2022/0140(COD) European Health Data Space
Next event: Indicative plenary sitting date 2023/11/08
Lead committee dossier:
Next event: Indicative plenary sitting date 2023/11/08
Progress: Awaiting committee decision
| Role | Committee | Rapporteur | Shadows |
|---|---|---|---|
| Joint Responsible Committee | ['ENVI', 'LIBE'] |
SOKOL Tomislav ( EPP),
TARDINO Annalisa ( ID)
|
ZARZALEJOS Javier ( EPP),
CERDAS Sara ( S&D),
VITANOV Petar ( S&D),
SOLÍS PÉREZ Susana ( Renew),
ĎURIŠ NICHOLSONOVÁ Lucia ( Renew),
BREYER Patrick ( Verts/ALE),
METZ Tilly ( Verts/ALE),
DE BLASIS Elisabetta ( ID),
KEMPA Beata ( ECR),
KOPCIŃSKA Joanna ( ECR),
ARVANITIS Konstantinos ( GUE/NGL),
KONEČNÁ Kateřina ( GUE/NGL)
|
| Committee Opinion | BUDG | ||
| Committee Opinion | IMCO |
KOVATCHEV Andrey ( EPP)
|
Adriana MALDONADO LÓPEZ ( S&D)
|
| Committee Opinion | ITRE |
BUŞOI Cristian-Silviu ( EPP)
|
Lead committee dossier:
Legal Basis:
RoP 57, RoP 58, TFEU 016-p2, TFEU 114
Legal Basis:
RoP 57, RoP 58, TFEU 016-p2, TFEU 114Subjects
Events
2023/11/08
Indicative plenary sitting date
2023/07/16
FR_SENATE - Contribution
Documents
2023/05/25
EP - Committee opinion
Documents
2023/05/23
EP - Committee opinion
Documents
2023/04/05
EP - Amendments tabled in committee
Documents
2023/04/05
EP - Amendments tabled in committee
Documents
2023/03/29
EP - Amendments tabled in committee
Documents
2023/03/29
EP - Amendments tabled in committee
Documents
2023/03/29
EP - Amendments tabled in committee
Documents
2023/03/29
EP - Amendments tabled in committee
Documents
2023/03/29
EP - Amendments tabled in committee
Documents
2023/03/29
EP - Amendments tabled in committee
Documents
2023/02/16
EP - Referral to associated committees announced in Parliament
2023/02/16
EP - Referral to joint committee announced in Parliament
2023/02/10
EP - Committee draft report
Documents
2023/02/08
CofR - Committee of the Regions: opinion
Documents
2023/01/31
EP - SOKOL Tomislav (EPP) appointed as rapporteur in ['ENVI', 'LIBE']
2023/01/31
EP - TARDINO Annalisa (ID) appointed as rapporteur in ['ENVI', 'LIBE']
2022/12/20
PT_PARLIAMENT - Contribution
Documents
2022/10/18
CZ_SENATE - Contribution
Documents
2022/07/08
EP - KOVATCHEV Andrey (EPP) appointed as rapporteur in IMCO
2022/06/26
CZ_CHAMBER - Contribution
Documents
2022/06/09
EP - BUŞOI Cristian-Silviu (EPP) appointed as rapporteur in ITRE
2022/06/06
EP - Committee referral announced in Parliament, 1st reading
2022/05/04
EC - Document attached to the procedure
Documents
2022/05/04
EC - Document attached to the procedure
Documents
2022/05/04
EC - Document attached to the procedure
Documents
2022/05/04
EC - Document attached to the procedure
Documents
2022/05/03
EC - Legislative proposal published
Details
PURPOSE: to establish a European Health Data Space for people and science.
PROPOSED ACT: Regulation of the European Parliament and of the Council.
ROLE OF THE EUROPEAN PARLIAMENT: the European Parliament decides in accordance with the ordinary legislative procedure and on an equal footing with the Council.
BACKGROUND: the COVID-19 pandemic has clearly shown the importance of electronic health data for policy-making in response to health emergencies. It has also highlighted the imperative of ensuring timely access to personal electronic health data for health threats preparedness and response, as well as for treatment, but also for research, innovation, patient safety, regulatory purposes, statistical purposes or personalised medicine.
However, the complexity of rules, structures and processes across Member States makes it difficult to access and share health data , especially cross-border. At present, individuals have difficulties in exercising their rights with regard to their electronic health data, in particular with regard to accessing and sharing their data nationally and across borders, despite the provisions of the General Data Protection Regulation (GDPR).
The European Health Data Space (EHDS) is the first proposal for a common domain-specific European data space . It will address health-specific challenges to electronic health data access and sharing and will be an integral part of building a European Health Union. EHDS will create a common space where natural persons can easily control their electronic health data. It will also make it possible for researchers, innovators and policy makers to use this electronic health data in a trusted and secure way that preserves privacy.
CONTENT: the proposed regulation has the following objectives:
- to establish the European Health Data Space (EHDS) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for other purposes that would benefit the society such as research, innovation, policy-making, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data);
- to improve the functioning of the internal market by establishing a uniform legal framework , in particular for the development, marketing and use of electronic health record systems (EHR systems) in line with EU values.
Primary use of electronic health data
Under the proposal, natural persons should have the right to access their personal electronic health data processed in the context of primary use of electronic health data, immediately, free of charge and in an easily readable, consolidated and accessible form . They should easily share such data with other health professionals within and between Member States in order to improve the delivery of health care.
Member States should ensure that patient records, electronic prescriptions, medical imaging images and reports, laboratory results and hospital discharge reports are issued and accepted in a common European electronic health record exchange format. Categories of electronic health data could be added by means of delegated acts.
When processing data in electronic format, health professionals would have access to the electronic health data of their natural person patients, regardless of the Member State of affiliation and the Member State of treatment.
To safeguard citizens' rights, all Member States should designate digital health authorities . The Commission would set up a central platform for digital health ( MyHealth@EU ) to provide services to support and facilitate the exchange of electronic health data between Member States' national contact points for digital health.
Interoperability and security
The proposal provides for the implementation of a mandatory self-certification scheme for EMR systems, under which EMR systems must comply with essential interoperability and security requirements. Manufacturers of electronic health record systems will have to certify compliance with these standards. This will ensure that different electronic health record systems are compatible and allow for easy transmission of electronic health data between them.
Improving the use of health data for research, innovation and policymaking
The EHDS creates a strong legal framework for the use of health data for research, innovation, public health, policy-making and regulatory purposes . Under strict conditions, researchers, innovators, public institutions or industry will have access to large amounts of high-quality health data, crucial to develop life-saving treatments, vaccines or medical devices and ensuring better access to healthcare and more resilient health systems.
To access this data, researchers, companies or institutions would have to apply for authorisation from the body responsible for access to health data, which will have to be set up in each Member State. Access would only be allowed if the requested data are used for specific purposes, in closed and secure environments and without revealing the identity of individuals. Any attempt to use the data for any measures detrimental to the natural person, to increase insurance premiums, to advertise products or treatments, or develop harmful products should be prohibited.
Member States should designate one or more health data access points responsible for granting access to electronic health data for secondary use. The Health Data Access Bodies would be connected to the new EU decentralised infrastructure for secondary use of data (HealthData@EU), which will be set up to support cross-border projects.
BUDGETARY IMPLICATIONS: the fulfilment of the obligations by the Commission and associated support actions under this legal proposal will require EUR 220 million between 2023 and 2027 and will be funded directly from the EU4Health programme (EUR 170 million) and supported further from the Digital Europe Programme (EUR 50 million). In both cases, the expenditure linked to this proposal will be covered within the programmed amounts of these programmes.
Documents
Documents
- Contribution: COM(2022)0197
- Committee opinion: PE740.773
- Committee opinion: PE742.310
- Amendments tabled in committee: PE745.533
- Amendments tabled in committee: PE745.471
- Amendments tabled in committee: PE745.527
- Amendments tabled in committee: PE745.528
- Amendments tabled in committee: PE745.529
- Amendments tabled in committee: PE745.530
- Amendments tabled in committee: PE745.531
- Amendments tabled in committee: PE745.532
- Committee draft report: PE742.387
- Committee of the Regions: opinion: CDR3754/2022
- Contribution: COM(2022)0197
- Contribution: COM(2022)0197
- Contribution: COM(2022)0197
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SEC(2022)0196
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2022)0130
- Document attached to the procedure: SWD(2022)0131
- Document attached to the procedure: EUR-Lex
- Document attached to the procedure: SWD(2022)0132
- Legislative proposal published: COM(2022)0197
- Legislative proposal published: EUR-Lex
- Document attached to the procedure: EUR-Lex SEC(2022)0196
- Document attached to the procedure: EUR-Lex SWD(2022)0130
- Document attached to the procedure: SWD(2022)0131
- Document attached to the procedure: EUR-Lex SWD(2022)0132
- Committee of the Regions: opinion: CDR3754/2022
- Committee draft report: PE742.387
- Amendments tabled in committee: PE745.527
- Amendments tabled in committee: PE745.528
- Amendments tabled in committee: PE745.529
- Amendments tabled in committee: PE745.530
- Amendments tabled in committee: PE745.531
- Amendments tabled in committee: PE745.532
- Amendments tabled in committee: PE745.533
- Amendments tabled in committee: PE745.471
- Committee opinion: PE742.310
- Committee opinion: PE740.773
- Contribution: COM(2022)0197
- Contribution: COM(2022)0197
- Contribution: COM(2022)0197
- Contribution: COM(2022)0197
| Amendments | Dossier |
| 2458 |
2022/0140(COD)
2023/03/09
IMCO
183 amendments...
Amendment 100 #
Proposal for a regulation Article 17 – paragraph 3 c (new) 3 c. Manufacturers shall make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account accessibility needs for persons with disabilities, allowing users to file complaints and to inform them of risks related to their health and safety or to other aspects of public interest protection and of any serious incident involving an EHR system.
Amendment 101 #
Proposal for a regulation Article 17 – paragraph 3 d (new) 3 d. Manufacturers shall investigate complaints and information on incidents involving an EHR system they made available on the market without undue delay and shall keep an internal register of those complaints as well as of systems recalls and any corrective measures taken to bring the EHR system into conformity.
Amendment 102 #
Proposal for a regulation Article 17 – paragraph 3 e (new) 3 e. Personal data stored in the internal register of complaints shall only be those personal data that are necessary for the manufacturer to investigate the complaint. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than 5 years after they have been encoded.
Amendment 103 #
Proposal for a regulation Article 18 – paragraph 1 1.
Amendment 104 #
Proposal for a regulation Article 18 – paragraph 2 – introductory part 2. An authorised representative shall perform the tasks specified in the mandate
Amendment 105 #
Proposal for a regulation Article 18 – paragraph 2 – point b (b)
Amendment 106 #
Proposal for a regulation Article 18 – paragraph 2 – point b (b) further to a reasoned request from a market surveillance authority, provide
Amendment 107 #
Proposal for a regulation Article 18 – paragraph 2 – point b a (new) (b a) immediately inform the manufacturer if the authorised representative has a reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection or if it is aware of any serious incident involving an EHR system;
Amendment 108 #
Proposal for a regulation Article 18 – paragraph 2 – point b b (new) (b b) immediately inform the manufacturer about complaints received by users;
Amendment 109 #
Proposal for a regulation Article 18 – paragraph 2 – point c a (new) (c a) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation and immediately inform the market surveillance authority of the Member State in which is established.
Amendment 110 #
2 a. Where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 17, the authorised representative shall be legally liable for non-compliance with this Regulation on the same basis as, and jointly and severally with, the manufacturer;
Amendment 111 #
Proposal for a regulation Article 18 – paragraph 2 b (new) 2 b. In case of change of the authorised representative, the detailed arrangements for the change shall be clearly defined in an agreement between the manufacturer, or where practicable the outgoing authorised representative, and the incoming authorised representative.That agreement shall address at least the following aspects: (a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative; (b) the transfer of documents, including confidentiality aspects and property rights;
Amendment 112 #
Proposal for a regulation Article 19 – paragraph 2 – point a (a) the manufacturer has drawn up the technical documentation and the EU declaration of conformity and ensure that it is made available to market surveillance authorities at least 6 months before an EHR system is placed on the market or put into service;
Amendment 113 #
Proposal for a regulation Article 19 – paragraph 2 – point a a (new) (a a) the manufacturer is identified and an authorised representative in accordance with Article 18 has been appointed;
Amendment 114 #
Proposal for a regulation Article 19 – paragraph 2 – point c (c) the EHR system is accompanied by the information sheet referred to in Article 25 and
Amendment 115 #
Proposal for a regulation Article 19 – paragraph 3 3. Importers shall indicate their name, registered trade name or registered trade mark
Amendment 116 #
Proposal for a regulation Article 19 – paragraph 5 5. Where an importer considers or has reason to believe that an EHR system is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. The importer shall i
Amendment 117 #
Proposal for a regulation Article 19 – paragraph 7 7. Importers shall,
Amendment 118 #
Proposal for a regulation Article 19 – paragraph 7 7. Importers shall
Amendment 119 #
Proposal for a regulation Article 19 – paragraph 7 a (new) 7 a. If the importer fails to cooperate with market surveillance authorities or if the information and documentation provided is incomplete or incorrect, market surveillance authorities shall take all appropriate measures to prohibit or restrict its EHR system from being available on the market, to withdraw it from the market or to recall it until the importer cooperates or provides complete and correct information.
Amendment 120 #
Proposal for a regulation Article 19 – paragraph 7 b (new) 7 b. Importers shall verify whether the communication channels referred to in Article 17(3c), are publicly available to users allowing them to submit complaints and communicate any risk related to their health and safety or to other aspects of public interest protection and of any serious incident involving an EHR system. If such channels are not available, the importer shall provide for them, taking into account accessibility needs for persons with disabilities.
Amendment 121 #
Proposal for a regulation Article 19 – paragraph 7 c (new) 7 c. Importers shall investigate complaints and information on incidents involving an EHR system they made available on the market and file those complaints, as well as of systems recalls and any corrective measures taken to bring the EHR system into conformity, in the register referred to in Article 17(3e) or in their own internal register. Importers shall keep the manufacturer, distributors and, where relevant, authorised representatives informed in a timely manner of the investigation performed and of the results of the investigation.
Amendment 122 #
Proposal for a regulation Article 19 – paragraph 7 d (new) 7 d. Personal data stored in the internal register of complaints shall only be those personal data that are necessary for the importer to investigate the complaint. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than five years after they have been encoded.
Amendment 123 #
Proposal for a regulation Article 20 – paragraph 1 – point c (c) the EHR system is accompanied by the information sheet referred to in Article 25 and
Amendment 124 #
Proposal for a regulation Article 20 – paragraph 3 3. Where a distributor considers or has reason to believe that an EHR system is not in conformity with the essential requirements laid down in Annex II, it shall not make the EHR system available on the market until it has been brought into conformity. Furthermore, the distributor shall i
Amendment 125 #
Proposal for a regulation Article 20 – paragraph 4 4. Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, and with the manufacturer, the importer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II
Amendment 126 #
Proposal for a regulation Article 20 – paragraph 4 4. Distributors shall
Amendment 127 #
Proposal for a regulation Article 20 – paragraph 4 a (new) 4 a. Distributors that have received complaints from users about suspected incidents involving an EHR system they made available on the market, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. They shall keep a register of complaints, of non-conforming EHR systems and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.
Amendment 128 #
Proposal for a regulation Article 21 – title Cases in which obligations of manufacturers of an EHR system apply to
Amendment 129 #
Proposal for a regulation Article 21 – paragraph 1 An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 17, where they made an EHR system available on the market under their own name or trademark or modify an EHR system already placed on the market in such a way that conformity with the applicable requirements may be affected. Second- hand economic operators, including refurbishers, who make available on the market second-hand EHR systems, whether prepared for re-use, checked, cleaned, repaired, refurbished or without any action on the product shall not be considered as modifying a product in such a way that conformity with the applicable requirements may be affected.
Amendment 130 #
Proposal for a regulation Article 21 – paragraph 1 An
Amendment 131 #
Proposal for a regulation Article 23 – title Amendment 132 #
Proposal for a regulation Article 23 – paragraph -1 (new) -1. The Commission shall promote European or international standards in respect of the essential requirements set out in Annex II. The Commission shall identify and analyse existing best practices in terms of interoperability or analyse the option to request development of European or internationally recognised standards, where appropriate.
Amendment 133 #
Proposal for a regulation Article 23 – paragraph 1 – subparagraph 1 The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. The Commission shall consult, when preparing implementing acts, the relevant stakeholders, including the European Data Protection Supervisor and the European Data Protection Board where common specifications have an impact on the data protection requirements of EHR systems. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.
Amendment 134 #
Proposal for a regulation Article 23 – paragraph 1 – subparagraph 1 Amendment 135 #
Proposal for a regulation Article 23 – paragraph 2 – point f (f) explanatory part, including any relevant implementation guidelines and justification why the use of international standard was not applicable or preferable.
Amendment 136 #
Proposal for a regulation Article 23 – paragraph 4 4. EHR systems, medical devices and high risk AI systems referred to in Article 14 that are in conformity with the international standards or common specifications referred to in paragraphs -1 or 1 shall be considered to be in conformity with the essential requirements covered by those specifications or parts thereof, set out in Annex II covered by those common specifications or the relevant parts of those common specifications.
Amendment 137 #
Proposal for a regulation Article 23 – paragraph 5 5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices or high-risk AI systems falling under other acts, such as Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], the adoption of those common specifications
Amendment 138 #
Proposal for a regulation Article 23 – paragraph 6 6. Where common specifications covering interoperability and security requirements of medical devices or high- risk AI systems falling under other acts such as Regulation (EU) 2017/745 or Regulation […] [AI Act COM/2021/206 final], impact EHR systems, the adoption of those common specifications shall be preceded by a consultation with the EHDS Board, especially its subgroup for Chapters II and III of this Regulation, and, where applicable, the European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679.
Amendment 139 #
Proposal for a regulation Article 24 – paragraph 1 1.
Amendment 140 #
Proposal for a regulation Article 24 – paragraph 2 2. The technical documentation shall be drawn up in such a way as to demonstrate that the EHR system complies with the essential requirements laid down in Annex II and provide market surveillance authorities with all the necessary information to assess the conformity of the EHR system with those requirements. It shall contain, at a minimum, the elements set out in Annex III. In case the system or any part of it complies with European standards or common specifications, the list of the relevant European standards and common specifications shall also be indicated.
Amendment 141 #
Proposal for a regulation Article 25 – paragraph 2 – point a (a) the identity, registered trade name or registered trademark, and the contact details of the manufacturer, including the postal and electronic address and the telephone number and, where
Amendment 142 #
Proposal for a regulation Article 25 – paragraph 3 3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems
Amendment 143 #
Proposal for a regulation Article 26 – paragraph 1 1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled. The manufacturer shall regularly update the EU declaration of conformity.
Amendment 144 #
Proposal for a regulation Article 26 – paragraph 4 4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for
Amendment 145 #
Proposal for a regulation Article 26 – paragraph 4 a (new) 4 a. The Commission is empowered to adopt delegated acts in accordance with Article 67 amending the minimum content of the EU declaration of conformity set out in Annex IV.
Amendment 146 #
Proposal for a regulation Article 27 – paragraph 1 1. The CE marking shall be affixed
Amendment 147 #
Proposal for a regulation Article 27 – paragraph 1 a (new) 1 a. The CE marking shall be affixed before making the EHR system available on the market.
Amendment 148 #
Proposal for a regulation Article 27 – paragraph 2 a (new) 2 a. Where EHR systems are subject to other Union legislation in respect of aspects not covered by this Regulation, which also requires the affixing of the CE marking, the CE marking shall indicate that the systems also fulfil the requirements of that other legislation.
Amendment 149 #
Proposal for a regulation Article 28 – paragraph 2 2. Member States shall designate the market surveillance authority or authorities responsible for the implementation of this Chapter. They shall entrust their market surveillance authorities with the powers,
Amendment 150 #
Proposal for a regulation Article 28 – paragraph 3 a (new) 3 a. Market surveillance authorities shall act as single contact points, and centralize all procedures and verifications avoiding duplicated procedures with the Artificial Intelligence Act (2021/0106(COD)), Medical Devices Regulation 2012/0266(COD), In vitro Diagnostic Medical Devices Regulation (2012/0267(COD)), Cyber Resilience Act (2022/0272(COD)).
Amendment 151 #
Proposal for a regulation Article 29 – paragraph 1 a (new) 1 a. Where a market surveillance authority, on the basis of the information and documentation demonstrating the conformity of an EHR system provided by the relevant economic operator, considers or has reason to believe that the EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, including before the EHR system is placed on the market or put into service, it shall perform all the necessary checks to ensure that the system is compliant with this Regulation.
Amendment 152 #
Proposal for a regulation Article 29 – paragraph 1 b (new) 1 b. Where a market surveillance authority considers or has reason to believe that an EHR system has caused damage to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately provide information and documentation, as applicable, to the affected person or user and, as appropriate, other third parties affected by the damage caused to the person or user, without prejudice to data protection rules.
Amendment 153 #
Proposal for a regulation Article 29 – paragraph 4 – subparagraph 2 Such notification shall be made, without prejudice to incident notification requirements under Directive (EU) 2016/1148, immediately after the manufacturer has established a causal link between the EHR system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than
Amendment 154 #
Proposal for a regulation Article 30 – paragraph 1 – introductory part 1. Where a market surveillance authority makes, inter alia, one of the following findings, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to
Amendment 155 #
Proposal for a regulation Article 30 – paragraph 1 – point a (a) the EHR system is not in conformity with essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;
Amendment 156 #
Proposal for a regulation Article 30 – paragraph 1 – point b (b) the technical documentation is either not available or not complete, or not in accordance with Article 24;
Amendment 157 #
Proposal for a regulation Article 30 – paragraph 1 – point b a (new) Amendment 158 #
Proposal for a regulation Article 30 – paragraph 1 – point c (c) the EU declaration of conformity has not been drawn up or has not been drawn up correctly as referred to in Article 26;
Amendment 159 #
Proposal for a regulation Article 30 – paragraph 1 – point d a (new) (d a) the registration obligations of Article 32 has not been fulfilled.
Amendment 160 #
Proposal for a regulation Article 31 Amendment 161 #
Proposal for a regulation Article 31 – paragraph 3 3. The Commission may consider the format and content of the label by use of European or international standards. In exceptional situations, if no international standard is fit for purpose, the Commission may, by means of implementing acts, determine the format and content of the label. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 162 #
6. If the wellness application is embedded in a device, the accompanying label
Amendment 163 #
Proposal for a regulation Article 32 – title Registration of EHR systems
Amendment 164 #
Proposal for a regulation Article 32 – paragraph 1 1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26
Amendment 165 #
Proposal for a regulation Article 32 – paragraph 2 2. Before placing on the market or putting into service an EHR system referred to in Article 14
Amendment 166 #
Proposal for a regulation Article 32 – paragraph 4 4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to determine the list of required data to be registered by the manufacturers of EHR systems
Amendment 167 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from fully completed or terminated clinical trials;
Amendment 168 #
Proposal for a regulation Article 33 – paragraph 4 4. Electronic health data entailing protected intellectual property and trade secrets from
Amendment 169 #
Proposal for a regulation Article 34 – paragraph 1 – point a a (new) (a a) activities for reasons of public interest in cases of serious public health threats.
Amendment 170 #
Proposal for a regulation Article 34 – paragraph 1 – point f (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, including supporting operational efficiency, improving the patient pathway and post- market monitoring to identify side effects and adverse events;
Amendment 171 #
Proposal for a regulation Article 34 – paragraph 1 – point f a (new) (f a) development and innovation activities for products or services, including health economics and health outcomes research studies;
Amendment 172 #
Proposal for a regulation Article 35 – paragraph 1 – introductory part 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 on case-by-case basis, if there is harm to patients or consumers from such use:
Amendment 173 #
Proposal for a regulation Article 37 – paragraph 1 – introductory part 1. Health data access bodies
Amendment 174 #
Proposal for a regulation Article 37 – paragraph 1 – point i (i)
Amendment 175 #
Proposal for a regulation Article 37 – paragraph 1 – point p Amendment 176 #
Proposal for a regulation Article 41 – paragraph 1 1.
Amendment 177 #
Proposal for a regulation Article 42 – paragraph 1 Amendment 178 #
Proposal for a regulation Article 42 – paragraph 1 1. Health data access bodies and single data holders may charge fees for making electronic health data available for secondary use. Any fees shall
Amendment 179 #
Proposal for a regulation Article 42 – paragraph 2 Amendment 180 #
Proposal for a regulation Article 42 – paragraph 3 Amendment 181 #
Proposal for a regulation Article 42 – paragraph 4 4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be
Amendment 182 #
Proposal for a regulation Article 42 – paragraph 5 Amendment 183 #
Proposal for a regulation Article 42 – paragraph 6 6.
Amendment 184 #
Proposal for a regulation Article 44 – paragraph 3 a (new) 3 a. The Commission shall, by means of implementing act, set out rules for risk- based anonymisation methodology, taking into consideration risk factors such as type of use, the safeguards in place, probability of re-identification of patients, sensitivity of type of data.
Amendment 185 #
Proposal for a regulation Article 46 – paragraph 11 11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites without prejudice to IP rights and relevant Union legislation. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.
Amendment 186 #
Proposal for a regulation Article 46 – paragraph 11 11.
Amendment 187 #
Proposal for a regulation Article 49 – paragraph 1 1. Where an applicant requests access to electronic health data only from a single data holder in a single Member State, by way of derogation from Article 45(1), that applicant may file a data access application or a data request directly to the data holder. The applicant may file a data access application or a data request also by other means of sharing health data using existing infrastructures and registries that have established data flows, technical architectures, governance models and data access. The Regulation shall not impede existing data sharing initiatives already in place in Union and Member States in order to enhance the interoperability and data exchange in the internal market. The data access application shall comply with the requirements set out in Article 45 and the data request shall comply with requirements in Article 47. Multi-country requests and requests requiring a combination of datasets from several data holders
Amendment 188 #
Proposal for a regulation Article 52 – paragraph 1 1. Each Member State
Amendment 189 #
Proposal for a regulation Article 52 – paragraph 8 8. The Member States and the Commission shall set up HealthData@EU to support
Amendment 190 #
Proposal for a regulation Article 63 – paragraph 1 In the context of international access and transfer of personal electronic health data, Member States may maintain or introduce further conditions, including limitations, in accordance with and under the conditions of article 9(4) of the Regulation (EU) 2016/679. Such limitations shall not entail storage requirements for health data that can be lawfully transferred to third countries in accordance with the requirements under Regulation […] [Data Governance Act COM/2020/767 final] and Chapter V of Regulation (EU) 2016/679 or stricter conditions under national law.
Amendment 191 #
Proposal for a regulation Article 64 – paragraph 1 1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor
Amendment 192 #
Proposal for a regulation Article 64 – paragraph 4 4. Stakeholders and relevant third parties, including
Amendment 193 #
Proposal for a regulation Article 67 – paragraph 4 4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State and targeted stakeholders, including health professionals and patients’ organisations, in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making.
Amendment 194 #
Proposal for a regulation Article 68 – paragraph 2 a (new) 2 a. In accordance with the Inter- Institutional Agreement of 13 April 2016 on Better Law-Making, the Commission will make use of expert groups, consult targeted stakeholders and carry out public consultations to gather broader expertise in the early preparation of draft implementing acts.
Amendment 195 #
Proposal for a regulation Article 69 – paragraph 1 Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are properly and effectively implemented. The penalties shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.
Amendment 196 #
Proposal for a regulation Article 69 – paragraph 1 a (new) When deciding on the amount of the penalty in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following: (a) the nature, gravity and duration of the infringement and of its consequences, taking into account the nature, scope as well as the number of users affected and the level of damage suffered by them; (b) whether penalties have been already applied by other competent authorities to the same infringing party; (c) the size and market share of the economic operator committing the infringement; (d) the intentional or negligent character of the infringement; (e) any action taken by the infringing party to mitigate the damage of the infringement; (f) the degree of responsibility of the infringing party taking into account technical and organisational measures implemented to prevent the infringement; (g) the degree of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement; (h) the manner in which the infringement became known to the competent authorities, in particular whether, and if so to what extent, the infringing party notified the infringement; (i) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement.
Amendment 197 #
Proposal for a regulation Article 69 – paragraph 1 a (new) Penalties shall at least include fines proportionate to the extent of non- compliance and to the turnover of the relevant economic operator. Fines shall be calculated in such a way as to make sure that they effectively deprive the economic operator of the economic benefits derived from their infringements. Fines shall be gradually increased for repeated infringements.
Amendment 198 #
Proposal for a regulation Article 69 – paragraph 1 b (new) In deciding whether to impose sanctions and, if so, in determining their nature and appropriate level, due account shall be taken of: (a) the nature, gravity and duration of the infringement; (b) any previous infringements by the economic operator of this Regulation; (c) the financial benefits gained or losses avoided by the economic operator due to the infringement, if the relevant data are available; (d) penalties imposed in respect of the same infringement in other Member States; (e) any action taken by the economic operator to remedy or to mitigate the adverse effects of the infringement; (f) any other aggravating or mitigating factors applicable to the circumstances of the case.
Amendment 199 #
Proposal for a regulation Article 69 – paragraph 1 b (new) The non-compliance of an EHR system with any requirements or obligations under this Regulation, including the supply of incorrect, incomplete or misleading information to national competent authorities, shall be subject to penalties of up to 20 000 000 EUR or up to 6% of its total worldwide annual turnover for the preceding financial year, whichever is higher.
Amendment 200 #
Proposal for a regulation Article 69 – paragraph 1 c (new) Member States shall ensure that any decision containing penalties related to the breach of the provisions of this Regulation is published no later than a month after the penalty is imposed.
Amendment 201 #
Proposal for a regulation Article 70 – paragraph 1 1. After 5 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. The evaluation shall include an assessment of a) the self-certification of
Amendment 202 #
Proposal for a regulation Article 70 – paragraph 1 1. After
Amendment 203 #
Proposal for a regulation Article 70 – paragraph 1 1. After
Amendment 204 #
Proposal for a regulation Article 70 – paragraph 2 Amendment 205 #
Proposal for a regulation Article 70 – paragraph 2 2. After
Amendment 206 #
Proposal for a regulation Article 70 – paragraph 3 3. Member States shall provide the Commission with the information necessary for the preparation of that report
Amendment 207 #
Proposal for a regulation Article 70 – paragraph 3 a (new) 3 a. The Commission shall be empowered to adopt, by 12 months after the entry into force of this Regulation, delegated acts to supplement this Regulation in order to: (a) set out the common result and impact oriented indicators to be used for reporting on the progress and for the purpose of monitoring and evaluation of this Regulation; (b) measure the costs, benefits and other health and economic results including trends per Member State in order to compare the effectiveness of implementation of this Regulation;and (c) define a methodology for reporting by Member States. The Commission shall regularly revise and, if necessary, update the common indicators.
Amendment 208 #
Proposal for a regulation Article 71 a (new) Article 71 a Amendment to Directive (EU) 2020/1828 on Representative Actions for the Protection of the Collective Interests of Consumers The following is added to Annex I: “(67) Regulation (EU) .../... of the European Parliament and of the Council on the European Health Data Space”
Amendment 209 #
Proposal for a regulation Article 71 a (new) Article 71 a Representative Actions Directive (EU) 2020/1828 shall apply to the representative actions brought against infringements by economic operators of provisions of this Regulation that harm or may harm the collective interests of consumers.
Amendment 210 #
Proposal for a regulation Article 72 – paragraph 3 – point a (a) from
Amendment 211 #
Proposal for a regulation Article 72 – paragraph 4 Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from
Amendment 212 #
Proposal for a regulation Annex II – point 3 – point 3.1 3.1. An EHR system shall be designed and developed in such a way that it ensures safe and secure processing of electronic health data,
Amendment 213 #
Proposal for a regulation Annex II – point 3 – point 3.8 3.8. An EHR system designed for the storage of electronic health data shall support different retention periods and access rights that take into account the origins and categories of electronic health data and the specific purpose of the data processing operations.
Amendment 31 #
Proposal for a regulation Recital 7 (7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border
Amendment 32 #
Proposal for a regulation Recital 7 (7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). A patient’s Covid vaccination status does not need to be included in the electronic health data. In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support
Amendment 33 #
Proposal for a regulation Recital 7 (7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results,
Amendment 34 #
Proposal for a regulation Recital 11 (11) Natural persons should be further empowered to exchange and to provide access to personal electronic health data to the health professionals of their choice, going beyond the right to data portability as established in Article 20 of Regulation (EU) 2016/679. This is necessary to tackle objective difficulties and obstacles in the current state of play. Under Regulation (EU) 2016/679, portability is limited only to data processed based on consent or contract, which excludes data processed under other legal bases, such as when the processing is based on law, for example when their processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. It only concerns data provided by the data subject to a controller, excluding many inferred or indirect data, such as diagnoses, or tests. Finally, under Regulation (EU) 2016/679, the natural person has the right to have the personal data transmitted directly from one controller to another only where technically feasible. That Regulation, however, does not impose an obligation to make this direct transmission technically feasible. All these elements limit the data portability and may limit its benefits for provision of high-quality, safe and efficient healthcare services to the natural person. Portability should give consumers more choice in the selection of healthcare provider, resulting in reduced healthcare costs, faster diagnosis and treatment time and overall better health outcomes.
Amendment 35 #
Proposal for a regulation Recital 16 (16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Such costs and health outcomes should be regularly assessed and quantified in order to measure the results of improved interoperability. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Cost reduction should be periodically reviewed and compared between Member States in order to identify best practices and deliver results in the whole internal market without potential fragmentation. Therefore, health professionals should be provided with appropriate electronic means, such as health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, the access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format.
Amendment 36 #
Proposal for a regulation Recital 16 (16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format
Amendment 37 #
Proposal for a regulation Recital 16 (16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, the Commission and the Member States should agree on ambitious time-based targets to implement improved health data interoperability across the Union. The access to
Amendment 38 #
Proposal for a regulation Recital 16 a (new) (16 a) Implementation of an interoperable European electronic health record exchange format should build on the existing investments and solutions already made in Member States. Existing health data infrastructures should be leveraged to allow continuity and build on existing expertise.
Amendment 39 #
Proposal for a regulation Recital 19 (19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path to the Digital Decade”. The EHDS should also contribute to other requirements, mainly to apply the once-only principle, where possible. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and
Amendment 40 #
Proposal for a regulation Recital 19 (19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons who so wish to have those data available in electronic format.
Amendment 41 #
(19 a) The once-only principle means that natural or legal persons provide data only once to public sector or EHDS including EHR systems under the primary use regime, while public sector bodies take the necessary steps to use such data for secondary use, while respecting data protection rules. It would avoid duplication and unnecessary burdens to healthcare professionals and providers, to provide data again.
Amendment 42 #
Proposal for a regulation Recital 23 (23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. To carry out their tasks, the digital health authorities should cooperate and exchange best practices at national and
Amendment 43 #
Proposal for a regulation Recital 23 (23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including
Amendment 44 #
Proposal for a regulation Recital 24 (24) Access to and transmission of electronic health data is relevant in cross- border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when
Amendment 45 #
Proposal for a regulation Recital 25 (25) In the context of MyHealth@EU, a central platform should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities among the Member States, as joint controllers, and prescribe its own obligations, as processor. Furthermore, to ensure the technological sovereignty of the Union and ensure the highest security standards, the platform should be licenced under an open source licence in line with the Open Source Strategy 2020-2023 (C(2020) 7149 final) and Commission decision 2021/C 495 I/01. This will increase transparency and ensure consumer trust and confidence in the platform.
Amendment 46 #
Proposal for a regulation Recital 25 a (new) (25 a) EHDS as a whole is a federated structure that can accommodate centralisation or decentralisation based on the Commission and Member States preferences in order to deliver resilient, secure and interoperable infrastructure. The structure should be chosen based on the in-depth analysis for each part of the Regulation.
Amendment 47 #
Proposal for a regulation Recital 29 (29) Software or module(s) of software which falls within the definition of a medical device or high-risk artificial intelligence (AI) system should be certified in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council49and Regulation […] of the European Parliament and of the Council [AI Act COM/2021/206 final], as
Amendment 48 #
Proposal for a regulation Recital 33 (33) Compliance with essential requirements on interoperability and security should be demonstrated by the manufacturers of EHR systems through the implementation of
Amendment 49 #
Proposal for a regulation Recital 33 a (new) (33 a) European or Interoperability standards should be aligned to the extent possible with best practices and existing technical solutions. The Commission should identify and analyse those best practices and commonly used existing technical solutions in Member States in order to avoid the burden of implementing additional regulatory requirements.
Amendment 50 #
Proposal for a regulation Recital 34 (34) In order to ensure an appropriate and effective enforcement of the requirements and obligations laid down in Chapter III of this Regulation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply. Depending on the organisation defined at national level, such market surveillance activities could be carried out by the digital health authorities ensuring the proper implementation of Chapter II or a separate market surveillance authority responsible for EHR systems. While designating digital health authorities as market surveillance authorities could have important practical advantages for the implementation of health and care, any conflicts of interest should be avoided, for instance by separating different tasks. Member States should ensure that market surveillance authorities have the necessary human, technical and financial resources, premises, infrastructure, and expertise to carry out their duties effectively.
Amendment 51 #
Proposal for a regulation Recital 35 Amendment 52 #
Proposal for a regulation Recital 36 (36) The distribution of information on certified EHR systems
Amendment 53 #
Proposal for a regulation Recital 38 (38) In the context of the EHDS, the electronic health data already exists and is being collected by healthcare providers, professional associations, public institutions, regulators, researchers, insurers etc. in the course of their activities. Some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records, genetic data, claims data, etc.), others are collected also for other purposes such as research, statistics, patient safety, regulatory activities or policy making (e.g. disease registries, policy making registries, registries concerning the side effects of medicinal products or medical devices, etc.). For instance, European databases that facilitate data (re)use are available in some areas, such as cancer (European Cancer Information System) or rare diseases (European Platform on Rare Disease
Amendment 54 #
Proposal for a regulation Recital 39 (39) The categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users, while remaining limited to data related to health or known to influence health. It can also include relevant data from the health system (electronic health records, claims data, disease registries,
Amendment 55 #
Proposal for a regulation Recital 40 (40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. In order to avoid a disproportionate burden on small entities, micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of EHDS. The public or private entities often receive public funding, from national or Union funds to collect and process electronic health data for research, statistics (official or not) or other similar purposes, including in area where the collection of such data is fragmented of difficult, such as rare diseases, cancer etc. Such data, collected and processed by data holders with the support of Union or national public funding, should be made available by data holders to health data access bodies, in order to maximise the impact of the public investment and support research, innovation, patient safety or policy making benefitting the society. In some Member States, private entities, including private healthcare providers and professional associations, play a pivotal role in the health sector. The health data held by such providers should also be made available for secondary use. At the same time, data benefiting from specific legal protection such as intellectual property from medical device companies or pharmaceutical companies
Amendment 56 #
Proposal for a regulation Recital 51 (51) As the resources of health data access bodies are limited, they can apply prioritisation rules,
Amendment 57 #
Proposal for a regulation Recital 68 (68) In order to ensure that EHDS fulfils its objectives, the power to adopt acts in accordance with Article 290 Treaty on the Functioning of the European Union should be delegated to the Commission in respect of different provisions of primary and secondary use of electronic health data. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Inter- institutional Agreement of 13 April 2016 on Better Law-Making
Amendment 58 #
Proposal for a regulation Recital 69 (69) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council
Amendment 59 #
Proposal for a regulation Recital 70 (70) Member States should take all necessary measures to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement. For certain specific infringements, Member States should take into account the margins and criteria set out in this Regulation. Moreover, the Member states should put in place communication campaigns to inform all relevant stakeholders, especially the industry, and society, about the infringements and all provisions of the Regulation in order to facilitate its implementation which needs to take especially into account the different digital developments of health systems across the EU.
Amendment 60 #
(71) In order to assess whether this Regulation reaches its objectives effectively and efficiently, is coherent and still relevant and provides added value at Union level the Commission should carry out an evaluation of this Regulation. The Commission should carry out a partial evaluation of this Regulation
Amendment 61 #
Proposal for a regulation Recital 73 a (new) (73 a) Consumers should be entitled to enforce their rights in relation to the obligations imposed on economic operators under this Regulation through representative actions in accordance with Directive (EU) 2020/1828 of the European Parliament and of the Council. For that purpose, this Regulation should provide that Directive (EU) 2020/1828 is applicable to the representative actions concerning infringements of the provisions of this Regulation that harm or can harm the collective interests of consumers. The Annex to that Directive should therefore be amended accordingly. It is for the Member States to ensure that that amendment is reflected in their transposition measures adopted in accordance with Directive (EU) 2020/1828, although the adoption of national transposition measures in this regard is not a condition for the applicability of that Directive to those representative actions. The applicability of Directive (EU) 2020/1828 to the representative actions brought against infringements by economic operators of provisions of this Regulation that harm or can harm the collective interests of consumers should start from the date of application of this Regulation.
Amendment 62 #
Proposal for a regulation Article 1 – paragraph 3 – point a (a) manufacturers and suppliers of EHR systems
Amendment 63 #
Proposal for a regulation Article 1 – paragraph 4 Directive 2013/87/EC Article 1 – paragraph 4 4. This Regulation shall be without prejudice to other Union legal acts regarding access to, sharing of or secondary use of electronic health data, or requirements related to the processing of data in relation to electronic health data, in particular Regulations (EU) 2016/679, (EU) 2018/1725, […] [Data Governance Act COM/2020/767 final], Directive (EU) 2016/943 and […] [Data Act COM/2022/68 final].
Amendment 64 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) ‘non-personal electronic health data’ means data
Amendment 65 #
Proposal for a regulation Article 2 – paragraph 2 – point h (h) ‘registration of electronic health data’ means the recording of health data in an electronic format, through manual entry of data, through the collection of data by a device, or through the conversion of non- electronic health data into an electronic format, to be processed in an EHR system
Amendment 66 #
Proposal for a regulation Article 2 – paragraph 2 – point m (m) ‘EHR’ (electronic health record) means any collection of past or present electronic health data, including physical and mental data, related to a natural person and collected in the health system, processed for healthcare or research purposes;
Amendment 67 #
Proposal for a regulation Article 2 – paragraph 2 – point m (m) ‘EHR’ (electronic health record) means an electronic collection of
Amendment 68 #
Proposal for a regulation Article 2 – paragraph 2 – point n (n) ‘EHR system’ (electronic health record system) means any appliance
Amendment 69 #
Proposal for a regulation Article 2 – paragraph 2 – point n Directive 2013/87/EC Article 2 – paragraph 2 – point n (n) ‘EHR system’ (electronic health record system) means any appliance or software primarily intended by the manufacturer to
Amendment 70 #
Proposal for a regulation Article 2 – paragraph 2 – point n a (new) (n a) ‘general software’ means any software that is not intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records, or that cannot be reasonably expected by the manufacturer to be mainly used for these purposes;
Amendment 71 #
Proposal for a regulation Article 2 – paragraph 2 – point o Amendment 72 #
Proposal for a regulation Article 2 – paragraph 2 – point o (o) ‘wellness application’ means any appliance or software intended by the manufacturer to be used by a natural person for processing electronic health data for
Amendment 73 #
Proposal for a regulation Article 2 – paragraph 2 – point o Directive 2013/87/EC Article 2 – paragraph 2 – point o (o) ‘wellness application’ means any appliance or software intended by the manufacturer to be used by a natural person for processing electronic health data for other purposes than healthcare, but related to healthcare, such as well-being and pursuing healthy life-styles;
Amendment 74 #
Proposal for a regulation Article 2 – paragraph 2 – point ae a (new) (ae a) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to an EHR system.
Amendment 75 #
Proposal for a regulation Article 3 – paragraph 1 1. Natural persons shall have the right to access their personal electronic health data processed in the context of primary use of electronic health data, immediately, free of charge and in an easily readable, consolidated and accessible form. Natural persons shall not have the right to change the relevant data.
Amendment 76 #
Proposal for a regulation Article 3 – paragraph 5 – subparagraph 1 – point a Directive 2013/87/EC (a) establish one or more electronic health data access services at national, regional or local level, using centralised or decentralised structure, enabling the exercise of rights referred to in paragraphs 1 and 2;
Amendment 77 #
Proposal for a regulation Article 3 – paragraph 10 10. Natural persons shall have the right to obtain information on
Amendment 78 #
Proposal for a regulation Article 6 – paragraph 1 – introductory part 1. The Commission shall, by means of implementing acts, lay down the technical specifications for the priority categories of personal electronic health data referred to
Amendment 79 #
Proposal for a regulation Article 10 – paragraph 2 – point m – point i (new) i) ensure robust cybersecurity measures to protect sensitive health data of users to thwart any attempts to breach the systems and steal or damage the data.
Amendment 80 #
Proposal for a regulation Article 12 – paragraph 1 1. The Commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between national contact points for digital health of the Member States. The central platform shall be licenced under an open- source licence and published in the Open Source code repository of the EU institutions.
Amendment 81 #
Proposal for a regulation Article 12 – paragraph 1 1. The Commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between national contact points for digital health of the Member States. The platform shall not enable the storage of electronic health data on the platform.
Amendment 82 #
Proposal for a regulation Article 12 – paragraph 4 4.
Amendment 83 #
Proposal for a regulation Chapter III – title III EHR systems
Amendment 84 #
Proposal for a regulation Article 14 – paragraph 3 a (new) 3 a. No later than 12 months after the entry into force of this Regulation, the Commission shall issue guidance to clarify requirement of the manufacturers to conduct conformity assessments under different Union legislation, such as Medical Device Regulations, Artificial Intelligence Act or EHDS. The guidance shall also clarify which rules apply to products that are covered by more regulated categories.
Amendment 85 #
Proposal for a regulation Article 14 – paragraph 4 4.
Amendment 86 #
Proposal for a regulation Article 14 a (new) Article 14 a Once only principle Natural or legal persons shall provide data to public sector bodies or EHR providers under the primary use regime only once, while public sector bodies may use such data for secondary purposes.
Amendment 87 #
Proposal for a regulation Article 15 – paragraph 1 1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter and in Annex II.
Amendment 88 #
Proposal for a regulation Article 17 – paragraph 1 – point b (b) draw up and keep up to date the technical documentation of their EHR systems in accordance with Article 24;
Amendment 89 #
Proposal for a regulation Article 17 – paragraph 1 – point c (c) ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 25 and by clear and complete
Amendment 90 #
Proposal for a regulation Article 17 – paragraph 1 – point g (g) take
Amendment 91 #
Proposal for a regulation Article 17 – paragraph 1 – point h (h) immediately inform the distributors of their EHR systems and, where applicable, the authorised representative and importers of any corrective action, recall or withdrawal;
Amendment 92 #
Proposal for a regulation Article 17 – paragraph 1 – point i (i) immediately inform the market surveillance authorities of the Member States in which they made their EHR systems available or put them into service of the non-
Amendment 93 #
Proposal for a regulation Article 17 – paragraph 1 – point i a (new) (i a) immediately inform the market surveillance authorities of the Member States in which they made their EHR systems available, where manufacturers consider or have reasons to believe that such systems present a risk to the health or safety of natural persons or to other aspects of public interest protection;
Amendment 94 #
Proposal for a regulation Article 17 – paragraph 1 – point j (j)
Amendment 95 #
Proposal for a regulation Article 17 – paragraph 1 – point j (j)
Amendment 96 #
Proposal for a regulation Article 17 – paragraph 1 – point k a (new) (k a) establish reporting channels and ensure their accessibility to allow for users to submit complaints or concerns regarding potential non-conformity of products; assess the complaints and concerns received, and inform market surveillance authorities in case of suspected non-compliance of the product; and keep a register of complaints and concerns received for 10 years and make it available upon request from a market surveillance authority.
Amendment 97 #
Proposal for a regulation Article 17 – paragraph 1 a (new) 1 a. If the manufacturer fails to cooperate with market surveillance authorities or if the information and documentation provided is incomplete or incorrect, market surveillance authorities shall take all appropriate measures to prohibit or restrict the relevant EHR system from being available on the market, to withdraw it from the market or to recall it until the manufacturer cooperates or provides complete and correct information;
Amendment 98 #
Proposal for a regulation Article 17 – paragraph 3 a (new) 3 a. A manufacturer of EHR systems established outside of the Union shall ensure that its authorised representative has the necessary documentation permanently available in order to fulfil the tasks referred to in Article 18(2).
Amendment 99 #
Proposal for a regulation Article 17 – paragraph 3 b (new) 3 b. Natural or legal persons may claim compensation for damage caused by a defective EHR system in accordance with applicable Union and national law. Manufacturers shall have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
source: 745.235
2023/03/10
ITRE
295 amendments...
Amendment 100 #
Proposal for a regulation Recital 65 (65) In order to promote the consistent application of this Regulation, a European Health Data Space Board (EHDS Board) should be set up. The Board should consists of representatives from digital health authorities, European Data Protection Board, European Data Protection Supervisor, European Medicines Agency, European Centre for Disease Prevention and Control, healthcare professionals, patient organizations, research community and health industry. All Board members have the same rights and responsibilities. Furthermore, experts of the European Parliament should be invited to attend the meetings of the EHDS Board. The EHDS Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. The EHDS Board should operate transparently with open publication of meeting dates and minutes of the discussion as well as an annual report. The Commission should participate in its activities and chair it. It should contribute to the consistent application of this Regulation throughout the Union, including by helping Member State to coordinate the use of electronic health data for healthcare, certification, but also concerning the secondary use of electronic health data. Given that, at national level, digital health authorities dealing with the primary use of electronic health data may be different to the health data access bodies dealing with the secondary use of electronic health data, the functions are different and there is a need for distinct cooperation in each of these areas, the EHDS Board should be able to set up subgroups dealing with these two functions, as well as other subgroups, as needed. For an efficient working method, the digital health authorities and health data access bodies should create networks
Amendment 101 #
Proposal for a regulation Article 1 – paragraph 1 1. This Regulation establishes the European Health Data Space (‘EHDS’) by
Amendment 102 #
Proposal for a regulation Article 1 – paragraph 2 – point a (a) strengthens the rights of natural persons in relation to the availability, sharing and control of their electronic health data;
Amendment 103 #
Proposal for a regulation Article 1 – paragraph 3 – point d (d) data recipients and users to whom electronic health data are made available by data holders in the Union.
Amendment 104 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) ‘non-personal electronic health data’ means data concerning health and genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679; and on a case by case basis pseudonymised data according to Article 4(5) of Regulation (EU) 2016/679
Amendment 105 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) ‘non-personal electronic health data’ means data concerning mental and physical health and
Amendment 106 #
Proposal for a regulation Article 2 – paragraph 2 – point b (b) ‘non-personal electronic health data’ means data concerning health and anonymised genetic data in electronic format that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
Amendment 107 #
Proposal for a regulation Article 2 – paragraph 2 – point f (f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals,
Amendment 108 #
Proposal for a regulation Article 2 – paragraph 2 – point f (f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals using commonly accepted open standards and open data formats, involving the exchange of information and knowledge without changing the content of the data between these organisations, software applications or devices, through the processes they support;
Amendment 109 #
(g) ‘European electronic health record exchange format’ means a structured, commonly used, open standard and machine-readable format that allows transmission of personal electronic health data between different software applications, devices and healthcare providers;
Amendment 110 #
Proposal for a regulation Article 2 – paragraph 2 – point l (l) ‘telemedicine’ means the provision of healthcare services,
Amendment 111 #
(m) ‘EHR’ (electronic health record) means a collection of electronic mental and physical health data related to a natural person and collected in the health system, processed for healthcare or research purposes;
Amendment 112 #
Proposal for a regulation Article 2 – paragraph 2 – point q – point i (i) the death of a natural person or serious damage to a natural person’s health or rights;
Amendment 113 #
Proposal for a regulation Article 2 – paragraph 2 – point y Amendment 114 #
Proposal for a regulation Article 2 – paragraph 2 – point y (y) ‘data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law,
Amendment 115 #
Proposal for a regulation Article 2 – paragraph 2 – point y (y) ‘data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation, in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or in the case of non-personal data, t
Amendment 116 #
Proposal for a regulation Article 2 – paragraph 2 – point z (z) ‘data user’ means a natural or legal person who has lawful access to personal or non-personal electronic health data
Amendment 117 #
Proposal for a regulation Article 2 – paragraph 2 – point a a (aa) ‘data permit’ means an administrative decision issued to a data user by a
Amendment 118 #
Proposal for a regulation Article 2 – paragraph 2 – point ad (ad) ‘data quality’ means the degree to which characteristics of electronic health data are suitable for
Amendment 119 #
(aea) ‘anonymised data’ or ‘data in anonymised format’ means personal data that have been anonymised in such a way as to prevent the data subject from being re-identified, including by drawing on state-of-the-art and future technologies and methods or other data.
Amendment 120 #
Proposal for a regulation Article 2 – paragraph 2 – point ae a (new) (aea) ‘data sharing’ means the provision defined in Article 2 (10) of the Regulation (EU) 2022/868;
Amendment 121 #
Proposal for a regulation Article 2 – paragraph 2 – point ae b (new) (aeb) ‘application processing body’ means a body set up in accordance with Article 36(1), fourth sentence, point (a), whose tasks include, in particular, checking data applications and issuing data permits.
Amendment 122 #
Proposal for a regulation Article 2 – paragraph 2 – point ae b (new) (aeb) 'pseudonymisation' means the processing defined in Article 4 (5) of the Regulation (EU) 2016/679.
Amendment 123 #
Proposal for a regulation Article 2 – paragraph 2 – point ae c (new) (aec) ‘pseudonymisation body’ means a body established in accordance with Article 36(1), fourth sentence, point (b), whose tasks include, in particular, the pseudonymisation of electronic health data.
Amendment 124 #
Proposal for a regulation Article 2 – paragraph 2 – point ae d (new) (aed) ‘health data access body’ means a body established in accordance with Article 36(1), fourth sentence, point (c), whose tasks include, in particular, the provision of a secure data processing environment.
Amendment 125 #
Proposal for a regulation Article 2 – paragraph 2 – point ae e (new) (aee) ‘bodies involved in health data access’ means bodies within the meaning of points (ag), (ah) and (ai) in so far as, in a specific case, they are involved in enabling secondary use.
Amendment 126 #
Proposal for a regulation Article 3 – paragraph 5 – subparagraph 1 – point a (a) establish one or more electronic health data access services at national, regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2; These bodies shall incorporate health professionals’ experience when dealing with the exercise of the rights set out in paragraph 7.
Amendment 127 #
Proposal for a regulation Article 3 – paragraph 5 – subparagraph 1 – point b (b) establish one or more proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf or to enable guardians to act on behalf of their dependent children in a legitimate manner in accordance with the Member State’s national standards.
Amendment 128 #
Proposal for a regulation Article 3 – paragraph 5 – subparagraph 2 The proxy services shall provide authorisations free of charge, electronically or on paper. They shall enable guardians or other representatives to be authorised, either automatically or upon request, to access electronic health data of the natural persons whose affairs they administer. Member States may provide that authorisations do not apply whenever necessary for reasons related to the protection of the natural person, and in particular based on patient safety and ethics. The proxy services shall be interoperable among Member States unless the proposed rectification concerns a data record made by a health service provider, in which case the provider concerned will have to approve the rectification or lodge their opposition before the health data processing service.
Amendment 129 #
Proposal for a regulation Article 4 – paragraph 1 – point b (b) ensure that the personal electronic health data of the natural persons they treat are updated with information related to the health services provided and, otherwise, update data on the health services that they offer.
Amendment 130 #
Proposal for a regulation Article 4 – paragraph 3 3. Member States shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals who lawfully carry out their work through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge. To that end, they may cooperate, where appropriate, with professional associations as provided for under national rules.
Amendment 131 #
Proposal for a regulation Article 4 – paragraph 4 4. Where access to electronic health data has been restricted by the natural person according to Article 3(9), the healthcare provider or health professionals shall not be informed of the content of the electronic health data without prior authorisation by the natural person, including where the provider or professional is informed of the existence and nature of the restricted electronic health data. However, health professionals should always be able to distinguish between the case where there is no data and where there is data, but access is restricted. In cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person, the healthcare provider or health professional may get access to the restricted electronic health data. Following such access, the healthcare provider or health professional shall inform the data holder and the natural person concerned or his/her guardians that access to electronic health data had been granted. Member States’ law may add additional safeguards.
Amendment 132 #
Proposal for a regulation Article 5 – paragraph 2 – introductory part 2. The Commission is empowered to adopt delegated acts in accordance with Article 67 to amend the list of priority categories of electronic health data in paragraph 1. Such delegated acts may also amend Annex I by adding, modifying or removing the minimum main characteristics of the priority categories of electronic health data and indicating, where relevant, deferred application date. The categories of electronic health data added through such delegated acts shall satisfy the following criteria:
Amendment 133 #
Proposal for a regulation Article 6 – paragraph 1 – introductory part 1. The Commission shall, by means of implementing acts, lay down the open technical specifications for the priority categories of personal electronic health data referred to in Article 5, setting out the European electronic health record exchange format. The format shall include the following elements:
Amendment 134 #
Proposal for a regulation Article 6 – paragraph 3 3. Member States shall ensure that the priority categories of personal electronic health data referred to in Article 5 are issued in the format referred to in paragraph 1 and such data shall be read and accepted by the data recipient including measures intended to ensure that priority categories of personal health data are translated into the language of the patient or health professional to the extent necessary for those health services to be provided.
Amendment 135 #
Proposal for a regulation Article 7 – paragraph 1 1. Member States shall ensure that, where data is processed in electronic format, health professionals
Amendment 136 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission shall, by means of
Amendment 137 #
Proposal for a regulation Article 9 – paragraph 2 2. The Commission shall, by means of
Amendment 138 #
Proposal for a regulation Article 9 – paragraph 3 3. The Commission and the Member States shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border digital health infrastructure referred to in Article 12(3).
Amendment 139 #
Proposal for a regulation Article 9 – paragraph 3 3. The Member States and the Commission shall implement
Amendment 140 #
Proposal for a regulation Article 9 – paragraph 4 4. The
Amendment 141 #
Proposal for a regulation Article 9 – paragraph 4 4. The
Amendment 142 #
Proposal for a regulation Article 10 – paragraph 2 – point m (m) cooperate with other relevant entities and bodies at national or Union level, to ensure interoperability, data portability and security of electronic health data, as well as with stakeholders representatives, including patients’ representatives, healthcare providers, health professionals, through the professional associations that represent them, industry associations;
Amendment 143 #
Proposal for a regulation Article 10 – paragraph 5 5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representatives and health representatives. Members of the digital health authority shall avoid any conflicts of interest.
Amendment 144 #
Proposal for a regulation Article 12 – paragraph 6 6. Member States shall ensure that pharmacies operating on their territories
Amendment 145 #
Proposal for a regulation Article 31 – paragraph 2 – point b (b) reference to open common specifications
Amendment 146 #
Proposal for a regulation Article 31 – paragraph 6 6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device and in the case of software, a digital label. 2D barcodes may also be used to display the label.
Amendment 147 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 1. Data holders shall make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter
Amendment 148 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 1. Data holders
Amendment 149 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 1. Data holders shall make the following categories of electronic data available, upon request and verifying that the natural person has not rejected the option of sharing their data for secondary use in accordance with the provisions of this Chapter:
Amendment 150 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 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, in accordance with the provisions of this Chapter:
Amendment 151 #
Proposal for a regulation Article 33 – paragraph 1 – point a (a) electronic health data from EHRs;
Amendment 152 #
Proposal for a regulation Article 33 – paragraph 1 – point d Amendment 153 #
Proposal for a regulation Article 33 – paragraph 1 – point d Amendment 154 #
Proposal for a regulation Article 33 – paragraph 1 – point d (d) health-related administrative data for population-wide predominantly publicly funded treatments, including claims and reimbursement data;
Amendment 155 #
Proposal for a regulation Article 33 – paragraph 1 – point e Amendment 156 #
Proposal for a regulation Article 33 – paragraph 1 – point e (e) anonymised human genetic, genomic and proteomic data;
Amendment 157 #
Proposal for a regulation Article 33 – paragraph 1 – point f (f) person generated electronic health data
Amendment 158 #
Proposal for a regulation Article 33 – paragraph 1 – point f (f) person generated electronic health data, including medical devices
Amendment 159 #
Proposal for a regulation Article 33 – paragraph 1 – point h (h) population wide electronic health data registries (public health registries);
Amendment 160 #
Proposal for a regulation Article 33 – paragraph 1 – point i (i) electronic health data from medical registries
Amendment 161 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from
Amendment 162 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from clinical trials in accordance with Regulation (EU) No 536/2014;
Amendment 163 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from clinical trials in so far as they have been completed;
Amendment 164 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from finalised clinical trials;
Amendment 165 #
Proposal for a regulation Article 33 – paragraph 1 – point m Amendment 166 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 167 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 168 #
Proposal for a regulation Article 33 – paragraph 1 – point n (n) electronic data related to insurance status, professional status, and education
Amendment 169 #
Proposal for a regulation Article 33 – paragraph 1 – point o a (new) (oa) Death registries, death certificates
Amendment 170 #
Proposal for a regulation Article 33 – paragraph 1 a (new) (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.
Amendment 171 #
Proposal for a regulation Article 33 – paragraph 2 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/EC
Amendment 172 #
Proposal for a regulation Article 33 – paragraph 2 (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
Amendment 173 #
Proposal for a regulation Article 33 – paragraph 3 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 , which are processed for secondary use or that may be processed for such purposes in accordance with applicable Union law or with national legislation implementing Union law.
Amendment 174 #
Proposal for a regulation Article 33 – paragraph 3 (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,
Amendment 175 #
Proposal for a regulation Article 33 – paragraph 3 a (new) 3a. When electronic health data is made available for secondary use through health data 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 should be closely monitored by the Commission and any exemption should be public.
Amendment 176 #
Proposal for a regulation Article 33 – paragraph 3 a (new) 3a. The natural person shall receive information about the benefits of providing access to their health date for secondary use.
Amendment 177 #
Proposal for a regulation Article 33 – paragraph 4 4. Electronic health data entailing protected intellectual property and trade secrets from
Amendment 178 #
Proposal for a regulation Article 33 – paragraph 4 4. Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use.
Amendment 179 #
Proposal for a regulation Article 33 – paragraph 4 (4) Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use
Amendment 180 #
Proposal for a regulation Article 33 – paragraph 4 a (new) (4a) extending the period for making data available to 24 months in order to allow for registration of property rights; or
Amendment 181 #
Proposal for a regulation Article 33 – paragraph 4 b (new) (4b) processing data to ensure that trade secrets are redacted.
Amendment 182 #
Proposal for a regulation Article 33 – paragraph 5 Amendment 183 #
Proposal for a regulation Article 33 – paragraph 5 5. Where the consent of the natural person is required by national or Union law, health data access bodies shall rely on the obligations laid down in the respective legislation and this Chapter to provide access to electronic health data ensuring the primacy of the individual fundamental rights.
Amendment 184 #
Proposal for a regulation Article 33 – paragraph 5 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
Amendment 185 #
Proposal for a regulation Article 33 – paragraph 6 (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.
Amendment 186 #
Proposal for a regulation Article 33 – paragraph 7 Amendment 187 #
Proposal for a regulation Article 33 – paragraph 7 Amendment 188 #
Proposal for a regulation Article 33 – paragraph 7 Amendment 189 #
Proposal for a regulation Article 33 – paragraph 7 7. The Commission shall periodically review the list in paragraph 1. The Commission is empowered to adopt delegated acts in accordance with
Amendment 190 #
Proposal for a regulation Article 33 – paragraph 7 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 after consultations with all stakeholders, including industry and ensuring public scrutiny for the changes.
Amendment 191 #
Proposal for a regulation Article 33 – paragraph 7 a (new) 7a. In order to protect the natural persons, but also with a view to public and national security Member States may limit the scope of data made available for secondary use.
Amendment 192 #
Proposal for a regulation Article 33 – paragraph 8 Amendment 193 #
Proposal for a regulation Article 33 – paragraph 8 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 and in accordance with the relevant security and privacy provisions.
Amendment 194 #
Proposal for a regulation Article 33 – paragraph 8 a (new) (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.
Amendment 195 #
Proposal for a regulation Article 33 a (new) Article 33a Rights of natural persons in relation to the secondary use Natural persons shall have the right to restrict access by health data access bodies to all or part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms.
Amendment 196 #
Proposal for a regulation Article 34 – paragraph 1 – introductory part (1)
Amendment 197 #
Proposal for a regulation Article 34 – paragraph 1 – point a (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 and efficacy of healthcare and of medicinal products or medical devices, for the purpose of the evaluation of the benefits and risks of medicinal products and of the identification and assessment of threats to human health posed by infectious diseases the EMA and ECDC shall be granted rapid and unrestricted access to the health data within the EHDS;
Amendment 198 #
Proposal for a regulation Article 34 – paragraph 1 – point a (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
Amendment 199 #
Proposal for a regulation Article 34 – paragraph 1 – point a (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;
Amendment 200 #
Proposal for a regulation Article 34 – paragraph 1 – point e a (new) (ea) Health Economics and Outcomes Research (HEOR);
Amendment 201 #
Proposal for a regulation Article 34 – paragraph 1 – point f (f)
Amendment 202 #
Proposal for a regulation Article 34 – paragraph 1 – point f (f) development
Amendment 203 #
Proposal for a regulation Article 34 – paragraph 1 – point f (f) development and innovation activities for products or services contributing to public health
Amendment 204 #
Proposal for a regulation Article 34 – paragraph 1 – point g (g) training, testing and
Amendment 205 #
Proposal for a regulation Article 34 – paragraph 1 – point g (g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to
Amendment 206 #
Proposal for a regulation Article 35 – paragraph 1 – introductory part Seeking or gaining access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 or made available according to this legislation for the following purposes shall be prohibited and subject to penalties :
Amendment 207 #
Proposal for a regulation Article 35 – paragraph 1 – point a (a) taking decisions or allowing actions of any kind 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;
Amendment 208 #
Proposal for a regulation Article 35 – paragraph 1 – point b (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 in order to limit or suspend their fundamental rights as identified by the ECHR;
Amendment 209 #
Proposal for a regulation Article 35 – paragraph 1 – point c (c) advertising or marketing activities
Amendment 210 #
Proposal for a regulation Article 35 – paragraph 1 – point e (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 or result in behavioural changes that reduce the freedom of choice or security of the natural persons.
Amendment 211 #
Proposal for a regulation Article 35 – paragraph 1 – point e a (new) (ea) reconstructing the identity of natural persons from datasets shared under this Regulation;
Amendment 212 #
Proposal for a regulation Article 35 – paragraph 1 – point e a (new) (ea) re-engineering medical devices or AI algorithms.
Amendment 213 #
Proposal for a regulation Article 35 – paragraph 1 – point e b (new) (eb) profiling of natural persons solely from the datasets shared under this Regulation or in combination with other data;
Amendment 214 #
Proposal for a regulation Article 35 – paragraph 1 – point e c (new) (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;
Amendment 215 #
Proposal for a regulation Article 35 – paragraph 1 – point e d (new) (ed) the sale of electronic health data made available under this Regulation.
Amendment 216 #
Proposal for a regulation Article 36 – title Amendment 217 #
Proposal for a regulation Article 36 – paragraph 1 (1) Member States shall each designate one or more
Amendment 218 #
Proposal for a regulation Article 36 – paragraph 1 a (new) (1a) application processing bodies, which may be administered by both public and private bodies;
Amendment 219 #
Proposal for a regulation Article 36 – paragraph 1 b (new) (1b) pseudonymisation bodies, which shall be administered by national public bodies; the European Union shall also create an independent European pseudonymisation body;
Amendment 220 #
Proposal for a regulation Article 36 – paragraph 1 c (new) (1c) access bodies, which shall be administered by national public bodies;
Amendment 221 #
Proposal for a regulation Article 36 – paragraph 2 (2) Member States shall ensure that each
Amendment 222 #
Proposal for a regulation Article 36 – paragraph 3 3. Member States shall ensure that essential health stakeholders’ representatives, including patient organisations, healthcare professionals and research community 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 not be bound by any instructions, when making their decisions.
Amendment 223 #
Proposal for a regulation Article 36 – paragraph 3 (3) In the performance of their tasks,
Amendment 224 #
Proposal for a regulation Article 36 – paragraph 4 (4) Member States shall communicate to the Commission the identity of the
Amendment 225 #
Proposal for a regulation Article 37 – title Tasks of
Amendment 226 #
Proposal for a regulation Article 37 – paragraph 1 – introductory part (1)
Amendment 227 #
Proposal for a regulation Article 37 – paragraph 1 – point a (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;
Amendment 228 #
Proposal for a regulation Article 37 – paragraph 1 – point b (b) access bodies shall support public sector bodies in carrying out the tasks enshrined in their mandate, based on national or Union law;
Amendment 229 #
Proposal for a regulation Article 37 – paragraph 1 – point c (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;
Amendment 230 #
Proposal for a regulation Article 37 – paragraph 1 – point d (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;
Amendment 231 #
Proposal for a regulation Article 37 – paragraph 1 – point e (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;
Amendment 232 #
Proposal for a regulation Article 37 – paragraph 1 – point f (f) bodies involved in accessing health shall take all measures necessary to preserve the confidentiality of IP rights and of trade secrets;
Amendment 233 #
Proposal for a regulation Article 37 – paragraph 1 – point g (g)
Amendment 234 #
Proposal for a regulation Article 37 – paragraph 1 – point i (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;
Amendment 235 #
Proposal for a regulation Article 37 – paragraph 1 – point j (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;
Amendment 236 #
Proposal for a regulation Article 37 – paragraph 1 – point k (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;
Amendment 237 #
Proposal for a regulation Article 37 – paragraph 1 – point l (l) application processing and access bodies shall jointly maintain a public information system to comply with the obligations laid down in Article 38;
Amendment 238 #
Proposal for a regulation Article 37 – paragraph 1 – point m (m) cooperate at Union and national level to lay down common approach, technical requirements and appropriate measure
Amendment 239 #
Proposal for a regulation Article 37 – paragraph 1 – point m (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;
Amendment 240 #
Proposal for a regulation Article 37 – paragraph 1 – point n (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;
Amendment 241 #
Proposal for a regulation Article 37 – paragraph 1 – point o (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
Amendment 242 #
Proposal for a regulation Article 37 – paragraph 1 – point q – introductory part (q) application processing bodies shall make public, through electronic means:
Amendment 243 #
Proposal for a regulation Article 37 – paragraph 1 – point q – point iii Amendment 244 #
Proposal for a regulation Article 37 – paragraph 1 – point q a (new) (qa) access bodies shall make public through electronic means the sanctions imposed under Article 43;
Amendment 245 #
Proposal for a regulation Article 37 – paragraph 1 – point r (r) bodies involved in accessing health data shall fulfil obligations towards natural persons pursuant to Article 38;
Amendment 246 #
Proposal for a regulation Article 37 – paragraph 1 – point s (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;
Amendment 247 #
Proposal for a regulation Article 37 – paragraph 1 – point t (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.
Amendment 248 #
Proposal for a regulation Article 37 – paragraph 2 – introductory part (2) In the exercise of their tasks,
Amendment 249 #
Proposal for a regulation Article 37 – paragraph 2 – point b (b) access bodies shall inform the relevant supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725
Amendment 250 #
Proposal for a regulation Article 37 – paragraph 2 – point c (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;
Amendment 251 #
Proposal for a regulation Article 37 – paragraph 2 – point c (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;
Amendment 252 #
Proposal for a regulation Article 37 – paragraph 2 – point d (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].
Amendment 253 #
Proposal for a regulation Article 37 – paragraph 4 (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
Amendment 254 #
Proposal for a regulation Article 38 – title Obligations of
Amendment 255 #
Proposal for a regulation Article 38 – paragraph 1 – introductory part (1)
Amendment 256 #
Proposal for a regulation Article 38 – paragraph 1 – point c (c) the applicable rights of natural persons in relation to secondary use of electronic health data including the right to opt out for certain type of data as defined in Article 33a (new);
Amendment 257 #
Proposal for a regulation Article 38 – paragraph 2 (2)
Amendment 258 #
Proposal for a regulation Article 38 – paragraph 3 (3) Where a
Amendment 259 #
Proposal for a regulation Article 38 – paragraph 4 (4) Member States shall regularly inform the public at large about the role and benefits of
Amendment 260 #
Proposal for a regulation Article 39 – title Reporting by
Amendment 261 #
Proposal for a regulation Article 39 – paragraph 1 – introductory part (1) Each
Amendment 262 #
Proposal for a regulation Article 39 – paragraph 1 – point b Amendment 263 #
Proposal for a regulation Article 39 – paragraph 2 (2) The reports shall be transmitted to the Commission.
Amendment 264 #
Proposal for a regulation Article 39 – paragraph 3 (3) The Commission is empowered to adopt delegated acts in accordance with Article 67 to modify the content of the annual activity reports.
Amendment 265 #
Proposal for a regulation Article 40 – paragraph 1 (1)
Amendment 266 #
Proposal for a regulation Article 40 – paragraph 1 a (new) 1a. Health data access bodies shall support non-for profits (specially patient and consumer organizations), public bodies like city councils or scientific societies, to register in as recognised data altruism organisations in accordance with Article 17 of Regulation (EU) 2022/868.
Amendment 267 #
Proposal for a regulation Article 41 – paragraph 1 (1) Where a data holder is obliged to make electronic health data available under Article 33 or under other Union law or national legislation implementing Union law, it shall cooperate in good faith with the health data access bodies or data users, where relevant.
Amendment 268 #
Proposal for a regulation Article 41 – paragraph 2 (2) The data holder shall communicate to the
Amendment 269 #
Proposal for a regulation Article 41 – paragraph 3 (3) Where a data quality and utility label accompanies the dataset pursuant to Article 56, the data holder shall provide sufficient documentation to the
Amendment 270 #
Proposal for a regulation Article 41 – paragraph 4 (4)
Amendment 271 #
Proposal for a regulation Article 41 – paragraph 7 Amendment 272 #
Proposal for a regulation Article 42 – paragraph 1 (1)
Amendment 273 #
Proposal for a regulation Article 42 – paragraph 5 (5) Where data holders and data users do not agree on the level of the fees within 1 month of the data permit being granted, the
Amendment 274 #
Proposal for a regulation Article 43 – paragraph 2 (2) When requesting from data users and data holders as well as other bodies involved in the access to health data the information that is necessary to verify compliance with this Chapter, the health data access bodies shall be proportionate to the performance of the compliance verification task.
Amendment 275 #
Proposal for a regulation Article 43 – paragraph 4 (4) Health data access bodies shall have the power to
Amendment 276 #
Proposal for a regulation Article 44 – paragraph 1 (1) The health data access body or the data holder shall ensure that access is only provided to requested electronic health data relevant for the purpose of processing indicated in the data access application by the data user and in line with the data permit granted.
Amendment 277 #
Proposal for a regulation Article 44 – paragraph 2 (2) The health data access bodies or data holders shall provide the electronic health data in an anonymised format, where appropriate using the pseudonymisation body as an intermediary, where the purpose of processing by the data user can be achieved with such data, taking into account the
Amendment 278 #
Proposal for a regulation Article 44 – paragraph 3 3. Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user or for the purpose of the evaluation of the benefits and risks of medicinal products and of the identification and assessment of threats to human health posed by infectious diseases, , the health data access bodies shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the health data access body. Data users shall not re-
Amendment 279 #
Proposal for a regulation Article 44 – paragraph 3 (3) Where the purpose of the data user’s processing cannot be achieved with anonymised data, taking into account the information provided by the data user, the health data access bodies or the data holder shall provide access to electronic health data in pseudonymised format. The information necessary to reverse the pseudonymisation shall be available only to the
Amendment 280 #
Proposal for a regulation Article 45 – paragraph 3 (3) Data users seeking access to electronic health data from more than one Member State shall submit a single application to one of the concerned
Amendment 281 #
Proposal for a regulation Article 45 – paragraph 4 – point a (a) a description of
Amendment 282 #
Proposal for a regulation Article 45 – paragraph 5 – subparagraph 2 Where the public sector bodies and the Union institutions, bodies, offices and agencies intend to access the electronic health data in pseudonymised format, a description of
Amendment 283 #
(1)
Amendment 284 #
Proposal for a regulation Article 46 – paragraph 1 1. Health data access bodies shall assess if the application fulfils one of the purposes listed in Article 34(1) of this Regulation, if the requested data is necessary for the purpose listed in the application and if the requirements in this Chapter are fulfilled by the applicant. If that is the case, the health data access body
Amendment 285 #
Proposal for a regulation Article 46 – paragraph 2 (2)
Amendment 286 #
Proposal for a regulation Article 46 – paragraph 3 3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay.
Amendment 287 #
Proposal for a regulation Article 46 – paragraph 3 (3) A
Amendment 288 #
Proposal for a regulation Article 46 – paragraph 4 (4) Following the issuance of the data permit, the
Amendment 289 #
Proposal for a regulation Article 46 – paragraph 4 4. Following the issuance of the data permit, the health data access body shall immediately request the electronic health data from the data holder. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders,
Amendment 290 #
Proposal for a regulation Article 46 – paragraph 5 (5) When the
Amendment 291 #
Proposal for a regulation Article 46 – paragraph 11 11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. Data users shall not be obliged to make public results or output in a way which compromises intellectual property rights contained therein. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.
Amendment 292 #
Proposal for a regulation Article 46 – paragraph 11 11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of
Amendment 293 #
Proposal for a regulation Article 46 – paragraph 11 (11) Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the
Amendment 294 #
Proposal for a regulation Article 46 – paragraph 12 (12) Data users shall inform the
Amendment 295 #
Proposal for a regulation Article 46 – paragraph 14 (14) The liability of health data access bodies
Amendment 296 #
Proposal for a regulation Article 47 – paragraph 1 (1) Any natural or legal person may submit a data request for the purposes referred to in Article 34. A health data access body shall only provide an answer to a data request, which is transmitted to it by the application processing body, in an anonymised statistical format and the data user shall have no access to the electronic health data used to provide this answer.
Amendment 297 #
Proposal for a regulation Article 48 Amendment 298 #
Proposal for a regulation Article 48 Amendment 299 #
Proposal for a regulation Article 48 Amendment 300 #
Proposal for a regulation Article 48 – paragraph 1 By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health data under this Article. For the purpose of the evaluation of the benefits and risks of medicinal products and of the identification and assessment of threats to human health posed by infectious diseases, the EMA and ECDC shall be granted rapid and unrestricted access to the health data within the EHDS. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from
Amendment 301 #
Proposal for a regulation Article 48 – paragraph 1 By derogation from Article 46 of this Regulation, a data permit shall not be required
Amendment 302 #
Proposal for a regulation Article 49 A
Amendment 303 #
Proposal for a regulation Article 49 A
Amendment 304 #
Proposal for a regulation Article 49 A
Amendment 305 #
Proposal for a regulation Article 50 – paragraph 2 (2) The health data access bodies shall ensure that electronic health data can be uploaded by data holders and can be accessed by the data user in a secure processing environment. The data users
Amendment 306 #
Proposal for a regulation Article 51 – paragraph 1 (1) The health data access bodies and the data users, including Union institutions, bodies, offices and agencies, shall be deemed joint controllers of electronic health data processed in accordance with data permit. In the event that the data holder provides access to the electronic health data to the data user without going through the health data access bodies, the data holder and data user shall be joint controllers of the electronic health data processed in accordance with the data permit.
Amendment 307 #
Proposal for a regulation Article 52 – paragraph 3 (3) Union institutions, bodies, offices and agencies in the health sector involved in research, health
Amendment 308 #
Proposal for a regulation Article 52 – paragraph 4 (4) Health-related research infrastructures or similar structures
Amendment 309 #
Proposal for a regulation Article 52 – paragraph 7 (7) The Commission is empowered to adopt delegated acts in accordance with Article 67 in order to amend this Article to add or remove categories of authorised health sector participants in HealthData@EU, taking into account the opinion of the joint controllership group pursuant to Article 66 of this Regulation.
Amendment 310 #
Proposal for a regulation Article 52 – paragraph 8 (8) The Member States and the Commission shall set up HealthData@EU to support and facilitate the cross-border access to electronic health data for secondary use in the health sector, connecting the national contact points for secondary use of electronic health data of all Member States and authorised participants in that infrastructure.
Amendment 311 #
Proposal for a regulation Article 53 – paragraph 1 (1) In the case of cross-border registries and databases, the
Amendment 312 #
Proposal for a regulation Article 53 – paragraph 2 (2) Where registries or databases from a number of Member States organise themselves into a single network of registries or databases at Union level, the associated registries may designate one of their members as a coordinator to ensure the provision of data from the registries’ network for secondary use. The
Amendment 313 #
Proposal for a regulation Article 54 – paragraph 1 (1) When handling an access application for cross-border access to electronic health data for secondary use,
Amendment 314 #
Proposal for a regulation Article 54 – paragraph 2 (2) A data permit issued by one
Amendment 315 #
Proposal for a regulation Article 55 – paragraph 1 (1) The
Amendment 316 #
Proposal for a regulation Article 61 – paragraph 1 Amendment 317 #
Proposal for a regulation Article 61 – paragraph 1 1. Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final]
Amendment 318 #
Proposal for a regulation Article 61 – paragraph 1 (1) Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (
Amendment 319 #
Proposal for a regulation Article 61 – paragraph 2 2. The enforced protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization techniques and range from denial to assignment to conditional authorization; they shall be specified and shall be
Amendment 320 #
Proposal for a regulation Article 61 – paragraph 2 2. The protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization and pseudonymisation techniques and shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].
Amendment 321 #
Proposal for a regulation Article 61 – paragraph 2 2.
Amendment 322 #
Proposal for a regulation Article 62 – paragraph 5 (5) The digital health authorities,
Amendment 323 #
Proposal for a regulation Article 64 – paragraph 1 1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The
Amendment 324 #
Proposal for a regulation Article 64 – paragraph 1 1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States, as well at least one patient organisation and one healthcare professional organization. Other national authorities, including market surveillance authorities referred to in Article 28,
Amendment 325 #
Proposal for a regulation Article 64 – paragraph 1 1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European or National Data Protection Supervisors may be invited or participate on their own initiative to the meetings, where the issues discussed are of relevance for them. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.
Amendment 326 #
Proposal for a regulation Article 64 – paragraph 3 3. The composition, organisation, functioning and cooperation of the sub- groups shall be set out in the rules of procedure put forward by the Commission after consultations with the Member States.
Amendment 327 #
Proposal for a regulation Article 64 – paragraph 4 4. Stakeholders and relevant third parties, including healthcare professionals, researchers and patients’ representatives, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.
Amendment 328 #
Proposal for a regulation Article 64 – paragraph 4 4. Stakeholders and relevant third parties, including patients’ and health professionals’ representatives, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.
Amendment 329 #
Proposal for a regulation Article 64 – paragraph 4 4. Stakeholders and relevant third parties, including patients’ representatives, shall be invited upon request to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.
Amendment 330 #
Proposal for a regulation Article 64 – paragraph 5 5. The EHDS Board shall cooperate with other relevant bodies, entities and experts, such as the European Data Innovation Board referred to in Article 26 of Regulation […] [Data Governance Act COM/2020/767 final], competent bodies set up under Article 7 of Regulation […] [Data Act COM/2022/68 final], supervisory bodies set up under Article 17 of Regulation […] [eID Regulation], European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679 and cybersecurity bodies, in particular the European Agency for Cybersecurity (ENISA).
Amendment 331 #
Proposal for a regulation Article 64 – paragraph 5 a (new) 5a. The EHDS Board is required to issue an annual report detailing the progress of the European Health Data Space's implementation as well as other pertinent advancements, including those pertaining to cross-border health data interoperability and related implementation obstacles.
Amendment 332 #
Proposal for a regulation Article 64 – paragraph 6 6. The
Amendment 333 #
Proposal for a regulation Article 65 – paragraph 2 – point b – point iii (iii) incentives policy for promoting data quality and interoperability improvement, including facilitating the development of harmonised guidance for anonymisation and pseudonymisation of health data;
Amendment 334 #
Proposal for a regulation Article 65 – paragraph 2 – point c a (new) (ca) to provide expertise on the amending of the list of minimum categories of electronic data for secondary use in accordance with Article 33(7);
Amendment 335 #
Proposal for a regulation Article 65 – paragraph 2 – point f (f) to facilitate the exchange of views on the secondary use of electronic health data with the relevant stakeholders, including representatives of patients, health professionals, researchers, industry representatives, regulators and policy makers in the health sector.
Amendment 336 #
Proposal for a regulation Article 67 – paragraph 2 (2) The power to adopt delegated acts referred to in Articles 5(2), 10(3), 25(3), 32(4), 33(7), 37(4), 39(3),
Amendment 337 #
Proposal for a regulation Article 69 – paragraph 1 Member States shall lay down the rules on penalties applicable to infringements of this Regulation, for all public and private stakeholders in particular for the non- respect of data access and usage provisions with intent or by negligence, and shall take all measures necessary to ensure that they are properly and effectively implemented. The penalties shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.
Amendment 338 #
Proposal for a regulation Article 72 – paragraph 3 – introductory part However, Articles 3, 4, 5, 6, 7, 12, 14, 23, 31 and 3
Amendment 339 #
Proposal for a regulation Article 72 – paragraph 3 – point c a (new) (ca) from 2 years after its entry into force to categories of electronic data that should be make available by data holders referred to in Article 33.
Amendment 340 #
Proposal for a regulation Annex II – point 2 – point 2.3 2.3. An EHR system that includes a functionality for entering structured personal electronic health data shall enable the entry of data structured in a structured way that supports the data sharing in a structured, commonly used, open and machine-
Amendment 341 #
2.4. An EHR system shall not include features that prohibit, restrict or place undue burden on authorised access, personal electronic health data sharing, or use of personal electronic health data for permitted purposes, in particular on the basis of commercial considerations and beyond security and legal safeguards requirements. .
Amendment 342 #
Proposal for a regulation Annex II – point 3 – point 3.1 3.1. An EHR system shall be designed and developed in such a way that it ensures highly safe and secure processing of electronic health data, and that it prevents unauthorised access to such data.
Amendment 343 #
Proposal for a regulation Annex II – point 3 – point 3.2 3.2. An EHR system designed to be used by health professionals shall provide reliable national mechanisms for the identification and authentication of health professionals, including checks on professional rights and qualifications.
Amendment 49 #
Proposal for a regulation Recital 1 (1) Whereas: The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for other purposes in the health sector that would benefit the society such as research, innovation, policy-making, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data). In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union values.
Amendment 50 #
Proposal for a regulation Recital 1 a (new) (1a) The EHDS constitutes a key component for the creation of a strong and resilient European Health Union to better protect the health of European citizens, prevent and address future pandemics and improve resilience of Europe’s health systems.
Amendment 51 #
Proposal for a regulation Recital 1 b (new) (1b) The following Regulation should work horizontally with other European programs such as the Digital Europe Programme, Connecting Europe Facility and Horizon Europe. The European Commission should ensure that other European programs complement and facilitate the implementation of the European Health Data Space.
Amendment 52 #
Proposal for a regulation Recital 1 c (new) (1c) Member States should cooperate in using interoperable standards together with European Digital Identity, facilitating the primary use of data in accordance with Article 9 of Regulation (EU)2016/679.
Amendment 53 #
Proposal for a regulation Recital 4 (4) The processing of personal electronic health data is subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council43and, for Union institutions and bodies, Regulation (EU) 2018/1725 of the European Parliament and of the Council44. References to the provisions of Regulation (EU) 2016/679 should be understood also as references to the corresponding provisions of Regulation (EU) 2018/1725 for Union institutions and bodies, where relevant. In addition, the Regulation should comply with Cyber Resilience Act. _________________ 43 Regulation (EU) 2016/679 of the
Amendment 54 #
Proposal for a regulation Recital 7 (7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border
Amendment 55 #
Proposal for a regulation Recital 10 a (new) (10a) Persons who suffer from rare diseases and who, in consequence, are more likely to have received inaccurate diagnoses, should also be enabled to request a rectification of the incorrect electronic health data, misdiagnoses and inconsistencies in their medical records or medical prescriptions, which should be processed in a timely manner.
Amendment 56 #
Proposal for a regulation Recital 13 (13) Natural persons may not want to allow access to some parts of their personal electronic health data while enabling
Amendment 57 #
Proposal for a regulation Recital 16 (16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as health professional portals, with access managed by the professional regulatory body, to use personal electronic health data for the exercise of their duties. Moreover, the access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format. None of the provisions of this regulation shall be construed as limiting health professionals’ obligation to behave in line with the relevant codes of conduct, ethical guidelines or other provisions governing ethical conduct with regard to the exchanging of, or access to, information, particularly in extreme or life-threatening situations.
Amendment 58 #
Proposal for a regulation Recital 17 a (new) (17a) With a view to improving interoperability and data sharing, Member States should aim to gradually implement the use of ICD-11, within the International Classification of Diseases, in the electronic health records systems, in order to ensure visibility within national health and social systems for affected patients including those suffering from rare diseases.
Amendment 59 #
Proposal for a regulation Recital 19 (19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path
Amendment 60 #
Proposal for a regulation Recital 19 a (new) (19a) The interoperability of the EHDS should contribute to high quality of European health data sets.
Amendment 61 #
Proposal for a regulation Recital 21 (21) Under Article 168 of the Treaty Member States are responsible for their health policy, in particular for decisions on the services (including telemedicine) that they provide and reimburse. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health
Amendment 62 #
Proposal for a regulation Recital 23 (23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including with insurance bodies, healthcare providers, manufacturers of EHR systems and wellness applications, as well as stakeholders from health or information technology sector, entities handling reimbursement schemes, health technology assessment bodies, medicinal products regulatory authorities and agencies, medical devices authorities, procurers and cybersecurity or e-ID authorities. (24 new) whereas there is technology that is advanced enough to ensure that this regulation does not oblige health professionals to enter data into information systems, and whereas it is a technological system that reads and interprets health care reports and can draw the most relevant conclusions; (This AM is a new consideration, but the at4am is not allowing us to add as a new one. Please take in to consideration.)
Amendment 63 #
Proposal for a regulation Recital 24 (24) Access to and transmission of electronic health data is relevant in cross- border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when
Amendment 64 #
Proposal for a regulation Recital 27 a (new) (27a) Highlights that the national and European electronic health record systems, databases and registries, where health data is processed and stored, provide the foundation on which the European Health Data Space rests. Recognises that static minimum requirements are not sufficient for meeting demands of data recipients and data users, notably in regard to creating a future-proof framework for European health data. Calls in this regard for support for research into the technology on which electronic health record systems, databases and registries are built in order to promote innovation in this field. Stresses that such research and innovation is essential for securing and preserving the position of Europe as a global frontrunner on health data usage, including the benefits this brings to citizens, industrial competiveness and other relevant interests.
Amendment 65 #
Proposal for a regulation Recital 30 (30) To further support interoperability and security, Member States may maintain or define specific rules for the procurement, reimbursement, financing or use of EHR systems at national level in the context of the organisation, delivery or financing of health services. Such specific rules should not impede the free movement of EHR systems in the Union unless those specific rules can be justified by overriding reasons of general interest relating to public health. Some Member States have introduced mandatory certification of EHR systems or mandatory interoperability testing for their connection to national digital health services. Such requirements are commonly reflected in procurements organised by healthcare providers, national or regional authorities. Mandatory certification of EHR systems at Union level should establish a baseline that can be used in procurements at national level.
Amendment 66 #
Proposal for a regulation Recital 35 (35) Users of wellness applications, such as mobile applications, should be informed about the capacity of such applications to be connected and to supply data to EHR systems or to national electronic health solutions, in cases where data produced by wellness applications is useful for healthcare purposes. The capability of those applications to export data in an interoperable format is also relevant for data portability purposes. Where applicable, users should be informed about the compliance of such applications with interoperability and security requirements. However, given the large number of wellness applications and the limited relevance for healthcare purposes of the data produced by many of them, a certification scheme for these applications would not be proportionate. A voluntary labelling scheme should therefore be established as an appropriate mechanism for enabling the transparency for the users of wellness applications regarding compliance with the requirements, thereby supporting users in their choice of appropriate wellness applications with high standards of interoperability and security. Labelling schemes may also include information for users on data protection rights and an indication of whether the application provider or browser operator has access in any way to the data generated by the application. The Commission may set out in implementing acts the details regarding the format and content of such label.
Amendment 67 #
(37) For the secondary use
Amendment 68 #
Proposal for a regulation Recital 38 (38) In the context of the EHDS, the electronic health data already exists and is being collected by healthcare providers, professional associations, public institutions, regulators, researchers, insurers etc. in the course of their activities. Some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records, genetic data, claims data, etc.), others are collected also for other purposes such as research, statistics, patient safety, regulatory activities or policy making (e.g. disease registries, policy making registries, registries concerning the side effects of medicinal products or medical devices, etc.). For instance, European databases that facilitate data (re)use are available in some areas, such as cancer (European Cancer Information System) or rare diseases (European Platform on Rare Disease Registration, ERN registries, etc.). These data should also be made available for secondary use. However, much of the existing health-related data is not made available for purposes other than that for which they were collected. This limits the ability of researchers, innovators,
Amendment 69 #
Proposal for a regulation Recital 38 (38) In the context of the EHDS, the electronic health data already exists and is being collected by healthcare providers, professional associations, public institutions, regulators, researchers, insurers etc. in the course of their activities. Some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records, genetic data, claims data, etc.), others are collected also for other purposes such as research, statistics, patient safety, regulatory activities or policy making (e.g. disease registries, policy making registries, registries concerning the side effects of medicinal products or medical devices, etc.). For instance, European databases that facilitate data (re)use are available in some areas, such as cancer (European Cancer Information System) or rare diseases (European Platform on Rare Disease Registration, ERN registries, etc.). These data
Amendment 70 #
Proposal for a regulation Recital 39 (39) The categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users, while remaining limited to data related to health or known to influence health. It can also include relevant data from the health system (electronic health records, claims data, disease registries, genomic data etc.)
Amendment 71 #
Proposal for a regulation Recital 40 (40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector
Amendment 72 #
Proposal for a regulation Recital 40 (40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. In order to avoid a disproportionate burden on small entities, micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of EHDS. The public or private entities often receive public funding, from national or Union funds to collect and process electronic health data for research, statistics (official or not) or other similar purposes, including in area where the
Amendment 73 #
Proposal for a regulation Recital 40 (40) The data holders can be public, non for profit or private health or care providers, public, non for profit and private organisations, associations or other entities, public and private entities that carry out research with regards to the health sector that process the categories of health and health related data mentioned above. In order to avoid a disproportionate burden on small entities, micro-enterprises are excluded from the obligation to make their data available for secondary use in the framework of EHDS. The public or private entities often receive public funding, from national or Union funds to collect and process electronic health data for research, statistics (official or not) or other similar purposes, including in area where the collection of such data is fragmented of difficult, such as rare diseases, cancer etc. Such data, collected and processed by data holders with the support of Union or national public funding,
Amendment 74 #
Proposal for a regulation Recital 41 (41) The secondary use of health data
Amendment 75 #
Proposal for a regulation Recital 41 (41) The secondary use of health data under EHDS should enable the public, private, not for profit entities, as well as individual researchers to have access to health data for research, innovation, policy making, educational activities, patient safety, regulatory activities or personalised medicine, in line with the purposes set out in this Regulation. Access to data for secondary use should contribute to the general interest of the society. Access to secondary health data for research and innovation to the development of medicines, medical devices, health care products and services should contribute to affordable and fair pricing for all European citizens when these products are placed on the market. Activities for which access in the context of this Regulation is lawful may include using the electronic health data for tasks carried out by public bodies, such as exercise of public duty, including public health surveillance, planning and reporting duties, health policy making, ensuring patient safety, quality of care, and the sustainability of health care systems. Public bodies and Union institutions, bodies, offices and agencies may require to have regular access to electronic health data for an extended period of time, including in order to fulfil
Amendment 76 #
Proposal for a regulation Recital 41 a (new) (41a) Natural persons need quality education to help them understand the advantages and benefits of providing access to their health data for the secondary use, without prejudice to their right to opt-out from such sharing. In addition to high-level of transparency in terms of how and where their data would be used.
Amendment 77 #
Proposal for a regulation Recital 42 (42)
Amendment 78 #
Proposal for a regulation Recital 43 (43) The health data access bodies should monitor the application of Chapter IV of this Regulation and contribute to its consistent application throughout the Union. For that purpose, the health data access bodies should cooperate with each other and with the Commission, without the need for any agreement between Member States on the provision of mutual assistance or on such cooperation. The health data access bodies should also cooperate with stakeholders, including patient organisations. Since the secondary use of health data involves the processing of personal data concerning health, the relevant provisions of Regulation (EU) 2016/679 apply and the supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 should be tasked with enforcing these rules. Moreover, given that health data are sensitive data and in a duty of loyal cooperation, the health data access bodies should inform the data protection authorities of any issues related to the data processing for secondary use, including penalties. In addition to the tasks necessary to ensure effective secondary use of health data, the health data access body should strive to expand the availability of additional health datasets, support the development of AI in health and promote the development of common standards. They should apply tested techniques that ensure electronic health data is processed in a manner that preserves the privacy of the information contained in the data for which secondary use is allowed, including techniques for pseudonymisation, anonymisation, generalisation, suppression and randomisation of personal data. In this regard, health data access bodies should cooperate cross-border and converge on common definitions and techniques. Health
Amendment 79 #
Proposal for a regulation Recital 43 (43)
Amendment 80 #
Proposal for a regulation Recital 44 (44) Considering the administrative burden for health data access bodies, application processing bodies and pseudonymisation bodies to inform the natural persons whose data are used in data projects within a secure processing environment, the exceptions provided for in Article 14(5) of Regulation (EU) 2016/679 should apply. Therefore, bodies involved in health data access
Amendment 81 #
Proposal for a regulation Recital 47 (47) Health data access bodies, pseudonymisation bodies, application processing bodies and single data holders should be allowed to charge fees based on the provisions of Regulation […] [Data Governance Act COM/2020/767 final] in relation to their tasks. Such fees may take into account the situation and interest of SMEs, individual researchers or public bodies. Data holders should be allowed to also charge fees for making data available. Such fees should
Amendment 82 #
Proposal for a regulation Recital 48 (48) In order to strengthen the enforcement of the rules on the secondary use of electronic health data, appropriate measures that can lead to penalties or temporary or definitive exclusions from the EHDS framework of the data users or data holders that do not comply with their obligations.
Amendment 83 #
Proposal for a regulation Recital 49 (49) Given the sensitivity of electronic health data, it is necessary to reduce risks on the privacy of natural persons by applying the data minimisation principle as set out in Article 5 (1), point (c) of Regulation (EU) 2016/679. Therefore, common standards for data anonymisation will be further developed and the use of anonymised electronic health data w
Amendment 84 #
Proposal for a regulation Recital 49 (49) Given the sensitivity of electronic health data, it is necessary to reduce risks on the privacy of natural persons by applying the data minimisation principle as set out in Article 5 (1), point (c) of Regulation (EU) 2016/679. Therefore, the use of anonymised electronic health data which is devoid of any personal data should be made available when possible and if the data user asks it. If the data user needs to use personal electronic health data, it should clearly indicate in its request the justification for the use of this type of data for the planned data processing activity. The personal electronic health data should only be made available in pseudonymised format and the permanent encryption key can only be held by the
Amendment 85 #
Proposal for a regulation Recital 50 (50) In order to ensure that all
Amendment 86 #
Proposal for a regulation Recital 51 (51) As the resources of
Amendment 87 #
Proposal for a regulation Recital 53 Amendment 88 #
Amendment 89 #
Proposal for a regulation Recital 53 (53)
Amendment 90 #
Proposal for a regulation Recital 54 (54) Given the sensitivity of electronic health data, data users should not have an unrestricted access to such data. All secondary use access to the requested electronic health data should be done through a secure processing environment. In order to ensure strong technical and security safeguards for the electronic health data, the health data access body or, where relevant, single data holder should provide access to such data in a secure processing environment, complying with the high technical and security standards set out pursuant to this Regulation. The requirements for secure processing environments and their development should strike an appropriate balance between security and functionality, taking into account technical feasibility and building on existing best practices. Some Member States took measures to locate such secure environments in Europe. The processing of personal data in such a secure environment should comply with Regulation (EU) 2016/679, including, where the secure environment is managed by a third party, the requirements of Article 28 and, where applicable, Chapter V. Such secure processing environment should reduce the privacy risks related to such processing activities and prevent the electronic health data from being transmitted directly to the data users. The health data access body or the data holder providing this service
Amendment 91 #
Proposal for a regulation Recital 55 (55) For the processing of electronic health data in the scope of a granted permit, the health data access bodies and the data users should be joint controllers in the sense of Article 26 of Regulation (EU) 2016/679, meaning that the obligations of joint controllers under that Regulation will apply. To support health data access bodies and data users, the Commission should, by means of an implementing act, provide a template for the joint controller arrangements health data access bodies and
Amendment 92 #
Proposal for a regulation Recital 55 (55) For the processing of electronic health data in the scope of a granted permit, the health data access bodies and the data users should be joint controllers in
Amendment 93 #
Proposal for a regulation Recital 56 (56) In case of cross-border registries or databases, such as the registries of European Reference Networks for Rare Diseases, which receive data from different healthcare providers in several Member States,
Amendment 94 #
Proposal for a regulation Recital 57 (57) The authorisation process to gain access to personal health data in different Member States can be repetitive and cumbersome for data users. Whenever possible, synergies should be established to reduce the burden and barriers for data users. One way to achieve this aim is to adhere to the “single application” principle whereby, with one application, the data user obtain authorisation from multiple
Amendment 95 #
(58)
Amendment 96 #
Proposal for a regulation Recital 61 a (new) (61a) In order to alleviate reported difficulties associated with the implementation of Regulation (EU) 2016/679, potential outcomes of the secondary use of health data, and its impact upon research, the Commission should conduct a study to examine the impact of Regulation (EU) 2016/679 and Regulation on EHDS on research. The study should be completed and published by not later than one year after the adoption of this Regulation. The study should examine divergence of implementation approaches and the impacts upon different areas of research. The study should include remedial recommendations.
Amendment 97 #
Proposal for a regulation Recital 64 (64) Certain categories of electronic health data can remain particularly sensitive even when they are in anonymised format and thus non-personal, as already specifically foreseen in the Data Governance Act. Even in situations of the use of state of the art anonymization techniques, there remains a residual risk that the capacity to re-identify could be or become available, beyond the means reasonably likely to be used. Such residual risk is present in relation to rare diseases (a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Union), where the limited numbers of case reduce the possibility to fully aggregate the published data in order to preserve the privacy of natural persons while also maintaining an appropriate level of granularity in order to remain meaningful. It can affect different types of health data depending on the level of granularity and description of the characteristics of data subjects, the number of people affected or and for instance in cases of data included in electronic health
Amendment 98 #
Proposal for a regulation Recital 64 (64) Certain categories of electronic health data can remain particularly sensitive even when they are in anonymised format and thus non-personal, as already specifically foreseen in the Data Governance Act. Even in situations of the use of state of the art anonymization techniques, there remains a residual risk that the capacity to re-identify could be or become available, beyond the means reasonably likely to be used. Such residual risk is present in relation to rare diseases (a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons in the Union), where the limited numbers of case reduce the possibility to fully aggregate the published data in order to preserve the privacy of natural persons while also maintaining an appropriate level of granularity in order to remain meaningful. It can affect different types of health data depending on the level of granularity and description of the characteristics of data subjects, the number of people affected or and for instance in cases of data included in electronic health records, disease registries, biobanks, person generated data etc. where the identification characteristics are broader and where, in combination with other information (e.g. in very small geographical areas) or through the technological evolution of methods which had not been available at the moment of anonymisation, can lead to the re- identification of the data subjects using means that are beyond those reasonably likely to be used. The realisation of such risk of re-identification of natural persons
Amendment 99 #
Proposal for a regulation Recital 64 a (new) source: 745.175
2023/03/30
ENVI, LIBE
1703 amendments...
Amendment 1000 #
Proposal for a regulation Article 19 – paragraph 2 – point a a (new) (a a) ensure that the appropriate conformity assessment procedures referred to in Article 27a have been carried out by the manufacturer
Amendment 1001 #
Proposal for a regulation Article 19 – paragraph 2 – point a a (new) (a a) the manufacturer is identified and an authorised representative in accordance with Article 18 has been appointed;
Amendment 1002 #
Proposal for a regulation Article 19 – paragraph 2 – point b (b) the EHR system bears the CE marking of conformity referred to in Article 27 ;
Amendment 1003 #
Proposal for a regulation Article 19 – paragraph 2 – point c (c) the EHR system is accompanied by the information sheet referred to in Article 25 and
Amendment 1004 #
Proposal for a regulation Article 19 – paragraph 3 3. Importers shall indicate their name, registered trade name or registered trade mark and the
Amendment 1005 #
Proposal for a regulation Article 19 – paragraph 5 5. Where an importer considers or has
Amendment 1006 #
Proposal for a regulation Article 19 – paragraph 5 5. Where an importer considers or has reason to believe that an EHR system is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into
Amendment 1007 #
Proposal for a regulation Article 19 – paragraph 6 6. Importers shall keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities for the period referred to in Article 17(3) and ensure that the technical documentation can be made available to those authorities, upon request. Where relevant, the source code or programmed logic included in the technical documentation shall be made available upon a reasoned request from competent national authorities provided that it is necessary in order for those authorities to be able to check compliance with the essential requirements set out in Annex II.
Amendment 1008 #
Proposal for a regulation Article 19 – paragraph 7 7. Importers shall,
Amendment 1009 #
Proposal for a regulation Article 19 – paragraph 7 7. Importers shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official languages of the Member State where the market surveillance authority is located. They shall cooperate with that authority, at its request,
Amendment 1010 #
Proposal for a regulation Article 19 – paragraph 7 7. Importers shall, further to a reasoned request from a
Amendment 1011 #
Proposal for a regulation Article 19 – paragraph 7 a (new) 7 a. Importers shall verify whether the communication channels referred to in Article 17(3c), are publicly available to consumers and professional users allowing them to submit complaints and communicate any risk related to their health and safety or to other aspects of public interest protection and of any serious incident involving an EHR system. If such channels are not available, the importer shall provide for them, taking into account accessibility needs of vulnerable populations including migrants, the elderly and persons with disabilities.
Amendment 1012 #
Proposal for a regulation Article 19 – paragraph 7 b (new) 7 b. If the importer fails to cooperate with market surveillance authorities or if the information and documentation provided is incomplete or incorrect, market surveillance authorities shall take all appropriate measures to prohibit or restrict its EHR system from being available on the market, to withdraw it from the market or to recall it until the importer cooperates or provides complete and correct information.
Amendment 1013 #
Proposal for a regulation Article 19 – paragraph 7 c (new) 7 c. Importers shall investigate complaints and information on incidents involving an EHR system they made available on the market and file those complaints, as well as of systems recalls and any corrective measures taken to bring the EHR system into conformity, in the register referred to in Article 17(3e) or in their own internal register. Importers shall keep the manufacturer, distributors and, where relevant, authorised representatives informed in a timely manner of the investigation performed and of the results of the investigation.
Amendment 1014 #
Proposal for a regulation Article 19 – paragraph 7 d (new) 7 d. Personal data stored in the internal register of complaints shall only be those personal data that are necessary for the importer to investigate the complaint. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than five years after they have been encoded.
Amendment 1015 #
Proposal for a regulation Article 20 – paragraph 1 – point a Amendment 1016 #
Proposal for a regulation Article 20 – paragraph 1 – point a a (new) (a a) ensure that the appropriate conformity assessment procedures referred to in Article 27a have been carried out by the manufacturer;
Amendment 1017 #
Proposal for a regulation Article 20 – paragraph 1 – point c (c) the EHR system is accompanied by the information sheet referred to in Article 25 and
Amendment 1018 #
Proposal for a regulation Article 20 – paragraph 1 a (new) 1 a. When making an EHR system available on the market, distributors shall act with due care in relation to the requirements of this Regulation.
Amendment 1019 #
Proposal for a regulation Article 20 – paragraph 3 3. Where a distributor considers or has reason to believe that an EHR system is not in conformity with the essential requirements laid down in Annex II, it shall not make the EHR system available on the market until it has been brought into conformity. Furthermore, the distributor shall i
Amendment 1020 #
Proposal for a regulation Article 20 – paragraph 4 4. Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, and with the manufacturer, the importer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II or to ensure that their EHR systems are withdrawn or recalled.
Amendment 1021 #
Proposal for a regulation Article 20 – paragraph 4 4. Distributors shall, further to a reasoned request from a
Amendment 1022 #
Proposal for a regulation Article 20 – paragraph 4 a (new) 4 a. Where a distributor considers or has reason to believe that an EHR system, which they have placed on the market, is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. In situations where the EHR system is already on the market, importers shall immediately take the corrective measures necessary to bring that EHR system into conformity, to withdraw it or recall it, as appropriate. The distributor shall inform without undue delay the manufacturer of such EHR system and the national competent authorities of the Member State in which it made the EHR system available, to that effect, giving details, in particular, of the non- conformity and of any corrective measures taken.
Amendment 1023 #
Proposal for a regulation Article 20 – paragraph 4 a (new) 4 a. Distributors that have received complaints from consumers or professional users about suspected incidents involving an EHR system they made available on the market, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative, and the importer. They shall keep a register of complaints, of non-conforming EHR systems and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.
Amendment 1024 #
Proposal for a regulation Article 20 – paragraph 4 b (new) 4 b. Distributors shall, further to a reasoned request from a competent national authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the competent national authority is located. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 1025 #
Proposal for a regulation Article 21 – title Cases in which obligations of manufacturers of an EHR system apply to
Amendment 1026 #
Proposal for a regulation Article 21 – paragraph 1 An
Amendment 1027 #
Proposal for a regulation Chapter III – Section 2 a (new) Amendment 1028 #
Proposal for a regulation Article 23 – paragraph 1 – subparagraph 1 The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a common template document and a time limit for implementing those common specifications. Those common specifications shall be based on existing harmonised standards or international standards and shall be adopted only after consulting the European standardisation organisations as well as the relevant stakeholders. Where relevant, the common specifications shall take into account the specificities and verify compatibility with sectorial legislation and harmonized standards of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14, including the state-of-the art standards for health informatics and the European electronic health record exchange format.
Amendment 1029 #
Proposal for a regulation Article 23 – paragraph 1 – subparagraph 1 The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. Those common specifications shall be issued in accordance with Article 10 of Regulation (EU) 1025/2012, and where relevant based on existing harmonised standards or relevant international standards, and shall be adopted only after consulting the European standardisation organisations as well as other relevant stakeholders. Where relevant, the common specifications shall take into
Amendment 1030 #
Proposal for a regulation Article 23 – paragraph 1 – subparagraph 1 The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a uniform template document and a time limit for implementing those common specifications. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.
Amendment 1031 #
Proposal for a regulation Article 23 – paragraph 1 – subparagraph 2 Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2), after consultation with the EHDS Board and other relevant stakeholders.
Amendment 1032 #
Proposal for a regulation Article 23 – paragraph 1 – subparagraph 2 Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2) after consultation with the EHDS Board and relevant stakeholders.
Amendment 1033 #
Proposal for a regulation Article 23 – paragraph 4 a (new) 4 a. Where common specifications have an impact on data protection requirements of EHR systems, they shall be subject to consultation with EDPB and EDPS before their adoption, pursuant to Article 42(2) of Regulation (EU) 2018/1725.
Amendment 1034 #
Proposal for a regulation Article 23 – paragraph 5 5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices or high-risk AI systems falling under other acts, such as Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], the adoption of those common specifications
Amendment 1035 #
Proposal for a regulation Article 23 – paragraph 6 6. Where common specifications covering interoperability and security requirements of medical devices or high- risk AI systems falling under other acts such as Regulation (EU) 2017/745 or
Amendment 1036 #
Proposal for a regulation Article 24 – paragraph 1 1.
Amendment 1037 #
Proposal for a regulation Article 24 – paragraph 2 2. The technical documentation shall be drawn up in such a way as to demonstrate that the EHR system complies
Amendment 1038 #
Proposal for a regulation Article 24 – paragraph 2 a (new) 2 a. To ensure conformity, templates for technical documentation are provided by the market surveillance authority of a Member State.
Amendment 1039 #
Proposal for a regulation Article 24 – paragraph 3 3. The technical documentation shall be drawn up in one of the official
Amendment 1040 #
Proposal for a regulation Article 25 – paragraph 2 – point a (a) the identity, registered trade name or registered trademark, and the contact details of the manufacturer including the postal and electronic address and the telephone number and, where applicable, of its authorised representative;
Amendment 1041 #
Proposal for a regulation Article 25 – paragraph 3 3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems
Amendment 1042 #
Proposal for a regulation Article 25 – paragraph 3 3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems
Amendment 1043 #
Proposal for a regulation Article 25 – paragraph 3 3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems
Amendment 1044 #
Proposal for a regulation Article 25 a (new) Article 25 a Presumption of conformity of EHR systems 1. An EHR system which is in conformity with harmonised standards as referred to in Article 23 shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those standards. 2. The Commission shall, as provided in Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards for the essential requirements set out in Annex II. 3. The Commission is empowered to adopt implementing acts establishing technical specifications for the essential requirements set out in Annex II where the following conditions have been fulfilled: (a) no reference to harmonised standards covering the relevant essential health and safety requirements is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012; (b) the Commission has requested one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements and there are undue delays in the standardisation procedure or the request has not been accepted by any of the European standardisation organisations. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 68(2). 4. An EHR system which is in conformity with the technical specifications shall be presumed to be in conformity with the essential requirements set out in Annex II covered by those technical specifications.
Amendment 1045 #
Proposal for a regulation Article 26 – paragraph 1 1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled. The manufacturer shall continuously update the EU declaration of conformity.
Amendment 1046 #
Proposal for a regulation Article 26 – paragraph 1 1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the
Amendment 1047 #
Proposal for a regulation Article 26 – paragraph 3 3. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into one or more official Union languages determined by the Member State(s) in which the EHR system is made available. Manufacturers shall provide a translation of the relevant parts of the technical documentation into all the official languages of Member States.
Amendment 1048 #
Proposal for a regulation Article 26 – paragraph 4 4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for
Amendment 1049 #
Proposal for a regulation Article 26 – paragraph 4 4. By
Amendment 1050 #
Proposal for a regulation Article 26 – paragraph 4 a (new) 4 a. The Commission is empowered to adopt delegated acts in accordance with Article 67 amending the minimum content of the EU declaration of conformity set out in Annex IV.
Amendment 1051 #
Proposal for a regulation Article 26 – paragraph 4 a (new) 4 a. The Commission shall draw up a standard uniform EU declaration of conformity and make it available in digital format in all the official Union languages.
Amendment 1052 #
Proposal for a regulation Article 26 – paragraph 4 a (new) 4a. The Commission shall publish a standard format for the EU declaration of conformity in digital form and accessible in all official EU languages.
Amendment 1053 #
Proposal for a regulation Article 26 a (new) Amendment 1054 #
Proposal for a regulation Article 27 – paragraph 1 a (new) 1 a. The CE marking shall be affixed before making the EHR system available on the market.
Amendment 1055 #
Proposal for a regulation Article 27 – paragraph 2 a (new) 2 a. Where EHR systems are subject to other Union legislation in respect of aspects not covered by this Regulation, which also requires the affixing of the CE marking, the CE marking shall indicate that the systems also fulfil the requirements of that other legislation.
Amendment 1056 #
Proposal for a regulation Article 27 a (new) Article 27 a Assessment of conformity Before an EHR system may be placed on the market a Notified Body has to: (1) assess if the EHR system is in conformity with the essential requirements laid down in Annex II; (2) assess if the EHR system is in conformity with the requirements laid down in Regulation... (Cyber Resilience Act COM/2022/457). (3) assess if the technical documentation is available and complete; (4) assess if the EHR system fulfils the requirements of the EU declaration of conformity Only after EU-wide approval has been issued, the CE marking can be affixed, together with an identification number.
Amendment 1057 #
Proposal for a regulation Article 27 a (new) Article 27 a Conformity assessment procedures for EHR systems 1. In order to certify the conformity of an EHR system with this Regulation, the manufacturer or its authorised representative, shall apply for EU type- examination procedure provided for in Annex IVa; 2. Notified bodies shall take into account the specific interests and needs of small and medium sized enterprises when setting the fees for conformity assessment and reduce those fees proportionately to their specific interests and needs.
Amendment 1058 #
Proposal for a regulation Article 27 b (new) Article 27 b Notification Member States shall notify the Commission and the other Member States of conformity assessment bodies authorised to carry out conformity assessments in accordance with this Regulation.
Amendment 1059 #
Proposal for a regulation Article 27 c (new) Article 27 c Notifying authorities 1. Member States shall designate a notifying authority that shall be responsible for setting up and carrying out the necessary procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, including compliance with Article 27j. 2. Member States may decide that the assessment and monitoring referred to in paragraph 1 shall be carried out by a national accreditation body within the meaning of and in accordance with Regulation (EC) No 765/2008. 3. Where the notifying authority delegates or otherwise entrusts the assessment, notification or monitoring referred to in paragraph 1 of this Article to a body, which is not a governmental entity that body shall be a legal entity and shall comply mutatis mutandis with the requirements laid down in Article 27d. In addition, that body shall have arrangements to cover liabilities arising out of its activities. 4. The notifying authority shall take full responsibility for the tasks performed by the body referred to in paragraph 3.
Amendment 1060 #
Proposal for a regulation Article 27 d (new) Article 27 d Requirements relating to notifying authorities 1. A notifying authority shall be established in such a way that no conflict of interest with conformity assessment bodies occurs. 2. A notifying authority shall be organised and operated so as to safeguard the objectivity and impartiality of its activities. 3. A notifying authority shall be organised in such a way that each decision relating to notification of a conformity assessment body is taken by competent persons different from those who carried out the assessment of the EHR system. 4. A notifying authority shall not offer or provide any activities that conformity assessment bodies perform, or consultancy services on a commercial or competitive basis. 5. A notifying authority shall safeguard the confidentiality of the information it obtains. 6. A notifying authority shall have a sufficient number of competent personnel at its disposal for the proper performance of its tasks.
Amendment 1061 #
Proposal for a regulation Article 27 e (new) Article 27 e Information obligation on notifying authorities Member States shall inform the Commission of their procedures for the assessment and notification of conformity assessment bodies and the monitoring of notified bodies, and of any changes thereto. The Commission shall make that information publicly available.
Amendment 1062 #
Proposal for a regulation Article 27 f (new) Amendment 1063 #
Proposal for a regulation Article 27 g (new) Article 27 g Presumption of conformity of notified bodies Where a conformity assessment body demonstrates its conformity with the criteria laid down in the relevant harmonised standards the references of which have been published in the Official Journal of the European Union, it shall be presumed to comply with the requirements set out in Article 27f in so far as the applicable harmonised standards cover those requirements.
Amendment 1064 #
Proposal for a regulation Article 27 h (new) Article 27 h Subsidiaries of and subcontracting by notified bodies 1. Where a notified body subcontracts specific tasks connected with conformity assessment or has recourse to a subsidiary, it shall ensure that the subcontractor or the subsidiary meets the requirements set out in Article 27f and shall inform the notifying authority accordingly. 2. A notified body shall take full responsibility for the tasks performed by subcontractors or subsidiaries wherever those are established. 3. Activities may be subcontracted or carried out by a subsidiary only with the agreement of the client. 4. A notified body shall keep at the disposal of the notifying authority the relevant documents concerning the assessment of the qualifications of the subcontractor or the subsidiary and the work carried out by them under Annex IVa.
Amendment 1065 #
Proposal for a regulation Article 27 i (new) Article 27 i Notification procedure 1. A notifying authority shall notify only conformity assessment bodies which have satisfied the requirements laid down in Article 27f. 2. The notifying authority shall send a notification to the Commission and the other Member States of each conformity assessment body referred to in paragraph 1, using the electronic notification tool developed and managed by the Commission. 3. The notification referred to in paragraph 2 shall include the following: (a) full details of the conformity assessment activities to be performed; (b) the relevant attestation of competence. 4. Where a notification is not based on an accreditation certificate referred to in Article 27i(2), the notifying authority shall provide the Commission and the other Member States with documentary evidence which attests to the conformity assessment body's competence and the arrangements in place to ensure that that body will be monitored regularly and will continue to satisfy the requirements laid down in Article 27f. 5. The conformity assessment body concerned may perform the activities of a notified body only where no objections are raised by the Commission or the other Member States within two weeks of the validation of the notification where it includes an accreditation certificate referred to in Article 27i(2), or within two months of the notification where it includes documentary evidence referred to in Article 27i(3). Only such a body shall be considered a notified body for the purposes of this Regulation. 6. The notifying authority shall notify the Commission and the other Member States of any subsequent relevant changes to the notification referred to in paragraph 2.
Amendment 1066 #
Proposal for a regulation Article 27 i (new) Article 27 i Application for notification 1. A conformity assessment body shall submit an application for notification to the notifying authority of the Member State in which it is established. 2. The application for notification shall be accompanied by a description of the conformity assessment activities, of the conformity assessment procedures set out in Annex IVa as well as by an accreditation certificate, where one exists, issued by a national accreditation body attesting that the conformity assessment body fulfils the requirements laid down in Article 27f. 3. Where the conformity assessment body concerned cannot provide an accreditation certificate as referred to in paragraph 2, it shall provide the notifying authority with all the documentary evidence necessary for the verification, recognition and regular monitoring of its compliance with the requirements laid down in Article 27f.
Amendment 1067 #
Proposal for a regulation Article 27 k (new) Article 27 k Identification numbers and lists of notified bodies 1. The Commission shall assign an identification number to a notified body. It shall assign a single such number even where the body is notified under several Union acts. 2. The Commission shall make publicly available the list of notified bodies including the identification numbers that have been assigned to them and the conformity assessment activities for which they have been notified. The Commission shall ensure that the list is kept up to date.
Amendment 1068 #
Proposal for a regulation Article 27 l (new) Article 27 l Changes to notifications 1. Where a notifying authority has ascertained or has been informed that a notified body no longer meets the requirements laid down in Article 27f, or that it is failing to fulfil its obligations as set out in Article 27m the notifying authority shall restrict, suspend or withdraw the notification, as appropriate, depending on the seriousness of the failure to meet those requirements or fulfil those obligations. It shall immediately inform the Commission and the other Member States accordingly. 2. In the event of restriction, suspension or withdrawal of notification, or where the notified body has ceased its activity, the notifying authority shall take appropriate steps to ensure that the files of that body are either processed by another notified body or kept available for the responsible notifying and market surveillance authorities at their request.
Amendment 1069 #
Proposal for a regulation Article 27 m (new) Article 27 m Challenge of the competence of notified bodies 1. The Commission shall investigate all cases where it doubts, or doubt is brought to its attention regarding, the competence of a notified body or the continued fulfilment by a notified body of the requirements and responsibilities to which it is subject. 2. The notifying authority shall provide the Commission, on request, with all information relating to the basis for the notification or the maintenance of the competence of the notified body concerned. 3. The Commission shall ensure that all sensitive information obtained in the course of its investigations is treated confidentially. 4. Where the Commission ascertains that a notified body does not meet or no longer meets the requirements for its notification, it shall adopt an implementing act requesting the notifying authority to take the necessary corrective measures, including the withdrawal of the notification if necessary. That implementing act shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 1070 #
Proposal for a regulation Article 27 n (new) Amendment 1071 #
Proposal for a regulation Article 27 o (new) Article 27 o Appeals against decisions of notified bodies A notified body shall ensure that a transparent and accessible appeals procedure against its decisions is available.
Amendment 1072 #
Proposal for a regulation Article 27 p (new) Article 27 p Information obligation on notified bodies 1. A notified body shall inform the notifying authority of the following: (a) any refusal, restriction, suspension or withdrawal of a certificate of conformity or approval decision; (b) any circumstances affecting the scope of, or the conditions for, its notification; (c) any request for information which it has received from market surveillance authorities regarding its conformity assessment activities; (d) on request, any conformity assessment activities performed within the scope of its notification and any other activity performed, including cross-border activities and subcontracting. 2. A notified body shall provide other notified bodies carrying out similar conformity assessment activities covering the same kinds of machinery product with relevant information on issues relating to negative and, on request, positive conformity assessment results.
Amendment 1073 #
Proposal for a regulation Article 27 q (new) Article 27 q Coordination of notified bodies The Commission shall ensure that appropriate coordination and cooperation between notified bodies are put in place and properly operated in the form of a sectoral group of notified bodies. A notified body shall participate in the work of that group, directly or by means of designated representatives.
Amendment 1074 #
Proposal for a regulation Article 27 q (new) Article 27 q Exchange of experience The Commission shall provide for the organisation of exchange of experience between the Member States' national authorities responsible for notification policy.
Amendment 1075 #
Proposal for a regulation Chapter III – Section 3 a (new) 3a Section 3a Conformity assessment
Amendment 1076 #
Proposal for a regulation Article 28 – paragraph 2 2. Member States shall designate the market surveillance authority or authorities responsible for the implementation of this Chapter. They shall entrust their market surveillance authorities with the
Amendment 1077 #
Proposal for a regulation Article 28 – paragraph 2 a (new) 2 a. Staff of market surveillance authorities shall have no direct or indirect economic, financial or personal conflicts of interest that might be considered prejudicial to their independence and, in particular, that they are not in a situation that may, directly or indirectly, affect the impartiality of their professional conduct.
Amendment 1078 #
Proposal for a regulation Article 28 – paragraph 2 b (new) 2 b. Pursuant to paragraph 2 of this article, Member States shall determine and publish the selection procedure for market surveillance authorities. They shall ensure that the procedure is transparent and does not allow for conflicts of interest.
Amendment 1079 #
Proposal for a regulation Article 28 – paragraph 4 a (new) 4 a. Market surveillance authorities shall immediately inform Notified Bodies about manufacturers of EHR systems that no longer comply with the requirements on the declaration of conformity.
Amendment 1080 #
Proposal for a regulation Article 29 – paragraph 1 1. Where a market surveillance authority
Amendment 1081 #
Proposal for a regulation Article 29 – paragraph 1 1. Where a market surveillance authority, or, in cases involving personal data, a supervisory authority under Regulation (EU) 2016/679, finds that an EHR system presents a risk to the health or safety of natural persons, to the protection of personal data or to other aspects of public interest protection, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to take all appropriate measures to ensure that the EHR system concerned no longer presents that risk when placed on the market to withdraw the EHR system from the market or to recall it within a reasonable period.
Amendment 1082 #
Proposal for a regulation Article 29 – paragraph 1 a (new) 1 a. Where a market surveillance authority, on the basis of the information and documentation demonstrating the conformity of an EHR system provided by the relevant economic operator, considers or has reason to believe that the EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, including before the EHR system is placed on the market or put into service, it shall perform all the necessary checks to ensure that the system is compliant with this Regulation.
Amendment 1083 #
Proposal for a regulation Article 29 – paragraph 1 a (new) 1 a. Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.
Amendment 1084 #
Proposal for a regulation Article 29 – paragraph 1 b (new) 1 b. Where a market surveillance authority considers or has reason to believe that an EHR system has caused damage to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately provide information and documentation, as applicable, to the affected person or user and, as appropriate, other third parties affected by the damage caused to the person or user, without prejudice to data protection rules.
Amendment 1085 #
Proposal for a regulation Article 29 – paragraph 3 3. The market surveillance authority
Amendment 1086 #
Proposal for a regulation Article 29 – paragraph 3 a (new) 3 a. Where a finding of a market surveillance authortiy, or a serious incident it is informed of, concerns personal data protection, the market surveillance authority shall, without undue delay, inform and cooperate with the relevant supervisory authorities under Regulation (EU) 2016/679.
Amendment 1087 #
Proposal for a regulation Article 29 – paragraph 4 – subparagraph 1 Manufacturers of EHR systems placed on the market shall report any serious incident involving an EHR system to the market surveillance authorities, or, in cases involving personal data, the supervisory authorities under Regulation (EU) 2016/679 of the Member States where such serious incident occurred and the corrective actions taken or envisaged by the manufacturer.
Amendment 1088 #
Proposal for a regulation Article 29 – paragraph 4 – subparagraph 2 Such notification shall be made, without prejudice to incident notification requirements under Directive (EU) 2016/1148, immediately after the manufacturer has established a causal link between the EHR system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than
Amendment 1089 #
Proposal for a regulation Article 29 – paragraph 5 5. The
Amendment 1090 #
Proposal for a regulation Article 30 – paragraph 1 – introductory part 1. Where a market surveillance authority makes one, inter alia, of the following findings, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to
Amendment 1091 #
Proposal for a regulation Article 30 – paragraph 1 – point a (a) the EHR system is not in conformity with essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;
Amendment 1092 #
Proposal for a regulation Article 30 – paragraph 1 – point b (b) the technical documentation is either not available or not complete
Amendment 1093 #
Proposal for a regulation Article 30 – paragraph 1 – point b a (new) (b a) the EHR systems is not accompanied by the information sheet provided for in Article 25, free of charge by the user, and by clear and complete instructions for use in accessible formats for persons with disabilities;
Amendment 1094 #
Proposal for a regulation Article 30 – paragraph 1 – point c (c) the EU declaration of conformity has not been drawn up or has not been drawn up correctly as referred to in Article 26;
Amendment 1095 #
Proposal for a regulation Article 30 – paragraph 1 – point d a (new) (d a) the registration obligations of Article 32 has not been fulfilled.
Amendment 1096 #
Proposal for a regulation Article 30 – paragraph 1 a (new) 1 a. Where the relevant economic operator does not take adequate corrective action within the period referred to in Article 29, paragraph 1, second subparagraph, the market surveillance authorities shall take all appropriate provisional measures to prohibit or restrict the EHR system being made available on their national market, to withdraw the machinery product from that market or to recall it. The market surveillance authorities shall inform the Commission and the other Member States, without delay, of those measures.
Amendment 1097 #
Proposal for a regulation Article 30 – paragraph 1 b (new) 1 b. The information referred to in paragraph 1.a, second subparagraph, shall include all available details, in particular the data necessary for the identification of the noncompliant EHR system, the origin of that EHR system, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator.In particular, the market surveillance authorities shall indicate whether the noncompliance is due to any of the following: (a) failure of the EHR system to meet the requirements relating to the essential requirements set out in Annex II; (b) shortcomings in the harmonised standards referred to in Article 25a(1); (c) shortcomings in the technical specifications referred to in Article 25a(4).
Amendment 1098 #
Proposal for a regulation Article 30 – paragraph 1 c (new) 1 c. Member States other than the Member State initiating the procedure under this Article shall without delay inform the Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the EHR system concerned, and, in the event of disagreement with the adopted national measure, of their objections.
Amendment 1099 #
Proposal for a regulation Article 30 – paragraph 1 d (new) 1 d. Where, within three months of receipt of the information referred to in paragraph 1a, second subparagraph, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by a Member State, that measure shall be deemed justified.
Amendment 1100 #
Proposal for a regulation Article 30 a (new) Article 30 a Union safeguard procedure 1. Where, on completion of the procedure set out in Article 29(2) and Article 30(1a), objections are raised against a measure taken by a Member State, or where the Commission considers a national measure to be contrary to Union legislation, the Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act in the form of a decision determining whether the national measure is justified or not. The Commission shall address its decision to all Member States and shall without delay communicate it to them and to the relevant economic operator or operators. That implementing act shall be adopted in accordance with the examination procedure referred to in Article 68(2a). 2. If the national measure is considered justified, all Member States shall take the necessary measures to ensure that the non-compliant EHR system is withdrawn from their market, and shall inform the Commission accordingly. If the national measure is considered unjustified, the Member State concerned shall withdraw that measure. Where the national measure is considered justified and the non-compliance of the EHR system is attributed to shortcomings in the harmonised standards or technical specifications referred to in Article 30(1b), points (b) and (c), of this Regulation, the Commission shall apply the procedure provided for in Article 11 of Regulation (EU) No 1025/2012.
Amendment 1101 #
Proposal for a regulation Article -31 (new) Article -31 Interoperability of wellness applications with EHR systems 1. Manufacturers of wellness applications may claim interoperability with an EHR system, after relevant conditions are met. When this is the case, the users of such wellness applications shall be duly informed about such interoperability and its effects. 2. The interoperability of wellness applications with EHR systems shall not mean automatic sharing or transmission of all or part of the health data from the wellness application with the EHR system. The sharing or transmission of such data shall only be possible pursuant to and in line with Article 3(6) of this Regulation and interoperability shall be limited exclusively to this end. The manufacturers of wellness applications claiming interoperability with an EHR system shall ensure that the user is able to choose which part of health data from the wellness application they want to insert in the EHR system. 3. Wellness applications shall not be able to access the information in EHRs nor extract any information from it.
Amendment 1102 #
Proposal for a regulation Article 31 Amendment 1103 #
Proposal for a regulation Article 31 Amendment 1104 #
Proposal for a regulation Article 31 Amendment 1105 #
Proposal for a regulation Article 31 Amendment 1106 #
Proposal for a regulation Article 31 – paragraph 1 1. Where a manufacturer of a wellness application claims interoperability with an EHR system and therefore compliance with the essential requirements laid down in Annex II and common specifications in Article 23, such wellness application
Amendment 1107 #
Proposal for a regulation Article 31 – paragraph 3 3. The Commission
Amendment 1108 #
Proposal for a regulation Article 31 – paragraph 4 4. The label shall be drawn-up in one or more official languages of the Union
Amendment 1109 #
Proposal for a regulation Article 31 – paragraph 4 4. The label shall be drawn-up in one or more
Amendment 1110 #
6. If the wellness application is embedded in a device, the accompanying label shall be placed on the device and in the case of software a digital label. 2D barcodes may also be used to display the label.
Amendment 1111 #
Proposal for a regulation Article 32 – title Registration of EHR systems
Amendment 1112 #
Proposal for a regulation Article 32 – title Registration of EHR systems
Amendment 1113 #
Proposal for a regulation Article 32 – title Registration of EHR systems
Amendment 1114 #
Proposal for a regulation Article 32 – paragraph 1 1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26
Amendment 1115 #
Proposal for a regulation Article 32 – paragraph 1 1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26
Amendment 1116 #
Proposal for a regulation Article 32 – paragraph 1 1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26
Amendment 1117 #
Proposal for a regulation Article 32 – paragraph 1 1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Articles 26 and
Amendment 1118 #
Proposal for a regulation Article 32 – paragraph 2 2. Before placing on the market or putting into service an EHR system referred to in Article 14
Amendment 1119 #
Proposal for a regulation Article 32 – paragraph 2 2. Before placing on the market or putting into service an EHR system referred to in Article 14
Amendment 1120 #
Proposal for a regulation Article 32 – paragraph 2 2. Before placing on the market or putting into service an EHR system
Amendment 1121 #
Proposal for a regulation Article 32 – paragraph 3 3. Medical devices or high-risk AI systems referred to in paragraphs 3 and 4 of Article 14 of this Regulation shall also be registered in the database established pursuant to Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], as applicable.
Amendment 1122 #
Proposal for a regulation Article 32 – paragraph 4 4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to determine the list of required data to be registered by the manufacturers of EHR systems
Amendment 1123 #
Proposal for a regulation Article 32 – paragraph 4 4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to determine the list of required data to be registered by the manufacturers of EHR systems
Amendment 1124 #
Proposal for a regulation Article 32 – paragraph 4 4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to determine the list of required data to be registered by the manufacturers of EHR systems
Amendment 1125 #
Proposal for a regulation Article -33 (new) 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.
Amendment 1126 #
Proposal for a regulation Article -33 a (new) 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.
Amendment 1127 #
Proposal for a regulation Article 33 – title Minimum categories of electronic health data for secondary use
Amendment 1128 #
Proposal for a regulation Article 33 – title Amendment 1129 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 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:
Amendment 1130 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 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:
Amendment 1131 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 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:
Amendment 1132 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 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:
Amendment 1133 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 1.
Amendment 1134 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 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:
Amendment 1135 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 1.
Amendment 1136 #
Proposal for a regulation Article 33 – paragraph 1 – introductory part 1.
Amendment 1138 #
Proposal for a regulation Article 33 – paragraph 1 – point a (a)
Amendment 1139 #
Proposal for a regulation Article 33 – paragraph 1 – point a (a)
Amendment 1140 #
Proposal for a regulation Article 33 – paragraph 1 – point a (a) electronic health data from EHRs;
Amendment 1141 #
Proposal for a regulation Article 33 – paragraph 1 – point a (a) electronic health data from EHRs ;
Amendment 1142 #
Proposal for a regulation Article 33 – paragraph 1 – point a (a) electronic health data from EHRs;
Amendment 1143 #
Proposal for a regulation Article 33 – paragraph 1 – point a (a) electronic health data from EHRs;
Amendment 1145 #
Proposal for a regulation Article 33 – paragraph 1 – point b Amendment 1146 #
Proposal for a regulation Article 33 – paragraph 1 – point b Amendment 1147 #
Proposal for a regulation Article 33 – paragraph 1 – point b (b) data on factors impacting on health, including social
Amendment 1148 #
Proposal for a regulation Article 33 – paragraph 1 – point b (b) data on factors impacting on health, including social, environmental behavioural determinants of health;
Amendment 1149 #
Proposal for a regulation Article 33 – paragraph 1 – point b (b)
Amendment 1150 #
Proposal for a regulation Article 33 – paragraph 1 – point b (b) data on factors impacting on health, including social, environmental behavioural determinants of health;
Amendment 1151 #
Proposal for a regulation Article 33 – paragraph 1 – point b (b) data on factors impacting on health, including social, environmental behavioural determinants of health;
Amendment 1152 #
Proposal for a regulation Article 33 – paragraph 1 – point c (c) relevant pathogen genomic data, impacting on human health
Amendment 1153 #
Proposal for a regulation Article 33 – paragraph 1 – point c (c) relevant pathogen
Amendment 1154 #
Proposal for a regulation Article 33 – paragraph 1 – point d Amendment 1155 #
Proposal for a regulation Article 33 – paragraph 1 – point d (d) health-related administrative data for population-wide predominantly publicly funded treatments, including claims and reimbursement data;
Amendment 1156 #
Proposal for a regulation Article 33 – paragraph 1 – point d (d) healthcare-related administrative data, including claims and reimbursement data;
Amendment 1157 #
Proposal for a regulation Article 33 – paragraph 1 – point d (d) healthcare-related administrative
Amendment 1158 #
Proposal for a regulation Article 33 – paragraph 1 – point d (d)
Amendment 1159 #
Proposal for a regulation Article 33 – paragraph 1 – point e Amendment 1160 #
Proposal for a regulation Article 33 – paragraph 1 – point e Amendment 1161 #
Proposal for a regulation Article 33 – paragraph 1 – point e Amendment 1162 #
Proposal for a regulation Article 33 – paragraph 1 – point e Amendment 1163 #
Proposal for a regulation Article 33 – paragraph 1 – point e Amendment 1164 #
Proposal for a regulation Article 33 – paragraph 1 – point e Amendment 1165 #
Proposal for a regulation Article 33 – paragraph 1 – point e (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;
Amendment 1166 #
Proposal for a regulation Article 33 – paragraph 1 – point e (e) extracts from human genetic, genomic and proteomic data, such as genetic markers;
Amendment 1167 #
Proposal for a regulation Article 33 – paragraph 1 – point f Amendment 1168 #
Amendment 1169 #
Proposal for a regulation Article 33 – paragraph 1 – point f Amendment 1170 #
Proposal for a regulation Article 33 – paragraph 1 – point f Amendment 1171 #
Proposal for a regulation Article 33 – paragraph 1 – point f (f) person
Amendment 1172 #
Proposal for a regulation Article 33 – paragraph 1 – point f (f) person generated electronic health data
Amendment 1173 #
Proposal for a regulation Article 33 – paragraph 1 – point f (f) person generated electronic health data
Amendment 1174 #
Proposal for a regulation Article 33 – paragraph 1 – point f (f) person generated electronic health data
Amendment 1175 #
Proposal for a regulation Article 33 – paragraph 1 – point f (f) person generated electronic health data, including medical devices
Amendment 1176 #
Proposal for a regulation Article 33 – paragraph 1 – point f (f) person generated electronic health data
Amendment 1177 #
Proposal for a regulation Article 33 – paragraph 1 – point g Amendment 1178 #
Proposal for a regulation Article 33 – paragraph 1 – point g Amendment 1179 #
Proposal for a regulation Article 33 – paragraph 1 – point g (g) identification data related to health professionals involved in
Amendment 1180 #
Proposal for a regulation Article 33 – paragraph 1 – point g (g) identification data related to health professionals involved in
Amendment 1181 #
Proposal for a regulation Article 33 – paragraph 1 – point h (h) population wide health data registries (public health registries) and patient demographic data;
Amendment 1182 #
Proposal for a regulation Article 33 – paragraph 1 – point h (h) population wide electronic health data registries (public health registries);
Amendment 1183 #
Proposal for a regulation Article 33 – paragraph 1 – point i (i) electronic health data from medical registries
Amendment 1184 #
Proposal for a regulation Article 33 – paragraph 1 – point j Amendment 1185 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from
Amendment 1186 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from
Amendment 1187 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from
Amendment 1188 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from
Amendment 1189 #
Proposal for a regulation Article 33 – paragraph 1 – point j (j) electronic health data from clinical trials in so far as they have been completed;
Amendment 1190 #
Proposal for a regulation Article 33 – paragraph 1 – point j a (new) (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).
Amendment 1191 #
Proposal for a regulation Article 33 – paragraph 1 – point j b (new) (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.
Amendment 1192 #
Proposal for a regulation Article 33 – paragraph 1 – point k (k) electronic health data from medical devices and from registries for medicinal products and medical devices, including medical audio and video material;
Amendment 1193 #
Proposal for a regulation Article 33 – paragraph 1 – point l (l) research cohorts, questionnaires and surveys related to health, including patient-reported outcome measures and patient-reported experience measures;
Amendment 1194 #
Proposal for a regulation Article 33 – paragraph 1 – point l (l) research cohorts, questionnaires and surveys related to health, including patient-reported outcomes and experience measures (PROMs and PREMs);
Amendment 1195 #
Proposal for a regulation Article 33 – paragraph 1 – point l (l) data from research cohorts, questionnaires and surveys related to health;
Amendment 1196 #
(l) data from research cohorts, questionnaires and surveys related to health;
Amendment 1197 #
Proposal for a regulation Article 33 – paragraph 1 – point l (l) data from research cohorts, questionnaires and surveys related to health;
Amendment 1198 #
Proposal for a regulation Article 33 – paragraph 1 – point m Amendment 1199 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 1200 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 1201 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 1202 #
Amendment 1203 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 1204 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 1205 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 1206 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 1207 #
Proposal for a regulation Article 33 – paragraph 1 – point n Amendment 1208 #
Proposal for a regulation Article 33 – paragraph 1 – point n (n) electronic data related to insurance status, professional status, education
Amendment 1209 #
Proposal for a regulation Article 33 – paragraph 1 – point n (n) electronic data related to insurance status, professional status, education
Amendment 1210 #
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.
Amendment 1211 #
Proposal for a regulation Article 33 – paragraph 1 a (new) 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;
Amendment 1212 #
Proposal for a regulation Article 33 – paragraph 1 a (new) 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.
Amendment 1213 #
Proposal for a regulation Article 33 – paragraph 1 a (new) 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.
Amendment 1214 #
Proposal for a regulation Article 33 – paragraph 1 a (new) 1 a. Health data of natural persons registered by health professionals in accordance with Article 7 shall be requested from the EHR systems concerned.
Amendment 1215 #
Proposal for a regulation Article 33 – paragraph 1 a (new) 1 a. This Regulation shall not apply to activities concerning public security, defence and national security.
Amendment 1216 #
Proposal for a regulation Article 33 – paragraph 2 Amendment 1217 #
Proposal for a regulation Article 33 – paragraph 2 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
Amendment 1218 #
Proposal for a regulation Article 33 – paragraph 2 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
Amendment 1219 #
Proposal for a regulation Article 33 – paragraph 2 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
Amendment 1220 #
Proposal for a regulation Article 33 – paragraph 2 2. The requirement in the first
Amendment 1221 #
Proposal for a regulation Article 33 – paragraph 2 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
Amendment 1222 #
Proposal for a regulation Article 33 – paragraph 2 a (new) 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.
Amendment 1223 #
Proposal for a regulation Article 33 – paragraph 3 Amendment 1224 #
Proposal for a regulation Article 33 – paragraph 3 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.
Amendment 1225 #
Proposal for a regulation Article 33 – paragraph 3 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
Amendment 1226 #
Proposal for a regulation Article 33 – paragraph 3 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
Amendment 1227 #
Proposal for a regulation Article 33 – paragraph 3 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,
Amendment 1228 #
Proposal for a regulation Article 33 – paragraph 3 a (new) 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.
Amendment 1229 #
Proposal for a regulation Article 33 – paragraph 3 a (new) 3 a. The natural person shall receive information about the benefits of providing access to their health data for secondary use.
Amendment 1230 #
Proposal for a regulation Article 33 – paragraph 4 Amendment 1231 #
Proposal for a regulation Article 33 – paragraph 4 4.
Amendment 1232 #
Proposal for a regulation Article 33 – paragraph 4 4. Electronic health data entailing protected intellectual property and trade secrets from
Amendment 1233 #
Proposal for a regulation Article 33 – paragraph 4 4.
Amendment 1234 #
Proposal for a regulation Article 33 – paragraph 4 4.
Amendment 1235 #
Proposal for a regulation Article 33 – paragraph 4 4. Electronic health data entailing protected intellectual property and trade secrets from
Amendment 1236 #
Proposal for a regulation Article 33 – paragraph 4 4.
Amendment 1237 #
Proposal for a regulation Article 33 – paragraph 4 4. Electronic health data entailing protected intellectual property and trade
Amendment 1238 #
Proposal for a regulation Article 33 – paragraph 4 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. Data holders may refuse to make data available if the confidentiality of the data is not adequately ensured.
Amendment 1239 #
Proposal for a regulation Article 33 – paragraph 4 4. Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall only be made available for secondary use
Amendment 1240 #
Proposal for a regulation Article 33 – paragraph 4 4. Electronic health data entailing protected intellectual property and trade secrets from private enterprises shall be made available for secondary use
Amendment 1241 #
Proposal for a regulation Article 33 – paragraph 4 a (new) 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.
Amendment 1242 #
Proposal for a regulation Article 33 – paragraph 4 a (new) 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.
Amendment 1243 #
Proposal for a regulation Article 33 – paragraph 4 a (new) 4a. Extending the period for making data available to 24 months in order to allow for registration of property rights; or
Amendment 1244 #
Proposal for a regulation Article 33 – paragraph 4 b (new) 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.
Amendment 1245 #
Proposal for a regulation Article 33 – paragraph 4 b (new) 4b. Processing data to ensure that trade secrets are redacted.
Amendment 1246 #
Proposal for a regulation Article 33 – paragraph 4 c (new) 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.
Amendment 1247 #
Proposal for a regulation Article 33 – paragraph 4 d (new) 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.
Amendment 1248 #
Proposal for a regulation Article 33 – paragraph 5 Amendment 1249 #
Amendment 1250 #
Proposal for a regulation Article 33 – paragraph 5 Amendment 1251 #
Proposal for a regulation Article 33 – paragraph 5 Amendment 1252 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1253 #
Proposal for a regulation Article 33 – paragraph 5 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.
Amendment 1254 #
Proposal for a regulation Article 33 – paragraph 5 5. Where the explicit consent of the natural person is required by
Amendment 1255 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1256 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1257 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1258 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1259 #
Proposal for a regulation Article 33 – paragraph 5 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.
Amendment 1260 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1261 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1262 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1263 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1264 #
Proposal for a regulation Article 33 – paragraph 5 5.
Amendment 1265 #
Proposal for a regulation Article 33 – paragraph 5 a (new) 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.
Amendment 1266 #
Proposal for a regulation Article 33 – paragraph 5 a (new) 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.
Amendment 1267 #
Proposal for a regulation Article 33 – paragraph 5 a (new) 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 us.
Amendment 1268 #
Proposal for a regulation Article 33 – paragraph 5 b (new) 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.
Amendment 1269 #
Proposal for a regulation Article 33 – paragraph 6 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.
Amendment 1270 #
Proposal for a regulation Article 33 – paragraph 6 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 combining it with other data for joint analysis.
Amendment 1271 #
Proposal for a regulation Article 33 – paragraph 7 Amendment 1272 #
Proposal for a regulation Article 33 – paragraph 7 Amendment 1273 #
Proposal for a regulation Article 33 – paragraph 7 Amendment 1274 #
Proposal for a regulation Article 33 – paragraph 7 Amendment 1275 #
Proposal for a regulation Article 33 – paragraph 7 Amendment 1276 #
Proposal for a regulation Article 33 – paragraph 7 Amendment 1277 #
Proposal for a regulation Article 33 – paragraph 7 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.
Amendment 1278 #
Proposal for a regulation Article 33 – paragraph 8 Amendment 1279 #
Proposal for a regulation Article 33 – paragraph 8 Amendment 1280 #
Proposal for a regulation Article 33 – paragraph 8 Amendment 1281 #
Proposal for a regulation Article 33 – paragraph 8 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
Amendment 1282 #
Proposal for a regulation Article 33 – paragraph 8 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
Amendment 1283 #
Proposal for a regulation Article 33 – paragraph 8 a (new) 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.
Amendment 1284 #
Proposal for a regulation Article 33 – paragraph 8 a (new) 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.
Amendment 1285 #
Proposal for a regulation Article 33 – paragraph 8 a (new) 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.
Amendment 1286 #
Proposal for a regulation Article 34 – paragraph 1 – introductory part 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:
Amendment 1287 #
Proposal for a regulation Article 34 – paragraph 1 – introductory part 1. Health data access bodies shall only provide access to electronic health data referred to in Article 33
Amendment 1288 #
Proposal for a regulation Article 34 – paragraph 1 – introductory part 1. Health data access bodies shall only provide access to electronic health data referred to in Article 33
Amendment 1289 #
Proposal for a regulation Article 34 – paragraph 1 – introductory part 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: :
Amendment 1290 #
Proposal for a regulation Article 34 – paragraph 1 – introductory part 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
Amendment 1291 #
Proposal for a regulation Article 34 – paragraph 1 – introductory part 1. Health data access bodies shall only provide access to electronic health data referred to in Article 33
Amendment 1292 #
Proposal for a regulation Article 34 – paragraph 1 – introductory part 1.
Amendment 1293 #
Proposal for a regulation Article 34 – paragraph 1 – point a (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;
Amendment 1294 #
Proposal for a regulation Article 34 – paragraph 1 – point a (a)
Amendment 1295 #
Proposal for a regulation Article 34 – paragraph 1 – point a (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;
Amendment 1296 #
Proposal for a regulation Article 34 – paragraph 1 – point a (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
Amendment 1297 #
Proposal for a regulation Article 34 – paragraph 1 – point a (a) activities for reasons of public interest in the area of public and occupational health
Amendment 1298 #
Proposal for a regulation Article 34 – paragraph 1 – point b (b) to support public sector bodies
Amendment 1299 #
Proposal for a regulation Article 34 – paragraph 1 – point b (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;
Amendment 1300 #
Proposal for a regulation Article 34 – paragraph 1 – point b (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;
Amendment 1301 #
Proposal for a regulation Article 34 – paragraph 1 – point b (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;
Amendment 1302 #
Proposal for a regulation Article 34 – paragraph 1 – point b (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, including optmising patient pathway;
Amendment 1303 #
Proposal for a regulation Article 34 – paragraph 1 – point b (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;
Amendment 1304 #
Proposal for a regulation Article 34 – paragraph 1 – point c (c) to produce national, multi-national and Union level official statistics
Amendment 1305 #
Proposal for a regulation Article 34 – paragraph 1 – point c (c) to produce national, multi-national and Union level official statistics as defined in Regulation (EU) 223/2009 related to health or care sectors;
Amendment 1306 #
Proposal for a regulation Article 34 – paragraph 1 – point c (c) to produce national, multi-national and Union level official, gender sensitive statistics related to health or care sectors;
Amendment 1307 #
Proposal for a regulation Article 34 – paragraph 1 – point c (c) to produce national, multi-national, regional, local and Union level official statistics related to health or care sectors;
Amendment 1308 #
Proposal for a regulation Article 34 – paragraph 1 – point d Amendment 1309 #
Proposal for a regulation Article 34 – paragraph 1 – point d Amendment 1310 #
Proposal for a regulation Article 34 – paragraph 1 – point d (d) higher education
Amendment 1311 #
Proposal for a regulation Article 34 – paragraph 1 – point d (d)
Amendment 1312 #
Proposal for a regulation Article 34 – paragraph 1 – point e (e) scientific research and development related to health
Amendment 1313 #
Proposal for a regulation Article 34 – paragraph 1 – point e (e) scientific research
Amendment 1314 #
Proposal for a regulation Article 34 – paragraph 1 – point e (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;
Amendment 1315 #
Proposal for a regulation Article 34 – paragraph 1 – point e (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;
Amendment 1316 #
Proposal for a regulation Article 34 – paragraph 1 – point e (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;
Amendment 1317 #
Proposal for a regulation Article 34 – paragraph 1 – point e (e) scientific research related to public health
Amendment 1318 #
Proposal for a regulation Article 34 – paragraph 1 – point f Amendment 1319 #
Proposal for a regulation Article 34 – paragraph 1 – point f Amendment 1320 #
Proposal for a regulation Article 34 – paragraph 1 – point f Amendment 1321 #
Proposal for a regulation Article 34 – paragraph 1 – point f Amendment 1322 #
Proposal for a regulation Article 34 – paragraph 1 – point f (f) development and innovation activities for products or services contributing to public health or social security, or ensuring high levels of quality
Amendment 1323 #
Proposal for a regulation Article 34 – paragraph 1 – point f (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
Amendment 1324 #
Proposal for a regulation Article 34 – paragraph 1 – point f (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;
Amendment 1325 #
Proposal for a regulation Article 34 – paragraph 1 – point f (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;
Amendment 1326 #
Proposal for a regulation Article 34 – paragraph 1 – point f (f) development and innovation activities for products or services contributing to public health or social security, or ensuring high levels of quality
Amendment 1327 #
Proposal for a regulation Article 34 – paragraph 1 – point f (f)
Amendment 1328 #
Proposal for a regulation Article 34 – paragraph 1 – point f (f) development and innovation activities for products or services contributing to public health
Amendment 1329 #
Proposal for a regulation Article 34 – paragraph 1 – point f (f) development and innovation activities for products or services contributing to public health
Amendment 1330 #
Proposal for a regulation Article 34 – paragraph 1 – point g Amendment 1331 #
Proposal for a regulation Article 34 – paragraph 1 – point g Amendment 1332 #
Proposal for a regulation Article 34 – paragraph 1 – point g Amendment 1333 #
Proposal for a regulation Article 34 – paragraph 1 – point g Amendment 1334 #
Proposal for a regulation Article 34 – paragraph 1 – point g Amendment 1335 #
Proposal for a regulation Article 34 – paragraph 1 – point g (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;
Amendment 1336 #
Proposal for a regulation Article 34 – paragraph 1 – point g (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;
Amendment 1337 #
Proposal for a regulation Article 34 – paragraph 1 – point g (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
Amendment 1338 #
Proposal for a regulation Article 34 – paragraph 1 – point g (g) training, testing and
Amendment 1339 #
Proposal for a regulation Article 34 – paragraph 1 – point g (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;
Amendment 1340 #
Proposal for a regulation Article 34 – paragraph 1 – point g (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;
Amendment 1341 #
Proposal for a regulation Article 34 – paragraph 1 – point g (g) training, testing and evaluating of algorithms, including in medical devices
Amendment 1342 #
Proposal for a regulation Article 34 – paragraph 1 – point g (g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to
Amendment 1343 #
Proposal for a regulation Article 34 – paragraph 1 – point h Amendment 1344 #
Proposal for a regulation Article 34 – paragraph 1 – point h Amendment 1345 #
Proposal for a regulation Article 34 – paragraph 1 – point h Amendment 1346 #
Proposal for a regulation Article 34 – paragraph 1 – point h Amendment 1347 #
Proposal for a regulation Article 34 – paragraph 1 – point h (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
Amendment 1348 #
Proposal for a regulation Article 34 – paragraph 1 – point h (h) providing personalised healthcare
Amendment 1349 #
Proposal for a regulation Article 34 – paragraph 1 – point h (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.
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