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Risk level: general Title IX — Post-Market Monitoring, Information Sharing, Market Surveillance

Article 78 — Confidentiality

Confidentiality 1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of information and data obtained in carrying out their tasks and activities in such a manner as to protect, in...

Article 78
Confidentiality
1. The Commission, market surveillance authorities and notified bodies and any other natural or legal person involved
in the application of this Regulation shall, in accordance with Union or national law, respect the confidentiality of
information and data obtained in carrying out their tasks and activities in such a manner as to protect, in particular:
ELI: http://data.europa.eu/eli/reg/2024/1689/oj 105/144
EN OJ L, 12.7.2024
(a) the intellectual property rights and confidential business information or trade secrets of a natural or legal person,
including source code, except in the cases referred to in Article 5 of Directive (EU) 2016/943 of the European
Parliament and of the Council( );57
(b) the effective implementation of this Regulation, in particular for the purposes of inspections, investigations or audits;
(c) public and national security interests;
(d) the conduct of criminal or administrative proceedings;
(e) information classified pursuant to Union or national law.
2. The authorities involved in the application of this Regulation pursuant to paragraph 1 shall request only data that is
strictly necessary for the assessment of the risk posed by AI systems and for the exercise of their powers in accordance with
this Regulation and with Regulation (EU) 2019/1020. They shall put in place adequate and effective cybersecurity measures
to protect the security and confidentiality of the information and data obtained, and shall delete the data collected as soon
as it is no longer needed for the purpose for which it was obtained, in accordance with applicable Union or national law.
3. Without prejudice to paragraphs 1 and 2, information exchanged on a confidential basis between the national
competent authorities or between national competent authorities and the Commission shall not be disclosed without prior
consultation of the originating national competent authority and the deployer when high-risk AI systems referred to in
point 1, 6 or 7 of Annex III are used by law enforcement, border control, immigration or asylum authorities and when such
disclosure would jeopardise public and national security interests. This exchange of information shall not cover sensitive
operational data in relation to the activities of law enforcement, border control, immigration or asylum authorities.
When the law enforcement, immigration or asylum authorities are providers of high-risk AI systems referred to in point 1,
6 or 7 of Annex III, the technical documentation referred to in Annex IV shall remain within the premises of those
authorities. Those authorities shall ensure that the market surveillance authorities referred to in Article 74(8) and (9), as
applicable, can, upon request, immediately access the documentation or obtain a copy thereof. Only staff of the market
surveillance authority holding the appropriate level of security clearance shall be allowed to access that documentation or
any copy thereof.
4. Paragraphs 1, 2 and 3 shall not affect the rights or obligations of the Commission, Member States and their relevant
authorities, as well as those of notified bodies, with regard to the exchange of information and the dissemination of
warnings, including in the context of cross-border cooperation, nor shall they affect the obligations of the parties concerned
to provide information under criminal law of the Member States.
5. The Commission and Member States may exchange, where necessary and in accordance with relevant provisions of
international and trade agreements, confidential information with regulatory authorities of third countries with which they
have concluded bilateral or multilateral confidentiality arrangements guaranteeing an adequate level of confidentiality.

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