HRA Organisation Ordinance (OrgO-HRA)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 11 Disclosure of personal data
1 Before the enforcement authority discloses personal data to the authorities responsible in accordance with Article 59 paragraphs 1 and 2 HRA, it shall solicit comments from the data subject, providing information at the same time on: a. the purpose of the disclosure of data; b. the nature of the data to be disclosed; and c. the data recipient. 2 The obligations specified in paragraph 1 do not apply if: a. the data subject already has the relevant information; b. ... c. there is an immediate risk of legal claims or important third-party interests being prejudiced, or the fulfilment of legal duties being prevented; or d. the data subject cannot be traced. 3 If data are to be published under Article 59 paragraph 3 HRA, all items which, when combined, would enable the data subject to be identified without disproportionate effort, must be made unrecognisable or deleted. These include in particular the name, address, date of birth and unique identification numbers.
Para. 2 let. a — Amended by Annex 2 No II 96 of the Data Protection Ordinance of 31 Aug. 2022, in force since 1 Sept. 2023 (AS 2022 568). Para. 2 let. b — Repealed by Annex 2 No II 96 of the Data Protection Ordinance of 31 Aug. 2022, with effect from 1 Sept. 2023 (AS 2022 568).
Art. 11a Data transmission by the cantons
The cantons shall transmit to the FOPH the data from the cantonal information system which it requires for: a. the provision of information for the public; b. the evaluation of human research legislation; c. the operation of the portal specified in Article 67 ClinO.
Art. 11a — Inserted by No I of the O of 7 June 2024, in force since 1 Nov. 2024 (AS 2024 324). let. c — SR 810.305
Art. 12 Exchange of data with foreign authorities and institutions
1 The following are authorised to exchange confidential data with foreign authorities and institutions or international bodies: a. the responsible ethics committee; b. the cantonal supervisory authority; c. the Swiss Agency for Therapeutic Products; and d. the FOPH. 2 Personal data may be disclosed abroad provided the Federal Council has established that the legislation in the State concerned or the international body guarantees an adequate level of protection in accordance with Article 16 paragraph 1 of the Data Protection Act of 25 September 2020 (FADP). If no assessment from the Federal Council is available, personal data may be disclosed abroad if there are sufficient guarantees, in particular contractual guarantees, to ensure an adequate level of protection in the State concerned. 3 In derogation from Article 16 paragraphs 1 and 2 FADP personal data may be disclosed abroad in the following cases: a. Disclosure is required in order to protect the life or the physical integrity of t
Art. 12 — Amended by Annex 2 No II 96 of the Data Protection Ordinance of 31 Aug. 2022, in force since 1 Sept. 2023 (AS 2022 568). Para. 2 — SR 235.1