20 Amendments of Tomislav SOKOL related to 2022/0140(COD)
Amendment 519 #
Proposal for a regulation
Article 2 – paragraph 2 – point c
Article 2 – paragraph 2 – point c
(c) ‘electronic health data’ means personal or non-personal electronic health data; processed by providers in the context of healthcare. Such data may include actionable health data, which is collected and processed by providers in the context of healthcare which provides clinical measurements/values that are usable by patients, healthcare professionals and researchers.
Amendment 601 #
Proposal for a regulation
Article 2 – paragraph 2 – point ae a (new)
Article 2 – paragraph 2 – point ae a (new)
(ae a) “real-world data” means routinely collected data relating to patient health status or the delivery of health care from a variety of sources other than traditional clinical trials.
Amendment 608 #
Proposal for a regulation
Article 2 – paragraph 2 – point ae b (new)
Article 2 – paragraph 2 – point ae b (new)
(ae b) 'real-world evidence' means information derived from analysis of real- world data.
Amendment 609 #
Proposal for a regulation
Article 2 – paragraph 2 – point ae c (new)
Article 2 – paragraph 2 – point ae c (new)
(ae c) ‘online pharmacy’ means a pharmacy legally established as such in a Member State for which a pharmacist within the meaning of Directive 2005/36/EC is responsible, which, by means of information society services directed to the public dispenses prescriptions, offers medicinal products for sale or provides other pharmaceutical services.
Amendment 613 #
Proposal for a regulation
Article 2 – paragraph 2 – point ae d (new)
Article 2 – paragraph 2 – point ae d (new)
(ae d) ‘Derived data’ means the improved, corrected, or enriched dataset provided to the data holder in accordance with Article 37(1)(p) of this Regulation, as well as any new or different form of the original electronic health data created by the data user(s), including any alternative or different representation or abstraction of the original data or any new form which would enable the original data to be identified or reverse engineered.
Amendment 735 #
Proposal for a regulation
Article 4 – paragraph 3
Article 4 – paragraph 3
3. Member States and, where appropriate, local or regional authorities shall ensure that access to at least the priority categories of electronic health data referred to in Article 5 is made available to health professionals, including for cross- border care, through health professional access services. Health professionals who are in possession of recognised electronic identification means shall have the right to use those health professional access services, free of charge.
Amendment 739 #
Proposal for a regulation
Article 4 – paragraph 3 a (new)
Article 4 – paragraph 3 a (new)
3 a. Member States shall establish policies aimed at providing health professionals with the digital skills, competences, infrastructures and tools required to fulfill the obligations set out in paragraph 1 of this Article.
Amendment 847 #
Proposal for a regulation
Article 10 – paragraph 2 – point h
Article 10 – paragraph 2 – point h
(h) contribute, at Union level, and in cooperation with the local and regional level within the Member States, to the development of the European electronic health record exchange format and to the elaboration of common specifications addressing interoperability, security, safety or fundamental right concerns in accordance with Article 23 and of the specifications of the EU database for EHR systems and wellness applications referred to in Article 32;
Amendment 861 #
Proposal for a regulation
Article 10 – paragraph 2 – point m
Article 10 – paragraph 2 – point m
(m) cooperate with other relevant entities and bodies at local, regional, national or Union level, to ensure interoperability, data portability and security of electronic health data, as well as with stakeholders representatives, including patients’ representatives, healthcare providers, health professionals, industry associations;
Amendment 1186 #
Proposal for a regulation
Article 33 – paragraph 1 – point j
Article 33 – paragraph 1 – point j
(j) electronic health data from clinical trialsfully completed clinical trials in accordance with definitions in Article 2(2) and Article 2(26) of Regulation (EU) No 536/2014;
Amendment 1234 #
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Electronic health data entailingWithout prejudice to the law relating to the protectedion of intellectual property and trade secreindustrial property (including of trade secrets)(“IP rights”) and commercial property, and subject to other provisions of this Regulation, electronic health data entailing protected IP rights from private enterprises shall be made available for secondary use. Where such data is made available for secondary use, all measures necessary to preserve the confidentiality of IP rights and(including trade secrets) shall be taken. Data sharing for secondary use shall be based on a data sharing agreement pursuant to Articles 46.6(g) and 46a.
Amendment 1253 #
Proposal for a regulation
Article 33 – paragraph 5
Article 33 – paragraph 5
5. Where the consent of the natural person is required by national law, health data access bodies shall rely on the obligations laid down in this Chapter to provide access to electronic health data. Natural persons persons that are subjects to secondary use of health data shall have the right to decline the processing of their health data. Health data access bodies shall provide for an accessible and easily understandable opt-out mechanism, whereby natural persons must be offered the possibility to explicitly express their wish not to have all or part of their personal electronic health data processed for some or all secondary use purposes. In situation where natural persons explicitly express their wish to use opt-out mechanism to data holders, data holders shall direct natural persons to the health data access bodies. The exercise of this right to opt-out shall not affect the lawfulness of the processing that took place under this Chapter IV before the individual opted-out.
Amendment 1381 #
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 with the exception of communication in line with approved regulatory information or to provide up-to date, verifiable and complete scientific information to health care professionals for educational purpose in line with Directive 2001/83/EC;
Amendment 1407 #
Proposal for a regulation
Article 35 – paragraph 1 – point e a (new)
Article 35 – paragraph 1 – point e a (new)
(e a) unfair commercial use or other unfair competition, in accordance with Article 39 of TRIPS Agreement;
Amendment 1410 #
Proposal for a regulation
Article 35 – paragraph 1 – point e b (new)
Article 35 – paragraph 1 – point e b (new)
(e b) using data from private enterprises in regulatory or reimbursement submissions for any generic or biosimilar product without an agreement from the private sector data holder while the data holder’s referenced product is under patent or regulatory data protection (including such use of data outside of the EU), or equivalent protected data of non- medicinal products such as medical devices and software medical devices.
Amendment 1788 #
Proposal for a regulation
Article 46 – paragraph 1
Article 46 – paragraph 1
1. Health data access bodies shall assess if the application fulfils one of the purposes listed in Article 34(1) of this Regulation, if the requested data is necessary for the purpose listed in the application and if the requirements in this Chapter are fulfilled by the applicant. If that is the case, the health data access body shall issue a data permitand only after any data sharing agreement(s) on mutually agreed terms required by this Regulation, such as set out in Article 46a, are signed, the health data access body shall issue a data permit. However, any assessments by health data access bodies of an application concerning any data under Article 33(4) shall require the health data access bodies to consult the data holder(s).
Amendment 1834 #
Proposal for a regulation
Article 46 – paragraph 6 – point f a (new)
Article 46 – paragraph 6 – point f a (new)
(f a) When required, signed data sharing agreements, as set out in Article 46a;
Amendment 1846 #
Proposal for a regulation
Article 46 – paragraph 11
Article 46 – paragraph 11
11. Data users shall make public the results or output (in accordance with the definition of results/outputs under Article 2) of the secondary use of electronic health data, including information relevant for the provision of healthcare, no later than 18 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 and in compliance with minimum requirements of what needs to be published, but such that this will not prejudice the IP rights in the secondary use results/outputs, particularly if the secondary use is for development or innovation as referred to in Article 34(f) , no later than 18 months after the completion of the electronic health data processing with a possible extension to 24 months if requested by data users due to sensitivity of health data in relation to IP rights. 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 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 1861 #
Proposal for a regulation
Article 46 a (new)
Article 46 a (new)
Article 46 a 1. In order for electronic health data entailing IP rights, including trade secrets, and commercial property from private enterprises to be made available for secondary use, the data user must sign a data sharing agreement with each private enterprise data holder. Such electronic health data shall not be made available to any data user for the purposes of secondary use unless and until the data user has signed the data sharing agreement. 2. The data sharing agreement shall set out all necessary measures to protect all IP rights, including trade secrets, and commercial property entailed in the electronic health data and additional conditions of access requested by the data holder. In particular, without limitations, it may include any or all of: a. a restriction on any use of the electronic health data outside the scope of the secondary use purposes specified in the data permit, including for any prohibited secondary use as set out in this Regulation, including Article 35; b. an undertaking by the data user to preserve and not infringe or misappropriate the IP rights, including trade secrets, of the data holder, including to (i) preserve the confidentiality of the data holder’s confidential information, including trade secrets, and (ii) not perform or enable any reverse engineering or other activity to identify the confidential information, including trade secrets, of the data holder; c. provisions to ensure the confidentiality of the electronic health data and confidential information, including trade secrets, of the data holder. For example, (i) a right of prior review by the data holder of any public disclosures or applications for registerable IP rights, including patent applications, intended by or on behalf of the data user(s), including under this Regulation, that relates to or arises from the use of the electronic health data,(including the results or outputs, including the right to delay or prohibit the publication, and (ii) data security requirements reasonably required by the data holder; d. a requirement for the data user to notify the data holder of the creation of any new IP from its use of the electronic health data and for granting the data holder non-exclusive, fully-paid up and royalty-free licence rights enabling the data holder and its affiliates to use any new IP, results and outputs for its own business purposes. Such licence shall only be sub-licensable to third parties working in collaboration with, or on behalf of, the data holder or one of its affiliates for the aforesaid purposes. Such a licence shall be non-transferable, except where needed in order to commercialise an existing product of the data holder or any of its affiliates; e. audit rights for the data holder to ensure compliance of the processing with the data sharing agreement; f. the data holder to own all and any derived data created by the data user(s), a requirement for the data user to assign to and notify the data holder of any derived data and to enable the data holder to obtain a copy of it, and the rights, obligations and undertakings of, and the restrictions on, the data user as it relates to the electronic health data and confidential information, including trade secrets, of the data holder to apply mutatis mutandis to any and all derived data.
Amendment 2047 #
Proposal for a regulation
Article 65 – paragraph 1 – point b – introductory part
Article 65 – paragraph 1 – point b – introductory part
(b) to issue written contributions and to exchange best practices on matters related to the coordination of the implementation at Member State level of this Regulation and of the delegated and implementing acts adopted pursuant to it, taking into account the regional and local level, in particular as regards: