21 Amendments of Silvia SARDONE related to 2022/0140(COD)
Amendment 161 #
Draft legislative resolution
Citation 8 a (new)
Citation 8 a (new)
— Having regard to the Commission's communication of 3 February 2021 on Europe's Beating Cancer Plan (COM(2021)0044),
Amendment 163 #
Draft legislative resolution
Citation 8 b (new)
Citation 8 b (new)
— Having regard to the EU's Framework Programme for Research and Innovation 2021-2027 (Horizon Europe) and the dedicated Horizon Europe Mission on Cancer,
Amendment 166 #
Draft legislative resolution
Citation 8 c (new)
Citation 8 c (new)
— Having regard to its resolution of 16 February 2022 on strenghtening Europe in the fight against cancer - towards a comprehensive and coordinated strategy (2020/2267(INI)), and the work of the Special Committee on Beating Cancer (BECA) in its mandate,
Amendment 218 #
Proposal for a regulation
Recital 10
Recital 10
(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data. Specifically relevant fields in the EHR should be clearly marked, such as patient ID, allergies, laboratory data, medical alerts, co- morbility and current medications. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.
Amendment 288 #
Proposal for a regulation
Recital 26
Recital 26
(26) In addition to services in MyHealth@EU for the exchange of personal electronic health data based on the European electronic health record exchange format, other services or supplementary infrastructures may be needed for example in cases of public health emergencies or where the architecture of MyHealth@EU is not suitable for the implementation of some use cases. Examples of such use cases include support for vaccination card functionalities, including the exchange of information on vaccination plans, or verification of vaccination certificates or other health-related certificates. This would be also important for introducing additional functionality for handling public health crises, such as support for contact tracing for the purposes of containing infectious diseases. Furthermore, in accordance with the strenghtened role of the European Center for Diseases Control and Prevention (ECDC), Member States should ensure that the ECDC receives real-time and comparable data on vaccination, including vaccination coverage listed on the ECDC vaccine schedule and vaccine-preventable disease surveillance. Connection of national contact points for digital health of third countries or interoperability with digital systems established at international level should be subject to a check ensuring the compliance of the national contact point with the technical specifications, data protection rules and other requirements of MyHealth@EU. A decision to connect a national contact point of a third country should be taken by data controllers in the joint controllership group for MyHealth@EU.
Amendment 320 #
Proposal for a regulation
Recital 37
Recital 37
(37) For the secondary use of the clinical data for research, innovation, policy making, regulatory purposes, patient safety or the treatment of other natural persons, the possibilities offered by Regulation (EU) 2016/679 for a Union law should be used as a basis and rules and mechanisms and providing suitable and specific measures to safeguard the rights and freedoms of the natural persons. This Regulation provides the legal basis in accordance with Articles 9(2) (g), (h), (i) and (j) of Regulation (EU) 2016/679 for the secondary use of health data, establishing the safeguards for processing, in terms of lawful purposes, trusted governance for providing access to health data (through health data access bodies) and processing in a secure environment, as well as modalities for data processing, set out in the data permit. At the same time, the data applicant should demonstrate a legal basis pursuant to Article 6 of Regulation (EU) 2016/679, based on which they could request access to data pursuant to this Regulation and should fulfil the conditions set out in Chapter IV. More specifically: for processing of electronic health data held by the data holder pursuant to this Regulation, this Regulation creates the legal obligation in the sense of Article 6(1) point (c) of Regulation (EU) 2016/679 for disclosing the data by the data holder to health data access bodies, while the legal basis for the purpose of the initial processing (e.g. delivery of care) is unaffected. This Regulation also meets the conditions for such processing pursuant to Articles 9(2) (h),(i),(j) of the Regulation (EU) 2016/679. This Regulation assigns tasks in the public interest to the health data access bodies (running the secure processing environment, processing data before they are used, etc.) in the sense of Article 6(1)(e) of Regulation (EU) 2016/679 to the health data access bodies, and meets the requirements of Article 9(2)(h),(i),(j) of the Regulation (EU) 2016/679. Therefore, in this case, this Regulation provides the legal basis under Article 6 and meets the requirements of Article 9 of that Regulation on the conditions under which electronic health data can be processed. In the case where the user has access to electronic health data (for secondary use of data for one of the purposes defined in this Regulation), the data user should demonstrate its legal basis pursuant to Articles 6(1), points (e) or (f), of Regulation (EU) 2016/679 and explain the specific legal basis on which it relies as part of the application for access to electronic health data pursuant to this Regulation: on the basis of the applicable legislation, where the legal basis under Regulation (EU) 2016/679 is Article 6(1), point (e), or on Article 6(1), point (f), of Regulation (EU) 2016/679. If the user relies upon a legal basis offered by Article 6(1), point (e), it should make reference to another EU or national law, different from this Regulation, mandating the user to process personal health data for the compliance of its tasks. If the lawful ground for processing by the user is Article 6(1), point (f), of Regulation (EU) 2016/679, in this case it is this Regulation that provides ththis Regulation provides the appropriate and necessary safeguards. In addition, this Regulation should create a right for data users to process special categories of personal data referred to Article 9(1) of Regulation (EU)2016/679 subject to those same safeguards. In this context, the data permits issued by the health data access bodies are an administrative decision defining the conditions for the access to the data.
Amendment 528 #
Proposal for a regulation
Article 2 – paragraph 2 – point e
Article 2 – paragraph 2 – point e
(e) ‘secondary use of electronic health data’ means the compatible further processing of electronic health data for purposes set out in Chapter IV of this Regulation, and, where such electronic health data is personal data, in accordance with Article 5(1)(b) of Regulation (EU) 2016/679. The data used may include personal electronic health data initially collected in the context of primary use, but also electronic health data collected for the purpose of the secondary use;
Amendment 571 #
Proposal for a regulation
Article 2 – paragraph 2 – point y
Article 2 – paragraph 2 – point y
(y) ‘data holder’ means any natural or legal person, which is an entity or a body in the health or care sector, or performing research in relation to these sectors, as well as Union institutions, bodies, offices and agencies who has the right or obligation,o has the right or obligation to make available the relevant and appropriate data pursuant to the relevant requirements laid down in this Regulation. This should be in accordance with this Regulation, applicable Union law or national legislation implementing Union law, or, in the case of non-personal data, through control of the technical design of a product and related services, the ability to make available, including to register, provide, restrict access or exchange certain data;. This definition should be supported by Annex [xxx] with the following specifications: a) The definition of "data holder" shall not include all entities that have an obligation to share data for any purpose (e.g. an obligation to share data with regulators to ensure rugulatory compliance); b) The definition of "data holder" shall not include all entities which simply process data for technical reasons (e.g. if an entity only holds data transiently in order to process it on the instructions of others); c) In the context of a clinical trial, the sponsor of the clinical trial will always be the sole data holder of electronic clinical trial data. Where the sponsor is located outside of the EU, its EU legal representative will assume the role of data holder or other designated entity established within the Community.
Amendment 1031 #
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 2
Article 23 – paragraph 1 – subparagraph 2
Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2), after consultation with the EHDS Board and other relevant stakeholders.
Amendment 1179 #
Proposal for a regulation
Article 33 – paragraph 1 – point g
Article 33 – paragraph 1 – point g
(g) identification data related to health professionals involved in the treatment of a natural personresearch should be limited to data which are absolutely necessary;
Amendment 1185 #
Proposal for a regulation
Article 33 – paragraph 1 – point j
Article 33 – paragraph 1 – point j
(j) electronic health data from clinical trialsfully completed clinical trials, in accordance with definitions in Article 2(2) and Article 2(26) of Regulation (EU) No 536/2014;
Amendment 1190 #
Proposal for a regulation
Article 33 – paragraph 1 – point j a (new)
Article 33 – paragraph 1 – point j a (new)
(j a) Data referred to in paragraph 1(j) should be made available in the format outlined in Annex IV in Regulation No 536/2014 or, if requested by the public sector, as defined in the Data Act Article 15 (a) or (b).
Amendment 1191 #
Proposal for a regulation
Article 33 – paragraph 1 – point j b (new)
Article 33 – paragraph 1 – point j b (new)
(j b) Regarding electronic health data referred to in paragraph 1(j) of this Article, a summary of results of the clinical trial will be published and individual patient data may be shared, in accordance with Article 37(4) of Regulation (EU) No 536/2014.
Amendment 1406 #
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(e a) Unfair commercial use or other unfair competitions, in accordance with Article 39 of TRIPS;
Amendment 1409 #
Proposal for a regulation
Article 35 – paragraph 1 – point e b (new)
Article 35 – paragraph 1 – point e b (new)
(e b) using data from private enterprises in regulatory or reimbursement submissions for any generic or biosimilar product without an agreement from the private sector data holder while the data holder's referenced product is under patent or regulatory data protection (including such use of data outside of the EU) or equivalent protected data of non- medicinal products, such as medical devices and software medical devices.
Amendment 1538 #
Proposal for a regulation
Article 37 – paragraph 4 a (new)
Article 37 – paragraph 4 a (new)
4 a. Following open and public consultations, the Commission shall adopt guidelines on the functioning of the health data access bodies to ensure coherent processes among them.
Amendment 1688 #
Proposal for a regulation
Article 43 – paragraph 10 a (new)
Article 43 – paragraph 10 a (new)
10 a. Data holders lawfully protecting their IP rights and commercial property shall not be subject to fines while any disputes concerning the protection of industrial and commercial property are being resolved, in order to avoid conflicting obligations.
Amendment 1689 #
Proposal for a regulation
Article 43 – paragraph 10 b (new)
Article 43 – paragraph 10 b (new)
10 b. Data holders that breach the Regulation are subject to fines.
Amendment 1913 #
Proposal for a regulation
Article 50 – paragraph 4
Article 50 – paragraph 4
4. The Commission shall, by means of implementing acts, provide for the technical, information security and interoperability requirements for the secure processing environments. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The EHDS Board shall ensure consistent provision of the secure processing environment compliant with the technical information security and interoperability requirements and enforce compliance across the Member States.
Amendment 2000 #
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 2105 #
Proposal for a regulation
Article 70 – paragraph 1 a (new)
Article 70 – paragraph 1 a (new)
1a. After two years from the entry into force of this Regulation, the Commission shall carry out an evaluation on the Union funding attributed to the setting up and working of the EHDS, notably as to the ability of Union bodies to carry out their tasks under this Regulation and of Member States to apply the Regulation in a uniform and coherent manner. The Commission shall submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by legislative proposals. Stakeholders shall be consulted in the preparation of the evaluation report.