Sittings · Compare
What changed
DRAFT EUROPEAN PARLIAMENT LEGISLATIVE RESOLUTION
– having regard to the opinion of the Committee of the Regions of 9 February 2023,
– having regard to RulesRule 59 and 40 of its Rules of Procedure,
– having regard to the opinions of the Committee on Industry, Research and Energy and of the Committee on Internal Market and Consumer Protection,
– having regard to the report of the Committee on the Environment, Public Health and Food Safety and the Committee on Civil Liberties, Justice and Home Affairs (A90000/2023),(A9-0395/2023),
1. Adopts its position at first reading hereinafter set out;
Proposal for a regulation
Recital 31
Or. en
Amendment 2
Proposal for a regulation
Recital 51 a (new)
Or. en
Amendment 3
Proposal for a regulation
Recital 7
Recital 1 b (new)
Or. en
Amendment 4
Proposal for a regulation
Recital 92
Or. en
Amendment 5
Proposal for a regulation
Recital 103
Or. en
Amendment 6
Proposal for a regulation
Recital 153 a (new)
Or. en
Amendment 7
Proposal for a regulation
Recital 18 a (new)
Recital 4
Or. en
Amendment 8
Proposal for a regulation
Recital 24
Recital 4 a (new)
Or. en
Amendment 9
Proposal for a regulation
Recital 255
Or. en
Amendment 10
Proposal for a regulation
Recital 365 a (new)
Or. en
Justification
The important role of real-world evidence for policy decision-making is currently not emphasised in the proposal. The amendment introduces a recital highlighting the potential application of real-world evidence, including the benefits for patients with certain diseases, including respiratory and rare diseases.
Amendment 11
Proposal for a regulation
Recital 377
Or. en
Amendment 12
Proposal for a regulation
Recital 399
Or. en
Amendment 13
Proposal for a regulation
Recital 39 a (new)
Recital 10
Or. en
Justification
In order to empower data subjects, they should have a say on the further use of their most private and sensitive data. The possibility to opt-out of processing for secondary use should be provided to preserve the essence of the right to data protection and to provide for suitable and specific measures to safeguard the fundamental rights and interests of data subjects (Art. 9(2) GDPR).
The issue is also one of trust between the patient and the HC provider: patients may no longer wish to share their health data with HC providers if the data are then automatically passed on for secondary use.
Amendment 14
Proposal for a regulation
Recital 40 a (new)
Recital 11
Or. en
Amendment 15
Proposal for a regulation
Recital 4712
Or. en
Justification
Consequence of proposed deletion of Article 49.
Amendment 16
Proposal for a regulation
Recital 4913
Or. en
Amendment 17
Proposal for a regulation
Recital 5314
Or. en
Justification
Consequence of proposed deletion of Article 49.
Amendment 18
Proposal for a regulation
Recital 5415
Or. en
Amendment 19
Proposal for a regulation
Recital 5516
Or. en
Amendment 20
Proposal for a regulation
Recital 57
Recital 16 a (new)
Or. en
Amendment 21
Proposal for a regulation
Recital 61 a (new)
Recital 17
Or. en
Amendment 22
Proposal for a regulation
Recital 63 a (new)
Recital 19
Or. en
Amendment 23
Proposal for a regulation
Recital 64 a (new)
Recital 20
Or. en
Amendment 24
Proposal for a regulation
Recital 6420 ba (new)
Or. en
Amendment 25
Proposal for a regulation
Recital 64 c (new)
Recital 21
Or. en
Amendment 26
Proposal for a regulation
Recital 64 d (new)
Recital 22
Or. en
Amendment 27
Proposal for a regulation
Recital 65
Recital 22 a (new)
Or. en
Amendment 28
Proposal for a regulation
Recital 69 a (new)
Recital 23
Or. en
Amendment 29
Proposal for a regulation
Recital 7424
Or. en
Amendment 30
Proposal for a regulation
Article 1 – paragraph 3 a (new)
Recital 25
Or. en
Amendment 31
Proposal for a regulation
Article 1 – paragraph 4
Recital 26
Or. en
Amendment 32
Proposal for a regulation
Article 2 – paragraph 1 – point a
Recital 34 a (new)
Or. en
Amendment 33
Proposal for a regulation
Article 2 – paragraph 1 – point c
Recital 35
Or. en
Amendment 34
Proposal for a regulation
Article 2 – paragraph 1 – point f a (new)
Recital 36 a (new)
Or. en
Amendment 35
Proposal for a regulation
Article 2 – paragraph 2 – point b
Recital 37
Or. en
Amendment 36
Proposal for a regulation
Article 2 – paragraph 2 – point e
Recital 37 a (new)
Or. en
Amendment 37
Proposal for a regulation
Article 2 – paragraph 2 – point m
Recital 38
Or. en
Amendment 38
Proposal for a regulation
Article 2 – paragraph 2 – point n
Recital 39
Or. en
Amendment 39
Proposal for a regulation
Article 2 – paragraph 2 – point q – introductory part
Recital 39 a (new)
Or. en
Amendment 40
Proposal for a regulation
Article 2 – paragraph 2 – point z
Recital 40
Or. en
Amendment 41
Proposal for a regulation
Article 2 – paragraph 2 – point z a (new)
Recital 40 a (new)
Or. en
Amendment 42
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Recital 40 b (new)
Or. en
Amendment 43
Proposal for a regulation
Article 2 – paragraph 2 – point ae b (new)
Recital 41
Or. en
Amendment 44
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 1 – point b
Recital 42
Or. en
Amendment 45
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 1 – point b a (new)
Recital 43
Or. en
Amendment 46
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 1
Recital 44
Or. en
Amendment 47
Proposal for a regulation
Article 3 – paragraph 9
Recital 46
Or. en
Amendment 48
Proposal for a regulation
Article 3 – paragraph 10
Recital 47
Or. en
Amendment 49
Proposal for a regulation
Article 3 – paragraph 12
Recital 48
Or. en
Amendment 50
Proposal for a regulation
Article 4 – paragraph 2
Recital 49
Or. en
Amendment 51
Proposal for a regulation
Article 4 – paragraph 3
Recital 50
Or. en
Amendment 52
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point f
Recital 50 a (new)
Or. en
Amendment 53
Proposal for a regulation
Article 5 – paragraph 1 – subparagraph 1 – point f a (new)
Recital 51
Or. en
Amendment 54
Proposal for a regulation
Article 5 – paragraph 2 a (new)
Recital 52
Or. en
Amendment 55
Proposal for a regulation
Article 6 – paragraph 1 – point a
Recital 53
Or. en
Amendment 56
Proposal for a regulation
Article 7 – paragraph 1 a (new)
Recital 54
Or. en
Amendment 57
Proposal for a regulation
Article 8 – paragraph 1
Recital 55
Or. en
Amendment 58
Proposal for a regulation
Article 10 – paragraph 2 – point m
Recital 59
Or. en
Amendment 59
Proposal for a regulation
Article 10 – paragraph 2 a (new)
Recital 61
Or. en
Amendment 60
Proposal for a regulation
Article 10 – paragraph 5
Recital 62 a (new)
Or. en
Amendment 61
Proposal for a regulation
Article 10 – paragraph 5 a (new)
Recital 63
Or. en
Amendment 62
Proposal for a regulation
Article 11 – paragraph 1
Recital 63 a (new)
Or. en
Amendment 63
Proposal for a regulation
ArticleRecital 1164 a (new)
Or. en
Amendment 64
Proposal for a regulation
Article 12 – paragraph 4
Recital 64 b (new)
Or. en
Amendment 65
Proposal for a regulation
Article 12 – paragraph 8
Recital 64 c (new)
Or. en
Amendment 66
Proposal for a regulation
Article 13 – paragraph 3 – subparagraph 1
Recital 65
Or. en
Amendment 67
Proposal for a regulation
Article 16 – paragraph 1 – introductory part
Recital 65 a (new)
Or. en
Amendment 68
Proposal for a regulation
Article 16 – paragraph 1 – point b
Recital 66 a (new)
Or. en
Amendment 69
Proposal for a regulation
Article 16 – paragraph 1 a (new)
Recital 66 b (new)
Or. en
Amendment 70
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1
Recital 66 c (new)
Or. en
Amendment 71
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Recital 66 d (new)
Or. en
Amendment 72
Proposal for a regulation
Article 29 – paragraph 1
Recital 66 e (new)
Or. en
Amendment 73
Proposal for a regulation
Article 31 – paragraph 6
Recital 66 f (new)
Or. en
Amendment 74
Proposal for a regulation
Article 31 – paragraph 9
Recital 66 g (new)
Or. en
Amendment 75
Proposal for a regulation
Article 33 – paragraph 1 – point a
Recital 66 h (new)
Or. en
Amendment 76
Proposal for a regulation
Article 33 – paragraph 1 – point b
Recital 66 i (new)
Or. en
Amendment 77
Proposal for a regulation
Article 33 – paragraph 1 – point d
Recital 66 j (new)
Or. en
Amendment 78
Proposal for a regulation
Article 33 – paragraph 1 – point f
Recital 66 k (new)
Or. en
Amendment 79
Proposal for a regulation
Article 33 – paragraph 1 – point g
Recital 66 l (new)
Or. en
Amendment 80
Proposal for a regulation
Article 33 – paragraph 1 – point j
Recital 69 a (new)
Or. en
Amendment 81
Proposal for a regulation
Article 33 – paragraph 1 – point l
Recital 70
Or. en
Amendment 82
Proposal for a regulation
Article 33 – paragraph 1 – point n
Recital 71
Or. en
Amendment 83
Proposal for a regulation
Article 33 – paragraph 3 a (new)
Recital 74
Or. en
Amendment 84
Proposal for a regulation
Article 33 – paragraph 5
Recital 76
Or. en
Justification
The possibility to opt-out of processing for secondary use should be provided to preserve the essence of the right to data protection and provide for suitable and specific measures to safeguard the fundamental rights and interests of data subjects (Art. 9(2) GDPR). The issue is also one of trust between the patient and the HC provider: patients may no longer wish to share their health data with HC providers if the data are then automatically passed on for secondary use.
Amendment 85
Proposal for a regulation
Article 341 – paragraph 12 – introductorypoint parta
Or. en
Amendment 86
Proposal for a regulation
Article 341 – paragraph 13 – point a
Or. en
Amendment 87
Proposal for a regulation
Article 34 – paragraph 1 – pointparagraph c4
Or. en
Amendment 88
Proposal for a regulation
Article 341 – paragraph 1 –4 pointa d(new)
Or. en
Amendment 89
Proposal for a regulation
Article 341 – paragraph 1 –5 pointa e(new)
Or. en
Amendment 90
Proposal for a regulation
Article 342 – paragraph 1 – point e – point i (new)c
Or. en
Amendment 91
Proposal for a regulation
Article 342 – paragraph 1 – point e2 – point ii (new)a
Or. en
Amendment 92
Proposal for a regulation
Article 342 – paragraph 12 – point fb
Or. en
Justification
Included in point e - point i
Amendment 93
Proposal for a regulation
Article 342 – paragraph 12 – point gd
Or. en
Justification
Included in point e- point ii
Amendment 94
Proposal for a regulation
Article 342 – paragraph 2 a– (new)point e
Or. en
Amendment 95
Proposal for a regulation
Article 352 – paragraph 12 – point aj
Or. en
Amendment 96
Proposal for a regulation
Article 352 – paragraph 12 – point bk
Or. en
Amendment 97
Proposal for a regulation
Article 362 – paragraph 2 – point l
Or. en
Amendment 98
Proposal for a regulation
Article 362 – paragraph 32 – point m
Or. en
Amendment 99
Proposal for a regulation
Article 362 – paragraph 42 a– (new)point n
Or. en
Amendment 100
Proposal for a regulation
Article 372 – paragraph 12 – point co
Or. en
Justification
Text simplification, see horizontal amendment introducing a definition of 'public sector body', which includes Union institutions, bodies, offices and agencies.
Amendment 101
Proposal for a regulation
Article 372 – paragraph 12 – point jq – introductory part
Or. en
Amendment 102
Proposal for a regulation
Article 372 – paragraph 42 – subparagraphpoint 1q a– (new)point i
Or. en
Amendment 103
Proposal for a regulation
Article 382 – paragraph 12 – point cy
Or. en
Amendment 104
Proposal for a regulation
Article 382 – paragraph 12 – point d a (new)z
Or. en
Amendment 105
Proposal for a regulation
Article 382 – paragraph 12 – point ez a (new)
Or. en
Amendment 106
Proposal for a regulation
Article 382 – paragraph 2 – point aa
Or. en
Justification
Alignment to Article 14 GDPR.
Amendment 107
Proposal for a regulation
Article 382 – paragraph 32 – point a ea (new)
Or. en
Amendment 108
Proposal for a regulation
Article 383 – paragraph 42
Or. en
Amendment 109
Proposal for a regulation
Article 383 – paragraph 2 a (new)
Or. en
Amendment 110
Proposal for a regulation
Article 38 b (new)
Article 3 – paragraph 3
Or. en
Amendment 111
Proposal for a regulation
Article 393 – paragraph 1 – subparagraph 1 a (new)4
Or. en
Amendment 112
Proposal for a regulation
Article 423 – paragraph 5 – subparagraph 1 – point a
Or. en
Justification
consequence of the proposed deletion of Article 49
Amendment 113
Proposal for a regulation
Article 423 – paragraph 45 – subparagraph 1 – point b
Or. en
Amendment 114
Proposal for a regulation
Article 433 – paragraph 45 – subparagraph 2
Or. en
Amendment 115
Proposal for a regulation
Article 433 – paragraph 5 a (new)
Or. en
Justification
Consequence of the proposed deletion of Article 49
Amendment 116
Proposal for a regulation
Article 443 – paragraph 16
Or. en
Amendment 117
Proposal for a regulation
Article 443 – paragraph 36 a (new)
Or. en
Amendment 118
Proposal for a regulation
Article 443 – paragraph 3 a (new)7
Or. en
Amendment 119
Proposal for a regulation
Article 453 – paragraph 28 – pointsubparagraph a1
Or. en
Amendment 120
Proposal for a regulation
Article 453 – paragraph 28 – pointsubparagraph f2
Or. en
Amendment 121
Proposal for a regulation
Article 453 – paragraph 28 – point f asubparagraph (new)3
Or. en
Amendment 122
Proposal for a regulation
Article 453 – paragraph 2 – point f b (new)9
Or. en
Amendment 123
Proposal for a regulation
Article 453 – paragraph 2 – point h a (new)10
Or. en
Amendment 124
Proposal for a regulation
Article 463 – paragraph 111
Or. en
Amendment 125
Proposal for a regulation
Article 463 – paragraph 212
Or. en
Amendment 126
Proposal for a regulation
Article 463 – paragraph 312 a (new)
Or. en
Justification
This provision would in practice void the core of the regulation. It would entail a fiction of a data authorization, at the expense of the fundamental rights of the data subjects and would not allow for controlling essential elements of the request, including the necessity and relevance of the data for the processing purpose pursued. In particular, applicants could benefit from the licensing fiction making unlawful or unlawful applications.
Amendment 127
Proposal for a regulation
Article 464 – paragraph 4-1 (new)
Or. en
Amendment 128
Proposal for a regulation
Article 49
Article 4 – paragraph 1 – point a
Or. en
Justification
Without the involvement and oversight by a health data access body, there is an important risk that the rights of the data subjects and safeguards contained in this Regulation might not be upheld.
Amendment 129
Proposal for a regulation
Article 504 – paragraph 1 – introductory part2
Or. en
Amendment 130
Proposal for a regulation
Article 504 – paragraph 1 –2 pointa b(new)
Or. en
Amendment 131
Proposal for a regulation
Article 504 – paragraph 2 b (new)
Or. en
Amendment 132
Proposal for a regulation
Article 514 – titleparagraph 3
Or. en
Amendment 133
Proposal for a regulation
Article 514 – paragraph 13 a (new)
Or. en
Amendment 134
Proposal for a regulation
Article 514 – paragraph 24
Or. en
Amendment 135
Proposal for a regulation
Article 525 – paragraph 41 – subparagraph 1 – introductory part
Or. en
Amendment 136
Proposal for a regulation
Article 525 – paragraph 51 – subparagraph 1 – point e
Or. en
Amendment 137
Proposal for a regulation
Article 565 – paragraph 31 – introductorysubparagraph part1 – point f
Or. en
Amendment 138
Proposal for a regulation
Article 605 – paragraph 21 – subparagraph 1 – point f a (new)
Or. en
Justification
The EDPB and EDPS consider in their Joint Opinion that the recommendations regarding data storage in the EU and compliance with Chapter V GDPR and in particular Article 48 GDPR would be best operationalised if they were embedded at an early stage when procuring or funding services provided by controllers and processors established in the EU processing personal electronic health data.
Amendment 139
Proposal for a regulation
Article 60 a (new)
Article 5 – paragraph 1 – subparagraph 2
Or. en
Justification
See the EDPB/EDPS Joint Opinion, citing the storage location requirement as set out in CJEU joined Cases C-293/12 and C-594/12 of 8 April 2014, Digital Rights Ireland Ltd, paras 68-69, and joined Cases C-203/15 and C-698/15 of 21 December 2016, Tele2 Sverige AB, para 122, which should apply a fortiori to electronic health data. See as well the data storage requirement laid down in Article 6(8) of Directive (EU) 2016/681 (EU PNR Directive).
Amendment 140
Proposal for a regulation
Article 635 – paragraph 1 – subparagraph 3
Or. en
Amendment 141
Proposal for a regulation
Article 63 a (new)
Article 5 – paragraph 2
Or. en
Amendment 142
Proposal for a regulation
Article 646 – paragraph 1 – introductory part
Or. en
Amendment 143
Proposal for a regulation
Article 646 – paragraph 41 – point a
Or. en
Amendment 144
Proposal for a regulation
Article 646 – paragraph 61 a– (new)point c
Or. en
Amendment 145
Proposal for a regulation
Article 656 – paragraph 1 – point asubparagraph a1 (new)
Or. en
Amendment 146
Proposal for a regulation
Article 656 – paragraph 1 – point b a (new)2
Or. en
Amendment 147
Proposal for a regulation
Article 656 – paragraph 1 – point b b (new)3
Or. en
Amendment 148
Proposal for a regulation
Article 657 – paragraph 1 – point e
Or. en
Amendment 149
Proposal for a regulation
Article 657 – paragraph 13 – point e asubparagraph (new)1
Or. en
Amendment 150
Proposal for a regulation
Article 657 – paragraph 13 a– (new)subparagraph 2
Or. en
Amendment 151
Proposal for a regulation
Article 657 – paragraph 2 – point f3 a (new)
Or. en
Amendment 152
Proposal for a regulation
Article 658 – paragraph 2 – point f b (new)1
Or. en
Amendment 153
Proposal for a regulation
Article 659 – paragraph 2 a (new)1
Or. en
Amendment 154
Proposal for a regulation
Article 699 – paragraph 12
Or. en
Amendment 155
Proposal for a regulation
Article 699 – paragraph 1 a (new)3
Or. en
Amendment 156
Proposal for a regulation
Article 69 a (new)
Article 9 – paragraph 4
Or. en
Amendment 157
Proposal for a regulation
Article 7010 – paragraph 12 – introductory part
Or. en
Amendment 158
Proposal for a regulation
Article 10 – paragraph 2 – point b
Amendment 159
Proposal for a regulation
Article 10 – paragraph 2 – point h
Amendment 160
Proposal for a regulation
Article 10 – paragraph 2 – point k
Amendment 161
Proposal for a regulation
Article 10 – paragraph 2 – point m
Amendment 162
Proposal for a regulation
Article 10 – paragraph 3
Amendment 163
Proposal for a regulation
Article 10 – paragraph 3 a (new)
Amendment 164
Proposal for a regulation
Article 10 – paragraph 5
Amendment 165
Proposal for a regulation
Article 10 – paragraph 5 a (new)
Amendment 166
Proposal for a regulation
Article 11 – paragraph 1
Amendment 167
Proposal for a regulation
Article 11 – paragraph 2
Amendment 168
Proposal for a regulation
Article 11 – paragraph 3 a (new)
Amendment 169
Proposal for a regulation
Article 11 a (new)
Amendment 170
Proposal for a regulation
Article 12 – paragraph 4
Amendment 171
Proposal for a regulation
Article 12 – paragraph 6
Amendment 172
Proposal for a regulation
Article 12 – paragraph 8
Amendment 173
Proposal for a regulation
Article 13 – paragraph 3
Amendment 174
Proposal for a regulation
Article 14 – paragraph 2
Amendment 175
Proposal for a regulation
Article 14 – paragraph 4
Amendment 176
Proposal for a regulation
Article 15 – paragraph 1
Amendment 177
Proposal for a regulation
Article 16 – paragraph 1 – introductory part
Amendment 178
Proposal for a regulation
Article 16 – paragraph 1 – point b
Amendment 179
Proposal for a regulation
Article 17 – paragraph 1 – point a
Amendment 180
Proposal for a regulation
Article 17 – paragraph 1 – point b
Amendment 181
Proposal for a regulation
Article 17 – paragraph 1 – point c
Amendment 182
Proposal for a regulation
Article 17 – paragraph 1 – point d
Amendment 183
Proposal for a regulation
Article 17 – paragraph 1 – point d a (new)
Amendment 184
Proposal for a regulation
Article 17 – paragraph 1 – point e
Amendment 185
Proposal for a regulation
Article 17 – paragraph 1 – point e a (new)
Amendment 186
Proposal for a regulation
Article 17 – paragraph 1 – point g
Amendment 187
Proposal for a regulation
Article 17 – paragraph 1 – point h
Amendment 188
Proposal for a regulation
Article 17 – paragraph 1 – point i
Amendment 189
Proposal for a regulation
Article 17 – paragraph 1 – point j
Amendment 190
Proposal for a regulation
Article 17 – paragraph 1 – point k
Amendment 191
Proposal for a regulation
Article 17 – paragraph 1 – point k a (new)
Amendment 192
Proposal for a regulation
Article 17 – paragraph 2
Amendment 193
Proposal for a regulation
Article 17 – paragraph 3
Amendment 194
Proposal for a regulation
Article 17 – paragraph 3 a (new)
Amendment 195
Proposal for a regulation
Article 17 – paragraph 3 b (new)
Amendment 196
Proposal for a regulation
Article 17 – paragraph 3 c (new)
Amendment 197
Proposal for a regulation
Article 18 – paragraph 2 – introductory part
Amendment 198
Proposal for a regulation
Article 18 – paragraph 2 – point a
Amendment 199
Proposal for a regulation
Article 18 – paragraph 2 – point b
Amendment 200
Proposal for a regulation
Article 18 – paragraph 2 – point b a (new)
Amendment 201
Proposal for a regulation
Article 18 – paragraph 2 – point b b (new)
Amendment 202
Proposal for a regulation
Article 18 – paragraph 2 – point c
Amendment 203
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Amendment 204
Proposal for a regulation
Article 19 – paragraph 2 – point a
Amendment 205
Proposal for a regulation
Article 19 – paragraph 2 – point a a (new)
Amendment 206
Proposal for a regulation
Article 19 – paragraph 2 – point b
Amendment 207
Proposal for a regulation
Article 19 – paragraph 2 – point c
Amendment 208
Proposal for a regulation
Article 19 – paragraph 3
Amendment 209
Proposal for a regulation
Article 19 – paragraph 4
Amendment 210
Proposal for a regulation
Article 19 – paragraph 5
Amendment 211
Proposal for a regulation
Article 19 – paragraph 7
Amendment 212
Proposal for a regulation
Article 19 – paragraph 7 a (new)
Amendment 213
Proposal for a regulation
Article 19 – paragraph 7 b (new)
Amendment 214
Proposal for a regulation
Article 20 – paragraph 1 – point a
Amendment 215
Proposal for a regulation
Article 20 – paragraph 1 – point b
Amendment 216
Proposal for a regulation
Article 20 – paragraph 1 – point c
Amendment 217
Proposal for a regulation
Article 20 – paragraph 2
Amendment 218
Proposal for a regulation
Article 20 – paragraph 3
Amendment 219
Proposal for a regulation
Article 20 – paragraph 4
Amendment 220
Proposal for a regulation
Article 21 – title
Amendment 221
Proposal for a regulation
Article 21 – paragraph 1
Amendment 222
Proposal for a regulation
Chapter III – Section 3 – title
Amendment 223
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1
Amendment 224
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Amendment 225
Proposal for a regulation
Article 23 – paragraph 4 a (new)
Amendment 226
Proposal for a regulation
Article 23 – paragraph 5
Amendment 227
Proposal for a regulation
Article 23 – paragraph 6
Amendment 228
Proposal for a regulation
Article 24 – paragraph 1
Amendment 229
Proposal for a regulation
Article 24 – paragraph 2
Amendment 230
Proposal for a regulation
Article 24 – paragraph 2 a (new)
Amendment 231
Proposal for a regulation
Article 24 – paragraph 3
Amendment 232
Proposal for a regulation
Article 25 – paragraph 1
Amendment 233
Proposal for a regulation
Article 25 – paragraph 2 – point a
Amendment 234
Proposal for a regulation
Article 25 – paragraph 2 – subparagraph 1a (new)
Amendment 235
Proposal for a regulation
Article 26 – paragraph 3
Amendment 236
Proposal for a regulation
Article 26 – paragraph 3 a (new)
Amendment 237
Proposal for a regulation
Article 26 – paragraph 4
Amendment 238
Proposal for a regulation
Article 26 – paragraph 4 a (new)
Amendment 239
Proposal for a regulation
Article 26 – paragraph 4 b (new)
Amendment 240
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Amendment 241
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Amendment 242
Proposal for a regulation
Article 27 – paragraph 2 b (new)
Amendment 243
Proposal for a regulation
Article 27 a (new)
Amendment 244
Proposal for a regulation
Article 27 aa (new)
Amendment 245
Proposal for a regulation
Article 27 b (new)
Amendment 246
Proposal for a regulation
Article 27 c (new)
Amendment 247
Proposal for a regulation
Article 27 d (new)
Amendment 248
Proposal for a regulation
Article 27 e (new)
Amendment 249
Proposal for a regulation
Article 27 f (new)
Amendment 250
Proposal for a regulation
Article 27 g(new)
Amendment 251
Proposal for a regulation
Article 27 h (new)
Amendment 252
Proposal for a regulation
Article 27 i (new)
Amendment 253
Proposal for a regulation
Article 27 j (new)
Amendment 254
Proposal for a regulation
Article 27 k (new)
Amendment 255
Proposal for a regulation
Article 27 l (new)
Amendment 256
Proposal for a regulation
Article 27 m (new)
Amendment 257
Proposal for a regulation
Article 27 n (new)
Amendment 258
Proposal for a regulation
Article 27 o (new)
Amendment 259
Proposal for a regulation
Article 27 p (new)
Amendment 260
Proposal for a regulation
Article 27 q (new)
Amendment 261
Proposal for a regulation
Article 27 r (new)
Amendment 262
Proposal for a regulation
Article 28 – paragraph 2
Amendment 263
Proposal for a regulation
Article 28 – paragraph 2 a (new)
Amendment 264
Proposal for a regulation
Article 28 – paragraph 2 b (new)
Amendment 265
Proposal for a regulation
Article 28 – paragraph 4 a (new)
Amendment 266
Proposal for a regulation
Article 28 – paragraph 4 b (new)
Amendment 267
Proposal for a regulation
Article 29 – paragraph 1
Amendment 268
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Amendment 269
Proposal for a regulation
Article 29 – paragraph 1 b (new)
Amendment 270
Proposal for a regulation
Article 29 – paragraph 3
Amendment 271
Proposal for a regulation
Article 29 – paragraph 3 a (new)
Amendment 272
Proposal for a regulation
Article 29 – paragraph 4 – subparagraph 1
Amendment 273
Proposal for a regulation
Article 29 – paragraph 4 – subparagraph 2
Amendment 274
Proposal for a regulation
Article 29 – paragraph 5
Amendment 275
Proposal for a regulation
Article 30 – paragraph 1 – introductory part
Amendment 276
Proposal for a regulation
Article 30 – paragraph 1 – point a
Amendment 277
Proposal for a regulation
Article 30 – paragraph 1 – point b
Amendment 278
Proposal for a regulation
Article 30 – paragraph 1 – point c
Amendment 279
Proposal for a regulation
Article 30 – paragraph 1 – point d a (new)
Amendment 280
Proposal for a regulation
Article 30 – paragraph 1 a (new)
Amendment 281
Proposal for a regulation
Article 30 – paragraph 1 b (new)
Amendment 282
Proposal for a regulation
Article 30 – paragraph 1 c (new)
Amendment 283
Proposal for a regulation
Article 30 – paragraph 1 d (new)
Amendment 284
Proposal for a regulation
Article 30 – paragraph 1 e (new)
Amendment 285
Proposal for a regulation
Article 30 a (new)
Amendment 286
Proposal for a regulation
Article 31 – title
Amendment 287
Proposal for a regulation
Article 31 – paragraph 1
Amendment 288
Proposal for a regulation
Article 31 – paragraph 3
Amendment 289
Proposal for a regulation
Article 31 – paragraph 4
Amendment 290
Proposal for a regulation
Article 31 – paragraph 6
Amendment 291
Proposal for a regulation
Article 31 – paragraph 9
Amendment 292
Proposal for a regulation
Article 31 – paragraph 10
Amendment 293
Proposal for a regulation
Article 31 a (new)
Amendment 294
Proposal for a regulation
Article 32 – paragraph 1
Amendment 295
Proposal for a regulation
Article 32 – paragraph 3
Amendment 296
Proposal for a regulation
Article 33 – title
Amendment 297
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Amendment 298
Proposal for a regulation
Article 33 – paragraph 1 – point a
Amendment 299
Proposal for a regulation
Article 33 – paragraph 1 – point b
Amendment 300
Proposal for a regulation
Article 33 – paragraph 1 – point c
Amendment 301
Proposal for a regulation
Article 33 – paragraph 1 – point d
Amendment 302
Proposal for a regulation
Article 33 – paragraph 1 – point e
Amendment 303
Proposal for a regulation
Article 33 – paragraph 1 – point f
Amendment 304
Proposal for a regulation
Article 33 – paragraph 1 – point f a (new)
Amendment 305
Proposal for a regulation
Article 33 – paragraph 1 – point g
Amendment 306
Proposal for a regulation
Article 33 – paragraph 1 – point j
Amendment 307
Proposal for a regulation
Article 33 – paragraph 1 – point l
Amendment 308
Proposal for a regulation
Article 33 – paragraph 1 – point n
Amendment 309
Proposal for a regulation
Article 33 – paragraph 2
Amendment 310
Proposal for a regulation
Article 33 – paragraph 4
Amendment 311
Proposal for a regulation
Article 33 – paragraph 5
Amendment 312
Proposal for a regulation
Article 33 – paragraph 5 a (new)
Amendment 313
Proposal for a regulation
Article 33 – paragraph 7
Amendment 314
Proposal for a regulation
Article 33 – paragraph 8
Amendment 315
Proposal for a regulation
Article 33 a (new)
Amendment 316
Proposal for a regulation
Article 34 – paragraph 1 – introductory part
Amendment 317
Proposal for a regulation
Article 34 – paragraph 1 – point a
Amendment 318
Proposal for a regulation
Article 34 – paragraph 1 – point b
Amendment 319
Proposal for a regulation
Article 34 – paragraph 1 – point c
Amendment 320
Proposal for a regulation
Article 34 – paragraph 1 – point d
Amendment 321
Proposal for a regulation
Article 34 – paragraph 1 – point e
Amendment 322
Proposal for a regulation
Article 34 – paragraph 1 – point f
Amendment 323
Proposal for a regulation
Article 34 – paragraph 1 – point g
Amendment 324
Proposal for a regulation
Article 34 – paragraph 1 – point h
Amendment 325
Proposal for a regulation
Article 34 – paragraph 2
Amendment 326
Proposal for a regulation
Article 34 – paragraph 4
Amendment 327
Proposal for a regulation
Article 35 – paragraph -1 (new)
Amendment 328
Proposal for a regulation
Article 35 – paragraph -1 a (new)
Amendment 329
Proposal for a regulation
Article 35 – paragraph 1 – introductory part
Amendment 330
Proposal for a regulation
Article 35 – paragraph 1 – point a
Amendment 331
Proposal for a regulation
Article 35 – paragraph 1 – point b
Amendment 332
Proposal for a regulation
Article 35 – paragraph 1 – point c
Amendment 333
Proposal for a regulation
Article 35 – paragraph 1 – point e
Amendment 334
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Amendment 335
Proposal for a regulation
Article 36 – paragraph 1
Amendment 336
Proposal for a regulation
Article 36 – paragraph 2
Amendment 337
Proposal for a regulation
Article 36 – paragraph 2 a (new)
Amendment 338
Proposal for a regulation
Article 36 – paragraph 3
Amendment 339
Proposal for a regulation
Article 36 – paragraph 3 a (new)
Amendment 340
Proposal for a regulation
Article 37 – paragraph 1 – point a
Amendment 341
Proposal for a regulation
Article 37 – paragraph 1 – point a a (new)
Amendment 342
Proposal for a regulation
Article 37 – paragraph 1 – point a b (new)
Amendment 343
Proposal for a regulation
Article 37 – paragraph 1 – point d
Amendment 344
Proposal for a regulation
Article 37 – paragraph 1 – point e
Amendment 345
Proposal for a regulation
Article 37 – paragraph 1 – point f
Amendment 346
Proposal for a regulation
Article 37 – paragraph 1 – point g
Amendment 347
Proposal for a regulation
Article 37 – paragraph 1 – point i
Amendment 348
Proposal for a regulation
Article 37 – paragraph 1 – point j a (new)
Amendment 349
Proposal for a regulation
Article 37 – paragraph 1 – point k
Amendment 350
Proposal for a regulation
Article 37 – paragraph 1 – point m
Amendment 351
Proposal for a regulation
Article 37 – paragraph 1 – point n
Amendment 352
Proposal for a regulation
Article 37 – paragraph 1 – point q – point i
Amendment 353
Proposal for a regulation
Article 37 – paragraph 1 – point q – point ii
Amendment 354
Proposal for a regulation
Article 37 – paragraph 1 – point q – point ii a (new)
Amendment 355
Proposal for a regulation
Article 37 – paragraph 1 – point q – point iii
Amendment 356
Proposal for a regulation
Article 37 – paragraph 1 – point r a (new)
Amendment 357
Proposal for a regulation
Article 37 – paragraph 2 – point a
Amendment 358
Proposal for a regulation
Article 37 – paragraph 2 – point a a (new)
Amendment 359
Proposal for a regulation
Article 37 – paragraph 2 – point b
Amendment 360
Proposal for a regulation
Article 37 – paragraph 2 – point c
Amendment 361
Proposal for a regulation
Article 37 – paragraph 4
Amendment 362
Proposal for a regulation
Article 38 – paragraph 1 – introductory part
Amendment 363
Proposal for a regulation
Article 38 – paragraph 1 – point a
Amendment 364
Proposal for a regulation
Article 38 – paragraph 1 – point c
Amendment 365
Proposal for a regulation
Article 38 – paragraph 1 – point d
Amendment 366
Proposal for a regulation
Article 38 – paragraph 1 – point d a (new)
Amendment 367
Proposal for a regulation
Article 38 – paragraph 1 – point d b (new)
Amendment 368
Proposal for a regulation
Article 38 – paragraph 2
Amendment 369
Proposal for a regulation
Article 38 – paragraph 3
Amendment 370
Proposal for a regulation
Article 38 a (new)
Amendment 371
Proposal for a regulation
Article 38 b (new)
Amendment 372
Proposal for a regulation
Article 39 – paragraph 1 – introductory part
Amendment 373
Proposal for a regulation
Article 39 – paragraph 1 – point a
Amendment 374
Proposal for a regulation
Article 39 – paragraph 1 – point c
Amendment 375
Proposal for a regulation
Article 39 – paragraph 1 – point d
Amendment 376
Proposal for a regulation
Article 39 – paragraph 1 – point e
Amendment 377
Proposal for a regulation
Article 39 – paragraph 1 – point j
Amendment 378
Proposal for a regulation
Article 39 – paragraph 1 – point l
Amendment 379
Proposal for a regulation
Article 39 – paragraph 2
Amendment 380
Proposal for a regulation
Article 39 – paragraph 3
Amendment 381
Proposal for a regulation
Article 40 – paragraph 1
Amendment 382
Proposal for a regulation
Article 40 – paragraph 2
Amendment 383
Proposal for a regulation
Article 41 – title
Amendment 384
Proposal for a regulation
Article 41 – paragraph 1
Amendment 385
Proposal for a regulation
Article 41 – paragraph 1 a (new)
Amendment 386
Proposal for a regulation
Article 41 – paragraph 1 b (new)
Amendment 387
Proposal for a regulation
Article 41 – paragraph 1 c (new)
Amendment 388
Proposal for a regulation
Article 41 – paragraph 2
Amendment 389
Proposal for a regulation
Article 41 – paragraph 3
Amendment 390
Proposal for a regulation
Article 41 – paragraph 4
Amendment 391
Proposal for a regulation
Article 41 – paragraph 5
Amendment 392
Proposal for a regulation
Article 41 – paragraph 6
Amendment 393
Proposal for a regulation
Article 41 – paragraph 7
Amendment 394
Proposal for a regulation
Article 41 a (new)
Amendment 395
Proposal for a regulation
Article 42 – paragraph 1
Amendment 396
Proposal for a regulation
Article 42 – paragraph 2
Amendment 397
Proposal for a regulation
Article 42 – paragraph 4
Amendment 398
Proposal for a regulation
Article 42 – paragraph 5
Amendment 399
Proposal for a regulation
Article 42 – paragraph 6
Amendment 400
Proposal for a regulation
Article 43 – title
Amendment 401
Proposal for a regulation
Article 43 – paragraph 1
Amendment 402
Proposal for a regulation
Article 43 – paragraph 2
Amendment 403
Proposal for a regulation
Article 43 – paragraph 3
Amendment 404
Proposal for a regulation
Article 43 – paragraph 4
Amendment 405
Proposal for a regulation
Article 43 – paragraph 5
Amendment 406
Proposal for a regulation
Article 43 – paragraph 6
Amendment 407
Proposal for a regulation
Article 43 – paragraph 7
Amendment 408
Proposal for a regulation
Article 43 – paragraph 7 a (new)
Amendment 409
Proposal for a regulation
Article 43 – paragraph 9
Amendment 410
Proposal for a regulation
Article 43 – paragraph 10
Amendment 411
Proposal for a regulation
Article 43 a (new)
Amendment 412
Proposal for a regulation
Article 44 – paragraph 1
Amendment 413
Proposal for a regulation
Article 44 – paragraph 2
Amendment 414
Proposal for a regulation
Article 44 – paragraph 3
Amendment 415
Proposal for a regulation
Article 44 – paragraph 3 a (new)
Amendment 416
Proposal for a regulation
Article 44 – paragraph 3 b (new)
Amendment 417
Proposal for a regulation
Article 45 – paragraph 1
Amendment 418
Proposal for a regulation
Article 45 – paragraph 2 – point -a (new)
Amendment 419
Proposal for a regulation
Article 45 – paragraph 2 – point a
Amendment 420
Proposal for a regulation
Article 45 – paragraph 2 – point a a (new)
Amendment 421
Proposal for a regulation
Article 45 – paragraph 2 – point a b (new)
Amendment 422
Proposal for a regulation
Article 45 – paragraph 2 – point b
Amendment 423
Proposal for a regulation
Article 45 – paragraph 2 – point c
Amendment 424
Proposal for a regulation
Article 45 – paragraph 2 – point d
Amendment 425
Proposal for a regulation
Article 45 – paragraph 2 – point e
Amendment 426
Proposal for a regulation
Article 45 – paragraph 2 – point f
Amendment 427
Proposal for a regulation
Article 45 – paragraph 2 – point g
Amendment 428
Proposal for a regulation
Article 45 – paragraph 2 – point h a (new)
Amendment 429
Proposal for a regulation
Article 45 – paragraph 2 – point h b (new)
Amendment 430
Proposal for a regulation
Article 45 – paragraph 2 – point h c (new)
Amendment 431
Proposal for a regulation
Article 45 – paragraph 3
Amendment 432
Proposal for a regulation
Article 45 – paragraph 4 – introductory part
Amendment 433
Proposal for a regulation
Article 45 – paragraph 4 – point a
Amendment 434
Proposal for a regulation
Article 45 – paragraph 4 – point b
Amendment 435
Proposal for a regulation
Article 45 – paragraph 5 – subparagraph 2
Amendment 436
Proposal for a regulation
Article 45 – paragraph 6
Amendment 437
Proposal for a regulation
Article 46 – paragraph 1
Amendment 438
Proposal for a regulation
Article 46 – paragraph 2
Amendment 439
Proposal for a regulation
Article 46 – paragraph 3
Amendment 440
Proposal for a regulation
Article 46 – paragraph 4
Amendment 441
Proposal for a regulation
Article 46 – paragraph 5
Amendment 442
Proposal for a regulation
Article 46 – paragraph 6 – introductory part
Amendment 443
Proposal for a regulation
Article 46 – paragraph 6 – point a
Amendment 444
Proposal for a regulation
Article 46 – paragraph 6 – point b
Amendment 445
Proposal for a regulation
Article 46 – paragraph 6 – point b a (new)
Amendment 446
Proposal for a regulation
Article 46 – paragraph 6 – point d
Amendment 447
Proposal for a regulation
Article 46 – paragraph 6 – point e
Amendment 448
Proposal for a regulation
Article 46 – paragraph 7
Amendment 449
Proposal for a regulation
Article 46 – paragraph 8
Amendment 450
Proposal for a regulation
Article 46 – paragraph 9
Amendment 451
Proposal for a regulation
Article 46 – paragraph 11
Amendment 452
Proposal for a regulation
Article 46 – paragraph 12
Amendment 453
Proposal for a regulation
Article 46 – paragraph 14
Amendment 454
Proposal for a regulation
Article 47 – title
Amendment 455
Proposal for a regulation
Article 47 – paragraph 1
Amendment 456
Proposal for a regulation
Article 47 – paragraph 2 – introductory part
Amendment 457
Proposal for a regulation
Article 47 – paragraph 3
Amendment 458
Proposal for a regulation
Article 48 – title
Amendment 459
Proposal for a regulation
Article 48 – paragraph 1
Amendment 460
Proposal for a regulation
Article 49
Amendment 461
Proposal for a regulation
Article 50 – paragraph 1 – introductory part
Amendment 462
Proposal for a regulation
Article 50 – paragraph 1 – point b
Amendment 463
Proposal for a regulation
Article 50 – paragraph 1 – point d
Amendment 464
Proposal for a regulation
Article 50 – paragraph 1 – point e
Amendment 465
Proposal for a regulation
Article 50 – paragraph 1 – point f a (new)
Amendment 466
Proposal for a regulation
Article 50 – paragraph 2
Amendment 467
Proposal for a regulation
Article 50 – paragraph 3
Amendment 468
Proposal for a regulation
Article 50 – paragraph 4
Amendment 469
Proposal for a regulation
Article 51 – title
Amendment 470
Proposal for a regulation
Article 51 – paragraph 1
Amendment 471
Proposal for a regulation
Article 52 – paragraph 3
Amendment 472
Proposal for a regulation
Article 52 – paragraph 5
Amendment 473
Proposal for a regulation
Article 52 – paragraph 12
Amendment 474
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – introductory part
Amendment 475
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – point a
Amendment 476
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 1 – point a a (new)
Amendment 477
Proposal for a regulation
Article 52 – paragraph 13 – subparagraph 2
Amendment 478
Proposal for a regulation
Article 53 – title
Amendment 479
Proposal for a regulation
Article 54 – title
Amendment 480
Proposal for a regulation
Article 54 – paragraph 1
Amendment 481
Proposal for a regulation
Article 55 – title
Amendment 482
Proposal for a regulation
Article 56 – paragraph 2 a (new)
Amendment 483
Proposal for a regulation
Article 56 – paragraph 3 – introductory part
Amendment 484
Proposal for a regulation
Article 57 – paragraph 1
Amendment 485
Proposal for a regulation
Article 59 – paragraph 1
Amendment 486
Proposal for a regulation
Article 59 a (new)
Amendment 487
Proposal for a regulation
Article 60 – paragraph 2 a (new)
Amendment 488
Proposal for a regulation
Article 60 a (new)
Amendment 489
Proposal for a regulation
Article 61 – title
Amendment 490
Proposal for a regulation
Article 61 – paragraph 1
Amendment 491
Proposal for a regulation
Article 61 – paragraph 2
Amendment 492
Proposal for a regulation
Article 63 – paragraph 1
Amendment 493
Proposal for a regulation
Article 63 a (new)
Amendment 494
Proposal for a regulation
Article 64 – paragraph 1
Amendment 495
Proposal for a regulation
Article 64 – paragraph 2
Amendment 496
Proposal for a regulation
Article 64 – paragraph 3
Amendment 497
Proposal for a regulation
Article 64 – paragraph 4
Amendment 498
Proposal for a regulation
Article 64 – paragraph 5
Amendment 499
Proposal for a regulation
Article 64 – paragraph 7 a (new)
Amendment 500
Proposal for a regulation
Article 64 – paragraph 8
Amendment 501
Proposal for a regulation
Article 64 a (new)
Amendment 502
Proposal for a regulation
Article 65 – paragraph -1 (new)
Amendment 503
Proposal for a regulation
Article 65 – paragraph 1 – point b – introductory part
Amendment 504
Proposal for a regulation
Article 65 – paragraph 1 – point b – point iii
Amendment 505
Proposal for a regulation
Article 65 – paragraph 1 – point b a (new)
Amendment 506
Proposal for a regulation
Article 65 – paragraph 1 – point d
Amendment 507
Proposal for a regulation
Article 65 – paragraph 1 – point e
Amendment 508
Proposal for a regulation
Article 65 – paragraph 2 – point b – point v
Amendment 509
Proposal for a regulation
Article 65 – paragraph 2 – point b – point vi
Amendment 510
Proposal for a regulation
Article 65 – paragraph 2 – point c
Amendment 511
Proposal for a regulation
Article 65 – paragraph 2 – point d
Amendment 512
Proposal for a regulation
Article 65 – paragraph 2 – point f
Amendment 513
Proposal for a regulation
Article 65 – paragraph 2 – point f a (new)
Amendment 514
Proposal for a regulation
Article 65 – paragraph 2 a (new)
Amendment 515
Proposal for a regulation
Article 65 – paragraph 2 b (new)
Amendment 516
Proposal for a regulation
Article 65 – paragraph 2 c (new)
Amendment 517
Proposal for a regulation
Article 66 – paragraph 3
Amendment 518
Proposal for a regulation
Article 66 – paragraph 6 a (new)
Amendment 519
Proposal for a regulation
Article 67 – paragraph 2
Amendment 520
Proposal for a regulation
Article 67 – paragraph 3
Amendment 521
Proposal for a regulation
Article 67 – paragraph 6
Amendment 522
Proposal for a regulation
Article 68 – paragraph 2 a (new)
Amendment 523
Proposal for a regulation
Article 69 – paragraph 1
Amendment 524
Proposal for a regulation
Article 69 a (new)
Amendment 525
Proposal for a regulation
Article 69 b (new)
Amendment 526
Proposal for a regulation
Article 69 c (new)
Amendment 527
Proposal for a regulation
Article 70 – paragraph 1
Amendment 528
Proposal for a regulation
Article 70 – paragraph 1 a (new)
Or. en
Amendment 529
Proposal for a regulation
Article 70 – paragraph 2
Amendment 530
Proposal for a regulation
Article 71 a (new)
Amendment 531
Proposal for a regulation
Article 72 – paragraph 2
Amendment 532
Proposal for a regulation
Article 72 – paragraph 3 – point b
Amendment 533
Proposal for a regulation
Article 72 – paragraph 3 – point c
Amendment 534
Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
Justification
This amendment aims to promote patients' understanding and control of their personal health data. The blood type is a relevant type of data that should be added to the priority categories of health data.
Amendment 535
Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
Amendment 536
Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
Amendment 537
Proposal for a regulation
Annex II – point 2 – point 2.3
Amendment 538
Proposal for a regulation
Annex II – point 2 – point 2.5
Amendment 539
Proposal for a regulation
Annex II – point 2 – point 2.5 a (new)
Amendment 540
Proposal for a regulation
Annex II – point 3 – point 3.1
Amendment 541
Proposal for a regulation
Annex II – point 3 – point 3.1
Amendment 542
Proposal for a regulation
Annex II – point 3 – point 3.8
Justification
Amendment in line with EDPB/EDPS joint opinion recommendation.
Amendment 543
Proposal for a regulation
Annex IV a (new)
EXPLANATORY STATEMENT
The rapporteurs note with some concern the relatively restrictive budget allocated for the EHDS in the Legislative Financial Statement and sees the risk that the allocated budget may not be sufficient in fully meeting the objectives of the proposal. Furthermore, it is the position of the Parliament that new Union initiatives should be met with fresh financial resources, while there is a genuine concern that the EHDS will compete with other actions under the EU4Health and Digital Europe programmes foreseen at the adoption of the 2021-2027 Multiannual Financial Framework. The Commission should therefore analyse the need for strengthening the budget allocated to the implementation of the EHDS as part of any revision of the MFF and in the proposal for a new MFF in the period after 2027.
ANNEX: ENTITIES OR PERSONS FROM WHOM THE RAPPORTEURS HAS RECEIVED INPUT
Pursuant to Article 8 of Annex I to the Rules of Procedure, the rapporteurs declares that they have received input from the following entities or persons in the preparation of the report, until the adoption thereof in committee:
MEP Tomislav Sokol:
MEP Annalisa Tardino:
The list above is drawn up under the exclusive responsibility of the rapporteur.
23.5.2023
OPINION OF THE COMMITTEE ON INDUSTRY, RESEARCH AND ENERGY
for the Committee on the Environment, Public Health and Food Safety and the Committee on Civil Liberties, Justice and Home Affairs
on the proposal for a regulation of the European Parliament and of the Council on European Health Data Space
(COM(2022)0197 – C90167/2022 – 2022/0140(COD))
Rapporteur for opinion: CristianSilviu Buşoi
(*) Associated committee – Rule 57 of the Rules of Procedure
SHORT JUSTIFICATION
The Rapporteur supports many elements of the European Health Data Space (EHDS) initiative, especially the provisions aimed at providing better health outcomes and promoting health innovation and research. The Rapporteur believes that the availability of cross-border health data can significantly improve patient care and contribute to more effective health policies at a European level. The Rapporteur also believes that this proposal can lead to significant benefits for individuals, patients, healthcare professionals, and society as a whole. Additionally, the Rapporteur supports this proposal as it can boost research and innovation, support the development of new drugs, devices, and treatments, and increase the efficiency and sustainability of healthcare systems.
However, the Rapporteur is of the opinion that some changes are necessary to ensure the success of the initiative. The Rapporteur believes that a prudent implementation of the GDPR is necessary to avoid unnecessary restrictions for health research and data sharing, key to apply artificial intelligence and machine learning tools to research, and to enabling the digital transformation of healthcare, to tackle disparities in prevention, diagnosis, and treatment around Europe. The EHDS will be a critical tool in managing and sharing health data across the European Union, but it must do so in a way that respects the privacy and rights of patients. As contact person for the EMA, the Rapporteur understands that the EMA and other regulatory authorities, such as national medicines’ agencies need to be seen and treated differently from all other data users in EHDS. The legal proposal already foresees this by recognizing regulatory authorities’ needs, and the Rapporteur further strengthens the text by allowing better informed regulatory decision making on benefits and risks of medicinal products, robust and speed up regulatory assessment of new medicinal products with the goal of making them faster available to patients and enhanced tools and processes available to monitor safety and effectiveness of medicines to the benefit of EU patients. Furthermore, the Rapporteur thinks that in order for health data to be useful across different systems, it is essential that we establish interoperable and common rules and standards. This means that data should be able to be exchanged seamlessly between different health systems, regardless of the platform or software used. Therefore, the Rapporteur opinion also underline that the lack of standardization in health data is a major obstacle to interoperability.
Finally, the Rapporteur is of the opinion that EHDS should build upon the already existing legislation such as the Data Governance Act and Data Act. These acts provide a solid foundation for the governance and management of health data, and we should work to align our efforts with their provisions. By doing so, the Rapporteur wants to ensure that the collection, processing, and use of health data is conducted in a responsible and transparent manner, while also protecting the privacy and security of individuals.
AMENDMENTS
The Committee on Industry, Research and Energy calls on the Committee on Civil Liberties, Justice and Home Affairs, as the committee responsible, to take into account the following amendments:
Amendment 1
Proposal for a regulation
Recital 1 a (new)
Amendment 2
Proposal for a regulation
Recital 1 b (new)
Amendment 3
Proposal for a regulation
Recital 1 c (new)
Amendment 4
Proposal for a regulation
Recital 4
Amendment 5
Proposal for a regulation
Recital 17
Amendment 6
Proposal for a regulation
Recital 27 a (new)
Amendment 7
Proposal for a regulation
Recital 29
Amendment 8
Proposal for a regulation
Recital 40
Amendment 9
Proposal for a regulation
Recital 41
Amendment 10
Proposal for a regulation
Recital 43
Amendment 11
Proposal for a regulation
Recital 53
Amendment 12
Proposal for a regulation
Recital 54
Amendment 13
Proposal for a regulation
Recital 61 a (new)
Amendment 14
Proposal for a regulation
Recital 63
Amendment 15
Proposal for a regulation
Recital 64
Amendment 16
Proposal for a regulation
Article 1 – paragraph 1
Amendment 17
Proposal for a regulation
Article 1 – paragraph 2 – point a
Amendment 18
Proposal for a regulation
Article 1 – paragraph 3 – point b
Amendment 19
Proposal for a regulation
Article 1 – paragraph 3 – point d
Amendment 20
Proposal for a regulation
Article 2 – paragraph 2 – point f
Amendment 21
Proposal for a regulation
Article 2 – paragraph 2 – point g
Amendment 22
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Amendment 23
Proposal for a regulation
Article 2 – paragraph 2 – point ae b (new)
Amendment 24
Proposal for a regulation
Article 9 – paragraph 2
Amendment 25
Proposal for a regulation
Article 9 – paragraph 3
Amendment 26
Proposal for a regulation
Article 9 – paragraph 4
Amendment 27
Proposal for a regulation
Article 10 – paragraph 2 – point g
Amendment 28
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1
Amendment 29
Proposal for a regulation
Article 23 – paragraph 5
Amendment 30
Proposal for a regulation
Article 33 – paragraph 1 – point a
Amendment 31
Proposal for a regulation
Article 33 – paragraph 1 – point d
Amendment 32
Proposal for a regulation
Article 33 – paragraph 1 – point e
Amendment 33
Proposal for a regulation
Article 33 – paragraph 1 – point i
Amendment 34
Proposal for a regulation
Article 33 – paragraph 1 – point j
Amendment 35
Proposal for a regulation
Article 33 – paragraph 3
Amendment 36
Proposal for a regulation
Article 33 – paragraph 4
Amendment 37
Proposal for a regulation
Article 33 – paragraph 5
Amendment 38
Proposal for a regulation
Article 33 – paragraph 7
Amendment 39
Proposal for a regulation
Article 33 – paragraph 8
Amendment 40
Proposal for a regulation
Article 33 a (new)
Amendment 41
Proposal for a regulation
Article 34 – paragraph 1 – point g
Amendment 42
Proposal for a regulation
Article 35 – paragraph 1 – introductory part
Amendment 43
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Amendment 44
Proposal for a regulation
Article 36 – paragraph 3
Amendment 45
Proposal for a regulation
Article 37 – paragraph 1 – point m
Amendment 46
Proposal for a regulation
Article 37 – paragraph 1 – point t a (new)
Amendment 47
Proposal for a regulation
Article 37 – paragraph 2 – point a a (new)
Amendment 48
Proposal for a regulation
Article 37 – paragraph 2 – point c
Amendment 49
Proposal for a regulation
Article 38 – paragraph 1 – point c
Amendment 50
Proposal for a regulation
Article 39 – paragraph 1 – introductory part
Amendment 51
Proposal for a regulation
Article 39 – paragraph 2
Amendment 52
Proposal for a regulation
Article 39 – paragraph 3
Amendment 53
Proposal for a regulation
Article 41 – paragraph 1
Amendment 54
Proposal for a regulation
Article 44 – paragraph 1
Amendment 55
Proposal for a regulation
Article 45 – paragraph 4 – point a
Amendment 56
Proposal for a regulation
Article 46 – paragraph 3
Amendment 57
Proposal for a regulation
Article 46 – paragraph 11
Amendment 58
Proposal for a regulation
Article 46 – paragraph 14
Amendment 59
Proposal for a regulation
Article 48 – paragraph 1
Amendment 60
Proposal for a regulation
Article 49
Amendment 61
Proposal for a regulation
Article 52 – paragraph 3
Amendment 62
Proposal for a regulation
Article 52 – paragraph 4
Amendment 63
Proposal for a regulation
Article 52 – paragraph 7
Amendment 64
Proposal for a regulation
Article 52 – paragraph 8
Amendment 65
Proposal for a regulation
Article 61 – paragraph 2
Amendment 66
Proposal for a regulation
Article 64 – paragraph 1
Amendment 67
Proposal for a regulation
Article 64 – paragraph 4
Amendment 68
Proposal for a regulation
Article 64 – paragraph 5
Amendment 69
Proposal for a regulation
Article 65 – paragraph 2 – point f
Amendment 70
Proposal for a regulation
Annex II – point 2 – point 2.4
Amendment 71
Proposal for a regulation
Annex II – point 3 – point 3.1
PROCEDURE – COMMITTEE ASKED FOR OPINION
FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION
25.5.2023
OPINION OF THE COMMITTEE ON THE INTERNAL MARKET AND CONSUMER PROTECTION
for the Committee on the Environment, Public Health and Food Safety and for the Committee on Civil Liberties, Justice and Home Affairs
on the proposal for a regulation of the European Parliament and of the Council on the European Health Data Space
(COM(2022)0197 – C90167/2022 – 2022/0140(COD))
Rapporteur for opinion: Andrey Kovatchev
(*) Associated committee – Rule 57 of the Rules of Procedure
SHORT JUSTIFICATION
This opinion focuses on the second pillar, Chapter III, which aims to implement a mandatory self-certification scheme for EHR systems, while complying with essential requirements on interoperability and security.
As Rapporteur for the IMCO Committee, I streamline the monitoring of the internal market. My draft opinion focuses on clarifying the definitions related to EHR, EHR systems, as well as introducing some new definition to allow for clear interpretation of the conditions set out in Chapter III of the proposal. Additionally, I propose to specify clearly the way in which the Commission will be creating the standards to apply to EHR systems through a clear reference to the use of international and harmonised standards, as well as the participation of all relevant stakeholders in this process.
My amendments further aim to define clearly the interplay between the EHDS and other sectoral legislation, especially for scenarios where devices would fall within the scope of more than one of these legislative acts.
An important addition is the requirement for the Commission and Member States to set explicit time-based targets for implementation and progress on cross-border health data interoperability and the relevant infrastructure.
This draft opinion aims to improve EHR systems by clarifying relevant definitions, ensuring that the Commission uses harmonised standards as the basis for setting EU-wide standards on security and interoperability for EHR systems, as well as reconciling the scope of the European Health Data Space with other sectoral legislation, such as the Medical Devices Regulation, the In-vitro Medical Device Regulation and the upcoming AI Act, and Data Act. By providing these clarifications, the proposed amendments intend to make the Commission’s proposal clearer and more predictable for stakeholders as well as clearly ensure the EU remains well connected globally and does not impose standards, which are not interoperable with global partners.
AMENDMENTS
The Committee on the Internal Market and Consumer Protection calls on the Committee on Civil Liberties, Justice and Home Affairs, as the committee responsible, to take into account the following amendments:
Amendment 1
Proposal for a regulation
Recital 7
Amendment 2
Proposal for a regulation
Recital 11
Amendment 3
Proposal for a regulation
Recital 16
Amendment 4
Proposal for a regulation
Recital 19
Amendment 5
Proposal for a regulation
Recital 19 a (new)
Amendment 6
Proposal for a regulation
Recital 23
Amendment 7
Proposal for a regulation
Recital 24
Amendment 8
Proposal for a regulation
Recital 25
Amendment 9
Proposal for a regulation
Recital 29
Amendment 10
Proposal for a regulation
Recital 34
Amendment 11
Proposal for a regulation
Recital 40
Amendment 12
Proposal for a regulation
Recital 51
Amendment 13
Proposal for a regulation
Recital 68
Amendment 14
Proposal for a regulation
Recital 69
Amendment 15
Proposal for a regulation
Recital 70
Amendment 16
Proposal for a regulation
Recital 71 a (new)
Amendment 17
Proposal for a regulation
Recital 72 a (new)
Amendment 18
Proposal for a regulation
Article 1 – paragraph 4
Amendment 19
Proposal for a regulation
Article 2 – paragraph 1 – point d a (new)
Amendment 20
Proposal for a regulation
Article 2 – paragraph 1 – point e
Amendment 21
Proposal for a regulation
Article 2 – paragraph 2 – point b
Amendment 22
Proposal for a regulation
Article 2 – paragraph 2 – point i a (new)
Amendment 23
Proposal for a regulation
Article 2 – paragraph 2 – point m
Amendment 24
Proposal for a regulation
Article 2 – paragraph 2 – point n
Amendment 25
Proposal for a regulation
Article 2 – paragraph 2 – point n a (new)
Amendment 26
Proposal for a regulation
Article 2 – paragraph 2 – point o
Amendment 27
Proposal for a regulation
Article 3 – paragraph 10
Amendment 28
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Amendment 29
Proposal for a regulation
Article 6 – paragraph 1 – introductory part
Amendment 30
Proposal for a regulation
Article 10 – paragraph 2 – point i a (new)
Amendment 31
Proposal for a regulation
Article 12 – paragraph 1
Amendment 32
Proposal for a regulation
Article 12 – paragraph 4
Amendment 33
Proposal for a regulation
Article 14 – paragraph 2 a (new)
Amendment 34
Proposal for a regulation
Article 14 – paragraph 4
Amendment 35
Proposal for a regulation
Article 15 – paragraph 1
Amendment 36
Proposal for a regulation
Article 16 – paragraph 1 – introductory part
Amendment 37
Proposal for a regulation
Article 16 – paragraph 1 – point b
Amendment 38
Proposal for a regulation
Article 17 – paragraph 1 – point b
Amendment 39
Proposal for a regulation
Article 17 – paragraph 1 – point c
Amendment 40
Proposal for a regulation
Article 17 – paragraph 1 – point g
Amendment 41
Proposal for a regulation
Article 17 – paragraph 1 – point h
Amendment 42
Proposal for a regulation
Article 17 – paragraph 1 – point i
Amendment 43
Proposal for a regulation
Article 17 – paragraph 1 – point i a (new)
Amendment 44
Proposal for a regulation
Article 17 – paragraph 1 – point k a (new)
Amendment 45
Proposal for a regulation
Article 17 – paragraph 1 a (new)
Amendment 46
Proposal for a regulation
Article 17 – paragraph 3
Amendment 47
Proposal for a regulation
Article 17 – paragraph 3 a (new)
Amendment 48
Proposal for a regulation
Article 17 – paragraph 3 b (new)
Amendment 49
Proposal for a regulation
Article 17 – paragraph 3 c (new)
Amendment 50
Proposal for a regulation
Article 17 – paragraph 3 d (new)
Amendment 51
Proposal for a regulation
Article 18 – paragraph 1
Amendment 52
Proposal for a regulation
Article 18 – paragraph 2 – introductory part
Amendment 53
Proposal for a regulation
Article 18 – paragraph 2 – point b
Amendment 54
Proposal for a regulation
Article 18 – paragraph 2 – point b a (new)
Amendment 55
Proposal for a regulation
Article 18 – paragraph 2 – point b b (new)
Amendment 56
Proposal for a regulation
Article 18 – paragraph 2 a (new)
Amendment 57
Proposal for a regulation
Article 19 – paragraph 2 – point a a (new)
Amendment 58
Proposal for a regulation
Article 19 – paragraph 2 – point c
Amendment 59
Proposal for a regulation
Article 19 – paragraph 3
Amendment 60
Proposal for a regulation
Article 19 – paragraph 5
Amendment 61
Proposal for a regulation
Article 19 – paragraph 7
Amendment 62
Proposal for a regulation
Article 19 – paragraph 7 a (new)
Amendment 63
Proposal for a regulation
Article 19 – paragraph 7 b (new)
Amendment 64
Proposal for a regulation
Article 19 – paragraph 7 c (new)
Amendment 65
Proposal for a regulation
Article 20 – paragraph 1 – point c
Amendment 66
Proposal for a regulation
Article 20 – paragraph 3
Amendment 67
Proposal for a regulation
Article 20 – paragraph 4
Amendment 68
Proposal for a regulation
Article 21 – title
Amendment 69
Proposal for a regulation
Article 21 – paragraph 1
Amendment 70
Proposal for a regulation
Article 21 – paragraph 1 a (new)
Amendment 71
Proposal for a regulation
Article 21 – paragraph 1 b (new)
Amendment 72
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1
Amendment 73
Proposal for a regulation
Article 23 – paragraph 5
Amendment 74
Proposal for a regulation
Article 23 – paragraph 6
Amendment 75
Proposal for a regulation
Article 24 – paragraph 1
Amendment 76
Proposal for a regulation
Article 24 – paragraph 2
Amendment 77
Proposal for a regulation
Article 25 – paragraph 2 – point a
Amendment 78
Proposal for a regulation
Article 26 – paragraph 4
Amendment 79
Proposal for a regulation
Article 26 – paragraph 4 a (new)
Amendment 80
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Amendment 81
Proposal for a regulation
Article 28 – paragraph 2
Amendment 82
Proposal for a regulation
Article 29 – paragraph 3
Amendment 83
Proposal for a regulation
Article 30 – paragraph 1 – introductory part
Amendment 84
Proposal for a regulation
Article 30 – paragraph 1 – point a
Amendment 85
Proposal for a regulation
Article 30 – paragraph 1 – point b
Amendment 86
Proposal for a regulation
Article 30 – paragraph 1 – point b a (new)
Amendment 87
Proposal for a regulation
Article 30 – paragraph 1 – point c
Amendment 88
Proposal for a regulation
Article 30 – paragraph 1 – point d a (new)
Amendment 89
Proposal for a regulation
Article 31 – paragraph 6
Amendment 90
Proposal for a regulation
Article 31 – paragraph 9
Amendment 91
Proposal for a regulation
Article 33 – paragraph 1 – point j
Amendment 92
Proposal for a regulation
Article 33 – paragraph 4
Amendment 93
Proposal for a regulation
Article 34 – paragraph 1 – point a a (new)
Amendment 94
Proposal for a regulation
Article 34 – paragraph 1 – point f
Amendment 95
Proposal for a regulation
Article 34 – paragraph 1 – point f a (new)
Amendment 96
Proposal for a regulation
Article 37 – paragraph 1 – point i
Amendment 97
Proposal for a regulation
Article 41 – paragraph 1
Amendment 98
Proposal for a regulation
Article 42 – paragraph 1
Amendment 99
Proposal for a regulation
Article 44 – paragraph 3 a (new)
Amendment 100
Proposal for a regulation
Article 46 – paragraph 11
Amendment 101
Proposal for a regulation
Article 49 – paragraph 1
Amendment 102
Proposal for a regulation
Article 64 – paragraph 1
Amendment 103
Proposal for a regulation
Article 65 – paragraph 1 – point e a (new)
Amendment 104
Proposal for a regulation
Article 65 – paragraph 1 – point e b (new)
Amendment 105
Proposal for a regulation
Article 67 – paragraph 4
Amendment 106
Proposal for a regulation
Article 68 – paragraph 2 a (new)
Amendment 107
Proposal for a regulation
Article 69 – paragraph 1
Amendment 108
Proposal for a regulation
Article 69 – paragraph 1 a (new)
Amendment 109
Proposal for a regulation
Article 69 – paragraph 1 b (new)
Amendment 110
Proposal for a regulation
Article 69 – paragraph 1 c (new)
Amendment 111
Proposal for a regulation
Article 69 – paragraph 1 d (new)
Amendment 112
Proposal for a regulation
Article 69 – paragraph 1 e (new)
Amendment 113
Proposal for a regulation
Article 69 – paragraph 1 f (new)
Amendment 114
Proposal for a regulation
Article 70 – paragraph 1
Amendment 115
Proposal for a regulation
Article 70 – paragraph 2
Amendment 116
Proposal for a regulation
Article 70 – paragraph 3
Amendment 117
Proposal for a regulation
Article 70 – paragraph 3 a (new)
Amendment 118
Proposal for a regulation
Article 72 – paragraph 3 – point a
Amendment 119
Proposal for a regulation
Annex II – point 3 – point 3.1
Amendment 120
Proposal for a regulation
Annex II – point 3 – point 3.8
ANNEX: LIST OF ENTITIES OR PERSONS FROM WHOM THE RAPPORTEUR HAS RECEIVED INPUT
The following list is drawn up on a purely voluntary basis under the exclusive responsibility of the rapporteur. The rapporteur has received input from the following entities or persons in the preparation of the draft opinion:
PROCEDURE – COMMITTEE ASKED FOR OPINION
FINAL VOTE BY ROLL CALL IN COMMITTEE ASKED FOR OPINION
PROCEDURE – COMMITTEE RESPONSIBLE
FINAL VOTE BY ROLL CALL IN COMMITTEE RESPONSIBLE