.

Or. es

Amendment 640

Kateřina Konečná

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) establish one or more electronic health data access services at national, regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2;

(a) establish one or more public electronic health data access services at national, regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2;

Or. en

Amendment 641

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) establish one or more electronic health data access services at national, regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2;

(a) establish one or more public electronic health data access services at national, regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2;

Or. en

Amendment 642

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

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) establish one or more electronic health data access services at national, regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2;

(a) establish one or more electronic health data access services at national or regional level enabling the exercise of rights referred to in this Article;

Or. en

Amendment 643

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

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf.

(b) establish one or more proxy services enabling:

(i) a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf, following the applicable provisions of the relevant Member State, for a specified period of time and if needed, for a specific purpose only;

(ii) a legal guardian of a natural person to access their electronic health data on their behalf, following the applicable provisions of the relevant Member State.

Or. en

Justification

For acting on behalf of someone else, one has to follow the applicable provisions of each Member State. This first depends on the national provisions implementing data protection legislation in each country, but also, depending on the country and needs, one might be asked to provide additional documents as proof of authority to act on behalf of another person (e.g. proof of identity,birth certificate if acting on behalf of a minor, power of attorney).

Amendment 644

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

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf.

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf or to enable legal guardians to act on behalf of their dependents in accordance with the national law of the Member State.

Or. en

Amendment 645

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf.

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf or to enable legal guardians as recognized by national law to act on behalf of their dependent children.

Or. en

Amendment 646

Margarita de la Pisa Carrión

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf.

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf in accordance with the provisions of Member States' legislation.

Or. es

Amendment 647

Javier Zarzalejos

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf.

(b) establish one or more proxy services enabling a natural person to legitimately authorise, under the national rules of the Member State, a legitimate legal representative of the patient to access their electronic health data on their behalf.

Or. en

Amendment 648

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf.

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf and on their request.

Or. en

Amendment 649

Kateřina Konečná

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf.

(b) establish one or more public proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf.

Or. en

Amendment 650

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 3 – paragraph 5 – subparagraph 2

Text proposed by the Commission

Amendment

The proxy services shall provide authorisations free of charge, electronically or on paper. They shall enable guardians or other representatives to be authorised, either automatically or upon request, to access electronic health data of the natural persons whose affairs they administer. Member States may provide that authorisations do not apply whenever necessary for reasons related to the protection of the natural person, and in particular based on patient safety and ethics. The proxy services shall be interoperable among Member States.

The proxy services shall provide authorisations in a transparent and easily understandable way, free of charge, electronically or on paper. Authorised natural persons and those acting on their behalf shall be informed about what authorisation rights they have, how to exercise them, and what they can expect from the authorisation process.

The electronic health data access services as well as the proxy services shall be easily accessible for persons with disabilities in accordance with Directive (EU) 2019/882.

The proxy services shall enable legal guardians or other representatives to be authorised, either automatically or upon request, to access electronic health data of the natural persons whose affairs they administer either for a specific purpose and time period or without limitation to administer their affairs. Member States may provide that authorisations do not apply whenever necessary for reasons related to the protection of the natural person, and in particular based on patient safety and ethics. The proxy services shall be interoperable among Member States.

The proxy services shall provide an easy complaint mechanism with a contact point designated to inform individuals of a way to seek redress or remedy if they believe that their authorisation rights have been violated.

Or. en

Amendment 651

Kateřina Konečná

Proposal for a regulation

Article 3 – paragraph 5 – subparagraph 2

Text proposed by the Commission

Amendment

The proxy services shall provide authorisations free of charge, electronically or on paper. They shall enable legal guardians as recognised by national law to be authorised, either automatically or upon request, to access electronic health data of the natural persons whose affairs they administer. Member States may provide that authorisations do not apply whenever necessary for reasons related to the protection of the natural person, and in particular based on patient safety and ethics. The proxy services shall be interoperable among Member States.

Or. en

Justification

The bodies that act as intermediaries for health data must be in public hands, both for the sake of transparency and for security reasons. In order to protect vulnerable people and their health data, only legal guardians who have been properly recognised by law should be able to have access to personal health data.

Amendment 652

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

Proposal for a regulation

Article 3 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. In addition to the electronic services referred to in paragraph 5 point (a), Member States shall also establish easily accessible support services for natural persons with adequately trained staff dedicated to assist them with exercising their rights referred to in this Article.

Or. en

Amendment 653

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6. Natural persons may, in accordance with the rules of the respective healthcare provider, insert their electronic health data in their own EHR or in that of natural persons whose health information they can access because they are proxies pursuant to paragraph 5, through electronic health data access services or applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative, shall not be available for secondary use, and shall only be considered as a clinical fact and made available for secondary use if validated by a registered healthcare professional of relevant specialisation responsible for the natural person’s treatment.

Or. en

Justification

Necessary to highlight the importance of healthcare providers being able to control which information can be added to the medical record. Otherwise, there is a risk of collecting large volumes of sensitive personal data that is of poor quality.

Amendment 654

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

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6. Natural persons may insert, access and export their electronic health data in and from their own EHR or in that of natural persons whose health information they can access, through electronic health data access services and applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative as non-validated, and information shall only be considered as a clinical fact if validated by an identified, registered health professional with the relevant competence. Natural persons shall not have the possibility to directly change data inserted by healthcare professionals. The process must be secure.

Or. en

Amendment 655

István Ujhelyi

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6. Natural persons may insert their electronic health data in their own EHR or in that of natural persons whose health information they can access, through electronic health data access services or applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative. These data are not the responsibility of healthcare providers who therefore do not have to ensure that they correspond to the requirements of the Regulation.

Or. en

Amendment 656

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

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6. Natural persons may insert their electronic health data in their own EHR or in that of natural persons whose health information they can access, through electronic health data access services or applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative until a relevant health professional validates the information, which would then be marked as confirmed by a healthcare professional.

Or. en

Justification

Given the importance of accurate personal health data in the electronic health records for the provision of healthcare, each addition by a natural person shall be validated by the relevant treating health professional.

Amendment 657

Javier Zarzalejos

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6. Natural persons may insert, access and download their electronic health data in and from their own EHR or in that of natural persons whose health information they can access, through electronic health data access services and applications linked to these services. That information shall be marked as inserted, accessed or downloaded by the natural person or by the legitimate legal representative of the patient.

Or. en

Amendment 658

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 659

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 3 – paragraph 6

Text proposed by the Commission

Amendment

6. Natural persons may insert, access and export their electronic health data in their own EHR or in that of natural persons whose health information they can access, through electronic health data access services or applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative.

Or. fr

Amendment 660

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 7

Text proposed by the Commission

Amendment

7. Member States shall ensure that, when exercising the right to rectification under Article 16 of Regulation (EU) 2016/679, natural persons can easily request rectification online through the electronic health data access services referred to in paragraph 5, point (a), of this Article. In accordance with Article 16 of Regulation (EU) 2016/679, natural persons shall not have the possibility to directly change data inserted by healthcare professionals. Such rectifications of clinical facts shall be validated by a registered healthcare professional of relevant specialisation responsible for the natural person’s treatment. The original data holder shall be responsible for the rectification.

Or. en

Amendment 661

Margarita de la Pisa Carrión

Proposal for a regulation

Article 3 – paragraph 7

Text proposed by the Commission

Amendment

7. Member States shall ensure that, when exercising the right to rectification under Article 16 of Regulation (EU) 2016/679, natural persons can easily request rectification online through the electronic health data access services referred to in paragraph 5, point (a), of this Article, unless the proposed rectification concerns a data record made by a health service provider, in which case the provider in question will have to approve the rectification or lodge its opposition before the health data processing service.

Or. es

Amendment 662

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

Proposal for a regulation

Article 3 – paragraph 7

Text proposed by the Commission

Amendment

Or. en

Amendment 663

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

Proposal for a regulation

Article 3 – paragraph 7

Text proposed by the Commission

Amendment

Or. en

Amendment 664

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

Natural persons shall have the right to give access to or request a controller or a data holder, including from the health or social security sector, to transmit all or part of their electronic health data to a data recipient of their choice from the health or social security sector, immediately, free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder. Where requested by the data subject, the controller, data holders, data recipients and their processors shall comply with the request and shall transmit the data in the format provided for in Article 5.

Or. en

Amendment 665

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

In accordance with paragraph 2 of Article 20 of Regulation (EU) 2016/679, natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit all of or part of their electronic health data to a data recipient of their choice from the health or social security sector, immediately, free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder. That data recipient shall be properly identified, including demonstrating that it belongs to the health or social security sectors.

Or. en

Amendment 666

Javier Zarzalejos

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

Natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit their electronic health data to a data recipient of their choice from the health or social security sector, immediately, free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder. The data recipients shall be easily identifiable to the natural persons transmitting their electronic health data and demonstrate their affiliation to the health or social security sector.

Or. en

Amendment 667

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

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

Natural persons shall have the right to give access to or request a data holder from the health sector and providing healthcare to transmit their electronic health data or only specific part of health data identified by the requesting natural persons or necessary for the purpose at stake to a health data recipient of their choice from the health or social security sector, immediately, free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder.

Or. en

Amendment 668

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

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

Natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit partially or totally, their electronic health data to a data recipient of their choice from the health or social security sector, immediately, free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder.

Or. en

Amendment 669

Mathilde Androuët

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

Natural persons shall have the right to give access to or request a data holder from the health or social security sector to transmit all or some of their electronic health data to a data recipient of their choice from the health or social security sector, immediately, free of charge and without hindrance from the data holder or from the manufacturers of the systems used by that holder.

Or. fr

Amendment 670

István Ujhelyi

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 671

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

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

When a natural person makes the request for transmission, the health data holder shall have the obligation to comply with it, in accordance with Articles 6(1) and 9(2) point (a) of the Regulation (EU) 2016/679.

Or. en

Amendment 672

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 3

Text proposed by the Commission

Amendment

By way of derogation from Article 9 of Regulation […] [Data Act COM/2022/68 final], the data recipient shall not be required to compensate the data holder for making electronic heath data available.

The data recipient shall compensate the data holder for the reasonable and non-discriminatory costs of making electronic health data available. A data holder, a data recipient or a third party shall not directly or indirectly charge data subjects a fee, compensation or costs for sharing data or accessing it.

Or. en

Amendment 673

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

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 674

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

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 4

Text proposed by the Commission

Amendment

Natural persons shall have the right that, where priority categories of personal electronic health data referred to in Article 5 are transmitted or made available by the natural person according to the European electronic health record exchange format referred to in Article 6, such data shall be read and accepted by other healthcare providers.

Or. en

Amendment 675

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 4

Text proposed by the Commission

Amendment

Natural persons shall have the right that, where priority categories of personal electronic health data referred to in Article 5 are transmitted or made available by the natural person according to the European electronic health record exchange format referred to in Article 6, other healthcare providers shall be able to read and accept such data.

Or. en

Amendment 676

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 4 a (new)

Text proposed by the Commission

Amendment

The Commission shall, by means of implementing acts, determine the requirements for the interoperable, cross-border mechanism for identifying data recipients and authenticating the receiving entity’s belonging to the health or social security sector.

Or. en

Amendment 677

Kateřina Konečná

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 4 a (new)

Text proposed by the Commission

Amendment

Or. en

Justification

There needs to be an effective way of confirming that any entity potentially receiving health data is a legitimate data recipient in the health and social security sector.

Amendment 678

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 8 – subparagraph 4 a (new)

Text proposed by the Commission

Amendment

This paragraph is without prejudice to limitations for the processing of personal health or genetic data under Member State law, pursuant to paragraph 4 of Article 9 of Regulation (EU) 2016/679.

Or. en

Amendment 679

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 3 – paragraph 9

Text proposed by the Commission

Amendment

9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of selected health professionals to all or a specific part of their electronic health data. Such restriction shall be easily identifiable in the EHR. When restricting the information, natural persons shall be made aware that restricting access may impact the provision of healthcare provied to them.

Member States shall establish the rules and specific safeguards regarding such restriction mechanisms, including the conditions of medical liability, respecting the rules provided for by Article 18 (2) and (3) of the Regulation (EU) 2016/679 concerning the right to restriction of data processing. The Commission shall establish guidelines regarding medical liability when diagnosing and treating patients based on incomplete information.

Or. en

Amendment 680

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

Proposal for a regulation

Article 3 – paragraph 9

Text proposed by the Commission

Amendment

9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. For judicial reasons strictly related to medical liability of health professionals, the date and time of omitted information must be recorded and only visible to the health data access bodies under these circumstances. The European Commission shall establish the rules and specific safeguards regarding such restriction mechanisms through a delegated act.

Or. en

Amendment 681

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 9

Text proposed by the Commission

Amendment

9. Without prejudice to Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of certain health professionals to all or part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms, which may also include the possibility of restrictions related to a specific category of health professionals. Natural persons shall be informed of the patient safety risks associated with limiting access to health data.

Or. en

Amendment 682

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 3 – paragraph 9

Text proposed by the Commission

Amendment

9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to confidentially restrict access of health professionals to all or part of their electronic health data, and the fact that such data has been restricted. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms, which shall also include the possibility to exercise geographical and temporal restrictions and restrictions related to a specific category of health professionals.

Or. en

Amendment 683

István Ujhelyi

Proposal for a regulation

Article 3 – paragraph 9

Text proposed by the Commission

Amendment

9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, Member States may grant natural persons the right to restrict access of health professionals to all or part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms, including the conditions of medical liability and whether such restrictions apply to health data for research or quality development purposes. The restricted information must be easily identified in the EHR.

Or. en

Amendment 684

Peter Liese

Proposal for a regulation

Article 3 – paragraph 9

Text proposed by the Commission

Amendment

9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms, including the terms of medical liability. It shall be clearly indicated in the EHR when access to information has been restricted by a natural person or by his or her representative.

Or. en

Justification

Liability of health professionals must be clarified in the case of diagnosis or treatment based on incomplete or intentionally blocked information.

Amendment 685

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 9

Text proposed by the Commission

Amendment

9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms, which may also include the possibility to exercise geographical and temporal restrictions and restrictions related to a specific category of health professionals.

Or. en

Amendment 686

Rob Rooken

Proposal for a regulation

Article 3 – paragraph 9

Text proposed by the Commission

Amendment

9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of healthcare providers, health professionals, data holders and data users to all or part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms.

Or. en

Amendment 687

Kateřina Konečná

Proposal for a regulation

Article 3 – paragraph 9

Text proposed by the Commission

Amendment

9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. The European Commission shall establish the rules and specific safeguards regarding such restriction mechanisms through a delegated act

Or. en

Justification

The specific rules and safeguards to ensure the right to restrict access by health professionals to all or part of patients' electronic health data should be established at European level, not at national level.

Amendment 688

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 9 a (new)

Text proposed by the Commission

Amendment

9 a. Member States may require the explicit consent of natural persons, or provide for the possibility for natural persons to refuse, the access to their personal electronic health data registered in an EHR system by electronic health data access services referred to in paragraph 5(a) of this Article and by health professional access services referred to in Article 4(3).

Or. en

Amendment 689

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. Natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare, including access to restricted data pursuant to paragraph 9. The information shall be provided immediately and free of charge through electronic health data access services, whenever such access has taken place. For this purpose, providers of electronic health records shall keep a record of who has accessed which data in the previous 24 months. Member States may provide for restrictions to this right in exceptional circumstances, where there are factual indications that disclosure would endanger the vital interests or rights of the health professional.

Or. en

Amendment 690

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. Natural persons shall receive an automatic notification on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. In order to demonstrate compliance with this provision, all relevant entities shall also maintain a record of those healthcare providers and health professionals who had access to data. The information shall be provided immediately and free of charge through electronic health data access services in a commonly accepted, interoperable, and machine-readable format. The information shall at least include the names of the health care providers controlling the data processing, the health data that was accessed, and the time of access.

Or. en

Amendment 691

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

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. Natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. In order to demonstrate compliance with this right, all relevant entities shall maintain a system of automated recording showing unequivocally who, when and where had access to data, accessible to the patient. The information shall be provided immediately and free of charge through electronic health data access services in a commonly accepted, interoperable format.

Or. en

Amendment 692

Rob Rooken

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

Or. en

Justification

Article 3 (10) ensures the control of natural persons over their own health data and enables them to identify potentially illegal access.

Amendment 693

István Ujhelyi

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. Natural persons shall have the right to know if healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. The information shall be provided free of charge through electronic health data access services. Member States may provide that the right to obtain information does not apply whenever necessary for reasons related to the protection and safety of healthcare providers and health professionals.

Or. en

Amendment 694

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 3 – paragraph 10

Text proposed by the Commission

Amendment

Or. en

Amendment 695

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. Natural persons shall have the right to receive automatically information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. All relevant entities shall maintain a record of those who have had access to data. The information shall be provided immediately and free of charge through electronic health data access services.

Or. en

Amendment 696

Jeroen Lenaers, Esther de Lange

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. Natural persons shall have the right to receive an automatic notification with information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare, and on the substance of the accessed data. The information shall be provided immediately and free of charge through electronic health data access services.

Or. en

Amendment 697

Pernille Weiss

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. Natural persons shall have the right to obtain information on any access to their electronic health data, including information about the identity of the person who accessed their electronic health data, which health data was accessed and the time of access. The information shall be provided immediately and free of charge through electronic health data access services.

Or. en

Amendment 698

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. Natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. The information shall be provided immediately and free of charge in a readable, consolidated and accessible format through electronic health data access services.

Or. fr

Amendment 699

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

Proposal for a regulation

Article 3 – paragraph 10

Text proposed by the Commission

Amendment

10. Natural persons shall have the right to obtain automatic notifications via email to be informed on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. The information shall be provided immediately and free of charge through electronic health data access services.

Or. en

Amendment 700

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 3 – paragraph 10 a (new)

Text proposed by the Commission

Amendment

10 a. Natural persons shall have the possibility to choose whether to receive notifications about which health professional and when have accessed their personal electronic health data, as well as the periodicity of such notifications. There should be an automatic notification for situations when a health professional accesses the personal electronic health data of a natural person for the first time.

Or. en

Amendment 701

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 3 – paragraph 11

Text proposed by the Commission

Amendment

11. The supervisory authority or authorities responsible for monitoring the application of Regulation (EU) 2016/679 shall also be responsible for monitoring the application of this Article, in accordance with the relevant provisions in Chapters VI, VII and VIII of Regulation (EU) 2016/679. They shall be competent to impose administrative fines up to the amount referred to in Article 83(5) of that Regulation. Those supervisory authorities and the digital health authorities referred to in Article 10 of this Regulation shall, where relevant, cooperate in the enforcement of this Regulation, within the remit of their respective competences.

deleted

Or. en

Justification

Moved to Article 10 and adapted to bring more clarity to the delineation of competences of digital health authorities and data protection authorities, in line with EDPB/EDPS joint opinion.

Amendment 702

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 11

Text proposed by the Commission

Amendment

Or. en

Amendment 703

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 3 – paragraph 11

Text proposed by the Commission

Amendment

Or. en

Justification

There should be no doubt who the responsible authority is. DPAs are solely responsible for monitoring the application of the GDPR.

Amendment 704

Lukas Mandl

Proposal for a regulation

Article 3 – paragraph 11

Text proposed by the Commission

Amendment

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

Or. en

Amendment 705

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 11

Text proposed by the Commission

Amendment

11. The supervisory authority or authorities responsible for monitoring the application of Regulation (EU) 2016/679 shall also be responsible for monitoring the application of this Article, in accordance with the relevant provisions of Regulation (EU) 2016/679. They shall be competent to impose administrative fines in accordance with Article 83 of that Regulation. Those supervisory authorities and the digital health authorities referred to in Article 10 of this Regulation shall, where relevant, cooperate in the enforcement of this Regulation, within the remit of their respective competences.

Or. en

Amendment 706

Konstantinos Arvanitis

Proposal for a regulation

Article 3 – paragraph 12

Text proposed by the Commission

Amendment

12. The Commission shall, by means of implementing acts, determine the requirements concerning the technical implementation of the rights set out in this Article. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

12. The Commission shall, by means of implementing acts, determine the requirements concerning the technical implementation of the rights set out in this Article, including technical and organisational measures to ensure the process of authentication of the authorised person referred to in point (b) of paragraph 5. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 707

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 3 – paragraph 12

Text proposed by the Commission

Amendment

12. The Commission shall, by means of delegated acts, determine the requirements concerning the technical implementation of the rights set out in this Article, including technical and organisational measures to ensure the process of authentication of the authorised person referred to in point (b) of paragraph 5.

Or. en

Amendment 708

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

Proposal for a regulation

Article 3 – paragraph 12

Text proposed by the Commission

Amendment

Or. en

Amendment 709

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 3 – paragraph 12 a (new)

Text proposed by the Commission

Amendment

12 a. Member States, including regional and local authorities, shall provide guidance to natural persons in relation to the use of the electronic health records and primary use of their personal electronic health data laid down in this Article. Such guidance shall take into account digital health literacy of vulnerable groups, including migrants, the elderly and persons with disabilities.

Or. en

Amendment 710

Konstantinos Arvanitis

Proposal for a regulation

Article 4 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Where they process data in an electronic format, health professionals shall:

1. Where they process data in an electronic format, health professionals shall, upon explicit consent from the natural persons under their treatment:

Or. en

Amendment 711

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

Proposal for a regulation

Article 4 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Where they process data in an electronic format, health professionals shall:

1. Where they process data in an electronic format, health professionals, including care management teams, shall:

Or. en

Amendment 712

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 4 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) have access to the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and the Member State of treatment;

(a) have access to the electronic health data of natural persons, where, and to the extent that, this is necessary for the purposes spelled out in point (h) of paragraph 2 of Article 9 of Regulation (EU) 2016/679, irrespective of the Member State of affiliation and the Member State of treatment, with the exceptions provided for in paragraphs 9 and 9a of Article 3;

Or. en

Amendment 713

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

Proposal for a regulation

Article 4 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) have access to the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and the Member State of treatment;

(a) have access to the electronic health data of natural persons under their treatment and for its sole purpose, including relevant administration, irrespective of the Member State of affiliation and the Member State of treatment, in accordance with Article 9(2) point (h) of Regulation 2016/679;

Or. en

Amendment 714

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

Proposal for a regulation

Article 4 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) have access to the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and the Member State of treatment;

(a) have access to the electronic health data of natural persons under their care and restrict to their functions of action, irrespective of the Member State of affiliation and the Member State of treatment;

Or. en

Amendment 715

Javier Zarzalejos

Proposal for a regulation

Article 4 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) have access to the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and the Member State of treatment;

(a) have access to the electronic health data of natural persons under their treatment, on a need-to-know basis, irrespective of the Member State of affiliation and the Member State of treatment;

Or. en

Amendment 716

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 4 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) have access to the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and the Member State of treatment;

(a) have access on a need-to-know basis to the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and the Member State of treatment;

Or. en

Amendment 717

Konstantinos Arvanitis

Proposal for a regulation

Article 4 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) have access to the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and the Member State of treatment;

(a) have access on a need-to-know basis to the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and the Member State of treatment;

Or. en

Amendment 718

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

Proposal for a regulation

Article 4 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) ensure that the personal electronic health data of the natural persons they treat are updated with information related to the health services provided.

(b) ensure that the personal electronic health data of the natural persons they care are updated with information related to the health services provided and, if not, update data concerning the health services provided by them.

Or. en

Amendment 719

Margarita de la Pisa Carrión

Proposal for a regulation

Article 4 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) ensure that the personal electronic health data of the natural persons they treat are updated with information related to the health services provided.

(b) ensure that the personal electronic health data of the natural persons they treat and the data connected with the health services offered to them are updated with information related to the health services provided.

Or. es

Amendment 720

Javier Zarzalejos

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. In line with the data minimisation principle provided for in Regulation (EU) 2016/679, Member States may establish rules providing for the categories of personal electronic health data required by different health professions. Such rules shall not be based on the source of electronic health data.

2. In line with the data minimisation principle provided for in Regulation (EU) 2016/679, Member States shall establish rules providing for the categories of personal electronic health data required by different health professions in accordance with the principles of purpose limitation and data minimisation. Such rules shall not be based on the source of electronic health data.

Or. en

Amendment 721

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

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. In line with the data minimisation principle provided for in Regulation (EU) 2016/679, Member States may establish rules providing for the categories of personal electronic health data required by different health professions, based on their qualification and area of expertise. Such rules shall not be based on the geographical source of electronic health data.

Or. en

Amendment 722

Konstantinos Arvanitis

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. In line with the data minimisation principle provided for in Regulation (EU) 2016/679, Member States shall establish rules providing for the categories of personal electronic health data required by different health professions or different healthcare tasks. Such rules shall not be based on the source of electronic health data.

Or. en

Amendment 723

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. In line with the data minimisation principle provided for in Regulation (EU) 2016/679, Member States shall establish rules providing for the categories of personal electronic health data required by different categories of health professions. Such rules shall not be based on the source of electronic health data.

Or. en

Amendment 724

Rob Rooken

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. In line with the data minimisation principle provided for in Regulation (EU) 2016/679, Member States shall establish rules providing for the categories of personal electronic health data required by different health professions. Such rules shall not be based on the source of electronic health data.

Or. en

Amendment 725

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 4 – paragraph 2

Text proposed by the Commission

Amendment

2. In line with the data minimisation principle provided for in Regulation (EU) 2016/679, Member States shall establish rules providing for the categories of personal electronic health data required by different health professions. Such rules shall not be based on the source of electronic health data.

Or. en

Amendment 726

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

Proposal for a regulation

Article 4 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Notwithstanding the national rules established pursuant to paragraph 2, natural persons shall be able to easily give acces to their electronic health data to a selected health professional through the health data access services, if they wish so.

Or. en

Amendment 727

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 4 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. With a view to meeting the obligations established in paragraph 1 of this article, Member States may provide health professionals with support to ensure that they have the requisite digital skills, infrastructure and tools.

Or. fr

Amendment 728

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

Proposal for a regulation

Article 4 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. In the case of treatment in a Member State other than the Member State of affiliation, the rules referred to in paragraph 2, if established, of the Member States of treatment apply.

Or. en

Justification

Modification based on Commission answers; it is important to clarify this explicitly in the text.

Amendment 729

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

3. Member States and, where appropriate, local or regional authorities shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services, where, and to the extent to, this is necessary for the purposes spelled out in point (h) of paragraph 2 of Regulation (EU) 2016/679, and with the exceptions provided for in paragraphs 9 and 9a of Article 3. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services regarding the electronic health data of natural persons under their treatment, irrespective of the Member State of affiliation and treatment, free of charge.

Or. en

Amendment 730

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 4 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals shall have access to electronic health data through health professional access services for the sole purpose of providing healthcare treatment, including relevant administration, and only through recognised electronic identification and authentication means, free of charge. The electronic health data in the electronic health records shall be structured in a user-friendly manner to allow for an easy use by health professionals.

Or. en

Amendment 731

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

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals lawfully exercising their activities through health professional access services and that health professionals can easily select specific relevant information in the EHR. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge. To this end, they may cooperate, where appropriate, with professional associations under the terms provided for by national rules.

Or. en

Amendment 732

Marian-Jean Marinescu

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

Or. en

Amendment 733

Margarita de la Pisa Carrión

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

Or. es

Amendment 734

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

3. Member States shall ensure that access to the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services, where the processing of health data is necessary. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge, where the processing of health data is necessary.

Or. en

Amendment 735

Tomislav Sokol

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

3. Member States and, where appropriate, local or regional authorities shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals, including for cross-border care, through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

Or. en

Amendment 736

Rob Rooken

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made only available for the purpose of the healthcare treatment, to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

Or. en

Amendment 737

Konstantinos Arvanitis

Proposal for a regulation

Article 4 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals through health professional access services, where the processing of health data is necessary. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.

Or. en

Amendment 738

Peter Liese

Proposal for a regulation

Article 4 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Member States shall establish policies aimed at providing health professionals with the digital skills, competences, infrastructures and tools required to fulfill the obligations set out in paragraph 1 of this Article.

Or. en

Justification

Given that digital health literacy varies across Member States, measures should be implemented, where needed, to ensure that healthcare professionals can meet their legal obligations. The necessary infrastructures and tools for healthcare professionals shall be established.

Amendment 739

Tomislav Sokol

Proposal for a regulation

Article 4 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 740

Rob Rooken

Proposal for a regulation

Article 4 – paragraph 4

Text proposed by the Commission

Amendment

4. Where access to electronic health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person, including where the provider or professional is informed of the existence and nature of the restricted electronic health data. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.

Or. en

Amendment 741

István Ujhelyi

Proposal for a regulation

Article 4 – paragraph 4

Text proposed by the Commission

Amendment

4. 4) Where access to electronic health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person. The existence of a restriction must be clearly indicated in the EHR. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Member States’ law may add additional safeguards

Or. en

Amendment 742

Andreas Glück

Proposal for a regulation

Article 4 – paragraph 4

Text proposed by the Commission

Amendment

4. Where access to electronic health data has been restricted by the natural person according to Article 3(9), the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person, including where the provider or professional is informed of the existence and nature of the restricted electronic health data. However, health professionals should always be able to distinguish between the case where there is no data, and where there is data but access is restricted. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards

Or. en

Justification

It should be mentioned where the right to data-restriction is given. Furthermore, it is important that health professionals can distinguish between the non-existence of an entry or a possible restriction to access for the data.

Amendment 743

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 4 – paragraph 4

Text proposed by the Commission

Amendment

4. Where access to electronic health data has been restricted by the natural person, pursuant to Article 3(9), the healthcare provider or health professionals shall not be informed of the content of the restricted electronic health data without prior explicit consent as defined in Article 9(2)(a) of Regulation (EU) 2016/679 by the natural person, including where the provider or professional is informed of the existence and nature of the restricted electronic health data. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data, in line with Article 6(1)(d) of of Regulation (EU) 2016/679. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.

Or. en

Amendment 744

Patrick Breyer

Proposal for a regulation

Article 4 – paragraph 4

Text proposed by the Commission

Amendment

4. Where access to electronic health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the existence, the nature and the content of the electronic health data without prior explicit consent by the natural person. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.

Or. en

Amendment 745

Peter Liese

Proposal for a regulation

Article 4 – paragraph 4

Text proposed by the Commission

Amendment

4. Where access to electronic health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person. It shall be clearly indicated in the EHR when access to information has been restricted by a natural person or by his or her representative. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.

Or. en

Justification

Health professionals must be made aware of the possibility incomplete or intentionally blocked information.

Amendment 746

Javier Zarzalejos

Proposal for a regulation

Article 4 – paragraph 4

Text proposed by the Commission

Amendment

4. Where access to electronic health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person, in which case the provider or professional will be informed of the existence and nature of the restricted electronic health data. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.

Or. en

Amendment 747

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 4 – paragraph 4

Text proposed by the Commission

Amendment

4. Where access to electronic health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior explicit consent by the natural person, including where the provider or professional is informed of the existence and nature of the restricted electronic health data. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.

Or. en

Amendment 748

Konstantinos Arvanitis

Proposal for a regulation

Article 4 – paragraph 4

Text proposed by the Commission

Amendment

4. Where access to electronic health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior explicit consent by the natural person, including where the provider or professional is informed of the existence and nature of the restricted electronic health data. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.

Or. en

Amendment 749

Christel Schaldemose

Proposal for a regulation

Article 4 – paragraph 4

Text proposed by the Commission

Amendment

4. Where access to health data has been restricted by the natural person, the healthcare provider or health professionals shall not be informed of the content of those health data without prior authorisation by the natural person. The provider or professional shall however be able to see that there is health data to which access has been restricted. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, or an obvious public interest, the healthcare provider or health professional may obtain access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.

Or. da

Justification

Health professionals and the healthcare provider should be able to see that information is there but has been blocked, even if they do not have access to the content. In order to provide good care, you need to know whether or not information is available. ‘An obvious public interest’ has been included in the light of arguments in favour of opening up data to safeguard other considerations. It might include infection control, for example.

Amendment 750

Sirpa Pietikäinen

Proposal for a regulation

Article 4 a (new)

Text proposed by the Commission

Amendment

Article 4 a

Reform of the European Health Insurance Card

1. Member States shall impose a reform of the European Health Insurance Card so that it can be utilized in accessing citizens' digital health data.

2. It should be ensured that the European Health Insurance Card has a chip or an equivalent access tool to access citizens' health data when they seek healthcare in different Member State than in their own. The system needs to be interoperable in all Member States.

Or. en

Amendment 751

István Ujhelyi

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

Where data is processed in electronic format, Member States shall implement access to and exchange of personal electronic health data for primary use fully or partially falling under the following categories:

(a) patient summaries including medication treatment information at hospital and ambulatory/day hospitals.

(b) electronic prescriptions across the continuum of care, including hospital and ambulatory/day hospitals.

(d) medical images and image reports;

(e) laboratory results;

(f) discharge reports.

Or. en

Amendment 752

Beata Kempa

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

Where data is registered in electronic format, Member States shall implement access to and exchange of personal electronic health data for primary use fully or partially falling under the following categories:

Or. en

Amendment 753

Joanna Kopcińska

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 754

Beata Kempa

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. pl

Amendment 755

Andreas Glück

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) information about consent for SoHO and organ donations as well as respective donation history;

Or. en

Justification

Adding information of patients willingness to donate can be useful. Furthermore, donation history can be of interest for the treating physician.

Amendment 756

Marian-Jean Marinescu

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) electronic prescriptions;

(b) electronic prescriptions in any language of the Union;

Or. en

Amendment 757

Andreas Glück

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) electronic prescriptions;

(b) electronic prescriptions and medication plans;

Or. en

Justification

Medication plans, including the substances of the respective drug, shall explicitly be included. This will be particularly important in the case of cross-border healthcare where doctors may need to prescribe locally available alternatives to the initially prescribed product.

Amendment 758

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

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) medical images and image reports;

(d) medical images and image reports and medical test results;

Or. en

Justification

Based on Annex I, medical images are “produced by technologies that are used to view the human body,” but an ECG does not allow to actually view the heart, it is only a recording of the heart's electrical activity. Therefore, amendment is necessary to make sure that also medical test results, such as ECG or holtermonitors, are covered. Annex I is amended accordingly.

Amendment 759

Marian-Jean Marinescu

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) medical images and image reports;

(d) medical images, image reports, audio and video;

Or. en

Amendment 760

Pernille Weiss

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point d

Text proposed by the Commission

Amendment

(d) medical images and image reports;

(d) medical images, image reports, audio and video;

Or. en

Amendment 761

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

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point f

Text proposed by the Commission

Amendment

(f) discharge reports.

(f) hospital discharge reports.

Or. en

Amendment 762

Javier Zarzalejos

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point f

Text proposed by the Commission

Amendment

(f) discharge reports.

(f) patient discharge reports.

Or. en

Amendment 763

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

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point f

Text proposed by the Commission

Amendment

(f) discharge reports.

(f) discharge reports;

Or. en

Amendment 764

Konstantinos Arvanitis

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point f a (new)

Text proposed by the Commission

Amendment

(f a) International Classification of Diseases (ICD) codes

Or. en

Amendment 765

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

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 1 – point f a (new)

Text proposed by the Commission

Amendment

(f a) medical directives.

Or. en

Amendment 766

Konstantinos Arvanitis

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

Access to and exchange of electronic health data for primary use may be enabled for other categories of personal electronic health data available in the EHR of natural persons.

deleted

Or. en

Amendment 767

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

Access to and exchange of electronic health data for primary use may be enabled for other categories of personal electronic health data available in the EHR of natural persons.

deleted

Or. en

Justification

It should be clear what kind of data will be shared, hence the list in par. 1.

Amendment 768

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

Access to and exchange of electronic health data for primary use may be enabled for other categories of personal electronic health data available in the EHR of natural persons.

Member States may by law enable access to and exchange of electronic health data for primary use for other categories of personal electronic health data available in the EHR of natural persons.

Or. en

Amendment 769

Joanna Kopcińska

Proposal for a regulation

Article 5 – paragraph 1 – subparagraph 3

Text proposed by the Commission

Amendment

Access to and exchange of electronic health data for primary use may be enabled for other categories of personal electronic health data available in the EHR of natural persons.

Member States may enable access to and exchange of electronic health data for primary use for other categories of personal electronic health data available in the EHR of natural persons,

Or. en

Amendment 770

Konstantinos Arvanitis

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list of priority categories of electronic health data in paragraph 1. Such delegated acts may also amend Annex I by adding, modifying or removing the main characteristics of the priority categories of electronic health data and indicating, where relevant, deferred application date. The categories of electronic health data added through such delegated acts shall satisfy the following criteria:

deleted

(a) the category is relevant for health services provided to natural persons;

(b) according to the most recent information, the category is used in a significant number of EHR systems used in Member States;

(c) international standards exist for the category that have been examined for the possibility of their application in the Union.

Or. en

Amendment 771

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

deleted

(a) the category is relevant for health services provided to natural persons;

(b) according to the most recent information, the category is used in a significant number of EHR systems used in Member States;

(c) international standards exist for the category that have been examined for the possibility of their application in the Union.

Or. en

Amendment 772

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

deleted

(a) the category is relevant for health services provided to natural persons;

(b) according to the most recent information, the category is used in a significant number of EHR systems used in Member States;

(c) international standards exist for the category that have been examined for the possibility of their application in the Union.

Or. en

Justification

The Commission cannot decide via a delegated act what kind of data could/should be shared. This is why we have the list in par. 1

Amendment 773

Kateřina Konečná

Proposal for a regulation

Article 5 – paragraph 2

Text proposed by the Commission

Amendment

deleted

(a) the category is relevant for health services provided to natural persons;

(b) according to the most recent information, the category is used in a significant number of EHR systems used in Member States;

(c) international standards exist for the category that have been examined for the possibility of their application in the Union.

Or. en

Justification

The Commission should not be able to modify the list of categories of personal data subject to mandatory availability for primary use so easily as change might require a re-evaluation of the risks to the fundamental rights and interests of the concerned individuals.

Amendment 774

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 5 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend Annex I by adding, modifying or removing the main characteristics of the priority categories of electronic health data.

Or. en

Justification

Amending the list of priority categories of electronic health data is a too important task to be left for a delegated act. It should be done through ordinary legislative procedure instead.

Amendment 775

Margarita de la Pisa Carrión

Proposal for a regulation

Article 5 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list of priority categories of electronic health data in paragraph 1. Such delegated acts may also amend Annex I by adding, modifying or removing the minimum characteristics of the priority categories of electronic health data and indicating, where relevant, deferred application date. The categories of electronic health data added through such delegated acts shall satisfy the following criteria:

Or. es

Amendment 776

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

Proposal for a regulation

Article 5 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the category is relevant for health services provided to natural persons;

deleted

Or. en

Amendment 777

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

Proposal for a regulation

Article 5 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) according to the most recent information, the category is used in a significant number of EHR systems used in Member States;

deleted

Or. en

Amendment 778

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

Proposal for a regulation

Article 5 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) international standards exist for the category that have been examined for the possibility of their application in the Union.

deleted

Or. en

Amendment 779

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 5 – paragraph 2 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The list of priority electronic health data categories set out in Annex I must not withdraw or change data useful for health professionals' work.

Or. fr

Amendment 780

Konstantinos Arvanitis

Proposal for a regulation

Article 5 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission shall, by means of implementing acts, lay down rules determining which health information domains and interoperability specifications, including standards, and profiles for representing and exchanging health data shall be included in the European electronic health record exchange format.

Or. en

Amendment 781

Konstantinos Arvanitis

Proposal for a regulation

Article 6 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission shall, by means of implementing acts, lay down the technical specifications for the priority categories of personal electronic health data referred to in Article 5, setting out the European electronic health record exchange format. The exchange format must be chosen in accordance with the feasibility of technical and organisational measures pursuant to Article 32 of Regulation (EU) 2016/679. The format shall include the following elements:

Or. en

Amendment 782

Lukas Mandl

Proposal for a regulation

Article 6 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Or. en

Amendment 783

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 6 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission shall, by means of implementing acts, lay down the open technical specifications for the priority categories of personal electronic health data referred to in Article 5, setting out the European electronic health record exchange format pursuant to the FAIR principle (findability, accessibility, interoperability, re-use). The format shall include the following elements:

Or. en

Amendment 784

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 6 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. The Commission shall, by means of implementing acts, lay down the technical specifications for the priority categories of personal electronic health data referred to in Article 5, setting out the European electronic health record exchange format, ensuring consistency with the technical specifications prevailing in the Member States. The format shall include the following elements:

Or. en

Amendment 785

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

Proposal for a regulation

Article 6 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) datasets containing electronic health data and defining structures, such as data fields and data groups for the content representation of clinical content and other parts of the electronic health data;

(a) harmonised datasets containing electronic health data and defining structures, such minimum as data fields and data groups for the content representation of clinical content and other parts of the electronic health data, that can be enlarged to include disease-specific data;

Or. en

Amendment 786

Kateřina Konečná

Proposal for a regulation

Article 6 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) harmonised datasets containing electronic health data and defining structures, such as minimum data fields and data groups for the content representation of clinical content and other parts of the electronic health data, that can be enlarged to include disease-specific data;

Or. en

Justification

The EHDS is a unique opportunity for patients to be empowered to make the best use of their personal health data individually and in partnership with healthcare providers, not only in a cross-border scenario but also to manage their inter-provider care and self-management. All patients should receive a minimum set of data in a common format that can be enlarged to include disease-specific data, if necessary. Patient organisations will play a key role as capacity-builders.

Amendment 787

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

Proposal for a regulation

Article 6 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) harmonised datasets containing electronic health data and defining structures, such as minimum data fields and data groups for the content representation of clinical content and other parts of the electronic health data that may be enlarged to include disease specific data;

Or. en

Amendment 788

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

Proposal for a regulation

Article 6 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The Commisssion shall ensure that those implementing acts contain the latest versions of healthcare coding systems and nomenclatures and that they are updated regularly in order to keep up with the revisions of the healthcare coding systems and nomenclatures.

Or. en

Amendment 789

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

Proposal for a regulation

Article 6 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. For the purpose of paragraph 1, the Commission shall consult and cooperate with relevant stakeholders, including patients’ representatives, healthcare providers, health professionals, industry associations, national competence centres, as well as other Union and national authorities with competence in relevant areas, to encourage and contribute to the elaboration and adoption of a European electronic health record exchange format.

Or. en

Amendment 790

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

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that the priority categories of personal electronic health data referred to in Article 5 are issued in the format referred to in paragraph 1 and such data shall be read and recognised as valid by the data recipient including measures aimed at ensuring priority categories of personal electronic health data are translated as necessary for the provision of healthcare to the language of the patient or the healthcare professional.

Or. en

Amendment 791

Margarita de la Pisa Carrión

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that the priority categories of personal electronic health data referred to in Article 5 are issued in the format referred to in paragraph 1 and such data shall be read and accepted by the data recipient. Likewise, access to personal health data in the language of the patient or the health professional shall be assured to the extent necessary to provide those health services effectively.

Or. es

Amendment 792

István Ujhelyi

Proposal for a regulation

Article 6 – paragraph 3

Text proposed by the Commission

Amendment

3. Member States shall ensure that the priority categories of personal electronic health data referred to in Article 5 are processed in electronic format across the continuum of care and are issued in the format referred to in paragraph 1 and such data shall be read and accepted by the data recipient

Or. en

Amendment 793

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

Proposal for a regulation

Article 6 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Member States shall ensure that the priority categories of personal electronic health data referred to in Article 5 are available in the language of the patient and the treating health professional.

Or. en

Amendment 794

Konstantinos Arvanitis

Proposal for a regulation

Article 6 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. When drafting the implementing acts, the Commission shall take all proper measures to ensure compatibility with existing data formats in Member States.

Or. en

Amendment 795

Maria Grapini

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall ensure that, where data is processed in electronic format, health professionals systematically register the relevant health data falling under at least the priority categories referred to in Article 5 concerning the health services provided by them to natural persons, in the electronic format in an EHR system.

Or. ro

Amendment 796

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

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

1. Where data is processed in electronic format, Member States shall facilitate health professionals to systematically register the relevant health data falling under at least the priority categories referred to in Article 5 concerning the health services provided by them to natural persons, in the electronic format in an EHR system.

Or. en

Amendment 797

Birgit Sippel

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall ensure that, where data is processed in electronic format, health professionals register the relevant health data falling under the priority categories referred to in Article 5 concerning the health services provided by them to natural persons, in the electronic format in an EHR system.

Or. en

Amendment 798

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 7 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall ensure that, where data is processed in electronic format, health professionals register the relevant health data falling under at least the priority categories referred to in Article 5 concerning the health services provided by them to natural persons, in the electronic format in an EHR system.

Or. en

Amendment 799

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

Proposal for a regulation

Article 7 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Where the personal health data have not been registered electronically prior to the application of this Regulation, Member States may require that such data is made available in electronic format pursuant to this Article. This shall not affect the obligation to make personal electronic health data, registered after the application of this Regulation, available in electronic format, pursuant to this Article.

Or. en

Justification

Moved here from Art. 3(4).

Amendment 800

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 7 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Member States may require the explicit consent of natural persons for, or provide for the possibility for natural persons to refuse, the registration of their health data by all or selected healthcare professionals in an EHR system.

Or. en

Justification

Member States should retain the right to require consent or an opt-out for a patient’s electronic health file, or for deciding which treatment providers should use it. That can be key to safeguard trust and acceptance of the system. Control over the use of health files only may be considered inadequate by patients also due to reports of unauthorised access to or unauthorised disclosure of health data (hacking or leaks). Patients may refrain from seeking treatment if they cannot keep certain therapies (psychotherapy, for drug abuse, violent behaviour) off their electronic health file.

Amendment 801

Maria Grapini

Proposal for a regulation

Article 7 – paragraph 2

Text proposed by the Commission

Amendment

2. Where electronic health data of a natural person is registered in a Member State that is not the Member State of affiliation of that person, the Member State of treatment shall ensure that the registration is performed under the person identification data of the natural person in the Member State of affiliation.

Or. ro

Amendment 802

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

Proposal for a regulation

Article 7 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2a. Member States shall ensure that the processing of personal electronic health data is located within the European Economic Area. When personal health data are accessed remotely, for example in case of use of hosting managed services, from a territory located outside of the European Economic Area which does not ensure an adequate level of data protection within the meaning of Article 45 of the GDPR, Member States ensure that measures are implemented to secure that this transfer is compliant with the GDPR and are made public by the data controller.

Or. fr

Amendment 803

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

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall, by means of implementing acts, determine the requirements for the registration of electronic health data by healthcare providers and natural persons, as relevant. Those implementing acts shall establish the following:

The Commission shall, by means of implementing acts, determine:

Or. en

Justification

The implementing act should only determine data quality requirements. Therefore the points (a) and (b) of this paragraph are deleted and only (c) is kept.

Amendment 804

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall, by means of delegated acts, determine the requirements for the registration of electronic health data by healthcare professionals and natural persons, as relevant. Those delegated acts shall establish the following:

Or. en

Amendment 805

Konstantinos Arvanitis

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall, by means of implementing acts, determine the requirements for the quality of data for the registration of electronic health data by healthcare providers and natural persons, as relevant.

Or. en

Amendment 806

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

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – introductory part

Text proposed by the Commission

Amendment

The Commission shall, by means of delegated acts, determine the requirements for the registration of electronic health data by healthcare providers and natural persons, as relevant. Those delegated acts shall establish the following:

Or. en

Amendment 807

Konstantinos Arvanitis

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) categories of healthcare providers that are to register health data electronically;

deleted

Or. en

Amendment 808

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

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) categories of healthcare providers that are to register health data electronically;

deleted

Or. en

Amendment 809

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – point a

Text proposed by the Commission

Amendment

(a) categories of healthcare providers that are to register health data electronically;

(a) categories of healthcare professionals that are to register health data electronically;

Or. en

Amendment 810

Konstantinos Arvanitis

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) categories of health data that are to be registered systematically in electronic format by healthcare providers referred to in point (a);

deleted

Or. en

Amendment 811

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

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) categories of health data that are to be registered systematically in electronic format by healthcare providers referred to in point (a);

deleted

Or. en

Amendment 812

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – point b

Text proposed by the Commission

Amendment

(b) categories of health data that are to be registered systematically in electronic format by healthcare providers referred to in point (a);

(b) categories of health data that are to be registered systematically in electronic format by healthcare professionals referred to in point (a);

Or. en

Amendment 813

Konstantinos Arvanitis

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 1 – point c

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 814

Konstantinos Arvanitis

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 815

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 7 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

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

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

Or. en

Amendment 816

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

Proposal for a regulation

Article 7 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. For the purpose of transparency and accountability, natural persons or their legal representatives must be able to see which healthcare professional accessed their electronic health record separately in each specific category and when.

Or. en

Amendment 817

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

Proposal for a regulation

Article 7 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. When health data is registered or updated, electronic health records must identify the time, person and location of the registry.

Or. en