Author

Tiziana Hongler

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In brief In its decision of 12 September 2022 (C-1256/2020), the Swiss Federal Administrative Court (FAC) confirmed that interpretive software that uses indicators such as calendar days and body temperature to monitor fertile and infertile phases of a menstrual cycle to achieve natural conception or prevent undesired pregnancy, qualifies as a medical device. This means that such software is subject to a conformity certification procedure with a notified body. In its reasoning, the FAC primarily focused…

In brief On 1 December 2022, Switzerland’s new Human Genetic Testing Act (HGTA) will enter into force. The new HGTA provides a comprehensive legal framework for all types of genetic testing (including direct-to-consumer genetic testing and lifestyle genetic testing) and implements stronger measures to protect privacy rights, prevent abuse of genetic data and ensure the quality of genetic tests and the interpretation of the results. As part of the comprehensive revision of the HGTA, the…