Implementation of AI systems in regulated environments for Life Sciences.

Identifier:  TFM:2520

Handle: https://hdl.handle.net/20.500.11797/TFM2520

Authors:  Matúz, Boglárka

Abstract:
With the rapid integration of artificial intelligence (AI) into healthcare, regulatory frameworks are evolving to ensure safe and ethical use. This thesis examines whether current AI regulations prioritize patient well-being or are shaped by bureaucratic considerations. A keyword-based content analysis of five key U.S. and European documents was conducted using both full-document and refined content-focused approaches. Normalized keyword frequencies informed a benchmark distinguishing patient-centered from bureaucratic emphasis. Results reveal variation across documents, with some showing a stronger procedural focus, highlighting the need for more balanced, patient-oriented regulatory language in the governance of AI systems in healthcare.