art_71__para_4

4. By way of exception from the right to opt out provided for in paragraph 1, a Member State may provide in its national law for a mechanism to make data for which a right to opt out has been exercised available, provided that all the following conditions are fulfilled: the health data access application or health data request is submitted by a public sector body or a Union institution, body, office or agency with a mandate to carry out tasks in the area of public health, or by another entity entrusted with carrying out public tasks in the area of public health, or acting on behalf of or commissioned by a public authority, and the processing of those data is necessary for any of the following purposes: the purposes referred to in Article 53(1), points (a), (b) and (c); scientific research for important reasons of public interest; those data cannot be obtained by alternative means in a timely and effective manner under equivalent conditions; the health data applicant has provided the justification referred to in Article 68(1), point (g), or in Article 69(2), point (g). The national law providing for such a mechanism shall provide for specific and suitable measures in order to protect the fundamental rights and the personal data of natural persons. Where a Member State has provided in its national law for the possibility to request access to data for which a right to opt out has been exercised and the conditions referred to in the first subparagraph of this paragraph are fulfilled, those data may be included when carrying out the tasks under Article 57(1), points (a)(i), (a)(iii) and (b).

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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.