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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AM_Com_LegReport

Amendment 818

Beata Kempa

Proposal for a regulation

Article 8

Text proposed by the Commission

Amendment

Article 8

deleted

8 Where a Member State accepts the provision of telemedicine services, it shall, under the same conditions, accept the provision of the services of the same type by healthcare providers located in other Member States.

Or. pl

Amendment 819

Joanna Kopcińska

Proposal for a regulation

Article 8

Text proposed by the Commission

Amendment

Article 8

deleted

Telemedicine in the context of cross-border healthcare

Or. en

Amendment 820

Kateřina Konečná

Proposal for a regulation

Article 8

Text proposed by the Commission

Amendment

Article 8

deleted

Telemedicine in the context of cross-border healthcare

Or. en

Justification

Article 8 risked further marketisation and commercialisation of the health sector and hence must be removed. It is also entirely unworkable as it does not address any of the many issues with cross-border telemedicine such as medical liability

Amendment 821

Pernille Weiss

Proposal for a regulation

Article 8

Text proposed by the Commission

Amendment

Article 8

deleted

Telemedicine in the context of cross-border healthcare

Or. en

Justification

This article goes beyond the scope of this Regulation, as it deals with treatment options rather than data access.

Amendment 822

Beata Kempa

Proposal for a regulation

Article 8

Text proposed by the Commission

Amendment

Article 8

deleted

Telemedicine in the context of cross-border healthcare

Or. en

Amendment 823

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Telemedicine is out of scope of the EHDS

Amendment 824

Konstantinos Arvanitis

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Risk of further marketization and commercialization of the health sector. Almost unworkable in practice, as core issues related to cross-border telemedicine are not addressed (e.g. medical liability).

Amendment 825

Christel Schaldemose

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the Commission

Amendment

deleted

Or. da

Justification

We take the view that this Article goes beyond the purpose of the Regulation, which is to share data, not offer treatment.

Amendment 826

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

Proposal for a regulation

Article 8 – paragraph 1

Text proposed by the Commission

Amendment

Where a Member State accepts the provision of telemedicine services, it shall, under the same conditions, accept the provision of the services of the same type by healthcare providers located in other Member States with the same rights and obligations to access and register electronic health data. Telemedicine services shall respect the national law of the Member State in which is being provided.

Or. en

Amendment 827

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 8 – paragraph 1

Text proposed by the Commission

Amendment

Where a Member State enables the provision of telemedicine services, it shall, under the same conditions and in a non-discriminatory manner, accept the provision of the services of the same type by healthcare providers located in other Member States.

Or. en

Amendment 828

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

Proposal for a regulation

Article 9 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a natural person uses telemedicine services or personal health data access services referred to in Article 3(5), point (a), that natural person shall have the right to identify electronically using any electronic identification means which is recognised pursuant to Article 6 of Regulation (EU) No 910/2014.

1. Where a natural person uses telemedicine services, that natural person shall have the right to identify electronically using any electronic identification means which is recognised pursuant to Article 6 of Regulation (EU) No 910/2014.

Where a natural person uses personal health data access services referred to in Article 3(5), point (a), that natural person shall identify electronically using any electronic identification means which is recognised pursuant to Article 6 of Regulation (EU) No 910/2014.

Or. en

Amendment 829

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 9 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a natural person uses personal health data access services referred to in Article 3(5), point (a), that natural person shall have the right to identify electronically using any electronic identification means which is recognised pursuant to Article 6 of Regulation (EU) No 910/2014.

Or. en

Amendment 830

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

Proposal for a regulation

Article 9 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Where a health professional provides telemedicine services or uses health professional access services referred to in Article 4(3), that health professional shall identify electronically using any electronic identification means which is recognised pursuant to Article 6 of Regulation (EU) No 910/2014.

Or. en

Amendment 831

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

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, determine the requirements for the interoperable, cross-border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final]. The mechanism shall facilitate the transferability of electronic health data in a cross-border context. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

2. The Commission shall, by means of implementing acts, determine the requirements for the interoperable, cross-border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final] with provisions for transition periods. The mechanism shall facilitate the transferability of electronic health data in a cross-border context. The Commission shall ensure that state-of-art technology is in place to meet the requirements. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 832

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

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, determine the requirements for the interoperable, cross-border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final]. The mechanism shall facilitate the transferability of electronic health data in a cross-border context and allow natural persons to easily access their electronic health record by identification and authentication under the new eID system. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 833

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of delegated acts, determine the requirements for the interoperable, cross-border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final]. The mechanism shall facilitate the secure transferability of electronic health data in a cross-border context. Those delegated acts shall be adopted in accordance with Article 67.

Or. en

Amendment 834

Konstantinos Arvanitis

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of implementing acts, determine the requirements for the interoperable, cross-border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014. The mechanism shall facilitate the transferability of electronic health data in a cross-border context. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 835

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

Proposal for a regulation

Article 9 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission shall, by means of delegated acts, determine the requirements for the interoperable, cross-border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final]. The mechanism shall facilitate the transferability of electronic health data in a cross-border context. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 836

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

Proposal for a regulation

Article 9 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border digital health infrastructure referred to in Article 12(3).

3. The Member States and the Commission shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border digital health infrastructure referred to in Article 12(3).

Or. en

Amendment 837

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 9 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission and Member States shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border digital health infrastructure referred to in Article 12(3).

Or. en

Amendment 838

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 9 – paragraph 4

Text proposed by the Commission

Amendment

4. The digital health authorities and the Commission shall implement the cross-border identification and authentication mechanism at Union and Member States’ level, respectively.

4. The Member States and the Commission shall implement the cross-border identification and authentication mechanism at Union and Member States’ level, respectively, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final].

Or. en

Justification

Identification and authentication mechanism are part of eIDAS and competence of Member States. Who exactly implements and controls the systems is to be left for MS decision.

Amendment 839

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

Proposal for a regulation

Article 10 – paragraph 1

Text proposed by the Commission

Amendment

1. Each Member State shall designate a digital health authority responsible for the implementation and enforcement of this Chapter at national level. The Member State shall communicate the identity of the digital health authority to the Commission by the date of application of this Regulation. Where a designated digital health authority is an entity consisting of multiple organisations, the Member State shall communicate to the Commission a description of the separation of tasks between the organisations. The Commission shall make this information publicly available.

1. Each Member State shall designate a digital health authority responsible for the implementation and enforcement of this Chapter at national level. Implementation shall be harmonised at national level and across Member States with the EHDS Board conducting an oversight and leadership role in achieving this. The Member State shall communicate the identity of the digital health authority to the Commission by the date of application of this Regulation. Where a designated digital health authority is an entity consisting of multiple organisations, the Member State shall communicate to the Commission a description of the separation of tasks between the organisations. The Commission shall make this information publicly available.

Or. en

Amendment 840

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. Each digital health authority shall be entrusted with the following tasks:

2. Each digital health authority shall be entrusted with the following tasks and powers:

Or. en

Amendment 841

Mathilde Androuët

Proposal for a regulation

Article 10 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ensure the implementation of the rights and obligations provided for in Chapters II and III by adopting necessary national, regional or local technical solutions and by establishing relevant rules and mechanisms, that is using solutions whose owners, whether public or private, and the infrastructure on which they rely are located in the European Union, so that EU law alone shall govern in the context of the EHDS;

Or. fr

Amendment 842

Lucia Ďuriš Nicholsonová, Susana Solís Pérez, Andreas Glück, Michal Šimečka

Proposal for a regulation

Article 10 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) ensure the implementation of the rights and obligations provided for in Chapters II and III by adopting necessary national or regional technical solutions and by establishing relevant rules and mechanisms;

Or. en

Amendment 843

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

Proposal for a regulation

Article 10 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) ensure that complete and up to date information about the implementation of rights and obligations provided for in in Chapters II and III is made readily available to natural persons, health professionals and healthcare providers;

Or. en

Amendment 844

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 10 – paragraph 2 – point f

Text proposed by the Commission

Amendment

(f) supervise the national contact points for digital health and cooperate with other digital health authorities and the Commission on further development of MyHealth@EU;

(f) supervise the contact points for digital health and cooperate with other digital health authorities and the Commission on further development of MyHealth@EU;

Or. en

Amendment 845

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point g

Text proposed by the Commission

Amendment

(g) ensure the implementation, at national level, of the European electronic health record exchange format, in cooperation with national authorities and stakeholders;

(g) ensure the implementation, at national level, of the European electronic health record exchange format, in cooperation with national authorities and stakeholders, including representatives of patients, consumers and healthcare professionals;

Or. en

Amendment 846

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 10 – paragraph 2 – point g

Text proposed by the Commission

Amendment

(g) ensure the implementation, at national level, of the European electronic health record exchange format, in cooperation with national authorities and stakeholders;

(g) ensure the implementation, at national level, of the European electronic health record exchange format, in cooperation with national authorities and stakeholders, in particular healthcare professionals;

Or. fr

Amendment 847

Tomislav Sokol

Proposal for a regulation

Article 10 – paragraph 2 – point h

Text proposed by the Commission

Amendment

(h) contribute, at Union level, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing interoperability, security, safety or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems and wellness applications referred to in Article 32;

(h) contribute, at Union level, and in cooperation with the local and regional level within the Member States, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing interoperability, security, safety or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems and wellness applications referred to in Article 32;

Or. en

Amendment 848

Tudor Ciuhodaru

Proposal for a regulation

Article 10 – paragraph 2 – point h

Text proposed by the Commission

Amendment

(h) contribute, at Union level, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing interoperability, the access period and the access process per se, and security, safety or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems and wellness applications referred to in Article 32;

Or. ro

Amendment 849

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point h

Text proposed by the Commission

Amendment

(h) contribute, at Union level, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing quality, interoperability, security, safety, ease of use, accessibility, non-discrimination or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems;

Or. en

Amendment 850

Rob Rooken

Proposal for a regulation

Article 10 – paragraph 2 – point h

Text proposed by the Commission

Amendment

Or. en

Amendment 851

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point h a (new)

Text proposed by the Commission

Amendment

(h a) support digital health literacy and promote awareness and understanding about the benefits, risks, rules and rights in relation to the use of EHR systems;

Or. en

Amendment 852

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point k

Text proposed by the Commission

Amendment

(k) offer, in compliance with national legislation, telemedicine services and ensure that such services are easy to use, accessible to different groups of natural persons and health professionals, including natural persons with disabilities, do not discriminate and offer the possibility of choosing between in person and digital services;

deleted

Or. en

Amendment 853

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

Proposal for a regulation

Article 10 – paragraph 2 – point k

Text proposed by the Commission

Amendment

(k) offer, in compliance with national legislation, telemedicine services and ensure that such services are easy to use, accessible and equitable to different groups of natural persons and health professionals, including natural persons with disabilities, do not discriminate and offer the possibility of choosing between in person and digital services;

Or. en

Amendment 854

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 10 – paragraph 2 – point k

Text proposed by the Commission

Amendment

(k) offer, in compliance with national legislation, telemedicine services and ensure that such services are easy to use, accessible to natural persons and health professionals, including natural persons with disabilities, under the same non-discriminatory conditions and offer the possibility of choosing between in person and digital services;

Or. en

Amendment 855

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

Proposal for a regulation

Article 10 – paragraph 2 – point k a (new)

Text proposed by the Commission

Amendment

(k a) ensure a communication plan to the natural person, health professional and stakeholders to inform the rights and obligations of which element of the EHDS and inform the natural person the advantages and potential gains to science and society of the primary and secondary use of electronic health data;

Or. en

Amendment 856

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

Proposal for a regulation

Article 10 – paragraph 2 – point k b (new)

Text proposed by the Commission

Amendment

(k b) offer, free of charge, accessible online training, to natural persons and health professionals on how to use electronic health data access service and health professional access service, respectively;

Or. en

Amendment 857

Lukas Mandl

Proposal for a regulation

Article 10 – paragraph 2 – point m

Text proposed by the Commission

Amendment

(m) cooperate with other relevant entities and bodies at national or Union level, to ensure interoperability, data portability and security of electronic health data, as well as with stakeholders representatives, including patients’ representatives, healthcare providers, health professionals, industry associations;

Or. en

Amendment 858

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point m

Text proposed by the Commission

Amendment

(m) cooperate with other relevant entities and bodies at local, regional, national or Union level, to ensure interoperability, data portability and security of electronic health data, as well as with stakeholders representatives, including patients’ and consumers’ representatives, healthcare providers, health professionals, industry associations;

Or. en

Amendment 859

Konstantinos Arvanitis

Proposal for a regulation

Article 10 – paragraph 2 – point m

Text proposed by the Commission

Amendment

Or. en

Amendment 860

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 10 – paragraph 2 – point m

Text proposed by the Commission

Amendment

(m) cooperate with other relevant entities and bodies at national or Union level, to ensure interoperability, data portability and security of electronic health data, as well as with stakeholders representatives through relevant associations, including representatives of patients, healthcare providers, health professionals, industry;

Or. en

Amendment 861

Tomislav Sokol

Proposal for a regulation

Article 10 – paragraph 2 – point m

Text proposed by the Commission

Amendment

(m) cooperate with other relevant entities and bodies at local, regional, national or Union level, to ensure interoperability, data portability and security of electronic health data, as well as with stakeholders representatives, including patients’ representatives, healthcare providers, health professionals, industry associations;

Or. en

Amendment 862

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point n

Text proposed by the Commission

Amendment

(n) cooperate with supervisory authorities in accordance with Regulation (EU) 910/2014, Regulation (EU) 2016/679 and Directive (EU) 2016/1148 of the European Parliament and of the Council56with other relevant authorities, including those competent for cybersecurity, electronic identification, the European Artificial Intelligence Board, the Medical Device Coordination Group, the European Data Innovation Board and the competent authorities under Regulation […] [Data Act COM/2022/68 final];

(n) cooperate in the enforcement of this Regulation, within the remit of their respective competences, with supervisory authorities in accordance with Regulation (EU) 910/2014, Regulation (EU) 2016/679 and Directive (EU) 2016/1148 of the European Parliament and of the Council56with other relevant authorities, including those competent for cybersecurity, electronic identification, the European Artificial Intelligence Board, the Medical Device Coordination Group, the European Data Innovation Board and the competent authorities under Regulation […] [Data Act COM/2022/68 final];

_________________

56 Directive (EU) 2016/1148 of the European Parliament and of the Council of 6 July 2016 concerning measures for a high common level of security of network and information systems across the Union (OJ L 194, 19.7.2016, p. 1).

Or. en

Amendment 863

Kateřina Konečná

Proposal for a regulation

Article 10 – paragraph 2 – point n a (new)

Text proposed by the Commission

Amendment

(n a) promote public awareness and understanding of the benefits, risks, rules, safeguards and rights in relation to the EHDS system.

Or. en

Justification

To achieve the objectives of the EHDS and ensure that individuals are familiar with the new system, digital health authorities should promote public awareness about the EHDS. Moreover, it is crucial to ensure that citizens lacking digital skills are not being left behind or discriminated and that the implementation of the EHDS reduces inequalities in healthcare.

Amendment 864

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point o – introductory part

Text proposed by the Commission

Amendment

(o) draw up, in collaboration where relevant with market surveillance authorities, an annual activity report, which shall contain a comprehensive overview of its activities. The report shall be transmitted to the Commission. The annual activity report shall follow a structure that is agreed at Union level within EHDS Board, to support benchmarking pursuant to Article 59. The report shall contain at least information concerning:

(o) draw up, in collaboration where relevant with market surveillance authorities, an annual activity report, which shall contain a comprehensive overview of its activities. The report shall be transmitted to the Commission and shall be published. The annual activity report shall follow a structure that is agreed at Union level within EHDS Board, to support benchmarking pursuant to Article 59. The report shall contain at least information concerning:

Or. en

Amendment 865

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point o – point vi a (new)

Text proposed by the Commission

Amendment

(vi a) amount of persons who have restricted or refused access to their data pursuant to paragraphs 9 and 9a of Article 3, and information about the scope of such restrictions by type of health professional or health data;

Or. en

Amendment 866

Rob Rooken

Proposal for a regulation

Article 10 – paragraph 2 – point o – point vii

Text proposed by the Commission

Amendment

(vii) number of certified EHR systems and labelled wellness applications enrolled in the EU database;

(vii) number of certified EHR systems enrolled in the EU database;

Or. en

Amendment 867

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point o a (new)

Text proposed by the Commission

Amendment

(o a) enforce the compliance with this Regulation, including by:

(i) conducting on-site and remote inspections, including unannounced ones;

(ii) issuing of administrative fines;

(iii) imposing on providers of EHRs or on other healthcare providers and professionals and other data holders and data users a ban on certain activities that are in violation of this Regulation.

Or. en

Amendment 868

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

Proposal for a regulation

Article 10 – paragraph 2 – point o a (new)

Text proposed by the Commission

Amendment

(o a) promote public awareness and understanding of the benefits, risks, rules, safeguards and rights in relation to the EHDS system;

Or. en

Amendment 869

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 10 – paragraph 2 – point o a (new)

Text proposed by the Commission

Amendment

(o a) promote public awareness and understanding of the benefits, risks, rules, safeguards and rights in relation to the EHDS system.

Or. en

Amendment 870

Konstantinos Arvanitis

Proposal for a regulation

Article 10 – paragraph 2 – point o a (new)

Text proposed by the Commission

Amendment

(o a) promote public awareness and understanding of the benefits, risks, rules, safeguards and rights in relation to the EHDS system.

Or. en

Amendment 871

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 2 – point o b (new)

Text proposed by the Commission

Amendment

(o b) promote public awareness and understanding of the benefits, risks, rules, safeguards and rights in relation to the EHDS system.

Or. en

Amendment 872

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

Proposal for a regulation

Article 10 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The supervisory authority or authorities responsible for monitoring the application of Regulation (EU) 2016/679 shall also be responsible for monitoring the application of Article 3, 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, consult and cooperate in the enforcement of this Regulation, within the remit of their respective competences.

Or. en

Justification

Clarification in line with EDPB/EDPS joint opinion.

Amendment 873

Konstantinos Arvanitis

Proposal for a regulation

Article 10 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Digital health authorities shall consult relevant data protection authorities on matters of particular importance for the protection of individuals’ rights and freedoms with regard to the processing of personal data.

Or. en

Amendment 874

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 10 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Digital health authorities shall assist relevant data protection authorities so as to ensure the protection of individuals’ rights and freedoms with regard to the processing of personal data.

Or. en

Amendment 875

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by entrusting the digital health authorities with additional tasks necessary to carry out the missions conferred on them by this Regulation and to modify the content of the annual report.

deleted

Or. en

Amendment 876

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 10 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 877

Konstantinos Arvanitis

Proposal for a regulation

Article 10 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Amendment 878

Kateřina Konečná

Proposal for a regulation

Article 10 – paragraph 3

Text proposed by the Commission

Amendment

Or. en

Justification

The Commission’s powers to modify the content of the annual activity report should be limited to ensure full transparency regarding the activities carried out by Digital Health Authorities.

Amendment 879

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 10 – paragraph 4

Text proposed by the Commission

Amendment

4. Each Member State shall ensure that each digital health authority is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and exercise of its powers. Digital health authorities and their members and staff shall have the qualifications, experience and skills required to carry out their duties and exercise their powers.

Or. en

Amendment 880

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 4

Text proposed by the Commission

Amendment

4. Each Member State shall ensure that each digital health authority is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and exercise of its powers. Each Member State shall by law provide for the details of the enforcement powers pursuant to point (p) of paragraph 2.

(Linked to point (p) of paragraph 2)

Or. en

Amendment 881

Kateřina Konečná

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

5. Essential health stakeholders’ representatives, including patient organisations, shall be present in the governance and decision-making structures of the digital health authority. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representatives. Members of the digital health authority shall avoid any conflicts of interest. The Commission shall be empowered to adopt delegated acts setting out what is likely to constitute a conflict of interests together with the procedure to be followed in such cases.

Or. en

Justification

The regulation must involve the main actors who will be impacted and who will be essential to its achievement: the health stakeholders. Concrete and meaningful involvement of patients’ representatives in the governance and decision-making structures of the DHA will be essential to ensure transparency, build a high level of trust and make sure patients’ needs are fully taken into consideration. In addition, the Commission should define more precisely what constitutes a conflict of interest, as unclear criteria lead to unpredictable engagement.

Amendment 882

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

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ and healthcare professionals’ representatives. Members of the digital health authority shall avoid any conflicts of interest. The Commission shall be empowered to adopt delegated acts setting out what is likely to constitute a conflict of interest together with the procedure to be followed in such cases.

Or. en

Amendment 883

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients, consumers and healthcare professionals’ representatives. Members of the digital health authority shall have no direct or indirect economic, financial or personal interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct.

Or. en

Amendment 884

Lukas Mandl

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

5. Essential health stakeholders representatives on national level, including patient organisations, social security institutions and healthcare professionals, shall be present in the governance and decision-making structures of the digital health authority. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representatives. Members of the digital health authority shall avoid any conflicts of interest.

Or. en

Amendment 885

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representatives. Members of the digital health authority shall avoid any conflicts of interest. Essential health stakeholders’ representatives on national level, including patient organisations, healthcare professionals and industry associations shall be present in the governance and decision-making structures of the digital health authority.

Or. en

Amendment 886

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

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including health professionals, patients and consummers' representatives. The stakeholders' representatives shall take part in the governance and decision-making structures of the digital health authority. Members of the digital health authority shall avoid any conflicts of interest.

Or. en

Amendment 887

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including representatives of patients, the industrial sector, SMEs, medical institutions, civil society, the university sector and research bodies. Members of the digital health authority shall avoid any conflicts of interest.

Or. fr

Amendment 888

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 10 – paragraph 5

Text proposed by the Commission

Amendment

5. In the performance of its tasks, the digital health authority shall actively cooperate and consult with essential health stakeholders’ representatives, including patients’ representatives, health professionals and healthcare providers. Members of the digital health authority shall avoid any conflicts of interest.

Or. en

Amendment 889

Margarita de la Pisa Carrión

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

Or. es

Amendment 890

Mathilde Androuët

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

Or. fr

Amendment 891

Konstantinos Arvanitis

Proposal for a regulation

Article 10 – paragraph 5

Text proposed by the Commission

Amendment

Or. en

Amendment 892

Konstantinos Arvanitis

Proposal for a regulation

Article 10 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Each Member State shall establish a complaint and redress mechanism to address conflicts of interests, negligence, or any other wrongdoing by the digital health authority.

Or. en

Amendment 893

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

Proposal for a regulation

Article 10 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. The Member States shall determine the selection procedure for health stakeholders referred to in paragraph 5 through an open, transparent and inclusive process.

Or. en

Amendment 894

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 10 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5a. Member States shall decide upon a selection procedure to ensure that the stakeholders referred to in paragraph 5 of this Article are representative.

Or. fr

Amendment 895

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

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the digital health authority. Where the complaint concerns the rights of natural persons pursuant to Article 3 of this Regulation, or any data protection aspects, the digital health authority shall inform the supervisory authorities under Regulation (EU) 2016/679 and send them a copy of the complaint in order to facilitate their assessment and investigation. Where a complaint concerning rights of natural persons pursuant to Article 3 is made solely to the supervisory authorities, they shall inform the digital health authorities and send them a copy.

Or. en

Amendment 896

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the digital health authority, where their rights laid down in this Regulation are affected. Where the complaint concerns the rights of natural persons pursuant to Article 3 of this Regulation, the digital health authority shall send a copy of the complaint to the supervisory authorities under Regulation (EU) 2016/679. The decision of the digital health authority shall not prejudice any measures taken by the data protection authorities within their competences under Regulation (EU) 2016/679.

Or. en

Amendment 897

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or collectively, with the digital health authority. Where the complaint concerns the rights of natural persons pursuant to Article 3 of this Regulation, the digital health authority shall send a copy of the complaint to and consult with the supervisory authorities under Regulation (EU) 2016/679. Those supervisory authorities shall be competent to treat the complaint in a separate proceeding, pursuant to their tasks and powers under that Regulation.

Or. en

Amendment 898

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

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the digital health authority. Where the complaint concerns the rights of natural persons pursuant to Article 3 of this Regulation, the digital health authority shall send a copy of the complaint to the supervisory authorities under Regulation (EU) 2016/679 and shall consult and cooperate with them in the handling of such complaints.

Or. en

Amendment 899

Konstantinos Arvanitis

Proposal for a regulation

Article 11 – paragraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 900

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

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

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

2. The digital health authority with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken. Where the complaint concerns data protection aspects, the digital health authority shall inform the complainant that the complaint was referred to the relevant supervisory authority under Regulation (EU) 2016/679, and that the supervisory authority will, from that time on, be the sole point of contact for the complainant in that matter.

Or. en

Amendment 901

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

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

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

2. The digital health authority with which the complaint has been lodged provides the complainant with information on the status of the complaint proceedings and of the decision taken to ensure full transparency of the process.

Or. en

Amendment 902

Rob Rooken

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

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

2. The digital health authority with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken. The digital health authority shall send a copy of the complaint to the relevant data protection supervisory authority.

Or. en

Amendment 903

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

Proposal for a regulation

Article 11 – paragraph 2

Text proposed by the Commission

Amendment

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

2. The digital health authority with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken and inform the legal authorities if applicable.

Or. en

Amendment 904

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

Proposal for a regulation

Article 11 – paragraph 3

Text proposed by the Commission

Amendment

3. Digital health authorities shall cooperate to handle and resolve complaints, including by exchanging all relevant information by electronic means, without undue delay.

3. Digital health authorities shall cooperate to handle and resolve complaints, including by exchanging all relevant information by electronic means, without undue delay and communicate on processing time and complaint resolution time.

Or. en

Amendment 905

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 11 a (new)

Text proposed by the Commission

Amendment

Article 11 a

Right to an effective remedy against a digital health authority

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

2. Without prejudice to any other administrative or non-judicial remedy, each natural or legal person shall have the right to an effective judicial remedy where the digital health authority which is competent pursuant to Article 10 does not handle a complaint or does not inform the natural or legal person within three months on the progress or outcome of the complaint lodged pursuant to Article 11.

3. Proceedings against a digital health authority shall be brought before the courts of the Member States where the digital health authority is established.

Or. en

Amendment 906

Konstantinos Arvanitis

Proposal for a regulation

Article 11 a (new)

Text proposed by the Commission

Amendment

Article 11 a

Right to an effective remedy against a digital health authority

3. Proceedings against a digital health authority shall be brought before the courts of the Member States where the digital health authority is established.

Or. en

Amendment 907

Mathilde Androuët

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between national contact points for digital health of the Member States. All infrastructure for this solution shall be located in the European Union and all actors involved shall be governed solely by EU law.

Or. fr

Amendment 908

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between national contact points for digital health of the Member States. The central platform shall be licenced under an open-source licence and published in the Open Source code repository of the EU institutions.

Or. en

Justification

In the EU’s Open Source Strategy 2020-2023, the Commission committed to leading by example to “leverage the innovative and collaborative power of open source”. Open source positively impacts the digital autonomy of Europe. By making the central platform open source, it will contribute to removing barriers to a Digital Single Market in Europe, it will ensure the creation of an interoperable, non-discriminatory and transparent procedures for the exchange of data.

Amendment 909

Konstantinos Arvanitis

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish a central platform to support and facilitate the exchange of electronic health data between national contact points for digital health of the Member States.

Or. en

Amendment 910

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 12 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between contact points for digital health of the Member States.

Or. en

Amendment 911

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 12 – paragraph 2

Text proposed by the Commission

Amendment

2. Each Member State shall designate one national contact point for digital health to ensure the connection to all other national contact points for digital health and to the central platform for digital health. Where a designated national contact point is an entity consisting of multiple organisations responsible for implementing different services, the Member State shall communicate to the Commission a description of the separation of tasks between the organisations. The national contact point for digital health shall be considered an authorised participant in the infrastructure. Each Member State shall communicate the identity of its national contact point to the Commission by [the date of application of this Regulation]. Such contact point may be established within the digital health authority established by Article 10 of this Regulation. Member States shall communicate to the Commission any subsequent modification of the identity of those contact points. The Commission and the Member States shall make this information publicly available.

2. Each Member State shall designate one national contact point for digital health to ensure the connection to all other national or, where applicable, regional contact points for digital health and to the central platform for digital health. Where a designated national contact point is an entity consisting of multiple organisations responsible for implementing different services, the Member State shall communicate to the Commission a description of the separation of tasks between the organisations. The national contact point for digital health shall be considered an authorised participant in the infrastructure. Each Member State shall communicate the identity of its national contact point to the Commission by [the date of application of this Regulation]. Such contact point may be established within the digital health authority established by Article 10 of this Regulation. Member States shall communicate to the Commission any subsequent modification of the identity of those contact points. The Commission and the Member States shall make this information publicly available.

Or. en

Amendment 912

Konstantinos Arvanitis

Proposal for a regulation

Article 12 – paragraph 3

Text proposed by the Commission

Amendment

3. Each national contact point for digital health shall enable the exchange of the personal electronic health data referred to in Article 5 with all other national contact points. The exchange shall be based on the European electronic health record exchange format.

Or. en

Amendment 913

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 12 – paragraph 3

Text proposed by the Commission

Amendment

3. Each contact point for digital health shall enable the exchange of the personal electronic health data referred to in Article 5 with all other contact points. The exchange shall be based on the European electronic health record exchange format.

Or. en

Amendment 914

Konstantinos Arvanitis

Proposal for a regulation

Article 12 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The implementing act shall include the target implementation dates, including for improved cross border health data interoperability, in consultation with the EHDS board. The European Union Agency for Cyber Security shall be consulted and closely involved in all steps of the procedure. Any measures adopted shall meet the highest technical standards in terms of security, confidentiality and protection of electronic health data.

Or. en

Amendment 915

Kateřina Konečná

Proposal for a regulation

Article 12 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The European Union Agency for Cyber Security shall be consulted and closely involved in all steps of the procedure. Any measures adopted shall meet the highest technical standards in terms of security, confidentiality and protection of electronic health data.

Or. en

Amendment 916

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 12 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The European Union Agency for Cyber Security shall be consulted and closely involved in all steps of the procedure. Any measures adopted shall meet the highest technical standards in terms of security, confidentiality and protection of electronic health data.

Or. en

Amendment 917

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 12 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The European Union Agency for Cyber Security shall be consulted and closely involved in all steps of the procedure. Any measures adopted shall meet the highest technical standards in terms of security, confidentiality and protection of electronic health data.

Or. en

Amendment 918

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

Proposal for a regulation

Article 12 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The implementing act shall include the agreement of target implementation dates, including for improved cross-border health data interoperability, in consultation with the EHDS board.

Or. en

Amendment 919

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

Proposal for a regulation

Article 12 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68(2a). The implementing act shall include target implementation dates, including for cross-border health data interoperability, in consultation with the EHDS Board.

Or. en

Amendment 920

Javier Zarzalejos

Proposal for a regulation

Article 12 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Commission shall in the development of technical implementing measures related to the security, confidentiality and data protection aspects of MyHealth@EU consult the European Union Agency for Cyber Security.

Or. en

Amendment 921

István Ujhelyi

Proposal for a regulation

Article 12 – paragraph 5

Text proposed by the Commission

Amendment

5. Member States shall ensure connection of all healthcare providers to their national contact points for digital health and shall ensure that those connected are enabled to perform two-way exchange of electronic health data with the national contact point for digital health.

5. Member States shall support and ensure connection of all regional and local healthcare providers to their national contact points for digital health and shall ensure that those connected are enabled to perform two-way exchange of electronic health data with the national contact point for digital health.

Or. en

Amendment 922

István Ujhelyi

Proposal for a regulation

Article 12 – paragraph 6

Text proposed by the Commission

Amendment

6. Member States shall ensure that pharmacies operating on their territories, including online pharmacies, are enabled to dispense electronic prescriptions issued by other Member States, under the conditions laid down in Article 11 of Directive 2011/24/EU. The pharmacies shall access and accept electronic prescriptions transmitted to them from other Member States through MyHealth@EU. Following dispensation of medicinal products based on an electronic prescription from another Member State, pharmacies shall report the dispensation to the Member State that issued the prescription, through MyHealth@EU.

6. Member States shall ensure that pharmacies across the continuum of care operating on their territories, including online, hospital and ambulatory/day hospital pharmacies, are enabled to dispense electronic prescriptions issued by other Member States, under the conditions laid down in Article 11 of Directive 2011/24/EU. The pharmacies shall access and accept electronic prescriptions transmitted to them from other Member States through MyHealth@EU. Following dispensation of medicinal products based on an electronic prescription from another Member State, all pharmacies shall report the dispensation to the Member State that issued the prescription, through MyHealth@EU.

Or. en

Amendment 923

Javier Zarzalejos

Proposal for a regulation

Article 12 – paragraph 6

Text proposed by the Commission

Amendment

6. Member States shall ensure that pharmacies operating on their territories are enabled to dispense electronic prescriptions issued by other Member States, under the conditions laid down in Article 11 of Directive 2011/24/EU. The pharmacies shall access and accept electronic prescriptions transmitted to them from other Member States through MyHealth@EU, granted that the requirements in Article 11 of Directive 2011/24/EU are fulfilled. Following dispensation of medicinal products based on an electronic prescription from another Member State, pharmacies shall report the dispensation to the Member State that issued the prescription, through MyHealth@EU.

Or. en

Amendment 924

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

Proposal for a regulation

Article 12 – paragraph 6

Text proposed by the Commission

Amendment

6. Member States shall ensure that pharmacies operating on their territories, including online pharmacies, are enabled to dispense electronic prescriptions issued by other Member States, under the conditions laid down in Article 11 of Directive 2011/24/EU. The pharmacies shall access and accept electronic prescriptions transmitted to them from other Member States through MyHealth@EU, without prejudice to Article 11 of Directive 2011/24. Following dispensation of medicinal products based on an electronic prescription from another Member State, pharmacies shall report the dispensation to the Member State that issued the prescription, through MyHealth@EU.

Or. en

Amendment 925

Margarita de la Pisa Carrión

Proposal for a regulation

Article 12 – paragraph 6

Text proposed by the Commission

Amendment

6. Member States shall ensure that pharmacies operating on their territories are enabled to dispense electronic prescriptions issued by other Member States, under the conditions laid down in Article 11 of Directive 2011/24/EU. The pharmacies shall access and accept electronic prescriptions transmitted to them from other Member States through MyHealth@EU. Following dispensation of medicinal products based on an electronic prescription from another Member State, pharmacies shall report the dispensation to the Member State that issued the prescription, through MyHealth@EU in accordance with national provisions on the matter.

Or. es

Amendment 926

Dolors Montserrat

Proposal for a regulation

Article 12 – paragraph 6

Text proposed by the Commission

Amendment

6. Member States shall ensure that pharmacies operating on their territories are enabled to dispense electronic prescriptions issued by other Member States, under the conditions laid down in Article 11 of Directive 2011/24/EU. The pharmacies shall access and accept electronic prescriptions transmitted to them from other Member States through MyHealth@EU. Following dispensation of medicinal products based on an electronic prescription from another Member State, pharmacies shall report the dispensation to the Member State that issued the prescription, through MyHealth@EU.

Or. es

Amendment 927

Joanna Kopcińska

Proposal for a regulation

Article 12 – paragraph 7

Text proposed by the Commission

Amendment

7. The national contact points for digital health shall act as joint controllers of the electronic health data communicated through ‘MyHealth@EU’ for the processing operations in which they are involved. The Commission shall act as processor, with the limitation to the central platform MyHealth@EU to provide services supporting and facilitating the electronic exchange of health data between national digital health contact points.

Or. en

Amendment 928

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 12 – paragraph 7

Text proposed by the Commission

Amendment

7. The national or, where applicable, regional contact points for digital health shall act as joint controllers of the electronic health data communicated through ‘MyHealth@EU’ for the processing operations in which they are involved. The Commission shall act as processor.

Or. en

Amendment 929

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 12 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. In order to guarantee the linguistic rights of natural persons to access and make use of their personal electronic health data, MyHealth@EU shall be accessible in the language of preference of the natural person, including all officially recognised lenguages in Member States.

Or. en

Amendment 930

Konstantinos Arvanitis

Proposal for a regulation

Article 12 – paragraph 8

Text proposed by the Commission

Amendment

8. The Commission shall, by means of implementing acts, allocate responsibilities among controllers and as regards the processor referred to in paragraph 7 of this Article, in accordance with Chapter IV of Regulation (EU) 2016/679. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

deleted

Or. en

Amendment 931

Beata Kempa

Proposal for a regulation

Article 12 – paragraph 9

Text proposed by the Commission

Amendment

9. The approval for individual authorised participants to join MyHealth@EU for different services, or to disconnect a participant shall be issued by the Joint Controllership group, based on the results of the compliance checks.

9. The approval for individual authorised participants to join MyHealth@EU for different services, or to disconnect a participant, shall be issued by the EHDS Board, based on the results of the capacity checks carried out by the Commission.

Or. pl

Amendment 932

Beata Kempa

Proposal for a regulation

Article 12 – paragraph 9

Text proposed by the Commission

Amendment

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

Or. en

Amendment 933

Joanna Kopcińska

Proposal for a regulation

Article 12 – paragraph 9

Text proposed by the Commission

Amendment

Or. en

Amendment 934

Rob Rooken

Proposal for a regulation

Article 13 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States may provide through MyHealth@EU supplementary services that facilitate telemedicine, mobile health, access by natural persons to their translated health data, exchange or verification of health-related certificates, including vaccination card services supporting public health and public health monitoring or digital health systems, services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and high-quality healthcare. The Commission shall, by means of implementing acts, set out the technical aspects of such provision. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

1. Member States may provide through MyHealth@EU supplementary services that facilitate telemedicine, mobile health and access by natural persons to their translated health data.

Or. en

Amendment 935

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 13 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States may provide through MyHealth@EU supplementary services that facilitate telemedicine, mobile health, access by natural persons to their translated health data and use of their language of preference, including all officially recognised languages in Member States, exchange or verification of health-related certificates, including vaccination card services supporting public health and public health monitoring or digital health systems, services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and high-quality healthcare. The Commission shall, by means of implementing acts, set out the technical aspects of such provision. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 936

Tudor Ciuhodaru

Proposal for a regulation

Article 13 – paragraph 2

Text proposed by the Commission

Amendment

2. The Commission and Member States may facilitate the exchange of electronic health data with other infrastructures, such as the Clinical Patient Management System or other services or infrastructures in the health, care or social security fields which may become authorised participants to MyHealth@EU. The Commission shall, by means of implementing acts, set out the technical aspects of such exchanges. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The connection of another infrastructure to the central platform for digital health shall be subject to a decision of the joint controllership group for MyHealth@EU referred to in Article 66.

2. The Commission and Member States may facilitate the exchange of electronic health data with other infrastructures, such as the Clinical Patient Management System or other services or infrastructures in the health, care or social security fields which may become authorised participants to MyHealth@EU. The Commission shall, by means of implementing acts, set out the technical aspects of such exchanges, with a focus on the mode and period of access, in compliance with patient data security measures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The connection of another infrastructure to the central platform for digital health shall be subject to a decision of the joint controllership group for MyHealth@EU referred to in Article 66.

Or. ro

Amendment 937

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 13 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Member States and the Commission shall seek to ensure interoperability of MyHealth@EU with technological systems established at international level for the exchange of electronic health data. The Commission may adopt an implementing act establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of MyHealth@EU for the purposes of the electronic health data exchange. Before adopting such an implementing act, a compliance check of the national contact point of the third country or of the system established at an international level shall be performed under the control of the Commission.

deleted

Or. en

Justification

The focus should be first on building and implementing the system at EU level and only later focus on opening it to third countries. Therefore, Article 70 is amended to ask for a specific assessment for expansion possibility to third countries.

Amendment 938

Rob Rooken

Proposal for a regulation

Article 13 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 939

Konstantinos Arvanitis

Proposal for a regulation

Article 13 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Or. en

Amendment 940

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 13 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Member States and the Commission shall seek to ensure interoperability of MyHealth@EU with technological systems established at international level for the exchange of electronic health data. The Commission may adopt a delegated act establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of MyHealth@EU for the purposes of the electronic health data exchange. Before adopting such a delegated act, a compliance check of the national contact point of the third country or of the system established at an international level shall be performed under the control of the Commission, including on whether the health data transfer stemming from such exchange complies with the rules in Chapter V of Regulation (EU) 2016/679.

Or. en

Amendment 941

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 13 – paragraph 3 – subparagraph 1

Text proposed by the Commission

Amendment

Member States and the Commission shall seek to ensure interoperability of MyHealth@EU with technological systems established at international level for the exchange of electronic health data. The Commission may adopt an implementing act establishing that a national contact point of a third country or a system established at an international level is compliant with requirements of MyHealth@EU for the purposes of the electronic health data exchange. Before adopting such an implementing act, a compliance check of the national contact point of the third country or of the system established at an international level, as well as a compliance check with the requirements of Chapter V of Regulation (EU) 2016/679, shall be performed under the control of the Commission.

Or. en

Amendment 942

Edina Tóth, Balázs Hidvéghi

Proposal for a regulation

Article 13 – paragraph 3 – subparagraph 1 a (new)

Text proposed by the Commission

Amendment

In addition to the compliance check, the national security interests of the Member States shall be also taken into account before adopting the implementing act.

Or. en

Amendment 943

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 13 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

The implementing acts referred to in the first subparagraph of this paragraph shall be adopted in accordance with the procedure referred to in Article 68. The connection of the national contact point of the third country or of the system established at an international level to the central platform for digital health, as well as the decision to be disconnected shall be subject to a decision of the joint controllership group for MyHealth@EU referred to in Article 66.

deleted

Or. en

Amendment 944

Rob Rooken

Proposal for a regulation

Article 13 – paragraph 3 – subparagraph 2

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 945

Rob Rooken

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III EHR systems and wellness applications

III EHR systems

Or. en

Amendment 946

Konstantinos Arvanitis

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III EHR systems and wellness applications

III EHR systems

Or. en

Amendment 947

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Chapter III – title

Text proposed by the Commission

Amendment

III EHR systems and wellness applications

III EHR systems

Or. en

Justification

In line with the exclusion of wellness apps from the scope of the proposal

Amendment 948

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 14 – paragraph 2

Text proposed by the Commission

Amendment

2. This Chapter shall not apply to general software used in a healthcare environment.

2. This Chapter shall not apply to general software used in a healthcare environment. Manufacturers of EHR systems that also qualify as medical devices as defined under Article 2(1) of Regulation (EU) 2017/745 and claim interoperability of those medical devices with EHR systems under this Regulation shall prove compliance with the essential requirements for interoperability laid down in Section 2 of Annex II to this Regulation. Article 23 of this Regulation shall be applicable to those medical devices.

Or. en

Amendment 949

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 14 – paragraph 3

Text proposed by the Commission

Amendment

3. Manufacturers of medical devices as defined in Article 2(1) of Regulation (EU) 2017/745 that claim interoperability of those medical devices with EHR systems shall prove compliance with the essential requirements on interoperability laid down in Section 2 of Annex II of this Regulation. Article 23 of this Chapter shall be applicable to those medical devices.

3. Manufacturers of medical devices as defined in Article 2(1) of Regulation (EU) 2017/745 that claim interoperability of those medical devices with EHR systems shall prove compliance with the essential requirements on quality and interoperability laid down in Section 2 of Annex II of this Regulation. Article 23 of this Chapter shall be applicable to those medical devices.

Or. en

Amendment 950

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 14 – paragraph 4

Text proposed by the Commission

Amendment

4. Providers of high-risk AI systems as defined in Article 6 of Regulation […] [AI act COM/2021/206 final], which does not fall within the scope of Regulation (EU) 2017/745, that claim interoperability of those AI systems with EHR systems will need to prove compliance with the essential requirements on interoperability laid down in Section 2 of Annex II of this Regulation. Article 23 of this Chapter shall be applicable to those high-risk AI systems.

4. Notwithstanding the obligations laid down in Regulation [AI act COM/2021/206 final], providers of high-risk AI systems as defined in Article 6 of Regulation […] [AI act COM/2021/206 final], which do not fall within the scope of Regulation (EU) 2017/745, that claim interoperability of those AI systems with EHR systems will need to prove compliance with the essential requirements on quality and interoperability laid down in Section 2 of Annex II of this Regulation. Article 23 of this Chapter shall be applicable to those high-risk AI systems. .

Or. en

Amendment 951

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

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter.

1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter. That compliance shall be accredited through an EHR conformity assessment procedure performed by notified bodies for EHR systems and products claiming interoperability, including technical solutions on interoperability and security.

Or. en

Justification

The introduction of third party conformity assessment of EHR systems requires the addition of a new chapter with provisions on such a third party assessment.

Amendment 952

Joanna Kopcińska

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter.

1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter and following the transitional periods laid down in Article 72.

Or. en

Amendment 953

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

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter.

1. EHR systems may be placed on the market or put into service only after a notified body has assessed and verified that the EHR system complies with the provisions laid down in this Chapter.

Or. en

Amendment 954

Konstantinos Arvanitis

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter.

1. EHR systems may be placed on the market or put into service only after a Notified Body confirms that the EHR system complies with the provisions laid down in this Chapter.

Or. en

Amendment 955

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter.

1. EHR systems may be placed on the market or put into service only after a notified body has confirmed that they comply with the provisions laid down in this Chapter.

Or. en

Amendment 956

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 15 – paragraph 1

Text proposed by the Commission

Amendment

1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter.

1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter and in Annex II of this Regulation.

Or. en

Amendment 957

Konstantinos Arvanitis

Proposal for a regulation

Article 16 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

If any economic operator, other than the manufacturer, makes modifications to the EHR system while deploying or using it, which lead to changes in the intended purpose and deployments recommendations for the EHR system as declared by the manufacturer, the economic operator shall assume the responsibilities of a manufacturer under this Regulation for the EHR system’s compliance with this Regulation. In case of any malfunctioning or deterioration in performance quality due to the changes made by the economic operator during deployment or use of the EHR system contrary to the manufacturer's recommendations for technical deployment of the system or purpose of its use, full responsibility for those modifications lays with the economic operator.

Or. en

Amendment 958

Mathilde Androuët

Proposal for a regulation

Article 17 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Manufacturers of EHR systems shall:

1. Manufacturers of EHR systems shall be located in the European Union and provide services whose use shall be governed solely by EU law, meaning that the infrastructure on which they rely shall be located in the European Union, and:

Or. fr

Amendment 959

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

Proposal for a regulation

Article 17 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) ensure that their EHR systems are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;

(a) ensure that their EHR systems are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 23 and that they follow the principles of data minimisation and data protection by design; for the latter, the manufacturers shall be encouraged to consult relevant supervisory authorities under Regulation (EU) 2016/679.

Or. en

Amendment 960

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

Proposal for a regulation

Article 17 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) ensure that their EHR systems are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;

(a) obtain for their EHR systems a certificate of compliance from an independent third-party body to attest their conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;

Or. en

Amendment 961

Sirpa Pietikäinen

Proposal for a regulation

Article 17 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) ensure that their EHR systems are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;

(a) ensure that their EHR systems are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 23 and interoperable between Member States;

Or. en

Amendment 962

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

Proposal for a regulation

Article 17 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) draw up the technical documentation of their EHR systems in accordance with Article 24;

(b) draw up the technical documentation of their EHR systems in accordance with Article 24 before placing their system on the market;

Or. en

Amendment 963

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) draw up the technical documentation of their EHR systems in accordance with Article 24;

(b) draw up and keep up to date the technical documentation of their EHR systems in accordance with Article 24;

Or. en

Amendment 964

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 25 and clear and complete instructions for use;

(c) ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 25 and by clear and complete instructions for use, including in accessible formats for vulnerable populations, including migrants, the elderly and persons with disabilities;

Or. en

Amendment 965

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

Proposal for a regulation

Article 17 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) draw up an EU declaration of conformity as referred to in Article 26;

(d) carry out the relevant conformity assessment procedures as referred to in Article 27a;

Or. en

Amendment 966

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

Proposal for a regulation

Article 17 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) draw up the EU declaration of conformity in accordance with Article 26 and affix the CE marking in accordance with Article 27 where compliance of the EHR system requirements laid down in Annex II has been demonstrated by that conformity assessment procedure;

Or. en

Amendment 967

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

Proposal for a regulation

Article 17 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) affix the CE marking in accordance with Article 27;

deleted

Or. en

Amendment 968

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) take without undue delay any necessary corrective action in respect of their EHR systems which are not in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems;

(g) take immediately any necessary corrective action in respect of their EHR systems when manufacturers consider or have reasons to believe that such systems are not in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems;

Or. en

Amendment 969

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

Proposal for a regulation

Article 17 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) take without undue delay any necessary corrective action in respect of their EHR systems which are not or are no longer in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems;

Or. en

Amendment 970

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) inform the distributors of their EHR systems and, where applicable, the authorised representative and importers of any corrective action, recall or withdrawal;

(h) immediately inform the distributors of their EHR systems and, where applicable, the authorised representative and importers of any corrective action, recall or withdrawal;

Or. en

Amendment 971

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

Proposal for a regulation

Article 17 – paragraph 1 – point i

Text proposed by the Commission

Amendment

(i) inform the market surveillance authorities of the Member States in which they made their EHR systems available or put them into service of the non-conformity and of any corrective action taken;

(i) inform the market surveillance authorities and notified bodies of the Member States in which they made their EHR systems available or put them into service of the non-conformity and of any corrective action taken;

Or. en

Amendment 972

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 1 – point i

Text proposed by the Commission

Amendment

(i) inform the market surveillance authorities of the Member States in which they made their EHR systems available or put them into service of the non-conformity and of any corrective action taken;

(i) immediately inform the market surveillance authorities of the Member States in which they made their EHR systems available or put them into service of the non-conformity and of any corrective action taken;

Or. en

Amendment 973

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 1 – point i a (new)

Text proposed by the Commission

Amendment

(i a) immediately inform the market surveillance authorities of the Member States in which they made their EHR systems available, where manufacturers consider or have reasons to believe that such systems present a risk to the health or safety of natural persons or to other aspects of public interest protection;

Or. en

Justification

EHR systems could present serious risks. However, such risks could be found not only by market surveillance authorities - as stated in Article 29 - but also by manufacturers and other actors in the supply chain. In that case, they should inform market surveillance authorities and then market surveillance authorities will oblige them to take corrective measures.

Amendment 974

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) upon request of a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of their EHR system with the essential requirements laid down in Annex II.

(j) at least 6 months before placing on the market or putting into service their EHR systems, provide market surveillance authorities in the Member States concerned with all the information and documentation necessary to demonstrate the conformity of their EHR system with the essential requirements laid down in Annex II.

Or. en

Justification

If manufacturers will provide information and documentation necessary to ensure compliance prior to putting the system into the market, market surveillance authorities could conduct checks on this basis.

Amendment 975

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

Proposal for a regulation

Article 17 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) upon request of a market surveillance authority or a notified body, provide it with all the information and documentation necessary to demonstrate the conformity of their EHR system with the essential requirements laid down in Annex II.

Or. en

Amendment 976

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

Proposal for a regulation

Article 17 – paragraph 1 – point k

Text proposed by the Commission

Amendment

(k) cooperate with market surveillance authorities, at their request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.

(k) cooperate with market surveillance authorities and notified bodies, at their request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.

Or. en

Amendment 977

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

Proposal for a regulation

Article 17 – paragraph 1 – point k – point i (new)

Text proposed by the Commission

Amendment

i) The Commission shall ensure the availability of independant certification third-party bodies in sufficient number to allow the certification of the EHR systems deployed by the Member States.

Or. en

Amendment 978

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. If the manufacturer fails to cooperate with market surveillance authorities or if the information and documentation provided is incomplete or incorrect, market surveillance authorities shall take all appropriate measures to prohibit or restrict the relevant EHR system from being available on the market, to withdraw it from the market or to recall it until the manufacturer cooperates or provides complete and correct information;

Or. en

Amendment 979

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

Proposal for a regulation

Article 17 – paragraph 2

Text proposed by the Commission

Amendment

2. Manufacturers of EHR systems shall ensure that procedures are in place to ensure that the design, development and deployment of an EHR system continues to comply with the essential requirements laid down in Annex II and the common specifications referred to in Article 23. Changes in EHR system design or characteristics shall be adequately taken into account and reflected in the technical documentation.

2. Manufacturers shall ensure that procedures are in place for EHR systems to remain in conformity with this Regulation. Changes in EHR system design or characteristics and changes in the harmonised standards or the technical specifications referred to in Annex II and III by reference to which the conformity of the EHR system is declared or by application of which its conformity is verified shall be adequately taken into account and reflected in the technical documentation.

When deemed appropriate with regard to the risks presented by EHR systems, manufacturers shall, to protect the rights of natural persons, carry out sample testing or put into service, investigate, and, if necessary, keep a register of complaints, of non-conforming EHR systems and EHR systems recalls, and shall keep distributors informed of any such monitoring.

Or. en

Amendment 980

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

Proposal for a regulation

Article 17 – paragraph 3

Text proposed by the Commission

Amendment

3. Manufacturers of EHR systems shall keep the technical documentation and the EU declaration of conformity for 10 years after the last EHR system covered by the EU declaration of conformity has been placed on the market.

3. Manufacturers of EHR systems shall keep the technical documentation and the EU declaration of conformity, where relevant, at the disposal of the market surveillance authorities for 10 years after the last EHR system conformity assessment. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from the competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.

Or. en

Amendment 981

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 3

Text proposed by the Commission

Amendment

3. Manufacturers of EHR systems shall keep the technical documentation and the EU declaration of conformity for at least 10 years after the last EHR system covered by the EU declaration of conformity has been placed on the market.

Or. en

Amendment 982

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

Proposal for a regulation

Article 17 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Manufacturers who consider or have reason to believe that an EHR system, which they have placed on the market or put into service is not in conformity with the essential requirements set out in Annex II shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or to recall it, as appropriate. Furthermore, where the EHR system presents a risk, manufacturers shall immediately inform the competent national authorities of the Member States in which they made the EHR system available on the market to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.

Or. en

Amendment 983

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. A manufacturer of EHR systems established outside of the Union shall ensure that its authorised representative has the necessary documentation permanently available in order to fulfil the tasks referred to in Article 18(2).

Or. en

Amendment 984

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

Proposal for a regulation

Article 17 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. Manufacturers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of the EHR system with the essential requirements set out in Annex II, in a language which can be easily understood by that authority. They shall cooperate with that authority, at its request, on any measures taken to eliminate the risks posed by the EHR system, which they have placed on the market or put into service.

Or. en

Amendment 985

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 3 b (new)

Text proposed by the Commission

Amendment

3 b. Natural or legal persons may claim compensation for damage caused by a defective EHR system in accordance with applicable Union and national law. Manufacturers shall have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.

Or. en

Amendment 986

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 3 c (new)

Text proposed by the Commission

Amendment

3 c. Manufacturers shall make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account accessibility needs for vulnerable populations, including migrants, the elderly and persons with disabilities, allowing consumers and professional users to file complaints and to inform them of risks related to their health and safety or to other aspects of public interest protection and of any serious incident involving an EHR system;

Or. en

Amendment 987

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 3 d (new)

Text proposed by the Commission

Amendment

3 d. Manufacturers shall investigate complaints and information on incidents involving an EHR system they made available on the market without undue delay and shall keep an internal register of those complaints as well as of systems recalls and any corrective measures taken to bring the EHR system into conformity;

Or. en

Amendment 988

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 17 – paragraph 3 e (new)

Text proposed by the Commission

Amendment

3 e. Personal data stored in the internal register of complaints shall only be those personal data that are necessary for the manufacturer to investigate the complaint. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than five years after they have been encoded.

Or. en

Amendment 989

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 18 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. An authorised representative shall perform the tasks specified in the mandate received from the manufacturer. The mandate shall allow the authorised representative to do at least the following:

2. An authorised representative shall perform the tasks specified in the mandate agreed with the manufacturer. The mandate shall allow the authorised representative to do at least the following:

Or. en

Amendment 990

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

Proposal for a regulation

Article 18 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) keep the EU declaration of conformity and the technical documentation at the disposal of market surveillance authorities for the period referred to in Article 17(3);

(a) keep the EU declaration of conformity and the technical documentation at the disposal of the national market surveillance authorities for the period referred to in Article 17(3);

Or. en

Amendment 991

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 18 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) further to a reasoned request from a market surveillance authority, provide that authority with all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II;

(b) at least 6 months before an EHR system is placed on the market or putting into service provide market surveillance authorities of the Member States concerned a copy of the mandate with all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II in an official language of the authority;

Or. en

Amendment 992

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 18 – paragraph 2 – point b a (new)

Text proposed by the Commission

Amendment

(b a) immediately inform the manufacturer if the authorised representative has a reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection or if it is aware of any serious incident involving an EHR system;

Or. en

Amendment 993

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 18 – paragraph 2 – point b b (new)

Text proposed by the Commission

Amendment

(b b) immediately inform the manufacturer about complaints received by consumers and professional users;

Or. en

Amendment 994

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

Proposal for a regulation

Article 18 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) cooperate with the market surveillance authorities, at their request, on any corrective action taken in relation to the EHR systems covered by their mandate.

(c) cooperate with the competent national authorities, at their request, on any corrective action taken in relation to the EHR systems covered by their mandate.

Or. en

Amendment 995

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 18 – paragraph 2 – point c a (new)

Text proposed by the Commission

Amendment

(c a) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation and immediately inform the market surveillance authority of the Member State in which is established.

Or. en

Amendment 996

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 18 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 17, the authorised representative shall be legally liable for non-compliance with this Regulation on the same basis as, and jointly and severally with, the manufacturer.

Or. en

Amendment 997

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 18 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

2 c. In case of change of the authorised representative, the detailed arrangements for the change shall be clearly defined in an agreement between the manufacturer, or where practicable the outgoing authorised representative, and the incoming authorised representative.That agreement shall address at least the following aspects:

(a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative;

(b) the transfer of documents, including confidentiality aspects and property rights.

Or. en

Amendment 998

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the manufacturer has drawn up the technical documentation and the EU declaration of conformity;

(a) the manufacturer has drawn up the technical documentation and the EU declaration of conformity and ensure that it is made available to market surveillance authorities at least 6 months before an EHR system is placed on the market or put into service;

Or. en

Amendment 999

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

Proposal for a regulation

Article 19 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the manufacturer has drawn up the technical documentation and the EU declaration of conformity;

(a) the manufacturer has drawn up the technical documentation

Or. en

Amendment 1000

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

Proposal for a regulation

Article 19 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) ensure that the appropriate conformity assessment procedures referred to in Article 27a have been carried out by the manufacturer

Or. en

Amendment 1001

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) the manufacturer is identified and an authorised representative in accordance with Article 18 has been appointed;

Or. en

Amendment 1002

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

Proposal for a regulation

Article 19 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) the EHR system bears the CE marking of conformity;

(b) the EHR system bears the CE marking of conformity referred to in Article 27 ;

Or. en

Amendment 1003

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) the EHR system is accompanied by the information sheet referred to in Article 25 and appropriate instructions for use.

(c) the EHR system is accompanied by the information sheet referred to in Article 25 and clear and complete instructions for use in accessible formats, including for persons with disabilities.

Or. en

Amendment 1004

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 3

Text proposed by the Commission

Amendment

3. Importers shall indicate their name, registered trade name or registered trade mark and the address at which they can be contacted in a document accompanying the EHR system.

3. Importers shall indicate their name, registered trade name or registered trade mark and the postal and electronic address and a telephone number at which they can be contacted in a document accompanying the EHR system. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.

Or. en

Amendment 1005

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

Proposal for a regulation

Article 19 – paragraph 5

Text proposed by the Commission

Amendment

5. Where an importer considers or has reason to believe that an EHR system, which they have placed on the market, is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. In situations where the EHR system is already on the market, importers shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or recall it, as appropriate. The importer shall inform without undue delay the manufacturer of such EHR system and the national competent authorities of the Member State in which it made the EHR system available, to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.

Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.

Or. en

Amendment 1006

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 5

Text proposed by the Commission

Amendment

5. Where an importer considers or has reason to believe that an EHR system is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. The importer shall immediately inform the manufacturer of such EHR system and the market surveillance authorities of the Member State in which it made the EHR system available, to that effect. Where an importer considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately inform the market surveillance authority of the Member State in which the importer is established, as well as the manufacturer and where applicable, the authorised representative.

Or. en

Amendment 1007

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

Proposal for a regulation

Article 19 – paragraph 6

Text proposed by the Commission

Amendment

6. Importers shall keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for the period referred to in Article 17(3) and ensure that the technical documentation can be made available to those authorities, upon request. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.

Or. en

Amendment 1008

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 7

Text proposed by the Commission

Amendment

7. Importers shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the market surveillance authority is located. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.

7. Importers shall, at least 6 months before placing on the market or putting into service an EHR system, provide market surveillance authorities of Member States concerned with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the market surveillance authority is located. They shall cooperate with that authority, at its request, and with the manufacturer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II, or to ensure that their EHR systems are withdrawn or recalled.

Or. en

Amendment 1009

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 19 – paragraph 7

Text proposed by the Commission

Amendment

7. Importers shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official languages of the Member State where the market surveillance authority is located. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.

Or. en

Amendment 1010

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

Proposal for a regulation

Article 19 – paragraph 7

Text proposed by the Commission

Amendment

7. Importers shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the competent national authority is located. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.

Or. en

Amendment 1011

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 7 a (new)

Text proposed by the Commission

Amendment

7 a. Importers shall verify whether the communication channels referred to in Article 17(3c), are publicly available to consumers and professional users allowing them to submit complaints and communicate any risk related to their health and safety or to other aspects of public interest protection and of any serious incident involving an EHR system. If such channels are not available, the importer shall provide for them, taking into account accessibility needs of vulnerable populations including migrants, the elderly and persons with disabilities.

Or. en

Amendment 1012

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 7 b (new)

Text proposed by the Commission

Amendment

7 b. If the importer fails to cooperate with market surveillance authorities or if the information and documentation provided is incomplete or incorrect, market surveillance authorities shall take all appropriate measures to prohibit or restrict its EHR system from being available on the market, to withdraw it from the market or to recall it until the importer cooperates or provides complete and correct information.

Or. en

Amendment 1013

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 7 c (new)

Text proposed by the Commission

Amendment

7 c. Importers shall investigate complaints and information on incidents involving an EHR system they made available on the market and file those complaints, as well as of systems recalls and any corrective measures taken to bring the EHR system into conformity, in the register referred to in Article 17(3e) or in their own internal register. Importers shall keep the manufacturer, distributors and, where relevant, authorised representatives informed in a timely manner of the investigation performed and of the results of the investigation.

Or. en

Amendment 1014

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 19 – paragraph 7 d (new)

Text proposed by the Commission

Amendment

7 d. Personal data stored in the internal register of complaints shall only be those personal data that are necessary for the importer to investigate the complaint. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than five years after they have been encoded.

Or. en

Amendment 1015

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

Proposal for a regulation

Article 20 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the manufacturer has drawn up the EU declaration of conformity;

deleted

Or. en

Amendment 1016

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

Proposal for a regulation

Article 20 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) ensure that the appropriate conformity assessment procedures referred to in Article 27a have been carried out by the manufacturer;

Or. en

Amendment 1017

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 20 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the EHR system is accompanied by the information sheet referred to in Article 25 and appropriate instructions for use;

(c) the EHR system is accompanied by the information sheet referred to in Article 25 and by clear and complete instructions for use in accessible formats, including for persons with disabilities;

Or. en

Amendment 1018

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

Proposal for a regulation

Article 20 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. When making an EHR system available on the market, distributors shall act with due care in relation to the requirements of this Regulation.

Or. en

Amendment 1019

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 20 – paragraph 3

Text proposed by the Commission

Amendment

3. Where a distributor considers or has reason to believe that an EHR system is not in conformity with the essential requirements laid down in Annex II, it shall not make the EHR system available on the market until it has been brought into conformity. Furthermore, the distributor shall immediately inform the manufacturer or the importer, as well as the market surveillance authorities of the Member states where the EHR system has been made available on the market, to that effect. Where a distributor considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately inform the market surveillance authority of the Member State in which the distributor is established, as well as the manufacturer, the importer and where applicable, the authorised representative.

Or. en

Amendment 1020

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 20 – paragraph 4

Text proposed by the Commission

Amendment

4. Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, and with the manufacturer, the importer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II or to ensure that their EHR systems are withdrawn or recalled.

Or. en

Amendment 1021

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

Proposal for a regulation

Article 20 – paragraph 4

Text proposed by the Commission

Amendment

4. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.

Or. en

Amendment 1022

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

Proposal for a regulation

Article 20 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Where a distributor considers or has reason to believe that an EHR system, which they have placed on the market, is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. In situations where the EHR system is already on the market, importers shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or recall it, as appropriate. The distributor shall inform without undue delay the manufacturer of such EHR system and the national competent authorities of the Member State in which it made the EHR system available, to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.

Or. en

Amendment 1023

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 20 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Distributors that have received complaints from consumers or professional users about suspected incidents involving an EHR system they made available on the market, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming EHR systems and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.

Or. en

Amendment 1024

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

Proposal for a regulation

Article 20 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4 b. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the competent national authority is located. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.

Or. en

Amendment 1025

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 21 – title

Text proposed by the Commission

Amendment

Cases in which obligations of manufacturers of an EHR system apply to importers and distributors

Cases in which obligations of manufacturers of an EHR system apply to other economic operators

Or. en

Amendment 1026

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 21 – paragraph 1

Text proposed by the Commission

Amendment

An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 17, where they made an EHR system available on the market under their own name or trademark or modify an EHR system already placed on the market in such a way that conformity with the applicable requirements may be affected.

An economic operator other than the manufacturer shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 17, where they made an EHR system available on the market under their own name or trademark or modify an EHR system already placed on the market in such a way that conformity with the applicable requirements may be affected.

Or. en

Amendment 1027

Lucia Ďuriš Nicholsonová, Susana Solís Pérez

Proposal for a regulation

Chapter III – Section 2 a (new)

Text proposed by the Commission

Amendment

2 a CONFORMITY ASSESSMENT

Article 22b

Conformity assessment procedure for EHR systems

1.Before placing an EHR system on the market, manufacturers of EHR systems shall use the conformity assessment procedure foreseen in this Article to demonstrate that the EHR system complies with the requirements set out in Article 17, in Annex II and with the applicable data privacy and data security requirements.

2.The manufacturer shall lodge an application for a conformity assessment procedure with the notified body of his or her choice, for EHR system concerned.The application shall include:

(a) a description of the EHR system

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

3.When a conformity assessment body notified under Article 22c (hereinafter referred to as a “notified body”) carries out the assessment, it shall evaluate, if necessary together with the manufacturer, the compliance of the EHR system with the requirement of this Regulation, in particular its compliance with the security and interoperability requirements set out in Annex II and with the applicable data protection and data security requirements.

4.Following its positive assessment, the notified body shall grant a conformity certificate for the EHR system.Member States shall ensure that their notified bodies do not grant a conformity certificate for an EHR system in respect of which a certificate has been refused or withdrawn.

Article 22c

Notification of conformity assessment bodies

Member States shall notify the Commission and the other Member States of bodies authorised to carry out third-party conformity assessment tasks in accordance with this Regulation.

Article 22d

Notifying authorities

1.Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies.

2.Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

3.Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 to a body, which is not a governmental entity that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 22e.In addition, that body shall have arrangements to cover liabilities arising out of its activities.

4.The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

Article 22e

Requirements relating to notifying authorities

1.A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

2.A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

3.A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment.

4.A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis.

5.A notifying authority shall safeguard the confidentiality of the information it obtains.

6.A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Article 22f

Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto.The Commission shall make that information publicly available.

Article 22g

Requirements relating to notified bodies

1.For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

2.A conformity assessment body shall be established under the national law of a Member State and have legal personality.

3.A conformity assessment body shall be a third-party body independent of the organisation or the EHR system it assesses.A body belonging to a business association or professional federation representing undertakings involved in the design, manufacture, provision, use or maintenance of EHR systems which it assesses, may, on the condition that its independence and the absence of any conflict of interest are demonstrated, be considered such a conformity assessment body.

4.A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, importer, distributor, installer, purchaser, owner, user or maintainer of EHR systems, that they assess or be the representative of any of those parties.A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, import, distribution, manufacture, marketing, installation, use or maintenance of those EHR systems, or represent the parties engaged in those activities.They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified.This shall in particular apply to consultancy services.A conformity assessment body shall ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities.

5.A conformity assessment body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence its judgement or the results of its conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6.A conformity assessment body shall be capable of carrying out all the conformity assessment tasks to verify the EHR’s compliance with Article 17 and Annex II and in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.At all times, and for each conformity assessment procedure and each EHR system for which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment tasks;

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures;

(c) appropriate policies and procedures to distinguish between tasks that it carries out as a notified body and other activities;

(d) procedures for the performance of conformity assessment activities.

A conformity assessment body shall have the means necessary to perform the technical and administrative tasks connected with the conformity assessment activities in an appropriate manner and shall have access to all necessary equipment or facilities.

7.The personnel responsible for carrying out conformity assessment tasks shall have the following:

(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c) appropriate knowledge and understanding of the essential security and interoperability requirements set out in Annex II and of the data protection and data security requirements applicable under Union and national legislations.

(d) the ability to draw up certificates, records and reports demonstrating that conformity assessments have been carried out.

8.The impartiality of a conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall be guaranteed.The remuneration of the top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not depend on the number of conformity assessments carried out or on the results of those assessments.

9.A conformity assessment body shall take out liability insurance unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

10.The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out the conformity assessment tasks in accordance with Article 22b, except in relation to the competent authorities of the Member State in which its tasks are carried out.Proprietary rights, intellectual property rights and trade secrets shall be protected.

Article 22h

Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 22g in so far as the applicable harmonised standards cover those requirements.

Article 22i

Subsidiaries of and subcontracting by notified bodies

1.Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 22g and shall inform the notifying authority accordingly.

2.A notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever those are established.

3.Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4.A notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Article 22b.

Article 22j

Application for notification

1.A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.

2.The application for notification shall be accompanied by a description of the conformity assessment activities, of the conformity assessment procedures set out in Article 22b and of the kinds or categories of EHR systems for which the conformity assessment body claims to be competent, as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 28.

3.Where the conformity assessment body concerned cannot provide an accreditation certificate as referred to in paragraph 2, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 22g.

Article 22k Notification procedure

1.A notifying authority shall notify only conformity assessment bodies which have satisfied the requirements laid down in Article 22g.

2.The notifying authority shall send a notification to the Commission and the other Member States, using the electronic notification tool developed and managed by the Commission.

3.The notification referred to in paragraph 2 shall include the following:

(a) full details of the conformity assessment activities to be performed;

(b) an indication of the conformity assessment module or modules and the kinds of EHR systems concerned;

4.Where a notification is not based on an accreditation certificate referred to in Article 31(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 28.

5.The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of the validation of the notification where it includes an accreditation certificate referred to in Article 31(2), or within two months of the notification where it includes documentary evidence referred to in Article 31(3) and in paragraph 4 of this Article.Only such a body shall be considered a notified body for the purposes of this Regulation.

6.The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification referred to in paragraph 2.

Article 22l

Identification numbers and lists of notified bodies

1.The Commission shall assign an identification number to a notified body.It shall assign a single such number even where the body is notified under several Union acts.

2.The Commission shall make publicly available the list of bodies notified under this Regulation including the identification numbers that have been assigned to them and the conformity assessment activities for which they have been notified.The Commission shall ensure that the list is kept up to date.

Article 22m

Changes to notifications

1.Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 22g, or that it is failing to fulfil its obligations as set out in Article 22o the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations.It shall immediately inform the Commission and the other Member States accordingly.

2.In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

Article 22n

Challenge of the competence of notified bodies

1.The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.

2.The notifying Member State shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.

3.The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

4.Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying Member State to take the necessary corrective measures, including the withdrawal of the notification if necessary.That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 46(2).

Article 22o

Operational obligations of notified bodies

1.A notified body shall carry out conformity assessments in accordance with the conformity assessment procedures set out in Article 22b.

2.A notified body shall perform its activities in a proportionate manner, avoiding unnecessary burdens for economic operators, and taking due account of the size of an undertaking, the sector in which the undertaking operates, the structure of the undertaking, the degree of complexity of the technology in question and the mass or serial nature of the production process.In so doing, the notified body shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the EHR system with the requirements of this Regulation.

3.Where a notified body finds that the essential security and interoperability requirements set out in Annex II and of the data protection and data security requirements applicable under Union and national legislations have not been met by a manufacturer, it shall require the manufacturer to take appropriate corrective actions and shall not issue a certificate of conformity or adopt an approval decision.

4.Where, in the course of the monitoring of conformity following the issue of an approval decision a notified body finds that a EHR system no longer complies, it shall require the manufacturer to take appropriate corrective actions and shall suspend or withdraw the approval decision, if necessary.

5.Where corrective actions are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates or approval decisions, as appropriate.

Article 22p

Appeals against decisions of notified bodies

A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.

Article 22q

Information obligation on notified bodies

1.A notified body shall inform the notifying authority of the following:

(a) any refusal, restriction, suspension or withdrawal of a certificate or approval decision;

(b) any circumstances affecting the scope of, or the conditions for, its notification;

(c) any request for information which it has received from market surveillance authorities regarding its conformity assessment activities;

(d) on request, any conformity assessment activities performed within the scope of its notification and any other activity performed, including cross-border activities and subcontracting.

2.A notified body shall provide the other bodies notified under this Regulation carrying out similar conformity assessment activities covering the same kinds of EHR systems with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Article 22r

Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.

Article 22s

Coordination of notified bodies

The Commission shall ensure that appropriate coordination and cooperation between bodies notified under this Regulation are put in place and properly operated in the form of a sectoral group of notified bodies. Notified bodies shall participate in the work of that group, directly or by means of designated representatives.

Or. en

Justification

This new section is necessary if third party conformity assessment of EHR systems is introduced.

Amendment 1028

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.

The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a common template document and a time limit for implementing those common specifications. Those common specifications shall be based on existing harmonised standards or international standards and shall be adopted only after consulting the European standardisation organisations as well as the relevant stakeholders. Where relevant, the common specifications shall take into account the specificities and verify compatibility with sectorial legislation and harmonized standards of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14, including the state-of-the art standards for health informatics and the European electronic health record exchange format.

Or. en

Amendment 1029

Pernille Weiss

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.

The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. Those common specifications shall be issued in accordance with Article 10 of Regulation (EU) 1025/2012, and where relevant based on existing harmonised standards or relevant international standards, and shall be adopted only after consulting the European standardisation organisations as well as other relevant stakeholders. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.

Or. en

Justification

The proper implementation and verification of the requirements set out in this Regulation will require methods, frameworks and requirements of a quality and substance provided by standards from acknowledged international Standard Development Organizations like ISO, CEN, CENELEC, IEC.

Amendment 1030

Konstantinos Arvanitis

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 1

Text proposed by the Commission

Amendment

The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.

The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a uniform template document and a time limit for implementing those common specifications. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.

Or. en

Amendment 1031

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

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

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2), after consultation with the EHDS Board and other relevant stakeholders.

Or. en

Amendment 1032

Konstantinos Arvanitis

Proposal for a regulation

Article 23 – paragraph 1 – subparagraph 2

Text proposed by the Commission

Amendment

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

Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2) after consultation with the EHDS Board and relevant stakeholders.

Or. en

Amendment 1033

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 23 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Where common specifications have an impact on data protection requirements of EHR systems, they shall be subject to consultation with EDPB and EDPS before their adoption, pursuant to Article 42(2) of Regulation (EU) 2018/1725.

Or. en

Amendment 1034

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 23 – paragraph 5

Text proposed by the Commission

Amendment

5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices or high-risk AI systems falling under other acts, such as Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], the adoption of those common specifications may be preceded by a consultation with the Medical Devices Coordination Group (MDCG) referred to in Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board referred to in Article 56 of Regulation […] [AI Act COM/2021/206 final], as applicable.

5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices or high-risk AI systems falling under other acts, such as Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], the adoption of those common specifications shall be preceded by a consultation with the Medical Devices Coordination Group (MDCG) referred to in Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board referred to in Article 56 of Regulation […] [AI Act COM/2021/206 final], as applicable, as well as the European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679.

Or. en

Amendment 1035

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 23 – paragraph 6

Text proposed by the Commission

Amendment

6. Where common specifications covering interoperability and security requirements of medical devices or high-risk AI systems falling under other acts such as Regulation (EU) 2017/745 or Regulation […] [AI Act COM/2021/206 final], impact EHR systems, the adoption of those common specifications shall be preceded by a consultation with the EHDS Board, especially its subgroup for Chapters II and III of this Regulation.

Or. en

Amendment 1036

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 24 – paragraph 1

Text proposed by the Commission

Amendment

1. The technical documentation shall be drawn up before the EHR system is placed on the market or put into service and shall be kept up-to-date.

1. Manufacturers shall draw up technical documentation before the EHR system is placed on the market or put into service and shall be kept up-to-date. The technical documentation shall be submitted to the market surveillance authorities of the Member States concerned at least 6 months before an EHR system is placed on the market or put into service.

Or. en

Amendment 1037

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 24 – paragraph 2

Text proposed by the Commission

Amendment

2. The technical documentation shall be drawn up in such a way as to demonstrate that the EHR system complies with the essential requirements laid down in Annex II and provide market surveillance authorities with all the necessary information to assess the conformity of the EHR system with those requirements. It shall contain, at a minimum, the elements set out in Annex III. In case the system or any part of it complies with European standards or common specifications, the list of the relevant European standards and common specifications shall also be indicated.

Or. en

Amendment 1038

Peter Liese

Proposal for a regulation

Article 24 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. To ensure conformity, templates for technical documentation are provided by the market surveillance authority of a Member State.

Or. en

Justification

A template for technical documentation can significantly reduce the overall burden for companies, especially SMEs.

Amendment 1039

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 24 – paragraph 3

Text proposed by the Commission

Amendment

3. The technical documentation shall be drawn up in one of the official languages of the Union. Following a reasoned request from the market surveillance authority of a Member State, the manufacturer shall provide a translation of the relevant parts of the technical documentation into the official language of that Member State.

Or. en

Amendment 1040

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 25 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) the identity, registered trade name or registered trademark, and the contact details of the manufacturer and, where applicable, of its authorised representative;

(a) the identity, registered trade name or registered trademark, and the contact details of the manufacturer including the postal and electronic address and the telephone number and, where applicable, of its authorised representative;

Or. en

Amendment 1041

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems and wellness applications referred to in Article 32, as an alternative to supplying the information sheet referred to in paragraph 1 with the EHR system.

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems, as an alternative to supplying the information sheet referred to in paragraph 1 with the EHR system.

Or. en

Justification

In line with the exclusion of wellness apps from the scope of the regulation

Amendment 1042

Konstantinos Arvanitis

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems, as an alternative to supplying the information sheet referred to in paragraph 1 with the EHR system.

Or. en

Amendment 1043

Rob Rooken

Proposal for a regulation

Article 25 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems referred to in Article 32, as an alternative to supplying the information sheet referred to in paragraph 1 with the EHR system.

Or. en

Amendment 1044

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

Proposal for a regulation

Article 25 a (new)

Text proposed by the Commission

Amendment

Article 25 a

Presumption of conformity of EHR systems

1. An EHR system which is in conformity with harmonised standards as referred to in Article 23 shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those standards.

2. The Commission shall, as provided in Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards for the essential requirements set out in Annex II.

3. The Commission is empowered to adopt implementing acts establishing technical specifications for the essential requirements set out in Annex II where the following conditions have been fulfilled:

(a) no reference to harmonised standards covering the relevant essential health and safety requirements is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;

(b) the Commission has requested one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements and there are undue delays in the standardisation procedure or the request has not been accepted by any of the European standardisation organisations.

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

4. An EHR system which is in conformity with the technical specifications shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those technical specifications.

Or. en

Amendment 1045

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled.

1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled. The manufacturer shall continuously update the EU declaration of conformity.

Or. en

Amendment 1046

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

Proposal for a regulation

Article 26 – paragraph 1

Text proposed by the Commission

Amendment

1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled.

Or. en

Amendment 1047

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 26 – paragraph 3

Text proposed by the Commission

Amendment

3. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into one or more official Union languages determined by the Member State(s) in which the EHR system is made available. Manufacturers shall provide a translation of the relevant parts of the technical documentation into all the official languages of Member States.

Or. en

Amendment 1048

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 26 – paragraph 4

Text proposed by the Commission

Amendment

4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the conformity of the EHR system.

4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for compliance with the requirements of this Regulation and all Union acts applicable to EHR systems.

Or. en

Amendment 1049

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

Proposal for a regulation

Article 26 – paragraph 4

Text proposed by the Commission

Amendment

4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the conformity of the EHR system.

4. By issuing the EU declaration of conformity to the health data access body, the notified body shall assume responsibility for the conformity of the EHR system.

Or. en

Amendment 1050

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 26 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Commission is empowered to adopt delegated acts in accordance with Article 67 amending the minimum content of the EU declaration of conformity set out in Annex IV.

Or. en

Amendment 1051

Konstantinos Arvanitis

Proposal for a regulation

Article 26 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Commission shall draw up a standard uniform EU declaration of conformity and make it available in digital format in all the official Union languages.

Or. en

Amendment 1052

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 26 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4a. The Commission shall publish a standard format for the EU declaration of conformity in digital form and accessible in all official EU languages.

Or. fr

Amendment 1053

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 26 a (new)

Text proposed by the Commission

Amendment

Article 26 a

Conformity assessment

Before an EHR system may be placed on the market a notified body has to:

(1) assess if the EHR system is in conformity with the essential requirements laid down in Annex II;

(2) assess if the EHR system is in conformity with the requirements laid down in Regulation... (Cyber Resilience Act COM/2022/457).

(3) assess if the technical documentation is available and complete;

(4) assess if the EHR system fulfils the requirements of the EU declaration of conformity.

Only after EU-wide approval has been issued, the CE marking can be affixed, together with an identification number.

Or. en

Justification

A self-declaration of conformity by the manufacturer is not enough, there needs to be a verification by a third party.

Amendment 1054

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 27 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The CE marking shall be affixed before making the EHR system available on the market.

Or. en

Amendment 1055

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 27 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Where EHR systems are subject to other Union legislation in respect of aspects not covered by this Regulation, which also requires the affixing of the CE marking, the CE marking shall indicate that the systems also fulfil the requirements of that other legislation.

Or. en

Amendment 1056

Konstantinos Arvanitis

Proposal for a regulation

Article 27 a (new)

Text proposed by the Commission

Amendment

Article 27 a

Assessment of conformity

Before an EHR system may be placed on the market a Notified Body has to:

(1) assess if the EHR system is in conformity with the essential requirements laid down in Annex II;

(2) assess if the EHR system is in conformity with the requirements laid down in Regulation... (Cyber Resilience Act COM/2022/457).

(3) assess if the technical documentation is available and complete;

(4) assess if the EHR system fulfils the requirements of the EU declaration of conformity

Only after EU-wide approval has been issued, the CE marking can be affixed, together with an identification number.

Or. en

Amendment 1057

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

Proposal for a regulation

Article 27 a (new)

Text proposed by the Commission

Amendment

Article 27 a

Conformity assessment procedures for EHR systems

1. In order to certify the conformity of an EHR system with this Regulation, the manufacturer or its authorised representative, shall apply for EU type-examination procedure provided for in Annex IVa;

2. Notified bodies shall take into account the specific interests and needs of small and medium sized enterprises when setting the fees for conformity assessment and reduce those fees proportionately to their specific interests and needs.

Or. en

Amendment 1058

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

Proposal for a regulation

Article 27 b (new)

Text proposed by the Commission

Amendment

Article 27 b

Notification

Member States shall notify the Commission and the other Member States of conformity assessment bodies authorised to carry out conformity assessments in accordance with this Regulation.

Or. en

Amendment 1059

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

Proposal for a regulation

Article 27 c (new)

Text proposed by the Commission

Amendment

Article 27 c

Notifying authorities

1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 27j.

2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008.

3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body, which is not a governmental entity that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 27d. In addition, that body shall have arrangements to cover liabilities arising out of its activities.

4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.

Or. en

Amendment 1060

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

Proposal for a regulation

Article 27 d (new)

Text proposed by the Commission

Amendment

Article 27 d

Requirements relating to notifying authorities

1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs.

2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities.

3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment of the EHR system.

4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis.

5. A notifying authority shall safeguard the confidentiality of the information it obtains.

6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.

Or. en

Amendment 1061

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

Proposal for a regulation

Article 27 e (new)

Text proposed by the Commission

Amendment

Article 27 e

Information obligation on notifying authorities

Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available.

Or. en

Amendment 1062

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

Proposal for a regulation

Article 27 f (new)

Text proposed by the Commission

Amendment

Article 27 f

Requirements relating to notified bodies

1. For the purposes of notification, a conformity assessment body shall meet the requirements laid down in paragraphs 2 to 11.

2. A conformity assessment body shall be established under the national law of a Member State and have legal personality.

3. A conformity assessment body shall be a third-party body independent of the organisation or the EHR system it assesses.

4. A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be the designer, manufacturer, supplier, installer, purchaser, owner, user or maintainer of an EHR system, that they assess, nor the representative of any of those parties.A conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment tasks shall not be directly involved in the design, manufacture, marketing, installation, use or maintenance of EHR systems, or represent the parties engaged in those activities. They shall not engage in any activity that may conflict with their independence of judgement or integrity in relation to conformity assessment activities for which they are notified. This shall in particular apply to consultancy services.A conformity assessment body shall ensure that the activities of its subsidiaries or subcontractors do not affect the confidentiality, objectivity or impartiality of its conformity assessment activities.

5. A conformity assessment body and its personnel shall carry out the conformity assessment activities with the highest degree of professional integrity and the requisite technical competence in the specific field and shall be free from all pressures and inducements, particularly financial, which might influence its judgement or the results of its conformity assessment activities, especially as regards persons or groups of persons with an interest in the results of those activities.

6. A conformity assessment body shall be capable of carrying out all the conformity assessment activities mentioned in Annexes IVa in relation to which it has been notified, whether those tasks are carried out by the conformity assessment body itself or on its behalf and under its responsibility.At all times, and for each conformity assessment procedure and each kind of a EHR system for which it has been notified, a conformity assessment body shall have at its disposal the necessary:

(a) personnel with technical knowledge and sufficient and appropriate experience to perform the conformity assessment activities;

(b) descriptions of procedures in accordance with which conformity assessment is carried out, ensuring the transparency and the ability of reproduction of those procedures;

(c) appropriate policies and procedures to distinguish between activities that it carries out as a notified body and other activities;

(d) procedures for the performance of conformity assessment activities which take due account of the size of an undertaking, the sector in which it operates, its structure and the degree of complexity of the technology in question.

7. The personnel responsible for carrying out conformity assessment tasks shall have the following:

(a) sound technical and vocational training covering all the conformity assessment activities in relation to which the conformity assessment body has been notified;

(b) satisfactory knowledge of the requirements of the assessments they carry out and adequate authority to carry out those assessments;

(c) the ability to draw up certificates, records and reports demonstrating that conformity assessments have been carried out.

8. The impartiality of a conformity assessment body, its top-level management and the personnel responsible for carrying out the conformity assessment activities shall be guaranteed.

The remuneration of the top-level management and the personnel responsible for carrying out the conformity assessment activities shall not depend on the number of conformity assessments carried out or on the results of those assessments.

9. A conformity assessment body shall take out liability insurance unless liability is assumed by the Member State in accordance with national law, or the Member State itself is directly responsible for the conformity assessment.

10. The personnel of a conformity assessment body shall observe professional secrecy with regard to all information obtained in carrying out the conformity assessment activities in accordance with Annexes IVa, except in relation to the competent authorities of the Member State in which its activities are carried out. Proprietary rights, intellectual property rights and trade secrets shall be protected.

11. A conformity assessment body shall participate in, or ensure that its personnel responsible for carrying out the conformity assessment activities are informed of, the relevant standardisation activities and the activities of the notified body coordination group established under Article 27r and shall apply as general guidance the administrative decisions and documents produced as a result of the work of that group.

Or. en

Amendment 1063

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

Proposal for a regulation

Article 27 g (new)

Text proposed by the Commission

Amendment

Article 27 g

Presumption of conformity of notified bodies

Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 27f in so far as the applicable harmonised standards cover those requirements.

Or. en

Amendment 1064

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

Proposal for a regulation

Article 27 h (new)

Text proposed by the Commission

Amendment

Article 27 h

Subsidiaries of and subcontracting by notified bodies

1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 27f and shall inform the notifying authority accordingly.

2. A notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever those are established.

3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client.

4. A notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IVa.

Or. en

Amendment 1065

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

Proposal for a regulation

Article 27 i (new)

Text proposed by the Commission

Amendment

Article 27 i

Notification procedure

1. A notifying authority shall notify only conformity assessment bodies which have satisfied the requirements laid down in Article 27f.

2. The notifying authority shall send a notification to the Commission and the other Member States of each conformity assessment body referred to in paragraph 1, using the electronic notification tool developed and managed by the Commission.

3. The notification referred to in paragraph 2 shall include the following:

(a) full details of the conformity assessment activities to be performed;

(b) the relevant attestation of competence.

4. Where a notification is not based on an accreditation certificate referred to in Article 27i(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 27f.

5. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of the validation of the notification where it includes an accreditation certificate referred to in Article 27i(2), or within two months of the notification where it includes documentary evidence referred to in Article 27i(3).

Only such a body shall be considered a notified body for the purposes of this Regulation.

6. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification referred to in paragraph 2.

Or. en

Amendment 1066

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

Proposal for a regulation

Article 27 i (new)

Text proposed by the Commission

Amendment

Article 27 i

Application for notification

1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established.

2. The application for notification shall be accompanied by a description of the conformity assessment activities, of the conformity assessment procedures set out in Annex IVa as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 27f.

3. Where the conformity assessment body concerned cannot provide an accreditation certificate as referred to in paragraph 2, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 27f.

Or. en

Amendment 1067

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

Proposal for a regulation

Article 27 k (new)

Text proposed by the Commission

Amendment

Article 27 k

Identification numbers and lists of notified bodies

1. The Commission shall assign an identification number to a notified body. It shall assign a single such number even where the body is notified under several Union acts.

2. The Commission shall make publicly available the list of notified bodies including the identification numbers that have been assigned to them and the conformity assessment activities for which they have been notified. The Commission shall ensure that the list is kept up to date.

Or. en

Amendment 1068

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

Proposal for a regulation

Article 27 l (new)

Text proposed by the Commission

Amendment

Article 27 l

Changes to notifications

1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 27f, or that it is failing to fulfil its obligations as set out in Article 27m the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly.

2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.

Or. en

Amendment 1069

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

Proposal for a regulation

Article 27 m (new)

Text proposed by the Commission

Amendment

Article 27 m

Challenge of the competence of notified bodies

1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject.

2. The notifying authority shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned.

3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially.

4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying authority to take the necessary corrective measures, including the withdrawal of the notification if necessary.

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

Or. en

Amendment 1070

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

Proposal for a regulation

Article 27 n (new)

Text proposed by the Commission

Amendment

Article 27 n

Operational obligations of notified bodies

1. A notified body shall carry out conformity assessments in accordance with the conformity assessment procedures set out in Annex IVa.

2. A notified body shall perform its activities in a proportionate manner, avoiding unnecessary burdens for economic operators, and taking due account of the size of an undertaking, the structure of the undertaking, the degree of complexity of the EHR system in question. In so doing, the notified body shall nevertheless respect the degree of rigour and the level of protection required for the compliance of the EHR system with the requirements of this Regulation.

3. Where, in the course of the monitoring of conformity following the issuance of a certificate of conformity or the adoption of an approval decision, a notified body finds that a EHR system no longer complies, it shall require the manufacturer to take appropriate corrective measures and shall suspend or withdraw the certificate of conformity or the approval decision, if necessary.

4. Where corrective measures are not taken or do not have the required effect, the notified body shall restrict, suspend or withdraw any certificates of conformity or approval decisions, as appropriate.

Or. en

Amendment 1071

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

Proposal for a regulation

Article 27 o (new)

Text proposed by the Commission

Amendment

Article 27 o

Appeals against decisions of notified bodies

A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.

Or. en

Amendment 1072

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

Proposal for a regulation

Article 27 p (new)

Text proposed by the Commission

Amendment

Article 27 p

Information obligation on notified bodies

1. A notified body shall inform the notifying authority of the following:

(a) any refusal, restriction, suspension or withdrawal of a certificate of conformity or approval decision;

(b) any circumstances affecting the scope of, or the conditions for, its notification;

(c) any request for information which it has received from market surveillance authorities regarding its conformity assessment activities;

(d) on request, any conformity assessment activities performed within the scope of its notification and any other activity performed, including cross-border activities and subcontracting.

2. A notified body shall provide other notified bodies carrying out similar conformity assessment activities covering the same kinds of machinery product with relevant information on issues relating to negative and, on request, positive conformity assessment results.

Or. en

Amendment 1073

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

Proposal for a regulation

Article 27 q (new)

Text proposed by the Commission

Amendment

Article 27 q

Coordination of notified bodies

The Commission shall ensure that appropriate coordination and cooperation between notified bodies are put in place and properly operated in the form of a sectoral group of notified bodies. A notified body shall participate in the work of that group, directly or by means of designated representatives.

Or. en

Amendment 1074

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

Proposal for a regulation

Article 27 q (new)

Text proposed by the Commission

Amendment

Article 27 q

Exchange of experience

The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.

Or. en

Amendment 1075

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

Proposal for a regulation

Chapter III – Section 3 a (new)

Text proposed by the Commission

Amendment

3 a Section 3a

Conformity assessment

Or. en

Amendment 1076

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 28 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall designate the market surveillance authority or authorities responsible for the implementation of this Chapter. They shall entrust their market surveillance authorities with the powers, resources, equipment and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. Member States shall communicate the identity of the market surveillance authorities to the Commission which shall publish a list of those authorities.

2. Member States shall designate the market surveillance authority or authorities responsible for the implementation of this Chapter. They shall entrust their market surveillance authorities with the necessary powers, financial resources, equipment, technical expertise, adequate staffing, and knowledge necessary for the proper performance of their tasks pursuant to this Regulation. Member States shall communicate the identity of the market surveillance authorities to the Commission which shall publish a list of those authorities.

Or. en

Amendment 1077

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 28 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Staff of market surveillance authorities shall have no direct or indirect economic, financial or personal conflicts of interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct.

Or. en

Amendment 1078

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 28 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. Pursuant to paragraph 2 of this article, Member States shall determine and publish the selection procedure for market surveillance authorities. They shall ensure that the procedure is transparent and does not allow for conflicts of interest.

Or. en

Amendment 1079

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

Proposal for a regulation

Article 28 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Market surveillance authorities shall immediately inform Notified Bodies about manufacturers of EHR systems that no longer comply with the requirements on the declaration of conformity.

Or. en

Amendment 1080

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

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a market surveillance authority finds that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to take all appropriate measures to ensure that the EHR system concerned no longer presents that risk when placed on the market to withdraw the EHR system from the market or to recall it within a reasonable period.

1. Where a market surveillance authority of one Member State have sufficient reason to believe that an EHR system presents a risk to the health, safety or rights of natural persons or to other aspects of public interest protection, they shall carry out an evaluation in relation to the EHR system concerned covering all relevant requirements laid down in this Regulation. Its authorised representatives and all other relevant economic operators shall cooperate as necessary with the market surveillance authorities for that purpose and take all appropriate measures to ensure that the EHR system concerned no longer presents that risk when placed on the market to withdraw the EHR system from the market or to recall it within a reasonable period.

Where, in the course of the evaluation referred to in the first subparagraph, the market surveillance authorities find that the EHR system does not comply with the requirements laid down in this Regulation, they shall without delay require the relevant economic operator to take all appropriate corrective action to bring the EHR system into compliance with those requirements, to withdraw the machinery product from the market, or to recall it within a reasonable period which is commensurate with the nature of the risk referred to in the first subparagraph.

The market surveillance authorities shall inform the relevant notified body accordingly.

Or. en

Amendment 1081

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 29 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a market surveillance authority, or, in cases involving personal data, a supervisory authority under Regulation (EU) 2016/679, finds that an EHR system presents a risk to the health or safety of natural persons, to the protection of personal data or to other aspects of public interest protection, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to take all appropriate measures to ensure that the EHR system concerned no longer presents that risk when placed on the market to withdraw the EHR system from the market or to recall it within a reasonable period.

Or. en

Amendment 1082

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 29 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Where a market surveillance authority, on the basis of the information and documentation demonstrating the conformity of an EHR system provided by the relevant economic operator, considers or has reason to believe that the EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, including before the EHR system is placed on the market or put into service, it shall perform all the necessary checks to ensure that the system is compliant with this Regulation.

Or. en

Amendment 1083

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

Proposal for a regulation

Article 29 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

Or. en

Amendment 1084

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 29 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. Where a market surveillance authority considers or has reason to believe that an EHR system has caused damage to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately provide information and documentation, as applicable, to the affected person or user and, as appropriate, other third parties affected by the damage caused to the person or user, without prejudice to data protection rules.

Or. en

Amendment 1085

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 29 – paragraph 3

Text proposed by the Commission

Amendment

3. The market surveillance authority shall immediately inform the Commission and the market surveillance authorities of other Member States of the measures ordered pursuant to paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the EHR system concerned, the origin and the supply chain of the EHR system, the nature of the risk involved and the nature and duration of the national measures taken.

3. The market surveillance authority, or, where applicable, the supervisory authority under Regulation (EU) 2016/679, shall immediately inform the Commission and the market surveillance authorities, or, if applicable, the supervisory authorities under Regulation (EU) 2016/679, of other Member States of the measures ordered pursuant to paragraph 1. That information shall include all available details, in particular the data necessary for the identification of the EHR system concerned, the origin and the supply chain of the EHR system, the nature of the risk involved and the nature and duration of the national measures taken.

Or. en

Amendment 1086

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 29 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Where a finding of a market surveillance authortiy, or a serious incident it is informed of, concerns personal data protection, the market surveillance authority shall, without undue delay, inform and cooperate with the relevant supervisory authorities under Regulation (EU) 2016/679.

Or. en

Amendment 1087

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 29 – paragraph 4 – subparagraph 1

Text proposed by the Commission

Amendment

Manufacturers of EHR systems placed on the market shall report any serious incident involving an EHR system to the market surveillance authorities of the Member States where such serious incident occurred and the corrective actions taken or envisaged by the manufacturer.

Manufacturers of EHR systems placed on the market shall report any serious incident involving an EHR system to the market surveillance authorities, or, in cases involving personal data, the supervisory authorities under Regulation (EU) 2016/679 of the Member States where such serious incident occurred and the corrective actions taken or envisaged by the manufacturer.

Or. en

Amendment 1088

Traian Băsescu

Proposal for a regulation

Article 29 – paragraph 4 – subparagraph 2

Text proposed by the Commission

Amendment

Such notification shall be made, without prejudice to incident notification requirements under Directive (EU) 2016/1148, immediately after the manufacturer has established a causal link between the EHR system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 15 days after the manufacturer becomes aware of the serious incident involving the EHR system.

Such notification shall be made, without prejudice to incident notification requirements under Directive (EU) 2016/1148, immediately after the manufacturer has established a causal link between the EHR system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 7 days after the manufacturer becomes aware of the serious incident involving the EHR system.

Or. ro

Amendment 1089

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 29 – paragraph 5

Text proposed by the Commission

Amendment

5. The market surveillance authorities referred to in paragraph 4 shall inform the other market surveillance authorities, without delay, of the serious incident and the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident.

5. The authorities referred to in paragraph 4 shall inform the other authorities, without delay, of the serious incident and the corrective action taken or envisaged by the manufacturer or required of it to minimise the risk of recurrence of the serious incident.

Or. en

Amendment 1090

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 30 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Where a market surveillance authority makes one of the following findings, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to put an end to the non-compliance concerned:

1. Where a market surveillance authority makes one, inter alia, of the following findings, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to bring the EHR system into conformity:

Or. en

Amendment 1091

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 30 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the EHR system is not in conformity with essential requirements laid down in Annex II;

(a) the EHR system is not in conformity with essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;

Or. en

Amendment 1092

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 30 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) the technical documentation is either not available or not complete;

(b) the technical documentation is either not available or not complete or not in accordance with Article 24;

Or. en

Amendment 1093

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 30 – paragraph 1 – point b a (new)

Text proposed by the Commission

Amendment

(b a) the EHR systems is not accompanied by the information sheet provided for in Article 25, free of charge by the user, and by clear and complete instructions for use in accessible formats for persons with disabilities;

Or. en

Amendment 1094

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 30 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) the EU declaration of conformity has not been drawn up or has not been drawn up correctly as referred to in Article 26;

Or. en

Amendment 1095

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 30 – paragraph 1 – point d a (new)

Text proposed by the Commission

Amendment

(d a) the registration obligations of Article 32 has not been fulfilled.

Or. en

Amendment 1096

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

Proposal for a regulation

Article 30 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Where the relevant economic operator does not take adequate corrective action within the period referred to in Article 29, paragraph 1, second subparagraph, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the EHR system being made available on their national market, to withdraw the machinery product from that market or to recall it.

The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.

Or. en

Amendment 1097

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

Proposal for a regulation

Article 30 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1 b. The information referred to in paragraph 1.a, second subparagraph, shall include all available details, in particular the data necessary for the identification of the noncompliant EHR system, the origin of that EHR system, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.In particular, the market surveillance authorities shall indicate whether the noncompliance is due to any of the following:

(a) failure of the EHR system to meet the requirements relating to the essential requirements set out in Annex II;

(b) shortcomings in the harmonised standards referred to in Article 25a(1);

Or. en

Amendment 1098

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

Proposal for a regulation

Article 30 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

1 c. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the EHR system concerned, and, in the event of disagreement with the adopted national measure, of their objections.

Or. en

Amendment 1099

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

Proposal for a regulation

Article 30 – paragraph 1 d (new)

Text proposed by the Commission

Amendment

1 d. Where, within three months of receipt of the information referred to in paragraph 1a, second subparagraph, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.

Or. en

Amendment 1100

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

Proposal for a regulation

Article 30 a (new)

Text proposed by the Commission

Amendment

Article 30 a

Union safeguard procedure

1. Where, on completion of the procedure set out in Article 29(2) and Article 30(1a), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not. The Commission shall address its decision to all Member States and shall without delay communicate it to them and to the relevant economic operator or operators. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 68(2a).

2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant EHR system is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure. Where the national measure is considered justified and the non-compliance of the EHR system is attributed to shortcomings in the harmonised standards or technical specifications referred to in Article 30(1b), points (b) and (c), of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.

Or. en

Amendment 1101

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

Proposal for a regulation

Article -31 (new)

Text proposed by the Commission

Amendment

Article -31

Interoperability of wellness applications with EHR systems

1. Manufacturers of wellness applications may claim interoperability with an EHR system, after relevant conditions are met. When this is the case, the users of such wellness applications shall be duly informed about such interoperability and its effects.

2. The interoperability of wellness applications with EHR systems shall not mean automatic sharing or transmission of all or part of the health data from the wellness application with the EHR system. The sharing or transmission of such data shall only be possible pursuant to and in line with Article 3(6) of this Regulation and interoperability shall be limited exclusively to this end. The manufacturers of wellness applications claiming interoperability with an EHR system shall ensure that the user is able to choose which part of health data from the wellness application they want to insert in the EHR system.

3. Wellness applications shall not be able to access the information in EHRs nor extract any information from it.

Or. en

Amendment 1102

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 31

Text proposed by the Commission

Amendment

Article 31

deleted

Voluntary labelling of wellness applications

1. Where a manufacturer of a wellness application claims interoperability with an EHR system and therefore compliance with the essential requirements laid down in Annex II and common specifications in Article 23, such wellness application may be accompanied by a label, clearly indicating its compliance with those requirements. The label shall be issued by the manufacturer of the wellness application.

2. The label shall indicate the following information:

(a) categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;

(b) reference to common specifications to demonstrate compliance;

3. The Commission may, by means of implementing acts, determine the format and content of the label. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

4. The label shall be drawn-up in one or more official languages of the Union or languages determined by the Member State(s) in which the in which the wellness application is placed on the market.

5. The validity of the label shall not exceed 5 years.

6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device. 2D barcodes may also be used to display the label.

7. The market surveillance authorities shall check the compliance of wellness applications with the essential requirements laid down in Annex II.

8. Each supplier of a wellness application, for which a label has been issued, shall ensure that the wellness application that is placed on the market or put into service is accompanied with the label for each individual unit, free of charge.

9. Each distributor of a wellness application for which a label has been issued shall make the label available to customers at the point of sale in electronic form or, upon request, in physical form.

10. The requirements of this Article shall not apply to wellness applications which are high-risk AI systems as defined under Regulation […] [AI Act COM/2021/206 final].

Or. en

Justification

Wellness applications should be outside of the scope of EHDS

Amendment 1103

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 31

Text proposed by the Commission

Amendment

Article 31

deleted

Voluntary labelling of wellness applications

2. The label shall indicate the following information:

(a) categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;

(b) reference to common specifications to demonstrate compliance;

4. The label shall be drawn-up in one or more official languages of the Union or languages determined by the Member State(s) in which the in which the wellness application is placed on the market.

5. The validity of the label shall not exceed 5 years.

6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device. 2D barcodes may also be used to display the label.

7. The market surveillance authorities shall check the compliance of wellness applications with the essential requirements laid down in Annex II.

9. Each distributor of a wellness application for which a label has been issued shall make the label available to customers at the point of sale in electronic form or, upon request, in physical form.

10. The requirements of this Article shall not apply to wellness applications which are high-risk AI systems as defined under Regulation […] [AI Act COM/2021/206 final].

Or. en

Justification

A Digital Single Market (DSM) in the area of health requires a system that enables records to be securely accessed by individuals and securely shared). This cannot be achieved by integrating data from “wellness apps” (from fitness trackers to menstruation or pregnancy apps), and which are not clinical or trustworthy, into the official health records of an individual. The types of data of wellness apps potentially inputted, their non-clinical nature and their “limited relevance for healthcare purposes” , risks creating barriers to their exchange, thereby creating barriers to DSM.

Amendment 1104

Rob Rooken

Proposal for a regulation

Article 31

Text proposed by the Commission

Amendment

Article 31

deleted

Voluntary labelling of wellness applications

2. The label shall indicate the following information:

(a) categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;

(b) reference to common specifications to demonstrate compliance;

4. The label shall be drawn-up in one or more official languages of the Union or languages determined by the Member State(s) in which the in which the wellness application is placed on the market.

5. The validity of the label shall not exceed 5 years.

6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device. 2D barcodes may also be used to display the label.

7. The market surveillance authorities shall check the compliance of wellness applications with the essential requirements laid down in Annex II.

9. Each distributor of a wellness application for which a label has been issued shall make the label available to customers at the point of sale in electronic form or, upon request, in physical form.

10. The requirements of this Article shall not apply to wellness applications which are high-risk AI systems as defined under Regulation […] [AI Act COM/2021/206 final].

Or. en

Justification

Wellness applications are prone to issues of data security and data privacy breaches. Linking data generated via wellness applications to electronic health reports or generally health data is not justified and should thus be rejected in this regulation.

Amendment 1105

Konstantinos Arvanitis

Proposal for a regulation

Article 31

Text proposed by the Commission

Amendment

Article 31

deleted

Voluntary labelling of wellness applications

2. The label shall indicate the following information:

(a) categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;

(b) reference to common specifications to demonstrate compliance;

4. The label shall be drawn-up in one or more official languages of the Union or languages determined by the Member State(s) in which the in which the wellness application is placed on the market.

5. The validity of the label shall not exceed 5 years.

6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device. 2D barcodes may also be used to display the label.

7. The market surveillance authorities shall check the compliance of wellness applications with the essential requirements laid down in Annex II.

9. Each distributor of a wellness application for which a label has been issued shall make the label available to customers at the point of sale in electronic form or, upon request, in physical form.

10. The requirements of this Article shall not apply to wellness applications which are high-risk AI systems as defined under Regulation […] [AI Act COM/2021/206 final].

Or. en

Amendment 1106

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

Proposal for a regulation

Article 31 – paragraph 1

Text proposed by the Commission

Amendment

1. Where a manufacturer of a wellness application claims interoperability with an EHR system and therefore compliance with the essential requirements laid down in Annex II and common specifications in Article 23, such wellness application shall be accompanied by a label, clearly indicating its compliance with those requirements. The label shall be issued by the manufacturer of the wellness application and the health data access body shall be informed.

Or. en

Amendment 1107

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

Proposal for a regulation

Article 31 – paragraph 3

Text proposed by the Commission

Amendment

3. The Commission shall, by means of implementing acts, determine the format and content of the label. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).

Or. en

Amendment 1108

Maria Grapini

Proposal for a regulation

Article 31 – paragraph 4

Text proposed by the Commission

Amendment

4. The label shall be drawn-up in one or more official languages of the Union or languages determined by the Member State(s) in which the in which the wellness application is placed on the market.

4. The label shall be drawn-up in one or more official languages of the Union, and obligatorily in the language of the Member State(s) in which the wellness application is placed on the market.

Or. ro

Amendment 1109

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 31 – paragraph 4

Text proposed by the Commission

Amendment

4. The label shall be drawn-up in one or more official languages of the Union or languages determined by the Member State(s) in which the in which the wellness application is placed on the market.

4. The label shall be drawn-up in one or more languages of the Union or languages determined by the Member State(s) in which the in which the wellness application is placed on the market.

Or. en

Amendment 1110

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

Proposal for a regulation

Article 31 – paragraph 6

Text proposed by the Commission

Amendment

6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device. 2D barcodes may also be used to display the label.

6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device and in the case of software a digital label. 2D barcodes may also be used to display the label.

Or. en

Amendment 1111

Rob Rooken

Proposal for a regulation

Article 32 – title

Text proposed by the Commission

Amendment

Registration of EHR systems and wellness applications

Registration of EHR systems

Or. en

Amendment 1112

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 32 – title

Text proposed by the Commission

Amendment

Registration of EHR systems and wellness applications

Registration of EHR systems

Or. en

Amendment 1113

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 32 – title

Text proposed by the Commission

Amendment

Registration of EHR systems and wellness applications

Registration of EHR systems

Or. en

Amendment 1114

Konstantinos Arvanitis

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26 and wellness applications for which a label has been issued pursuant to Article 31.

1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26.

Or. en

Amendment 1115

Rob Rooken

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26;

Or. en

Amendment 1116

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26.

Or. en

Amendment 1117

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 32 – paragraph 1

Text proposed by the Commission

Amendment

1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Articles 26 and 26a.

Or. en

Amendment 1118

Konstantinos Arvanitis

Proposal for a regulation

Article 32 – paragraph 2

Text proposed by the Commission

Amendment

2. Before placing on the market or putting into service an EHR system referred to in Article 14 or a wellness application referred to in Article 31, the manufacturer of such EHR system or wellness application or, where applicable, its authorised representative shall register the required data into the EU database referred to in paragraph 1.

2. Before placing on the market or putting into service an EHR system referred to in Article 14, the manufacturer of such EHR system or, where applicable, its authorised representative shall register the required data into the EU database referred to in paragraph 1.

Or. en

Amendment 1119

Rob Rooken

Proposal for a regulation

Article 32 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1120

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 32 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1121

Konstantinos Arvanitis

Proposal for a regulation

Article 32 – paragraph 3

Text proposed by the Commission

Amendment

3. Medical devices or high-risk AI systems referred to in paragraphs 3 and 4 of Article 14 of this Regulation shall be registered in the database established pursuant to Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], as applicable.

3. Medical devices or high-risk AI systems referred to in paragraphs 3 and 4 of Article 14 of this Regulation shall also be registered in the database established pursuant to Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], as applicable.

Or. en

Amendment 1122

Rob Rooken

Proposal for a regulation

Article 32 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to determine the list of required data to be registered by the manufacturers of EHR systems and wellness applications pursuant to paragraph 2.

4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to determine the list of required data to be registered by the manufacturers of EHR systems pursuant to paragraph 2.

Or. en

Amendment 1123

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 32 – paragraph 4

Text proposed by the Commission

Amendment

Or. en

Amendment 1124

Konstantinos Arvanitis

Proposal for a regulation

Article 32 – paragraph 4

Text proposed by the Commission

Amendment

Or. en