EHDS, Article 50, DE

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 Recommendation 2003/361/EC.

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.

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