Article 102
Evaluation, review and progress report
In short: the EU will do an annual evaluation of the actual effect of the EHDS regulation. In 2033 an overall
evaluation will be done, which may lead to amendmend of the regulation.
(The quoted article below has been added to remove wording related to secondary use of data - a scenario that's out of scope for this website)
- 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:
- (a) the possibilities of further extending interoperability between EHR systems and electronic health data access services other than those established by the Member States;
- (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;
- By 26 March 2035, 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.
- 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.
- Every year following 25 March 2025 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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About Ringholm bv
Ringholm bv is a group of European experts in the field of messaging standards and systems integration in healthcare IT.
We provide the industry's most advanced training courses and consulting on healthcare information exchange standards.
