Disruptive Technology in Business: Future Impact on Legal Support Needs

The use of AI for the generation of information related not only to safety, appropriate use, and efficacy, but also to the clinical and economic value of RWE medical treatments can add immense value to all clinical information and health data held by public and/or private entities. AI and the use of natural language processing (NLP) in the framework of research studies represents a paradigm shift, which not only implies a substantial change in the methodology used to carry out such studies, but also brings countless advantages both in the generation of clinical value and in the optimization of time and resources. For all this, the regulatory context is one of the fronts to be addressed when dealing with health data and presents new and complex horizons to explore and implement (e.g. European Health Data Space, Data Governance Act, Synthetic Control Arms…).