27 Amendments of Patrizia TOIA related to 2022/0140(COD)
Amendment 50 #
Proposal for a regulation
Recital 1 a (new)
Recital 1 a (new)
(1a) The EHDS constitutes a key component for the creation of a strong and resilient European Health Union to better protect the health of European citizens, prevent and address future pandemics and improve resilience of Europe’s health systems.
Amendment 51 #
Proposal for a regulation
Recital 1 b (new)
Recital 1 b (new)
(1b) The following Regulation should work horizontally with other European programs such as the Digital Europe Programme, Connecting Europe Facility and Horizon Europe. The European Commission should ensure that other European programs complement and facilitate the implementation of the European Health Data Space.
Amendment 52 #
Proposal for a regulation
Recital 1 c (new)
Recital 1 c (new)
(1c) Member States should cooperate in using interoperable standards together with European Digital Identity, facilitating the primary use of data in accordance with Article 9 of Regulation (EU)2016/679.
Amendment 53 #
Proposal for a regulation
Recital 4
Recital 4
(4) The processing of personal electronic health data is subject to the provisions of Regulation (EU) 2016/679 of the European Parliament and of the Council43and, for Union institutions and bodies, Regulation (EU) 2018/1725 of the European Parliament and of the Council44. References to the provisions of Regulation (EU) 2016/679 should be understood also as references to the corresponding provisions of Regulation (EU) 2018/1725 for Union institutions and bodies, where relevant. In addition, the Regulation should comply with Cyber Resilience Act. _________________ 43 Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation) (OJ L 119, 4.5.2016, p. 1). 44 Regulation (EU) 2018/1725 of the European Parliament and of the Council of 23 October 2018 on the protection of natural persons with regard to the processing of personal data by the Union institutions, bodies, offices and agencies and on the free movement of such data, and repealing Regulation (EC) No 45/2001 and Decision No 1247/2002/EC (OJ L 295, 21.11.2018, p. 39).
Amendment 60 #
Proposal for a regulation
Recital 19 a (new)
Recital 19 a (new)
(19a) The interoperability of the EHDS should contribute to high quality of European health data sets.
Amendment 75 #
Proposal for a regulation
Recital 41
Recital 41
(41) The secondary use of health data under EHDS should enable the public, private, not for profit entities, as well as individual researchers to have access to health data for research, innovation, policy making, educational activities, patient safety, regulatory activities or personalised medicine, in line with the purposes set out in this Regulation. Access to data for secondary use should contribute to the general interest of the society. Access to secondary health data for research and innovation to the development of medicines, medical devices, health care products and services should contribute to affordable and fair pricing for all European citizens when these products are placed on the market. Activities for which access in the context of this Regulation is lawful may include using the electronic health data for tasks carried out by public bodies, such as exercise of public duty, including public health surveillance, planning and reporting duties, health policy making, ensuring patient safety, quality of care, and the sustainability of health care systems. Public bodies and Union institutions, bodies, offices and agencies may require to have regular access to electronic health data for an extended period of time, including in order to fulfil their mandate, which is provided by this Regulation. Public sector bodies may carry out such research activities by using third parties, including sub-contractors, as long as the public sector body remain at all time the supervisor of these activities. The provision of the data should also support activities related to scientific research (including private research), development and innovation, producing goods and services for the health or care sectors, such as innovation activities or training of AI algorithms that could protect the health or care of natural persons. In some cases, the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural persons. There is a need for public bodies to go beyond the emergency scope of Chapter V of Regulation […] [Data Act COM/2022/68 final]. However, the public sector bodies may request the support of health data access bodies for processing or linking data. This Regulation provides a channel for public sector bodies to obtain access to information that they require for fulfilling their tasks assigned to them by law, but does not extend the mandate of such public sector bodies. Any attempt to use the data for any measures detrimental to the natural person, to increase insurance premiums, to advertise products or treatments, or develop harmful products should be prohibited.
Amendment 76 #
Proposal for a regulation
Recital 41 a (new)
Recital 41 a (new)
(41a) Natural persons need quality education to help them understand the advantages and benefits of providing access to their health data for the secondary use, without prejudice to their right to opt-out from such sharing. In addition to high-level of transparency in terms of how and where their data would be used.
Amendment 105 #
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 mental and physical 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;
Amendment 107 #
Proposal for a regulation
Article 2 – paragraph 2 – point f
Article 2 – paragraph 2 – point f
(f) ‘interoperability’ means the ability of organisations as well as software applications or devices from the same manufacturer or different manufacturers to interact towards mutually beneficial goals, involving the exchange of information and knowledge without changing the content or quality of the data between these organisations, software applications or devices, through the processes they support, enabling data portability across data holders and health care providers for data recipients and data users;
Amendment 111 #
(m) ‘EHR’ (electronic health record) means a collection of electronic mental and physical health data related to a natural person and collected in the health system, processed for healthcare or research purposes;
Amendment 120 #
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Article 2 – paragraph 2 – point ae a (new)
(aea) ‘data sharing’ means the provision defined in Article 2 (10) of the Regulation (EU) 2022/868;
Amendment 122 #
Proposal for a regulation
Article 2 – paragraph 2 – point ae b (new)
Article 2 – paragraph 2 – point ae b (new)
(aeb) 'pseudonymisation' means the processing defined in Article 4 (5) of the Regulation (EU) 2016/679.
Amendment 136 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission shall, by means of implementingdelegated acts, determine the requirements for the interoperable, cross- border identification and authentication mechanism for natural persons and health professionals, in accordance with Regulation (EU) No 910/2014 as amended by [COM(2021) 281 final]. The mechanism shall facilitate the transferability of electronic health data in a cross-border context. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 139 #
Proposal for a regulation
Article 9 – paragraph 3
Article 9 – paragraph 3
3. The Member States and the Commission shall implement services required by the interoperable, cross-border identification and authentication mechanism referred to in paragraph 2 of this Article at Union level, as part of the cross-border digital health infrastructure referred to in Article 12(3).
Amendment 141 #
Proposal for a regulation
Article 9 – paragraph 4
Article 9 – paragraph 4
4. The digital health authoritiMember States and the Commission shall implement the cross- border identification and authentication mechanism at Union and Member States’ level, respectively.
Amendment 149 #
Proposal for a regulation
Article 33 – paragraph 1 – introductory part
Article 33 – paragraph 1 – introductory part
1. Data holders shall make the following categories of electronic data available, upon request and verifying that the natural person has not rejected the option of sharing their data for secondary use in accordance with the provisions of this Chapter:
Amendment 152 #
Proposal for a regulation
Article 33 – paragraph 1 – point d
Article 33 – paragraph 1 – point d
Amendment 164 #
Proposal for a regulation
Article 33 – paragraph 1 – point j
Article 33 – paragraph 1 – point j
(j) electronic health data from finalised clinical trials;
Amendment 176 #
Proposal for a regulation
Article 33 – paragraph 3 a (new)
Article 33 – paragraph 3 a (new)
3a. The natural person shall receive information about the benefits of providing access to their health date for secondary use.
Amendment 187 #
Proposal for a regulation
Article 33 – paragraph 7
Article 33 – paragraph 7
Amendment 200 #
Proposal for a regulation
Article 34 – paragraph 1 – point e a (new)
Article 34 – paragraph 1 – point e a (new)
(ea) Health Economics and Outcomes Research (HEOR);
Amendment 266 #
Proposal for a regulation
Article 40 – paragraph 1 a (new)
Article 40 – paragraph 1 a (new)
1a. Health data access bodies shall support non-for profits (specially patient and consumer organizations), public bodies like city councils or scientific societies, to register in as recognised data altruism organisations in accordance with Article 17 of Regulation (EU) 2022/868.
Amendment 320 #
Proposal for a regulation
Article 61 – paragraph 2
Article 61 – paragraph 2
2. The protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization and pseudonymisation techniques 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 324 #
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, as well at least one patient organisation and one healthcare professional organization. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor mayshall be invited 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 327 #
Proposal for a regulation
Article 64 – paragraph 4
Article 64 – paragraph 4
4. Stakeholders and relevant third parties, including healthcare professionals, researchers and patients’ representatives, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.
Amendment 330 #
Proposal for a regulation
Article 64 – paragraph 5
Article 64 – paragraph 5
5. The EHDS Board shall cooperate with other relevant bodies, entities and experts, such as the European Data Innovation Board referred to in Article 26 of Regulation […] [Data Governance Act COM/2020/767 final], competent bodies set up under Article 7 of Regulation […] [Data Act COM/2022/68 final], supervisory bodies set up under Article 17 of Regulation […] [eID Regulation], European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679 and cybersecurity bodies, in particular the European Agency for Cybersecurity (ENISA).
Amendment 342 #
Proposal for a regulation
Annex II – point 3 – point 3.1
Annex II – point 3 – point 3.1
3.1. An EHR system shall be designed and developed in such a way that it ensures highly safe and secure processing of electronic health data, and that it prevents unauthorised access to such data.