19 Amendments of Sirpa PIETIKÄINEN related to 2022/0140(COD)
Amendment 160 #
Draft legislative resolution
Citation 4 a (new)
Citation 4 a (new)
— Having regard to the WHO One Health Initiative,
Amendment 172 #
Proposal for a regulation
Recital 1
Recital 1
(1) The aim of this Regulation is to establish the European Health Data Space (‘EHDS’) in order to improve access to and control by natural persons over their personal electronic health data in the context of healthcare (primary use of electronic health data), as well as for other purposes that would benefit the society such as research, innovation, policy- making, patient safety, personalised medicine, official statistics or regulatory activities (secondary use of electronic health data), and in line with the objectives of the WHO One Health Initiative. In addition, the goal is to improve the functioning of the internal market by laying down a uniform legal framework in particular for the development, marketing and use of electronic health record systems (‘EHR systems’) in conformity with Union values.
Amendment 193 #
Proposal for a regulation
Recital 5
Recital 5
(5) More and more Europeans cross national borders to work, study, visit relatives or to travel. To facilitate the exchange of health data, and in line with the need for empowering citizens, they should be able to access their health data in an electronic format that can be recognised and accepted across the Union. Such personal electronic health data could include personal data related to the physical or mental health of a natural person, including the provision of health care services, which reveal information about their health status, personal data relating to the inherited or acquired genetic characteristics of a natural person which give unique information about the physiology or the health of that natural person and which result, in particular, from an analysis of a biological sample from the natural person in question, as well as data determinants of health, such as behaviour, environmental, physical influences, medical care, social or educational factors. Electronic health data also includes data that has been initially collected for research, statistics, policy making or regulatory purposes and may be made available according to the rules in Chapter IV. The electronic health data concern all categories of those data, irrespective to the fact that such data is provided by the data subject or other natural or legal persons, such as health professionals, or is processed in relation to a natural person’s health or well-being and should also include inferred and derived data, such as diagnostics, tests and medical examinations, as well as data observed and recorded by automatic means. Such way of easily accessing a citizen’s health data could for example be through a renewed European Health Insurance Card with an access tool to health data and that is interoperable in all Member States.
Amendment 203 #
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. To enable free movement of personal health data in the Union, Member States shall ensure their EHR systems are interoperable within the Member States and can operate with the EHR systems of other Member States as well as with MyHealth@EU.
Amendment 213 #
Proposal for a regulation
Recital 9
Recital 9
(9) At the same time, it should be considered that immediate access to certain types of personal electronic health data may be harmful for the safety of natural persons, unethical or inappropriate. For example, it could be unethical to inform a patient through an electronic channel about a diagnosis with an incurable disease that is likely to lead to their swift passing instead of providing this information in a consultation with the patient first. Therefore, a possibility for limited exceptions in the implementation of this right should be ensured. Such an exception may be imposed by the Member States where this exception constitutes a necessary and proportionate measure in a democratic society, in line with the requirements of Article 23 of Regulation (EU) 2016/679. Such restrictions should be implemented by delaying the display of the concerned personal electronic health data to the natural person for a limited period. Where health data is only available on paper, if the effort to make data available electronically is disproportionate, there should be no obligation that such health data is converted into electronic format by Member States. Any digital transformation in the healthcare sector should aim to be inclusive and benefit also natural persons with limited ability to access and use digital services. Natural persons should be able to provide an authorisation to the natural persons of their choice, such as to their relatives or other close natural persons, enabling them to access or control access to their personal electronic health data or to use digital health services on their behalf. Such authorisations may also be useful for convenience reasons in other situations. Proxy services should be established by Member States to implement these authorisations, and they should be linked to personal health data access services, such as patient portals on patient-facing mobile applications. The proxy services should also enable guardians to act on behalf of their dependent children; in such situations, authorisations could be automatic. In order to take into account cases in which the display of some personal electronic health data of minors to their guardians could be contrary to the interests or will of the minor, Member States should be able to provide for such limitations and safeguards in national law, as well as the necessary technical implementation. Personal health data access services, such as patient portals or mobile applications, should make use of such authorisations and thus enable authorised natural persons to access personal electronic health data falling within the remit of the authorisation, in order for them to produce the desired effect.
Amendment 217 #
Proposal for a regulation
Recital 10
Recital 10
(10) Some Member States allow natural persons to add electronic health data to their EHRs or to store additional information in their separate personal health record that can be accessed by health professionals. However, this is not a common practice in all Member States and therefore should be established by the EHDS across the EU. Information inserted by natural persons may not be as reliable as electronic health data entered and verified by health professionals, therefore it should be clearly marked to indicate the source of such additional data. Specifically relevant fields in the EHR should be clearly marked, such as patient ID, allergies, laboratory data, medical images, medical alerts, and current medication. Enabling natural persons to more easily and quickly access their electronic health data also further enables them to notice possible errors such as incorrect information or incorrectly attributed patient records and have them rectified using their rights under Regulation (EU) 2016/679. In such cases, natural person should be enabled to request rectification of the incorrect electronic health data online, immediately and free of charge, for example through the personal health data access service. Data rectification requests should be assessed and, where relevant, implemented by the data controllers on case by case basis, if necessary involving health professionals.
Amendment 251 #
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”. 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, chronic diseases and/or conditions and their medication 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. Such way of electronic format of data could also be a renewed European Health Insurance Card with an access tool to health data that is interoperable in all Member States. _________________ 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 280 #
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 and ensure patient safety 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. 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 326 #
Proposal for a regulation
Recital 38
Recital 38
(38) In the context of the EHDS, the electronic health data already exists and is being collected by healthcare providers, professional associations, public institutions, regulators, researchers, insurers etc. in the course of their activities. Some categories of data are collected primarily for the provisions of healthcare (e.g. electronic health records, genetic data, claims data, etc.), others are collected also for other purposes such as research, statistics, patient safety, regulatory activities or policy making (e.g. disease registries, policy making registries, registries concerning the side effects of medicinal products or medical devices, etc.). For instance, European databases that facilitate data (re)use are available in some areas, such as cancer (European Cancer Information System) or rare diseases (European Platform on Rare Disease Registration, ERN registries, etc.). These data should also be made available for secondary use. However, much of the existing health-related data is not made available for purposes other than that for which they were collected. This limits the ability of researchers, innovators, policy- makers, regulators and doctors to use those data for different purposes, including research, innovation, policy-making, regulatory purposes, patient safety or personalised medicine. In order to fully unleash the benefits of the secondary use of electronic health data, all data holders should contribute to this effort in making different categories of electronic health data they are holding available for secondary use. Provided that it complies with conditions of relevant articles of the Regulation (EU) 2016/679, it should also be possible to combine individual’s electronic health data with other types of data, for example consumer behavioural data for research purposes as long as the data is anonymised.
Amendment 381 #
Proposal for a regulation
Recital 47
Recital 47
(47) Health data access bodies and single data holders should be allowed to charge fees based on the provisions of Regulation […] [Data Governance Act COM/2020/767 final] in relation to their tasks. Such fees may take into account the situation and interest of SMEs, individual researchers or public bodies. Data holders should be allowed to also charge fees for making data available. Such fees should reflect the costs for providing such services but not be significantly higher or unjustified. Private data holders may also charge fees for the collection of data. In order to ensure a harmonised approach concerning fee policies and structure, the Commission may adopt implementing acts. Provisions in Article 10 of the Regulation [Data Act COM/2022/68 final] should apply for fees charged under this Regulation.
Amendment 429 #
Proposal for a regulation
Recital 55
Recital 55
(55) For the processing of electronic health data in the scope of a granted permit, the health data access bodies and the data users should be joint controllers in the sense of Article 26 of Regulation (EU) 2016/679, meaning that the obligations of joint controllers under that Regulation will apply. To support health data access bodies and data users, the Commission should, by means of an implementing act, provide a template for the joint controller arrangements health data access bodies and data users will have to enter into. In order to achieve an inclusive and sustainable framework for multi-country secondary use of electronic health data, a cross-border infrastructure should be established. HealthData@EU should accelerate the secondary use of electronic health data while increasing legal certainty, respecting the privacy of natural persons and being interoperable. Due to the sensitivity of health data, principles such as “privacy by design” and “bring questions to data instead of moving data” should be respected whenever possible. Authorised participants in HealthData@EU could be health data access bodies, research infrastructures established as an European Research Infrastructure Consortium (‘ERIC’) under Council Regulation (EC) No 723/200950or similar structures established under another Union legislation, as well as other types of entities, including infrastructures under the European Strategy Forum on Research Infrastructures (ESFRI), infrastructures federated under the European Open Science Cloud (EOSC). Other authorised participants should obtain the approval of the joint controllership group for joining HealthData@EU. On the other hand, HealthData@EU should enable the secondary use of different categories of electronic health data, including linking of the health data with data from other data spaces such as environment, agriculture, social etc. The Commission could provide a number of services within HealthData@EU, including supporting the exchange of information amongst health data access bodies and authorised participants for the handling of cross- border access requests, maintaining catalogues of electronic health data available through the infrastructure, network discoverability and metadata queries, connectivity and compliance services. The Commission may also set up a secure environment, allowing data from different national infrastructures to be transmitted and analysed, at the request of the controllers. The Commission digital strategy promote the linking of the various common European data spaces. For the health sector, interoperability with the sectors such as the environmental, social, agricultural and consumersectors may be relevant for additional insights on health determinants. For the sake of IT efficiency, rationalisation and interoperability of data exchanges, existing systems for data sharing should be reused as much as possible, like those being built for the exchange of evidences under the once only technical system of Regulation (EU) 2018/1724 of the European Parliament and of the Council51. _________________ 50 Council Regulation (EC) No 723/2009 of 25 June 2009 on the Community legal framework for a European Research Infrastructure Consortium (ERIC) (OJ L 206, 8.8.2009, p. 1). 51 Regulation (EU) 2018/1724 of the European Parliament and of the Council of 2 October 2018 establishing a single digital gateway to provide access to information, to procedures and to assistance and problem-solving services and amending Regulation (EU) No 1024/2012 (OJ L 295, 21.11.2018, p. 1).
Amendment 435 #
Proposal for a regulation
Recital 61
Recital 61
(61) Cooperation and work is ongoing between different professional organisations, the Commission and other institutions to set up minimum data fields and other characteristics of different datasets (registries for instance). This work is more advanced in areas such as cancer, rare diseases, and statistics and shall be taken into account when defining new standards. However, many datasets are not harmonised, raising comparability issues and making cross-border research difficult. For example, the terminology used in disease classification (essential for providing a diagnosis) varies across member states, where adoption of the latest update to the International Classification of Diseases could improve interoperability of such patient data. Therefore, more detailed rules should be set out in implementing acts to ensure a harmonised provision, coding and registration of electronic health data. Member States should work towards delivering sustainable economic and social benefits of European electronic health systems and services and interoperable applications, with a view to achieving a high level of trust and security, enhancing continuity of healthcare and ensuring access to safe and high-quality healthcare.
Amendment 437 #
Proposal for a regulation
Recital 62
Recital 62
(62) The Commission should support Member States in building capacity, interoperability and effectiveness in the area of digital health systems for primary and secondary use of electronic health data. Member States should be supported to strengthen their capacity and improve the interoperability of their digital health systems within and between Member States. Activities at Union level, such as benchmarking and exchange of best practices are relevant measures in this respect.
Amendment 750 #
Proposal for a regulation
Article 4 a (new)
Article 4 a (new)
Article 4 a Reform of the European Health Insurance Card 1. Member States shall impose a reform of the European Health Insurance Card so that it can be utilized in accessing citizens' digital health data. 2. It should be ensured that the European Health Insurance Card has a chip or an equivalent access tool to access citizens' health data when they seek healthcare in different Member State than in their own. The system needs to be interoperable in all Member States.
Amendment 961 #
Proposal for a regulation
Article 17 – paragraph 1 – point a
Article 17 – paragraph 1 – point a
(a) ensure that their EHR systems are in conformity with the essential requirements laid down in Annex II and with the common specifications in accordance with Article 23 and interoperable between Member States;
Amendment 1213 #
Proposal for a regulation
Article 33 – paragraph 1 a (new)
Article 33 – paragraph 1 a (new)
1 a. The data made available by data holders needs to be gender-aggregated and gender sensitive for research purposes, as well as analysed in a gender sensitive manner.
Amendment 1283 #
Proposal for a regulation
Article 33 – paragraph 8 a (new)
Article 33 – paragraph 8 a (new)
8 a. Provided that it complies with conditions of relevant articles of the Regulation (EU) 2016/679, it should also be possible in secondary use of data to combine individual’s electronic health data with other types of data, for example consumer behavioural data for research purposes as long as the data is anonymised.
Amendment 1306 #
Proposal for a regulation
Article 34 – paragraph 1 – point c
Article 34 – paragraph 1 – point c
(c) to produce national, multi-national and Union level official, gender sensitive statistics related to health or care sectors;
Amendment 1351 #
Proposal for a regulation
Article 34 – paragraph 1 – point h a (new)
Article 34 – paragraph 1 – point h a (new)
(h a) the need to analyse received data in gender sensitive manner.