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Data & Privacy
AI & Trust
Cybersecurity
Digital Services & Media
CHAPTER I
GENERAL PROVISIONSArticles 1 — 2
CHAPTER II
PRIMARY USEArticles 3 — 24
CHAPTER III
EHR SYSTEMS AND WELLNESS APPLICATIONSArticles 25 — 49
CHAPTER IV
SECONDARY USEArticles 50 — 81
CHAPTER V
ADDITIONAL ACTIONSArticles 82 — 91
CHAPTER VI
EUROPEAN GOVERNANCE AND COORDINATIONArticles 92 — 96
CHAPTER VII
DELEGATION OF POWERS AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER VIII
MISCELLANEOUSArticles 99 — 104
CHAPTER IX
DEFERRED APPLICATION, TRANSITIONAL AND FINAL PROVISIONSArticles 105 — 105
ANNEXES
In order to strengthen the enforcement of the rules of this Regulation, penalties, including administrative fines, should be imposed for any infringement of this Regulation, in addition to, or instead of, appropriate measures imposed by health data access bodies pursuant to this Regulation. The imposition of penalties, including administrative fines, should be subject to appropriate procedural safeguards in accordance with the general principles of Union law and the Charter of Fundamental Rights of the European Union, including effective judicial protection and due process.
It is appropriate to lay down provisions enabling health data access bodies to apply administrative fines for certain infringements of this Regulation which should be considered under this Regulation to be serious infringements, such as the re-identification of natural persons, downloading personal electronic health data outside of the secure processing environment or processing of data for prohibited uses or uses not covered by a data permit. This Regulation should specify those infringements and the upper limit and criteria for setting the related administrative fines, which should be determined by the competent health data access body in each individual case, taking into account all the relevant circumstances of the specific situation, having due regard in particular to the nature, gravity and duration of the infringement and its consequences and the measures taken to ensure compliance with the obligations under this Regulation and to prevent or mitigate the consequences of the infringement. For the purposes of the imposition of administrative fines under this Regulation, the concept of undertaking should be understood in accordance with Articles 101 and 102 TFEU. It should be for the Member States to determine whether and to what extent public authorities should be subject to administrative fines. Imposing an administrative fine or giving a warning should not affect the enforcement of other powers of the health data access bodies or of other penalties under this Regulation.
Member States should take all measures necessary to ensure that the provisions of this Regulation are implemented, including by laying down effective, proportionate and dissuasive penalties for their infringement. When deciding on the amount of the penalty for each individual case, Member States should take into account the limits and criteria set out in this Regulation. Re-identification of natural persons should be considered a serious breach of this Regulation.