Delegated Act

Delegated Act

In short: An EU law may explictely delegate the creation of delegated acts to the EU commission. A delegated act may not change the essential elements of the EU law itself.

The Commission adopts delegated acts on the basis of a delegation granted in the text of an EU law, in this case a legislative act. The Commission's power to adopt delegated acts is subject to strict limits:

• the delegated act cannot change the essential elements of the law
• the legislative act must define the objectives, content, scope and duration of the delegation of power
• Parliament and Council may revoke the delegation or express objections to the delegated act

The Commission prepares and adopts delegated acts after consulting expert groups, composed of representatives from each EU country, which meet on a regular or occasional basis.

Citizens and other stakeholders can provide feedback on the draft text of a delegated act during a four-week period. There are some exceptions, for example, in case of emergency or when citizens and stakeholders have already contributed. More details in the better regulation toolbox.

Once the Commission has adopted the act, Parliament and Council generally have two months to formulate any objections. If they do not, the delegated act enters into force.

Adopted acts contain an 'explanatory memorandum' summarising the feedback received and how it was used.

Discussion

In the context of EHDS, Article 97 details that EHDS allows for three delegated acts: when it comes to primary use the main article of relevance is 14(2).

To qoute 14(2): The Commission is empowered to adopt delegated acts in accordance with Article 97 to amend this Regulation by amending Annex I through the addition, modification or removal of the main characteristics of the priority categories of personal electronic health data as referred to in paragraph 1, provided that the amendments are aimed at adapting the priority categories of personal electronic health data to technical developments and international standards. Moreover, additions and modifications of those characteristics shall satisfy both of the following criteria:

• (a)the characteristic is relevant for healthcare provided to natural persons;
• (b)the characteristic is used in the majority of Member States according to the most recent information.

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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.