+SECTION 2 Governance and mechanisms for secondary use
---+Article 55 Health data access bodies
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---+Article 56 Union health data access service
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---+Article 57 Tasks of health data access bodies
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---+Article 58 Obligations of health data access bodies towards natural persons
------+Article 58 1
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---+Article 59 Reporting by health data access bodies
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---+Article 60 Duties of health data holders
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---+Article 61 Duties of health data users
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---+Article 62 Fees
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---+Article 63 Enforcement by health data access bodies
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---+Article 64 General conditions for the imposition of administrative fines by health data access bodies
------+Article 64 1
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---+Article 65 Relationship with supervisory authorities under Regulation (EU) 2016/679

SECTION 2 Governance and mechanisms for secondary use

SECTION 2 Governance and mechanisms for secondary use

1. Panoramica

,
Titolo Regolamentazione
Article 55 Health data access bodies
Article 56 Union health data access service
Article 57 Tasks of health data access bodies
Article 58 Obligations of health data access bodies towards natural persons
Article 59 Reporting by health data access bodies
Article 60 Duties of health data holders
Article 61 Duties of health data users
Article 62 Fees
Article 63 Enforcement by health data access bodies
Article 64 General conditions for the imposition of administrative fines by health data access bodies
Article 65 Relationship with supervisory authorities under Regulation (EU) 2016/679

Article 65

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

The supervisory authority or authorities responsible for monitoring and enforcing the application of Regulation (EU) 2016/679 shall also be competent for monitoring and enforcing the application of the right to opt out from the processing of personal electronic health data for secondary use pursuant to Article 71. Those supervisory authorities shall be empowered to impose administrative fines up to the amount referred to in Article 83 of Regulation (EU) 2016/679.

The supervisory authorities referred to in the first paragraph of this Article and the health data access bodies referred to in Article 55 of this Regulation shall, where relevant, cooperate in the enforcement of this Regulation, within the remit of their respective competences. The relevant provisions of Regulation (EU) 2016/679 shall apply mutatis mutandis.

1.1 Riferimenti

1.2 Requisiti identificati

1.3 Standard correlati

2. Requisiti identificati

Requisiti
Fonte Requisito

3. Standard correlati

Standard
Fonte Requisito