21 Amendments of Clara AGUILERA related to 2022/0140(COD)
Amendment 50 #
Proposal for a regulation
Recital 34
Recital 34
(34) In order to ensure an appropriate and effective enforcement of the requirements and obligations laid down in Chapter III of this Regulation, the system of market surveillance and compliance of products established by Regulation (EU) 2019/1020 should apply. Depending on the organisation defined at national level, such market surveillance activities could be carried out by the digital health authorities ensuring the proper implementation of Chapter II or a separate market surveillance authority responsible for EHR systems. While designating digital health authorities as market surveillance authorities could have important practical advantages for the implementation of health and care, any conflicts of interest should be avoided, for instance by separating different tasks. Member States should ensure that market surveillance authorities have the necessary human, technical and financial resources, premises, infrastructure, and expertise to carry out their duties effectively.
Amendment 60 #
(71) In order to assess whether this Regulation reaches its objectives effectively and efficiently, is coherent and still relevant and provides added value at Union level the Commission should carry out an evaluation of this Regulation. The Commission should carry out a partial evaluation of this Regulation 53 years after its entry into force, on the self-certification of EHR systems and the need to introduce a conformity assessment procedure performed by notified bodies, and an overall evaluation 7 years after the entry into force of this Regulation. The Commission should submit reports on its main findings following each evaluation to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions.
Amendment 66 #
Proposal for a regulation
Article 2 – paragraph 2 – point m
Article 2 – paragraph 2 – point m
(m) ‘EHR’ (electronic health record) means any collection of past or present electronic health data, including physical and mental data, related to a natural person and collected in the health system, processed for healthcare or research purposes;
Amendment 68 #
Proposal for a regulation
Article 2 – paragraph 2 – point n
Article 2 – paragraph 2 – point n
(n) ‘EHR system’ (electronic health record system) means any appliance or softwar, software or other article intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records, or that can be reasonably expected by the manufacturer to be mainly used for these purposes;
Amendment 70 #
Proposal for a regulation
Article 2 – paragraph 2 – point n a (new)
Article 2 – paragraph 2 – point n a (new)
(n a) ‘general software’ means any software that is not intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewing electronic health records, or that cannot be reasonably expected by the manufacturer to be mainly used for these purposes;
Amendment 72 #
Proposal for a regulation
Article 2 – paragraph 2 – point o
Article 2 – paragraph 2 – point o
(o) ‘wellness application’ means any appliance or software intended by the manufacturer to be used by a natural person for processing electronic health data for other purposes than healthcare, such as well-being and pursuing healthy life- stylhealthy life-style and well-being purposes, or that can be reasonably expected by the manufacturer to be mainly used for these purposes;
Amendment 95 #
Proposal for a regulation
Article 17 – paragraph 1 – point j
Article 17 – paragraph 1 – point j
(j) upon request of aprovide market surveillance authority, provide ities with all the information and documentation necessary to demonstrate the conformity of their EHR system with the essential requirements laid down in Annex II prior to making it available or putting it into service.
Amendment 96 #
Proposal for a regulation
Article 17 – paragraph 1 – point k a (new)
Article 17 – paragraph 1 – point k a (new)
(k a) establish reporting channels and ensure their accessibility to allow for users to submit complaints or concerns regarding potential non-conformity of products; assess the complaints and concerns received, and inform market surveillance authorities in case of suspected non-compliance of the product; and keep a register of complaints and concerns received for 10 years and make it available upon request from a market surveillance authority.
Amendment 106 #
Proposal for a regulation
Article 18 – paragraph 2 – point b
Article 18 – paragraph 2 – point b
(b) further to a reasoned request from a market surveillance authority, provide thatmarket surveillance authorityies with all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II;
Amendment 126 #
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Distributors shall, further to a reasoned request from a provide market surveillance authority, provide ities with all the information and documentation necessary to demonstrate the conformity of an EHR system prior to making it available on the market. They shall cooperate with that authority, at its request, on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II.
Amendment 129 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
An importer or distributor shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 17, where they made an EHR system available on the market under their own name or trademark or modify an EHR system already placed on the market in such a way that conformity with the applicable requirements may be affected. Second- hand economic operators, including refurbishers, who make available on the market second-hand EHR systems, whether prepared for re-use, checked, cleaned, repaired, refurbished or without any action on the product shall not be considered as modifying a product in such a way that conformity with the applicable requirements may be affected.
Amendment 133 #
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
The Commission shall, by means of implementing acts, adopt common specifications in respect of the essential requirements set out in Annex II, including a time limit for implementing those common specifications. The Commission shall consult, when preparing implementing acts, the relevant stakeholders, including the European Data Protection Supervisor and the European Data Protection Board where common specifications have an impact on the data protection requirements of EHR systems. Where relevant, the common specifications shall take into account the specificities of medical devices and high risk AI systems referred to in paragraphs 3 and 4 of Article 14.
Amendment 146 #
Proposal for a regulation
Article 27 – paragraph 1
Article 27 – paragraph 1
1. The CE marking shall be affixed visibly, legibly and indelibly to the accompanying documents of the EHR system and, where applicable, to the packaging, and, where possible, to the EHR system itself.
Amendment 150 #
Proposal for a regulation
Article 28 – paragraph 3 a (new)
Article 28 – paragraph 3 a (new)
3 a. Market surveillance authorities shall act as single contact points, and centralize all procedures and verifications avoiding duplicated procedures with the Artificial Intelligence Act (2021/0106(COD)), Medical Devices Regulation 2012/0266(COD), In vitro Diagnostic Medical Devices Regulation (2012/0267(COD)), Cyber Resilience Act (2022/0272(COD)).
Amendment 197 #
Proposal for a regulation
Article 69 – paragraph 1 a (new)
Article 69 – paragraph 1 a (new)
Penalties shall at least include fines proportionate to the extent of non- compliance and to the turnover of the relevant economic operator. Fines shall be calculated in such a way as to make sure that they effectively deprive the economic operator of the economic benefits derived from their infringements. Fines shall be gradually increased for repeated infringements.
Amendment 198 #
Proposal for a regulation
Article 69 – paragraph 1 b (new)
Article 69 – paragraph 1 b (new)
In deciding whether to impose sanctions and, if so, in determining their nature and appropriate level, due account shall be taken of: (a) the nature, gravity and duration of the infringement; (b) any previous infringements by the economic operator of this Regulation; (c) the financial benefits gained or losses avoided by the economic operator due to the infringement, if the relevant data are available; (d) penalties imposed in respect of the same infringement in other Member States; (e) any action taken by the economic operator to remedy or to mitigate the adverse effects of the infringement; (f) any other aggravating or mitigating factors applicable to the circumstances of the case.
Amendment 200 #
Proposal for a regulation
Article 69 – paragraph 1 c (new)
Article 69 – paragraph 1 c (new)
Member States shall ensure that any decision containing penalties related to the breach of the provisions of this Regulation is published no later than a month after the penalty is imposed.
Amendment 203 #
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
1. After 53 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to Chapter III, and 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 a proposal for its amendment especially with regards to a transition from self-certification to third- party certification. The evaluation shall include an assessment of the self- certification of EHR systems and reflect onconsider the need to introduce a conformity assessment procedure performed by notified bodies as a way to better ensure protection of electronic health data.
Amendment 208 #
Proposal for a regulation
Article 71 a (new)
Article 71 a (new)
Article 71 a Amendment to Directive (EU) 2020/1828 on Representative Actions for the Protection of the Collective Interests of Consumers The following is added to Annex I: “(67) Regulation (EU) .../... of the European Parliament and of the Council on the European Health Data Space”
Amendment 212 #
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 safe and secure processing of electronic health data, and that it prevents unauthorised access to such data, and that it duly takes into consideration the principles of data minimization and data protection by design.
Amendment 213 #
Proposal for a regulation
Annex II – point 3 – point 3.8
Annex II – point 3 – point 3.8
3.8. An EHR system designed for the storage of electronic health data shall support different retention periods and access rights that take into account the origins and categories of electronic health data and the specific purpose of the data processing operations.