This is a study on the development of an intelligent digital platform for Biovigilance, capable of recording structured and unstructured data, in Web and Mobile environments, of sending the automatically compiled data to remote servers, of generating computational panels of analytical results (dashboards) , capable of supporting the production of insights.
The platform (https://biovigilancia.org/home) built for the National Biovigilance System aims to:
(1) Allow the continued recording of new adverse events, in a 100% user-friendly manner. (2) Allow surveys to be carried out with different stakeholders: donors/recipients, hospital managers, health professionals and researchers/teachers. (3) Generate graphs for intuitive visualization of the indicators collected in the surveys, through a results dashboard. (4) Ensure a system of restrictive access so that information of general interest is public, while those with more sensitive characteristics remain accessible only to representatives of the institutions involved in the project.
The platform is divided into three parts (Figure 1):

- Situational research: recurrent mapping of adverse events involving human cells, tissues and organs for transplantation.
- Report an adverse event: register here any adverse events related to human transplants and help Brazilian Biovigilance fulfill its role.
- Restricted functions: this area is intended for researchers and health managers directly involved in the project, with login and password access.
Adverse event reporting is based on the structure of the Notify Library (https://www.notifylibrary.org/) and is designed to allow for broad inclusion and exclusion of variables. Its basic structure separates adverse events as donor-related and recipient-related.
The main restricted functions of the platform are: consultations on sensitive research or not yet publicly disclosed and consultations on the results dashboard involving strategic actions that in some way may be negatively affected by the wide publicity.
The operation of this section came from the implementation of a multi-user authentication system, which allows us to approve specific registrations, blocking subjects without the necessary permissions, as well as cyber attacks.
The National Biovigilance System Platform dashboard is based on a data visualization framework called Shiny. It has graphics of high visual appeal and great informational power.
The idea is that the dashboard is continuously fed with collected and reported data, so that the visualizations are always current.

We are currently developing artificial intelligence on the platform so that we can predict the next adverse events and thus contribute to improving safety in the therapeutic use of organs, tissues and cells.