Regulation


Privacy, data and cyber security


Here are some of the most important pieces of legislation that you may use when dealing with matters relating to data protection, privacy, data and cyber security.


eHealth, medical devices and life sciences


USA

The USA have the most comprehensive and mature legal framework and guidance documents relating to digital health compared to other countries.  It would be unrealistic to list them all, so you will find here some links to hot topics related to digital health and technologies in the context of health.

Europe

Europe has an harmonized legislative framework and common standards relating to health. With no central agency handling drugs and medical devices, each EU country has its own health-related regulatory agency and, therefore, different approaches. 

Switzerland

The Swiss framework is based on the EU framework. Some EU text are even copied into some Swiss laws or referenced as being directly applicable in Switzerland. Swissmedic is the health regulatory authority responsible for drugs and medical devices market access.