Article 102

The Commission will evaluate the Regulation eight years after its entry into force, reporting on key findings to the European Parliament, Council, and other EU bodies, with recommendations for amendments if needed. The evaluation will assess areas such as interoperability, data categories, opt-out mechanisms, stricter national measures, and the certification framework for EHR systems. A comprehensive review, including the efficiency of systems for accessing electronic health data, will follow two years later. Member States must provide necessary information for these evaluations. Annual progress reports will track implementation readiness until full application.

Evaluation, review and progress report
1.
By ... [eight years from the date of entry into force of this Regulation], 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:

  • (a) the possibilities of further extending interoperability between EHR systems and electronic health data access services other than those established by the Member States;

  • (b) the need to update the data categories referred to in Article 51 and the purposes listed in Article 53(1);

  • (c) 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;

  • (d) the use and implementation of any stricter measures introduced pursuant to Article 51(4);

  • (e) the exercise and implementation of the right referred to in Article 8;

  • (f) an assessment of the certification framework for EHR systems established in Chapter III and the need to introduce further tools regarding conformity assessment;

  • (g) an assessment of the functioning of the internal market for EHR systems;

  • (h) an assessment of the costs and benefits of the implementation of the provisions for secondary use laid down in Chapter IV;

  • (i) the application of fees as referred to in Article 62.
2.
By ... [10 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, 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. That evaluation shall include an assessment of the efficiency and functioning of the systems providing for access to electronic health data for further processing, carried out on the basis of Union or national law referred to in Article 1(7), with regard to their impact on the implementation of this Regulation.
3.
Member States shall provide the Commission with the information necessary for the preparation of the reports referred to in paragraphs 1 and 2 and the Commission shall take that information duly into account in those reports.
4.
Every year following ... [date of the entry into force of this Regulation] until the end of the year in which all provisions of this Regulation apply as provided for in Article 105, the Commission shall submit a progress report to the Council on the preparations for the full implementation of this Regulation. That progress report shall contain information about the degree of progress and the readiness of the Member States in relation to the implementation of this Regulation, including an assessment of the feasibility of reaching the timeframes laid down in Article 105 and may also contain recommendations for Member States to improve preparedness for the application of this Regulation.

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