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

AM_Com_LegReport

Amendment 1125

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

Proposal for a regulation

Article -33 (new)

Text proposed by the Commission

Amendment

Article -33

Scope

This Chapter shall apply to situations of secondary use of electronic health data where a health data user seeks access to such data, as referred to in Article 33, from one or more health data holders as defined in Article 2 (y) of this Regulation.

Or. en

Justification

Necessary addition to mirror Article -3 and to clarify that in secondary use health data holder is broader than in primary use.

Amendment 1126

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

Proposal for a regulation

Article -33 a (new)

Text proposed by the Commission

Amendment

Article -33 a

Rights of natural persons in relation to the secondary use of electronic health data

Natural persons shall have the right to opt-out from sharing their electronic health data for secondary use. A mechanism shall be put in place to allow natural persons the flexibility to determine the categories of electronic health data and/or purposes from which they wish to opt out. Such mechanism shall be easily accessible, comprehensible and actionable.

Or. en

Amendment 1127

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

Proposal for a regulation

Article 33 – title

Text proposed by the Commission

Amendment

Minimum categories of electronic data for secondary use

Minimum categories of electronic health data for secondary use

Or. en

Amendment 1128

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – title

Text proposed by the Commission

Amendment

Minimum categories of electronic data for secondary use

Categories of electronic data for secondary use

Or. en

Amendment 1129

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

1. Data holders shall make the following categories of electronic data available for secondary use upon request and only with consent from the data subject in the case of personal data, and with the option to give or refuse consent for individual data categories and purposes, in accordance with the provisions of this Chapter:

Or. en

Amendment 1130

Jessica Polfjärd

Proposal for a regulation

Article 33 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

1. Data holders shall make the following categories of electronic data available, taking into account the differences in administrative, logistical and resource requirements for each category in the member states, for secondary use in accordance with the provisions of this Chapter:

Or. en

Amendment 1131

Margarita de la Pisa Carrión

Proposal for a regulation

Article 33 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter, in such a manner so as not to conflict with the holder’s legal and ethical obligations:

Or. es

Amendment 1132

Tudor Ciuhodaru

Proposal for a regulation

Article 33 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

1. Data holders shall, through a secure system ensuring protection of the patients’ data, make the following categories of electronic data available for secondary use, in accordance with the provisions of this Chapter:

Or. ro

Amendment 1133

Konstantinos Arvanitis

Proposal for a regulation

Article 33 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

1. After having obtained consent of the data subjects, data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

Or. en

Amendment 1134

Mathilde Androuët

Proposal for a regulation

Article 33 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

1. Data holders shall make the following categories of non-personal electronic data available for secondary use in accordance with the provisions of this Chapter:

Or. fr

Amendment 1135

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

Proposal for a regulation

Article 33 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

1. This Chapter shall apply to the following categories of electronic health data available for secondary use:

Or. en

Amendment 1136

Traian Băsescu

Proposal for a regulation

Article 33 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:

1. This Chapter shall apply to the following categories of electronic data for secondary use, in accordance with the provisions of this Chapter:

Or. ro

Amendment 1137

Beata Kempa

Proposal for a regulation

Article 33 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) EHRs;

deleted

Or. en

Amendment 1138

Javier Zarzalejos

Proposal for a regulation

Article 33 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) EHRs;

(a) electronic health data from EHRs, including the categories in Article 5 of this Regulation.

Or. en

Amendment 1139

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) EHRs;

(a) electronic health data from EHRs, including the categories in Article 5 of this Regulation;

Or. en

Amendment 1140

Traian Băsescu

Proposal for a regulation

Article 33 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) EHRs;

(a) electronic health data from EHRs;

Or. ro

Amendment 1141

Rob Rooken

Proposal for a regulation

Article 33 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) EHRs;

(a) electronic health data from EHRs ;

Or. en

Amendment 1142

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

Proposal for a regulation

Article 33 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) EHRs;

(a) electronic health data from EHRs;

Or. en

Amendment 1143

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

Proposal for a regulation

Article 33 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) EHRs;

(a) electronic health data from EHRs;

Or. en

Amendment 1144

Beata Kempa

Proposal for a regulation

Article 33 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) EHRs;

(a) non-personal EHRs;

Or. pl

Amendment 1145

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) data impacting on health, including social, environmental behavioural determinants of health;

deleted

Or. en

Justification

This type of data is too broad and vague to be included.

Amendment 1146

Rob Rooken

Proposal for a regulation

Article 33 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) data impacting on health, including social, environmental behavioural determinants of health;

deleted

Or. en

Amendment 1147

Javier Zarzalejos

Proposal for a regulation

Article 33 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) data impacting on health, including social, environmental behavioural determinants of health;

(b) data on factors impacting on health, including social environmental behavioural determinants of health, but excluding data relating to criminal convictions and offences;

Or. en

Amendment 1148

Traian Băsescu

Proposal for a regulation

Article 33 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) data impacting on health, including social, environmental behavioural determinants of health;

(b) data on factors impacting on health, including social, environmental behavioural determinants of health;

Or. ro

Amendment 1149

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) data impacting on health, including social, environmental behavioural determinants of health;

(b) non-personal data about determinants impacting health, including social, environmental and behavioural;

Or. en

Amendment 1150

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

Proposal for a regulation

Article 33 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) data impacting on health, including social, environmental behavioural determinants of health;

(b) data on factors impacting on health, including social, environmental behavioural determinants of health;

Or. en

Amendment 1151

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

Proposal for a regulation

Article 33 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) data impacting on health, including social, environmental behavioural determinants of health;

(b) data on factors impacting on health, including social, environmental behavioural determinants of health;

Or. en

Amendment 1152

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1153

Beata Kempa

Proposal for a regulation

Article 33 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. pl

Amendment 1154

Beata Kempa

Proposal for a regulation

Article 33 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) health-related administrative data, including claims and reimbursement data;

deleted

Or. pl

Amendment 1155

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) health-related administrative data, including claims and reimbursement data;

(d) health-related administrative data for population-wide predominantly publicly funded treatments, including claims and reimbursement data;

Or. de

Amendment 1156

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

Proposal for a regulation

Article 33 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) health-related administrative data, including claims and reimbursement data;

(d) healthcare-related administrative data, including claims and reimbursement data;

Or. en

Amendment 1157

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) health-related administrative data, including claims and reimbursement data;

(d) healthcare-related administrative data;

Or. en

Amendment 1158

Rob Rooken

Proposal for a regulation

Article 33 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) health-related administrative data, including claims and reimbursement data;

(d) administrative data underlying the provision of health care services;

Or. en

Amendment 1159

Beata Kempa

Proposal for a regulation

Article 33 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) human genetic, genomic and proteomic data;

deleted

Or. pl

Amendment 1160

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) human genetic, genomic and proteomic data;

deleted

Or. de

Amendment 1161

Rob Rooken

Proposal for a regulation

Article 33 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) human genetic, genomic and proteomic data;

deleted

Or. en

Amendment 1162

Konstantinos Arvanitis

Proposal for a regulation

Article 33 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) human genetic, genomic and proteomic data;

deleted

Or. en

Amendment 1163

Beata Kempa

Proposal for a regulation

Article 33 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) human genetic, genomic and proteomic data;

deleted

Or. en

Amendment 1164

Joanna Kopcińska

Proposal for a regulation

Article 33 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) human genetic, genomic and proteomic data;

deleted

Or. en

Amendment 1165

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) human genetic, genomic and proteomic data;

(e) human genetic, genomic and proteomic data. This data shall only be used for the purposes in points (a), (b) or (c) of paragraph 1 of Article 34;

Or. en

Amendment 1166

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

Proposal for a regulation

Article 33 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) human genetic, genomic and proteomic data;

(e) extracts from human genetic, genomic and proteomic data, such as genetic markers;

Or. en

Amendment 1167

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

deleted

Or. en

Amendment 1168

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

deleted

Or. en

Justification

This type of data is too broad and vague to be included.

Amendment 1169

Konstantinos Arvanitis

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

deleted

Or. en

Amendment 1170

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

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

deleted

Or. en

Amendment 1171

Beata Kempa

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

(f) person-generated electronic health data, including medical devices;

Or. pl

Amendment 1172

Andreas Glück

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

(f) person generated electronic health data via medical devices

Or. en

Justification

Data for secondary use will only have value if its reliable and its quality is guaranteed. Thus, only person generated data via classified medical devices should be included

Amendment 1173

Kateřina Konečná

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

(f) person generated electronic health data from medical devices;

Or. en

Justification

Wellness and other digital health applications collect personal data that are not related to health such as location, meaning they should not be included. Wellness and behaviour data may indirectly reveal sensitive information.

Amendment 1174

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

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

(f) person generated electronic health data from medical devices;

Or. en

Amendment 1175

Rob Rooken

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

(f) person generated electronic health data, including medical devices;

Or. en

Amendment 1176

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

Proposal for a regulation

Article 33 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;

(f) person generated electronic health data from medical devices, wellness applications or other digital health applications;

Or. en

Amendment 1177

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) identification data related to health professionals involved in the treatment of a natural person;

deleted

Or. en

Amendment 1178

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) identification data related to health professionals involved in the treatment of a natural person;

deleted

Or. en

Justification

It is not clear what the added value of this information would be, especially as by design most of the data should be anonymised anyway.

Amendment 1179

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 33 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) identification data related to health professionals involved in the treatment of a natural person;

(g) identification data related to health professionals involved in research should be limited to data which are absolutely necessary;

Or. en

Amendment 1180

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 33 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) identification data related to health professionals involved in the treatment of a natural person;

(g) identification data related to health professionals involved in research should be limited to data which is absolutely necessary;

Or. en

Amendment 1181

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

Proposal for a regulation

Article 33 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) population wide health data registries (public health registries);

(h) population wide health data registries (public health registries) and patient demographic data;

Or. en

Amendment 1182

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) population wide health data registries (public health registries);

(h) population wide electronic health data registries (public health registries);

Or. de

Amendment 1183

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

Proposal for a regulation

Article 33 – paragraph 1 – point i

Text proposed by the Commission

Amendment

(i) electronic health data from medical registries for specific diseases;

(i) electronic health data from medical registries;

Or. en

Justification

The limitation to specific diseases needs to be deleted as the scope would be too narrow. As it stands, it would exclude data on the treatment of e.g. severe accidental injuries.

Amendment 1184

Javier Zarzalejos

Proposal for a regulation

Article 33 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) electronic health data from clinical trials;

deleted

Or. en

Amendment 1185

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 33 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) electronic health data from clinical trials;

(j) electronic health data from fully completed clinical trials, in accordance with definitions in Article 2(2) and Article 2(26) of Regulation (EU) No 536/2014;

Or. en

Amendment 1186

Tomislav Sokol

Proposal for a regulation

Article 33 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) electronic health data from clinical trials;

(j) electronic health data from fully completed clinical trials in accordance with definitions in Article 2(2) and Article 2(26) of Regulation (EU) No 536/2014;

Or. en

Amendment 1187

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 33 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) electronic health data from clinical trials;

(j) electronic health data from fully completed clinical trials in accordance with definitions in Article 2(2) and Article 2(26) of Regulation (EU) No 536/2014;

Or. en

Amendment 1188

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

Proposal for a regulation

Article 33 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) electronic health data from clinical trials;

(j) electronic health data from fully concluded or terminated clinical trials, in accordance with Regulation 536/2014;

Or. en

Amendment 1189

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) electronic health data from clinical trials;

(j) electronic health data from clinical trials in so far as they have been completed;

Or. de

Amendment 1190

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 33 – paragraph 1 – point j a (new)

Text proposed by the Commission

Amendment

(j a) Data referred to in paragraph 1(j) should be made available in the format outlined in Annex IV in Regulation No 536/2014 or, if requested by the public sector, as defined in the Data Act Article 15 (a) or (b).

Or. en

Amendment 1191

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 33 – paragraph 1 – point j b (new)

Text proposed by the Commission

Amendment

(j b) Regarding electronic health data referred to in paragraph 1(j) of this Article, a summary of results of the clinical trial will be published and individual patient data may be shared, in accordance with Article 37(4) of Regulation (EU) No 536/2014.

Or. en

Amendment 1192

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

Proposal for a regulation

Article 33 – paragraph 1 – point k

Text proposed by the Commission

Amendment

(k) electronic health data from medical devices and from registries for medicinal products and medical devices;

(k) electronic health data from medical devices and from registries for medicinal products and medical devices, including medical audio and video material;

Or. en

Amendment 1193

Pernille Weiss

Proposal for a regulation

Article 33 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) research cohorts, questionnaires and surveys related to health;

(l) research cohorts, questionnaires and surveys related to health, including patient-reported outcome measures and patient-reported experience measures;

Or. en

Amendment 1194

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

Proposal for a regulation

Article 33 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) research cohorts, questionnaires and surveys related to health;

(l) research cohorts, questionnaires and surveys related to health, including patient-reported outcomes and experience measures (PROMs and PREMs);

Or. en

Amendment 1195

Traian Băsescu

Proposal for a regulation

Article 33 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) research cohorts, questionnaires and surveys related to health;

(l) data from research cohorts, questionnaires and surveys related to health;

Or. ro

Amendment 1196

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) research cohorts, questionnaires and surveys related to health;

(l) data from research cohorts, questionnaires and surveys related to health;

Or. en

Amendment 1197

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) research cohorts, questionnaires and surveys related to health;

(l) data from research cohorts, questionnaires and surveys related to health;

Or. en

Amendment 1198

Christian Doleschal

Proposal for a regulation

Article 33 – paragraph 1 – point m

Text proposed by the Commission

Amendment

(m) electronic health data from biobanks and dedicated databases;

deleted

Or. de

Amendment 1199

Beata Kempa

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

deleted

Or. pl

Amendment 1200

Konstantinos Arvanitis

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

deleted

Or. en

Amendment 1201

Joanna Kopcińska

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

deleted

Or. en

Amendment 1202

Sophia in 't Veld, Véronique Trillet-Lenoir

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

deleted

Or. en

Amendment 1203

Rob Rooken

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

deleted

Or. en

Amendment 1204

Beata Kempa

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

deleted

Or. en

Amendment 1205

Véronique Trillet-Lenoir, Fabienne Keller, Max Orville

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

deleted

Or. en

Amendment 1206

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

deleted

Or. en

Amendment 1207

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

deleted

Or. en

Justification

It is unclear why tis type of data would be needed in the first place.

Amendment 1208

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

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

(n) electronic data related to insurance status, professional status, education;

Or. en

Amendment 1209

Kateřina Konečná

Proposal for a regulation

Article 33 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) electronic data related to insurance status, professional status, education, lifestyle, wellness and behaviour data relevant to health;

(n) electronic data related to insurance status, professional status, education and lifestyle data relevant to health;

Or. en

Justification

Amendment 1210

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Data in categories (b) and (l) shall only be made available if the data have been collected systematically and comprehensively from data subjects. The fact that a public body, a body governed by public law or a public undertaking within the meaning of Regulation (EU) 2022/868 [Data Governance Act] is involved in the collection of data shall not constitute predominantly public funding of data collection. Data holders shall not be obliged to make unlisted categories of data available for secondary use in accordance with the provisions of this Chapter.

Or. de

Amendment 1211

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 33 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Data holders have the right to refuse access to the data referred to in par.1 for one of the following reasons:

a) if there are legal or contractual impediments that prevent the data holder from sharing;

b) if it could compromise the scientific integrity of a scientific research study, including a clinical trial;

c) if it could compromise the protection of data entailing IP rights (including trade secrets) or commercial property, with the scope of each category of data to be further clarified;

Or. en

Amendment 1212

Javier Zarzalejos

Proposal for a regulation

Article 33 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Data holders have the right to refuse access to their data if there are legal or contractual impediments that prevent them from sharing, if it could compromise the scientific integrity of a scientific research study, including a clinical trial, or if it could compromise the protection of IP rights (including trade secrets) or commercial property.

Or. en

Amendment 1213

Sirpa Pietikäinen

Proposal for a regulation

Article 33 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The data made available by data holders needs to be gender-aggregated and gender sensitive for research purposes, as well as analysed in a gender sensitive manner.

Or. en

Amendment 1214

Konstantinos Arvanitis

Proposal for a regulation

Article 33 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Health data of natural persons registered by health professionals in accordance with Article 7 shall be requested from the EHR systems concerned.

Or. en

Amendment 1215

Joanna Kopcińska

Proposal for a regulation

Article 33 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. This Regulation shall not apply to activities concerning public security, defence and national security.

Or. en

Amendment 1216

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

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59.

deleted

_________________

59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

Or. en

Justification

Moved to Art. 41 which contains duties of health data holders.

Amendment 1217

Dolors Montserrat

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59.

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59. The requirement in the first subparagraph shall not apply to data holders who fall within the category of small enterprises in the context of health professional practices.

_________________

59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

Or. es

Amendment 1218

Margarita de la Pisa Carrión

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59.

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59nor to the category of small enterprises in the context of health professional practices.

_________________

59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

Or. es

Amendment 1219

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59.

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises and small enterprises in the context of healthcare professionals’ practices and pharmacies as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59.

_________________

59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

Or. en

Amendment 1220

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

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59.

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro and small enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59in the context of healthcare provision.

_________________

59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

Or. en

Amendment 1221

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 2

Text proposed by the Commission

Amendment

2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59.

2. The requirement in the first sentence of the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59.

_________________

59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).

Or. de

Amendment 1222

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

Proposal for a regulation

Article 33 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission, together with the Member States, will define measures to protect the personal data of healthcare professionals involved in the treatment of a natural person, in order to prevent the possibility of identifying which prescriptions doctors administer to their patients.

Or. en

Amendment 1223

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission

Amendment

3. The electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health, research, innovation, policy making, official statistics, patient safety or regulatory purposes, collected by entities and bodies in the health or care sectors, including public and private providers of health or care, entities or bodies performing research in relation to these sectors, and Union institutions, bodies, offices and agencies.

deleted

Or. en

Justification

Paragraph 1 already defines the data categories to be made available for secondary use.

Amendment 1224

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

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission

Amendment

3. The electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health, research, innovation, policy making, official statistics, patient safety or regulatory purposes, including real-world data and real-world evidence, collected by entities and bodies in the health or care sectors, including public and private providers of health or care, entities or bodies performing research in relation to these sectors, and Union institutions, bodies, offices and agencies.

Or. en

Amendment 1225

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission

Amendment

3. The electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health, research, innovation, policy making, official statistics, patient safety or regulatory purposes, collected by entities and bodies in the health sector, including public and private providers of health or care, entities or bodies performing research in relation to these sectors, and Union institutions, bodies, offices and agencies.

Or. de

Amendment 1226

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission

Amendment

3. The electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health, research, innovation, policy making, official statistics, patient safety or regulatory purposes, collected by entities and bodies in the health or care sectors, including public providers of health or care, entities or bodies performing research in relation to these sectors, and Union institutions, bodies, offices and agencies.

Or. en

Amendment 1227

Konstantinos Arvanitis

Proposal for a regulation

Article 33 – paragraph 3

Text proposed by the Commission

Amendment

3. The electronic health data referred to in paragraph 1 shall cover data processed for the provision of health or care or for public health, research, policy making, official statistics, patient safety or regulatory purposes, collected by entities and bodies in the health or care sectors, including public and private providers of health or care, entities or bodies performing research in relation to these sectors, and Union institutions, bodies, offices and agencies.

Or. en

Amendment 1228

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. When electronic health data is made available for secondary use through health data access bodies, the beneficiary shall respect the principle of open science, and provide open access to research or processing results, following the principle ‘as open as possible, as closed as necessary’, in full respect of this Regulation and other applicable laws. Derogations from the open access requirements and open access practices shall be duly justified. The Commission shall closely monitor this, and any derogations shall be made public on the Commission’s web-portal.

Or. en

Justification

Following Horizon Europe pattern, and considering that secondary use is an additional befit for some stakeholder, this advantage has to come with a public return.

Amendment 1229

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

Proposal for a regulation

Article 33 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. The natural person shall receive information about the benefits of providing access to their health data for secondary use.

Or. en

Amendment 1230

Giuseppe Ferrandino

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use. Where such data is made available for secondary use, all measures necessary to preserve the confidentiality of IP rights and trade secrets shall be taken.

deleted

(One of the fundamental principles of intellectual property and commercial property is that they can only be used by the owner or by others with the owner's permission only. In terms of trade secret law, the trade secret holder must take appropriate steps to prevent the disclosure of relevant information and data. It appears that the proposal requires the owner to grant others permission to use their intellectual property or commercial property, including the disclosure of trade secrets.)

Or. en

Amendment 1231

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Without prejudice to the law relating to the protection of intellectual property and industrial property (including of trade secrets) (“IP rights”) and commercial property, electronic health data entailing protected IP rights from private enterprises shall be made available for secondary use. Data sharing should be based on a data sharing agreement persuant to Articles 46.6(g) and 46A between data holders and data users that respects the conditions of use listed in article 33(4a). Where such data is made available for secondary use, all measures necessary to preserve the confidentiality of IP rights, including trade secrets, shall be taken in advance. The data holder shall identify the data which are protected as trade secrets. When no agreement is reached regarding the necessary measures to preserve the confidentiality of trade secrets or the recepient fails to implement those measures, the data holder is entitled to refuse the user’s access to data which are protected as trade secrets.

Or. en

Amendment 1232

Andreas Glück

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Electronic health data entailing protected intellectual property and trade secrets from health data holders shall be made available for secondary use. For data defined under Article 33 (k) (medical devices) where data holder can demonstrate that data are derived or inferred by means of complex proprietary algorithms and can lead to reverse engineering, data holder should be entitled to refer to data coordinator as established under Article 31 of Regulation (Data Act) to request a restriction or limitation of the sharing of data. Where such data is made available for secondary use, all measures necessary to preserve IP rights and confidentiality of trade secrets shall be taken. This regulation is without prejudice to Union and national legal acts providing for the protection of intellectual property rights, including Directive 2001/29/EC, Directive 2004/48/EC, Directive (EU) 2016/943 and Directive (EU) 2019/790.

Or. en

Justification

This AM is inspired from the proposal on the Data Act. It ensures that as much data as possible will be shared while justified interest of data holders are duly respected. Whenever concerns with regard to the sharing of data arise, the data holder should should request an exemption to share the data from the data controller. At the same time it should be noted, that this mechanism is without prejudice to existing Union Regulation as mentioned

Amendment 1233

Javier Zarzalejos

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Without prejudice to the law relating to the protection of intellectual property, industrial property and commercial property rights, and subject to other provisions of this Regulation, electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use only if all measures necessary to preserve the confidentiality of IP rights (including trade secrets) are taken. Data sharing should be based on a data sharing agreement that respects the provisions of Union legislation, in particular of Directive on the Protection of Trade Secrets (Directive (EU) 2016/943, Article 6(2)(e) of the Data Act, Article 39 of TRIPS, and of Articles 9, 11 and 13 Directive 2004/48 on the enforcement of intellectual property rights in relation to preliminary injunctions, injunctions and damages.

Or. en

Amendment 1234

Tomislav Sokol

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Without prejudice to the law relating to the protection of intellectual property and industrial property (including of trade secrets)(“IP rights”) and commercial property, and subject to other provisions of this Regulation, electronic health data entailing protected IP rights from private enterprises shall be made available for secondary use. Where such data is made available for secondary use, all measures necessary to preserve the confidentiality of IP rights (including trade secrets) shall be taken. Data sharing for secondary use shall be based on a data sharing agreement pursuant to Articles 46.6(g) and 46a.

Or. en

Amendment 1235

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

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Electronic health data entailing protected intellectual property and trade secrets from health data holders shall be made available for secondary use. Where such data is made available for secondary use, all technical and organisational measures necessary to preserve the confidentiality of IP rights and confidentiality of trade secrets shall be taken by the health data access body and in consultation with the data holder. This regulation is without prejudice to existing relevant Union legislation, including Directive 2004/48/EC, Directive 2001/29/EC, Directive (EU) 2016/943 and Directive (EU) 2019/790.

Or. en

Amendment 1236

Pernille Weiss

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Without prejudice to applicable legislation on intellectual property rights, regulatory data protection and trade secrets, electronic health data entailing protected intellectual property, regulatory data protection or trade secrets from private enterprises shall be made available for secondary use. Where such data is made available for secondary use, all measures necessary to preserve the confidentiality of IP rights, protected regulatory data and trade secrets shall be taken.

Or. en

Amendment 1237

Axel Voss

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Electronic health data entailing protected intellectual property and trade secrets shall not be made available for secondary use.

Or. en

Amendment 1238

Margarita de la Pisa Carrión

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

Or. es

Amendment 1239

Jessica Polfjärd

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall only be made available for secondary use when all measures necessary to preserve the confidentiality of IP rights and trade secrets have been taken.

Or. en

Amendment 1240

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 4

Text proposed by the Commission

Amendment

4. Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use if and to the extent that all measures necessary to preserve the confidentiality of IP rights and trade secrets can be taken, for example by taking the following measures:

Or. de

Amendment 1241

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

Proposal for a regulation

Article 33 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Health data holders shall, when making available to health data access bodies relevant electronic health data pursuant to Article 41(1) which contains intellectual property or trade secrets, inform the data access body that this is the case and indicate which parts of the datasets are concerned.

Or. en

Amendment 1242

Peter Liese

Proposal for a regulation

Article 33 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Given its ability to further decode confidential patient information, constitutional (germline) genomic data must be strongly protected, and it should be processed separately from somatic molecular data.

Or. en

Justification

Constitutional (germline) genomic data, can be used to decode confidential patient information; hence it should be particularly well protected and processed separately from somatic molecular data.

Amendment 1243

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4a. Extending the period for making data available to 24 months in order to allow for registration of property rights; or

Or. de

Amendment 1244

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

Proposal for a regulation

Article 33 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4 b. Should the health data access body be in no position to ensure the protection of IP rights and the confidentiality of trade secrets, it shall refuse the granting of the relevant health data access permit to the health data user.

Or. en

Amendment 1245

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 4 b (new)

Text proposed by the Commission

Amendment

4b. Processing data to ensure that trade secrets are redacted.

Or. de

Amendment 1246

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

Proposal for a regulation

Article 33 – paragraph 4 c (new)

Text proposed by the Commission

Amendment

4 c. Health data holders and health data users may conclude data sharing agreements with regards to the exchange of data containing IP and trade secrets. Such negotiations shall be overseen by the relevant health data access body.

Or. en

Amendment 1247

Proposal for a regulation

Article 33 – paragraph 4 d (new)

Text proposed by the Commission

Amendment

4 d. Public sector bodies or Union institutions, agencies and bodies that obtain access to electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, shall take all specific technical and organisational measures necessary to preserve the confidentiality of such data.

Or. en

Justification

Moved to this Article from Art. 34(4) in order to put all IP-related provisions together in one place.

Amendment 1248

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

deleted

Or. de

Amendment 1249

Konstantinos Arvanitis

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

deleted

Or. en

Amendment 1250

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

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

deleted

Or. en

Amendment 1251

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

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

deleted

Or. en

Amendment 1252

Javier Zarzalejos

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. Natural persons that are subjects to secondary use of health data shall have the right to decline the processing of their health data. Health data access bodies shall provide for an accessible and easily understandable opt-out mechanism, whereby natural persons must be offered the possibility to restrict full or partial access to their personal health data for all or parts of secondary use. Data subjects should indicate this decision to the health data access bodies. In situation where natural persons explicitly express their wish to use opt-out mechanism to data holders, data holders shall direct natural persons to the health data access bodies, which shall provide an opt-out template for the data subject. The exercise of this right to opt-out shall not affect the lawfulness of the processing that took place under Chapter IV before the individual opted-out. The opt-out mechanism shall function without prejudice to Article 21(6) of Regulation (EU) 2016/679, whereby the right to object may be restricted when the processing of personal data is necessary for the performance of a task carried out for reasons of public interest.

Or. en

Amendment 1253

Tomislav Sokol

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data. Natural persons persons that are subjects to secondary use of health data shall have the right to decline the processing of their health data. Health data access bodies shall provide for an accessible and easily understandable opt-out mechanism, whereby natural persons must be offered the possibility to explicitly express their wish not to have all or part of their personal electronic health data processed for some or all secondary use purposes. In situation where natural persons explicitly express their wish to use opt-out mechanism to data holders, data holders shall direct natural persons to the health data access bodies. The exercise of this right to opt-out shall not affect the lawfulness of the processing that took place under this Chapter IV before the individual opted-out.

Or. en

Amendment 1254

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. Where the explicit consent of the natural person is required by Member State law pursuant to paragraph 4 of Article 9 of Regulation (EU) 2016/679, health data access bodies shall ensure the related obligations are met prior to providing access to electronic health data pursuant to Chapter IV of this Regulation. Where Member State law, pursuant to the same provision, excludes the giving of consent for certain data categories or processing purposes, the data must not be processed under the provisions of this Chapter.

Or. en

Amendment 1255

Cristian-Silviu Buşoi

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. Natural persons that are subjects to secondary use of health data shall have the right to decline the processing of their health data, except for the uses covered under Article 34(1) (a)-(c). In all other cases, health data access bodies shall provide for an accessible and easily understandable opt-out mechanism, whereby natural persons must be offered the possibility to explicitly express their wish not to have all or part of their personal electronic health data processed for some or all secondary use purposes. In situation where natural persons explicitly express their wish to use the opt-out mechanism to data holders, data holders shall direct natural persons to the health data access bodies.

Or. en

Amendment 1256

Konstantinos Arvanitis

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

Or. en

Justification

Fallback approach, in case our preferred option of opt-in does not find a majority.

Amendment 1257

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. An accessible and easily understandable mechanism shall be provided to natural persons, whereby they shall be asked for their consent to have their health data processed for some or all of the purposes of secondary use, by one or more data users. If a natural person does not give explicit consent, their health data shall not be processed for secondary use. Natural persons shall retain the right to withdraw their consent at any moment. Where data users process electronic health data solely on the basis of consent within the meaning of Article 4(11) of Regulation (EU) 2016/679, the scope of all possible processing should be determined by the scope of the prior obtained consent.

Or. en

Amendment 1258

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. To the extent the electronic health data referred to in paragraph 1(a) includes personal data, the individual concerned shall be offered an additional safeguard in the form of a right to opt-out from the use of his personal data under Chapter IV of this regulation. The exercise of this right to opt-out shall not affect the lawfulness of the processing that took place under this Chapter IV before the individual opted-out

Or. en

Amendment 1259

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

Health data access bodies shall in general use an opt-out regime for consent. An opt-in regime shall be put in place as an exception for consent from people with rare diseases.

Or. fr

Justification

The fact that patients with rare diseases are at higher risk of being identified, even with the use of anonymisation techniques, warrants having an additional layer of security to the granting of consent.

Amendment 1260

Mathilde Androuët

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. As a matter of principle, the right to object is to be granted to natural persons whose health data is used for secondary purposes, so that they are able to fully consent to the use of the said health data. This right shall be freely exercised, without constraint, by the user, who may at any time decide to review the choice they made regarding the use of their health data for secondary purposes.

Or. fr

Amendment 1261

Traian Băsescu

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. The consent of the natural persons or their representatives must be sought for the processing of all or part of the electronic health data for secondary use. They shall also have the right to refuse, or alter their decision on, the processing of health data for secondary use, without this in any way affecting the quality of the healthcare received.

Or. ro

Amendment 1262

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. Natural persons shall have the right to decline the processing of their health data. Health data access bodies shall provide for an accessible and easily understandable opt-out mechanism, whereby natural persons must be offered the possibility to explicitly express their wish not to have their personal electronic health data processed for secondary use purposes.

Or. en

Amendment 1263

István Ujhelyi

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. Health data access bodies shall ensure that national requirements for access to electronic health data, such as the consent of natural persons, a right to object to the disclosure of their health data or the involvement of ethics committees, are met before providing access to electronic health data.

Or. en

Amendment 1264

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

Proposal for a regulation

Article 33 – paragraph 5

Text proposed by the Commission

Amendment

5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data.

5. Natural persons that are subjects to secondary use of health data shall be asked for explicit consent prior to the processing of their health data. Health data access bodies shall provide for an accesible and easily understandable opt-in mechanism.

Or. en

Amendment 1265

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

Proposal for a regulation

Article 33 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Natural persons shall have the right to decline the processing of parts or all of their electronic health data for secondary use. In this regard, health data access bodies shall provide an easily understandable and accessible opt-out mechanism in a user-friendly format whereby natural persons have the option to explicitly remove parts or all of their electronic health data to be processed for some or all secondary use purposes.

Or. en

Amendment 1266

Kateřina Konečná

Proposal for a regulation

Article 33 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

5 a. Health data access bodies shall provide for an accessible and easily understandable opt-out mechanism, whereby natural persons shall be required to explicitly express their wish not to have their personal electronic health data processed for secondary use.

Or. en

Justification

Patients are generally willing to share their health data provided that appropriate and informed consent is given, in particular in view of the large number of categories of health data made available in the context of the EHDS. An opt-out mechanism would give patients and citizens the choice to control their own health data. Opt-out mechanisms for processing health data are already in place in several Member States.

Amendment 1267

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

Proposal for a regulation

Article 33 – paragraph 5 a (new)

Text proposed by the Commission

Amendment

Or. en

Amendment 1268

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

Proposal for a regulation

Article 33 – paragraph 5 b (new)

Text proposed by the Commission

Amendment

5 b. For the categories of electronic health data referred to in (e) and (m) of the first paragraph, health data access bodies shall only provide this health data for secondary use processing after natural persons have explicitly consented to its use. Such an opt-in mechanism shall be easily understandable and accessible and provided for in a user-friendly format whereby data subjects are made aware of the sensitive nature of the data.

Or. en

Amendment 1269

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 6

Text proposed by the Commission

Amendment

6. Where a public sector body obtains data in emergency situations as defined in Article 15, point (a) or (b) of the Regulation […] [Data Act COM/2022/68 final], in accordance with the rules laid down in that Regulation, it may be supported by a health data access body to provide technical support to process the data or combing it with other data for joint analysis.

6. Where a public sector body obtains data in emergency situations as defined in Article 15, point (a) or (b) of the Regulation […] [Data Act COM/2022/68 final], in accordance with the rules laid down in that Regulation, it may be supported by a health data access body or a pseudonymisation body to provide technical support to process the data or combing it with other data for joint analysis.

Or. de

Amendment 1270

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 6

Text proposed by the Commission

Amendment

Or. en

Amendment 1271

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data.

deleted

Or. en

Justification

The Commission should not be given the power to amend the list in par. 1.

Amendment 1272

Konstantinos Arvanitis

Proposal for a regulation

Article 33 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data.

deleted

Or. en

Amendment 1273

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

Article 33 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data.

deleted

Or. en

Justification

Amending the list of available health data for secondary use is a too important task to be left for a delegated act. It requires ordinary legislative procedure.

Amendment 1274

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

Proposal for a regulation

Article 33 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data.

deleted

Or. en

Amendment 1275

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data.

deleted

Or. en

Justification

Given the fact that this is a central aspect of the proposed legislation, it should be only changed through a proper co-decision process.

Amendment 1276

Kateřina Konečná

Proposal for a regulation

Article 33 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data.

deleted

Or. en

Justification

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

Amendment 1277

Pernille Weiss

Proposal for a regulation

Article 33 – paragraph 7

Text proposed by the Commission

Amendment

7. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data.

7. The Commission shall periodically review the list in paragraph 1. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list in paragraph 1 to adapt it to the evolution of available electronic health data. The EHDS Board shall be consulted as part of the periodical review.

Or. en

Amendment 1278

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 8

Text proposed by the Commission

Amendment

8. Health data access bodies may provide access to additional categories of electronic health data that they have been entrusted with pursuant to national law or based on voluntary cooperation with the relevant data holders at national level, in particular to electronic health data held by private entities in the health sector.

deleted

Or. de

Amendment 1279

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

Proposal for a regulation

Article 33 – paragraph 8

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

This provision should be deleted in order to ensure coherent approach across Member States and any revision or expansion should follow a harmonised EU approach.

Amendment 1280

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 33 – paragraph 8

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Par. 1 already provides the list of categories.

Amendment 1281

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 33 – paragraph 8

Text proposed by the Commission

Amendment

Or. en

Amendment 1282

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 33 – paragraph 8

Text proposed by the Commission

Amendment

8. Health data access bodies may provide access to additional categories of electronic health data that they have been entrusted with pursuant to national law, in particular to electronic health data held by private entities in the health sector, in accordance with the relevant security and data protection provisions.

Or. en

Amendment 1283

Sirpa Pietikäinen

Proposal for a regulation

Article 33 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8 a. Provided that it complies with conditions of relevant articles of the Regulation (EU) 2016/679, it should also be possible in secondary use of data to combine individual’s electronic health data with other types of data, for example consumer behavioural data for research purposes as long as the data is anonymised.

Or. en

Amendment 1284

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 33 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8 a. Regarding the electronic health data referred to in paragraph 1(j) of this Article, a summary of results of the clinical trial shall be published, and individual patient data may be shared, in accordance with Article 37(4) of Regulation (EU) No 536/2014.

Or. en

Amendment 1285

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 33 – paragraph 8 a (new)

Text proposed by the Commission

Amendment

8a. Electronic health data from biobanks and dedicated databases, as well as human genetic, genomic and proteomic data, may be shared by the data holder on a voluntary basis in accordance with the rules of this Regulation.

Or. de

Amendment 1286

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 34 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies with:

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 to a health data user only with the explicit consent from the data subject in the case of personal data. Without such consent, any health data may only be made accessible after it has been fully and irreversibly anonymised, where necessary by aggregating the health data of several groups of persons. In addition, any data may only be made accessible where the intended purpose of processing pursued by the applicant complies with:

Or. en

Justification

Patients may refrain from treatment if they can’t trust the confidentiality. Asking their consent before using identifiable health data for different (secondary) purposes is in line with the Helsinki declaration. 75% of citizens want to be asked for their consent before their health data is granted for research. Most MS currently either require consent or don’t allow for secondary use. Having to actively engage with an authority to opt out risks being a theoretical option. Also, patients should be able to waive the requirement to seek their consent for all or specified purposes.

Amendment 1287

Konstantinos Arvanitis

Proposal for a regulation

Article 34 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies with:

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 to a health data user where the processing of the data by the applicant is necessary for one of the following purposes, and in accordance with Article 6(1)(c) and Article 9(2)(g), (h), (i) and (j) of Regulation (EU) 2016/679:

Or. en

Amendment 1288

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 34 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies with:

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 to a health data user where the processing of the data by the applicant is necessary for one of the following purposes, in accordance with Article 6(1)(c) and Article 9(2)(g), (h), (i) and (j) of Regulation (EU) 2016/679:

Or. en

Justification

The whole article needs to be aligned with the GDPR.

Amendment 1289

Kateřina Konečná

Proposal for a regulation

Article 34 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies with:

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant is of public interest and complies with: :

Or. en

Amendment 1290

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

Proposal for a regulation

Article 34 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies with:

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 to a health data user where the intended purpose of processing is one or more of the following:

Or. en

Amendment 1291

Véronique Trillet-Lenoir, Fabienne Keller, Max Orville

Proposal for a regulation

Article 34 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies with:

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 to a health data user willing to processing for the following purposes:

Or. en

Amendment 1292

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 34 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies with:

1. Application processing bodies shall only authorise access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies with:

Or. de

Amendment 1293

Andreas Glück

Proposal for a regulation

Article 34 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) activities for reasons of public interest in the area of public and occupational health, such as protection against serious cross-border threats to health, public health surveillance or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices, identification of environmental factors on health, identification of work related risks and evaluation of preventive measure taken;

Or. en

Justification

The data on environmental factors (33.1b) or on work status (33.1n) will provided. Thus, they shall also be used in order to determine their effects on health

Amendment 1294

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 34 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) the protection against serious cross-border threats to health, and ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices;

Or. en

Justification

Text should be more precise and clear.

Amendment 1295

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

Proposal for a regulation

Article 34 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) activities for reasons of public interest in the area of public and occupational health, such as protection against serious cross-border threats to health, public health surveillance, monitoring and evaluating health programmes or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices;

Or. en

Amendment 1296

Cristian-Silviu Buşoi

Proposal for a regulation

Article 34 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) activities for reasons of public interest in the area of public and occupational health, such as protection against serious cross-border threats to health, public health surveillance or ensuring high levels of quality, safety and efficacy of healthcare and of medicinal products or medical devices;

Or. en

Amendment 1297

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

Proposal for a regulation

Article 34 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) activities for reasons of public interest in the area of public and occupational health: protection against serious cross-border threats to health, public health surveillance or ensuring high levels of quality and safety of healthcare and of medicinal products or medical devices;

Or. en

Amendment 1298

Beata Kempa

Proposal for a regulation

Article 34 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;

(b) to support public sector bodies in the health or care sector;

Or. pl

Amendment 1299

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 34 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;

(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates, where processing is necessary for reasons of substantial public interest;

Or. en

Amendment 1300

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

Proposal for a regulation

Article 34 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;

(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, as well as, where national laws apply, professional associations, in the health or care sector to carry out their tasks defined in their mandates;

Or. en

Amendment 1301

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 34 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;

(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates, where this is necessary to meet a substantial public interest;

Or. en

Amendment 1302

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

Proposal for a regulation

Article 34 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;

Or. en

Amendment 1303

Margarita de la Pisa Carrión

Proposal for a regulation

Article 34 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) to support public sector bodies or Union institutions, agencies and bodies including regulatory authorities, in the health or care sector to carry out their tasks defined in their mandates;

(b) to support public sector bodies or Union institutions, agencies and bodies, including regulatory authorities and professional associations, in the health or care sector to carry out their tasks defined in their mandates;

Or. es

Amendment 1304

Kateřina Konečná

Proposal for a regulation

Article 34 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) to produce national, multi-national and Union level official statistics as defined in Regulation (EU) 223/2009 related to health or care sectors; such as levels of vaccination coverage both for cross-border health emergencies and routine immunisation;

Or. en

Amendment 1305

Konstantinos Arvanitis

Proposal for a regulation

Article 34 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) to produce national, multi-national and Union level official statistics as defined in Regulation (EU) 223/2009 related to health or care sectors;

Or. en

Amendment 1306

Sirpa Pietikäinen

Proposal for a regulation

Article 34 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) to produce national, multi-national and Union level official, gender sensitive statistics related to health or care sectors;

Or. en

Amendment 1307

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 34 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) to produce national, multi-national, regional, local and Union level official statistics related to health or care sectors;

Or. en

Amendment 1308

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 34 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) education or teaching activities in health or care sectors;

deleted

Or. en

Amendment 1309

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 34 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) education or teaching activities in health or care sectors;

deleted

Or. en

Justification

Alignment with GDPR

Amendment 1310

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

Proposal for a regulation

Article 34 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) education or teaching activities in health or care sectors;

(d) higher education, continuing proffessional development or higher education teaching activities in health or care sectors;

Or. en

Amendment 1311

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

Proposal for a regulation

Article 34 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) education or teaching activities in health or care sectors;

(d) university and post-university teaching activities in health or care sectors;

Or. en

Amendment 1312

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 34 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) scientific research related to health or care sectors;

(e) scientific research and development related to health or care sectors for the prevention, early detection, diagnosis, treatment, rehabilitation, supportive care or healthcare management, including behavioural, fundamental, exploratory or applied health research;

Or. en

Amendment 1313

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

Proposal for a regulation

Article 34 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) scientific research related to health or care sectors;

(e) scientific research demonstrably linked to health or care sectors, such as prevention, early detection, diagnosis, treatment, rehabilitation or healthcare management, including fundamental, exploratory or applied healthcare research;

Or. en

Amendment 1314

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

Proposal for a regulation

Article 34 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) scientific research related to health or care sectors;

(e) scientific research related to health or care sectors for prevention, early detection, diagnosis, treatment, rehabilitation or healthcare management, including fundamental, exploratory or applied healthcare research;

Or. en

Amendment 1315

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 34 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) scientific research related to health or care sectors;

(e) scientific research related to health or care sectors, contributing to public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;

Or. en

Amendment 1316

Margarita de la Pisa Carrión

Proposal for a regulation

Article 34 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) scientific research related to health or care sectors;

(e) scientific research related to health or care sectors for the purpose of improving medical diagnostics or health services or the development of new products and services;

Or. es

Amendment 1317

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 34 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) scientific research related to health or care sectors;

(e) scientific research related to public health or care sectors;

Or. en

Amendment 1318

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1319

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Covered in the e)

Amendment 1320

Rob Rooken

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1321

Konstantinos Arvanitis

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1322

Kateřina Konečná

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) development and innovation activities for products or services contributing to public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices, and ensuring benefit to the end-users of the innovation, such as patients, healthcare professionals and health administrators, which is defined in partnership with them.

Or. en

Justification

The purposes for re-use are not properly delimited and could include any form of development and innovation activities for products or services contributing to public health or social security. Patient data should be used for the benefit of providing better healthcare to patients and to improve public health. Data used to drive advancements in treatments, medicines, devices and services should, for instance, lead to innovation bringing better health outcomes to patients, including answering the patients’ unmet needs

Amendment 1323

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

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) development and innovation activities for products or services contributing to public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices and ensuring benefit to end-users of the innovation, such as patients, health professionals and health administrators.

Or. en

Amendment 1324

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

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) development and innovation activities for products or services demonstrably contributing to public health or social security, or ensuring high levels of quality and safety of health or care, of medicinal products or of medical devices, including scientific research into their efficiency and efficacy and post-market safety monitoring;

Or. en

Amendment 1325

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

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) development and innovation activities for products or services contributing to public health or social security and intended for healthcare or long-term care purposes, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;

Or. en

Amendment 1326

Pernille Weiss

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

Or. en

Amendment 1327

Andreas Glück

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) acitivities for the development, placing on the market, advancement and surveillance of products or services related to health or care sectors;

Or. en

Justification

In addition to development of products, it should also be possible to use data for surveillance and an improvement quality.

Amendment 1328

Beata Kempa

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) development and innovation activities for products or services contributing to public health or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;

Or. pl

Amendment 1329

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 34 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) development and innovation activities for products or services contributing to public health, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;

Or. de

Amendment 1330

Beata Kempa

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

deleted

Or. pl

Amendment 1331

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1332

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Covered in e)

Amendment 1333

Konstantinos Arvanitis

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1334

Rob Rooken

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1335

Kateřina Konečná

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to the public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices; and ensuring benefit to the end-users, such as patients, healthcare professionals and health administrators, which is defined in partnership with them;

Or. en

Amendment 1336

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

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to the public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices and ensuring benefit to the end-users, such as patients, healthcare professionals and health administrators;

Or. en

Amendment 1337

Pernille Weiss

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) training, testing and evaluating of algorithms, including in medical devices, in vitro diagnostic medical devices, AI systems and digital health applications, contributing to the public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products, medical devices or in vitro diagnostic medical devices;

Or. en

Amendment 1338

Andreas Glück

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) training, testing and validating of algorithms, including in medical devices, AI systems and digital applications related to health in accordance with the AI Act (COM/2021/206 final);

Or. en

Justification

Widen the scope for the usage while referring to respective legislation at Union-level.

Amendment 1339

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

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to the public health or social security and intended for healthcare or long-term care purposes, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;

Or. en

Amendment 1340

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

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, demonstrably contributing to the public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;

Or. en

Amendment 1341

Rob Rooken

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) training, testing and evaluating of algorithms, including in medical devices and AI systems, contributing to the public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;

Or. en

Amendment 1342

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 34 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to public health, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;

Or. de

Amendment 1343

Beata Kempa

Proposal for a regulation

Article 34 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

deleted

Or. pl

Amendment 1344

Konstantinos Arvanitis

Proposal for a regulation

Article 34 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

deleted

Or. en

Amendment 1345

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 34 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

deleted

Or. en

Amendment 1346

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

Proposal for a regulation

Article 34 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

deleted

Or. en

Amendment 1347

Giuseppe Ferrandino

Proposal for a regulation

Article 34 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons; analyze general trends and patterns in population health status to develop more competitive rates for insurance products

Or. en

Amendment 1348

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 34 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

(h) providing personalised healthcare.

Or. en

Amendment 1349

Pernille Weiss

Proposal for a regulation

Article 34 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

(h) improving delivery of healthcare, optimising patient pathways and providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons and real world evidence.

Or. en

Amendment 1350

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

Proposal for a regulation

Article 34 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

(h) improving delivery of care, optimising patient pathway and providing personalised healthcare consisting in assessing, maintaining or restoring the state of health of natural persons, based on the health data of other natural persons.

Or. en

Amendment 1351

Sirpa Pietikäinen

Proposal for a regulation

Article 34 – paragraph 1 – point h a (new)

Text proposed by the Commission

Amendment

(h a) the need to analyse received data in gender sensitive manner.

Or. en

Amendment 1352

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

Proposal for a regulation

Article 34 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The purposes referred to in paragraph 1 shall be compatible with the purposes for which data were originally collected pursuant to Article 6(4) of Regulation (EU) 2016/679.

Or. en

Amendment 1353

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

Proposal for a regulation

Article 34 – paragraph 2

Text proposed by the Commission

Amendment

2. Access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant fulfils one of the purposes referred to in points (a) to (c) of paragraph 1 shall only be granted to public sector bodies and Union institutions, bodies, offices and agencies exercising their tasks conferred to them by Union or national law, including where processing of data for carrying out these tasks is done by a third party on behalf of that public sector body or of Union institutions, agencies and bodies.

2. The purposes referred to in points (a) to (c) of paragraph 1 shall be reserved for public sector bodies and Union institutions, bodies, offices and agencies exercising their tasks conferred to them by Union or national law, including where processing of data for carrying out these tasks is done by a third party on behalf of that public sector body or of Union institutions, agencies and bodies.

Or. en

Amendment 1354

Maria Grapini

Proposal for a regulation

Article 34 – paragraph 2

Text proposed by the Commission

Amendment

Or. ro

Amendment 1355

Konstantinos Arvanitis

Proposal for a regulation

Article 34 – paragraph 2

Text proposed by the Commission

Amendment

2. Access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant fulfils one of the purposes referred to in points (a) and (b) of paragraph 1 shall only be granted to public sector bodies and Union institutions, bodies, offices and agencies exercising their tasks conferred to them by Union or national law, including where processing of data for carrying out these tasks is done by a third party on behalf of that public sector body or of Union institutions, agencies and bodies.

Or. en

Amendment 1356

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 34 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. In accordance with Article 21(6) of Regulation (EU) 2016/679, where personal data are processed for statistical or scientific research purposes as referred to in points (c), (e) and (h) of paragraph 1, the data subject, on grounds relating to his or her particular situation, shall have the right to object to processing of personal data concerning him or her, unless the processing is necessary for the performance of a task carried out for reasons of public interest.

Or. en

Justification

Alignment with GDPR

Amendment 1357

Cristian-Silviu Buşoi

Proposal for a regulation

Article 34 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Where data subjects wish to generally or partially opt-out of having their personal electronic health data processed for secondary use, in accordance with Article 33(5), for any of the purposes listed in paragraph 1 (d), (e), (f), (g) and (h), they shall indicate so to the health data access body.

Or. en

Amendment 1358

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

Proposal for a regulation

Article 34 – paragraph 4

Text proposed by the Commission

Amendment

4. Public sector bodies or Union institutions, agencies and bodies that obtain access to electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, shall take all specific measures necessary to preserve the confidentiality of such data.

deleted

Or. en

Justification

Moved to Art. 33(4d) to put all IP-related provisions in one place.

Amendment 1359

Pernille Weiss

Proposal for a regulation

Article 34 – paragraph 4

Text proposed by the Commission

Amendment

4. Public sector bodies or Union institutions, agencies and bodies that obtain access to electronic health data entailing IP rights, regulatory data protection or trade secrets in the exercise of the tasks conferred to them by Union law or national law, shall, upon consultation with the data holder, take all specific measures necessary to preserve the confidentiality of such data.

Or. en

Amendment 1360

Jessica Polfjärd

Proposal for a regulation

Article 34 – paragraph 4

Text proposed by the Commission

Amendment

4. Public sector bodies or Union institutions, agencies and bodies that obtain access to electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, must take all specific measures necessary to preserve the confidentiality of such data.

Or. en

Amendment 1361

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 34 – paragraph 4

Text proposed by the Commission

Amendment

4. Public sector bodies or Union institutions, agencies and bodies that obtain access to non-personal electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, shall take all specific measures necessary to preserve the confidentiality of such data.

Or. en

Amendment 1362

Peter Liese

Proposal for a regulation

Article 34 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Neither the use nor registration of electronic health data for secondary purposes in the European Health Data Space shall hinder the development of research programmes by curtailing the use of shared data between two or more teams within the same country or across several countries.

Or. en

Justification

Research programmes involving multiple research teams from different EU Member States fulfill an essential role in driving research in Europe, including research in the cancer field. Given its intent to boost science and innovation in Europe, the European Health Data Space should not create unintended barriers curtailing the use of shared data between these teams.

Amendment 1363

Konstantinos Arvanitis

Proposal for a regulation

Article 34 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Scientific research referred to in Article 34 point (e) of paragraph 1, as well as further research based on results of research through secondary use of health data according to this Regulation, shall provide a public return and be publicly accessible.

Or. en

Amendment 1364

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

Proposal for a regulation

Article 35 – title

Text proposed by the Commission

Amendment

Prohibited secondary use of electronic health data

Prohibited purposes of secondary use of electronic health data

Or. en

Amendment 1365

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 35 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Seeking access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall be prohibited:

Seeking or gaining access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for any purposes not listed in Article 34 shall be prohibited and subject to penalties laid down in Articles 43 and 69.

Seeking or gaining access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall constitute an aggravated case of breaching the rules of this Regulation, and shall be subject to higher penalties, in accordance with point (i) of paragraph 2a of Article 69:

(Linked to article 69)

Or. en

Amendment 1366

Mathilde Androuët

Proposal for a regulation

Article 35 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Seeking access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall be prohibited:

Seeking access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall be prohibited and subject to sanction applicable in the jurisdiction of the Member State in which the offence occurred:

Or. fr

Amendment 1367

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

Proposal for a regulation

Article 35 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

Seeking access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall be prohibited:

Seeking access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall be prohibited and subject to effective, proportionate and dissuasive sanctions:

Or. en

Amendment 1368

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 35 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) taking decisions detrimental to a natural person based on their electronic health data; in order to qualify as “decisions”, they must produce legal effects or similarly significantly affect those natural persons;

(a) taking decisions detrimental to a natural person based on their electronic health data, such as offers of employment, offering less favourable terms in the provision of goods or services such as insurance or other financial services; in order to qualify as “decisions”, they must produce legal effects or similarly significantly affect those natural persons;

Or. en

Amendment 1369

Giuseppe Ferrandino

Proposal for a regulation

Article 35 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) a) taking decisions detrimental to a natural person based on their electronic health data, including but not limited to offers of employment, offering less favourable terms in the provision of goods or services; in order to qualify as “decisions”, they must produce legal effects or similarly significantly affect those natural persons;

Or. en

Amendment 1370

Konstantinos Arvanitis

Proposal for a regulation

Article 35 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) taking decisions detrimental to a natural person based on their electronic health data;

Or. en

Amendment 1371

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

Proposal for a regulation

Article 35 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) taking decisions detrimental to a natural person or a group of natural persons based on their electronic health data; in order to qualify as “decisions”, they must produce legal effects or similarly significantly affect those natural persons;

Or. en

Amendment 1372

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

Proposal for a regulation

Article 35 – paragraph 1 – point a

Text proposed by the Commission

Amendment

Or. en

Amendment 1373

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 35 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) taking any decision related to a natural person based on their electronic health data; in order to qualify as “decisions”, they must produce legal effects or similarly significantly affect those natural persons;

Or. en

Amendment 1374

Lídia Pereira

Proposal for a regulation

Article 35.º – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums;

deleted

Or. pt

Amendment 1375

Giuseppe Ferrandino

Proposal for a regulation

Article 35 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums;

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums; except for purposes consistent with scientific research activities, such as the analysis of general trends and patterns in the state of population health, and the development and innovation of products and services in the health or care sector, including in particular the purposes set forth in Article 34 points (e), (f), and (h)

Or. en

Amendment 1376

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 35 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums;

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums or taking any other decisions in relation to a natural person or groups of natural persons to discriminate on the basis of the health data obtained;

Or. fr

Amendment 1377

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

Proposal for a regulation

Article 35 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums;

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance or credit contract or to modify their contributions and insurance premiums or conditions of loans or exclude them from the benefit of participating in clinical trials;

Or. en

Amendment 1378

Mathilde Androuët

Proposal for a regulation

Article 35 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums;

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract, of a bank loan and its present or future terms, or to modify their contributions and insurance premiums;

Or. fr

Amendment 1379

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 35 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums;

Or. en

Amendment 1380

Konstantinos Arvanitis

Proposal for a regulation

Article 35 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) taking decisions in relation to a natural person or groups of natural persons to exclude them from the benefit of an insurance contract or to modify their contributions and insurance premiums;

Or. en

Amendment 1381

Tomislav Sokol

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) advertising or marketing activities towards health professionals, organisations in health or natural persons with the exception of communication in line with approved regulatory information or to provide up-to date, verifiable and complete scientific information to health care professionals for educational purpose in line with Directive 2001/83/EC;

Or. en

Amendment 1382

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1383

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) advertising or marketing activities or, any other economic or financial activity aimed at making corporative profits, towards health professionals, organisations in health or natural persons;

Or. en

Amendment 1384

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Justification

Given the sensitive nature of health data, and the potential harm to individuals and society, the data made available according to this legislation should not be used in any advertising or marketing activities

Amendment 1385

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1386

Konstantinos Arvanitis

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1387

Kateřina Konečná

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Justification

The processing of health data for all advertising purposes should be prohibited, regardless of the target audience.

Amendment 1388

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

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1389

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

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Justification

Use for all advertising or marketing activities should be prohibited, regardless of the target groups of such activities.

Amendment 1390

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

Proposal for a regulation

Article 35 – paragraph 1 – point c

Text proposed by the Commission

Amendment

Or. en

Amendment 1391

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 35 – paragraph 1 – point c a (new)

Text proposed by the Commission

Amendment

(c a) developing or conducting any activity aimed at profiling of or discriminating against individuals;

Or. en

Amendment 1392

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 35 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages, tobacco products, or goods or services which are designed or modified in such a way that they contravene public order or morality.

(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages, tobacco and nicotine products, or goods or services which are designed or modified in such a way that they incite addiction, harm public health and environment or contravene public order or morality or result in behavioural changes that reduce the freedom of choice or security of the natural persons.

Or. en

Justification

Practices that take advantage of psychology research and potentially influence the consumer choice or electoral rights, based on health data, should not be permitted.

Amendment 1393

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

Proposal for a regulation

Article 35 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages, tobacco and nicotine products, weaponries or products, goods or services which are designed or modified in such a way that they incite chemical, behavioural or any other type of addiction or that they contravene public order or morality.

Or. en

Amendment 1394

Traian Băsescu

Proposal for a regulation

Article 35 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages or tobacco products.

Or. ro

Amendment 1395

Margarita de la Pisa Carrión

Proposal for a regulation

Article 35 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages, tobacco products or those that may cause addiction, or goods or services which are designed or modified in such a way that they contravene public order or morality.

Or. es

Amendment 1396

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

Proposal for a regulation

Article 35 – paragraph 1 – point e

Text proposed by the Commission

Amendment

Or. en

Amendment 1397

Konstantinos Arvanitis

Proposal for a regulation

Article 35 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) developing products or services that may harm individuals and societies at large, including, but not limited to illicit drugs, alcoholic beverages, tobacco or nicotine or vaping products, or goods or services which are designed or modified in such a way that they contravene public order or morality.

Or. en

Amendment 1398

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) unfair commercial use or other unfair competition, in accordance with Article 39 of TRIPS; using data from private enterprises in regulatory or reimbursement submissions for any generic or biosimilar product without an agreement from the private sector data holder while the data holder’s referenced product is under patent or regulatory data protection (including such use of data outside of the EU), or equivalent protected data of nonmedicinal products such as medical devices and software medical devices

Or. en

Amendment 1399

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) calculating reimbursement, costs or expenditures relating to healthcare provision to be borne by natural persons, private or public insurance, or public bodies, including, but not limited to, the development and amendment of healthcare provider payment systems;

Or. en

Amendment 1400

Pernille Weiss

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) all acts of unfair competition or unfair commercial use, in accordance with Article 10bis of the Paris Convention for the Protection of Industrial Property and Article 39 of the Agreement on Trade-Related Aspects of Intellectual Property;

Or. en

Amendment 1401

Nathalie Colin-Oesterlé

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(ea) to obtain strategic information about a competitor, such as the production method behind their product or service.

Or. fr

Amendment 1402

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

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) automated individual decision-making, including profiling, in accordance with Article 22 of the Regulation (EU) 2016/679;

Or. en

Amendment 1403

Kateřina Konečná

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) automated individual decision-making, including profiling, in accordance with Article 22 of the Regulation (EU) 2016/679.

Or. en

Justification

Personal health characteristics should not be used to make automated decisions, such as employment, loan and insurance decisions, and to profile an individual. Patients with chronic diseases are particularly vulnerable to automated individual decision-making and profiling, as their chronic condition could be used to make decisions against them or categorise them and lead to discrimination based on predictive and not factual health data.

Amendment 1404

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

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) automated individual decision-making, including profiling, in accordance with Article 22 of the Regulation (EU) 2016/679.

Or. en

Amendment 1405

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(ea) reconstructing the identity of natural persons from datasets shared under this Regulation;

Or. de

Amendment 1406

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) Unfair commercial use or other unfair competitions, in accordance with Article 39 of TRIPS;

Or. en

Amendment 1407

Tomislav Sokol

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) unfair commercial use or other unfair competition, in accordance with Article 39 of TRIPS Agreement;

Or. en

Amendment 1408

Javier Zarzalejos

Proposal for a regulation

Article 35 – paragraph 1 – point e a (new)

Text proposed by the Commission

Amendment

(e a) data of pharmaceutical prescriptions or medical devices used, by commercial name.

Or. en

Amendment 1409

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 35 – paragraph 1 – point e b (new)

Text proposed by the Commission

Amendment

(e b) using data from private enterprises in regulatory or reimbursement submissions for any generic or biosimilar product without an agreement from the private sector data holder while the data holder's referenced product is under patent or regulatory data protection (including such use of data outside of the EU) or equivalent protected data of non-medicinal products, such as medical devices and software medical devices.

Or. en

Amendment 1410

Tomislav Sokol

Proposal for a regulation

Article 35 – paragraph 1 – point e b (new)

Text proposed by the Commission

Amendment

(e b) using data from private enterprises in regulatory or reimbursement submissions for any generic or biosimilar product without an agreement from the private sector data holder while the data holder’s referenced product is under patent or regulatory data protection (including such use of data outside of the EU), or equivalent protected data of non-medicinal products such as medical devices and software medical devices.

Or. en

Amendment 1411

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 35 – paragraph 1 – point e b (new)

Text proposed by the Commission

Amendment

(eb) profiling of natural persons solely from the datasets shared under this Regulation or in combination with other data;

Or. de

Amendment 1412

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

Proposal for a regulation

Article 35 – paragraph 1 – point e b (new)

Text proposed by the Commission

Amendment

(e b) data of pharmaceutical prescriptions or medical devices by commercial name, with the exception of usage by public authorities.

Or. en

Amendment 1413

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 35 – paragraph 1 – point e b (new)

Text proposed by the Commission

Amendment

(e b) automated individual decision-making, including profiling, in accordance with Article 22 of the Regulation (EU) 2016/679.

Or. en

Amendment 1414

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 35 – paragraph 1 – point e c (new)

Text proposed by the Commission

Amendment

(ec) the targeted use of data shared under this Regulation to obtain intellectual property or trade secrets of competitors or information that allows conclusions to be drawn about the business performance of a specific market operator;

Or. de

Amendment 1415

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

Proposal for a regulation

Article 35 – paragraph 1 – point e c (new)

Text proposed by the Commission

Amendment

(e c) national defense and security.

Or. en

Amendment 1416

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 35 – paragraph 1 – point e d (new)

Text proposed by the Commission

Amendment

(ed) the sale of electronic health data made available under this Regulation.

Or. de

Amendment 1417

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

Proposal for a regulation

Article 35 – paragraph 1 – point e d (new)

Text proposed by the Commission

Amendment

(e d) confidential data used by public bodies which are market regulators.

Or. en

Amendment 1418

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

Proposal for a regulation

Article 35 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

Any other misuse of electronic health data, including its use for permissible purposes other than those specified in the data permit or data request, shall also be prohibited and subject to effective, proportionate and dissuasive sanctions.

Or. en

Amendment 1419

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 35 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

The infringement by secondary use data users of the purposes defined in the previous paragraph shall entail the termination of access and processing electronic health data obtained via a data permit issued pursuant Articles 43 and 46.

Or. en

Amendment 1420

Joanna Kopcińska

Proposal for a regulation

Article 35 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

This Regulation shall not apply to activities concerning public security, defence and national security.

Or. en

Amendment 1421

Beata Kempa

Proposal for a regulation

Article 35 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

This Regulation shall not apply to activities concerning public security, defence and national security

Or. en

Amendment 1422

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 36 – title

Text proposed by the Commission

Amendment

Health data access bodies

Bodies involved in accessing health data

Or. de

Amendment 1423

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 36 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall designate one or more health data access bodies responsible for granting access to electronic health data for secondary use. Member States may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this Article. Where a Member State designates several health data access bodies, it shall designate one health data access body to act as coordinator, with responsibility for coordinating requests with the other health data access bodies.

1. Member States shall each designate one or more bodies involved in accessing health data that are responsible for granting access to electronic health data for secondary use. Member States may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies or private legal persons that fulfil the conditions set out in this Article. Where a Member State designates several bodies involved in accessing health data, it shall designate one body to act as coordinator, with responsibility for coordinating requests with the other bodies involved in accessing health data. The following legally and organisationally independent bodies may be involved in accessing electronic health data:

Or. de

Amendment 1424

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 36 – paragraph 1

Text proposed by the Commission

Amendment

1. Health data access bodies shall be public entities or bodies. Member States shall designate one or more public health data access bodies responsible for granting access to electronic health data for secondary use. Member States may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this Article. Where a Member State designates several health data access bodies, it shall designate one health data access body to act as coordinator, with responsibility for coordinating requests with the other health data access bodies.

Or. en

Amendment 1425

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

Proposal for a regulation

Article 36 – paragraph 1

Text proposed by the Commission

Amendment

1. Member States shall designate one or more health data access bodies responsible for carrying out the tasks referred to in Articles 37, 38 and 39 of this Regulation. Member States may either establish one or more new public sector bodies or rely on existing public sector bodies or on internal services of public sector bodies that fulfil the conditions set out in this Article. Where a Member State designates several health data access bodies, it shall designate one health data access body to act as coordinator, with responsibility for coordinating data access applications and requests with the other health data access bodies.

Or. en

Amendment 1426

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 36 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Health data access bodies shall consist of two distinct parts, which shall be legally and organisationally separate from each other:

(a) Authorisation bodies, which decide about data access applications pursuant to Article 37(1) and make the data accessible to authorised data users in a secure processing environment;

(b) Trust bodies, which receive the electronic health data from data holders pursuant to Article 37(1a) and are responsible for disclosing the data to the authorisation bodies.

Or. en

Amendment 1427

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

Proposal for a regulation

Article 36 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. Each health data access body shall contribute to the consistent application of this Regulation throughout the Union. For that purpose, the health data access bodies shall cooperate with each other and with the supervisory authorities under Regulation (EU) 2016/679 as well as with the Commission and where relevant with the EDPB and the EDPS.

Or. en

Amendment 1428

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 36 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1a. Application processing bodies, which may be administered by both public and private bodies.

Or. de

Amendment 1429

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 36 – paragraph 1 b (new)

Text proposed by the Commission

Amendment

1b. Pseudonymisation bodies, which shall be administered by national public bodies; the European Union shall also create an independent European pseudonymisation body.

Or. de

Amendment 1430

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 36 – paragraph 1 c (new)

Text proposed by the Commission

Amendment

1c. Access bodies, which shall be administered by national public bodies.

Or. de

Amendment 1431

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 36 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall ensure that each body involved in accessing health data is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers. Certification shall be required for approval and designation as an application processing body. Application processing bodies shall carry out their tasks in an impartial, transparent, consistent and timely manner. Senior managers and staff members of the authorities responsible shall not engage in any activity that may conflict with their independence of judgment or integrity in carrying out the tasks entrusted to them.

Or. de

Amendment 1432

Pernille Weiss

Proposal for a regulation

Article 36 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall ensure that each health data access body is provided with the human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers. This shall include sufficient administrative, technical and scientific personnel, including expertise in relevant areas such as data management, data protection, data science, healthcare and intellectual property rights.

Or. en

Amendment 1433

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 36 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall ensure that each health data access body is provided with human resources with necessary legal and technical expertise, including ethical boards and committees, and financial resources, premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers.

Or. en

Amendment 1434

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

Proposal for a regulation

Article 36 – paragraph 2

Text proposed by the Commission

Amendment

2. Member States shall ensure that each health data access body is provided with adequate human, technical and financial resources, premises and infrastructure necessary for the effective performance of its tasks and the exercise of its powers, including those related to the participation in the EHDS Board.

Or. en

Amendment 1435

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 36 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1436

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

Proposal for a regulation

Article 36 – paragraph 2

Text proposed by the Commission

Amendment

Or. en

Amendment 1437

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

Proposal for a regulation

Article 36 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. Member States shall provide for each member of their data access body to be appointed by means of a transparent procedure by: their parliament; their government; their head of State; or an independent body entrusted with the appointment under Member State law. Members as well as staff shall have the qualifications, experience and skills required to perform their duties and exercise their powers, in particular in the area of ethics, cybersecurity, protection of intellectual property and trade secrets, healthcare, scientific research, artificial intelligence and other relevant areas, as well as the protection of personal data and specifically data concerning health.

Or. en

Amendment 1438

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 36 – paragraph 2 a (new)

Text proposed by the Commission

Amendment

2 a. The Commission shall be empowered to adopt delegated acts for the provision of a uniform pseudonymisation procedure.

Or. en

Amendment 1439

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

Proposal for a regulation

Article 36 – paragraph 2 b (new)

Text proposed by the Commission

Amendment

2 b. The health data access bodies shall set up application review committees, composed of at least 3 persons, to examine each health data access application. The composition of such committees shall be diverse and tailored to the specific cases and expertise required and shall include one expert in ethics. For applications that pose very minimal ethical or social risks, health data access bodies may set up simplified ethics assessment procedure.

Or. en

Amendment 1440

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

Proposal for a regulation

Article 36 – paragraph 2 c (new)

Text proposed by the Commission

Amendment

2 c. The Commission shall, in consultation and cooperation with relevant experts, create guidelines with minimum standards for the work of the review committees.

Or. en

Amendment 1441

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

Proposal for a regulation

Article 36 – paragraph 2 d (new)

Text proposed by the Commission

Amendment

2 d. Each Member State shall ensure that each health data access body chooses and has its own staff which shall be subject to the exclusive direction of the member or members of the data access body concerned.

The duties of a member shall end in the event of the expiry of the term of office, resignation or compulsory retirement, in accordance with the law of the Member State concerned. A member shall be dismissed only in cases of serious misconduct or if the member no longer fulfils the conditions required for the performance of the duties.

Or. en

Amendment 1442

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients and consumers, data holders and data users, and with data protection experts. Health data access bodies shall actively cooperate with the authorities responsible for the application of EU and national data protection legislation. Staff members of health data access bodies shall have no direct or indirect economic, financial or personal conflicts of interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct. Health data access bodies shall not be bound by any instructions, when making their decisions.

Or. en

Amendment 1443

Kateřina Konečná

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

3. Essential health stakeholders’ representatives, including patient organisations, shall be present in the governance and decision-making structures of the health data access bodies. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall actively cooperate with the relevant bodies or authorities responsible for the application of EU and national data protection legislation, when making their decisions.

Or. en

Justification

The health data access bodies are responsible for the secondary use of data, including granting permits. They will be the decision-makers on behalf of society. The involvement of patient organisations is therefore crucial, not only to ensure that the needs of patients are fully taken into account, but also to ensure transparency, democratic and inclusive governance. This is already the case in the French health data access body, the Health Data Hub, where the vice-president is the president of the national platform of patient and health system user organisations.

Amendment 1444

Marian-Jean Marinescu

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data should be trained at local level on how to operate the Health Data Space. Appropriate funding should be ensured by the Member State for regular trainings and regular digital literacy courses as means to reduce fragmentation and build trust. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions and a conflict of interest policy should be put into place

Or. en

Amendment 1445

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

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

3. Health data access bodies and their members and staff, including application review committees shall act with complete independence in performing their tasks and exercising their powers in accordance with this Regulation. They shall avoid any conflicts of interest and remain free from external influence, whether direct or indirect, and shall neither seek nor take instructions from anybody. Members of health data access bodies, including application review committees, shall refrain from any action incompatible with their duties and shall not, during their term of office, engage in any incompatible occupation, whether gainful or not.

Or. en

Justification

Amendment necessary to strengthen independence provisions following the model of supervisory authorities under Regulation 2016/679. The part on stakeholders can be deleted here because it is already covered in Article 37(2).

Amendment 1446

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

Or. en

Amendment 1447

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

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Stakeholders' representatives, including health professionals, patients and consummers' organisations, shall take part in the governance and decision-making structures of the health data access bodies. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

Or. en

Amendment 1448

Maite Pagazaurtundúa, Susana Solís Pérez, Michal Šimečka

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. To this end, it shall establish strict rules of incompatibility for its personnel and cooling-off periods for those who wish to access the bodies, as well as for those who are no longer in office. Health data access bodies shall not be bound by any instructions, when making their decisions.

Or. en

Amendment 1449

Konstantinos Arvanitis

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall be free of any conflicts of interest. Health data access bodies shall actively cooperate with the relevant bodies or authorities responsible for the application of EU and national data protection legislation. When making their decisions, health data access bodies shall otherwise not be bound by any instructions.

Or. en

Amendment 1450

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

Or. en

Amendment 1451

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 36 – paragraph 3

Text proposed by the Commission

Amendment

3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.

3. In the performance of their tasks, the bodies involved in accessing health data shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of bodies involved in accessing health data shall avoid any conflicts of interest. Bodies involved in accessing health data shall not be bound by any instructions, when making their decisions.

Or. de

Amendment 1452

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 36 – paragraph 3 a (new)

Text proposed by the Commission

Amendment

3 a. Member States shall determine and publish the selection procedure for health stakeholders referred to in paragraph 3. They shall ensure that the procedure is transparent and does not allow for conflicts of interest.

Or. en

Amendment 1453

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 36 – paragraph 4

Text proposed by the Commission

Amendment

4. Member States shall communicate to the Commission the identity of the health data access bodies designated pursuant to paragraph 1 by the date of application of this Regulation. They shall also communicate to the Commission any subsequent modification of the identity of those bodies. The Commission and the Member States shall make this information publicly available.

4. Member States shall communicate to the Commission the identity of the bodies designated pursuant to paragraph 1 by the date of application of this Regulation. They shall also communicate to the Commission any subsequent modification of the identity of those bodies. The Commission and the Member States shall make this information publicly available.

Or. de

Amendment 1454

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

Proposal for a regulation

Article 36 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The Member States shall determine the selection procedure for health stakeholders referred to in paragraph 3 through an open, transparent and inclusive process.

Or. en

Amendment 1455

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – title

Text proposed by the Commission

Amendment

Tasks of health data access bodies

Tasks of bodies involved in accessing health data

Or. de

Amendment 1456

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall carry out the following tasks:

1. The authorisation bodies within the health data access bodies shall carry out the following tasks:

Or. en

Amendment 1457

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – introductory part

Text proposed by the Commission

Amendment

1. Health data access bodies shall carry out the following tasks:

1. Bodies involved in accessing health data shall carry out the following tasks:

Or. de

Amendment 1458

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) decide on data access applications pursuant to Article 45, authorise and issue data permits pursuant to Article 46 to access electronic health data falling within their national remit for secondary use and decide on data requests in accordance with Chapter II of Regulation […] [Data Governance Act COM/2020/767 final] and this Chapter. This includes deciding on whether the data shall be made accessible in anonymised or pseudonymised form, based on its own thorough assessment of any reasons provided by the data applicant pursuant to paragraph (d) of paragraph 2 of Article 45;

Or. en

Amendment 1459

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) application processing bodies shall decide on data access applications pursuant to Article 45, authorise and issue data permits pursuant to Article 46 to access electronic health data falling within their national remit for secondary use and decide on data requests in accordance with Chapter II of Regulation […] [Data Governance Act COM/2020/767 final] and this Chapter;

Or. de

Amendment 1460

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

Proposal for a regulation

Article 37 – paragraph 1 – point a

Text proposed by the Commission

Amendment

(a) decide on data access applications pursuant to Article 45 where the application concerns anonymised electronic health data; where the application concerns pseudonymised electronic health data, the decision-making shall be done in close cooperation with relevant supervisory authorities under Regulation (EU) 2016/679;

Or. en

Amendment 1461

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

Proposal for a regulation

Article 37 – paragraph 1 – point a a (new)

Text proposed by the Commission

Amendment

(a a) authorise and issue data permits pursuant to Article 46 to access electronic health data falling within their national remit for secondary use and decide on data requests in accordance with Chapter II of Regulation […] [Data Governance Act COM/2020/767 final] and this Chapter;

Or. en

Amendment 1462

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

Proposal for a regulation

Article 37 – paragraph 1 – point a b (new)

Text proposed by the Commission

Amendment

(a b) request electronic health data referred to in Article 33 from relevant health data holders pursuant to a data permit or a data request granted;

Or. en

Amendment 1463

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point b

Text proposed by the Commission

Amendment

(b) support public sector bodies in carrying out the tasks enshrined in their mandate, based on national or Union law;

(b) access bodies shall support public sector bodies in carrying out the tasks enshrined in their mandate, based on national or Union law;

Or. de

Amendment 1464

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) support Union institutions, bodies, offices and agencies in carrying out tasks enshrined in the mandate of Union institutions, bodies, offices and agencies, based on national or Union law;

(c) support Union institutions, bodies, offices and agencies in carrying out the tasks enshrined in their mandate, based on Union law;

Or. en

Amendment 1465

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point c

Text proposed by the Commission

Amendment

(c) support Union institutions, bodies, offices and agencies in carrying out tasks enshrined in the mandate of Union institutions, bodies, offices and agencies, based on national or Union law;

(c) access bodies shall support Union institutions, bodies, offices and agencies in carrying out tasks enshrined in the mandate of Union institutions, bodies, offices and agencies, based on national or Union law;

Or. de

Amendment 1466

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) process electronic health data for the purposes set out in Article 34, including the collection, combination, preparation and disclosure of those data for secondary use on the basis of a data permit;

deleted

Or. en

Justification

Moved to paragraph 1a(new)

Amendment 1467

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

Proposal for a regulation

Article 37 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) process electronic health data referred to in Article 33, including gathering, combination, preparation, anonymisation and pseudonymisation of those data for secondary use on the basis of a data permit;

Or. en

Amendment 1468

Tudor Ciuhodaru

Proposal for a regulation

Article 37 – paragraph 1 – point d

Text proposed by the Commission

Amendment

Or. ro

Amendment 1469

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point d

Text proposed by the Commission

Amendment

(d) access bodies shall process electronic health data for the purposes set out in Article 34, including the collection, combination, preparation and disclosure of those data for secondary use on the basis of a data permit;

Or. de

Amendment 1470

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

Proposal for a regulation

Article 37 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) process electronic health data from other relevant data holders based on a data permit or a data request for a purposes laid down in Article 34;

deleted

Or. en

Amendment 1471

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) process electronic health data from other relevant data holders based on a data permit or a data request for a purposes laid down in Article 34;

deleted

Or. en

Justification

Moved to paragraph 1a(new)

Amendment 1472

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point e

Text proposed by the Commission

Amendment

(e) process electronic health data from other relevant data holders based on a data permit or a data request for a purposes laid down in Article 34;

(e) access bodies shall process electronic health data from other relevant data holders based on a data permit or a data request for a purposes laid down in Article 34;

Or. de

Amendment 1473

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) take all measures necessary to preserve the confidentiality of IP rights and of trade secrets;

deleted

Or. en

Justification

Moved to paragraph 1a(new)

Amendment 1474

Javier Zarzalejos

Proposal for a regulation

Article 37 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) take all measures necessary to preserve the confidentiality of IP rights and of trade secrets;

(f) take all measures necessary to preserve the confidentiality of IP rights and of trade secrets included in, but not limited to the Directive on the Protection of Trade Secrets (Directive (EU) 2016/943);

Or. en

Amendment 1475

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) take all measures necessary to preserve the confidentiality of IP rights and of trade secrets;

(f) bodies involved in accessing health data shall take all measures necessary to preserve the confidentiality of IP rights and of trade secrets;

Or. de

Amendment 1476

Pernille Weiss

Proposal for a regulation

Article 37 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) take all measures necessary to preserve the confidentiality of IP rights and of trade secrets;

(f) take all measures necessary to preserve the confidentiality of IP rights and of trade secrets and of protected regulatory data;

Or. en

Amendment 1477

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

Proposal for a regulation

Article 37 – paragraph 1 – point f

Text proposed by the Commission

Amendment

(f) take all measures necessary to preserve the confidentiality of IP rights and of trade secrets;

(f) take all measures necessary to preserve IP rights and the confidentiality of trade secrets;

Or. en

Amendment 1478

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) gather and compile or provide access to the necessary electronic health data from the various data holders whose electronic health data fall within the scope of this Regulation and put those data at the disposal of data users in a secure processing environment in accordance with the requirements laid down in Article 50;

deleted

Or. en

Justification

Moved to paragraph 1a(new)

Amendment 1479

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) where electronic health data are not accessed directly between data holder and data user, or where the data of a number of holders need to be merged, the access bodies concerned, with the assistance of pseudonymisation bodies, shall gather and compile the necessary electronic health data from the various data holders whose electronic health data fall within the scope of this Regulation and put those data at the disposal of data users in a secure processing environment in accordance with the requirements laid down in Article 50;

Or. de

Amendment 1480

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

Proposal for a regulation

Article 37 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) based on a data permit, provide access to health data referred to in Article 33 to health data users in a secure processing environment in accordance with the requirements laid down in Article 50 and store the data for the period of the duration of the data permit;

Or. en

Amendment 1481

Luisa Regimenti, Massimiliano Salini, Aldo Patriciello, Fulvio Martusciello

Proposal for a regulation

Article 37 – paragraph 1 – point g

Text proposed by the Commission

Amendment

(g) gather and compile or provide access to the necessary electronic health data from the various data holders whose electronic health data fall within the scope of this Regulation, ensuring a secure sharing environment, and put those data at the disposal of data users in a secure processing environment in accordance with the requirements laid down in Article 50;

Or. en

Amendment 1482

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point h

Text proposed by the Commission

Amendment

(h) contribute to data altruism activities in accordance with Article 40;

deleted

Or. en

Justification

Moved to paragraph 1a(new)

Amendment 1483

Beata Kempa

Proposal for a regulation

Article 37 – paragraph 1 – point i

Text proposed by the Commission

Amendment

(i) support the development of AI systems, the training, testing and validating of AI systems and the development of harmonised standards and guidelines under Regulation […] [AI Act COM/2021/206 final] for the training, testing and validation of AI systems in health;

deleted

Or. pl

Amendment 1484

Birgit Sippel, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 37 – paragraph 1 – point i

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

The Commission’s proposal incentivises aggregation of large datasets from different contexts. It fails to recognise that this approach could pose risks to individuals and communities. It can also perpetuate health disparities. This is especially the case when AI systems are developed and deployed in health care. We suggest that the processing of electronic health data for secondary use be allowed only in public interest such as evidence-based policy making, and for scientific or statistical research.

Amendment 1485

Konstantinos Arvanitis

Proposal for a regulation

Article 37 – paragraph 1 – point i

Text proposed by the Commission

Amendment

deleted

Or. en

Amendment 1486

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point i

Text proposed by the Commission

Amendment

deleted

Or. en

Justification

Moved to paragraph 1a(new)

Amendment 1487

Jessica Polfjärd

Proposal for a regulation

Article 37 – paragraph 1 – point i

Text proposed by the Commission

Amendment

(i) provide with expertise to support the development of AI systems, the training, testing and validating of AI systems and the development of harmonised standards and guidelines under Regulation […] [AI Act COM/2021/206 final] for the training, testing and validation of AI systems in health;

Or. en

Amendment 1488

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point i

Text proposed by the Commission

Amendment

(i) access bodies shall support the development of AI systems, the training, testing and validating of AI systems and the development of harmonised standards and guidelines under Regulation […] [AI Act COM/2021/206 final] for the training, testing and validation of AI systems in health;

Or. de

Amendment 1489

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;

deleted

Or. en

Justification

Moved to paragraph 1a(new)

Amendment 1490

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

Proposal for a regulation

Article 37 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;

(j) cooperate with and supervise data holders to enable them to enact their rights to opt-out of data processing for secondary use as referred to in Article 33(5a) and to opt-in for data processing for the specific categories of data referred to in Article 33(5b) ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;

Or. en

Amendment 1491

Birgit Sippel, Paul Tang, Maria Grapini

on behalf of the S&D Group

Petar Vitanov

Proposal for a regulation

Article 37 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;

(j) cooperate with and supervise data holders, assist them in order to ensure respect of data subjects' consent as referred to in Article 33(5), and ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;

Or. en

Amendment 1492

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 37 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;

(j) cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56, as well as support them in order to ensure respect of the right to opt-out of data subjects referred to in Article 33(5);

Or. en

Amendment 1493

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point j

Text proposed by the Commission

Amendment

(j) cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;

(j) application processing bodies shall cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;

Or. de

Amendment 1494

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

Proposal for a regulation

Article 37 – paragraph 1 – point k

Text proposed by the Commission

Amendment

(k) maintain a management system to record and process data access applications, data requests and the data permits issued and data requests answered, providing at least information on the name of the data applicant, the purpose of access the date of issuance, duration of the data permit and a description of the data application or the data request;

(k) maintain a management system to record and process data access applications, data requests, the decisions on these applications and the data permits issued and data requests answered, providing at least information on the name of the data applicant, the purpose of access, the date of issuance, duration of the data permit and a description of the data application or the data request;

Or. en

Amendment 1495

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point k

Text proposed by the Commission

Amendment

(k) application processing bodies shall maintain a management system to record and process data access applications, data requests and the data permits issued and data requests answered, providing at least information on the name of the data applicant, the purpose of access the date of issuance, duration of the data permit and a description of the data application or the data request;

Or. de

Amendment 1496

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point l

Text proposed by the Commission

Amendment

(l) maintain a public information system to comply with the obligations laid down in Article 38;

(l) application processing and access bodies shall jointly maintain a public information system to comply with the obligations laid down in Article 38;

Or. de

Amendment 1497

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

Proposal for a regulation

Article 37 – paragraph 1 – point m

Text proposed by the Commission

Amendment

(m) cooperate at Union and national level to lay down appropriate measures and requirements for accessing electronic health data in a secure processing environment;

(m) cooperate at Union and national level to lay down a common approach, technical requirements and appropriate measures and requirements for accessing electronic health data in a secure processing environment;

Or. en

Amendment 1498

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 37 – paragraph 1 – point m

Text proposed by the Commission

Amendment

(m) cooperate at Union and national level to lay down appropriate measures and requirements for accessing electronic health data in a secure processing environment;

(m) cooperate at Union, national and, where applicable, regional level to lay down appropriate measures and requirements for accessing electronic health data in a secure processing environment;

Or. en

Amendment 1499

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point m

Text proposed by the Commission

Amendment

(m) cooperate at Union and national level to lay down appropriate measures and requirements for accessing electronic health data in a secure processing environment;

(m) access bodies shall cooperate at Union and national level to lay down appropriate measures and requirements for accessing electronic health data in a secure processing environment;

Or. de

Amendment 1500

Javier Zarzalejos

Proposal for a regulation

Article 37 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) cooperate at Union and national level and provide advice to the Commission on techniques and best practices for electronic health data use and management;

(n) cooperate at Union and national level and provide advice to the Commission on techniques and best practices for the secondary use of electronic health data use and management;

Or. en

Amendment 1501

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 37 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) cooperate at Union and national level and provide advice to the Commission on techniques and best practices for electronic health data use and management;

(n) cooperate at Union, national and, where applicable, regional level and provide advice to the Commission on techniques and best practices for electronic health data use and management;

Or. en

Amendment 1502

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

Proposal for a regulation

Article 37 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) cooperate at Union and national level and provide advice to the Commission on techniques and best practices for electronic health data use and management;

(n) cooperate at Union and national level and provide advice to the Commission on techniques and best practices for the secondary use of electronic health data and management;

Or. en

Amendment 1503

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point n

Text proposed by the Commission

Amendment

(n) cooperate at Union and national level and provide advice to the Commission on techniques and best practices for electronic health data use and management;

(n) access bodies shall cooperate at Union and national level and provide advice to the Commission on techniques and best practices for electronic health data use and management;

Or. de

Amendment 1504

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point o

Text proposed by the Commission

Amendment

(o) facilitate cross-border access to electronic health data for secondary use hosted in other Member States through HealthData@EU and cooperate closely with each other and with the Commission.

deleted

Or. en

Justification

Moved to paragraph 1a(new)

Amendment 1505

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point o

Text proposed by the Commission

Amendment

(o) facilitate cross-border access to electronic health data for secondary use hosted in other Member States through HealthData@EU and cooperate closely with each other and with the Commission.

(o) access bodies shall facilitate cross-border access to electronic health data for secondary use hosted in other Member States through HealthData@EU and cooperate closely with each other and with the Commission;

Or. de

Amendment 1506

Pernille Weiss

Proposal for a regulation

Article 37 – paragraph 1 – point p

Text proposed by the Commission

Amendment

(p) send to the data holder free of charge, by the expiry of the data permit, a copy of the corrected, annotated or enriched dataset, as applicable, and a description of the operations performed on the original dataset;

(p) inform the data holder when electronic health data made available for secondary use entails their intellectual property, trade secrets or regulatory data and upon request send to the data holder free of charge, by the expiry of the data permit, a copy of the corrected, annotated or enriched dataset, as applicable, and a description of the operations performed on the original dataset;

Or. en

Amendment 1507

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point q – introductory part

Text proposed by the Commission

Amendment

(q) make public, through electronic means:

(q) application processing bodies shall make public, through electronic means:

Or. de

Amendment 1508

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

Proposal for a regulation

Article 37 – paragraph 1 – point q – point i

Text proposed by the Commission

Amendment

(i) a national dataset catalogue that shall include details about the source and nature of electronic health data, in accordance with Articles 56 and 58, and the conditions for making electronic health data available. The national dataset catalogue shall also be made available to single information points under Article 8 of Regulation […] [Data Governance Act COM/2020/767 final];

(i) a national dataset catalogue in accordance with Articles 55, 56 and 58 of this Regulation and the conditions for making electronic health data available. The national dataset catalogue shall also be made available to single information points under Article 8 of Regulation […] [Data Governance Act COM/2020/767 final];

Or. en

Amendment 1509

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 37 – paragraph 1 – point q – point i

Text proposed by the Commission

Amendment

(i) a dataset catalogue that shall include details about the source and nature of electronic health data, in accordance with Articles 56 and 58, and the conditions for making electronic health data available. The national dataset catalogue shall also be made available to single information points under Article 8 of Regulation […] [Data Governance Act COM/2020/767 final];

Or. en

Amendment 1510

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

Proposal for a regulation

Article 37 – paragraph 1 – point q – point ii

Text proposed by the Commission

Amendment

(ii) all data permits, requests and applications on their websites within 30 working days after issuance of the data permit or reply to a data request;

(ii) all health data applications and requests without undue delay after their reception;

Or. en

Amendment 1511

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

Proposal for a regulation

Article 37 – paragraph 1 – point q – point ii a (new)

Text proposed by the Commission

Amendment

(ii a) all health data permits or requests granted as well as denied, together with justification, within 30 working days after their issuance;

Or. en

Amendment 1512

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point q – point iii

Text proposed by the Commission

Amendment

(iii) penalties applied pursuant to Article 43;

deleted

Or. de

Amendment 1513

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 – point q – point iii

Text proposed by the Commission

Amendment

(iii) penalties applied pursuant to Article 43;

(iii) penalties applied pursuant to Article 69;

(Due to alignment of art. 43 with art. 69)

Or. en

Amendment 1514

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 37 – paragraph 1 – point q – point iv a (new)

Text proposed by the Commission

Amendment

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

Or. en

Amendment 1515

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point q a (new)

Text proposed by the Commission

Amendment

(qa) access bodies shall make public through electronic means the sanctions imposed under Article 43;

Or. de

Amendment 1516

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point r

Text proposed by the Commission

Amendment

(r) fulfil obligations towards natural persons pursuant to Article 38;

(r) bodies involved in accessing health data shall fulfil obligations towards natural persons pursuant to Article 38;

Or. de

Amendment 1517

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

Proposal for a regulation

Article 37 – paragraph 1 – point r a (new)

Text proposed by the Commission

Amendment

(r a) monitor and supervise compliance by data users and data holders with the requirements laid down in this Chapter; where personal data are concerned, the monitoring and compliance shall be carried out in close cooperation with relevant supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725; monitoring and supervision shall include regular audits on health data users regarding their processing of electronic health data in the secure processing environment;

Or. en

Amendment 1518

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point s

Text proposed by the Commission

Amendment

(s) request from data users and data holders all the relevant information to verify the implementation of this Chapter;

(s) access bodies shall, if they have reasonable grounds to suspect an infringement, request from data users and data holders all the relevant information to verify the implementation of this Chapter;

Or. de

Amendment 1519

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 1 – point t

Text proposed by the Commission

Amendment

(t) fulfil any other tasks related to making available the secondary use of electronic health data in the context of this Regulation.

(t) bodies involved in accessing health data shall fulfil any other tasks related to making available the secondary use of electronic health data in the context of this Regulation to the extent that these tasks fall within their remit.

Or. de

Amendment 1520

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 37 – paragraph 1 – point t a (new)

Text proposed by the Commission

Amendment

(t a) terminate the data permit to a secondary use data user in case it contravened the purposes defined in Article 35.

Or. en

Amendment 1521

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 1 a (new)

Text proposed by the Commission

Amendment

1 a. The trust bodies within the health data access bodies shall carry out the following tasks:

(a) process electronic health data for the purposes set out in Article 34, including the collection, combination, preparation and disclosure of those data for secondary use on the basis of a data permit;

(b) process electronic health data from other relevant data holders based on a data permit or a data request for a purpose laid down in Article 34;

(d) gather and compile or provide access to the necessary electronic health data from the various data holders whose electronic health data fall within the scope of this Regulation and put those data at the disposal of data users in a secure processing environment in accordance with the requirements laid down in Article 50;

(e) contribute to data altruism activities in accordance with Article 40;

(f) support the development of AI systems, the training, testing and validating of AI systems and the development of harmonised standards and guidelines under Regulation […] [AI Act COM/2021/206 final] for the training, testing and validation of AI systems in health;

(g) cooperate with and supervise data holders to ensure the consistent and accurate implementation of the data quality and utility label set out in Article 56;assist data holders to ensure they fully respect any refusals or restrictions for access for primary use pursuant to paragraphs 9 and 9a of Article 3;

(h) facilitate cross-border access to anonymised electronic health data for secondary use hosted in other Member States through HealthData@EU and cooperate closely with each other and with the Commission.

Or. en

Amendment 1522

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 2 – introductory part

Text proposed by the Commission

Amendment

2. In the exercise of their tasks, health data access bodies shall:

2. In the exercise of their tasks, bodies involved in accessing health data shall proceed as follows:

Or. de

Amendment 1523

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 2 – point a

Text proposed by the Commission

Amendment

(a) cooperate with supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 in relation to personal electronic health data and the EHDS Board;

(a) cooperate with supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 in relation to personal electronic health data;

Or. en

Amendment 1524

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

Proposal for a regulation

Article 37 – paragraph 2 – point a a (new)

Text proposed by the Commission

Amendment

(a a) immediately notify the relevant supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of any potential issue related to the processing of personal electronic health data for secondary use to ensure application and enforcement of this Regulation and relevant provisions of the aforementioned Regulations, including penalties.

Or. en

Amendment 1525

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) inform the relevant supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 where a health data access body has imposed penalties or other measures pursuant to Article 43 in relation to processing personal electronic health data and where such processing refers to an attempt to re-identify an individual or unlawful processing of personal electronic health data;

(b) access bodies shall inform the relevant supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 where a health data access body has imposed penalties or other measures pursuant to Article 43 in relation to processing personal electronic health data and where such processing refers to an attempt to re-identify an individual or unlawful processing of personal electronic health data;

Or. de

Amendment 1526

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 2 – point b

Text proposed by the Commission

Amendment

(b) inform the relevant supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 where a health data access body has imposed penalties or other measures pursuant to Article 69 in relation to processing personal electronic health data, or where such processing refers to an attempt to re-identify an individual or unlawful processing of personal electronic health data;

(Due to alignment between art. 43 and art. 69)

Or. en

Amendment 1527

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) cooperate with stakeholders, including patient organisations, representatives from natural persons, health professionals, researchers, and ethical committees, where applicable in accordance with Union and national law;

(c) bodies involved in accessing health data shall cooperate with stakeholders, including patient organisations, representatives from natural persons, health professionals, researchers, and ethical committees, where applicable in accordance with Union and national law;

Or. de

Amendment 1528

Pernille Weiss

Proposal for a regulation

Article 37 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) cooperate with all relevant stakeholders, including patient organisations, representatives from natural persons, health professionals, researchers, industry representatives and ethical committees, where applicable in accordance with Union and national law;

Or. en

Amendment 1529

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 2 – point c

Text proposed by the Commission

Amendment

(c) cooperate with stakeholders, including patient and consumer organisations, representatives from natural persons, health professionals, researchers, and ethical committees, where applicable in accordance with Union and national law;

Or. en

Amendment 1530

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) cooperate with other national competent bodies, including the national competent bodies supervising data altruism organisations under Regulation […] [Data Governance Act COM/2020/767 final], the competent authorities under Regulation […] [Data Act COM/2022/68 final] and the national competent authorities for Regulations (EU) 2017/745 and Regulation […] [AI Act COM/2021/206 final] .

(d) bodies involved in accessing health data shall cooperate with other national competent bodies, including the national competent bodies supervising data altruism organisations under Regulation […] [Data Governance Act COM/2020/767 final], the competent authorities under Regulation […] [Data Act COM/2022/68 final] and the national competent authorities for Regulations (EU) 2017/745 and Regulation […] [AI Act COM/2021/206 final] .

Or. de

Amendment 1531

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 37 – paragraph 2 – point d

Text proposed by the Commission

Amendment

(d) cooperate with other competent bodies, including the national competent bodies supervising data altruism organisations under Regulation […] [Data Governance Act COM/2020/767 final], the competent authorities under Regulation […] [Data Act COM/2022/68 final] and the national competent authorities for Regulations (EU) 2017/745 and Regulation […] [AI Act COM/2021/206 final] .

Or. en

Amendment 1532

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

Proposal for a regulation

Article 37 – paragraph 2 – point d a (new)

Text proposed by the Commission

Amendment

(d a) cooperate with European institutions and agencies, where applicable in accordance with Union law.

Or. en

Amendment 1533

Antoni Comín i Oliveres, Carles Puigdemont i Casamajó

Proposal for a regulation

Article 37 – paragraph 3

Text proposed by the Commission

Amendment

3. The health data access bodies may provide assistance to public sector bodies where those public sector bodies access electronic health data on the basis of Article 14 of Regulation […] [Data Act COM/2022/68 final].

3. The health data access bodies shall provide assistance to public sector bodies where those public sector bodies access electronic health data on the basis of Article 14 of Regulation […] [Data Act COM/2022/68 final].

Or. en

Amendment 1534

Tilly Metz, Patrick Breyer

on behalf of the Verts/ALE Group

Proposal for a regulation

Article 37 – paragraph 4

Text proposed by the Commission

Amendment

4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list of tasks in paragraph 1 of this Article, to reflect the evolution of activities performed by health data access bodies.

deleted

Or. en

Amendment 1535

Christian Doleschal, Angelika Niebler

Proposal for a regulation

Article 37 – paragraph 4

Text proposed by the Commission

Amendment

Or. de

Amendment 1536

Konstantinos Arvanitis

Proposal for a regulation

Article 37 – paragraph 4 – subparagraph 1 (new)

Text proposed by the Commission

Amendment

The Commission shall adopt guidelines on the functioning of the health data access bodies to ensure coherent processes among them.

Or. en

Amendment 1537

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

Proposal for a regulation

Article 37 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. The EDPB shall provide health data acces bodies with specific guidelines and minimum standards of anonymisation and pseudonymisation for the purposes in this Regulation in order to ensure the same level of quality of anonymisation and pseudonymisation across Member States.

The guidelines shall be based on state-of-the-art technology in this regard, which in turn shall be used by the health data access bodies when carrying out their task of anonymisation or pseudonymisation of electronic health data.

The guidelines shall be regularly updated, in line with technological progress in this field.

Or. en

Amendment 1538

Elisabetta De Blasis, Silvia Sardone

Proposal for a regulation

Article 37 – paragraph 4 a (new)

Text proposed by the Commission

Amendment

4 a. Following open and public consultations, the Commission shall adopt guidelines on the functioning of the health data access bodies to ensure coherent processes among them.

Or. en