Data & Privacy
AI & Trust
Cybersecurity
Digital Services & Media
CHAPTER I
GENERAL PROVISIONSArticles 1 — 4
CHAPTER II
PROHIBITED AI PRACTICESArticles 5 — 5
CHAPTER III
HIGH-RISK AI SYSTEMSArticles 6 — 49
CHAPTER IV
TRANSPARENCY OBLIGATIONS FOR PROVIDERS AND DEPLOYERS OF CERTAIN AI SYSTEMSArticles 50 — 50
CHAPTER V
GENERAL-PURPOSE AI MODELSArticles 51 — 56
CHAPTER VI
MEASURES IN SUPPORT OF INNOVATIONArticles 57 — 63
CHAPTER VII
GOVERNANCEArticles 64 — 70
CHAPTER VIII
EU DATABASE FOR HIGH-RISK AI SYSTEMSArticles 71 — 71
CHAPTER IX
POST-MARKET MONITORING, INFORMATION SHARING AND MARKET SURVEILLANCEArticles 72 — 94
CHAPTER X
CODES OF CONDUCT AND GUIDELINESArticles 95 — 96
CHAPTER XI
DELEGATION OF POWER AND COMMITTEE PROCEDUREArticles 97 — 98
CHAPTER XII
PENALTIESArticles 99 — 101
CHAPTER XIII
FINAL PROVISIONSArticles 102 — 113
ANNEXES
Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, high-risk AI systems which fall within the scope of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, in accordance with that regulation may demonstrate compliance with the cybersecurity requirements of this Regulation by fulfilling the essential cybersecurity requirements set out in that regulation. When high-risk AI systems fulfil the essential requirements of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, they should be deemed compliant with the cybersecurity requirements set out in this Regulation in so far as the achievement of those requirements is demonstrated in the EU declaration of conformity or parts thereof issued under that regulation. To that end, the assessment of the cybersecurity risks, associated to a product with digital elements classified as high-risk AI system according to this Regulation, carried out under a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements, should consider risks to the cyber resilience of an AI system as regards attempts by unauthorised third parties to alter its use, behaviour or performance, including AI specific vulnerabilities such as data poisoning or adversarial attacks, as well as, as relevant, risks to fundamental rights as required by this Regulation.
The conformity assessment procedure provided by this Regulation should apply in relation to the essential cybersecurity requirements of a product with digital elements covered by a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and classified as a high-risk AI system under this Regulation. However, this rule should not result in reducing the necessary level of assurance for critical products with digital elements covered by a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements. Therefore, by way of derogation from this rule, high-risk AI systems that fall within the scope of this Regulation and are also qualified as important and critical products with digital elements pursuant to a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements and to which the conformity assessment procedure based on internal control set out in an annex to this Regulation applies, are subject to the conformity assessment provisions of a regulation of the European Parliament and of the Council on horizontal cybersecurity requirements for products with digital elements insofar as the essential cybersecurity requirements of that regulation are concerned. In this case, for all the other aspects covered by this Regulation the respective provisions on conformity assessment based on internal control set out in an annex to this Regulation should apply. Building on the knowledge and expertise of ENISA on the cybersecurity policy and tasks assigned to ENISA under the Regulation (EU) 2019/881 of the European Parliament and of the Council , the Commission should cooperate with ENISA on issues related to cybersecurity of AI systems.
It is appropriate that, without prejudice to the use of harmonised standards and common specifications, providers of a high-risk AI system that has been trained and tested on data reflecting the specific geographical, behavioural, contextual or functional setting within which the AI system is intended to be used, should be presumed to comply with the relevant measure provided for under the requirement on data governance set out in this Regulation. Without prejudice to the requirements related to robustness and accuracy set out in this Regulation, in accordance with Article 54(3) of Regulation (EU) 2019/881, high-risk AI systems that have been certified or for which a statement of conformity has been issued under a cybersecurity scheme pursuant to that Regulation and the references of which have been published in the should be presumed to comply with the cybersecurity requirement of this Regulation in so far as the cybersecurity certificate or statement of conformity or parts thereof cover the cybersecurity requirement of this Regulation. This remains without prejudice to the voluntary nature of that cybersecurity scheme.