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 50
Applicability to health data holders
1. The following categories of health data holders shall be exempt from the obligations on health data holders laid down in this Chapter:
(a) natural persons, including individual researchers;
(b) legal persons that qualify as microenterprises as defined in Article 2(3) of the Annex to Commission SME Definition Recommendation.
2. Member States may provide in their national law that the obligations of health data holders laid down in this Chapter apply to the health data holders referred to in paragraph 1 which fall under their jurisdiction.
3. Member States may provide in their national law that the duties of certain categories of health data holders are to be fulfilled by health data intermediation entities. In that case, the data shall nevertheless be considered as being made available by several health data holders.
4. Member States shall notify to the Commission the national law referred to in paragraphs 2 and 3 by 26 March 2029. Any subsequent law or amendment affecting such law shall be notified to the Commission without delay.
Related Recitals