EHDS, Article 71, EU

1. Natural persons shall have the right to opt out at any time, and without providing any reason, from the processing of personal electronic health data relating to them for secondary use under this Regulation. The exercise of that right shall be reversible.

2. Member States shall provide for an accessible and easily understandable opt-out mechanism to exercise the right established in paragraph 1, whereby natural persons may explicitly state that they do not wish to have their personal electronic health data processed for secondary use.

3. Once natural persons have exercised the right to opt out, and where personal electronic health data relating to them can be identified in a dataset, personal electronic health data relating to those natural persons shall not be made available or otherwise processed pursuant to data permits issued under Article 68 or health data requests under Article 69 approved after the natural person has exercised the right to opt out.

The first subparagraph of this paragraph shall not affect the processing for secondary use of personal electronic health data relating to those natural persons pursuant to data permits or health data requests that were issued or approved before the natural persons exercised their right to opt out.

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:

(a)

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:

(i)

the purposes referred to in Article 53(1), points (a), (b) and (c);

(ii)

scientific research for important reasons of public interest;

(b)

those data cannot be obtained by alternative means in a timely and effective manner under equivalent conditions;

(c)

Official source

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