Regulatory Assessment of Software as Medical Device with a Focus on Inclusion and Equity in Artificial Intelligence Applications in Healthcare

Abstract

Artificial intelligence applied to diagnostic and treatment software is already a reality in Brazil. These types of software must be regulated by the Brazilian National Health Surveillance Agency under the category of Software as a Medical Device (SaMD). The main requirements evaluated by the Brazilian agency are the safety and efficacy of the SaMD. This article discusses the regulatory assessment of the SaMD with a view to ensuring inclusion and equity in artificial intelligence. Given the potential for discriminatory outcomes in SaMD, Brazilian Health Surveillance Agency must oversee these technologies and ensure that the databases used represent the populations the software is intended to serve—and, whenever possible, verify their robustness. Given the novelty of the subject, preliminary findings suggest that the Brazilian agency should require detailed disclosure of the data used and the training history of SaMD. Therefore, it is incumbente upon the Brazilian National Health Surveillance Agency to ensure that the creation, development, and use of SaMD in diagnostics and treatments are equitable.