20 Amendments of Nicola BEER related to 2022/0140(COD)
Amendment 72 #
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 protection which shall be treated accordingly. 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 78 #
Proposal for a regulation
Recital 43
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 data access bodies can prepare datasets to the data user requirement linked to the issued data permit. This includes rules for anonymization of microdata sets.
Amendment 101 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes the European Health Data Space (‘EHDS’) by providing for rules, common and interoperable standards and, practices, and infrastructures and a governance framework for the primary and secondary use of electronic health data.
Amendment 102 #
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, sharing and control of their electronic health data;
Amendment 103 #
Proposal for a regulation
Article 1 – paragraph 3 – point d
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
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 131 #
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 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 146 #
Proposal for a regulation
Article 31 – paragraph 6
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 151 #
Proposal for a regulation
Article 33 – paragraph 1 – point a
Article 33 – paragraph 1 – point a
(a) electronic health data from EHRs;
Amendment 157 #
Proposal for a regulation
Article 33 – paragraph 1 – point f
Article 33 – paragraph 1 – point f
(f) person generated electronic health data, including via medical devices, wellness applications or other digital health applications;
Amendment 160 #
Proposal for a regulation
Article 33 – paragraph 1 – point i
Article 33 – paragraph 1 – point i
(i) electronic health data from medical registries for specific diseases;
Amendment 162 #
Proposal for a regulation
Article 33 – paragraph 1 – point j
Article 33 – paragraph 1 – point j
(j) electronic health data from clinical trials in accordance with Regulation (EU) No 536/2014;
Amendment 177 #
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. For data defined under Article 33 (k) (medical devices) where data holder can demonstrate that data are derived or inferred by means of complex proprietary algorithms and can lead to reverse engineering, data holder should be entitled to refer to data coordinator as established under Article 31 of Regulation (Data Act) to request a restriction or limitation of the sharing of data. Where such data is made available for secondary use, all measures necessary to preserve theIP rights and confidentiality of IP rights and trade secrets shall be taken. This regulation is without prejudice to Union and national legal acts providing for the protection of intellectual property rights, including Directive 2001/29/EC, Directive 2004/48/EC, Directive (EU) 2016/943 and Directive (EU) 2019/790.
Amendment 195 #
Proposal for a regulation
Article 33 a (new)
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 199 #
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 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 201 #
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
(f) development and innovation activities for products oractivities for the development, placing on the market, advancement and seurvices contributing to public health or social security, or ensuring high levels of quality and safety ofeillance of products or services related to health or care, of medicinal products or of medical device sectors;
Amendment 204 #
Proposal for a regulation
Article 34 – paragraph 1 – point g
Article 34 – paragraph 1 – point g
(g) training, testing and evaluidating 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 related to health in accordance with the AI Act (COM/2021/206 final);
Amendment 238 #
Proposal for a regulation
Article 37 – paragraph 1 – point m
Article 37 – paragraph 1 – point m
(m) cooperate at Union and national level to lay down common approach, technical requirements and appropriate measures and requirements for accessing electronic health data in a secure processing environment;
Amendment 256 #
Proposal for a regulation
Article 38 – paragraph 1 – point c
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 292 #
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 compromising on IP and trade secrets defined in 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.