Abstract

In today’s digitalized world, new technologies have been modifying not only the forms of patient care but also clinical research, where handling sensitive personal data is essential to verify the safety and efficacy of drugs or medical products under study and it constitutes a determining factor for research success. There are consolidated regulatory frameworks for the protection of personal data, being the reference those established by Europe and the United States of America, although the Latin American region has also made progress in this regard. New strategies then emerge for conducting clinical trials where digital technologies and safeguarding the privacy and confidentiality of the sensitive data of the participants of such tests are especially important: digital clinical trials, characterized by the use of such technologies in different stages of its realization and with numerous purposes. This modality offers numerous advantages both to researchers, sponsors, patients themselves and the rest of actors involved in studies. However, there are also multiple challenges that must be addressed from technical, legal and bioethical perspectives.