art_102__para_1

1. By 26 March 2033, the Commission shall carry out a targeted evaluation of this Regulation, and submit a report on its main findings to the European Parliament, the Council, the European Economic and Social Committee and the Committee of the Regions, accompanied, where appropriate, by a proposal for its amendment. That evaluation shall cover the following: the possibilities of further extending interoperability between EHR systems and electronic health data access services other than those established by the Member States; the need to update the data categories referred to in Article 51 and the purposes listed in Article 53(1); the implementation and use by natural persons of the mechanisms to opt out from secondary use referred to in Article 71, in particular on the impact of those mechanisms on public health, scientific research and fundamental rights; the use and implementation of any stricter measures introduced pursuant to Article 51(4); the exercise and implementation of the right referred to in Article 8; an assessment of the certification framework for EHR systems established in Chapter III and the need to introduce further tools regarding conformity assessment; an assessment of the functioning of the internal market for EHR systems; an assessment of the costs and benefits of the implementation of the provisions for secondary use laid down in Chapter IV; the application of fees as referred to in Article 62.

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Source: EUR-Lex (Cellar) · retrieved 2026-10-15 · Text as adopted (Official Journal); later amendments are not incorporated in this text.