Activities of Eugen JURZYCA 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 (47)
Amendment 34 #
Proposal for a regulation
Recital 11
Recital 11
(11) Natural persons should be further empowered to exchange and to provide access to personal electronic health data to the health professionals of their choice, going beyond the right to data portability as established in Article 20 of Regulation (EU) 2016/679. This is necessary to tackle objective difficulties and obstacles in the current state of play. Under Regulation (EU) 2016/679, portability is limited only to data processed based on consent or contract, which excludes data processed under other legal bases, such as when the processing is based on law, for example when their processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller. It only concerns data provided by the data subject to a controller, excluding many inferred or indirect data, such as diagnoses, or tests. Finally, under Regulation (EU) 2016/679, the natural person has the right to have the personal data transmitted directly from one controller to another only where technically feasible. That Regulation, however, does not impose an obligation to make this direct transmission technically feasible. All these elements limit the data portability and may limit its benefits for provision of high-quality, safe and efficient healthcare services to the natural person. Portability should give consumers more choice in the selection of healthcare provider, resulting in reduced healthcare costs, faster diagnosis and treatment time and overall better health outcomes.
Amendment 35 #
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. Such costs and health outcomes should be regularly assessed and quantified in order to measure the results of improved interoperability. 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. Cost reduction should be periodically reviewed and compared between Member States in order to identify best practices and deliver results in the whole internal market without potential fragmentation. 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 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 38 #
Proposal for a regulation
Recital 16 a (new)
Recital 16 a (new)
(16 a) Implementation of an interoperable European electronic health record exchange format should build on the existing investments and solutions already made in Member States. Existing health data infrastructures should be leveraged to allow continuity and build on existing expertise.
Amendment 39 #
Proposal for a regulation
Recital 19
Recital 19
(19) The level of availability of personal health and genetic data in an electronic format varies between Member States. The EHDS should make it easier for natural persons to have those data available in electronic format. This would also contribute to the achievement of the target of 100% of Union citizens having access to their electronic health records by 2030, as referred to in the Policy Programme “Path to the Digital Decade”. The EHDS should also contribute to other requirements, mainly to apply the once-only principle, where possible. In order to make electronic health data accesible and transmissible, such data should be accessed and transmitted in an interoperable common European electronic health record exchange format, at least for certain categories of electronic health data, such as patient summaries, electronic prescriptions and dispensations, medical images and image reports, laboratory results and discharge reports, subject to transition periods. Where personal electronic health data is made available to a healthcare provider or a pharmacy by a natural person, or is transmitted by another data controller in the European electronic health record exchange format, the electronic health data should be read and accepted for the provision of healthcare or for dispensation of a medicinal product, thus supporting the provision of the health care services or the dispensation of the electronic prescription. Commission Recommendation (EU) 2019/24345provides the foundations for such a common European electronic health record exchange format. The use of European electronic health record exchange format should become more generalised at EU and national level. While the eHealth Network under Article 14 of Directive 2011/24/EU of the European Parliament and of the Council46recommended Member States to use the European electronic health record exchange format in procurements, in order to improve interoperability, uptake was limited in practice, resulting in fragmented landscape and uneven access to and portability of electronic health data. _________________ 45 Commission Recommendation (EU) 2019/243 of 6 February 2019 on a European Electronic Health Record exchange format (OJ L 39, 11.2.2019, p. 18). 46 Directive 2011/24/EU of the European Parliament and of the Council of 9 March 2011 on the application of patients’ rights in cross-border healthcare (OJ L 88, 4.4.2011, p. 45).
Amendment 41 #
(19 a) The once-only principle means that natural or legal persons provide data only once to public sector or EHDS including EHR systems under the primary use regime, while public sector bodies take the necessary steps to use such data for secondary use, while respecting data protection rules. It would avoid duplication and unnecessary burdens to healthcare professionals and providers, to provide data again.
Amendment 42 #
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 and exchange best practices 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 44 #
Proposal for a regulation
Recital 24
Recital 24
(24) Access to and transmission of electronic health data is relevant in cross- border healthcare situations, as it may support continuity of healthcare when natural persons travel to other Member States or change their place of residence. Continuity of care and rapid access to personal electronic health data is even more important for residents in border regions, crossing the border frequently to get health care. In many border regions, some specialised health care services may be available closer across the border rather than in the same Member State. An infrastructure is needed for the transmission of personal electronic health data across borders, in situations where a natural person is using services of a healthcare provider established in another Member State. A voluntary infrastructure for that purpose, MyHealth@EU, has been established as part of the actions provided for in Article 14 of Directive 2011/24/EU. Through MyHealth@EU, Member States started to provide natural persons with the possibility to share their personal electronic health data with healthcare providers when travelling abroad. To further support such possibilities, the participation of Member States in the digital infrastructure MyHealth@EU should become mandatory. Making interoperability mandatory would overcome the market coordination failure. Introducing interoperability standards at EU level is likely to be more effective than at national level. All Member States should join the infrastructure and connect healthcare providers and pharmacies to it, as this is necessary for the implementation of the rights of natural persons to access and make use of their personal electronic health data regardless of the Member State. The infrastructure should be gradually expanded to support further categories of electronic health data.
Amendment 46 #
Proposal for a regulation
Recital 25 a (new)
Recital 25 a (new)
(25 a) EHDS as a whole is a federated structure that can accommodate centralisation or decentralisation based on the Commission and Member States preferences in order to deliver resilient, secure and interoperable infrastructure. The structure should be chosen based on the in-depth analysis for each part of the Regulation.
Amendment 47 #
Proposal for a regulation
Recital 29
Recital 29
(29) Software or module(s) of software which falls within the definition of a medical device or high-risk artificial intelligence (AI) system should be certified in accordance with Regulation (EU) 2017/745 of the European Parliament and of the Council49and Regulation […] of the European Parliament and of the Council [AI Act COM/2021/206 final], as applicable. The essential requirements on interoperability of this Regulation should only apply to the extent that the manufacturer of a medical device or high- risk AI system, which is providing electronic health data to be processed as part of the EHR system, claims interoperability with such EHR system. In such case, the provisions on international standards andcommon specifications for EHR systems should be applicable to those medical devices and high-risk AI systems. _________________ 49 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC (OJ L 117, 5.5.2017, p. 1).
Amendment 48 #
Proposal for a regulation
Recital 33
Recital 33
(33) Compliance with essential requirements on interoperability and security should be demonstrated by the manufacturers of EHR systems through the implementation of common specifications. To that endinternational standards or common specifications, if duly justified where the international standard is not available. Applying common specifications may lead to the risk of using outdated data formats that are e.g., no longer secure and therefore restrictive, hampering patient safety, innovation and introducing additional barriers for European companies operating globally. To that end, in exceptional situation, implementing powers should be conferred on the Commission to determine such common specifications regarding datasets, coding systems, technical specifications, including standards, specifications and profiles for data exchange, as well as requirements and principles related to security, confidentiality, integrity, patient safety and protection of personal data as well as specifications and requirements related to identification management and the use of electronic identification. Digital health authorities should contribute to the development of such common specifications.
Amendment 49 #
Proposal for a regulation
Recital 33 a (new)
Recital 33 a (new)
(33 a) European or Interoperability standards should be aligned to the extent possible with best practices and existing technical solutions. The Commission should identify and analyse those best practices and commonly used existing technical solutions in Member States in order to avoid the burden of implementing additional regulatory requirements.
Amendment 56 #
Proposal for a regulation
Recital 51
Recital 51
(51) As the resources of health data access bodies are limited, they can apply prioritisation rules, for instthe Commission should issue guidance on prioritising public institutions before private entitiation criteria. In general, the request with potential overall highes,t but they should not make any discrimination between the national or from organisations from other Member States within the same category of prioritiesenefit for the citizens and Union should be prioritised, for example research and development of technologies and innovations in the healthcare sector. The common criteria should avoid fragmentation of the single market. The data user should be able to extend the duration of the data permit in order, for example, to allow access to the datasets to reviewers of scientific publication or to enable additional analysis of the dataset based on the initial findings. This would require an amendment of the data permit and may be subject to an additonal fee. However, in all the cases, the data permit should reflect theses additionals uses of the dataset. Preferably, the data user should mention them in their initial request for the issuance of the data permit. In order to ensure a harmonised approach between health data access bodies, the Commission should support the harmonisation of data permit.
Amendment 63 #
Proposal for a regulation
Article 1 – paragraph 4
Article 1 – paragraph 4
Directive 2013/87/EC
Article 1 – paragraph 4
Article 1 – paragraph 4
4. This Regulation shall be without prejudice to other Union legal acts regarding access to, sharing of or secondary use of electronic health data, or requirements related to the processing of data in relation to electronic health data, in particular Regulations (EU) 2016/679, (EU) 2018/1725, […] [Data Governance Act COM/2020/767 final], Directive (EU) 2016/943 and […] [Data Act COM/2022/68 final].
Amendment 69 #
Proposal for a regulation
Article 2 – paragraph 2 – point n
Article 2 – paragraph 2 – point n
Directive 2013/87/EC
Article 2 – paragraph 2 – point n
Article 2 – paragraph 2 – point n
(n) ‘EHR system’ (electronic health record system) means any appliance or software primarily intended by the manufacturer to be used for storing, intermediating, importing, exporting, converting, editing or viewconsolidate, share and retaing electronic health records;
Amendment 73 #
Proposal for a regulation
Article 2 – paragraph 2 – point o
Article 2 – paragraph 2 – point o
Directive 2013/87/EC
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, but related to healthcare, such as well-being and pursuing healthy life-styles;
Amendment 76 #
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 1 – point a Directive 2013/87/EC
Article 3 – paragraph 5 – subparagraph 1 – point a Directive 2013/87/EC
(a) establish one or more electronic health data access services at national, regional or local level, using centralised or decentralised structure, enabling the exercise of rights referred to in paragraphs 1 and 2;
Amendment 78 #
Proposal for a regulation
Article 6 – paragraph 1 – introductory part
Article 6 – paragraph 1 – introductory part
1. The Commission shall, by means of implementing acts, lay down the technical specifications for the priority categories of personal electronic health data referred to in Article 5, setting out the European electronic health record exchange format. When setting out the European electronic health record exchange format, the Commission shall primarily consider the existing international standards and the formats already used in the Member States. The format shall include the following elements:
Amendment 81 #
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 platform shall not enable the storage of electronic health data on the platform.
Amendment 82 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. TNo later than 12 months after the entry into force of the Regulation, the Commission shall, by means of implementing acts, adopt the necessary measures for the technical development of MyHealth@EU, detailed rules concerning the security, confidentiality and protection of electronic health data and the conditions and compliance checks necessary to join and remain connected to MyHealth@EU and conditions for temporary or definitive exclusion from MyHealth@EU. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 84 #
Proposal for a regulation
Article 14 – paragraph 3 a (new)
Article 14 – paragraph 3 a (new)
3 a. No later than 12 months after the entry into force of this Regulation, the Commission shall issue guidance to clarify requirement of the manufacturers to conduct conformity assessments under different Union legislation, such as Medical Device Regulations, Artificial Intelligence Act or EHDS. The guidance shall also clarify which rules apply to products that are covered by more regulated categories.
Amendment 86 #
Proposal for a regulation
Article 14 a (new)
Article 14 a (new)
Article 14 a Once only principle Natural or legal persons shall provide data to public sector bodies or EHR providers under the primary use regime only once, while public sector bodies may use such data for secondary purposes.
Amendment 131 #
Proposal for a regulation
Article 23 – title
Article 23 – title
Amendment 132 #
Proposal for a regulation
Article 23 – paragraph -1 (new)
Article 23 – paragraph -1 (new)
-1. The Commission shall promote European or international standards in respect of the essential requirements set out in Annex II. The Commission shall identify and analyse existing best practices in terms of interoperability or analyse the option to request development of European or internationally recognised standards, where appropriate.
Amendment 134 #
Proposal for a regulation
Article 23 – paragraph 1 – subparagraph 1
Article 23 – paragraph 1 – subparagraph 1
Amendment 135 #
Proposal for a regulation
Article 23 – paragraph 2 – point f
Article 23 – paragraph 2 – point f
(f) explanatory part, including any relevant implementation guidelines and justification why the use of international standard was not applicable or preferable.
Amendment 136 #
Proposal for a regulation
Article 23 – paragraph 4
Article 23 – paragraph 4
4. EHR systems, medical devices and high risk AI systems referred to in Article 14 that are in conformity with the international standards or common specifications referred to in paragraphs -1 or 1 shall be considered to be in conformity with the essential requirements covered by those specifications or parts thereof, set out in Annex II covered by those common specifications or the relevant parts of those common specifications.
Amendment 161 #
Proposal for a regulation
Article 31 – paragraph 3
Article 31 – paragraph 3
3. The Commission may consider the format and content of the label by use of European or international standards. In exceptional situations, if no international standard is fit for purpose, the Commission may, by means of implementing acts, determine the format and content of the label. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2).
Amendment 162 #
6. If the wellness application is embedded in a device, the accompanying label shallmay be placed on the device. 2D barcodes may also be used to display the label.
Amendment 169 #
Proposal for a regulation
Article 34 – paragraph 1 – point a a (new)
Article 34 – paragraph 1 – point a a (new)
(a a) activities for reasons of public interest in cases of serious public health threats.
Amendment 170 #
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, including supporting operational efficiency, improving the patient pathway and post- market monitoring to identify side effects and adverse events;
Amendment 171 #
Proposal for a regulation
Article 34 – paragraph 1 – point f a (new)
Article 34 – paragraph 1 – point f a (new)
(f a) development and innovation activities for products or services, including health economics and health outcomes research studies;
Amendment 172 #
Proposal for a regulation
Article 35 – paragraph 1 – introductory part
Article 35 – paragraph 1 – introductory part
Seeking access to and processing electronic health data obtained via a data permit issued pursuant to Article 46 for the following purposes shall be prohibited on case-by-case basis, if there is harm to patients or consumers from such use:
Amendment 173 #
Proposal for a regulation
Article 37 – paragraph 1 – introductory part
Article 37 – paragraph 1 – introductory part
1. Health data access bodies shallmay carry out the following tasks:
Amendment 175 #
Proposal for a regulation
Article 37 – paragraph 1 – point p
Article 37 – paragraph 1 – point p
Amendment 177 #
Proposal for a regulation
Article 42 – paragraph 1
Article 42 – paragraph 1
Amendment 179 #
Proposal for a regulation
Article 42 – paragraph 2
Article 42 – paragraph 2
Amendment 180 #
Proposal for a regulation
Article 42 – paragraph 3
Article 42 – paragraph 3
Amendment 181 #
Proposal for a regulation
Article 42 – paragraph 4
Article 42 – paragraph 4
4. Any fees charged to data users pursuant to this Article by the health data access bodies or data holders shall be transparent and proportionate to the cost of collecting and making electronic health data available for secondary use, objectively justified and shall not restrict competition. The support received by the data holder from donations, public national or Union funds, to set up, develop or update tat dataset shall be excluded from this calculation. The specific interests and needs of SMEs, public bodies, Union institutions, bodies, offices and agencies involved in research, health policy or analysis, educational institutions and healthcare providers shall be taken into account when setting the fees, by reducing those fees proportionately to their size or budget.
Amendment 182 #
Proposal for a regulation
Article 42 – paragraph 5
Article 42 – paragraph 5
Amendment 183 #
Proposal for a regulation
Article 42 – paragraph 6
Article 42 – paragraph 6
6. TNo later than 12 months after the entry into force of the Regulation, the Commission mayshall, by means of implementing acts, lay down principles and rules for the fee policies and fee structures. Those implementing acts shall be adopted in accordance with the advisory procedure referred to in Article 68(2). The fee structure shall maximise the data- driven network effects. The Commission may consider different solutions, including steep data access fees and provisions to remunerate the data provider, as a one-size-fits-all solution is not effective.
Amendment 184 #
Proposal for a regulation
Article 44 – paragraph 3 a (new)
Article 44 – paragraph 3 a (new)
3 a. The Commission shall, by means of implementing act, set out rules for risk- based anonymisation methodology, taking into consideration risk factors such as type of use, the safeguards in place, probability of re-identification of patients, sensitivity of type of data.
Amendment 187 #
Proposal for a regulation
Article 49 – paragraph 1
Article 49 – paragraph 1
1. Where an applicant requests access to electronic health data only from a single data holder in a single Member State, by way of derogation from Article 45(1), that applicant may file a data access application or a data request directly to the data holder. The applicant may file a data access application or a data request also by other means of sharing health data using existing infrastructures and registries that have established data flows, technical architectures, governance models and data access. The Regulation shall not impede existing data sharing initiatives already in place in Union and Member States in order to enhance the interoperability and data exchange in the internal market. The data access application shall comply with the requirements set out in Article 45 and the data request shall comply with requirements in Article 47. Multi-country requests and requests requiring a combination of datasets from several data holders shallmay be adressed to health data access bodies.
Amendment 189 #
Proposal for a regulation
Article 52 – paragraph 8
Article 52 – paragraph 8
8. The Member States and the Commission shall set up HealthData@EU to support and facilitate the cross-border access to electronic health data for secondary use, connecting the national contact points for secondary use of electronic health data of all Member States and authorised participants in that infrastructure. The Commission shall use a decentralised structure to facilitate the cross-border access to electronic health data for secondary use.
Amendment 201 #
Proposal for a regulation
Article 70 – paragraph 1
Article 70 – paragraph 1
1. After 5 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 a) the self-certification of EHR systems and reflect on the need to introduce a conformity assessment procedure performed by notified bodies. ; b) impacts of EHR systems on health outcomes for patients, including impact on standardised preventable and treatable mortality rate, life expectancy and patients’ healthcare utilisation (number of visits); c) impacts of EHR systems on healthcare economic performance; d) the data portability rights, including the impact on portability transaction costs and impact on selection of health service providers, healthcare costs, diagnosis and treatment speed; e) resilience and flexibility of the EHR systems and secondary data sharing framework in order to assess the readiness for potential future crisis; f) the implementation of technological innovations in the healthcare sector, including the development of new drugs and medical procedures; g) interoperability model in place in Member States, including best practices analysis concerning the cost-benefit results, transparency, decentralisation level; h) the analysis of market coordination failure before and after implementation and related monetary benefit from reducing information asymmetries between medical service providers per Member State; i) impact on information asymmetry between patients and health care providers per Member State; j) contribution to additional investments in the Union and related net impact on productivity and economic growth; k) quality and coverage of access of health professionals to the medical records of patients per Member State, including impact on reduction of duplications and errors and reduction of administration time and costs; l) overlaps and incoherences with other Union and national legislation, including the quantification of related extra costs of overlaps and related regulatory uncertainty. Inter alia, the assessment shall analyse alignment with the General Data Protection Regulation, Data Governance Act, Data Act, AI Act and Regulations on cybersecurity.
Amendment 204 #
Proposal for a regulation
Article 70 – paragraph 2
Article 70 – paragraph 2
Amendment 206 #
Proposal for a regulation
Article 70 – paragraph 3
Article 70 – paragraph 3
3. Member States shall provide the Commission with the information necessary for the preparation of that report. and shall report to the Commission on the common indicators.
Amendment 207 #
Proposal for a regulation
Article 70 – paragraph 3 a (new)
Article 70 – paragraph 3 a (new)
3 a. The Commission shall be empowered to adopt, by 12 months after the entry into force of this Regulation, delegated acts to supplement this Regulation in order to: (a) set out the common result and impact oriented indicators to be used for reporting on the progress and for the purpose of monitoring and evaluation of this Regulation; (b) measure the costs, benefits and other health and economic results including trends per Member State in order to compare the effectiveness of implementation of this Regulation;and (c) define a methodology for reporting by Member States. The Commission shall regularly revise and, if necessary, update the common indicators.