17 Amendments of Francesca DONATO related to 2022/0140(COD)
Amendment 69 #
Proposal for a regulation
Recital 38
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 shcould also be made available on a voluntary basis and with the prior informed consent of individuals to whom the data relates, 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, policy- makers, regulators and doctors to use those data for different purposes, including research, innovation, policy-making, regulatory purposes, patient safety or personalised medicine. In order to fully unleash the benefits of the secondary use of electronic health data, all data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use.
Amendment 70 #
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 shcould be made available on a voluntary basis 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 73 #
Proposal for a regulation
Recital 40
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, shcould 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 often enjoy copyright protection or similar types of protection. However, public authorities and regulators should have access to such data, for instance in the event of pandemics, to verify defective devices and protect human health. In times of severe public health concerns (for example, PIP breast implants fraud) it appeared very difficult for public authorities to get access to such data to understand the causes and knowledge of manufacturer concerning the defects of some devices. The COVID-19 pandemic also revealed the difficulty for policy makers to have access to health data and other data related to health. Such data should be made available for public and regulatory activities, supporting public bodies to carry out their legal mandate, while complying with, where relevant and possible, the protection enjoyed by commercial data. Specific rules in relation to the secondary use of health data should be provided. Data altruism activities may be carried out by different entities, in the context of Regulation […] [Data Governance Act COM/2020/767 final] and taking into account the specificities of the health sector.
Amendment 148 #
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. Data holders shall, on a voluntary basis and with the prior informed consent of the individual persons to whom the data relates, can make the following categories of electronic data available for secondary use in accordance with the provisions of this Chapter:
Amendment 153 #
Proposal for a regulation
Article 33 – paragraph 1 – point d
Article 33 – paragraph 1 – point d
Amendment 167 #
Proposal for a regulation
Article 33 – paragraph 1 – point n
Article 33 – paragraph 1 – point n
Amendment 184 #
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., if not in conflict with national legislation;
Amendment 186 #
Proposal for a regulation
Article 33 – paragraph 7
Article 33 – paragraph 7
Amendment 198 #
Proposal for a regulation
Article 34 – paragraph 1 – point a
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, safety and effectiveness of healthcare and of medicinal products or medical devices, in order to evaluate the risks and benefits of pharmaceutical products approved, authorized by or submitted for approval or authorization to the EMA or other national pharmaceutical agencies;
Amendment 207 #
Proposal for a regulation
Article 35 – paragraph 1 – point a
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
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 299 #
Proposal for a regulation
Article 48
Article 48
Amendment 317 #
Proposal for a regulation
Article 61 – paragraph 1
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], provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.
Amendment 319 #
Proposal for a regulation
Article 61 – paragraph 2
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 detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].
Amendment 325 #
Proposal for a regulation
Article 64 – paragraph 1
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 329 #
Proposal for a regulation
Article 64 – paragraph 4
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 332 #
Proposal for a regulation
Article 64 – paragraph 6
Article 64 – paragraph 6
6. The Commission shall chairParliamentary committee ENVI, LIBE and ITRE, represented by their respective Presidents or Vice Presidents, shall chair in rotation the meetings of the EHDS Board.