Activities of Rob ROOKEN related to 2022/0140(COD)
Plenary speeches (1)
European Health Data Space (debate)
Amendments (46)
Amendment 195 #
Proposal for a regulation
Recital 5
Recital 5
(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, such as behaviour, environmental, physical influences, medical care, social or educational factorsmedical care. Electronic health data also includes data that has been initially collected for research, statistics, policy making or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means.
Amendment 207 #
Proposal for a regulation
Recital 7
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 context, Union action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it.
Amendment 212 #
Proposal for a regulation
Recital 9
Recital 9
Amendment 272 #
Proposal for a regulation
Recital 23
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.
Amendment 286 #
Proposal for a regulation
Recital 26
Recital 26
Amendment 309 #
Proposal for a regulation
Recital 35
Recital 35
Amendment 315 #
Proposal for a regulation
Recital 36
Recital 36
(36) The distribution of information on certified EHR systems and labelled wellness applications is necessary to enable procurers and users of such products to find interoperable solutions for their specific needs. A database of interoperable EHR systems and wellness applications, which are not falling within the scope of Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final] should therefore be established at Union level, similar to the European database on medical devices (Eudamed) established by Regulation (EU) 2017/745. The objectives of the EU database of interoperable EHR systems and wellness applications should be to enhance overall transparency, to avoid multiple reporting requirements and to streamline and facilitate the flow of information. For medical devices and AI systems, the registration should be maintained under the existing databases established respectively under Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final], but the compliance with interoperability requirements should be indicated when claimed by manufacturers, to provide information to procurers.
Amendment 338 #
Proposal for a regulation
Recital 39
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.), as well as data with an impact on health (for example consumption of different substances, homelessness, health insurance, minimum income, professional status, behaviour, including environmental factors (for example, pollution, radiation, use of certain chemical substances). They can also include person-generated data, such as data from medical devices, wellness applications or other wearables and digital health applications. The data user who benefits from access to datasets provided under this Regulation could enrich the data with various corrections, annotations and other improvements, for instance by supplementing missing or incomplete data, thus improving the accuracy, completeness or quality of data in the dataset. To support the improvement of the original database and further use of the enriched dataset, the dataset with such improvements and a description of the changes should be made available free of charge to the original data holder. The data holder should make available the new dataset, unless it provides a justified notification against it to the health data access body, for instance in cases of low quality of the enrichment. Secondary use of non-personal electronic data should also be ensured. In particular, pathogen genomic data hold significant value for human health, as proven during the COVID-19 pandemic. Timely access to and sharing of such data has proven to be essential for the rapid development of detection tools, medical countermeasures and responses to public health threats. The greatest benefit from pathogen genomics effort will be achieved when public health and research processes share datasets and work mutually to inform and improve each other.
Amendment 470 #
Proposal for a regulation
Article 1 – paragraph 2 – point a
Article 1 – paragraph 2 – point a
(a) strengthens the rights of natural persons in relation to the availability and control of their electronic health data, both in the primary as in the secondary use thereof;
Amendment 485 #
Proposal for a regulation
Article 1 – paragraph 3 – point a
Article 1 – paragraph 3 – point a
(a) manufacturers and suppliers of EHR systems and wellness applications placed on the market and put into service in the Union and the users of such products;
Amendment 488 #
Amendment 539 #
Proposal for a regulation
Article 2 – paragraph 2 – point h
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 or a wellness application;
Amendment 562 #
Proposal for a regulation
Article 2 – paragraph 2 – point o
Article 2 – paragraph 2 – point o
Amendment 628 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
Amendment 686 #
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of health professionalcare providers, health professionals, data holders and data users to all or part of their electronic health data. Member States shall establish the rules and specific safeguards regarding such restriction mechanisms.
Amendment 692 #
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. Natural persons shall have the right to obtain information on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare by means of an automatic notification procedure. The information shall be provided immediately and free of charge through electronic health data access services. The information shall include the names of the health care providers controlling the data processing, the health data that was accessed, and the time of access.
Amendment 724 #
Proposal for a regulation
Article 4 – paragraph 2
Article 4 – paragraph 2
2. In line with the data minimisation principle provided for in Regulation (EU) 2016/679, Member States mayshall establish rules providing for the categories of personal electronic health data required by different health professions. Such rules shall not be based on the source of electronic health data.
Amendment 736 #
Proposal for a regulation
Article 4 – paragraph 3
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 only available for the purpose of the healthcare treatment, to health professionals 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. .
Amendment 740 #
Proposal for a regulation
Article 4 – paragraph 4
Article 4 – paragraph 4
4. Where access to electronic health data has been restricted by the natural person, 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. 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 850 #
Proposal for a regulation
Article 10 – paragraph 2 – point h
Article 10 – paragraph 2 – point h
(h) contribute, at Union level, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing interoperability, security, safety or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems and wellness applications referred to in Article 32;
Amendment 866 #
Proposal for a regulation
Article 10 – paragraph 2 – point o – point vii
Article 10 – paragraph 2 – point o – point vii
(vii) number of certified EHR systems and labelled wellness applications enrolled in the EU database;
Amendment 902 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The digital health authority with which the complaint has been lodged shall inform the complainant of the progress of the proceedings and of the decision taken. The digital health authority shall send a copy of the complaint to the relevant data protection supervisory authority.
Amendment 934 #
Proposal for a regulation
Article 13 – paragraph 1
Article 13 – paragraph 1
1. Member States may provide through MyHealth@EU supplementary services that facilitate telemedicine, mobile health, and access by natural persons to their translated health data, exchange or verification of health-related certificates, including vaccination card services supporting public health and public health monitoring or digital health systems, services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of care and ensuring access to safe and high-quality healthcare. The Commission shall, by means of implementing acts, set out the technical aspects of such provision. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 938 #
Proposal for a regulation
Article 13 – paragraph 3 – subparagraph 1
Article 13 – paragraph 3 – subparagraph 1
Amendment 944 #
Proposal for a regulation
Article 13 – paragraph 3 – subparagraph 2
Article 13 – paragraph 3 – subparagraph 2
Amendment 945 #
Proposal for a regulation
Chapter III – title
Chapter III – title
III EHR systems and wellness applications
Amendment 1043 #
Proposal for a regulation
Article 25 – paragraph 3
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 and wellness applications referred to in Article 32, as an alternative to supplying the information sheet referred to in paragraph 1 with the EHR system.
Amendment 1104 #
Proposal for a regulation
Article 31
Article 31
Amendment 1111 #
Proposal for a regulation
Article 32 – title
Article 32 – title
Registration of EHR systems and wellness applications
Amendment 1115 #
Proposal for a regulation
Article 32 – paragraph 1
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 and wellness applications for which a label has been issued pursuant to Article 31.;
Amendment 1119 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. Before placing on the market or putting into service an EHR system referred to in Article 14 or a wellness application referred to in Article 31, the manufacturer of such EHR system or wellness application or, where applicable, its authorised representative shall register the required data into the EU database referred to in paragraph 1.
Amendment 1122 #
Proposal for a regulation
Article 32 – paragraph 4
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 and wellness applications pursuant to paragraph 2.
Amendment 1141 #
Proposal for a regulation
Article 33 – paragraph 1 – point a
Article 33 – paragraph 1 – point a
(a) electronic health data from EHRs ;
Amendment 1146 #
Proposal for a regulation
Article 33 – paragraph 1 – point b
Article 33 – paragraph 1 – point b
Amendment 1158 #
Proposal for a regulation
Article 33 – paragraph 1 – point d
Article 33 – paragraph 1 – point d
(d) health-related administrative data, including claims and reimbursement data underlying the provision of health care services;
Amendment 1161 #
Proposal for a regulation
Article 33 – paragraph 1 – point e
Article 33 – paragraph 1 – point e
Amendment 1175 #
Proposal for a regulation
Article 33 – paragraph 1 – point f
Article 33 – paragraph 1 – point f
(f) person generated electronic health data, including medical devices, wellness applications or other digital health applications;
Amendment 1203 #
Proposal for a regulation
Article 33 – paragraph 1 – point n
Article 33 – paragraph 1 – point n
Amendment 1320 #
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
Amendment 1334 #
Proposal for a regulation
Article 34 – paragraph 1 – point g
Article 34 – paragraph 1 – point g
Amendment 1341 #
Proposal for a regulation
Article 34 – paragraph 1 – point g
Article 34 – paragraph 1 – point g
(g) training, testing and evaluating of algorithms, including in medical devices, and 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;
Amendment 1562 #
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. Health data access bodies shall not be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.
Amendment 1612 #
Proposal for a regulation
Article 41 – paragraph 1
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 compliance with the requirements set out in Article 32 of Regulation (EU) 2016/679, and in good faith with the health data access bodies, where relevant.
Amendment 1704 #
Proposal for a regulation
Article 44 – paragraph 3
Article 44 – paragraph 3
Amendment 1793 #
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, and if individuals have the option to opt-out with respect to the secondary use of their personal health data. If that is the case, the health data access body shall issue a data permit.
Amendment 1931 #
Proposal for a regulation
Article 52 – paragraph 5
Article 52 – paragraph 5