Changes from adopted text to adopted text

RemovedArticle 65 – paragraph 2 b (new): 2b. The EHDS board may commission studies and other initiatives in order to support the implementation and development of the EHDS.

RemovedArticle 65 – paragraph 2 c (new): 2c. The EHDS Board shall publish an annual report to include the implementation status of the EHDS and other relevant points of development, including with respect to cross-border health data interoperability, and related implementation challenges.

RemovedArticle 66 – paragraph 3: 3. Stakeholders and relevant third parties, including patients’, health professionals’, consumers’ and industry representatives, may be invited to attend meetings of the groups and to participate in their work.

RemovedArticle 66 – paragraph 6 a (new): 6a. The groups shall consult relevant experts when carrying out their tasks, as well as on technical implementing measures related to cybersecurity, confidentiality and data protection, in particular experts from ENISA, EDPB and EDPS.

RemovedArticle 67 – paragraph 2: 2. The power to adopt delegated acts referred to in Articles 5(2), 7(3), 9(2) 10(3), 13(3) 25(3), 32(4), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 52(13), 56(4) and 63a(2) shall be conferred on the Commission for an indeterminate period of time from the date of entry into force of this Regulation.

RemovedArticle 67 – paragraph 3: 3. The power to adopt delegated acts referred to in Articles 5(2), 7(3) 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 52(13), 56(4) and 63a(2) may be revoked at any time by the European Parliament or by the Council. A decision to revoke shall put an end to the delegation of the power specified in that decision. It shall take effect the day following the publication of the decision in the Official Journal of the European Union or at a later date specified therein. It shall not affect the validity of any delegated acts already in force.

RemovedArticle 67 – paragraph 6: 6. A delegated act adopted pursuant to Articles 5(2), 7(3), 9(2), 13(3), 25(3), 32(4), 37(4), 39(3), 41(7), 45(7), 46(8), 52(7), 52(13), 56(4) or 63a(2) shall enter into force only if no objection has been expressed either by the European Parliament or by the Council within a period of 3 months of notification of that act to the European Parliament and to the Council or if, before the expiry of that period, the European Parliament and the Council have both informed the Commission that they will not object. That period shall be extended by 3 months at the initiative of the European Parliament or of the Council.

RemovedArticle 68 – paragraph 2 a (new): 2a. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

RemovedArticle 69 – paragraph 1: Member States shall lay down the rules on other penalties applicable to infringements of this Regulation in particular for infringements which are not subject to administrative fines pursuant to Article 43a, and shall take all measures necessary to ensure that they are implemented. The penalties shall be effective, proportionate and dissuasive. Member States shall notify the Commission of those rules and measures by date of application of this Regulation and shall notify the Commission without delay of any subsequent amendment affecting them.

RemovedArticle 69 a (new): Article 69a / Right to receive compensation / Any person who has suffered material or non-material damage as a result of an infringement of this Regulation shall have the right to receive compensation, in accordance with national and Union law.

RemovedArticle 69 b (new): Article 69b / Representation of a natural person / Where a natural person considers that their rights under this Regulation have been infringed, they shall have the right to mandate a not-for-profit body, organisation or association which is constituted in accordance with the law of a Member State, has statutory objectives which are in the public interest and is active in the field of the protection of personal data, to lodge a complaint on their behalf or to exercise the rights referred to in Article 11a.

RemovedArticle 69 c (new): Article 69c / Suspension of proceedings / 1. Where a competent court of a Member State seised of proceedings against a decision by a digital health authority or health data access body has reason to believe that proceedings concerning the same access to electronic health data by the same health data user, such as for the same purpose of processing for secondary use are brought before a competent court in another Member State, it shall contact that court in order to confirm the existence of such related proceedings. / 2. Where proceedings concerning the same subject matter and the same digital health authority or health data access body are pending before a court in another Member State, any court other than the court first seised may stay its proceedings or may, at the request of one of the parties, decline jurisdiction in favour of the court first seised if that court has jurisdiction over the proceedings in question and its law permits the consolidation of such related proceedings.

RemovedArticle 70 – paragraph 1: 1. By 5 years from the entry into force of this Regulation, the Commission shall carry out a targeted evaluation of this Regulation especially with regards to the possibilities to further extend interoperability between EHR systems and electronic health data access services other than those established by the Member States, the possibility of expanding the access to MyHealth@EU infrastructure to third countries and international organisations, the need to update the data categories in Article 33 and the purposes of use in Article 34, the implementation and use by natural persons of the opt-out mechanism in secondary use as referred to in Article 33(5a), and opt-in mechanism in secondary use as referred to in Article 33(5b), the use and implementation of the right referred to in Article 3(9), as well as the application of fees as referred to in Article 42 and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment.

RemovedArticle 70 – paragraph 1 a (new): 1a. By ... [please insert the date two years from the entry into force of this Regulation], the Commission shall carry out an evaluation of the Union funding attributed to the setting up and functioning of the EHDS, in particular concerning the ability of the bodies established under this Regulation to carry out their tasks and obligations under this Regulation and of Member States in relation to applying the Regulation in a uniform and coherent manner. The Commission shall submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by the necessary measures.

RemovedArticle 70 – paragraph 2: 2. After 7 years from the entry into force of this Regulation, the Commission shall carry out an overall evaluation of this Regulation, and submit a report on its main findings to the European Parliament and to the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment or other appropriate measures.

RemovedArticle 71 a (new): Article 71a / Amendments to Directive (EU) 2020/1828 / In the Annex to Directive (EU) 2020/1828, the following point is added: / (XX) Regulation (EU) XXX of the European Parliament and of the Council on the European Health Data Space.

RemovedArticle 72 – paragraph 2: It shall apply from 24 months after its entry into force.

RemovedArticle 72 – paragraph 3 – point b: (b) from 3 years after date of entry into application to categories of personal electronic health data referred to in Article 5(1), points (d), (e) (f), and (fa) and to EHR systems intended by the manufacturer to process such categories of data;

RemovedArticle 72 – paragraph 3 – point c: deleted

RemovedAnnex II – point 2 – point 2.3: 2.3. An EHR system that includes a functionality for entering structured personal electronic health data shall enable the entry of data structured in a structured way that supports the data sharing in a structured, commonly used, open and machine-readable format, enabling system to system communication.

RemovedAnnex II – point 2 – point 2.5: 2.5. An EHR system shall not include features that prohibit, restrict or place undue burden on authorised exporting of personal electronic health data for the reasons of replacing the EHR system by another product. Authorised exporting of personal electronic health data shall be free of charge, without undue delay, or in in any event within one month from the request and in a structured, commonly used and machine-readable format, in line with the interoperability and security requirements to be developed according to Articles 23 and 50.

RemovedAnnex II – point 2 – point 2.5 a (new): 2.5a. An EHR system shall be developed in interoperable format that enables data portability.

RemovedAnnex II – point 3 – point 3.1: 3.1. An EHR system shall be designed and developed in such a way that it ensures highly safe and secure processing of electronic health data, and that it prevents unauthorised access to such data.

RemovedAnnex II – point 3 – point 3.1: 3.1. An EHR system shall be designed and developed in such a way that it ensures safe and secure processing of electronic health data, and that it prevents unauthorised access to such data, and that it duly takes into consideration the principles of data minimisation and data protection by design.

RemovedAnnex II – point 3 – point 3.8: 3.8. An EHR system designed for the storage of electronic health data shall support different retention periods and access rights that take into account the origins and categories of electronic health data as well as the specific purposes of data processing.

RemovedAnnex IV a (new): ANNEX IVa / 1. EU type-examination is the part of a conformity assessment procedure in which a notified body examines the technical design of an EHR system and verifies and attests that the technical design of the EHR system meets the applicable requirements of this Regulation. / 2. EU type-examination shall be carried out by assessment of the adequacy of the technical design of the EHR system through examination of the technical documentation, plus examination of a specimen of the EHR system that is representative of the production envisaged (production type). / 3. Application for EU type-examination / The manufacturer shall lodge an application for EU type-examination with a single notified body of his or her choice. The application shall include: / (a) the name and address of the manufacturer and, if the application is lodged by an authorised representative, the name and address of that authorised representative; / (b) a written declaration that the same application has not been lodged with any other notified body; / (c) the technical documentation described in Annex III; / (d) the specimen(s) of the EHR system representative of the production envisaged. The notified body may request further specimens if needed for carrying out the test programme. / 4. EU type-examination / The notified body shall: / (a) examine the technical documentation to assess the adequacy of the technical design of the EHR system; / (b) verify that the EHR system has been manufactured in conformity …