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

Official HTML ↗ PDF DOCX

AM_Com_LegReport

Amendment 159

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

Draft legislative resolution

Citation 2

Draft legislative resolution

Amendment

— having regard to Article 294(2) and Articles 16 and 114 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0167/2022),

— having regard to Article 294(2) and Articles 16, 114 and 168 of the Treaty on the Functioning of the European Union, pursuant to which the Commission submitted the proposal to Parliament (C9-0167/2022),

Or. en

Amendment 160

Sirpa Pietikäinen

Draft legislative resolution

Citation 4 a (new)

Draft legislative resolution

Amendment

— Having regard to the WHO One Health Initiative,

Or. en

Amendment 161

Elisabetta De Blasis, Silvia Sardone

Draft legislative resolution

Citation 8 a (new)

Draft legislative resolution

Amendment

— Having regard to the Commission's communication of 3 February 2021 on Europe's Beating Cancer Plan (COM(2021)0044),

Or. en

Amendment 162

Kateřina Konečná

Draft legislative resolution

Citation 8 a (new)

Draft legislative resolution

Amendment

— Having regard to the Commission's communication of 3 February 2021 on Europe’s Beating Cancer Plan (COM(2021)0044),

Or. en

Amendment 163

Elisabetta De Blasis, Silvia Sardone

Draft legislative resolution

Citation 8 b (new)

Draft legislative resolution

Amendment

— Having regard to the EU's Framework Programme for Research and Innovation 2021-2027 (Horizon Europe) and the dedicated Horizon Europe Mission on Cancer,

Or. en

Amendment 164

Kateřina Konečná

Draft legislative resolution

Citation 8 b (new)

Draft legislative resolution

Amendment

— Having regard to the EU’s Framework Programme for Research and Innovation 2021-2027 (Horizon Europe) and the dedicated Horizon Europe Mission on Cancer,

Or. en

Amendment 165

Kateřina Konečná

Draft legislative resolution

Citation 8 c (new)

Draft legislative resolution

Amendment

— Having regard to the European Parliament resolution of 16 February 2022 on strengthening Europe in the fight against cancer – towards a comprehensive and coordinated strategy (2020/2267(INI)), and the work of the Special Committee on Beating Cancer (BECA) in its mandate,

Or. en

Amendment 166

Elisabetta De Blasis, Silvia Sardone

Draft legislative resolution

Citation 8 c (new)

Draft legislative resolution

Amendment

— Having regard to its resolution of 16 February 2022 on strenghtening Europe in the fight against cancer - towards a comprehensive and coordinated strategy (2020/2267(INI)), and the work of the Special Committee on Beating Cancer (BECA) in its mandate,

Or. en

Amendment 167

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16 and 114 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16, 114 and 168 thereof,

Or. en

Amendment 168

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

Proposal for a regulation

Citation 1

Text proposed by the Commission

Amendment

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16 and 114 thereof,

Having regard to the Treaty on the Functioning of the European Union, and in particular Articles 16, 114 and 168 thereof,

Or. en

Amendment 169

Mathilde Androuët

Proposal for a regulation

Citation 2

Text proposed by the Commission

Amendment

Having regard to the proposal from the European Commission,

Having regard to the proposal from the European Commission, reject the proposal for a regulation on the European Health Data Space.

Or. fr

Justification

This text raises concerns about individual and collective freedoms, particularly as regards data management, protection and use. Furthermore, the centralisation of health data and the fact that access could be given to non-governmental entities or private companies is also a worry. It is therefore vital to ensure that health data is responsibly and transparently managed and that the applicable rules are clear and harmonised across the EU.

Amendment 170

Mathilde Androuët

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for other purposes that would benefit the society such as research, innovation, policy-making, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data). In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union values.

Or. fr

Amendment 171

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

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to grant access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for the improvement for other purposes that would benefit the society such as research, innovation, policy-making, health threats preparedness and control, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data). In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal and technical framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union values.

Or. en

Amendment 172

Sirpa Pietikäinen

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for other purposes that would benefit the society such as research, innovation, policy-making, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data), and in line with the objectives of the WHO One Health Initiative. In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union values.

Or. en

Amendment 173

Tudor Ciuhodaru

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

Or. ro

Amendment 174

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Recital 1

Text proposed by the Commission

Amendment

(1) The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for other purposes in the health sector that would benefit the society such as research, innovation, policy-making, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data). In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union values.

Or. de

Amendment 175

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

(1 a) In line with the One Health and Health in All Policies principles, legally defined in Article 3 of the Regulation (EU) No 2022/2371 of the European Parliament and of the Council of 23 November 2022 on serious cross-border threats to health and repealing Decision No 1082/2013/EU, the protection of human health is a matter which has a cross-cutting dimension and is relevant to numerous Union policies and activities. Following these two principles, the Union has created, develops and monitors its EHDS.

Or. en

Amendment 176

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

Proposal for a regulation

Recital 1 a (new)

Text proposed by the Commission

Amendment

(1 a) The EHDS constitutes a key component for the creation of a strong and resilient European Health Union to better protect the health of European citizens, prevent and address future pandemics and improve resilience of Europe’s health systems.

Or. en

Amendment 177

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

Proposal for a regulation

Recital 1 b (new)

Text proposed by the Commission

Amendment

(1 b) This Regulation should work horizontally with other European programs such as the Digital Europe Programme, Connecting Europe Facility and Horizon Europe. The European Commission should ensure that other European programs complement and facilitate the implementation of the European Health Data Space.

Or. en

Amendment 178

Mathilde Androuët

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) The COVID-19 pandemic has highlighted the imperative of having timely access to electronic health data for health threats preparedness and response, as well as for diagnosis and treatment and secondary use of health data. Such timely access would have contributed, through efficient public health surveillance and monitoring, to a more effective management of the pandemic, and ultimately would have helped to save lives. In 2020, the Commission urgently adapted its Clinical Patient Management System, established by Commission Implementing Decision (EU) 2019/126941, to allow Member States to share electronic health data of COVID-19 patients moving between healthcare providers and Member States during the peak of the pandemic, but this was only an emergency solution, showing the need for a structural approach at Member States and Union level.

deleted

_________________

41 Commission Implementing Decision (EU) 2019/1269 of 26 July 2019 amending Implementing Decision 2014/287/EU setting out criteria for establishing and evaluating European Reference Networks and their Members and for facilitating the exchange of information and expertise on establishing and evaluating such Networks (OJ L 200, 29.7.2019, p. 35).

Or. fr

Justification

The difficulties the EU faced in making use of primary health data during the devastating COVID-19 pandemic cannot be used as a pretext to justify the EU’s failure to effectively protect people’s health during the pandemic and to accelerate the sharing of sensitive data that remain personal property.

Amendment 179

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

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) The COVID-19 pandemic has highlighted the imperative of having timely access to quality electronic health data for health threats preparedness and response, as well as for prevention, diagnosis and treatment and secondary use of health data. Such timely access would have contributed, through efficient public health surveillance and monitoring, to a more effective management of the pandemic, to reduced costs and an improved response to health threats and ultimately would have helped to save more lives. In 2020, the Commission urgently adapted its Clinical Patient Management System, established by Commission Implementing Decision (EU) 2019/126941, to allow Member States to share electronic health data of COVID-19 patients moving between healthcare providers and Member States during the peak of the pandemic, but this was only an emergency solution, showing the need for a structural and systemicapproach at Member States and Union level.

_________________

Or. en

Amendment 180

Tudor Ciuhodaru

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

_________________

Or. ro

Amendment 181

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

Proposal for a regulation

Recital 2

Text proposed by the Commission

Amendment

(2) The COVID-19 pandemic has highlighted the imperative of having timely access to quality electronic health data for health threats preparedness and response, as well as for prevention, diagnosis and treatment and secondary use of health data. Such timely access would have contributed, through efficient public health surveillance and monitoring, to a more effective management of the pandemic, and ultimately would have helped to save lives. In 2020, the Commission urgently adapted its Clinical Patient Management System, established by Commission Implementing Decision (EU) 2019/126941, to allow Member States to share electronic health data of COVID-19 patients moving between healthcare providers and Member States during the peak of the pandemic, but this was only an emergency solution, showing the need for a structural approach at Member States and Union level.

_________________

Or. en

Amendment 182

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Recital 2 a (new)

Text proposed by the Commission

Amendment

(2 a) It is important to bear in mind that health data is not a natural resource that is available for exploitation, but a very sensitive resource which can put individuals, families and companies at risk. Among other relevant legal provisions, this Regulations sets out that electronic health data should be stored in the territory of the Union. It also seeks to ensure the right of every patient to have their data stored with the doctor or therapist of their choice, not remotely, but accessible, and ensure that it is not at risk of hacking. Finally, patients should be asked to give their consent to share their data. Therefore, patients should be asked to be totally in charge of their data and if they want to share it.

Or. en

Amendment 183

Mathilde Androuët

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) The COVID-19 crisis strongly anchored the work of the eHealth Network, a voluntary network of digital health authorities, as the main pillar for the development of mobile contact tracing and warning applications and the technical aspects of the EU Digital COVID Certificates. It also highlighted the need for sharing electronic health data that are findable, accessible, interoperable and reusable (‘FAIR principles’), and ensuring that electronic health data are as open as possible and as closed as necessary. Synergies between the EHDS, the European Open Science Cloud42and the European Research Infrastructures should be ensured, as well as lessons learned from data sharing solutions developed under the European COVID-19 Data Platform.

deleted

_________________

42 EOSC Portal (eosc-portal.eu).

Or. fr

Amendment 184

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

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) The COVID-19 crisis strongly anchored the work of the eHealth Network, a voluntary network of digital health authorities, as the main pillar for the development of mobile contact tracing and warning applications and the technical aspects of the EU Digital COVID Certificates. It also highlighted the value of access to real time data to steer effective policy responses and the need for sharing electronic health data that are findable, accessible, interoperable and reusable (‘FAIR principles’), and ensuring that electronic health data are as open as possible and as closed as necessary. Synergies between the EHDS, the European Open Science Cloud42and the European Research Infrastructures should be ensured, as well as lessons learned from data sharing solutions developed under the European COVID-19 Data Platform.

_________________

42 EOSC Portal (eosc-portal.eu).

Or. en

Amendment 185

Tudor Ciuhodaru

Proposal for a regulation

Recital 3

Text proposed by the Commission

Amendment

(3) The COVID-19 crisis strongly anchored the work of the eHealth Network, a voluntary network of digital health authorities, as the main pillar for the development of mobile contact tracing and warning applications and the technical aspects of the EU Digital COVID Certificates. It also highlighted the need for sharing electronic health data that are findable, accessible, interoperable and reusable (‘FAIR principles’), and ensuring that electronic health data are as open as possible and as closed as necessary so as to protect patients' personal data and information. Synergies between the EHDS, the European Open Science Cloud42and the European Research Infrastructures should be ensured, as well as lessons learned from data sharing solutions developed under the European COVID-19 Data Platform.

_________________

42 EOSC Portal (eosc-portal.eu).

Or. ro

Amendment 186

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 3 a (new)

Text proposed by the Commission

Amendment

(3 a) Given the extreme sensitivity of information regarding person’s physical and mental health, this Regulation seeks to provide sufficient safeguards on both EU and national level to ensure a high degree of data privacy, security, confidentiality and ethical use. Such safeguards are necessary to promote trust in safe handling of natural person’s health data for primary and secondary use. To achieve these objectives, pursuant to Article 9(4) of Regulation (EU) 2016/679, Member States may impose additional restrictions to the rights and obligations laid down in Chapters II and IV of this Regulation.

Or. en

Amendment 187

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

(4) The processing of personal electronic health data is subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council43and, for Union institutions and bodies, Regulation (EU) 2018/1725 of the European Parliament and of the Council44. References to the provisions of Regulation (EU) 2016/679 should be understood also as references to the corresponding provisions of Regulation (EU) 2018/1725 for Union institutions and bodies, where relevant.

(4) The processing of personal electronic health data is subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council43and, for Union institutions and bodies, Regulation (EU) 2018/1725 of the European Parliament and of the Council44and Regulation (EU)2022/868 of the European Parliament and Council44a. References to the provisions of Regulation (EU) 2016/679 should be understood also as references to the corresponding provisions of Regulation (EU) 2018/1725 for Union institutions and bodies, where relevant.

_________________

43 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1).

44 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).

44a Regulation (EU) 2022/868 of the European Parliament and of the Council of 30 May 2022 on European data governance and amending Regulation (EU) 2018/1724 (Data Governance Act) (OJ L 152,3.6.2022, p.1)

Or. en

Amendment 188

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

Proposal for a regulation

Recital 4

Text proposed by the Commission

Amendment

_________________

Or. en

Amendment 189

Traian Băsescu

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4a) Personal health data is to be processed in a lawful, fair and transparent manner in respect of the data subject and in a manner that ensures proper security of the personal data, including protection against unauthorised or unlawful processing and against accidental loss, destruction or damage, using appropriate technical or organisational measures.

Or. ro

Amendment 190

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

Proposal for a regulation

Recital 4 a (new)

Text proposed by the Commission

Amendment

(4 a) The European Health Data Space implementation should comply with the European ethical principles for digital health adopted by the eHealth network on January 26, 2022. Monitoring the application of the ethical principles should be part of the tasks of the European Health Data Space Board.

Or. en

Amendment 191

Mathilde Androuët

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, such as behaviour, environmental, physical influences, medical care, social or educational factors. Electronic health data also includes data that has been initially collected for research, statistics, policy making or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means.

Or. fr

Justification

Personal electronic health data, especially primary data, remain personal property and only the owner can decide on the data content to be shared. Anonymised data for research, statistics, policy making or regulatory purposes (secondary data) must not be traded for profit.

Amendment 192

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

Or. en

Amendment 193

Sirpa Pietikäinen

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

Or. en

Amendment 194

Tudor Ciuhodaru

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an appropriate and secure electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, the necessary treatment, especially when this is long-term, and which also relates to the provision of associated healthcare services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, such as behaviour, environmental, physical influences, medical care, social or educational factors. Electronic health data also includes data that has been initially collected for research, statistics, policy making or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means.

Or. ro

Amendment 195

Rob Rooken

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, medical care. Electronic health data also includes data that has been initially collected for research, statistics or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means.

Or. en

Amendment 196

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

Proposal for a regulation

Recital 5

Text proposed by the Commission

Amendment

(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, such as behaviour, environmental, physical influences, medical care, social or educational factors. Electronic health data also includes data that has been initially collected for research, statistics, threat assessment, policy making or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means.

Or. en

Amendment 197

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 5 a (new)

Text proposed by the Commission

Amendment

(5 a) Improving digital health literacy for both natural persons and their healthcare professionals is key in order to achieve trust, safety and appropriate use of health data and hence achieving a successful implementation of this Regulation. Improving digital health literacy is fundamental in order to empower natural persons to have true control over their health data and actively manage their health and care, and understand the implications of disclosing such data for both primary and secondary use. Particular attention should be given to vulnerable populations, including migrants, the elderly and persons with disabilities. Healthcare professionals and IT operators should have sufficient training in working with new digital infrastructures to ensure cybersecurity and ethical management of health data.

Or. en

Amendment 198

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Recital 6

Text proposed by the Commission

Amendment

(6) Chapter III of Regulation (EU) 2016/679 sets out specific provisions concerning the rights of natural persons in relation to the processing of their personal data. EHDS builds upon these rights and further develops some of them. The EHDS should support the coherent implementation of those rights as applied to electronic health data, regardless of the Member State in which the personal electronic health data are processed, type of healthcare provider, sources of data or Member State of affiliation of the natural person. The rights and rules related to the primary use of personal electronic health data under Chapter II and III of this Regulation concern all categories of those data, irrespective of how they have been collected or who has provided hem, of the legal ground for the processing under Regulation (EU) 2016/679 or the status of the controller as a public or private organisation of the legal ground for their processing.

(6) Chapter III of Regulation (EU) 2016/679 sets out specific provisions concerning the rights of natural persons in relation to the processing of their personal data. EHDS builds upon these rights and further develops some of them. The EHDS should support the coherent implementation of those rights as applied to electronic health data, regardless of the Member State in which the personal electronic health data are processed, type of healthcare provider, sources of data or Member State of affiliation of the natural person. The rights and rules related to the primary use of personal electronic health data under Chapter II and III of this Regulation concern all categories of those data, irrespective of how they have been collected or who has provided hem, of the legal ground for the processing under Regulation (EU) 2016/679 or the status of the controller as a public organisation, or a private non-profit organisation, of the legal ground for their processing.

Or. en

Amendment 199

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it.

(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it. In this respect, and in order to avoid administrative fragmentation and to achieve a sufficiently interoperable, understandable and user-friendly system in all Member States and regions, appropriate funding and administrative support at Union level should be considered. Allowing for a fully decentralised federated data system at Union level has the potential to save infrastructure costs and to mitigate privacy concerns, as well as push the privacy-efficiency trade-off further out, generating the same efficiency levels for more privacy. Federated learning systems bring the algorithms to the data and researchers can retrieve only derived data, not the underlying individual electronic health registers.

Or. en

Amendment 200

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

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, and other complementary exams of diagnosis and therapeutics, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). To this end, Member States should ensure a common standard for health care data exchange to ensure and facilitate the data exchange and translation to the Union official languages. However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it. In this respect, appropriate funding and appropriate support at EU level should be considered as a means to reduce fragmentation, heterogeneity, and division and to achieve a system that is user-friendly and intuitive in all countries.

Or. en

Amendment 201

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

Recital 7

Text proposed by the Commission

Amendment

Or. en

Amendment 202

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved access to their own personal electronic health data and are empowered to share it. Electronic health records and the technological infrastructures that support them shall be retained, where possible, and Member States shall further their interoperability and compliance with the provisions of this Regulation.

Or. es

Justification

Member States and health professionals have made major technical and economic investments. The EHDS shall seek to maintain existing infrastructure to the extent possible and avoid creating artificial burdens of excessive obligations when implementing new systems.

Amendment 203

Sirpa Pietikäinen

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

Or. en

Amendment 204

Tudor Ciuhodaru

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided secure health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved access to their own personal electronic health data and are empowered to share it. Those data also need to be properly secured and protected against cyberattacks.

Or. ro

Amendment 205

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) In health systems, personal electronic health data is usually gathered in health records, which typically consist of an electronic collection of a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed in both an electronic or analogue format, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in a cross-border context, Union action is needed in order to ensure individuals have improved access to their own personal electronic health data and are empowered to share it.

Or. en

Amendment 206

Mathilde Androuët

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data, action to offer better protection is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it if they wish to do so and under conditions respecting anonymity and the principle that no profit should be made.

Or. fr

Amendment 207

Rob Rooken

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it.

Or. en

Amendment 208

Konstantinos Arvanitis

Proposal for a regulation

Recital 7

Text proposed by the Commission

Amendment

(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it.

Or. en

Amendment 209

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

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) The right of access to data by a natural person, established by Article 15 of Regulation (EU) 2016/679, should be further developed in the health sector. Under Regulation (EU) 2016/679, controllers do not have to provide access immediately. While patient portals, mobile applications and other personal health data access services exist in many places, including national solutions in some Member States, the right of access to health data is still commonly implemented in many places through the provision of the requested health data in paper format or as scanned documents, which is time-consuming. This may severely impair timely access to health data by natural persons, and may have a negative impact on natural persons who need such access immediately due to urgent circumstances pertaining to their health condition.

Or. en

Amendment 210

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) The right of access to data by a natural person, established by Article 15 of Regulation (EU) 2016/679, should be further developed in the health sector. Under Regulation (EU) 2016/679, controllers do not have to provide access immediately. This may severely impair timely access to health data by natural persons, and may have a negative impact on natural persons who need such access immediately due to urgent circumstances pertaining to their health condition.

Or. en

Amendment 211

Tudor Ciuhodaru

Proposal for a regulation

Recital 8

Text proposed by the Commission

Amendment

(8) The right of access to data by a natural person, established by Article 15 of Regulation (EU) 2016/679, should be further developed in the health sector, in parallel with the measures on access to, and protection, of those data. Under Regulation (EU) 2016/679, controllers do not have to provide access immediately. While patient portals, mobile applications and other personal health data access services exist in many places, including national solutions in some Member States, the right of access to health data is still commonly implemented in many places through the provision of the requested health data in paper format or as scanned documents, which is time-consuming. This may severely impair timely access to health data by natural persons, and may have a negative impact on natural persons who need such access immediately due to urgent circumstances pertaining to their health condition.

Or. ro

Amendment 212

Rob Rooken

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

[...]

deleted

Or. en

Amendment 213

Sirpa Pietikäinen

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) At the same time, it should be considered that immediate access to certain types of personal electronic health data may be harmful for the safety of natural persons, unethical or inappropriate. For example, it could be unethical to inform a patient through an electronic channel about a diagnosis with an incurable disease that is likely to lead to their swift passing instead of providing this information in a consultation with the patient first. Therefore, a possibility for limited exceptions in the implementation of this right should be ensured. Such an exception may be imposed by the Member States where this exception constitutes a necessary and proportionate measure in a democratic society, in line with the requirements of Article 23 of Regulation (EU) 2016/679. Such restrictions should be implemented by delaying the display of the concerned personal electronic health data to the natural person for a limited period. Where health data is only available on paper, if the effort to make data available electronically is disproportionate, there should be no obligation that such health data is converted into electronic format by Member States. Any digital transformation in the healthcare sector should aim to be inclusive and benefit also natural persons with limited ability to access and use digital services. Natural persons should be able to provide an authorisation to the natural persons of their choice, such as to their relatives or other close natural persons, enabling them to access or control access to their personal electronic health data or to use digital health services on their behalf. Such authorisations may also be useful for convenience reasons in other situations. Proxy services should be established by Member States to implement these authorisations, and they should be linked to personal health data access services, such as patient portals on patient-facing mobile applications. The proxy services should also enable guardians to act on behalf of their dependent children; in such situations, authorisations could be automatic. In order to take into account cases in which the display of some personal electronic health data of minors to their guardians could be contrary to the interests or will of the minor, Member States should be able to provide for such limitations and safeguards in national law, as well as the necessary technical implementation. Personal health data access services, such as patient portals or mobile applications, should make use of such authorisations and thus enable authorised natural persons to access personal electronic health data falling within the remit of the authorisation, in order for them to produce the desired effect.

(9) At the same time, it should be considered that immediate access to certain types of personal electronic health data may be harmful for the safety of natural persons, unethical or inappropriate. For example, it could be unethical to inform a patient through an electronic channel about a diagnosis with an incurable disease that is likely to lead to their swift passing instead of providing this information in a consultation with the patient first. Therefore, a possibility for limited exceptions in the implementation of this right should be ensured. Such an exception may be imposed by the Member States where this exception constitutes a necessary and proportionate measure in a democratic society, in line with the requirements of Article 23 of Regulation (EU) 2016/679. Such restrictions should be implemented by delaying the display of the concerned personal electronic health data to the natural person for a limited period. Any digital transformation in the healthcare sector should aim to be inclusive and benefit also natural persons with limited ability to access and use digital services. Natural persons should be able to provide an authorisation to the natural persons of their choice, such as to their relatives or other close natural persons, enabling them to access or control access to their personal electronic health data or to use digital health services on their behalf. Such authorisations may also be useful for convenience reasons in other situations. Proxy services should be established by Member States to implement these authorisations, and they should be linked to personal health data access services, such as patient portals on patient-facing mobile applications. The proxy services should also enable guardians to act on behalf of their dependent children; in such situations, authorisations could be automatic. In order to take into account cases in which the display of some personal electronic health data of minors to their guardians could be contrary to the interests or will of the minor, Member States should be able to provide for such limitations and safeguards in national law, as well as the necessary technical implementation. Personal health data access services, such as patient portals or mobile applications, should make use of such authorisations and thus enable authorised natural persons to access personal electronic health data falling within the remit of the authorisation, in order for them to produce the desired effect.

Or. en

Amendment 214

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

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) At the same time, it should be considered that immediate access to certain types of personal electronic health data may be harmful for the safety of natural persons, unethical or inappropriate. For example, it could be unethical to inform a patient through an electronic channel about a diagnosis with an incurable disease that is likely to lead to their swift passing instead of providing this information in a consultation with the patient first. Therefore, a possibility for limited exceptions in the implementation of this right should be ensured. Such an exception may be imposed by the Member States where this exception constitutes a necessary and proportionate measure in a democratic society, in line with the requirements of Article 23 of Regulation (EU) 2016/679. Such restrictions should be implemented by delaying the display of the concerned personal electronic health data to the natural person for a limited period until the moment of contact between the patient and the health professional. The availability of health data prior to the implementation of this regulation should happen in a timely manner in electronic format through a process facilitated by Member States. Any digital transformation in the healthcare sector should aim to be inclusive and benefit also natural persons with limited ability to access and use digital services. Natural persons should be able to provide an authorisation to the natural persons of their choice, such as to their relatives or other close natural persons, enabling them to access or control access to their personal electronic health data or to use digital health services on their behalf. Such authorisations may also be useful for convenience reasons in other situations. Proxy services should be established by Member States to implement these authorisations, and they should be linked to personal health data access services, such as patient portals on patient-facing mobile applications. The proxy services should also enable guardians to act on behalf of their dependent children; in such situations, authorisations could be automatic. In order to take into account cases in which the display of some personal electronic health data of minors to their guardians could be contrary to the interests or will of the minor, Member States should be able to provide for such limitations and safeguards in national law, as well as the necessary technical implementation. Personal health data access services, such as patient portals or mobile applications, should make use of such authorisations and thus enable authorised natural persons to access personal electronic health data falling within the remit of the authorisation, in order for them to produce the desired effect.

Or. en

Amendment 215

Traian Băsescu

Proposal for a regulation

Recital 9

Text proposed by the Commission

Amendment

(9) At the same time, it should be considered that immediate access to certain types of personal electronic health data may be harmful for the safety of natural persons, unethical or inappropriate. For example, it could be unethical to inform a patient through an electronic channel about a diagnosis with an incurable disease that is likely to lead to their swift passing instead of providing this information in a consultation with the patient first. Therefore, a possibility for limited exceptions in the implementation of this right should be ensured. Such an exception may be imposed by the Member States where this exception constitutes a necessary and proportionate measure in a democratic society, in line with the requirements of Article 23 of Regulation (EU) 2016/679. Such restrictions should be implemented by delaying the display of the concerned personal electronic health data to the natural person for a limited period. Where health data is only available on paper, if the effort to make data available electronically is disproportionate, there should be no obligation that such health data is converted into electronic format by Member States. Any digital transformation in the healthcare sector must aim to be inclusive and benefit also natural persons with limited ability to access and use digital services. Natural persons must be able to provide an authorisation to the natural persons of their choice, such as to their relatives or other close natural persons, enabling them to access or control access to their personal electronic health data or to use digital health services on their behalf. Such authorisations may also be useful for convenience reasons in other situations. Proxy services should be established by Member States to implement these authorisations, and they should be linked to personal health data access services, such as patient portals on patient-facing mobile applications. The proxy services should also enable guardians to act on behalf of their dependent children; in such situations, authorisations could be automatic. In order to take into account cases in which the display of some personal electronic health data of minors to their guardians could be contrary to the interests or will of the minor, Member States should be able to provide for such limitations and safeguards in national law, as well as the necessary technical implementation. Personal health data access services, such as patient portals or mobile applications, should make use of such authorisations and thus enable authorised natural persons to access personal electronic health data falling within the remit of the authorisation, in order for them to produce the desired effect.

Or. ro

Amendment 216

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.

(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be validated by a registered healthcare professional of relevant specialisation responsible for the natural person’s treatment. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural persons should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and implemented by the data controllers on a case by case basis involving health professionals responsible for the natural person’s treatment.

Or. en

Amendment 217

Sirpa Pietikäinen

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data. Specifically relevant fields in the EHR should be clearly marked, such as patient ID, allergies, laboratory data, medical images, medical alerts, and current medication. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.

Or. en

Amendment 218

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data. Specifically relevant fields in the EHR should be clearly marked, such as patient ID, allergies, laboratory data, medical alerts, co-morbility and current medications. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.

Or. en

Amendment 219

Dolors Montserrat

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. In any case, a clearly distinct section in the clinical history separate from the information recorded by professionals should be created. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.

Or. es

Amendment 220

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

Recital 10

Text proposed by the Commission

Amendment

(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data until a relevant health professional validates the information, which would then be marked as confirmed by a health professional. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.

Or. en

Amendment 221

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

Proposal for a regulation

Recital 10

Text proposed by the Commission

Amendment

(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data and does not have the same clinical or legal value as information provided by a healthcare professional. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis involving health professionals.

Or. en

Amendment 222

Tudor Ciuhodaru

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11) Natural persons should be further empowered to exchange and to provide access to personal electronic health data to the health professionals of their choice, going beyond the right to data portability as established in Article 20 of Regulation (EU) 2016/679. This is necessary to tackle objective difficulties and obstacles in the current state of play. Under Regulation (EU) 2016/679, portability is limited only to data processed based on consent or contract, which excludes data processed under other legal bases, such as when the processing is based on law, for example when their processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. It only concerns data provided by the data subject to a controller, excluding many inferred or indirect data, such as diagnoses, or tests. Finally, under Regulation (EU) 2016/679, the natural person has the right to have the personal data transmitted directly from one controller to another only where technically feasible. That Regulation, however, does not impose an obligation to make this direct transmission technically feasible. All these elements limit the data portability and may limit its benefits for provision of high-quality, safe and efficient healthcare services to the natural person.

(11) Natural persons should be further empowered to exchange and to provide access to personal electronic health data to the health professionals of their choice, going beyond the right to data portability as established in Article 20 of Regulation (EU) 2016/679. This is necessary to tackle objective difficulties and obstacles in the current state of play. Under Regulation (EU) 2016/679, portability is limited only to data processed based on consent or contract, which excludes data processed under other legal bases, such as when the processing is based on law, for example when their processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. It only concerns data provided by the data subject to a controller, excluding many inferred or indirect data, such as diagnoses, or tests. Finally, under Regulation (EU) 2016/679, the natural person has the right to have the personal data transmitted directly from one controller to another only where technically feasible and if the appropriate protection measures and complied with. That Regulation, however, does not impose an obligation to make this direct transmission technically feasible. All these elements limit the data portability and may limit its benefits for provision of high-quality, safe and efficient healthcare services to the natural person.

Or. ro

Amendment 223

Mathilde Androuët

Proposal for a regulation

Recital 11

Text proposed by the Commission

Amendment

(11) Natural persons should be further empowered to exchange, in a voluntary and informed manner, and to provide access to personal electronic health data to the health professionals of their choice, going beyond the right to data portability as established in Article 20 of Regulation (EU) 2016/679. This is necessary to tackle objective difficulties and obstacles in the current state of play. Under Regulation (EU) 2016/679, portability is limited only to data processed based on consent or contract, which excludes data processed under other legal bases, such as when the processing is based on law, for example when their processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. It only concerns data provided by the data subject to a controller, excluding many inferred or indirect data, such as diagnoses, or tests. Finally, under Regulation (EU) 2016/679, the natural person has the right to have the personal data transmitted directly from one controller to another only where technically feasible. That Regulation, however, does not impose an obligation to make this direct transmission technically feasible. All these elements limit the data portability and may limit its benefits for provision of high-quality, safe and efficient healthcare services to the natural person.

Or. fr

Amendment 224

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) Natural persons should be able to exercise control over the transmission of personal electronic health data to other healthcare providers. Healthcare providers and other organisations providing EHRs should facilitate the exercise of this right. Stakeholders such as healthcare providers, digital health service providers, manufacturers of EHR systems or medical devices should not limit or block the exercise of the right of portability because of the use of proprietary standards or other measures taken to limit the portability. For these reasons, the framework laid down by this Regulation builds on the right to data portability established in Regulation (EU) 2016/679 by ensuring that natural persons as data subjects can transmit their electronic health data, including inferred data, irrespective of the legal basis for processing the electronic health data. This right should apply to electronic health data processed by public or private controllers, irrespective of the legal basis for processing the data under in accordance with the Regulation (EU) 2016/679. This right should apply to all electronic health data.

(12) Natural persons should be able to exercise control over the transmission of personal electronic health data to other healthcare providers and be informed of the patient safety risks associated with limiting access to health data. Healthcare providers and other organisations providing EHRs should facilitate the exercise of this right. Stakeholders such as healthcare providers, digital health service providers, manufacturers of EHR systems or medical devices should not limit or block the exercise of the right of portability because of the use of proprietary standards or other measures taken to limit the portability. For these reasons, the framework laid down by this Regulation builds on the right to data portability established in Regulation (EU) 2016/679 by ensuring that natural persons as data subjects can transmit their electronic health data, including inferred data, irrespective of the legal basis for processing the electronic health data. This right should apply to electronic health data processed by public or private controllers, irrespective of the legal basis for processing the data in accordance with the Regulation (EU) 2016/679. This right should apply to all electronic health data. For this purpose, providers of electronic health records shall keep a record of who has accessed which data in the last 24 months.

Or. en

Amendment 225

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

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) Natural persons should be able to exercise control over the transmission of personal electronic health data to other healthcare providers. Healthcare providers and other organisations providing EHRs should facilitate the exercise of this right. Stakeholders such as healthcare providers, digital health service providers, manufacturers of EHR systems or medical devices should not limit or block the exercise of the right of portability because of the use of proprietary standards or other measures taken to limit the portability. Healthcare providers must follow data minimization principles when requesting personal health data, limiting it to the strictly necessary and justified data for a given service. For these reasons, the framework laid down by this Regulation builds on the right to data portability established in Regulation (EU) 2016/679 by ensuring that natural persons as data subjects can transmit their electronic health data, including inferred data, irrespective of the legal basis for processing the electronic health data. This right should apply to electronic health data processed by public or private controllers, irrespective of the legal basis for processing the data under in accordance with the Regulation (EU) 2016/679. This right should apply to all electronic health data.

Or. en

Amendment 226

Traian Băsescu

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) Natural persons must be able to exercise control over the transmission of personal electronic health data to other healthcare providers. Healthcare providers and other organisations providing EHRs should facilitate the exercise of this right. Stakeholders such as healthcare providers, digital health service providers, manufacturers of EHR systems or medical devices should not limit or block the exercise of the right of portability because of the use of proprietary standards or other measures taken to limit the portability. For these reasons, the framework laid down by this Regulation builds on the right to data portability established in Regulation (EU) 2016/679 by ensuring that natural persons as data subjects can transmit their electronic health data, including inferred data, irrespective of the legal basis for processing the electronic health data. This right should apply to electronic health data processed by public or private controllers, irrespective of the legal basis for processing the data under in accordance with the Regulation (EU) 2016/679. This right should apply to all electronic health data.

Or. ro

Amendment 227

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Recital 12

Text proposed by the Commission

Amendment

(12) Natural persons should be able to exercise control over the transmission of personal electronic health data to other healthcare providers. Healthcare providers and other organisations providing EHRs should facilitate the exercise of this right. Stakeholders such as healthcare providers, digital health service providers, manufacturers of EHR systems or medical devices should not limit or block the exercise of the right of portability because of the use of proprietary standards or other measures taken to limit the portability. For these reasons, the framework laid down by this Regulation builds on the right to data portability established in Regulation (EU) 2016/679 by ensuring that natural persons as data subjects can transmit their electronic health data, including inferred data, irrespective of the legal basis for processing the electronic health data. This right should apply to electronic health data processed by public controllers, irrespective of the legal basis for processing the data under in accordance with the Regulation (EU) 2016/679. This right should apply to all electronic health data.

Or. en

Amendment 228

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling access to other parts. Such selective sharing of personal electronic health data should be supported. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. According to Regulation (EU) 2016/679, vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider cannot take the data into account when providing health services.

(13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling access to other parts, or they may want to wholly refuse access to their personal electronic health data by electronic health data access services and health professional access services. Such selective and patient-centric control of personal electronic health data should be supported. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. According to Regulation (EU) 2016/679, vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law, together with patient-centric guidance to natural persons in relation to the use of electronic health records and primary use of their personal electronic health data. Guidance should be tailored to the patient’s level of digital health literacy, with specific care for vulnerable groups, such as migrants, the elderly, and persons with disabilities. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider cannot take the data into account when providing health services.

Or. en

Amendment 229

Mathilde Androuët

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) Natural persons have the right to deny access to their personal electronic health data while enabling access to others so that they can be consulted by clearly identified people and organisations. Such selective sharing of personal electronic health data should be supported if natural persons have clearly and voluntarily agreed to such sharing, and in particular according to Regulation (EU) 2016/679, where vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal electronic health data based on the vital interest of another natural person should take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law, which would thus be imposed on other Member States that do not have the same mechanisms.

Or. fr

Justification

A health service provider’s inability to provide an adequate health service cannot be justified by the unavailability of personal electronic health data.

Amendment 230

Mathilde Androuët

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) Natural persons have the right to deny access to some parts or all of their personal electronic health data while enabling access to other parts so that they can be consulted by clearly identified people and organisations. Such selective sharing of personal electronic health data should be supported only if the natural persons have clearly and voluntarily agreed to such sharing, and in particular according to Regulation (EU) 2016/679, where vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. These situations must be expressly identified and defined. Processing of personal electronic health data based on the vital interest of another natural person should take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law and be applied to the national laws of other Member States which do not have the same mechanisms.

Or. fr

Justification

Emergency situations cannot justify allowing access to individuals’ health data without their explicit consent.

Amendment 231

Javier Zarzalejos

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

Or. en

Amendment 232

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

Recital 13

Text proposed by the Commission

Amendment

(13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling access to other parts. Such selective sharing of personal electronic health data should be supported but the restrictions on information should be easily identifiable by health professionals in the EHR in order to take due regard to the fact that the information is incomplete, when treating the patient. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. According to Regulation (EU) 2016/679, vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider cannot take the data into account when providing health services.

Or. en

Amendment 233

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling access to other parts. Such selective sharing of personal electronic health data should be supported. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. According to Regulation (EU) 2016/679, vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law. Given the unequal access to sexual and reproductive healthcare among the Member States, natural persons should always retain the right to withhold that kind of information from their doctors. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider cannot take the data into account when providing health services.

Or. en

Amendment 234

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

Or. es

Amendment 235

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

Proposal for a regulation

Recital 13

Text proposed by the Commission

Amendment

(13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling access to other parts. Such selective sharing of personal electronic health data should be supported. However, such restrictions may have life threatening consequences and, therefore, access to personal electronic health data should be possible to protect vital interests as an emergency override. According to Regulation (EU) 2016/679, vital interests refer to situations in which it is necessary to protect an interest which is essential for the life of the data subject or that of another natural person dependent on that information. Processing of personal electronic health data based on the vital interest of another natural person should in principle take place only where the processing cannot be manifestly based on another legal basis. More specific legal provisions on the mechanisms of restrictions placed by the natural person on parts of their personal electronic health data should be provided by Member States in national law. Because the unavailability of the restricted personal electronic health data may impact the provision or quality of health services provided to the natural person, he/she should assume responsibility for the fact that the healthcare provider cannot take the data into account when providing health services.

Or. en

Amendment 236

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 14

Text proposed by the Commission

Amendment

(14) In the context of the EHDS, natural persons should be able to exercise their rights as they are enshrined in Regulation (EU) 2016/679. The supervisory authorities established pursuant to Article 51 of Regulation (EU) 2016/679 should remain competent, in particular to monitor the processing of personal electronic health data and to address any complaints lodged by the natural persons. In order to carry out their tasks in the health sector and uphold the natural persons’ rights, digital health authorities should cooperate with the supervisory authorities under Regulation (EU) 2016/679.

(14) In the context of the EHDS, natural persons should be able to exercise their rights without prejudice to Regulation (EU) 2016/679. The supervisory authorities established pursuant to Article 51 of Regulation (EU) 2016/679 should remain competent, in particular to monitor the processing of personal electronic health data and to address any complaints lodged by the natural persons. In order to carry out their tasks in the health sector and uphold the natural persons’ rights, digital health authorities should cooperate with the supervisory authorities under Regulation (EU) 2016/679.

Or. en

Amendment 237

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

Proposal for a regulation

Recital 15

Text proposed by the Commission

Amendment

(15) Article 9(2), point (h), of Regulation (EU) 2016/679 provides for exceptions where the processing of senstitive data is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health care or treatment or the management of health care systems and services on the basis of Union or Member State law. This Regulation should provide conditions and safeguards for the processing of electronic health data by healthcare providers and health professionals in line with Article 9(2), point (h), of Regulation (EU) 2016/679 with the purpose of accessing personal electronic health data provided by the natural person or transmitted from other healthcare providers. However, this Regulation should be without prejudice to the national laws concerning the processing of health data, including the legislation establishing categories of health professionals that can process different categories of electronic health data.

(15) Article 9(2), point (h), of Regulation (EU) 2016/679 provides for exceptions where the processing of sensitive data is necessary for the purposes of preventive or occupational medicine, for the assessment of the working capacity of the employee, medical diagnosis, the provision of health care or treatment or the management of health care systems and services on the basis of Union or Member State law. This Regulation should provide conditions and safeguards for the processing of electronic health data by healthcare providers and health professionals in line with Article 9(2), point (h), of Regulation (EU) 2016/679 with the purpose of accessing personal electronic health data provided by the natural person or transmitted from other healthcare providers. However, this Regulation should be without prejudice to the national laws concerning the processing of health data, including the legislation establishing categories of health professionals that can process different categories of electronic health data.

Or. en

Amendment 238

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

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, the access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format.

(16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care, avoiding duplications and errors and reducing costs. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as appropriate electronic and digital devices and health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, the access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format. None of the provisions in this Regulation should be interpreted as limiting the obligation of healthcare professionals to conduct themselves in accordance with the applicable codes of conduct, deontological guidelines or other provisions governing ethical conduct with respect to sharing or accessing information, particularly in life-threatening or extreme situations.

Or. en

Amendment 239

Dolors Montserrat

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

Or. es

Amendment 240

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format via commonly accepted open standards and open data formats, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as health professional portals, to use personal electronic health data for the exercise of their duties on a need to know basis in regards to the person under their treatment, irrespective of the Member State of affiliation and treatment. Moreover, the Commission and the Member States should agree on time-based targets to implement improved health data interoperability across the Union. The access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format.

Or. en

Amendment 241

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

Or. es

Amendment 242

Tudor Ciuhodaru

Proposal for a regulation

Recital 16

Text proposed by the Commission

Amendment

(16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers, provided that access to that data is properly secured, can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, the access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format.

Or. ro

Amendment 243

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospital discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.

Or. en

Amendment 244

Mathilde Androuët

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

Or. fr

Amendment 245

Tudor Ciuhodaru

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospital discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission, especially in the case of cross-border patients or of people who find themselves in another Member State for a limited period of time and may need healthcare assistance for a variety of reasons. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general, for cross-border patients or people who find themselves in another Member State for a limited period of time and may need healthcare assistance for a variety of reasons.

Or. ro

Amendment 246

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

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, hospital discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.

Or. en

Amendment 247

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

Proposal for a regulation

Recital 17

Text proposed by the Commission

Amendment

(17) The relevance of different categories of electronic health data for different healthcare scenarios varies. Different categories have also achieved different levels of maturity in standardisation, and therefore the implementation of mechanisms for their exchange may be more or less complex depending on the category. Therefore, the improvement of interoperability and data sharing should be gradual and prioritisation of categories of electronic health data is needed. Categories of electronic health data such as patient summary, electronic prescription and dispensation, laboratory results and reports, health units discharge reports, medical images and reports have been selected by the eHealth Network as most relevant for the majority of healthcare situations and should be considered as priority categories for Member States to implement access to them and their transmission. When further needs for the exchange of more categories of electronic health data are identified for healthcare purposes, the list of priority categories should be expanded. The Commission should be empowered to extend the list of priority categories, after analysing relevant aspects related to the necessity and possibility for the exchange of new datasets, such as their support by systems established nationally or regionally by the Member States. Particular attention should be given to the data exchange in border regions of neighbouring Member States where the provision of cross-border health services is more frequent and needs even quicker procedures than across the Union in general.

Or. en

Amendment 248

Mathilde Androuët

Proposal for a regulation

Recital 18

Text proposed by the Commission

Amendment

(18) Access and sharing of electronic health data should be enabled for all the data that exist in the EHR of a natural person, when technically feasible. However, some electronic health data may not be structured or coded, and the transmission between healthcare providers may be limited or only possible in formats that do not allow for translation (when data is shared cross-borders). In order to provide enough time to prepare for implementation, dates of deferred application should be determined to allow for achieving legal, organisational, semantic and technical readiness for the transmission of different categories of electronic health data. When need for the exchange of new categories of electronic health data is identified, related dates of application should be determined in order to allow for the implementation of this exchange.

(18) Access and sharing of electronic health data should be enabled for all the data that exist in the EHR of a natural person, only when the person in question has given their explicit consent. However, some electronic health data may not be structured or coded, and the transmission between healthcare providers may be limited or only possible in formats that do not allow for translation (when data is shared cross-borders). In order to provide enough time to prepare for implementation, dates of deferred application should be determined to allow for achieving legal, organisational, semantic and technical readiness for the transmission of different categories of electronic health data. When need for the exchange of new categories of electronic health data is identified, related dates of application should be determined in order to allow for the implementation of this exchange.

Or. fr

Amendment 249

Dolors Montserrat

Proposal for a regulation

Recital 18 a (new)

Text proposed by the Commission

Amendment

(18 a) In order to avoid an exponential quantitative increase in the risks of misuse (intentional or accidental) of individual citizens’ health data, a risk management plan should be defined and the ethical and deontological aspects of medical practice in this context of interoperability in the primary use of data and all ethical aspects and respect for citizens' autonomy in the secondary use of health data should be taken into account.

Or. es

Amendment 250

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path to the Digital Decade”. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data.

(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format as well as to give them better control over accessing and sharing their personal electronic health data. To this end, Member States should retain the right to require user consent, or at least provide the possibility for natural persons, to refuse the registration of their electronic health file by all or selected healthcare professionals in an EHR system. Such mechanisms are key trust safeguards in the system that secure greater decentralization and user-centricity over their data. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format based on commonly accepted open standards and open data formats, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data.

_________________

45 Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18).

46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

Or. en

Amendment 251

Sirpa Pietikäinen

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path to the Digital Decade”. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results, chronic diseases and/or conditions and their medication and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data. Such way of electronic format of data could also be a renewed European Health Insurance Card with an access tool to health data that is interoperable in all Member States.

_________________

45 Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18).

46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

Or. en

Amendment 252

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path to the Digital Decade”. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, with her total knowledge and consent, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data.

_________________

45 Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18).

46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

Or. en

Amendment 253

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

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path to the Digital Decade”. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data.

_________________

45 Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18).

46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

Or. en

Amendment 254

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 19

Text proposed by the Commission

Amendment

(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path to the Digital Decade”. In order to make electronic health data accessible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data.

_________________

45 Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18).

46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients' rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).

Or. es

Amendment 255

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

Proposal for a regulation

Recital 19 a (new)

Text proposed by the Commission

Amendment

(19 a) The interoperability of the EHDS should contribute to high quality of European health data sets.

Or. en

Amendment 256

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

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) While EHR systems are widely spread, the level of digitalisation of health data varies in Member States depending on data categories and on the coverage of healthcare providers that register health data in electronic format. In order to support the implementation of data subjects’ rights of access to and exchange of electronic health data, Union action is needed to avoid further fragmentation. In order to contribute to a high quality and continuity of healthcare, certain categories of health data should be registered in electronic format systematically and according to specific data quality requirements. The European electronic health record exchange format should form the basis for specifications related to the registration and exchange of electronic health data. The Commission should be empowered to adopt implementing acts for determining additional aspects related to the registration of electronic health data, such as categories of healthcare providers that are to register health data electronically, categories of data to be registered electronically, or data quality requirements.

Or. en

Amendment 257

Tudor Ciuhodaru

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) While EHR systems are widely spread, the level of digitalisation of health data varies in Member States depending on data categories and on the coverage of healthcare providers that register health data in electronic format. In order to support the implementation of data subjects’ rights of access to and exchange of electronic health data, Union action is needed to avoid further fragmentation. In order to contribute to a high quality and continuity of healthcare, certain categories of health data should be registered in electronic format systematically and according to specific data quality requirements, including measures on access to, and the protection of, those data. The European electronic health record exchange format should form the basis for specifications related to the registration and exchange of electronic health data. The Commission should be empowered to adopt implementing acts for determining additional aspects related to the registration of electronic health data, such as categories of healthcare providers that are to register health data electronically, categories of data to be registered electronically, or data quality and data security requirements.

Or. ro

Amendment 258

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 20

Text proposed by the Commission

Amendment

(20) While EHR systems are widely spread, the level of digitalisation of health data varies in Member States depending on data categories and on the coverage of healthcare professionals that register health data in electronic format. In order to support the implementation of data subjects’ rights of access to and exchange of electronic health data, Union action is needed to avoid further fragmentation. In order to contribute to a high quality and continuity of healthcare, certain categories of health data should be registered in electronic format systematically and according to specific data quality requirements. The European electronic health record exchange format should form the basis for specifications related to the registration and exchange of electronic health data. The Commission should be empowered to adopt delegated acts for determining additional aspects related to the registration of electronic health data, such as categories of healthcare professionals that are to register health data electronically, categories of data to be registered electronically, or data quality requirements.

Or. en

Amendment 259

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

Proposal for a regulation

Recital 20 a (new)

Text proposed by the Commission

Amendment

(20 a) In order to support the successful implementation of the EHDS and the execution of an effective landscape of European health data cooperation, the European Commission and Member States should agree on time-based targets to implement improved health data interoperability across the European Union with a range of targets and milestones to be reviewed and assessed in an annual report.

Or. en

Amendment 260

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Under Article 168 of the Treaty Member States are responsible for their health policy, in particular for decisions on the services (including telemedicine) that they provide and reimburse. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health services such as telemedicine, including online pharmacy services. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.

deleted

Or. en

Justification

Telemedicine falls out of scope of the EHDS

Amendment 261

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

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Under Article 168 of the Treaty Member States are responsible for their health policy, in particular for decisions on the services that they provide and reimburse. Telemedicine and online pharmacy services have the potential to reduce health inequalities and reinforce the free movement of european citizens across borders. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health services such as telemedicine and online pharmacy services. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.

Or. en

Amendment 262

Dolors Montserrat

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Under Article 168 of the Treaty Member States are responsible for their health policy, in particular for decisions on the services (including telemedicine) that they provide and reimburse. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health services. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.

Or. es

Amendment 263

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Under Article 168 of the Treaty Member States are responsible for their health policy, in particular for decisions on the services (including telemedicine) that they provide and reimburse. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health services. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.

Or. es

Amendment 264

Javier Zarzalejos

Proposal for a regulation

Recital 21

Text proposed by the Commission

Amendment

(21) Under Article 168 of the Treaty Member States are responsible for their health policy, in particular for decisions on the services (including telemedicine) that they provide and reimburse. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health services such as telemedicine. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.

Or. en

Amendment 265

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

Proposal for a regulation

Recital 21 a (new)

Text proposed by the Commission

Amendment

(21 a) Telemedicine is becoming an increasingly important tool that can provide patients access to care and tackle inequities. Digital and other technological tools can minimize the circumstance of remote care, however, telemedicine should not be viewed as a replacement for in-person medicine, as there are certain conditions and procedures that require physical examination and intervention.

Or. en

Amendment 266

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Regulation (EU) No 910/2014 of the European Parliament and of the Council47lays down the conditions under which Members States perform identification of natural persons in cross-border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires a secure access to electronic health data, including in cross-border scenarios where the health professional and the natural person are from different Member States, to avoid cases of unauthorised access. At the same time, the existence of different means of electronic identification should not be a barrier for exercising the rights of natural persons and health professionals. The rollout of interoperable, cross-border identification and authentication mechanisms for natural persons and health professionals across the EHDS requires strengthening cooperation at Union level in the European Health Data Space Board (‘EHDS Board’).As the rights of the natural persons in relation to the access and transmission of personal electronic health data should be implemented uniformly across the Union, a strong governance and coordination is necessary at both Union and Member State level. Member States should establish relevant digital health authorities for the planning and implementation of standards for electronic health data access, transmission and enforcement of rights of natural persons and health professionals. In addition, governance elements are needed in Member States to facilitate the participation of national actors in the cooperation at Union level, channelling expertise and advising the design of solutions necessary to achieve the goals of the EHDS. Digital health authorities exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. Digital health authorities should be established in all Member States, as separate organisations or as part of the currently existing authorities.

(22) Regulation (EU) No 910/2014 of the European Parliament and of the Council47lays down the conditions under which Members States perform identification of natural persons in cross-border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires a secure access to electronic health data, including in cross-border scenarios where the health professional and the natural person are from different Member States, to avoid cases of unauthorised access. At the same time, the existence of different means of electronic identification should not be a barrier for exercising the rights of natural persons and health professionals.Digital Health Authorities, including at regional and local level, should also support digital health literacy and public awareness, while ensuring that the implementation of this Regulation contributes to reducing inequalities and does not discriminate against vulnerable populations. The rollout of interoperable, cross-border identification and authentication mechanisms for natural persons and health professionals across the EHDS requires strengthening cooperation at Union level in the European Health Data Space Board (‘EHDS Board’).As the rights of the natural persons in relation to the access and transmission of personal electronic health data should be implemented uniformly across the Union, a strong governance and coordination is necessary at both Union and Member State level. Member States should establish relevant digital health authorities for the planning and implementation of standards for electronic health data access, transmission and enforcement of rights of natural persons and health professionals. In addition, governance elements are needed in Member States to facilitate the participation of national actors in the cooperation at Union level, channelling expertise and advising the design of solutions necessary to achieve the goals of the EHDS. Digital health authorities exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. Digital health authorities should be established in all Member States, as separate organisations or as part of the currently existing authorities. The EHDS Board, digital health authorities and health data access bodies should establish transparent methods for stakeholder engagement, particularly with representatives of patients, consumers and healthcare professionals.The EHDS Board, digital health authorities and health data access bodies should adhere to a high degree of transparency of its outputs and all its members, observers and experts should act independently, in the public interest and be free from any external influence that might affect the impartiality of their professional conduct.

_________________

47 Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73).

Or. en

Amendment 267

Konstantinos Arvanitis

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Regulation (EU) No 910/2014 of the European Parliament and of the Council47lays down the conditions under which Members States perform identification of natural persons in cross-border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires a secure access to electronic health data, including in cross-border scenarios where the health professional and the natural person are from different Member States, to avoid cases of unauthorised access. At the same time, the existence of different means of electronic identification should not be a barrier for exercising the rights of natural persons and health professionals. The rollout of interoperable, cross-border identification and authentication mechanisms for natural persons and health professionals across the EHDS requires strengthening cooperation at Union level in the European Health Data Space Board (‘EHDS Board’).As the rights of the natural persons in relation to the access and transmission of personal electronic health data should be implemented uniformly across the Union, a strong governance and coordination is necessary at both Union and Member State level. Member States should establish relevant digital health authorities for the planning and implementation of standards for electronic health data access, transmission and enforcement of rights of natural persons and health professionals. Digital Health Authorities should be in charge of promoting digital literacy and public awareness, while ensuring that the implementation of this Regulation contributes to reducing inequalities and does not discriminate against people lacking digital skills.In addition, governance elements are needed in Member States to facilitate the participation of national actors in the cooperation at Union level, channelling expertise and advising the design of solutions necessary to achieve the goals of the EHDS. Digital health authorities exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. Digital health authorities should be established in all Member States, as separate organisations or as part of the currently existing authorities.

_________________

Or. en

Amendment 268

Kateřina Konečná

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Regulation (EU) No 910/2014 of the European Parliament and of the Council lays down the conditions under which Members States perform identification of natural persons in cross-border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires a secure access to electronic health data, including in cross-border scenarios where the health professional and the natural person are from different Member States, to avoid cases of unauthorised access. At the same time, the existence of different means of electronic identification should not be a barrier for exercising the rights of natural persons and health professionals. The rollout of interoperable, cross-border identification and authentication mechanisms for natural persons and health professionals across the EHDS requires strengthening cooperation at Union level in the European Health Data Space Board (‘EHDS Board’).As the rights of the natural persons in relation to the access and transmission of personal electronic health data should be implemented uniformly across the Union, a strong governance and coordination is necessary at both Union and Member State level. Member States should establish relevant digital health authorities for the planning and implementation of standards for electronic health data access, transmission and enforcement of rights of natural persons and health professionals. Digital Health Authorities should also be in charge of promoting digital literacy and public awareness, while ensuring that the implementation of this Regulation contributes to reducing inequalities and does not discriminate against people lacking digital skills. In addition, governance elements are needed in Member States to facilitate the participation of national actors in the cooperation at Union level, channelling expertise and advising the design of solutions necessary to achieve the goals of the EHDS. Digital health authorities exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. Digital health authorities should be established in all Member States, as separate organisations or as part of the currently existing authorities.

_________________

Or. en

Amendment 269

Mathilde Androuët

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Regulation (EU) No 910/2014 of the European Parliament and of the Council47lays down the conditions under which Members States perform identification of natural persons in cross-border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires a secure access to electronic health data, including in cross-border scenarios where the health professional and the natural person are from different Member States, to avoid cases of unauthorised access. At the same time, the existence of different means of electronic identification should not be a barrier for exercising the rights of natural persons and health professionals. The rollout of interoperable, cross-border identification and authentication mechanisms for natural persons and health professionals across the EHDS requires strengthening cooperation at Union level in the European Health Data Space Board (‘EHDS Board’). As the rights of the natural persons in relation to the access and transmission of personal electronic health data should be implemented uniformly across the Union, a strong governance and coordination is necessary at both Union and Member State level. As a condition for the implementation of the EHDS,Member States should establish relevant digital health authorities for the planning and implementation of standards for electronic health data access, transmission and enforcement of rights of natural persons and health professionals, which should apply the same level of digital security requirements in order to ensure an optimal level of health data protection for users. In addition, governance elements are needed in Member States to facilitate the participation of national actors in the cooperation at Union level, channelling expertise and advising the design of solutions necessary to achieve the goals of the EHDS. Digital health authorities exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. Digital health authorities should be established in all Member States, as separate organisations or as part of the currently existing authorities.

_________________

Or. fr

Amendment 270

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

Proposal for a regulation

Recital 22

Text proposed by the Commission

Amendment

(22) Regulation (EU) No 910/2014 of the European Parliament and of the Council47lays down the conditions under which Members States perform identification of natural persons in cross-border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires a secure access to electronic health data, including in cross-border scenarios where the health professional and the natural person are from different Member States, to avoid cases of unauthorised access. At the same time, the existence of different means of electronic identification should not be a barrier for exercising the rights of natural persons and health professionals. The rollout of interoperable, cross-border identification and authentication mechanisms for natural persons and health professionals across the EHDS requires strengthening cooperation at Union level in the European Health Data Space Board (‘EHDS Board’). In the future, the identification and authentication for access to EHR should be facilitated by the new eID system that will be set up under the revised Regulation (EU) No 910/2014.As the rights of the natural persons in relation to the access and transmission of personal electronic health data should be implemented uniformly across the Union, a strong governance and coordination is necessary at both Union and Member State level. Member States should establish relevant digital health authorities for the planning and implementation of standards for electronic health data access, transmission and enforcement of rights of natural persons and health professionals. In addition, governance elements are needed in Member States to facilitate the participation of national actors in the cooperation at Union level, channelling expertise and advising the design of solutions necessary to achieve the goals of the EHDS. Digital health authorities exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. Digital health authorities should be established in all Member States, as separate organisations or as part of the currently existing authorities.

_________________

Or. en

Amendment 271

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

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including with insurance bodies, healthcare providers, manufacturers of EHR systems and wellness applications, as well as stakeholders from health or information technology sector, entities handling reimbursement schemes, health technology assessment bodies, medicinal products regulatory authorities and agencies, medical devices authorities, procurers and cybersecurity or e-ID authorities.

(23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. Digital health authorities should ensure that appropriate training initiatives are undertaken at the local level. In particular, health professionals should be informed and trained with respect to their rights and obligations under the present Regulation. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including with insurance bodies, healthcare providers, healthcare professionals, manufacturers of EHR systems and wellness applications, as well as other stakeholders from health or information technology sector, entities handling reimbursement schemes, health technology assessment bodies, medicinal products regulatory authorities and agencies, medical devices authorities, procurers and cybersecurity or e-ID authorities.

Or. en

Amendment 272

Rob Rooken

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including with healthcare providers, manufacturers of EHR systems, as well as stakeholders from health or information technology sector, entities handling reimbursement schemes, health technology assessment bodies, medicinal products regulatory authorities and agencies, medical devices authorities, procurers and cybersecurity authorities.

Or. en

Amendment 273

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

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national and regional technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including with insurance bodies, healthcare providers, manufacturers of EHR systems and wellness applications, as well as stakeholders from health or information technology sector, entities handling reimbursement schemes, health technology assessment bodies, medicinal products regulatory authorities and agencies, medical devices authorities, procurers and cybersecurity or e-ID authorities.

Or. en

Amendment 274

Konstantinos Arvanitis

Proposal for a regulation

Recital 23

Text proposed by the Commission

Amendment

(23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including with insurance bodies, healthcare providers, manufacturers of EHR systems, as well as stakeholders from health or information technology sector, entities handling reimbursement schemes, health technology assessment bodies, medicinal products regulatory authorities and agencies, medical devices authorities, procurers and cybersecurity or e-ID authorities.

Or. en

Justification

Horizontal amendment to remove wellness applications from the proposed regulation in general.

Amendment 275

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Access to and transmission of electronic health data is relevant in cross-border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data.

(24) Access to and transmission of electronic health data is relevant in cross-border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States and, where applicable, regions in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data. Finally, in order to guarantee the linguistic rights of natural persons to access and make use of their personal electronic health data, MyHealth@EU should be accessible in the language of preference of the natural person, including all officially recognised languages in Member States.

Or. en

Amendment 276

Mathilde Androuët

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Access to and transmission of electronic health data is relevant in cross-border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. Member States who so wish should be able to join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State.

Or. fr

Amendment 277

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

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Access to and transmission of electronic health data is relevant in cross-border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructure and connect healthcare providers to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data, and funding as well as other means of European level support should be considered.

Or. en

Amendment 278

Tudor Ciuhodaru

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Access to and transmission of electronic health data is relevant in cross-border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence, or when they work in a Member State other than the one in which they live. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data.

Or. ro

Amendment 279

Mathilde Androuët

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Access to and transmission of electronic health data is relevant in cross-border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. All Member States who wish to shall be able to join the digital infrastructure MyHealth@EU and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data.

Or. fr

Amendment 280

Sirpa Pietikäinen

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Access to and transmission of electronic health data is relevant in cross-border healthcare situations, as it may support continuity of healthcare and ensure patient safety when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data.

Or. en

Amendment 281

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 24

Text proposed by the Commission

Amendment

(24) Access to and transmission of electronic health data is relevant in cross-border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. All Member States should join the infrastructure and connect healthcare providers to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data.

Or. es

Amendment 282

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) In the context of MyHealth@EU, a central platform should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities among the Member States, as joint controllers, and prescribe its own obligations, as processor.

(25) In the context of MyHealth@EU, a central open source platform licensed under an open source licence should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities among the Member States, as joint controllers, and prescribe its own obligations, as processor. Furthermore, to ensure the technological sovereignty of the Union and ensure the highest security standards, the platform should be licenced under an open source licence in line with the Open Source Strategy 2020-2023 (C(2020) 7149 final) and Commission decision 2021/C 495 I/01. This would increase transparency and ensure consumer trust and confidence in the platform.

Or. en

Amendment 283

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) In the context of MyHealth@EU, a central platform should provide a common infrastructure for the Member States and all their regions to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities among the Member States, as joint controllers, and prescribe its own obligations, as processor. Where applicable, regions with health competences should also be entrusted such tasks.

Or. en

Amendment 284

Mathilde Androuët

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) In the context of MyHealth@EU, a central platform, whose infrastructure shall be managed by a European actor on European soil, should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities among the Member States, as joint controllers, and prescribe its own obligations, as processor.

Or. fr

Amendment 285

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

Proposal for a regulation

Recital 25

Text proposed by the Commission

Amendment

(25) In the context of MyHealth@EU, a central platform should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities with time-based targets among the Member States, as joint controllers, and prescribe its own obligations, as processor.

Or. en

Amendment 286

Rob Rooken

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) In addition to services in MyHealth@EU for the exchange of personal electronic health data based on the European electronic health record exchange format, other services or supplementary infrastructures may be needed for example in cases of public health emergencies or where the architecture of MyHealth@EU is not suitable for the implementation of some use cases. Examples of such use cases include support for vaccination card functionalities, including the exchange of information on vaccination plans, or verification of vaccination certificates or other health-related certificates. This would be also important for introducing additional functionality for handling public health crises, such as support for contact tracing for the purposes of containing infectious diseases. Connection of national contact points for digital health of third countries or interoperability with digital systems established at international level should be subject to a check ensuring the compliance of the national contact point with the technical specifications, data protection rules and other requirements of MyHealth@EU. A decision to connect a national contact point of a third country should be taken by data controllers in the joint controllership group for MyHealth@EU.

deleted

Or. en

Amendment 287

Mathilde Androuët

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

Or. fr

Amendment 288

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) In addition to services in MyHealth@EU for the exchange of personal electronic health data based on the European electronic health record exchange format, other services or supplementary infrastructures may be needed for example in cases of public health emergencies or where the architecture of MyHealth@EU is not suitable for the implementation of some use cases. Examples of such use cases include support for vaccination card functionalities, including the exchange of information on vaccination plans, or verification of vaccination certificates or other health-related certificates. This would be also important for introducing additional functionality for handling public health crises, such as support for contact tracing for the purposes of containing infectious diseases. Furthermore, in accordance with the strenghtened role of the European Center for Diseases Control and Prevention (ECDC), Member States should ensure that the ECDC receives real-time and comparable data on vaccination, including vaccination coverage listed on the ECDC vaccine schedule and vaccine-preventable disease surveillance. Connection of national contact points for digital health of third countries or interoperability with digital systems established at international level should be subject to a check ensuring the compliance of the national contact point with the technical specifications, data protection rules and other requirements of MyHealth@EU. A decision to connect a national contact point of a third country should be taken by data controllers in the joint controllership group for MyHealth@EU.

Or. en

Amendment 289

Kateřina Konečná

Proposal for a regulation

Recital 26

Text proposed by the Commission

Amendment

(26) In addition to services in MyHealth@EU for the exchange of personal electronic health data based on the European electronic health record exchange format, other services or supplementary infrastructures may be needed for example in cases of public health emergencies or where the architecture of MyHealth@EU is not suitable for the implementation of some use cases. Examples of such use cases include support for vaccination card functionalities, including the exchange of information on vaccination plans, or verification of vaccination certificates or other health-related certificates. This would be also important for introducing additional functionality for handling public health crises, such as support for contact tracing for the purposes of containing infectious diseases. Furthermore, in accordance with the strengthened role of the European Center for Diseases Control and Prevention (ECDC), Member States should ensure that the ECDC receives real-time and comparable data on vaccination including vaccination coverage listed on the ECDC vaccine schedule and vaccine preventable disease surveillance. Connection of national contact points for digital health of third countries or interoperability with digital systems established at international level should be subject to a check ensuring the compliance of the national contact point with the technical specifications, data protection rules and other requirements of MyHealth@EU. A decision to connect a national contact point of a third country should be taken by data controllers in the joint controllership group for MyHealth@EU.

Or. en

Amendment 290

István Ujhelyi

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. At the same time, the EU should invest in and promote the equal development of a basic understanding of digital health/data literacy and skills (e-health, m-health literacy) in the Member States for the public at large to empower the citizen in healthcare and the citizen’s knowledge on their health data. Citizens need to understand that they have the right to give and revoke an approval to use their data. Digital health/data literacy and skills should be promoted in the formation for healthcare professionals and a point of attention in (continued) education. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council. If patients engage virtually with their healthcare providers, patients need to understand the privacy and security policies and also how to keep their information private and secure. The staff, working in a healthcare organisation, need to understand the privacy and security policies of the organization. Regular security awareness training is essential to cybersecurity in healthcare so that members of the staff are aware of threats and what to do in case of actual security incidents.

_________________

48 Regulation (EU) 2019/881 of the European Parliament and of the Council of 17 April 2019 on ENISA (the European Union Agency for Cybersecurity) and on information and communications technology cybersecurity certification and repealing Regulation (EU) No 526/2013 (Cybersecurity Act) (OJ L 151, 7.6.2019, p. 15).

Or. en

Amendment 291

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

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union, as well as to instill the trust of citizens. To that end, a mandatory conformity assessment by notified bodies for EHR systems processing one or more priority categories of electronic health data should be conducted to overcome market fragmentation while ensuring compliance with robust security and data protection requirements. Through this conformity assessment, notified bodies should ascertain that EHR systems prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

_________________

Or. en

Amendment 292

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory conformity assessment procedure for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this procedure, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. Considering the sensitive data that will be processed via these systems, a self-certification regime is not an adequate option. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

_________________

Or. en

Amendment 293

Mathilde Androuët

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store in the Member States of the Union and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

_________________

Or. fr

Amendment 294

Konstantinos Arvanitis

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory third-party certification scheme by an independent body for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

_________________

Or. en

Amendment 295

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

Recital 27

Text proposed by the Commission

Amendment

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory third party assessment scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this third party assessment, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

_________________

Or. en

Amendment 296

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 27

Text proposed by the Commission

Amendment

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

(27) In order to ensure respect for the rights of natural persons and health professionals, EHR systems marketed in the internal market of the Union should be able to store and transmit, in a secure way, high quality electronic health data. This is a key principle of the EHDS to ensure the secure and free movement of electronic health data across the Union. To that end, a mandatory ex-ante self-certification scheme for EHR systems processing one or more priority categories of electronic health data should be established to overcome market fragmentation while ensuring a proportionate approach. Through this self-certification, EHR systems should prove compliance with essential requirements on interoperability and security, set at Union level. In relation to security, essential requirements should cover elements specific to EHR systems, as more general security properties should be supported by other mechanisms such as cybersecurity schemes under Regulation (EU) 2019/881 of the European Parliament and of the Council48.

_________________

Or. en

Amendment 297

Pernille Weiss

Proposal for a regulation

Recital 27 a (new)

Text proposed by the Commission

Amendment

(27 a) EHDS relies on national and European electronic health record systems, databases, and registries. In this regard, obligations are set out in Chapter III of this Regulation. It should however be recognized, that setting up obligations is not sufficient for creating a future-proof framework, which supports Europe's leadership position in health data usage and reap its benefits for citizens, industry, and other interests. As a supplement to obligations, there should be more research into the digital technology on which electronic health record systems, databases and registries are built in order to foster innovation.

Or. en

Amendment 298

Konstantinos Arvanitis

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28) While EHR systems specifically intended by the manufacturer to be used for processing one or more specific categories of electronic health data should be subject to mandatory self-certification, software for general purposes should not be considered as EHR systems, even when used in a healthcare setting, and should therefore not be required to comply with the provisions of Chapter III.

(28) While EHR systems specifically intended by the manufacturer to be used for processing one or more specific categories of electronic health data should be subject to mandatory third-party certification scheme by an independent body, software for general purposes should not be considered as EHR systems, even when used in a healthcare setting, and should therefore not be required to comply with the provisions of Chapter III.

Or. en

Amendment 299

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

Proposal for a regulation

Recital 28

Text proposed by the Commission

Amendment

(28) While EHR systems specifically intended by the manufacturer to be used for processing one or more specific categories of electronic health data should be subject to a mandatory conformity assessment by a notified body, software for general purposes should not be considered as EHR systems, even when used in a healthcare setting, and should therefore not be required to comply with the provisions of Chapter III.

Or. en

Amendment 300

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

Recital 28

Text proposed by the Commission

Amendment

(28) While EHR systems specifically intended by the manufacturer to be used for processing one or more specific categories of electronic health data should be subject to mandatory third party assessment, software for general purposes should not be considered as EHR systems, even when used in a healthcare setting, and should therefore not be required to comply with the provisions of Chapter III.

Or. en

Amendment 301

Nathalie Colin-Oesterlé

Proposal for a regulation

Recital 28 a (new)

Text proposed by the Commission

Amendment

(28a) Manufacturers of EHR systems which are not primarily intended to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records shall be encouraged to allow data generated by their device or software to be stored on the EHR system.

Or. fr

Amendment 302

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

Proposal for a regulation

Recital 30

Text proposed by the Commission

Amendment

(30) To further support interoperability and security, Member States may maintain or define specific rules for the procurement, reimbursement, financing or use of EHR systems at national level in the context of the organisation, delivery or financing of health services. Such specific rules should not impede the free movement of EHR systems in the Union. Some Member States have introduced mandatory certification of EHR systems or mandatory interoperability testing for their connection to national digital health services. Such requirements are commonly reflected in procurements organised by healthcare providers, national or regional authorities. Mandatory certification of EHR systems at Union level should establish a baseline that can be used in procurements at national level.

(30) To further support interoperability and security, Member States may maintain or define specific rules for the procurement, reimbursement, financing or use of EHR systems at national level in the context of the organisation, delivery or financing of health services. Such specific rules should not impede the free movement of EHR systems in the Union. Some Member States have introduced mandatory certification of EHR systems or mandatory interoperability testing for their connection to national digital health services. Such requirements are commonly reflected in procurements organised by healthcare providers, national or regional authorities. Mandatory certification of EHR systems at Union level via a conformity assessment procedure should establish a baseline that can be used in procurements at national level.

Or. en

Amendment 303

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

Proposal for a regulation

Recital 33

Text proposed by the Commission

Amendment

(33) Compliance with essential requirements on interoperability and security should be demonstrated by the manufacturers of EHR systems through the implementation of common specifications. To that end, implementing powers should be conferred on the Commission to determine such common specifications regarding datasets, coding systems, technical specifications, including standards, specifications and profiles for data exchange, as well as requirements and principles related to security, confidentiality, integrity, patient safety and protection of personal data as well as specifications and requirements related to identification management and the use of electronic identification. Digital health authorities should contribute to the development of such common specifications.

Or. en

Amendment 304

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

Proposal for a regulation

Recital 34

Text proposed by the Commission

Amendment

(34) In order to ensure an appropriate and effective enforcement of the requirements and obligations laid down in Chapter III of this Regulation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply. Depending on the organisation defined at national level, such market surveillance activities could be carried out by the digital health authorities ensuring the proper implementation of Chapter II or a separate market surveillance authority responsible for EHR systems. While designating digital health authorities as market surveillance authorities could have important practical advantages for the implementation of health and care, any conflicts of interest should be avoided, for instance by separating different tasks.

(34) In order to ensure an appropriate and effective enforcement of the requirements and obligations laid down in Chapter III of this Regulation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply. Depending on the organisation defined at national level, such market surveillance activities could be carried out by the digital health authorities ensuring the proper implementation of Chapter II, notified bodies for EHR systems or a separate market surveillance authority responsible for EHR systems. While designating digital health authorities or national notified bodies as market surveillance authorities could have important practical advantages for the implementation of health and care, any conflicts of interest should be avoided, for instance by separating different tasks.

Or. en

Amendment 305

Mathilde Androuët

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

(35) Users of wellness applications, such as mobile applications, should be informed about the capacity of such applications to be connected and to supply data to EHR systems or to national electronic health solutions, in cases where data produced by wellness applications is useful for healthcare purposes. The capability of those applications to export data in an interoperable format is also relevant for data portability purposes. Where applicable, users should be informed about the compliance of such applications with interoperability and security requirements. However, given the large number of wellness applications and the limited relevance for healthcare purposes of the data produced by many of them, a certification scheme for these applications would not be proportionate. A voluntary labelling scheme should therefore be established as an appropriate mechanism for enabling the transparency for the users of wellness applications regarding compliance with the requirements, thereby supporting users in their choice of appropriate wellness applications with high standards of interoperability and security. The Commission may set out in implementing acts the details regarding the format and content of such label.

deleted

Or. fr

Justification

As all wellness applications are made by profit-making companies for commercial purposes, they should not be allowed to exchange data with EHR systems or national electronic health solutions.

Amendment 306

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Wellness applications should not be included in the scope of the EHDS as they do not provide the same level of data quality and can reveal personal information beyond what is strictly relevant to healthcare.

Amendment 307

Konstantinos Arvanitis

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 308

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

deleted

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 309

Rob Rooken

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 310

Dolors Montserrat

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

(35) Users of wellness applications, such as mobile applications, should be informed about the capacity of such applications to be connected and to supply data to EHR systems or to national electronic health solutions, in cases where data produced by wellness applications is useful for healthcare purposes. The capability of those applications to export data in an interoperable format is also relevant for data portability purposes. Where applicable, users should be informed about the compliance of such applications with interoperability and security requirements. However, given the large number of wellness applications and the limited relevance for healthcare purposes of the data produced by many of them, a certification scheme for these applications would not be proportionate. A voluntary labelling scheme should therefore be established as an appropriate mechanism for enabling the transparency for the users of wellness applications regarding compliance with the requirements, thereby supporting users in their choice of appropriate wellness applications with high standards of interoperability and security. Labelling schemes may also include information for users on data protection rights and an indication of whether the application provider or browser operator has access in any way to the data generated by the application. The Commission may set out in implementing acts the details regarding the format and content of such label.

Or. es

Amendment 311

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

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

(35) Users of wellness applications, such as mobile applications, should be informed about the capacity of such applications to be connected and to supply data to EHR systems or to national electronic health solutions, in cases where data produced by wellness applications is useful for healthcare purposes. The capability of those applications to export data in an interoperable format is also relevant for data portability purposes. Where applicable, users should be informed about the compliance of such applications with interoperability and security requirements. However, given the large number of wellness applications and the limited relevance for healthcare purposes of the data produced by many of them, a certification scheme for these applications would not be proportionate. A mandatory labelling scheme should therefore be established as an appropriate mechanism for enabling the transparency for the users of wellness applications regarding compliance with the requirements, thereby supporting users in their choice of appropriate wellness applications with high standards of interoperability and security. Such labelling schemes should also include information for users on data protection rights and an indication of whether the provider of the app or the browser operator has access to data generated by the app in any way. The Commission should set out in implementing acts the details regarding the format and content of such label.

Or. en

Amendment 312

Margarita de la Pisa Carrión

Proposal for a regulation

Recital 35

Text proposed by the Commission

Amendment

Or. es

Amendment 313

Konstantinos Arvanitis

Proposal for a regulation

Recital 36

Text proposed by the Commission

Amendment

(36) The distribution of information on certified EHR systems and labelled wellness applications is necessary to enable procurers and users of such products to find interoperable solutions for their specific needs. A database of interoperable EHR systems and wellness applications, which are not falling within the scope of Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final] should therefore be established at Union level, similar to the European database on medical devices (Eudamed) established by Regulation (EU) 2017/745. The objectives of the EU database of interoperable EHR systems and wellness applications should be to enhance overall transparency, to avoid multiple reporting requirements and to streamline and facilitate the flow of information. For medical devices and AI systems, the registration should be maintained under the existing databases established respectively under Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final], but the compliance with interoperability requirements should be indicated when claimed by manufacturers, to provide information to procurers.

(36) The distribution of information on certified EHR systems is necessary to enable procurers and users of such products to find interoperable solutions for their specific needs. A database of interoperable EHR systems which are not falling within the scope of Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final] should therefore be established at Union level, similar to the European database on medical devices (Eudamed) established by Regulation (EU) 2017/745. The objectives of the EU database of interoperable EHR systems should be to enhance overall transparency, to avoid multiple reporting requirements and to streamline and facilitate the flow of information. For medical devices and AI systems, the registration should be maintained under the existing databases established respectively under Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final], but the compliance with interoperability requirements should be indicated when claimed by manufacturers, to provide information to procurers.

Or. en

Amendment 314

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 36

Text proposed by the Commission

Amendment

(36) The distribution of information on certified EHR systems is necessary to enable procurers and users of such products to find interoperable solutions for their specific needs. A database of interoperable EHR systems, which are not falling within the scope of Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final] should therefore be established at Union level, similar to the European database on medical devices (Eudamed) established by Regulation (EU) 2017/745. The objectives of the EU database of interoperable EHR systems should be to enhance overall transparency, to avoid multiple reporting requirements and to streamline and facilitate the flow of information. For medical devices and AI systems, the registration should be maintained under the existing databases established respectively under Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final], but the compliance with interoperability requirements should be indicated when claimed by manufacturers, to provide information to procurers.

Or. en

Amendment 315

Rob Rooken

Proposal for a regulation

Recital 36

Text proposed by the Commission

Amendment

(36) The distribution of information on certified EHR systems is necessary to enable procurers and users of such products to find interoperable solutions for their specific needs. A database of interoperable EHR systems, which are not falling within the scope of Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final] should therefore be established at Union level, similar to the European database on medical devices (Eudamed) established by Regulation (EU) 2017/745. The objectives of the EU database of interoperable EHR systems should be to enhance overall transparency, to avoid multiple reporting requirements and to streamline and facilitate the flow of information. For medical devices and AI systems, the registration should be maintained under the existing databases established respectively under Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final], but the compliance with interoperability requirements should be indicated when claimed by manufacturers, to provide information to procurers.

Or. en

Amendment 316

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

Recital 36 a (new)

Text proposed by the Commission

Amendment

(36 a) The uptake of real-world data and real-world evidence, including patient reported outcomes, for evidence-based regulatory and policy purposes as well as for research, health technology assessment and clinical objectives should be encouraged. Real-world data and real-world evidence have the potential to complement randomised clinical trial data and is particularly relevant when assessing safety and medicinal effectiveness of innovative products, such as, but not limited to Advanced Therapies Medicinal Products (ATMPs), particularly in the rare disease domain.

Or. en

Amendment 317

Cristian-Silviu Buşoi

Proposal for a regulation

Recital 36 a (new)

Text proposed by the Commission

Amendment

(36 a) For the purpose of the evaluation of the benefits and risks of medicinal products and of the identification and assessment of threats to human health posed by infectious diseases, the EMA and the ECDC shall be granted rapid access to the health data within the EHDS.

Or. en

Amendment 318

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) For the secondary use of the clinical data for research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides the safeguards. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.

(37) For the secondary use of the personal electronic health data for research and development, policy making, regulatory purposes, patient safety or the treatment of natural persons, the requirements provided for in Regulation (EU) 2016/679 for a Union law should be used as a basis. For processing of personal electronic health data for secondary use, a legal basis set out in points (a), (c), (e) of Article 6(1) combined with a further legal basis set out in Article 9(2) of Regulation (EU) 2016/679 is required. The most relevant processing grounds listed in Article 9(2) of Regulation (EU) 2016/679 in this context concern the consent of the data subject (point (a)), substantial public interest (point (g)), the provision of health or social care (point (h)), public interest in the area of public health (point (i)), and research (point (j)). Hence, this Regulation provides the specific legal basis for such processing in accordance with Article 9(2) (a), (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 in combination with Articles 9(2) (a), (g), (h), (i) and (j) of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. For processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. The data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data, in accordance with Regulation (EU) 2016/679 and this Regulation.

Or. en

Amendment 319

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) For the secondary use, not requiring consent, of certain clinical data for health-related research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use, not requiring consent, of certain health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to that health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of certain electronic health data held by the data holder pursuant to this Regulation, this Regulation, in certain cases, creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing that data, for secondary use, by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to bodies involved in accessing health data (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. This applies equally to the activities of the application processing body that examines and, where appropriate, approves data access applications by data users, without storing health data itself, and to the activities of the pseudonymisation body that pseudonymises the electronic health data prior to storage at health data access bodies. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which certain electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides the safeguards. In this context, the data permits issued by the application processing bodies are an administrative decision defining the conditions for the access to the data.

Or. de

Amendment 320

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) For the secondary use of the clinical data for research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, this Regulation provides the appropriate and necessary safeguards. In addition, this Regulation should create a right for data users to process special categories of personal data referred to Article 9(1) of Regulation (EU)2016/679 subject to those same safeguards. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.

Or. en

Amendment 321

Stelios Kympouropoulos

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) For the secondary use of the clinical data for research, innovation, health professionals' training, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides the safeguards. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.

Or. en

Amendment 322

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) For the secondary use of the clinical data for research, innovation, scientific development, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides the safeguards. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.

Or. en

Amendment 323

Mathilde Androuët

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) For the secondary use of the electronic health data for research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically, for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides the safeguards. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.

Or. fr

Amendment 324

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

Proposal for a regulation

Recital 37

Text proposed by the Commission

Amendment

(37) For the secondary use of the clinical data for research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, the necessary safeguards must be determined in accordance to this Regulation. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.

Or. en