European Health Data Space Regulation
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Table of Contents
Chapter I – General provisions
Chapter II – Primary use
Chapter III – Ehr systems and wellness applications
Chapter IV – Secondary use
Chapter V – Additional actions
Chapter VI – European governance and coordination
Chapter VII – Delegation of powers and committee procedure
Chapter VIII – Miscellaneous
Chapter IX – Deferred application, transitional and final provisions
Recitals (115)
Annexes
Article 10
Right of natural persons to opt out in primary use
1. Member States’ laws may provide that natural persons have the right to opt out from the access to their personal electronic health data registered in an EHR system through the electronic health data access services referred to in Articles 4 and 12. In such cases, Member States shall ensure that the exercise of that right is reversible.
2. If a Member State provides for a right referred to in paragraph 1 of this Article, it shall establish the rules and specific safeguards regarding the opt-out mechanism. In particular, Member States may provide for a healthcare provider or health professional to be able to get access to the personal electronic health data in cases where processing is necessary in order to protect the vital interests of the data subject or of another natural person as referred to in Article 9(2), point (c), of General Data Protection Regulation (GDPR), even if the patient has exercised the right to opt out in primary use.