Big data, AI/LM, digital software solutions are now at the center of the business "Raison d'Etre" strategy of BigTechs. It is not surprising to see these data giants driving the digital transformation of health because the prospects are phenomenal. However, if on the one hand the development and commercialization of digital technologies by BigTech inexorably accelerate the necessary digitalization of our health ecosystems; on the other hand, it is essential to set up a legal and ethical framework at European level around the use of health data, this point is all the more important with the development of algorithms more and more more complex and evolving (LM). This framework must be based on 3 axes: The protection of health data (GDPR) - The regulations around health software using health data (eg SaMD) - cybersecurity. These points are essential because they will guarantee the trust that all market players (including patients) will have in these new technologies that may be perceived in a way intrusive and obscure due to the complexity. This notion of trust is addressed in the White Paper on "Artificial Intelligence: a European approach to excellence and trust"** published by the European Commission 2020.
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