Activities of Kateřina KONEČNÁ related to 2022/0140(COD)
Shadow reports (1)
REPORT on the proposal for a regulation of the European Parliament and of the Council on the European Health Data Space
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 (57)
Amendment 31 #
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. The implementation costs for connecting healthcare professionals to the EHDS, including new infrastructure and cybersecurity maintenance, capacity building and additional administrative data workload, cannot be carried by healthcare professionals themselves. Member States need to ensure that EU financial incentives are distributed evenly and fairly among those impacted by the proposal. The time spent by healthcare professionals validating and rectifying the electronic health record needs to be accounted for by Member States.
Amendment 57 #
Proposal for a regulation
Recital 68
Recital 68
(68) In order to ensure that EHDS fulfils its objectives, the power to adopt acts in accordance with Article 290 Treaty on the Functioning of the European Union should be delegated to the Commission in respect of different provisions of primary and secondary use of electronic health data. It is of particular importance that the Commission carry out appropriate consultations during its preparatory work, including at expert level, and that those consultations be conducted in accordance with the principles laid down in the Inter- institutional Agreement of 13 April 2016 on Better Law-Making52. In particular, to ensure equal participation in the preparation of delegated acts, the European Parliament and the Council receive all documents at the same time as Member States’ experts, and their experts systematically have access to meetings of Commission expert groups dealing with the preparation of delegated acts. _________________ 52 OJ L 123, 12.5.2016, p. 1In accordance with the Inter-Institutional Agreement of 13 April 2016 on Better Law-Making, the Commission will also resort to public consultations to gather the necessary expertise. In particular, health professionals and patients’ representatives shall be consulted prior to the adoption of delegated acts.
Amendment 58 #
Proposal for a regulation
Recital 69
Recital 69
(69) In order to ensure uniform conditions for the implementation of this Regulation, implementing powers should be conferred on the Commission. Those powers should be exercised in accordance with Regulation (EU) No 182/2011 of the European Parliament and of the Council53. _________________ 53 Regulation (EU) No 182/. In accordance with the Inter-Institutional Agreement of 13 April 20116 of the European Parliament and of the Council of 16 February 2011 laying down the rules and general principles concerning mechanisms for control by the Member States of the Commission's exercise of implementing powers (OJ L 55, 28.2.2011, p. 13)n Better Law-Making, the Commission will make use of expert groups, consult targeted stakeholders and carry out public consultation to gather broader expertise in the early preparation of draft implementing acts. In particular, health professionals and patients’ representatives shall be consulted. .
Amendment 162 #
Draft legislative resolution
Citation 8 a (new)
Citation 8 a (new)
— Having regard to the Commission's communication of 3 February 2021 on Europe’s Beating Cancer Plan (COM(2021)0044),
Amendment 164 #
Draft legislative resolution
Citation 8 b (new)
Citation 8 b (new)
— Having regard to the EU’s Framework Programme for Research and Innovation 2021-2027 (Horizon Europe) and the dedicated Horizon Europe Mission on Cancer,
Amendment 165 #
Draft legislative resolution
Citation 8 c (new)
Citation 8 c (new)
— Having regard to the European Parliament resolution of 16 February 2022 on strengthening Europe in the fight against cancer – towards a comprehensive and coordinated strategy (2020/2267(INI)), and the work of the Special Committee on Beating Cancer (BECA) in its mandate,
Amendment 192 #
Proposal for a regulation
Article 64 – paragraph 4
Article 64 – paragraph 4
4. Stakeholders and relevant third parties, including patients’ representatives of patients, healthcare presentativeofessionals, academia and researchers, shall be invited to attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.
Amendment 193 #
Proposal for a regulation
Article 67 – paragraph 4
Article 67 – paragraph 4
4. Before adopting a delegated act, the Commission shall consult experts designated by each Member State and targeted stakeholders, including health professionals and patients’ organisations, in accordance with the principles laid down in the Inter-institutional Agreement of 13 April 2016 on Better Law-Making.
Amendment 194 #
Proposal for a regulation
Article 68 – paragraph 2 a (new)
Article 68 – paragraph 2 a (new)
2 a. In accordance with the Inter- Institutional Agreement of 13 April 2016 on Better Law-Making, the Commission will make use of expert groups, consult targeted stakeholders and carry out public consultations to gather broader expertise in the early preparation of draft implementing acts.
Amendment 268 #
Proposal for a regulation
Recital 22
Recital 22
(22) Regulation (EU) No 910/2014 of the European Parliament and of the Council47 lays down the conditions under which Members States perform identification of natural persons in cross- border situations using identification means issued by another Member State, establishing rules for the mutual recognition of such electronic identification means. The EHDS requires a secure access to electronic health data, including in cross-border scenarios where the health professional and the natural person are from different Member States, to avoid cases of unauthorised access. At the same time, the existence of different means of electronic identification should not be a barrier for exercising the rights of natural persons and health professionals. The rollout of interoperable, cross-border identification and authentication mechanisms for natural persons and health professionals across the EHDS requires strengthening cooperation at Union level in the European Health Data Space Board (‘EHDS Board’).As the rights of the natural persons in relation to the access and transmission of personal electronic health data should be implemented uniformly across the Union, a strong governance and coordination is necessary at both Union and Member State level. Member States should establish relevant digital health authorities for the planning and implementation of standards for electronic health data access, transmission and enforcement of rights of natural persons and health professionals. Digital Health Authorities should also be in charge of promoting digital literacy and public awareness, while ensuring that the implementation of this Regulation contributes to reducing inequalities and does not discriminate against people lacking digital skills. In addition, governance elements are needed in Member States to facilitate the participation of national actors in the cooperation at Union level, channelling expertise and advising the design of solutions necessary to achieve the goals of the EHDS. Digital health authorities exist in most of the Member States and they deal with EHRs, interoperability, security or standardisation. Digital health authorities should be established in all Member States, as separate organisations or as part of the currently existing authorities. _________________ 47 Regulation (EU) No 910/2014 of the European Parliament and of the Council of 23 July 2014 on electronic identification and trust services for electronic transactions in the internal market and repealing Directive 1999/93/EC (OJ L 257, 28.8.2014, p. 73).
Amendment 289 #
Proposal for a regulation
Recital 26
Recital 26
(26) In addition to services in MyHealth@EU for the exchange of personal electronic health data based on the European electronic health record exchange format, other services or supplementary infrastructures may be needed for example in cases of public health emergencies or where the architecture of MyHealth@EU is not suitable for the implementation of some use cases. Examples of such use cases include support for vaccination card functionalities, including the exchange of information on vaccination plans, or verification of vaccination certificates or other health-related certificates. This would be also important for introducing additional functionality for handling public health crises, such as support for contact tracing for the purposes of containing infectious diseases. Furthermore, in accordance with the strengthened role of the European Center for Diseases Control and Prevention (ECDC), Member States should ensure that the ECDC receives real-time and comparable data on vaccination including vaccination coverage listed on the ECDC vaccine schedule and vaccine preventable disease surveillance. Connection of national contact points for digital health of third countries or interoperability with digital systems established at international level should be subject to a check ensuring the compliance of the national contact point with the technical specifications, data protection rules and other requirements of MyHealth@EU. A decision to connect a national contact point of a third country should be taken by data controllers in the joint controllership group for MyHealth@EU.
Amendment 325 #
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 shouldmight 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 that would benefit the public interest.
Amendment 360 #
Proposal for a regulation
Recital 41
Recital 41
(41) The secondary use of health data under EHDS should enable the public, private, not for profit entities, as well as individual researchers to have access to health data for research, innovation, policy making, educational activities, patient safety, regulatory activitiin line with the purposes set out in this Regulation. Access to data for secondary use should contribute to the general interest of the society and lead to better, more affordable and accessible health products and services for personalised medicine, in line with the purposes set out in this Regulation. Access to data for secondary use should contribute to the general interest of the societyall natural persons. For this purpose pharmaceutical and medical devices companies must be fully transparent about the uses of EHDS data and its contribution to product development. In addition, to maximise public return, data access requests should include commitments on the availability and affordability of end products such as medicines. Activities for which access in the context of this Regulation is lawful may include using the electronic health data for tasks carried out by public bodies, such as exercise of public duty, including public health surveillance, planning and reporting duties, health policy making, ensuring patient safety, quality of care, and the sustainability of health care systems. Public bodies and Union institutions, bodies, offices and agencies may require to have regular access to electronic health data for an extended period of time, including in order to fulfil their mandate, which is provided by this Regulation. Public sector bodies may carry out such research activities by using third parties, including sub-contractors, as long as the public sector body remain at all time the supervisor of these activities. The provision of the data should also support activities related to scientific research (including private research), development and innovation, producing goods and services for the health or care sectors, such as innovation activities or training of AI algorithms that could protect the health or care of natural persons. In some cases, the information of some natural persons (such as genomic information of natural persons with a certain disease) could support the diagnosis or treatment of other natural personsof public interest. There is a need for public bodies to go beyond the emergency scope of Chapter V of Regulation […] [Data Act COM/2022/68 final]. However, the public sector bodies may request the support of health data access bodies for processing or linking data. This Regulation provides a channel for public sector bodies to obtain access to information that they require for fulfilling their tasks assigned to them by law, but does not extend the mandate of such public sector bodies. Any attempt to use the data for any measures detrimental to the natural person, to increase insurance premiums, to advertise products or treatments, or develop harmful products should be prohibited.
Amendment 525 #
Proposal for a regulation
Article 2 – paragraph 2 – point d
Article 2 – paragraph 2 – point d
(d) ‘primary use of electronic health data’ means the processing of personal electronic health data for the provision of health services to assess, maintain or restore the state of health of the natural person to whom that data relates, including the prescription, dispensation and provision of medicinal products and medical devices, as well as for relevant social security, and administrative or reimbursement services;
Amendment 598 #
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Article 2 – paragraph 2 – point ae a (new)
(ae a) ‘innovation activities’ means new products, services and models foreseen to improve health outcomes, cost efficiency and any other areas as recognised by the end-users of the innovation such as patients, healthcare professionals and health administrators.
Amendment 640 #
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 1 – point a
Article 3 – paragraph 5 – subparagraph 1 – point a
(a) establish one or more public electronic health data access services at national, regional or local level enabling the exercise of rights referred to in paragraphs 1 and 2;
Amendment 649 #
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 1 – point b
Article 3 – paragraph 5 – subparagraph 1 – point b
(b) establish one or more public proxy services enabling a natural person to authorise other natural persons of their choice to access their electronic health data on their behalf.
Amendment 651 #
Proposal for a regulation
Article 3 – paragraph 5 – subparagraph 2
Article 3 – paragraph 5 – subparagraph 2
The proxy services shall provide authorisations free of charge, electronically or on paper. They shall enable legal guardians or other representativesas recognised by national law to be authorised, either automatically or upon request, to access electronic health data of the natural persons whose affairs they administer. Member States may provide that authorisations do not apply whenever necessary for reasons related to the protection of the natural person, and in particular based on patient safety and ethics. The proxy services shall be interoperable among Member States.
Amendment 677 #
Proposal for a regulation
Article 3 – paragraph 8 – subparagraph 4 a (new)
Article 3 – paragraph 8 – subparagraph 4 a (new)
The Commission shall, by means of implementing acts, determine the requirements for the interoperable, cross- border mechanism for identifying data recipients and authenticating the receiving entity’s belonging to the health or social security sector.
Amendment 687 #
Proposal for a regulation
Article 3 – paragraph 9
Article 3 – paragraph 9
9. Notwithstanding Article 6(1), point (d), of Regulation (EU) 2016/679, natural persons shall have the right to restrict access of health professionals to all or part of their electronic health data. Member StatesThe European Commission shall establish the rules and specific safeguards regarding such restriction mechanisms. through a delegated act
Amendment 773 #
Amendment 786 #
Proposal for a regulation
Article 6 – paragraph 1 – point a
Article 6 – paragraph 1 – point a
(a) harmonised datasets containing electronic health data and defining structures, such as minimum data fields and data groups for the content representation of clinical content and other parts of the electronic health data, that can be enlarged to include disease-specific data;
Amendment 820 #
Proposal for a regulation
Article 8
Article 8
Amendment 863 #
Proposal for a regulation
Article 10 – paragraph 2 – point n a (new)
Article 10 – paragraph 2 – point n a (new)
(n a) promote public awareness and understanding of the benefits, risks, rules, safeguards and rights in relation to the EHDS system.
Amendment 878 #
Proposal for a regulation
Article 10 – paragraph 3
Article 10 – paragraph 3
3. The Commission is empowered to adopt delegated acts in accordance with Article 67 to supplement this Regulation by entrusting the digital health authorities with additional tasks necessary to carry out the missions conferred on them by this Regulation and to modify the content of the annual report.
Amendment 881 #
Proposal for a regulation
Article 10 – paragraph 5
Article 10 – paragraph 5
5. Essential health stakeholders’ representatives, including patient organisations, shall be present in the governance and decision-making structures of the digital health authority. In the performance of its tasks, the digital health authority shall actively cooperate with stakeholders’ representatives, including patients’ representatives. Members of the digital health authority shall avoid any conflicts of interest. The Commission shall be empowered to adopt delegated acts setting out what is likely to constitute a conflict of interests together with the procedure to be followed in such cases.
Amendment 915 #
Proposal for a regulation
Article 12 – paragraph 4
Article 12 – paragraph 4
4. 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). The European Union Agency for Cyber Security shall be consulted and closely involved in all steps of the procedure. Any measures adopted shall meet the highest technical standards in terms of security, confidentiality and protection of electronic health data.
Amendment 1173 #
Proposal for a regulation
Article 33 – paragraph 1 – point f
Article 33 – paragraph 1 – point f
(f) person generated electronic health data, including from medical devices, wellness applications or other digital health applications;
Amendment 1209 #
Proposal for a regulation
Article 33 – paragraph 1 – point n
Article 33 – paragraph 1 – point n
(n) electronic data related to insurance status, professional status, education, and lifestyle, wellness and behaviour data relevant to health;
Amendment 1266 #
Proposal for a regulation
Article 33 – paragraph 5 a (new)
Article 33 – paragraph 5 a (new)
5 a. Health data access bodies shall provide for an accessible and easily understandable opt-out mechanism, whereby natural persons shall be required to explicitly express their wish not to have their personal electronic health data processed for secondary use.
Amendment 1276 #
Proposal for a regulation
Article 33 – paragraph 7
Article 33 – paragraph 7
Amendment 1289 #
Proposal for a regulation
Article 34 – paragraph 1 – introductory part
Article 34 – paragraph 1 – introductory part
1. Health data access bodies shall only provide access to electronic health data referred to in Article 33 where the intended purpose of processing pursued by the applicant is of public interest and complies with: :
Amendment 1304 #
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 statistics related to health or care sectorsas defined in Regulation (EU) 223/2009 related to health or care sectors; such as levels of vaccination coverage both for cross-border health emergencies and routine immunisation;
Amendment 1322 #
Proposal for a regulation
Article 34 – paragraph 1 – point f
Article 34 – paragraph 1 – point f
(f) development and innovation activities for products or services contributing to public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices;, and ensuring benefit to the end-users of the innovation, such as patients, healthcare professionals and health administrators, which is defined in partnership with them.
Amendment 1335 #
Proposal for a regulation
Article 34 – paragraph 1 – point g
Article 34 – paragraph 1 – point g
(g) training, testing and evaluating of algorithms, including in medical devices, AI systems and digital health applications, contributing to the public health or social security, or ensuring high levels of quality and safety of health care, of medicinal products or of medical devices; and ensuring benefit to the end-users, such as patients, healthcare professionals and health administrators, which is defined in partnership with them;
Amendment 1387 #
Proposal for a regulation
Article 35 – paragraph 1 – point c
Article 35 – paragraph 1 – point c
(c) advertising or marketing activities towards health professionals, organisations in health or natural persons;
Amendment 1403 #
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(e a) automated individual decision- making, including profiling, in accordance with Article 22 of the Regulation (EU) 2016/679.
Amendment 1443 #
Proposal for a regulation
Article 36 – paragraph 3
Article 36 – paragraph 3
3. Essential health stakeholders’ representatives, including patient organisations, shall be present in the governance and decision-making structures of the health data access bodies. In the performance of their tasks, health data access bodies shall actively cooperate with stakeholders’ representatives, especially with representatives of patients, data holders and data users. Staff of health data access bodies shall avoid any conflicts of interest. Health data access bodies shall not be bound by any instructionsactively cooperate with the relevant bodies or authorities responsible for the application of EU and national data protection legislation, when making their decisions.
Amendment 1553 #
Proposal for a regulation
Article 38 – paragraph 1 – point e a (new)
Article 38 – paragraph 1 – point e a (new)
(e a) The record on who has been granted access to the data, the legal basis and the purpose, in accordance with Union and national law.
Amendment 1560 #
Proposal for a regulation
Article 38 – paragraph 2
Article 38 – paragraph 2
2. HAt the request of a natural person or a group representing natural persons, health data access bodies shall not be obliged to provide the specific information under Article 14 of Regulation (EU) 2016/679 to each natural person concerning the use of their health data for projects subject to a data permit and shall provide general public information on all the data permits issued pursuant to Article 46.
Amendment 1573 #
Proposal for a regulation
Article 38 – paragraph 4
Article 38 – paragraph 4
4. Member States shall regularly inform the public at large about the role and benefits of health data access bodies, as well as the risks and consequences linked with individual and collective digital health data rights arising from this Regulation.
Amendment 1603 #
Proposal for a regulation
Article 39 – paragraph 3
Article 39 – paragraph 3
Amendment 1654 #
Proposal for a regulation
Article 42 – paragraph 5 a (new)
Article 42 – paragraph 5 a (new)
5 a. The profits generated from the collection or use of health data shall be put to the benefit of Member States’ health systems.
Amendment 1666 #
Proposal for a regulation
Article 43 – paragraph 4
Article 43 – paragraph 4
4. Health data access bodies shall have the power to revoke the data permit issued pursuant to Article 46 and stop the affected electronic health data processing operation carried out by the data user in order to ensure the cessation of the non- compliance referred to in paragraph 3, immediately or within a reasonable time limit, and shall take appropriate and proportionate measures aimed at ensuring compliant processing by the data users. In this regard, the health data access bodies shall be able, where appropriate, to revoke the data permit and to exclude the data user from any access to electronic health data for a period of up to 5 years., and fines shall be imposed in accordance with Article 83 of the Regulation (EU) 2016/679
Amendment 1670 #
Proposal for a regulation
Article 43 – paragraph 4 a (new)
Article 43 – paragraph 4 a (new)
4 a. Any natural person affected by a breach of the data permit issued pursuant to Articles 35 and 46 shall have the right to an effective judicial remedy before a tribunal in accordance with Article 47 of the Charter of Fundamental Rights of the European Union.
Amendment 1718 #
Proposal for a regulation
Article 44 – paragraph 3 a (new)
Article 44 – paragraph 3 a (new)
3 a. Taking into account the state of the art and the nature, scope, context and purposes of processing as well as the risk of varying likelihood and severity for the rights and freedoms of natural persons, the health data access body shall apply appropriate anonymisation or pseudonymisation techniques to ensure a high level of security appropriate to the risk of re-identification.
Amendment 1739 #
Proposal for a regulation
Article 45 – paragraph 2 – point a a (new)
Article 45 – paragraph 2 – point a a (new)
(a a) demonstrable evidence that the stated purpose is of public interest;
Amendment 1757 #
Proposal for a regulation
Article 45 – paragraph 2 – point h a (new)
Article 45 – paragraph 2 – point h a (new)
(h a) a communication plan defining audiences and tools to publicly inform on the results or outcomes of the access to the data in accordance with Article 46(11).
Amendment 1817 #
Proposal for a regulation
Article 46 – paragraph 3
Article 46 – paragraph 3
3. A health data access body shall issue or refuse a data permit within 2 months of receiving the data access application. By way of derogation from that Regulation […] [Data Governance Act COM/2020/767 final], the health data access body may extend the period for responding to a data access application by 2 additional months where necessary, taking into account the complexity of the request. In such cases, the health data access body shall notify the applicant as soon as possible that more time is needed for examining the application, together with the reasons for the delay. Where a health data access body fails to provide a decision within the time limit, the data permit shall be issued.
Amendment 1852 #
Proposal for a regulation
Article 46 – paragraph 11
Article 46 – paragraph 11
11. Data users shall make public the results or output of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 182 months after the completion of the electronic health data processing or after having received the answer to the data request referred to in Article 47. Those results or output shall only contain anonymised data. The data user shall inform the health data access bodies from which a data permit was obtained and support them to make the information public in lay summaries on health data access bodies’ websites. Whenever the data users have used electronic health data in accordance with this Chapter, they shall acknowledge the electronic health data sources and the fact that electronic health data has been obtained in the context of the EHDS.
Amendment 1997 #
Proposal for a regulation
Article 61 – paragraph 1
Article 61 – paragraph 1
1. Non-personal electronic data made available by health data access bodies, that are based on a natural person’s electronic data falling within one of the categories of Article 33 [(a), (e), (f), (i), (j), (k), (m)] shall be deemed highly sensitive within the meaning of Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final], provided that their transfer to third countries presents a risk of re-identification through means going beyond those likely reasonably to be used, in view of the limited number of natural persons involved in that data, the fact that they are geographically scattered or the technological developments expected in the near future.
Amendment 2002 #
Proposal for a regulation
Article 61 – paragraph 2
Article 61 – paragraph 2
2. The protective measures for the categories of data mentioned in paragraph 1 shall depend on the nature of the data and anonymization techniques and shall be detailed in the Delegated Act under the empowerment set out in Article 5(13) of Regulation […] [Data Governance Act COM/2020/767 final].
Amendment 2008 #
Proposal for a regulation
Article 61 – paragraph 2 a (new)
Article 61 – paragraph 2 a (new)
2a. Where a health data access body has reason to believe that the transfer or access to non-personal data may lead to a risk of re-identification of non-personal or anonymised data, the health data access body shall request the relevant bodies or authorities competent pursuant to applicable data protection legislation for authorisation before transferring or giving access to data.
Amendment 2027 #
Proposal for a regulation
Article 64 – paragraph 1
Article 64 – paragraph 1
1. A European Health Data Space Board (EHDS Board) is hereby established to facilitate cooperation and the exchange of information among Member States. The EHDS Board shall be composed of the high level representatives of digital health authorities and health data access bodies of all the Member States, as well as representatives of health stakeholders, including patient organisations. Other national authorities, including market surveillance authorities referred to in Article 28, European Data Protection Board and European Data Protection Supervisor may be invited to the meetings, where the issues discussed are of relevance for them. The Board may also invite experts and observers to attend its meetings, and may cooperate with other external experts as appropriate. Other Union institutions, bodies, offices and agencies, research infrastructures and other similar structures shall have an observer role.
Amendment 2038 #
Proposal for a regulation
Article 64 – paragraph 4
Article 64 – paragraph 4
4. SHealth stakeholders and relevant third parties, including patients’ representatives, shall be invited toand relevant third parties, shall attend meetings of the EHDS Board and to participate in its work, depending on the topics discussed and their degree of sensitivity.
Amendment 2096 #
Proposal for a regulation
Article 69 a (new)
Article 69 a (new)
Amendment 2134 #
Proposal for a regulation
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
Annex I – Table A - MAIN CHARACTERISTICS OF ELECTRONIC HEALTH DATA CATEGORIES
Electronic health data category Main characteristics of electronic health data included under the category 1. Patient summary Electronic health data that includes important clinical facts related to an identified person and that is essential for the provision of safe and efficient healthcare to that person. The patient summary shall be harmonized across Member States and include a minimum data set that can be expanded to include disease-specific data. The following information is part of a patient summary: 1. Personal details 2. Contact information 3. Information on insurance 4. Allergies 5. Medical alerts 6. Vaccination/prophylaxis information, possibly in the form of a vaccination card 7. Current, resolved, closed or inactive problems 8. Textual information related to medical history 9. Medical devices and implants 10. Procedures 11. Functional status 12. Current and relevant past medicines 13. Social history observations related to health 14. Pregnancy history 15. Patient provided data 16. Observation results pertaining to the health condition 17. Plan of care 18. Information on a rare disease such as details about the impact or characteristics of the disease 18a (new) Blood type 2. Electronic prescription Electronic health data constituting a prescription for a medicinal product as defined in Article 3(k) of Directive 2011/24/EU. 3. Electronic dispensation Information on the supply of a medicinal product to a natural person by a pharmacy based on an electronic prescription. 4. Medical image and image Electronic health data related to the use of or produced report by technologies that are used to view the human in order to prevent, diagnose, monitor, or treat medical conditions. 5. Laboratory result Electronic health data representing results of studies performed notably through in vitro diagnostics such as clinical biochemistry, haematology, transfusion medicine, microbiology, immunology, and others, and including, where relevant, reports supporting the interpretation of the results. 6. Discharge report Electronic health data related to a healthcare encounter or episode of care and including essential information about admission, treatment and discharge of a natural person. Or. enJustification This amendment aims to promote patients' understanding and control of their personal health data. The blood type is a relevant type of data that should be added to the priority categories of health data.