Activities of Alexandra GEESE related to 2022/0140(COD)
Shadow opinions (1)
OPINION on the proposal for a regulation of the European Parliament and of the Council on the European Health Data Space
Amendments (87)
Amendment 33 #
Proposal for a regulation
Recital 7
Recital 7
(7) In health systems, personal electronic health data is usually gathered in electronic health records, which typically contain a natural person’s medical history, diagnoses and treatment, medications, allergies, immunisations, as well as radiology images and laboratory results, spread between different entities from the health system (general practitioners, hospitals, pharmacies, care services). In order to enable that electronic health data to be accessed, shared and changed by the natural persons or health professionals, some Member States have taken the necessary legal and technical measures and set up centralised infrastructures connecting EHR systems used by healthcare providers and natural persons. Alternatively, some Member States support public and private healthcare providers to set up personal health data spaces to enable interoperability between different healthcare providers. Several Member States have also supported or provided health data access services for patients and health professionals (for instance through patients or health professional portals). They have also taken measures to ensure that EHR systems or wellness applications are able to transmit electronic health data with the central EHR system (some Member States do this by ensuring, for instance, a system of certification). However, not all Member States have put in place such systems, and the Member States that have implemented them have done so in a fragmented manner. In order to facilitate the free movement of personal health data across the Union and avoid negative consequences for patients when receiving healthcare in cross-border context, Union action is needed in order to ensure individuals have improved acess to their own personal electronic health data and are empowered to share it.
Amendment 37 #
Proposal for a regulation
Recital 16
Recital 16
(16) Timely and full access of health professionals to the medical records of patients is fundamental for ensuring continuity of care and avoiding duplications and errors. However, due to a lack of interoperability, in many cases, health professionals cannot access the complete medical records of their patients and cannot make optimal medical decisions for their diagnosis and treatment, which adds considerable costs for both health systems and natural persons and may lead to worse health outcomes for natural persons. Electronic health data made available in interoperable format, which can be transmitted between healthcare providers can also reduce the administrative burden on health professionals of manually entering or copying health data between electronic systems. Therefore, health professionals should be provided with appropriate electronic means, such as health professional portals, to use personal electronic health data for the exercise of their duties. Moreover, the Commission and the Member States should agree on ambitious time-based targets to implement improved health data interoperability across the Union. The access to personal health records should be transparent to the natural persons and natural persons should be able to exercise full control over such access, including by limiting access to all or part of the personal electronic health data in their records. Health professionals should refrain from hindering the implementation of the rights of natural persons, such as refusing to take into account electronic health data originating from another Member State and provided in the interoperable and reliable European electronic health record exchange format.
Amendment 43 #
Proposal for a regulation
Recital 23
Recital 23
(23) Digital health authorities should have sufficient technical skills, possibly bringing together experts from different organisations. The activities of digital health authorities should be well-planned and monitored in order to ensure their efficiency. Digital health authorities should take necessary measures to ensuring rights of natural persons by setting up national, regional, and local technical solutions such as national EHR, patient portals, data intermediation systems. When doing so, they should apply common standards and specifications in such solutions, promote the application of the standards and specifications in procurements and use other innovative means including reimbursement of solutions that are compliant with interoperability and security requirements of the EHDS. To carry out their tasks, the digital health authorities should cooperate at national and Union level with other entities, including with insurance bodies, healthcare providers, manufacturers of EHR systems and wellness applications, as well as stakeholders from health or information technology sector, entities handling reimbursement schemes, health technology assessment bodies, medicinal products regulatory authorities and agencies, medical devices authorities, procurers and cybersecurity or e-ID authorities.
Amendment 45 #
Proposal for a regulation
Recital 25
Recital 25
(25) In the context of MyHealth@EU, a central platform should provide a common infrastructure for the Member States to ensure connectivity and interoperability in an efficient and secure way. In order to guarantee compliance with data protection rules and to provide a risk management framework for the transmission of personal electronic health data, the Commission should, by means of implementing acts, allocate specific responsibilities among the Member States, as joint controllers, and prescribe its own obligations, as processor. Furthermore, to ensure the technological sovereignty of the Union and ensure the highest security standards, the platform should be licenced under an open source licence in line with the Open Source Strategy 2020-2023 (C(2020) 7149 final) and Commission decision 2021/C 495 I/01. This will increase transparency and ensure consumer trust and confidence in the platform.
Amendment 51 #
Proposal for a regulation
Recital 35
Recital 35
Amendment 52 #
Proposal for a regulation
Recital 36
Recital 36
(36) The distribution of information on certified EHR systems and labelled wellness applications is necessary to enable procurers and users of such products to find interoperable solutions for their specific needs. A database of interoperable EHR systems and wellness applications, which are not falling within the scope of Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final] should therefore be established at Union level, similar to the European database on medical devices (Eudamed) established by Regulation (EU) 2017/745. The objectives of the EU database of interoperable EHR systems and wellness applications should be to enhance overall transparency, to avoid multiple reporting requirements and to streamline and facilitate the flow of information. For medical devices and AI systems, the registration should be maintained under the existing databases established respectively under Regulations (EU) 2017/745 and […] [AI act COM/2021/206 final], but the compliance with interoperability requirements should be indicated when claimed by manufacturers, to provide information to procurers.
Amendment 54 #
Proposal for a regulation
Recital 39
Recital 39
(39) The categories of electronic health data that can be processed for secondary use should be broad and flexible enough to accommodate the evolving needs of data users, while remaining limited to data related to health or known to influence health. It can also include relevant data from the health system (electronic health records, claims data, disease registries, genomic data etc.), as well as data with an impact on health (for example consumption of different substances, homelessness, health insurance, minimum income, professional status, behaviour, including environmental factors (for example, pollution, radiation, use of certain chemical substances). They can also include person- generated data, such as data from medical devices, wellness applications or other wearables and digital health applications. The data user who benefits from access to datasets provided under this Regulation could enrich the data with various corrections, annotations and other improvements, for instance by supplementing missing or incomplete data, thus improving the accuracy, completeness or quality of data in the dataset. To support the improvement of the original database and further use of the enriched dataset, the dataset with such improvements and a description of the changes should be made available free of charge to the original data holder. The data holder should make available the new dataset, unless it provides a justified notification against it to the health data access body, for instance in cases of low quality of the enrichment. Secondary use of non-personal electronic data should also be ensured. In particular, pathogen genomic data hold significant value for human health, as proven during the COVID-19 pandemic. Timely access to and sharing of such data has proven to be essential for the rapid development of detection tools, medical countermeasures and responses to public health threats. The greatest benefit from pathogen genomics effort will be achieved when public health and research processes share datasets and work mutually to inform and improve each other.
Amendment 61 #
Proposal for a regulation
Recital 73 a (new)
Recital 73 a (new)
(73 a) Consumers should be entitled to enforce their rights in relation to the obligations imposed on economic operators under this Regulation through representative actions in accordance with Directive (EU) 2020/1828 of the European Parliament and of the Council. For that purpose, this Regulation should provide that Directive (EU) 2020/1828 is applicable to the representative actions concerning infringements of the provisions of this Regulation that harm or can harm the collective interests of consumers. The Annex to that Directive should therefore be amended accordingly. It is for the Member States to ensure that that amendment is reflected in their transposition measures adopted in accordance with Directive (EU) 2020/1828, although the adoption of national transposition measures in this regard is not a condition for the applicability of that Directive to those representative actions. The applicability of Directive (EU) 2020/1828 to the representative actions brought against infringements by economic operators of provisions of this Regulation that harm or can harm the collective interests of consumers should start from the date of application of this Regulation.
Amendment 62 #
Proposal for a regulation
Article 1 – paragraph 3 – point a
Article 1 – paragraph 3 – point a
(a) manufacturers and suppliers of EHR systems and wellness applications placed on the market and put into service in the Union and the users of such products; (This amendment applies throughout the text.)
Amendment 64 #
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 formatin electronic format relevant for health research that falls outside the definition of personal data provided in Article 4(1) of Regulation (EU) 2016/679;
Amendment 65 #
Proposal for a regulation
Article 2 – paragraph 2 – point h
Article 2 – paragraph 2 – point h
(h) ‘registration of electronic health data’ means the recording of health data in an electronic format, through manual entry of data, through the collection of data by a device, or through the conversion of non- electronic health data into an electronic format, to be processed in an EHR system or a wellness application;
Amendment 67 #
Proposal for a regulation
Article 2 – paragraph 2 – point m
Article 2 – paragraph 2 – point m
(m) ‘EHR’ (electronic health record) means an electronic collection of electronic health data related to a natural person and collected in the health system, processed for healthcare purposes;
Amendment 71 #
Proposal for a regulation
Article 2 – paragraph 2 – point o
Article 2 – paragraph 2 – point o
Amendment 74 #
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Article 2 – paragraph 2 – point ae a (new)
(ae a) ‘common specifications’ (CS) means a set of technical and/or clinical requirements, other than a standard, that provides a means of complying with the legal obligations applicable to an EHR system.
Amendment 80 #
Proposal for a regulation
Article 12 – paragraph 1
Article 12 – paragraph 1
1. The Commission shall establish a central platform for digital health to provide services to support and facilitate the exchange of electronic health data between national contact points for digital health of the Member States. The central platform shall be licenced under an open- source licence and published in the Open Source code repository of the EU institutions.
Amendment 83 #
Proposal for a regulation
Chapter III – title
Chapter III – title
III EHR systems and wellness applications
Amendment 85 #
Proposal for a regulation
Article 14 – paragraph 4
Article 14 – paragraph 4
4. PNotwithstanding the obligations laid down in Regulation [AI act COM/2021/206 final], providers of high- risk AI systems as defined in Article 6 of Regulation […] [AI act COM/2021/206 final], which does not fall within the scope of Regulation (EU) 2017/745, that claim interoperability of those AI systems with EHR systems will need to prove compliance with the essential requirements on interoperability laid down in Section 2 of Annex II of this Regulation. Article 23 of this Chapter shall be applicable to those high-risk AI systems.
Amendment 87 #
Proposal for a regulation
Article 15 – paragraph 1
Article 15 – paragraph 1
1. EHR systems may be placed on the market or put into service only if they comply with the provisions laid down in this Chapter and in Annex II.
Amendment 88 #
Proposal for a regulation
Article 17 – paragraph 1 – point b
Article 17 – paragraph 1 – point b
(b) draw up and keep up to date the technical documentation of their EHR systems in accordance with Article 24;
Amendment 89 #
Proposal for a regulation
Article 17 – paragraph 1 – point c
Article 17 – paragraph 1 – point c
(c) ensure that their EHR systems are accompanied, free of charge for the user, by the information sheet provided for in Article 25 and by clear and complete instructions for use in accessible formats for persons with disabilities;
Amendment 90 #
Proposal for a regulation
Article 17 – paragraph 1 – point g
Article 17 – paragraph 1 – point g
(g) take without undue dimmediatelay any necessary corrective action in respect of their EHR systems whichen manufacturers consider or have reasons to believe that such systems are not in conformity with the essential requirements laid down in Annex II, or recall or withdraw such systems;
Amendment 91 #
Proposal for a regulation
Article 17 – paragraph 1 – point h
Article 17 – paragraph 1 – point h
(h) immediately inform the distributors of their EHR systems and, where applicable, the authorised representative and importers of any corrective action, recall or withdrawal;
Amendment 92 #
Proposal for a regulation
Article 17 – paragraph 1 – point i
Article 17 – paragraph 1 – point i
(i) immediately inform the market surveillance authorities of the Member States in which they made their EHR systems available or put them into service of the non- conformity and of any corrective action taken;
Amendment 93 #
Proposal for a regulation
Article 17 – paragraph 1 – point i a (new)
Article 17 – paragraph 1 – point i a (new)
(i a) immediately inform the market surveillance authorities of the Member States in which they made their EHR systems available, where manufacturers consider or have reasons to believe that such systems present a risk to the health or safety of natural persons or to other aspects of public interest protection;
Amendment 94 #
Proposal for a regulation
Article 17 – paragraph 1 – point j
Article 17 – paragraph 1 – point j
(j) upon request of a market surveillance authority, provide itat least 6 months before placing on the market or putting into service their EHR systems, provide market surveillance authorities of the Member States concerned with all the information and documentation necessary to demonstrate the conformity of their EHR system with the essential requirements laid down in Annex II.
Amendment 97 #
Proposal for a regulation
Article 17 – paragraph 1 a (new)
Article 17 – paragraph 1 a (new)
1 a. If the manufacturer fails to cooperate with market surveillance authorities or if the information and documentation provided is incomplete or incorrect, market surveillance authorities shall take all appropriate measures to prohibit or restrict the relevant EHR system from being available on the market, to withdraw it from the market or to recall it until the manufacturer cooperates or provides complete and correct information;
Amendment 98 #
Proposal for a regulation
Article 17 – paragraph 3 a (new)
Article 17 – paragraph 3 a (new)
3 a. A manufacturer of EHR systems established outside of the Union shall ensure that its authorised representative has the necessary documentation permanently available in order to fulfil the tasks referred to in Article 18(2).
Amendment 99 #
Proposal for a regulation
Article 17 – paragraph 3 b (new)
Article 17 – paragraph 3 b (new)
3 b. Natural or legal persons may claim compensation for damage caused by a defective EHR system in accordance with applicable Union and national law. Manufacturers shall have measures in place to provide sufficient financial coverage in respect of their potential liability under Directive 85/374/EEC, without prejudice to more protective measures under national law.
Amendment 100 #
Proposal for a regulation
Article 17 – paragraph 3 c (new)
Article 17 – paragraph 3 c (new)
3 c. Manufacturers shall make publicly available communication channels such as a telephone number, electronic address or dedicated section of their website, taking into account accessibility needs for persons with disabilities, allowing users to file complaints and to inform them of risks related to their health and safety or to other aspects of public interest protection and of any serious incident involving an EHR system.
Amendment 101 #
Proposal for a regulation
Article 17 – paragraph 3 d (new)
Article 17 – paragraph 3 d (new)
3 d. Manufacturers shall investigate complaints and information on incidents involving an EHR system they made available on the market without undue delay and shall keep an internal register of those complaints as well as of systems recalls and any corrective measures taken to bring the EHR system into conformity.
Amendment 102 #
Proposal for a regulation
Article 17 – paragraph 3 e (new)
Article 17 – paragraph 3 e (new)
3 e. Personal data stored in the internal register of complaints shall only be those personal data that are necessary for the manufacturer to investigate the complaint. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than 5 years after they have been encoded.
Amendment 103 #
Proposal for a regulation
Article 18 – paragraph 1
Article 18 – paragraph 1
1. Prior to making an EHR system available on the Union market, a manufacturer of an EHR system established outsidWhere a manufacturer of an EHR system is established outside of the Union, the EHR system may only be made available ofn the Union shallmarket if the manufacturer appoints, by written mandate, appoint an authorised representative which is established in the Union.
Amendment 104 #
Proposal for a regulation
Article 18 – paragraph 2 – introductory part
Article 18 – paragraph 2 – introductory part
2. An authorised representative shall perform the tasks specified in the mandate received fromagreed with the manufacturer. The mandate shall allow the authorised representative to do at least the following:
Amendment 105 #
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 that authorityat least 6 months before placing an EHR system on the market or putting it into service, provide the market surveillance authorities of the Member States concerned with a copy of the mandate and with all the information and documentation necessary to demonstrate the conformity of an EHR system with the essential requirements laid down in Annex II in an official language which can be understood by that authority;
Amendment 107 #
Proposal for a regulation
Article 18 – paragraph 2 – point b a (new)
Article 18 – paragraph 2 – point b a (new)
(b a) immediately inform the manufacturer if the authorised representative has a reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection or if it is aware of any serious incident involving an EHR system;
Amendment 108 #
Proposal for a regulation
Article 18 – paragraph 2 – point b b (new)
Article 18 – paragraph 2 – point b b (new)
(b b) immediately inform the manufacturer about complaints received by users;
Amendment 109 #
Proposal for a regulation
Article 18 – paragraph 2 – point c a (new)
Article 18 – paragraph 2 – point c a (new)
(c a) terminate the mandate if the manufacturer acts contrary to its obligations under this Regulation and immediately inform the market surveillance authority of the Member State in which is established.
Amendment 110 #
2 a. Where the manufacturer is not established in a Member State and has not complied with the obligations laid down in Article 17, the authorised representative shall be legally liable for non-compliance with this Regulation on the same basis as, and jointly and severally with, the manufacturer;
Amendment 111 #
Proposal for a regulation
Article 18 – paragraph 2 b (new)
Article 18 – paragraph 2 b (new)
2 b. In case of change of the authorised representative, the detailed arrangements for the change shall be clearly defined in an agreement between the manufacturer, or where practicable the outgoing authorised representative, and the incoming authorised representative.That agreement shall address at least the following aspects: (a) the date of termination of the mandate of the outgoing authorised representative and date of beginning of the mandate of the incoming authorised representative; (b) the transfer of documents, including confidentiality aspects and property rights;
Amendment 112 #
Proposal for a regulation
Article 19 – paragraph 2 – point a
Article 19 – paragraph 2 – point a
(a) the manufacturer has drawn up the technical documentation and the EU declaration of conformity and ensure that it is made available to market surveillance authorities at least 6 months before an EHR system is placed on the market or put into service;
Amendment 113 #
Proposal for a regulation
Article 19 – paragraph 2 – point a a (new)
Article 19 – paragraph 2 – point a a (new)
(a a) the manufacturer is identified and an authorised representative in accordance with Article 18 has been appointed;
Amendment 114 #
Proposal for a regulation
Article 19 – paragraph 2 – point c
Article 19 – paragraph 2 – point c
(c) the EHR system is accompanied by the information sheet referred to in Article 25 and appropriaby clear and complete instructions for use. in accessible formats for persons with disabilities.
Amendment 115 #
Proposal for a regulation
Article 19 – paragraph 3
Article 19 – paragraph 3
3. Importers shall indicate their name, registered trade name or registered trade mark and the address, the postal and electronic address and the telephone number at which they can be contacted in a document accompanying the EHR system. They shall ensure that any additional label does not obscure any information on the label provided by the manufacturer.
Amendment 116 #
Proposal for a regulation
Article 19 – paragraph 5
Article 19 – paragraph 5
5. Where an importer considers or has reason to believe that an EHR system is not in conformity with the essential requirements in Annex II, it shall not make that system available on the market until that system has been brought into conformity. The importer shall inform without undue delaymmediately inform the manufacturer of such EHR system and the market surveillance authorities of the Member State in which it made the EHR system available, to that effect. Where an importer considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately inform the market surveillance authority of the Member State in which the importer is established, as well as the manufacturer and where applicable, the authorised representative.
Amendment 117 #
Proposal for a regulation
Article 19 – paragraph 7
Article 19 – paragraph 7
7. Importers shall, further to a reasoned request from a market surveillance authority, provide itat least 6 months before placing on the market or putting into service an EHR system, provide market surveillance authorities of the Member States concerned with all the information and documentation necessary to demonstrate the conformity of an EHR system in the official language of the Member State where the market surveillance authority is located. TheyImporters shall cooperate with that authority, at its request, and with the manufacturer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II, or to ensure that their EHR systems are withdrawn or recalled.
Amendment 119 #
Proposal for a regulation
Article 19 – paragraph 7 a (new)
Article 19 – paragraph 7 a (new)
7 a. If the importer fails to cooperate with market surveillance authorities or if the information and documentation provided is incomplete or incorrect, market surveillance authorities shall take all appropriate measures to prohibit or restrict its EHR system from being available on the market, to withdraw it from the market or to recall it until the importer cooperates or provides complete and correct information.
Amendment 120 #
Proposal for a regulation
Article 19 – paragraph 7 b (new)
Article 19 – paragraph 7 b (new)
7 b. Importers shall verify whether the communication channels referred to in Article 17(3c), are publicly available to users allowing them to submit complaints and communicate any risk related to their health and safety or to other aspects of public interest protection and of any serious incident involving an EHR system. If such channels are not available, the importer shall provide for them, taking into account accessibility needs for persons with disabilities.
Amendment 121 #
Proposal for a regulation
Article 19 – paragraph 7 c (new)
Article 19 – paragraph 7 c (new)
7 c. Importers shall investigate complaints and information on incidents involving an EHR system they made available on the market and file those complaints, as well as of systems recalls and any corrective measures taken to bring the EHR system into conformity, in the register referred to in Article 17(3e) or in their own internal register. Importers shall keep the manufacturer, distributors and, where relevant, authorised representatives informed in a timely manner of the investigation performed and of the results of the investigation.
Amendment 122 #
Proposal for a regulation
Article 19 – paragraph 7 d (new)
Article 19 – paragraph 7 d (new)
7 d. Personal data stored in the internal register of complaints shall only be those personal data that are necessary for the importer to investigate the complaint. Such data shall only be kept as long as it is necessary for the purpose of investigation and no longer than five years after they have been encoded.
Amendment 123 #
Proposal for a regulation
Article 20 – paragraph 1 – point c
Article 20 – paragraph 1 – point c
(c) the EHR system is accompanied by the information sheet referred to in Article 25 and appropriaby clear and complete instructions for use in accessible formats for persons with disabilities;
Amendment 124 #
Proposal for a regulation
Article 20 – paragraph 3
Article 20 – paragraph 3
3. Where a distributor considers or has reason to believe that an EHR system is not in conformity with the essential requirements laid down in Annex II, it shall not make the EHR system available on the market until it has been brought into conformity. Furthermore, the distributor shall inform without undue delaymmediately inform the manufacturer or the importer, as well as the market surveillance authorities of the Member states where the EHR system has been made available on the market, to that effect. Where a distributor considers or has reason to believe that an EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately inform the market surveillance authority of the Member State in which the distributor is established, as well as the manufacturer, the importer and where applicable, the authorised representative.
Amendment 125 #
Proposal for a regulation
Article 20 – paragraph 4
Article 20 – paragraph 4
4. Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, and with the manufacturer, the importer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring their EHR systems in conformity with the essential requirements laid down in Annex II. or to ensure that their EHR systems are withdrawn or recalled.
Amendment 127 #
Proposal for a regulation
Article 20 – paragraph 4 a (new)
Article 20 – paragraph 4 a (new)
4 a. Distributors that have received complaints from users about suspected incidents involving an EHR system they made available on the market, shall immediately forward this information to the manufacturer and, where applicable, the manufacturer's authorised representative and the importer. They shall keep a register of complaints, of non-conforming EHR systems and of recalls and withdrawals, and keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring and provide them with any information upon their request.
Amendment 128 #
Proposal for a regulation
Article 21 – title
Article 21 – title
Cases in which obligations of manufacturers of an EHR system apply to importers and distribuother economic operators
Amendment 130 #
Proposal for a regulation
Article 21 – paragraph 1
Article 21 – paragraph 1
An importer or distributoeconomic operator other than the manufacturer 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.
Amendment 137 #
Proposal for a regulation
Article 23 – paragraph 5
Article 23 – paragraph 5
5. Where common specifications covering interoperability and security requirements of EHR systems affect medical devices or high-risk AI systems falling under other acts, such as Regulations (EU) 2017/745 or […] [AI Act COM/2021/206 final], the adoption of those common specifications mayshall be preceded by a consultation with the Medical Devices Coordination Group (MDCG) referred to in Article 103 of Regulation (EU) 2017/745 or the European Artificial Intelligence Board referred to in Article 56 of Regulation […] [AI Act COM/2021/206 final], as applicable, as well as the European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679 .
Amendment 138 #
Proposal for a regulation
Article 23 – paragraph 6
Article 23 – paragraph 6
6. Where common specifications covering interoperability and security requirements of medical devices or high- risk AI systems falling under other acts such as Regulation (EU) 2017/745 or Regulation […] [AI Act COM/2021/206 final], impact EHR systems, the adoption of those common specifications shall be preceded by a consultation with the EHDS Board, especially its subgroup for Chapters II and III of this Regulation, and, where applicable, the European Data Protection Board referred to in Article 68 of Regulation (EU) 2016/679.
Amendment 139 #
Proposal for a regulation
Article 24 – paragraph 1
Article 24 – paragraph 1
1. ThManufacturers shall draw up and keep up-to-date technical documentation shall be drawn up before the EHR system is placed on the market or put into service and shall be . The technical documentation shall be submitted to the markept up-to-datsurveillance authorities of the Member States concerned at least 6 months before an EHR system is placed on the market or put into service.
Amendment 140 #
Proposal for a regulation
Article 24 – paragraph 2
Article 24 – paragraph 2
2. The technical documentation shall be drawn up in such a way as to demonstrate that the EHR system complies with the essential requirements laid down in Annex II and provide market surveillance authorities with all the necessary information to assess the conformity of the EHR system with those requirements. It shall contain, at a minimum, the elements set out in Annex III. In case the system or any part of it complies with European standards or common specifications, the list of the relevant European standards and common specifications shall also be indicated.
Amendment 141 #
Proposal for a regulation
Article 25 – paragraph 2 – point a
Article 25 – paragraph 2 – point a
(a) the identity, registered trade name or registered trademark, and the contact details of the manufacturer, including the postal and electronic address and the telephone number and, where applicable, of its authorised representative;
Amendment 142 #
Proposal for a regulation
Article 25 – paragraph 3
Article 25 – paragraph 3
3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by allowing manufacturers to enter the information referred to in paragraph 2 into the EU database of EHR systems and wellness applications referred to in Article 32, as an alternative to supplying the information sheet referred to in paragraph 1 with the EHR system.
Amendment 143 #
Proposal for a regulation
Article 26 – paragraph 1
Article 26 – paragraph 1
1. The EU declaration of conformity shall state that the manufacturer of the EHR system has demonstrated that the essential requirements laid down in Annex II have been fulfilled. The manufacturer shall regularly update the EU declaration of conformity.
Amendment 144 #
Proposal for a regulation
Article 26 – paragraph 4
Article 26 – paragraph 4
4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the conformity ofcompliance with the requirements of this Regulation and of all Union acts applicable to the EHR system.
Amendment 145 #
Proposal for a regulation
Article 26 – paragraph 4 a (new)
Article 26 – paragraph 4 a (new)
4 a. The Commission is empowered to adopt delegated acts in accordance with Article 67 amending the minimum content of the EU declaration of conformity set out in Annex IV.
Amendment 147 #
Proposal for a regulation
Article 27 – paragraph 1 a (new)
Article 27 – paragraph 1 a (new)
1 a. The CE marking shall be affixed before making the EHR system available on the market.
Amendment 148 #
Proposal for a regulation
Article 27 – paragraph 2 a (new)
Article 27 – paragraph 2 a (new)
2 a. Where EHR systems are subject to other Union legislation in respect of aspects not covered by this Regulation, which also requires the affixing of the CE marking, the CE marking shall indicate that the systems also fulfil the requirements of that other legislation.
Amendment 151 #
Proposal for a regulation
Article 29 – paragraph 1 a (new)
Article 29 – paragraph 1 a (new)
1 a. Where a market surveillance authority, on the basis of the information and documentation demonstrating the conformity of an EHR system provided by the relevant economic operator, considers or has reason to believe that the EHR system presents a risk to the health or safety of natural persons or to other aspects of public interest protection, including before the EHR system is placed on the market or put into service, it shall perform all the necessary checks to ensure that the system is compliant with this Regulation.
Amendment 152 #
Proposal for a regulation
Article 29 – paragraph 1 b (new)
Article 29 – paragraph 1 b (new)
1 b. Where a market surveillance authority considers or has reason to believe that an EHR system has caused damage to the health or safety of natural persons or to other aspects of public interest protection, it shall immediately provide information and documentation, as applicable, to the affected person or user and, as appropriate, other third parties affected by the damage caused to the person or user, without prejudice to data protection rules.
Amendment 153 #
Proposal for a regulation
Article 29 – paragraph 4 – subparagraph 2
Article 29 – paragraph 4 – subparagraph 2
Such notification shall be made, without prejudice to incident notification requirements under Directive (EU) 2016/1148, immediately after the manufacturer has established a causal link between the EHR system and the serious incident or the reasonable likelihood of such a link, and, in any event, not later than 157 days after the manufacturer becomes aware of the serious incident involving the EHR system.
Amendment 154 #
Proposal for a regulation
Article 30 – paragraph 1 – introductory part
Article 30 – paragraph 1 – introductory part
1. Where a market surveillance authority makes, inter alia, one of the following findings, it shall require the manufacturer of the EHR system concerned, its authorised representative and all other relevant economic operators to put an end to the non-compliance concernedbring the EHR system into conformity:
Amendment 155 #
Proposal for a regulation
Article 30 – paragraph 1 – point a
Article 30 – paragraph 1 – point a
(a) the EHR system is not in conformity with essential requirements laid down in Annex II and with the common specifications in accordance with Article 23;
Amendment 156 #
Proposal for a regulation
Article 30 – paragraph 1 – point b
Article 30 – paragraph 1 – point b
(b) the technical documentation is either not available or not complete, or not in accordance with Article 24;
Amendment 157 #
Proposal for a regulation
Article 30 – paragraph 1 – point b a (new)
Article 30 – paragraph 1 – point b a (new)
Amendment 158 #
Proposal for a regulation
Article 30 – paragraph 1 – point c
Article 30 – paragraph 1 – point c
(c) the EU declaration of conformity has not been drawn up or has not been drawn up correctly as referred to in Article 26;
Amendment 159 #
Proposal for a regulation
Article 30 – paragraph 1 – point d a (new)
Article 30 – paragraph 1 – point d a (new)
(d a) the registration obligations of Article 32 has not been fulfilled.
Amendment 160 #
Proposal for a regulation
Article 31
Article 31
Amendment 163 #
Proposal for a regulation
Article 32 – title
Article 32 – title
Registration of EHR systems and wellness applications
Amendment 164 #
Proposal for a regulation
Article 32 – paragraph 1
Article 32 – paragraph 1
1. The Commission shall establish and maintain a publicly available database with information on EHR systems for which an EU declaration of conformity has been issued pursuant to Article 26 and wellness applications for which a label has been issued pursuant to Article 31.
Amendment 165 #
Proposal for a regulation
Article 32 – paragraph 2
Article 32 – paragraph 2
2. Before placing on the market or putting into service an EHR system referred to in Article 14 or a wellness application referred to in Article 31, the manufacturer of such EHR system or wellness application or, where applicable, its authorised representative shall register the required data into the EU database referred to in paragraph 1.
Amendment 166 #
Proposal for a regulation
Article 32 – paragraph 4
Article 32 – paragraph 4
4. The Commission is empowered to adopt delegated acts in accordance with Article 67 to determine the list of required data to be registered by the manufacturers of EHR systems and wellness applications pursuant to paragraph 2.
Amendment 191 #
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. 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 195 #
Proposal for a regulation
Article 69 – paragraph 1
Article 69 – paragraph 1
Member States shall lay down the rules on penalties applicable to infringements of this Regulation and shall take all measures necessary to ensure that they are properly and effectively implemented. The penalties shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.
Amendment 196 #
Proposal for a regulation
Article 69 – paragraph 1 a (new)
Article 69 – paragraph 1 a (new)
When deciding on the amount of the penalty in each individual case, all relevant circumstances of the specific situation shall be taken into account and due regard shall be given to the following: (a) the nature, gravity and duration of the infringement and of its consequences, taking into account the nature, scope as well as the number of users affected and the level of damage suffered by them; (b) whether penalties have been already applied by other competent authorities to the same infringing party; (c) the size and market share of the economic operator committing the infringement; (d) the intentional or negligent character of the infringement; (e) any action taken by the infringing party to mitigate the damage of the infringement; (f) the degree of responsibility of the infringing party taking into account technical and organisational measures implemented to prevent the infringement; (g) the degree of cooperation with the competent authorities, in order to remedy the infringement and mitigate the possible adverse effects of the infringement; (h) the manner in which the infringement became known to the competent authorities, in particular whether, and if so to what extent, the infringing party notified the infringement; (i) any other aggravating or mitigating factor applicable to the circumstances of the case, such as financial benefits gained, or losses avoided, directly or indirectly, from the infringement.
Amendment 199 #
Proposal for a regulation
Article 69 – paragraph 1 b (new)
Article 69 – paragraph 1 b (new)
The non-compliance of an EHR system with any requirements or obligations under this Regulation, including the supply of incorrect, incomplete or misleading information to national competent authorities, shall be subject to penalties of up to 20 000 000 EUR or up to 6% of its total worldwide annual turnover for the preceding financial year, whichever is higher.
Amendment 202 #
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. The evaluation shall include an assessment of the self-certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies, as well as the need to designate a public testing facility of a Member State as a Union testing facility, pursuant to Article 21 of Regulation (EU) 2019/1020.
Amendment 205 #
Proposal for a regulation
Article 70 – paragraph 2
Article 70 – paragraph 2
2. After 75 years from the entry into force of this Regulation, the Commission shall carry out an overall evaluation of this Regulation, 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.
Amendment 209 #
Proposal for a regulation
Article 71 a (new)
Article 71 a (new)
Article 71 a Representative Actions Directive (EU) 2020/1828 shall apply to the representative actions brought against infringements by economic operators of provisions of this Regulation that harm or may harm the collective interests of consumers.