Activities of Dita CHARANZOVÁ related to 2022/0140(COD)
Plenary speeches (1)
European Health Data Space (debate)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on the European Health Data Space
Amendments (11)
Amendment 53 #
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 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, 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. Additionally, cybersecurity is of utmost importance in the healthcare sector, especially when it comes to protecting health data. That is why robust cybersecurity measures should be implemented by the national digital health authorities in order to protect sensitive health data of users to thwart any attempts to breach the systems and steal or damage the data.
Amendment 55 #
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, 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 often enjoy copyright protection or similar types of protectionshould be provided with the level of confidentiality protection mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) and the Trade Secrets Directive (2016/943), with the protection of the main IP rights i.e. patents, supplementary protection certificates (SPCs), utility models, copyright, trademarks, database and design rights. 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 59 #
Proposal for a regulation
Recital 70
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 75 #
Proposal for a regulation
Article 3 – paragraph 1
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 77 #
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. Natural persons shall have the right to obtain information on thewhich healthcare providers and health professionals that haveve specifically accessed their electronic health data and the reason of why these actors accessed this data in the context of healthcare. The information shall be provided immediately, automatically, and free of charge through electronic health data access services.
Amendment 79 #
Proposal for a regulation
Article 10 – paragraph 2 – point m – point i (new)
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 167 #
Proposal for a regulation
Article 33 – paragraph 1 – point j
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
Article 33 – paragraph 4
4. Electronic health data entailing protected intellectual property and trade secrets from private enterprisehealth data holders shall be made available for secondary use. Where such data is made available for secondary use, all measures necessary to preserve IP rights and the confidentiality of IP rights and trade secrets shall be takentrade secrets must be taken. The sharing of health data for secondary use including the sharing of clinical trial data, shall be shared without prejudice to existing relevant Union legislation including Directive 2004/48/EC, Directive 2001/29/EC, Directive (EU) 2016/943, Directive (EU) 2019/790 and Regulation (EU) No 536/2014.
Amendment 185 #
Proposal for a regulation
Article 46 – paragraph 11
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 210 #
Proposal for a regulation
Article 72 – paragraph 3 – point a
Article 72 – paragraph 3 – point a
(a) from 14 year after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (a), (b) and (c), and to EHR systems intended by the manufacturer to process such categories of data.;
Amendment 211 #
Proposal for a regulation
Article 72 – paragraph 4
Article 72 – paragraph 4
Chapter III shall apply to EHR systems put into service in the Union pursuant to Article 15(2) from 34 years after date of entry into application.