10 Amendments of Dolors MONTSERRAT related to 2022/0140(COD)
Amendment 219 #
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. In any case, a clearly distinct section in the clinical history separate from the information recorded by professionals should be created. 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. 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 239 #
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 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. None of the provisions of this regulation shall be construed as limiting health professionals’ obligation to behave in line with the relevant codes of conduct, ethical guidelines or other provisions governing ethical conduct with regard to the exchanging of, or access to, information, particularly in extreme or life-threatening situations.
Amendment 249 #
Proposal for a regulation
Recital 18 a (new)
Recital 18 a (new)
(18 a) In order to avoid an exponential quantitative increase in the risks of misuse (intentional or accidental) of individual citizens’ health data, a risk management plan should be defined and the ethical and deontological aspects of medical practice in this context of interoperability in the primary use of data and all ethical aspects and respect for citizens' autonomy in the secondary use of health data should be taken into account.
Amendment 262 #
Proposal for a regulation
Recital 21
Recital 21
(21) Under Article 168 of the Treaty Member States are responsible for their health policy, in particular for decisions on the services (including telemedicine) that they provide and reimburse. Different reimbursement policies should, however, not constitute barriers to the free movement of digital health services such as telemedicine, including online pharmacy services. When digital services accompany the physical provision of a healthcare service, the digital service should be included in the overall care provision.
Amendment 310 #
Proposal for a regulation
Recital 35
Recital 35
(35) Users of wellness applications, such as mobile applications, should be informed about the capacity of such applications to be connected and to supply data to EHR systems or to national electronic health solutions, in cases where data produced by wellness applications is useful for healthcare purposes. The capability of those applications to export data in an interoperable format is also relevant for data portability purposes. Where applicable, users should be informed about the compliance of such applications with interoperability and security requirements. However, given the large number of wellness applications and the limited relevance for healthcare purposes of the data produced by many of them, a certification scheme for these applications would not be proportionate. A voluntary labelling scheme should therefore be established as an appropriate mechanism for enabling the transparency for the users of wellness applications regarding compliance with the requirements, thereby supporting users in their choice of appropriate wellness applications with high standards of interoperability and security. Labelling schemes may also include information for users on data protection rights and an indication of whether the application provider or browser operator has access in any way to the data generated by the application. The Commission may set out in implementing acts the details regarding the format and content of such label.
Amendment 391 #
Proposal for a regulation
Recital 49
Recital 49
(49) Given the sensitivity of electronic health data, it is necessary to reduce risks on the privacy of natural persons by applying the data minimisation principle as set out in Article 5 (1), point (c) of Regulation (EU) 2016/679. Therefore, common standards for data anonymisation will be further developed and the use of anonymised electronic health data which is devoid ofithout any personal data should be made available when possible and if the data user asks itwill be facilitated wherever possible, excluding possibilities for re-use of data that cannot be anonymised or pseudonymised. Requests for pseudonymised data shall be duly justified. If the data user needs to use personal electronic health data, it should clearly indicate in its request the justification for the use of this type of data for the planned data processing activity. The personal electronic health data should only be made available in pseudonymised format and the encryption key can only be held by the health data access body. Data users should not attempt to re-identify natural persons from the dataset provided under this Regulation, subject to administrative or possible criminal penalties, where the national laws foresee this. However, this should not prevent, in cases where the results of a project carried out based on a data permit has a health benefit or impact to a concerned natural person (for instance, discovering treatments or risk factors to develop a certain disease), the data users would inform the health data access body, which in turn would inform the concerned natural person(s). Moreover, the applicant can request the health data access bodies to provide the answer to a data request, including in statistical form. In this case, the data users would not process health data and the health data access body would remain sole controller for the data necessary to provide the answer to the data request.
Amendment 475 #
Proposal for a regulation
Article 1 – paragraph 2 – point b
Article 1 – paragraph 2 – point b
(b) lays down rules for the placing on the market, making available on the market or putting into service of electronic health records systems (‘EHR systems’) in the Union for all electronic health applications that use data and produce wearables, health apps, telemedicine platforms, etc., with those data;
Amendment 546 #
Proposal for a regulation
Article 2 – paragraph 2 – point l
Article 2 – paragraph 2 – point l
(l) ‘telemedicine’ means the provision of healthcare services, including remote care and online pharmacies, through the use of information and communication technologies, in situations where the health professional and the patient (or several health professionals) are not in the same location;
Amendment 926 #
Proposal for a regulation
Article 12 – paragraph 6
Article 12 – paragraph 6
6. Member States shall ensure that pharmacies operating on their territories, including online pharmacies, are enabled to dispense electronic prescriptions issued by other Member States, under the conditions laid down in Article 11 of Directive 2011/24/EU. The pharmacies shall access and accept electronic prescriptions transmitted to them from other Member States through MyHealth@EU. Following dispensation of medicinal products based on an electronic prescription from another Member State, pharmacies shall report the dispensation to the Member State that issued the prescription, through MyHealth@EU.
Amendment 1217 #
Proposal for a regulation
Article 33 – paragraph 2
Article 33 – paragraph 2
2. The requirement in the first subparagraph shall not apply to data holders that qualify as micro enterprises as defined in Article 2 of the Annex to Commission Recommendation 2003/361/EC59. The requirement in the first subparagraph shall not apply to data holders who fall within the category of small enterprises in the context of health professional practices. _________________ 59 Commission Recommendation of 6 May 2003 concerning the definition of micro, small and medium-sized enterprises (OJ L 124, 20.5.2003, p. 36).