Testing Limits: the  Regulatory Sandbox and the Future of Supplementary Health in Brazil

Authors

DOI:

https://doi.org/10.11606/issn.2316-9044.rdisan.2026.232583

Keywords:

Innovation, Private Health Insurance, Regulation, Regulatory Sandbox

Abstract

This paper analyzes Normative Resolution No. 621/2024, which establishes guidelines for implementing the experimental regulatory environment, the regulatory sandbox, at the Brazilian Regulatory Agency for Private Health Insurance and Plans. In the context of supplementary private health care the use of a regulatory sandbox could bring significant advancements to the sector—provided that institutional instruments are adequately designed to avoid favoring specific interest groups that influence health policy formulation. The study aims to contribute to the debate on regulatory innovation in supplementary private health insurance by offering insights to improve the normative proposal and fostering reflections on the feasibility of a regulatory sandbox in this context. A bibliographic and documentar review was conducted to understand the regulatory framework, along with a case study involving a detailed legal analysis of an agency’s normative proposal. The analysis revealed that the agency’s proposal has the potential to foster innovation in the sector but exhibits gaps related to participation criteria and the mitigation of regulatory risks. Based on the findings, measures were suggested to enhance the instrument’s legal security and transparency.

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Author Biography

  • Lidiane Mazzoni, University of São Paulo

    Ph.D. candidate at the School of Public Health of the Universidade de São Paulo (USP); M.Sc. in Collective Health from the USP Faculty of Medicine. Coordinator of the graduate program in Supplementary Health at the Business and Insurance School (ENS). Attorney-at-law.

References

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Published

11/09/2026

Issue

Section

Original Articles

How to Cite

Mazzoni, L. (2026). Testing Limits: the  Regulatory Sandbox and the Future of Supplementary Health in Brazil. Journal of Health Law, 26, e0010. https://doi.org/10.11606/issn.2316-9044.rdisan.2026.232583