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Art. 62a

812.21TPAFederal ActJan 1, 2002Original source
  1. Federal and cantonal authorities, regional centres and third parties entrusted with enforcement tasks may, to the extent necessary to fulfil their duties under this Act, process the following sensitive personal data:^1 a. data on health: 1.2 for official market surveillance, 2. to exercise vigilance in connection with incoming notifications on adverse effects and events and on quality defects, 3. to verify clinical trials on the basis of incoming notifications and inspections, or 4.3^ in connection with applications for temporary authorisations as specified in Article 9b paragraph 1 and for exemptions for medical devices as specified in Article 46 paragraph 3 letter b; b. data on administrative or criminal prosecutions and sanctions: 1. within the framework of procedures for granting establishment licences, or 2. to assess whether an investigator is qualified for conducting clinical trials.
  2. Sensitive personal data pursuant to paragraph 1 letter a shall be made anonymous wherever possible.
  3. The Federal Council shall issue implementing provisions on:
    1. responsibility for data processing;
    2. the scope of access rights for retrieval procedures;
    3. the length of time the data is to be kept;
    4. the archiving and destruction of data;
    5. data security.

Footnotes

  1. Amended by Annex 1 No II 74 of the Data Protection Act of 25 Sept. 2020, in force since 1 Sept. 2023 (AS 2022 491;BBl 2017 6941).

  2. Amended by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961;BBl 2019 1).

  3. Inserted by No I of the FA of 22 March 2019, in force since 26 May 2021 (AS 2020 2961;BBl 2019 1).

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