EHDS
Data & Privacy
- Data Act
- Data Governance Act
- EHDS
- ePrivacy Directive
- GDPR
- GDPR Procedural Regulation
AI & Trust
- Artificial Intelligence Act
- Product Liability Directive
Cybersecurity
- Cyber Resilience Act
- Cybersecurity Act
- DORA
- NIS2
Digital Services & Media
- Digital Markets Act
- Digital Services Act
- European Media Freedom Act
European Health Data Space Regulation
- Recitals
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
EHDS
EHDS Article 71. Right to opt out from the processing of personal electronic health data for secondary use
- 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)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).
- 5.The rules on any mechanism to implement exceptions provided for under paragraph 4 by way of exception from paragraph 1 shall respect the essence of the fundamental rights and freedoms and shall be a necessary and proportionate measure in a democratic society to fulfil purposes of public interest in the area of legitimate scientific and societal objectives.
- 6.Any processing carried out in accordance with a mechanism to implement exceptions provided for under paragraph 4 of this Article shall comply with the requirements of this Chapter, in particular the prohibition on re-identifying or attempting to re-identify natural persons in accordance with Article 61(3). Any legislative measure providing for a mechanism in national law as referred to in paragraph 4 of this Article shall include specific provisions for the safety, and the protection of the rights, of natural persons.
- 7.Member States shall notify without delay the Commission of the provisions of their national law which they adopt pursuant to paragraph 4 and of any subsequent amendment affecting them.
- 8.When the purposes of the processing of personal electronic health data by a health data holder do not or no longer require the identification of a data subject by the controller, that health data holder shall not be obliged to maintain, acquire or process additional information in order to identify the data subject for the sole purpose of complying with the right to opt out under this Article.