27 Amendments of Nathalie COLIN-OESTERLÉ related to 2022/0140(COD)
Amendment 301 #
Proposal for a regulation
Recital 28 a (new)
Recital 28 a (new)
(28a) Manufacturers of EHR systems which are not primarily intended to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records shall be encouraged to allow data generated by their device or software to be stored on the EHR system.
Amendment 363 #
(41a) The secondary use of electronic health data is essential to furthering research, finding new treatments and improving European patients’ health. The sharing of that data promises to foster collaboration between research and development teams from one or more Member States, particularly in certain fields such as cancer, mental illness and rare diseases.
Amendment 405 #
Proposal for a regulation
Recital 51
Recital 51
(51) As the resources of health data access bodies are limited, they can apply prioritisation rules, for instance prioritising public institutions before private entities, but they should not make any discrimination between the national or from organisations from other Member States within the same category of priorities. The data user should be able to extend the duration of the data permit in order, for example, to allow access to the datasets to reviewers of scientific publication or to enable additional analysis of the dataset based on the initial findings. This would require an amendment of the data permit and may be subject to an additonal fee. However, in all the cases, the data permit should reflect theses additionals uses of the dataset. Preferably, the data user should mention them in their initial request for the issuance of the data permit. In order to ensure a harmonised approach between health data access bodies, the Commission should support the harmonisation of data permit.
Amendment 537 #
Proposal for a regulation
Article 2 – paragraph 2 – point g
Article 2 – paragraph 2 – point g
(g) ‘European electronic health record exchange format’ means a structured, commonly used and machine-readable format that allows transmission of personal electronic health data between different software applications, devices and healthcare providers; that format shall be easy to read, consolidated and accessible when sent to a natural person in accordance with Article 3 of this Regulation;
Amendment 559 #
Proposal for a regulation
Article 2 – paragraph 2 – point n
Article 2 – paragraph 2 – point n
(n) ‘EHR system’ (electronic health record system) means any appliance or software intended by the manufacturerwhose primary purpose is to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records;
Amendment 622 #
Proposal for a regulation
Article 3 – paragraph 2
Article 3 – paragraph 2
2. Natural persons shall have the right to receive an electronic copy or a hard copy of their electronic health data upon request to a health professional, in the European electronic health record exchange format referred to in Article 6, of at least their electronic health data in the priority categories referred to in Article 5.;
Amendment 632 #
Proposal for a regulation
Article 3 – paragraph 3
Article 3 – paragraph 3
3. In accordance with Article 23 of Regulation (EU) 2016/679, Member States may restrict the scope of this righte right provided for in paragraph 1 whenever necessary for the protection of the natural person based on patient safety and ethics by delaying their access to their personal electronic health data for a limited period of time until a health professional can properly communicate and explain to the natural person information that can have a significant impact on his or her health.
Amendment 659 #
Proposal for a regulation
Article 3 – paragraph 6
Article 3 – paragraph 6
6. Natural persons may insert, access and export their electronic health data in their own EHR or in that of natural persons whose health information they can access, through electronic health data access services or applications linked to these services. That information shall be marked as inserted by the natural person or by his or her representative.
Amendment 698 #
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. The information shall be provided immediately and free of charge in a readable, consolidated and accessible format through electronic health data access services.
Amendment 727 #
Proposal for a regulation
Article 4 – paragraph 2 a (new)
Article 4 – paragraph 2 a (new)
2a. With a view to meeting the obligations established in paragraph 1 of this article, Member States may provide health professionals with support to ensure that they have the requisite digital skills, infrastructure and tools.
Amendment 779 #
Proposal for a regulation
Article 5 – paragraph 2 – subparagraph 1 (new)
Article 5 – paragraph 2 – subparagraph 1 (new)
The list of priority electronic health data categories set out in Annex I must not withdraw or change data useful for health professionals' work.
Amendment 846 #
Proposal for a regulation
Article 10 – paragraph 2 – point g
Article 10 – paragraph 2 – point g
(g) ensure the implementation, at national level, of the European electronic health record exchange format, in cooperation with national authorities and stakeholders, in particular healthcare professionals;
Amendment 887 #
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representatives of patients, the industrial sector, SMEs, medical institutions, civil society, the university sector and research bodies. Members of the digital health authority shall avoid any conflicts of interest.
Amendment 894 #
Proposal for a regulation
Article 10 – paragraph 5 a (new)
Article 10 – paragraph 5 a (new)
5a. Member States shall decide upon a selection procedure to ensure that the stakeholders referred to in paragraph 5 of this Article are representative.
Amendment 1052 #
Proposal for a regulation
Article 26 – paragraph 4 a (new)
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 1259 #
Proposal for a regulation
Article 33 – paragraph 5
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. Health data access bodies shall in general use an opt-out regime for consent. An opt- in regime shall be put in place as an exception for consent from people with rare diseases.
Amendment 1376 #
Proposal for a regulation
Article 35 – paragraph 1 – point b
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 taking any other decisions in relation to a natural person or groups of natural persons to discriminate on the basis of the health data obtained;
Amendment 1401 #
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(ea) to obtain strategic information about a competitor, such as the production method behind their product or service.
Amendment 1644 #
Proposal for a regulation
Article 42 – paragraph 4
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 transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The fees shall be calculated according to objective criteria, in particular the completeness and representativeness of the data, the number of patients concerned, the scarcity of the data and the cost of any processes used to make the data accessible, such as anonymisation. The support received by the data holder from donations, public national or Union fundgrants, to set up, develop or update tat dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.
Amendment 1676 #
Proposal for a regulation
Article 43 – paragraph 5
Article 43 – paragraph 5
5. Where data holders withhold the electronic health data from health data access bodies with the manifest intention of obstructing the use of electronic health data, or do not respect the deadlines set out in Article 41, the health data access body shall have the power to fine the data holder with fines for each day of delay, which shall be transparent and proportionate. The amount of the fines shall be established by the health data access body in accordance with the tasks of the EHDS Board, set out in Article 65 of this Regulation. In case of repeated breaches by the data holder of the obligation of loyal cooperation with the health data access body, that body can exclude the data holder from participation in the EHDS for a period of up to 5 years. Where a data holder has been excluded from the participation in the EHDS pursuant to this Article, following manifest intention of obstructing the secondary use of electronic health data, it shall not have the right to provide access to health data in accordance with Article 49.
Amendment 1687 #
Proposal for a regulation
Article 43 – paragraph 10
Article 43 – paragraph 10
10. The Commission mayshall issues guidelines on penalties to be applied by the health data access bodies.
Amendment 1698 #
Proposal for a regulation
Article 44 – paragraph 2
Article 44 – paragraph 2
2. The health data access bodies shall provide the electronic health data in an anonymised format, where the purpose of processing by the data user can be achieved with such data, taking into account the information provided by the data user. The health data access bodies shall specify which entity has been tasked with anonymisation and which anonymisation standard has been applied. Specific provisions shall be put in place for data on rare diseases.
Amendment 1783 #
Proposal for a regulation
Article 45 – paragraph 6
Article 45 – paragraph 6
6. The Commission mayshall, by means of implementing acts, set out the templates for the data access application referred to in this Article, the data permit referred to in Article 46 and the data request referred to in Article 47. Those implementing acts shall be adopted in accordance with the procedure referred to in Article 68(2) and shall be limited to what is strictly necessary to avoid any unnecessary administrative burden.
Amendment 1821 #
Proposal for a regulation
Article 46 – paragraph 3
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. Where a health data access body fails to provide a decision within the time limit, the data permit shall not be issued.
Amendment 2057 #
Proposal for a regulation
Article 65 – paragraph 2 – point b – point v
Article 65 – paragraph 2 – point b – point v
(v) the establishment, calculation and application of penalties;
Amendment 2065 #
Proposal for a regulation
Article 65 – paragraph 2 – point d a (new)
Article 65 – paragraph 2 – point d a (new)
(da) Propose updates of the concepts of personal health data, non-personal health data and anonymisation techniques in line with Regulation (EU) 2016/679 and the existing recommendations at EU and international level;
Amendment 2072 #
Proposal for a regulation
Article 66 – paragraph 3
Article 66 – paragraph 3
3. Stakeholders and relevant third parties, including patients’ and healthcare professionals’ representatives, may be invited to attend meetings of the groups and to participate in their work.