11 Amendments of Erik POULSEN related to 2022/0140(COD)
Amendment 353 #
Proposal for a regulation
Recital 40 a (new)
Recital 40 a (new)
(40 a) Clinical trials are of utmost importance for fostering innovation within Europe in the benefit of European patients. In order to incentivise continuous European leadership in this domain, the sharing of the clinical trials data through the EHDS for secondary use should not compromise the scientific integrity of and investment in these clinical trials, in line with Regulation (EU) 536/2014.
Amendment 466 #
Proposal for a regulation
Article 1 – paragraph 1
Article 1 – paragraph 1
1. This Regulation establishes the European Health Data Space (‘EHDS’) by providing for rules, common standards and practices, infrastructures and a governance framework for the primary and secondary use of electronic health data. The European Health Data Space (‘EHDS’) shall, with respect for the principle of subsidiarity, complement and not replace Member States' national rules and policy principles for the use of both primary and secondary health data.
Amendment 789 #
Proposal for a regulation
Article 6 – paragraph 2 a (new)
Article 6 – paragraph 2 a (new)
2 a. For the purpose of paragraph 1, the Commission shall consult and cooperate with relevant stakeholders, including patients’ representatives, healthcare providers, health professionals, industry associations, national competence centres, as well as other Union and national authorities with competence in relevant areas, to encourage and contribute to the elaboration and adoption of a European electronic health record exchange format.
Amendment 1235 #
Proposal for a regulation
Article 33 – paragraph 4
Article 33 – paragraph 4
4. Electronic health data entailing protected intellectual property and trade secrets from private enterprisehealth data holders shall be made available for secondary use. Where such data is made available for secondary use, all technical and organisational measures necessary to preserve the confidentiality of IP rights and confidentiality of trade secrets shall be taken by the health data access body and in consultation with the data holder. This regulation is without prejudice to existing relevant Union legislation, including Directive 2004/48/EC, Directive 2001/29/EC, Directive (EU) 2016/943 and Directive (EU) 2019/790.
Amendment 1241 #
Proposal for a regulation
Article 33 – paragraph 4 a (new)
Article 33 – paragraph 4 a (new)
4 a. Health data holders shall, when making available to health data access bodies relevant electronic health data pursuant to Article 41(1) which contains intellectual property or trade secrets, inform the data access body that this is the case and indicate which parts of the datasets are concerned.
Amendment 1244 #
Proposal for a regulation
Article 33 – paragraph 4 b (new)
Article 33 – paragraph 4 b (new)
4 b. Should the health data access body be in no position to ensure the protection of IP rights and the confidentiality of trade secrets, it shall refuse the granting of the relevant health data access permit to the health data user.
Amendment 1246 #
Proposal for a regulation
Article 33 – paragraph 4 c (new)
Article 33 – paragraph 4 c (new)
4 c. Health data holders and health data users may conclude data sharing agreements with regards to the exchange of data containing IP and trade secrets. Such negotiations shall be overseen by the relevant health data access body.
Amendment 1247 #
Proposal for a regulation
Article 33 – paragraph 4 d (new)
Article 33 – paragraph 4 d (new)
4 d. Public sector bodies or Union institutions, agencies and bodies that obtain access to electronic health data entailing IP rights and trade secrets in the exercise of the tasks conferred to them by Union law or national law, shall take all specific technical and organisational measures necessary to preserve the confidentiality of such data.
Amendment 1467 #
Proposal for a regulation
Article 37 – paragraph 1 – point d
Article 37 – paragraph 1 – point d
(d) process electronic health data for the purposes set outreferred to in Article 343, including gathe collectionring, combination, preparation and disclosure, anonymisation and pseudonymisation of those data for secondary use on the basis of a data permit;
Amendment 1524 #
Proposal for a regulation
Article 37 – paragraph 2 – point a a (new)
Article 37 – paragraph 2 – point a a (new)
(a a) immediately notify the relevant supervisory authorities under Regulation (EU) 2016/679 and Regulation (EU) 2018/1725 of any potential issue related to the processing of personal electronic health data for secondary use to ensure application and enforcement of this Regulation and relevant provisions of the aforementioned Regulations, including penalties.
Amendment 1537 #
Proposal for a regulation
Article 37 – paragraph 4 a (new)
Article 37 – paragraph 4 a (new)
4 a. The EDPB shall provide health data acces bodies with specific guidelines and minimum standards of anonymisation and pseudonymisation for the purposes in this Regulation in order to ensure the same level of quality of anonymisation and pseudonymisation across Member States. The guidelines shall be based on state-of- the-art technology in this regard, which in turn shall be used by the health data access bodies when carrying out their task of anonymisation or pseudonymisation of electronic health data. The guidelines shall be regularly updated, in line with technological progress in this field.