29 Amendments of Fabienne KELLER related to 2022/0140(COD)
Amendment 190 #
Proposal for a regulation
Recital 4 a (new)
Recital 4 a (new)
(4 a) The European Health Data Space implementation should comply with the European ethical principles for digital health adopted by the eHealth network on January 26, 2022. Monitoring the application of the ethical principles should be part of the tasks of the European Health Data Space Board.
Amendment 699 #
Proposal for a regulation
Article 3 – paragraph 10
Article 3 – paragraph 10
10. Natural persons shall have the right to obtain informationautomatic notifications via email to be informed on the healthcare providers and health professionals that have accessed their electronic health data in the context of healthcare. The information shall be provided immediately and free of charge through electronic health data access services.
Amendment 711 #
Proposal for a regulation
Article 4 – paragraph 1 – introductory part
Article 4 – paragraph 1 – introductory part
1. Where they process data in an electronic format, health professionals, including care management teams, shall:
Amendment 802 #
Proposal for a regulation
Article 7 – paragraph 2 a (new)
Article 7 – paragraph 2 a (new)
Amendment 831 #
Proposal for a regulation
Article 9 – paragraph 2
Article 9 – paragraph 2
2. The Commission shall, by means of implementing 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] with provisions for transition periods. The mechanism shall facilitate the transferability of electronic health data in a cross-border context. The Commission shall ensure that state-of-art technology is in place to meet the requirements. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 886 #
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representativeshealth professionals, patients and consummers' representatives. The stakeholders' representatives shall take part in the governance and decision-making structures of the digital health authority. Members of the digital health authority shall avoid any conflicts of interest.
Amendment 893 #
Proposal for a regulation
Article 10 – paragraph 5 a (new)
Article 10 – paragraph 5 a (new)
5 a. The Member States shall determine the selection procedure for health stakeholders referred to in paragraph 5 through an open, transparent and inclusive process.
Amendment 898 #
Proposal for a regulation
Article 11 – paragraph 1
Article 11 – paragraph 1
1. Without prejudice to any other administrative or judicial remedy, natural and legal persons shall have the right to lodge a complaint, individually or, where relevant, collectively, with the digital health authority. Where the complaint concerns the rights of natural persons pursuant to Article 3 of this Regulation, the digital health authority shall informsend a copy of the complaint to the supervisory authorities under Regulation (EU) 2016/679 and shall consult and cooperate with them in the handling of such complaints.
Amendment 901 #
Proposal for a regulation
Article 11 – paragraph 2
Article 11 – paragraph 2
2. The digital health authority with which the complaint has been lodged shall informprovides the complainant of the progress of the proceedings and of the decision takenwith information on the status of the complaint proceedings and of the decision taken to ensure full transparency of the process.
Amendment 904 #
Proposal for a regulation
Article 11 – paragraph 3
Article 11 – paragraph 3
3. Digital health authorities shall cooperate to handle and resolve complaints, including by exchanging all relevant information by electronic means, without undue delay and communicate on processing time and complaint resolution time.
Amendment 960 #
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) ensure thatobtain for their EHR systems are in certificate of compliance from an independent third-party body to attest their conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;
Amendment 977 #
Proposal for a regulation
Article 17 – paragraph 1 – point k – point i (new)
Article 17 – paragraph 1 – point k – point i (new)
i) The Commission shall ensure the availability of independant certification third-party bodies in sufficient number to allow the certification of the EHR systems deployed by the Member States.
Amendment 1170 #
Proposal for a regulation
Article 33 – paragraph 1 – point f
Article 33 – paragraph 1 – point f
Amendment 1205 #
Proposal for a regulation
Article 33 – paragraph 1 – point n
Article 33 – paragraph 1 – point n
Amendment 1267 #
Proposal for a regulation
Article 33 – paragraph 5 a (new)
Article 33 – paragraph 5 a (new)
5 a. Health data access bodies shall provide for an accessible and easily understandable opt-out mechanism, whereby natural persons shall be required to explicitly express their wish not to have their personal electronic health data processed for secondary us.
Amendment 1291 #
Proposal for a regulation
Article 34 – paragraph 1 – introductory part
Article 34 – paragraph 1 – introductory part
1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant complies withto a health data user willing to processing for the following purposes:
Amendment 1323 #
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
(f) development and innovation activities for products or services contributing to public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices; and ensuring benefit to end-users of the innovation, such as patients, health professionals and health administrators.
Amendment 1336 #
Proposal for a regulation
Article 34 – paragraph 1 – point g
Article 34 – paragraph 1 – point g
(g) training, testing and evaluating 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 and ensuring benefit to the end-users, such as patients, healthcare professionals and health administrators;
Amendment 1390 #
Proposal for a regulation
Article 35 – paragraph 1 – point c
Article 35 – paragraph 1 – point c
(c) advertising or marketing activities towards health professionals, organisations in health or natural persons;
Amendment 1402 #
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(e a) automated individual decision- making, including profiling, in accordance with Article 22 of the Regulation (EU) 2016/679;
Amendment 1447 #
Proposal for a regulation
Article 36 – paragraph 3
Article 36 – paragraph 3
3. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Stakeholders' representatives, including health professionals, patients and consummers' organisations, shall take part in the governance and decision-making structures of the health data access bodies. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructions, when making their decisions.
Amendment 1454 #
Proposal for a regulation
Article 36 – paragraph 4 a (new)
Article 36 – paragraph 4 a (new)
4 a. The Member States shall determine the selection procedure for health stakeholders referred to in paragraph 3 through an open, transparent and inclusive process.
Amendment 1544 #
(c) the applicable rights of natural persons in relation to secondary use of electronic health data, in particular the right to opt-out pursuant to Article 33, including detailed information on how to exercise them;
Amendment 1554 #
Proposal for a regulation
Article 38 – paragraph 1 – point e a (new)
Article 38 – paragraph 1 – point e a (new)
(e a) The mention to whom has been granted access to the data and the purpose of the use.
Amendment 1572 #
Proposal for a regulation
Article 38 – paragraph 4
Article 38 – paragraph 4
4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies, as well as the risks and consequences linked with individual and collective digital health data rights arising from this regulation.
Amendment 1881 #
Proposal for a regulation
Article 48 – paragraph 1
Article 48 – paragraph 1
By derogation from Article 46 of this Regulation, a data permit shall not be required to access the electronic health dataMember States may allow national and European public institutions, agencies bodies and offices, under specific conditions, to access data without requiring a data permit under this Aarticle. When carrying out those tasks under Article 37 (1), points (b) and (c), the health data access body shall inform public sector bodies and the Union institutions, offices, agencies and bodies, about the availability of data within 2 months of the data access application, in accordance with Article 9 of Regulation […] [Data Governance Act COM/2020/767 final]. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final ], the health data access body may extend the period by 2 additional months where necessary, taking into account the complexity of the request. The health data access body shall make available the electronic health data to the data user within 2 months after receiving them from the data holders, unless it specifies that it will provide the data within a longer specified timeframe.
Amendment 1906 #
Proposal for a regulation
Article 50 – paragraph 1 – point f a (new)
Article 50 – paragraph 1 – point f a (new)
(fa) ensure that the secure processing environment is located within the European Economic Area. Where personal health data are accessed remotely, including where hosting managed services are used, from a territory located outside of the European Economic Area that does not ensure an adequate level of data protection within the meaning of Article 45 of Regulation (EU) 2016/679, the health data access body shall ensure that this transfer is compliant with that Regulation.
Amendment 2025 #
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 as representatives of stakeholders, including health professionals, patients and consumers' organisations. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor may 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 2037 #
Proposal for a regulation
Article 64 – paragraph 4
Article 64 – paragraph 4
4. Stakeholders and relevant third parties, including patients’health professionals, patients and consumers' 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.