+SECTION 2 Governance for primary use
---+Article 19 Digital health authorities
------+Article 19 1
------+Article 19 2
------+Article 19 3
------+Article 19 4
------+Article 19 5
---+Article 20 Reporting by digital health authorities
------+Article 20 (a)
------+Article 20 (b)
------+Article 20 (c)
------+Article 20 (d)
------+Article 20 (e)
------+Article 20 (f)
---+Article 21 Right to lodge a complaint with a digital health authority
------+Article 21 1
------+Article 21 2
------+Article 21 3
------+Article 21 4
------+Article 21 5
---+Article 22 Relationship with supervisory authorities under Regulation (EU) 2016/679

SECTION 2 Governance for primary use

SECTION 2 Governance for primary use

1. Overview

,
Article 19 Digital health authorities
Article 20 Reporting by digital health authorities

Digital health authorities designated pursuant to Article 19 shall publish an activity report every two years, which shall contain a comprehensive overview of their activities. If a Member State designates more than one digital health authority, one of them shall be responsible for the drawing up of the report and, in doing so, it shall request the necessary information from the other digital health authorities. That activity report shall follow a structure agreed at Union level within the European Health Data Space Board (the ‘EHDS Board’) referred to in Article 92. That activity report shall contain at least information concerning:
Article 21 Right to lodge a complaint with a digital health authority
Article 22 Relationship with supervisory authorities under Regulation (EU) 2016/679

Article 22

Relationship with supervisory authorities under Regulation (EU) 2016/679

The supervisory authority or supervisory authorities responsible for monitoring and enforcing the application of Regulation (EU) 2016/679 shall also be competent for monitoring and enforcing the application of Articles 3 and 5 to 10 of this Regulation. The relevant provisions of Regulation (EU) 2016/679 shall apply mutatis mutandis. Supervisory authorities shall be empowered to impose administrative fines up to the amount referred to in Article 83(5) of Regulation (EU) 2016/679.

The supervisory authorities referred to in the first paragraph of this Article and digital health authorities referred to in Article 19 shall, where relevant, cooperate in the enforcement of this Regulation, within the remit of their respective competences.

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements

3. Related Standards

Standards
  • Builddate: 05.03.2025 00:00:00 -Doknr: CELEX:32025R0327
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